Comparison Matrix ISO 9001:2015 & IATF 16949 vs ISO/TS 16949:2009 Dv!op" an" #rovi"" $%:
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Comparison Matrix ISO 9001:2015 & IATF 16949 vs ISO/TS 16949:2009
ISO 9001:01! " I#$F 01% cl clause
ISO&$S 1%9'9:009 clause
(omments
The text that is bolded is text from IATF 16949. 16949.
The text that is bolded is automotive text from ISO/TS 16949. 16949.
The comments that are bolded relate to the automotive requirements requirements
$he normal te)t is from ISO 9001:01!
$he normal te)t is from ISO 9001:00*
$he comments in normal te)t relate to ISO 9001:01!
Fore!ord This Automotive "ualit# $ana%ement S#stem Standard& herein referred to as 'Automotive "$S Standard' or 'IATF 16949&' alon% !ith a((licable automotive customer)s(ecific requirements& ISO 9**1+,*1requirements& and ISO 9***+,*1defines the fundamental qualit# mana%ement s#stem requirements for automotive (roduction and relevant service (arts or%ani.ations As such& this Automotive "$S Standard cannot be considered a stand)alone "$S Standard but has to be com(rehended as a su((lement to and used in conunction !ith ISO 9**1+,*1- ISO 9**1+,*1- is (ublished as a se(arate ISO Standard
The automotive requirements are no! in a se(arate document& IATF 16949& !hich is This Technic Tec hnical al S(ecification& cou(led cou(le d !ith not an ISO standard IATF 16949 is a((licable customer )s(ecifi c intended to be used !ith ISO9**1+,*1-5 in requirements& fact IATF 16949 refers to ISO 9**1 defines defi nes the fundamen fund amental tal qualit qua lit# # throu%hout the various various clauses IATF mana%eme mana %ement nt s#stem s#ste m requireme requ irements nts for 16949 is also intended to be used !ith the those customer s(ecific requirements subscrib subs cribin% in% to this Technica Tech nical l S(ecification Annex A 0control (lan (lan of IATF 16949 is a normative (art of IATF 16949 and therefore contains requirements that must be met
IATF 16949+,*16 01st edition re(resents an innovative document& %iven the stron% orientation to the customer& !ith inclusion of a number of consolidated (revious customer s(ecific requirements Annex 2 is (rovided (rovided for %uidance to im(lement the IATF 16949 requirements unless other!ise s(ecified b# customer s(ecific requirements
Annex A 03ontrol lan lan is a normative (art of
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this Automotive "$S standard
4 Contxt o t( orani3ation '.1 +nderstandin, the or,ani-ation and its conte)t
4o equialent clause
$he or,ani-ation shall determine e)ternal and internal issues that are releant to its /ur/ose and its strate,ic direction and that affect its ailit to achiee the intended result2s3 of its qualit mana,ement mana,em ent sstem. sstem . $he or,ani-ation shall monitor and reiew information aout these e)ternal and internal issues.
$he issues can relate to:
4O$5 1 Issues can include /ositie and ne,atie factors or conditions conditions for considera consideration. tion.
S#3 ?ar7et " com/etition $echnolo, deelo/ment (ultural " social directions directions 5conomic deelo/ment International $rade
4O$5 +nderstandin, +nderstandin, the e)ternal conte)t can e facilitated considerin, issues arisin, from le,al6 technolo,ical6 com/etitie6 mar7et6 cultural6 social and economic enironments6 whether international6 national6 re,ional or local.
For automotive s(ecificall# le%al issues could relate to 1 assen%er restraints , n%ine air emissions 7 2ra8in% s#stems 4 xterior li%ht illumi illuminat nation ion and others others de(endin% de(endin% on the t#(es of (roducts (roducts and (osition (osition in the su((l# chain
4O$5 8 4O$5 +nder +n dersta stand ndin, in, the int intern ernal al cont conte) e)tt can e facilitated consideri considerin, n, issues related to alues6 alues6 culture6 7nowled,e 7nowled,e and /erformance /erformance of the or,ani-ation.
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enerall or,ani-ations address this deelo/in, a ision statement and a mission statement these are deelo/ed into a lon, term strate,ic direction and a strate,ic /lan. $hese further lead to shorter 8 to ! ear usiness deelo/ment /lans6 which are su//orted annual ,oals and o;ecties. For small to medium si-e or,ani-ations6 these ma e unstated and undocumented and e in the mind of the owner or ma not e)ist at all.
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4.2 +nderstandin, +nderstandin, the needs and e)/ectations of interested /arties
o )'iva!nt +!a's
Owner2s3 A indiiduals6 indiiduals6 inestment com/anies6 cor/orate ownershi/6 stoc7holders
Due to their effect or /otential effect on the or,ani-ations ailit to consistentl /roide /roducts and serices serices that meet customer and a//licale statutor and re,ulator requirements6 the or,ani-ation shall determine:
5m/loees Re,ulators (ustomers (om/etitors $rade #ssociations #ssociations State and local usiness communit Owners Su//liers 4ei,hors
2.a) the interested /arties that are releant to the qualit mana,ement sstem 2.b) the requirements of these interested /arties that are releant to the qualit mana,ement sstem.
For automotive s(ecificall#& s(ecificall#& interested (arties could could include AIA& SA& SA& :OT and A& ISO/TS certificati on bod#
$he or,ani-ation shall monitor and reiew information aout these interested /arties and their releant requirements.
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Or,ani-ations Or,ani-ations interested /arties include:
For Tier , and belo!& interested (arties include the O$s that their customers su((l# to
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4.3 Determinin, the sco/e of the qualit mana,ement sstem
4.2.2
$he or,ani-ation shall determine the oundaries and a//licailit of the qualit mana,ement sstem to estalish its sco/e. Bhen determinin, this sco/e6 the or,ani-ation shall consider:
3.a) the e)ternal and internal issues referred to in '.1 '.1 3.b) the requirements of releant interested /arties referred to in '. '. 3.c) the /roducts or,ani-ation.
and
serices
Quality manual
The organization shall establish and maintain a quality manual that includes ..a3 the sco/e of the qualit qualit mana,ement sstem6 includin, details of and ;ustification for an e)clusions 2see 1.36
Sco/e requirements are more e)/licit
,)'ir" Contnt $/es of /roducts " serices #//lication of all requirements from ISO 9001 that are a//licale A if the hae actiities&/rocesses actiities&/rocesses the are to e included Coundaries of the Q?S ustification ustification for an e)clusions
of the
$he or,ani-ation shall a//l all the requirements of this Internation International al Standard if the are a//licale within the determined sco/e of its qualit mana,ement sstem.
Sco/e determined considerin, e)ternal " internal issues6 requirements of interested /arties " /roducts " serices
$he sco/e of the or,ani-ations qualit mana,ement sstem shall e aailale and e maintained as documented information. $he sco/e shall state the t/es of /roducts and serices coered6 and /roide ;ustification for an requirement of this International Standard that the or,ani-ation determines is nota//licale to the sco/e of its qualit mana,ement sstem. (onformit to this International Standard ma onl e claimed if the requirements determined as not ein, a//licale do not affect the or,ani-ations ailit or res/onsiilit to ensure the conformit of its /roducts and serices and the enhancement of customer satisfaction. 471 :eterminin% th the sc sco(e of of th the qual qualit it# # mana mana%e %eme ment nt s#st s#stem em ; su((lemental Su((ortin% functions& !hether on)site
Automotive S(ecific+ S(ecific+ Sco(e must include su((ortin% functions& 0remote and on)site Onl# (ermitted exclusion is (roduct desi%n and develo(ment and this
4.4 Qualit mana,ement sstem 4.4.1 $he or,ani-ation shall estalish6 im/lement6 maintain and continuall im/roe a qualit mana,ement sstem6 includin, the /rocesses needed and their interactions6 in accordance with the requirements of this International Standard.
$he or,ani-ation shall determine the /rocesses needed for the qualit mana,ement sstem and their a//lication throu,hout the or,ani-ati or,ani-ation6 on6 and shall: 4.1.a) determine the in/uts required and the out/uts e)/ected from these /rocesses
4.1.b) determine the sequence and interaction of these /rocesses 4.1.c) determine and a//l the criteria and methods 2includin, monitorin,6 measurements and related /erformance indicator indicators3 s3 needed to ensure the effectie o/eration and control of these /rocesses 4.1.d) determine the resources needed for these /rocesses and ensure their aailailit 4.1.e) assi,n the res/onsiilities and authorities for these /rocesses 4.1.f) address the ris7s and o//ortunities as determined in accordance with the requirements of %.1 %.1 4.1.g) ealuate these /rocesses and im/lement an chan,es
41 nra! r)'irmnts $he or,ani-ation shall estalish6 document6 im/lement and maintain a qualit mana,ement sstem and continuall im/roe its effectieness in accordance with the requirements requirements of this International Standard. $he or,ani-ation shall a3determine the /rocesses needed for the qualit mana,ement sstem and their a//lication throu,hout the or,ani-ation 2see 1.36 3determine the sequence and interaction interaction of these /rocesses6 c3 determine criteria and methods needed to ensure that oth the o/eration and control of of these /rocesses are effectie6 d3ensure the aailailit of resources and information necessar to su//ort the o/eration and monitorin, monitorin, of these /rocesses6 e3monitor6 measure where a//licale6 and analse these /rocesses6 and f3 im/lement actions necessar to achiee /lanned results and continual im/roement of these /rocesses. the or,ani-ation in accordance with the requirements of this International Standard. Bhere an or,ani-ation or,ani-ation chooses to outsource an /rocess that affects /roduct conformit to requirements6 the or,ani-ation shall ensure control oer such /rocesses. $he t/e and e)tent of control to e a//lied to these outsourced /rocesses shall e defined within the qualit mana,ement sstem. 4O$5 1 =rocesses needed for the qualit mana,ement sstem referred to aoe include
#ro+ss Approa+( a""itions/+(ans #ssi,n res/onsiilities res/onsiilities " authorities for the /rocesses #ddress ris7s and o//ortunities with with lin7 to %.1
Discussion of outsourced /rocesses moed to a reference in clause *.1 which refers to control descried in clause *.' asicall the /urchasin, requirements
Automotive has added added s(ecific !ordin% requirin% the "$S to lead to conformance of the (roduct to requirements includin% customer&
needed to ensure that these /rocesses achiee their intended results
/rocesses for mana,ement actiities6 /roision of resources6 /roduct reali-ation6 measurement6 analsis and im/roement.
4.1.h) im/roe the /rocesses and the qualit mana,ement sstem.
4O$5 #n Eoutsourced /rocess is a /rocess that the or,ani-ation needs for its qualit mana,ement sstem and which the or,ani-ation or,ani-ation chooses to hae /erformed an e)ternal /art.
4411 3onfor 3onforman mance ce of (roduc (roducts ts and (rocesses The or%ani.ation shall ensure conformance of all (roducts and (rocesses& includin% service (arts and those that are outsourced& to all a((licable customer& statutor#& and re%ulator# requirements 0see Section <4,,
4O$5 8 5nsurin, control oer outsourced /rocesses does not asole the or,ani-ation of the res/onsiilit of conformit to all customer6 statutor and re,ulator requirements. $he t/e and e)tent of control to e a//lied to the outsourced /rocess can e influenced factors such as the /otential im/act of the outsourced /rocess on the or,ani-ationGs ca/ailit to /roide /roduct that conforms to requirements6
a)
441 441, , roduc roductt safet# safet# The or%ani.ation shall have documented (rocesses for the b) the de,ree to which the control for mana%ement of (roduct)safet# related the /rocess is shared6 (roducts and manufacturin% c) the ca/ailit of achiein, the (rocesses& !hich shall shall include but not necessar control throu,h the be limited to the follo!in%& !here a//lication of H.'. a((licable+ a3 identification b# the or%ani.ation of statutor# statutor# and re%ulator# re%ulator# (roduct)saf (roduct)safet# et# requirements5 411 =>A >A? ? >" >"@I @I>$ >$=T =TS S; 3 customer notification of = S@?$=TA? requirements in item a5 c3 s(ecial a((rovals for desi%n F$A5 nsurin% nsu rin% control cont rol over ove r outsou out source rced d identi tifi fica cati tion on of (rod (roduc uctt safe safet# t#) ) (rocesses shall d3 iden not n ot abso ab solv lve e the th e related characteristics5 or%ani or% ani.at .ation ion of the res(on res (onsib sibili ilit# t# of e3 identification and controls of safet#) confor con formi mit# t# to all customer requirements related characteristics of (roduct and =OT6 See also 41 4 1 and 417 =O T6 at the (oint of manufacture5 f3 s(ecial a((roval of control (lans and (rocess F$As5 ,3 reaction (lans 0see Section 91115 h3 defined res(onsibilities& definition of escalation (rocess and flo! of information& includin% to( mana%ement& and customer notification5
statutor# and re%ulator# requirements
=o! need a documented (rocess for the mana%ement of (roduct B safet# related (roducts and (rocesses Identification of safet# related requirements and inclusion in F$As& control (lans& controls such as !or8 instructions& flo! do!n to su((liers& trainin% This clause requires more detailed control over safet# related (roducts& (rocesses and characteristics This control includes s(ecial a((rovals for F$As and control (lans and an# chan%es There is a lot more detail relatin% to the control of these safet# related requirements
trainin% identified b# the or%ani.ation or customer for (ersonnel involved in (roduct)safet# related (roducts and associated manufacturin% (rocesses5 chan%es of (roduct or (rocess (rocess shall be a((roved (rior to im(lementation& includin% evaluation of (otential effects on (roduct safet# from (rocess and (roduct chan%es chan%es 0see ISO 9**1& Section <765 8 transfer of requirements !ith re%ard to (roduct safet# throu%hout the su((l# chain& includin% customer)desi%nated sources 0see Section <4715 I (roduct traceabilit# b# manufactured lot 0at a minimum throu%hout the su((l# chain 0see Section <-,15 m lessons learned for ne! (roduct introduction i3
=OT+ S(ecial a((roval is an additional a((roval b# the function 0t#(icall# the customer that is res(onsible to a((rove such documents !ith safet#)related content
4.4.2
$o the e)tent necessar6 the or,ani-ation shall:
4.2.a) maintain documented information to su//ort the o/eration of its /rocesses 4.2.b) retain documented information to hae confidence that the /rocesses are ein, carried out as /lanned.
5 a"rs(ip 5.1
1.1.a) ta7in, accountailit for the effectieness of the qualit mana,ement sstem 1.1.b) ensurin, that the qualit /olic and qualit o;ecties are estalished for the qualit mana,ement sstem and are com/atile com/ati le with the conte)t and strate,ic direction of the or,ani-ation 1.1.c) ensurin, the inte,ration of the qualit mana,ement sstem requirements into the or,ani-ations usiness /rocesses
d) /romotin, the use of the /rocess a//roach and ris7 ased thin7in, e) ensurin, that the resources needed for the qualit mana,ement sstem are aailale f) communicatin, the im/ortance of effectie qualit mana,ement and of conformin, to the qualit mana,ement sstem requirements
$o/ ?ana,ement A new&now e)/licit commitments and accountailities: accountailities: 5/1
Mana Manam mn ntt +ommit +ommitm mnt nt
#ccountailit for effectieness effectieness of the the Q?S $o/ mana,ement shall /roide eidence of its commitment to the deelo/ment and im/lementation of the quali t mana,ement sstem and continuall im/roin, its effectieness a) communicatin, to the or,ani-ation the im/ortance of meetin, customer as well as statutor and re,ulator requirements6 b) estalishin, the qualit /olic6 c)
ensurin, that qualit o;ecties are estalished6
d) conductin, mana,ement reiews6 and e) ensurin, the aailailit aailailit of resources. resources.
5nsurin, Q?S achiees intended results (om/atile with Strate,ic Direction of or,ani-ation Inte,ration Inte,ration with usiness /rocesses 2inter/reted in conte)t of nature of or,ani-ation A for /rofit not for /rofit /riate6 /ulic3
g) ensurin, that the qualit mana,ement sstem achiees its intended results h)
en,a,in,6 directin, and su//ortin, /ersons to contriute to the effectieness effecti eness of the qualit mana,ement sstem
i)
/romotin, im/roement
) su//ortin, other releant mana,ement roles to demonstrate their leadershi/ as it a//lies to their areas of res/onsiilit.
This clause no! requires three cor(orate res(onsibilit# (olicies+ Anti)briber# (olic# m(lo#ee 3ode of 3onduct DhistleB2lo!in% olic#
4O$5 Reference to Eusiness in this International Standard can e inter/reted roadl to mean those actiities that are core to the /ur/oses of the or,ani-ations e)istence6 whether the or,ani-ation is /ulic6 /riate6 for /rofit or not for /rofit.
-111 3or(orate res(onsibilit# The or%ani.ation shall define and im(lement cor(orate res(onsibilit# (olicies& includin% at a minimum an anti) briber# (olic#& an em(lo#ee code of conduct& and an ethics escalation (olic# 0'!histle)blo!in% (olic#' -11, -11, rocess rocess effectiveness effectiveness and efficienc# efficienc# To( To( mana mana%e %eme ment nt shal shalll revi revie! e! the the (roduct reali.ation (rocesses and su(( su((or ortt (roc (roces esse ses s to eval evalua uate te and and im(ro m(rov ve the their eff effecti ective ven ness ess and and effici efficienc enc# # The result results s of the (roces (rocess s revie! revie! activi activitie ties s shall shall be includ included ed as in(ut in(ut to the mana%e mana%emen mentt revie! revie! 0see 0see Section 97,1 -117 -117 rocess rocess o!ners o!ners To( mana%ement shall identif# (rocess
The (rocess effectiveness and efficienc# evaluation is no! an in(ut to mana%ement revie! 511 >O3SS FFI3I=3C To( mana%eme mana %ement nt shall revi re vie! e! the th e (roduct reali.atio reali .ation n (rocesses and the su((ort (rocesses to assure their effectiveness effectiveness and efficienc#
=o! requires the s(ecific identification and com(etenc# of (rocess o!ners
o!ners !ho are res(onsible for mana%in% the or%ani.ationEs (rocesses and related out(uts rocess o!ners shall understand their roles and be com(etent to (erform those roles 0see ISO 9**1& Section ,
5.1.2 (ustomer Focus
$o/ mana,ement shall demonstrate leadershi/ and commitment with res/ect to customer focus ensurin, that: 1.2.a) customer and a//licale statutor and re,ulator requirements are determined6 understood and consistentl met
1.2.b) the ris7s and o//ortunities that can affect conformit of /roducts and serices and the ailit to enhance customer satisfaction are determined and addressed 1.2.c) the focus on enhancin, customer satisfaction is maintained.
52 C'stomr o+'s $o/ mana,ement shall ensure that customer requirements are determined and are met with the aim of enhancin, customer satisfaction satisfaction 2see H..1 and *..13.
(ustomer focus tie to re,ulator requirements as well as customer requirements
(ustomer focus tie to ris7 as affectin, /roducts " serices
!. =olic
5.2.1
Dv!opin t( )'a!it% po!i+% $o/ mana,ement shall estalish6 im/lement and maintain a qualit /olic that: a) is a//ro/riate to the /ur/ose and conte)t of the or,ani-ation and su//orts its strate,ic direction
b)/roides a framewor7 framewor7 for settin, qual it o;ecties c) includes a commitment commitment to satisf a//licale a//lical e requirements d)includes a commitment to continual im/roement of the qualit mana,ement sstem. 522 Comm'ni+atin t( )'a!it% po!i+% $he qualit /olic shall: a) e aailale and e maintained as documented information
5.3 7'a!it% po!i+% $o/ mana,ement shall ensure that the qualit /olic a) is a//ro/riate to the /ur/ose of the or,ani-ation6
#o!i+% ties to (onte)t of or,ani-ation Strate,ic direction
b) includes a commitment to com/l
with requirements and continuall continuall im/roe the effectieness of the qualit mana,ement sstem6 c) /roides a framewor7 for
estalishin, and reiewin, qualit o;ecties6
Reiew for continuin, suitailit was remoed
d) is communicated and understood within
the or,ani-ation6 and
#ailailit to interested interested /arties added
e) is reiewed for continuin, suitailit.
b)e communicated6 understood and a//lied within the or,ani-a or,ani-ation tion c) e aailale to releant interested /arties6 as a//ro/riate. 58 Or,ani-ational roles6 res/onsiilities and authorities $o/ mana,ement mana,ement shall ensure that the res/onsiilities res/onsi ilities and authorities for releant roles are assi,ned6 communicated communicated and understood within the or,ani-ation. $o/ mana,ement shall assi,n the res/onsiilit and authorit for: a) ensurin, that the qualit mana,ement sstem conforms to the requirements
551 Res/onsiilit and authorit $o/ mana,ement shall ensure that res/onsiilities res/onsiilities and authorities are defined and communicated within the or,ani-ation. ..2 Manamnt rprsntativ $o/ mana,ement shall a//oint a memer of the or,ani-ationGs mana,ement who6 irres/ectie of other res/onsiilities6 shall hae res/onsiilit res/onsiilit and authorit that
$here is no lon,er a /osition of Emana,ement re/resentatie $here are now ! res/onsiilities and authorities that need to e assi,ned.
of this International Standard
b)ensurin, that the /rocesses are delierin, their intended out/uts c) re/ortin, on the /erformance of the qualit mana,ement sstem and on o//ortunities for im/roement im/roement 2see 10.136 10.1 36 in /articular to to/ mana,ement d)ensurin, the /romotion of customer focus throu,hout the or,ani-ation e) ensurin, that the inte,rit of the qualit mana,ement sstem is maintained when chan,es to thequalit mana,ement sstem are /lanned and im/lemented.
includes
a) ensurin, that /rocesses needed for the qualit mana,ement sstem are estalished6 im/lemented and maintained6 b) re/ortin, to to/ mana,ement on the /erformance of the qualit mana,ement sstem and an need for im/roement6 and c) ensurin, the /romotion of awareness of
customer requirements throu,hout the or,ani-ation. 4O$5 $he res/onsiilit res/onsiilit of a mana,ement mana,ement re/resentatie re/resentatie can include liaison with e)ternal /arties on matters relatin, to the qualit mana,ement sstem. sstem.
5511 >S >SO=SI O=SI2I?I 2I?ITC TC FO> "@A?I "@A?ITC TC $an a%ers rs !ith !it h res(on res (onsi sibil bilit# it# and -71 Or%ani.ational roles& res(onsibilities& $ana%e authorit# and authorities ; su((lemental To( mana%ement mana%ement shall assi%n for correc cor rectiv tive e action act ion shall sha ll be (rom(tl# (ersonnel !ith the res(onsibilit# res(onsibilit# and infor inf ormed med of (roducts or (rocesses !hich !hich authorit# to ensure that customer do not confor con form m to requir req uireme ements nts requirements are met These ersonnel res(on res (onsib sible le for confo co nform rmit# it# to assi%nments shall be documented (roduct requirements shall have ha ve the th e This includes but is not limited to the auth au thor orit it# # to sto( st o( (roduction to correct selection of s(ecial characteristics& qualit qua lit# # (roblems settin% qualit# obectives and related roducti rod uction on o(eratio o(er ations ns across acro ss all shifts shif ts shall shal l trainin%& corrective corrective and (reventive be staf st affe fed d !ith !i th (ersonnel (ersonnel in char ch ar%e %e of& of & or actions& (roduct desi%n and dele%ate dele %ated d res(onsi res( onsibili bilit# t# for& for & ensuri en surin% n% develo(ment& ca(acit# anal#sis& confor con formi mit# t# to (roduct to (roduct requirements requi rements lo%istics information& customer scorecards& and customer (ortals -7, >es(onsibilit# and authorit# for (roduct requirements and corrective actions To( mana%ement shall ensure that+ a3 (ersonnel res(onsible for conformit# to (roduct requirements have the authorit# to sto( shi(ment and sto( (roduction to !.!..1 3@STO$> >>S=TATI
These are the res(onsibilities of the customer re(resentative in ISO/TS 16949 and have been ex(anded a bit All these res(onsibilities res(onsibilities should be documented some!here for exam(le ob descri(tions or qualit# manual or (rocedures
correct qualit# (roblems5 =OT :ue to the (rocess desi%n in some industries& it mi%ht not al!a#s be (ossible to sto( (roduction (roduction immediatel# In this case& the affected batch must be contained and shi(ment to the customer (revented 3 (ersonnel !ith authorit# and res(onsibilit# for corrective action are (rom(tl# informed of (roducts (roducts or (rocesses that do not conform conform to requirements to ensure that nonconformin% (roduct is not shi((ed to the customer and that all (otential nonconformin% (roduct is identified and contained5 c3 (roduction o(erations across across all shifts are staffed !ith (ersonnel in char%e of& or dele%ated res(onsibilit# for& ensurin% conformit# to (roduct requirements
To( mana%em mana %ement ent shall shal l desi%na des i%nate te (ersonnel !ith res(on res (onsib sibil ilit# it# and author aut horit# it# to ensur ens ure e that tha t custom cus tomer er requi re quirem rement ents s are addressed This Th is includ inc ludes es select sel ection ion of s(ecial characteristics& settin set tin% % qualit qua lit# # obectiv obe ctives es and related rela ted trainin% trai nin%& & correcti corr ective ve and (reventive actions& (roduct actions& (roduct desi%n and develo(ment
6 #!annin
6.1
A+tions to a""rss ris9s an" opport'nitis 542 Qualit mana,ement sstem 611 Bhen /lannin, for the qualit /lannin, mana,ement sstem6 the or,ani-ation shall $o/ mana,ement shall ensure that consider the issues referred to in '.1 and the 4.2.a) the /lannin, of the qualit requirements referred to in '. '. and determine mana,ement sstem is carried out in the ris7s and o//ortunities that need to e order to meet the requirements ,ien addressed to: in '.16 as well as the qualit a) ,ie assurance that the qualit o;ecties6 and mana,ement sstem can achiee its intended result2s3 result2s3 4.2.b) the inte,rit of the qualit mana,ement sstem is maintained b)enhance desirale effects when chan,es to the qualit c) /reent6 or reduce6 undesired effects mana,ement sstem are /lanned and im/lemented. d)achiee im/roement. $he or,ani-ation shall /lan: 6/1/2 a) actions to address these ris7s and o//ortunities
b)how to: 1)
inte,rate and im/lement the actions into its qualit mana,ement sstem /rocesses 2see '.' '.'3 3
2)
ealuate the effectieness of these actions. #ctions ta7en to address ris7s and o//ortunities shall e /ro/ortionate to the /otential im/act on the conformit of /roducts and serices. 4O$5 1 O/tions to address ris7s can include aoidin, ris76 ta7in, ris7 in order to /ursue an o//ortunit6 eliminatin, the ris7 source6 chan,in, the li7elihood or consequences6 sharin, the ris76 or retainin, ris7 informed decision. 4O$5 O//ortunities can lead to the ado/tion of new /ractices6 launchin, launchin, new /roducts6 o/enin, new mar7ets6 addressin, new clients6 uildin, /artnershi/s6 /artnershi/s6 usin, new
$here is not a com/arale clause in 00* ersion onl the er ,eneral that /lannin, of the Q?S should meet meet the /rocess a//roach requirements and qualit o;ecties $his reision e)/ects that the Q?S addresses identified ris7s arisin, from the consideration of the conte)t of the or,ani-ation and the requirements of interested /arties $he conte)t of the or,ani-ation or,ani-ation mi,ht lead to ris7s such as: =roduct ris7s A FD#6 DO$6 5=# 2e)am/les ,as milea,e requirements on ehicles /roduct shi//in, ris7sha-ardous materials ehicle li,htin, requirements food and dru, ris7s3 $he requirements of interested /arties ma lead to ris7s identified durin, contract reiew such as short delier times or difficult /roduct requirements or su//liers ailit to /roide raw materials or com/onents
?ost of our clients will identif ris7s durin, contract reiew and ta7e actions such as ne,otiatin, ne,otiatin, delier dates or ta7in, e)ce/tion to /roduct requirements or ealuatin, ris7s durin, desi,n actiities actiities 2es/eciall desi,n reiews6 erification and alidation3 or identifin, ris7s when selectin, and ealuatin, su//liers
technolo, and other desirale and iale /ossiilities /ossiilit ies to address addre ss the or,ani-ations or its customers needs
61,1 61,1 >is8 anal#sis anal#sis The or%ani.ation shall include in its ris8 anal#sis& at a minimum& lessons learned from (roduct recalls& (roduct audits& field returns and re(airs& com(laints& scra(& and re!or8 The or%ani.ati or%ani.ation on shall shall retain documented documented information as evidence of the results of ris8 anal#sis 61,, 61,, reventive reventive action action The or%ani.ation shall determine and im(lement action0s to eliminate the causes of (otential nonconformities in order to (revent their occurrence reventive actions shall be a((ro(riate to the severit# of the (otential issues The or%ani.ation shall establish a (rocess to lessen the the im(act of ne%ative effects of ris8 includin% the follo!in%+ a3 determinin% (otential nonconformities and their causes5 3 eval evalua uati tin% n% the the need need for for acti action on to (revent occurrence of nonconformities5 nonconformities5 c3 determinin determinin% % and im(lement im(lementin% in% action action needed5 d3 docu docume ment nted ed info inform rmat atio ion n of acti action on ta8en5 e3 revi revie! e!in in% % the the effe effect ctiv iven enes ess s of the the (reventive action ta8en5 ta8en5 f3 utili. utili.in% in% lesson lessons s learne learned d to (reven (revent t recurr recurrenc ence e in simila similarr (roces (rocesses ses 0see 0see ISO 9**1& Section 16 682 3O=TI==3C ?A=S The or%ani.ati or%a ni.ation on shall (re(are shall (re(are 61,7 3ontin%enc# (lans contin%e cont in%enc# nc# (lans to satisf# customer The or%ani.ation shall+ requ re quir irem emen ents ts in the th e even ev entt of an f.a3 iden identi tif# f# and and eval evalua uate te inte intern rnal al and and emer%en emer %enc# c# such suc h as utilit# util it# interru( inte rru(tion tions& s& extern external al ris8s ris8s to all manufa manufactu cturin rin% % labour labo ur shorta%e shor ta%es& s& 8e# equi(me equi (ment nt failur fai lure e (rocesses and infrastructure equi(ment equi(ment and field fiel d returns retu rns essential to maintain (roduction out(ut and to ensure that customer requirements are met5 f.3 define contin%enc# (lans accordin% to
IATF 16949 ex(ects that (erformance data/indicators such recalls& audit results& returns G re(airs& com(laints& scra( G re!or8 to be tied into the ris8 anal#sis Similar to the ex(ectation that returns& scra( and com(laints !ere ex(ected to be tied to the F$As in ISO/TS 16949& but this is broader and ties to all of the ris8 anal#ses mechanisms used b# the or%ani.ation
This clause adds in the (revious (reventive action requirements requirements but in the context of requirin% s(ecific actions to address ris8s
This clause includes the ISO/TS 16949 contin%enc# (lan requirements !hich is no! tied to and based on the ris8 anal#sis There should be consistenc# bet!een the ris8 anal#sis and the contin%enc# (lans These requirements no! include+ 1. A (rocess to notif# customers of an# incidents 0extent G duration affectin%
f.c3
f.d3
f.e3
f.f3
f.,3
ris8 and im(act to the customer5 (re(are contin%enc# (lans for continuit# of su((l# in the event of an# of the follo!in%+ 8e# equi(ment failures 0also see Section <-6115 interru(tion from from extern externall all# # (rovid (rovided ed (roduc (roducts& ts& (rocesses& and services5 recurrin% natural disasters5 fire5 utilit# interr interru(t u(tion ions5 s5 labour labour shorta shorta%es %es55 or infrastructure disru(tions5 incl includ ude e& as a su( su((lem (lemen entt to the the cont contin in%e %enc nc# # (lan (lans& s& a noti notifi fica cati tion on (rocess to the customer and other intere intereste sted d (artie (arties s for the extent extent and durati duration on of an# situat situation ion im(act im(actin% in% customer o(erations5 (eriodicall# test the contin%enc# (lans for effectivene effectiveness ss 0e%& 0e%& simulation simulations& s& as a((ro(riate5 conduct contin%enc# (lan revie!s 0at a minimum annuall# usin% a multid multidisc isci(l i(lina inar# r# team team includ includin% in% to( mana%ement& and u(date as required5 document document the contin%enc contin%enc# # (lans and reta retain in docu docum mente ented d inf informa ormati tio on describin% describin% an# revision0s revision0s& & includin% includin% the the (ers (erson on0s 0s !ho !ho auth author ori. i.ed ed the the chan%e0s
The contin%enc# (lans shall include (rovisions to validate validate that the manufactured (roduct continues to meet meet customer s(ecifications after the re)start of (roduction follo!in% an emer%enc# in !hich (roduction !as sto((ed and if the re%ular shutdo!n (rocesses !ere not follo!ed
o(erations that is continuit# of su((l# , Incl Includ uded ed s(ec s(eciific ficall# all# are are 8e# 8e# equi(ment failure& su((l# chain 0externall# (rovided (roduct G services& natural disasters5 fire5 utilit# interru(tion5 labor shorta%es or infrastructure disru(tion 7 erio eriodi dica calll# test estin% in% the the (lan (lans s for for effectiveness 4 >evie! of th the (l (lans annuall#
The contin%enc# (lan needs to include the validation of (roduct follo!in% an emer%enc# and if the re%ular shutdo!n (rocess !as not follo!ed follo!ed
%. Qualit o;ecties and /lannin, to achiee them $he or,ani-ation shall estalish 6/2/1 qualit o;ecties at releant functions6 leels and /rocesses needed for the qualit mana,ement sstem. $he qualit o;ecties shall: a) e consistent with the qualit /olic
b)
e measurale
c)
ta7e into account a//licale requirements
54 #!annin 541
7'a!it% o$+tivs
$o/ mana,ement shall ensure that qualit o;ecties6 includ in, those ne eded to meet requirements for /roduct Jsee H.1 a3K6 are estalished at releant functions and leels within the or,ani-ation. $he qualit o;ecties o;ecties shall e measurale and consistent with the qualit /olic. /olic.
Some additional requirements for e)am/le releance to /roduct conformit and customer satisfaction
d) e releant to conformit of /roducts and serices and to enhancement of customer satisfaction e)
e monitored
f)
e communicated
g) e u/dated as a//ro/riate. $he or,ani-ation shall maintain documented information on the qualit o;ecties. 622 Bhen /lannin, how to achiee its qualit o;ecties6 the or,ani-ation shall determine: a) what will e done b) what resources will e required c)
who will e res/onsile
d) when it will e com/leted e) how the results will e ealuated.
#n action /lan is now e)/ected for the qualit o;ecties
6,,1 "ualit# obectives and (lannin% to achieve them ; su((lemental To( mana%ement shall ensure that qualit# obectives to meet customer requirements are defined& established& and maintained for relevant functions& (rocesses& and levels throu%hout the or%ani.ation
-411 -4 11 "ualit# "uali t# obective obe ctives s ; Su((leme Su(( lemental ntal To( mana%em mana %ement ent shall shal l define qualit# obectiv obe ctives es and measurem meas urement ents s that shall shal l be be incl in clud uded ed in the th e busi bu sine ness ss (lan (lan and used to de(lo# de( lo# the quali qua lit# t# (olic# (olic#
=OT6 =O T6 "ualit "ua lit# # obect ob ective ives s should sho uld addre add ress ss custo cus tomer mer ex(ect ex( ectati ations ons and be achiev ach ievabl able e The results of the or%ani.ationEs revie! !ithi n a defined defi ned time (eriod (er iod re%ardin% interested (arties and their relevant !ithin requirements shall be considered !hen the or%ani.ation establishes its annual 0at a minimum qualit# obectives and related (erformance tar%ets 0internal 0internal and external
I#$F 1%9'9 requires annual o;ecties I#$F 1%9'9 also ties the estalishment of o;ecties to the interested /arties and their requirements6 which ties o;ecties to O5?s for tier su//liers and elow.
%.8 =lannin, of chan,es chan,es Bhen the or,ani-ation determines the need for chan,es to the qualit mana,ement sstem6 the chan,es shall e carried out in a /lanned manner 2see '.'3. $he or,ani-ation shall consider: 3.a) the /ur/ose of the chan,es and their /otential consequences
3.b) the inte,rit of the qualit mana,ement sstem
542 Qualit mana,ement sstem /lannin, $o/ mana,ement shall ensure that 4.2.a) the /lannin, of the qualit mana,ement sstem is carried out in order to meet the requirements ,ien in '.16 as well as the qualit o;ecties6 and the inte,rit of the qualit mana,ement sstem is maintained when chan,es to the qualit mana,ement sstem are /lanned and im/lemented.
4.2.b)
3.c) the aailailit of resources 3.d) the allocation or reallocation of res/onsi res/onsiilities ilities and authorities.
; S'pport H.1 Resources H.1.1 eneral $he or,ani-ation shall determine and /roide the resources needed for the estalishment6 im/lementation6 maintenance and continual im/roement of the qualit mana,ement sstem. $he or,ani-ation shall consider:
a) the ca/ailities of6 and constraints on6 e)istin, internal resources b)what needs to e otained from e)ternal /roiders.
#op! ;/1/2 $he or,ani-ation shall determine and /roide the /ersons necessar for the effectie im/lementation of its qualit mana,ement sstem and for the o/eration and control of its /rocesses.
Q?S chan,e control more detailed
61
=roision of resources $he or,ani-ation shall determine and /roide the resources needed 1.a) to im/lement and maintain the qualit mana,ement sstem and continuall im/roe its effectieness6 and 1.b) to enhance customer satisfaction meetin, customer requirements.
4o essential chan,es some e)/lanation e)/lanation wordin, added
;18 Inrastr'+t'r $he or,ani-ation shall determine6 /roide and maintain the infrastructure necessar for the o/eration of its /rocesses and to achiee conformit of /roducts and serices. 4O$5
Infr In fras astr truc uctu ture re can inc ncllude de::
a) uildin,s and associated utilities b) equi/ment equi/ment66 includin, hardware and software c) trans/ortation resourc resources es d) information and communication technolo, .
Infrastructure $he or,ani-ation shall determine6 /roide and maintain the infrastructure needed to achiee conformit to /roduct requirements. Infrastructure includes6 as a//licale6
4o essential chan,es some word smithin,
uildin,s6 wor7s/ace and associated utilities6 3.a)
/rocess equi/ment 2oth hardware and software36 and 3.b)
3.c) su//ortin, serices 2such as trans/ort6
communication or information sstems3.
171 lant& facilit#& and equi(ment (lannin% The relationshi( of (lant& facilit# and The or%ani.ation shall use a 681 ?A=T& FA3I?ITC FA3I ?ITC A=: "@I "@I$= $=T T equi(ment to ris8 identification and multidisci(linar# a((roach includin% ris8 miti%ation !as added ?A==I= identification and ris8 miti%ation methods The or%ani.ati or%an i.ation on shall use a for develo(in% and im(rovin% (lant& multidis mult idisci(li ci(linar# nar# a((roach a((r oach 0see 711 71 1 for facilit#& and equi(ment (lans In desi%nin% develo(in devel o(in% % (lant& facilit# facilit# and equi(ment (lant la#outs& the or%ani.ation or%ani.ation shall+ (lans lant la nt la#out la# outs s shall sha ll o(timi.e material a3 o(timi.e material flo!& material travel& handl ha ndlin% in% and value)ad value )added ded use of handlin%& and value)added use of floo fl oorr floor s(ace includin% control of s(ace& and shall sh all facilitate s#nchronous s#nchronous nonconformin% (roduct& and material flo! $ethods $eth ods shall shal l be develo(ed 3 facilitate facilitate s#nchrono s#nchronous us material material flo!& and im(lemente im(lem ented d to evaluate eval uate and monitor monit or as a((licable The connection bet!een ne! (roduct and the effectiv effe ctivenes eness s of existin% exist in% o(eratio o(er ations ns $ethods shall be develo(ed and =OT These requireme requi rements nts should focus ne! o(erations/chan%es to o(erations and im(lemented to evaluate manufacturin% on lean lea n manuf man ufact actur urin% in% (rinci(les and the manufacturin% feasibilit# and ca(acit# added feasibilit# for ne! (roduct or ne! lin8 lin 8 to the th e effect eff ective ivenes ness s of the th e quali qu alit# t# (lannin% !ere added o(erations $anufacturin% feasibilit# mana%ement s#stem assessments shall include ca(acit# (lannin% These methods methods shall also be a((licable for evaluatin% (ro(osed chan%es to existin% o(erations The or%ani.ation shall maintain (rocess effectiveness& includin% (eriodic re) evaluation relative to ris8& to incor(orate
The connection bet!een (rocess effectiveness and ris8s !as added
an# chan%es made durin% (rocess a((roval& control (lan maintenance 0see Section <-11& and verification of ob set)u(s 0see Section <-17
The assessments of manufacturin% feasibilit# and ca(acit# (lannin% are no! in(uts to mana%ement revie!
Assessments of manufacturin% manufacturin% feasibilit# and evaluation of ca(acit# (lannin% shall be in(uts to mana%ement revie!s 0see ISO 9**1& Section 97 =OT 1 These requirements should include the a((lication of lean manufacturin% (rinci(les =OT , These requirements should a((l# to on)site su((lier activities& as a((licable ;14 5nironment for the o/eration of /rocesses $he or,ani-ation shall determine6 /roide and maintain the enironment necessar for the o/eration of its /rocesses and to achiee conformit of /roducts and serices. 4O$5 # su suit ita al le e en eniro ronm nme ent can e a comination of human and /hsical factors6 such as: a) social 2e.,. non discriminator6 discrimi nator6 calm6 non confrontational3
Bor7 enironment as it a//lies to o/eration of the /rocesses as well as the /roduct
Bor7 enironment 64 $he or,ani-ation shall determine and mana,e the wor7 enironment needed to achiee conformit to /roduct requirements. 4O$5 $he term Ewor7 enironment enironment relates to those conditions under which wor7 is /erformed includin, /hsical6 enironmental and other factors 2such as noise6 tem/erature6 humidit6 li,htin, or weather3.
This !as added to the ISO 9**1+,*1!ordin%
b) /scholo,ical 2e.,. stressreducin,6
urnout /reention6 emotionall /rotectie3 c) /hsical 2e.,. tem/erature6 heat6
humidit6 li,ht6 airflow6 h,iene6 noise3. $hese factors can differ sustantiall de/endin, on the /roducts and serices /roided.
641
>SO >SO== ==? ? SAF SAFTC TC TO A3HI A3HI 3O=FO> $ITC TO >O:@3 3O=FO>$ITC >O:@3T T >"@I> >"@I>$=T $=TS S rod r oduc uctt safe sa fet# t# and an d mean me ans s to mini mi nimi mi.e .e (otential ris8s ris 8s to em(lo# em( lo#ees ees shall sha ll be addres add ressed sed b# the or%ani or% ani.at .ation ion&& es(eci es( eciall all# # in the desi%n des i%n and develo dev elo(me (ment nt (rocess and in manufacturin% manufacturin% (rocess (rocess activities
=OT Dhere third)(art# certification to ISO 4-**1 0or equivalent is reco%ni.ed& it ma# be used to demonstrate the or%ani.ationEs conformit# to the 642 3?A=? 3?A=?I=SS I=SS OF >$I >$ISS SS (ersonnel safet# as(ects as(ects of this
=o chan%es
requirement
141 nvironment for the o(eration of (rocesses ; su((lemental su((lemental The or%ani.ation shall maintain its (remises in a state of of order& cleanliness& and re(air that is consistent !ith the (roduct and manufacturin% manufacturin% (rocess needs
The or%ani.ati or%an i.ation on shall shal l maint ma intain ain its (remises in a state of order& cleanlin clea nliness ess and an d re(a re (air ir cons co nsis iste tent nt !ith !i th the th e (roduct and manufac turin% turi n% (rocess (rocess needs needs
;15 Monitorin an" mas'rin rso'r+s nra! ;/1/5/1 $he or,ani-ation shall determine and /roide the resources needed to ensure alid and reliale results when monitorin, or measurin, is used to erif the conformit of /roducts and serices to requirements. $he or,ani-ation shall ensure that the resources /roided: 4.a) are suitale suitale for the s/ecific s/ecific t/e of monitorin, and measurement actiities ein, underta7en b) are maintained to ensure their continuin, fitness for their /ur/ose. $he or,ani-ation shall retain a//ro/riate documented information as eidence of fitness for /ur/ose of the monitorin, and measurement resources.
1511 Mas'rmnt s%stms ana!%sis Statisti+a! st'"is s(a!! $ +on"'+t" to ana!%s t( variation prsnt in t( rs'!ts o a+( t%p o insp+tion* mas'rmnt* an" tst )'ipmnt s%stm i"ntii" in t( +ontro! p!an T( ana!%ti+a! mt(o"s an" a++ptan+ +ritria 's" s(a!! +onorm to t(os in rrn+ man'a!s on mas'rmnt s%stms ana!%sis Ot(r ana!%ti+a! mt(o"s an" a++ptan+ +ritria ma% $ 's" i approv" $% t( +'stomr ,+or"s o +'stomr a++ptan+ o a!trnativ mt(o"s s(a!! $ rtain" a!on it( rs'!ts rom a!trnativ mas'rmnt s%stms ana!%sis #rioriti3ation o MSA st'"is s(o'!" o+'s on +riti+a! or sp+ia! pro"'+t or pro+ss +(ara+tristi+s
;6 Contro! o monitorin monitorin an" mas'rin )'ipmnt $he or,ani-ation shall determine the monitorin, and measurement to e underta7en and the monitorin, and measurin, equi/ment needed to /roide eidence of conformit of /roduct to determined requirements. requirements.
(aliration moed under resources clause It at first a//ears6 that software is not coered an more ut the wordin, was chan,ed from Eequi/ment to Eresources so it still is coered
$he or,ani-ation shall estalish /rocesses to ensure that monitorin, and measurement can e carried out and are carried out in a manner that is consistent with the monitorin, and measurement requirements. requirements. Bhere necessar to ensure alid results6 measurin, equi/ment shall a) e calirated or erified6 or oth6 at s/ecified interals6 or /rior to use6 a,ainst measurement standards traceale traceale to international international or national measurement standards where no such standards e)ist6 the asis asis used for caliration or erification shall e recorded 2see '..'3 b) e ad;usted or read;usted as necessar c) hae identification identification in order to determine its caliration status d) e safe,uarded from ad;ustments that would inalidate the measurement result
e /rotected from dama,e and deterioration durin, handlin,6 maintenance and stora,e. e)
The measurement s#stems anal#sis requirements are the same5 there is an added note about (rioriti.ation of $SA studies to focus on critical/s(ecial characteristics
;61 $AS@>$= $AS@> $=T T SCS SCST$ T$ A=A?CSI A=A?CSIS S Statistical studi es shall be cond co nduc ucte ted d to Mas'rmnt tra+a$i!it% ;/1/5/2 anal#s ana l#se e the variat var iation ion (resent in the results Bhen measurement traceailit is a of each ea ch t#(e t# (e of meas me asur urin in% % and an d test te st requirement6 or is considered the equi(men equi (mentt s#stem s#st em This Thi s requirem requ irement ent shall or,ani-ation to e an essential /art of a((l# a(( l# to measu mea sure remen mentt s#stem s#s tems s refere ref erence nced d /roidin, confidence in the alidit of in the contr con trol ol (lan The anal#tical anal# tical measurement results6 measurin, equi/ment method met hods s and acce(t acc e(tanc ance e criter cri teria ia used use d shall conf co nfor orm m to those tho se in custom cus tomer er shall e: referenc refe rence e manuals manua ls on measurem meas urement ent a) calirated or erified6 or oth6 at s/ecified s#stems s#ste ms anal#sis anal# sis Other anal#tical anal# tical method met hods s interals6 or /rior to use6 a,ainst and an d acce ac ce(t (tan ance ce crit cr iter eria ia ma# ma # be used us ed if measurement standards traceale to a((rov a(( roved ed b# the custo cus tomer mer international or national measurement standards when no such standards e)ist6 the asis used for caliration caliration or erification shall e retained as documented information b)identified in order to determine their status
c) safe ,uarded from ad;ustmen ad;ustments6 ts6 dama,e or deterioration that would inalidate the caliration status and susequent measurement results. $he or,ani-ation shall determine if the alidit of /reious measurement results has een adersel affected when measurin, equi/ment is found to e unfit f or its intended /ur/ose6 and shall ta7e a//ro/riate action as necessar. =OT A number or another identifier traceable to the device calibration record meets the intent of the requirements in ISO 9**1+,*1-
In addition6 the or,ani-ation shall assess and record the alidit of the /reious measurin, results when the equi/ment is found not to conform to requirements. $he or,ani-ation shall ta7e a//ro/riate action on the equi/ment and an /roduct affected. Records of the results of caliration and erification shall e maintained 2see '..'3. Bhen used in the monitorin, and measurement of s/ecified requirements6 the ailit of com/uter software to satisf the intended a//lication shall e confirmed. $his shall e underta7en /rior to initial use and reconfirmed as necessar.
4O$5 (onfirmation of the ailit of com/uter software to satisf the intended a//lication would t/icall 1-,1 3alibration/verification records include its erification and confi,uration The or%ani.ation shall have a documented mana,ement to maintain its suitailit for (rocess for mana%in% c calibration/verification alibration/verification use. records >ecords of the calibration/verification
A documented (rocess (rocess is required for mana%in% calibration/verification records This clause on calibration/verification records is ex(anded to cover out of
activit# for all %au%es and measurin% and tolerance %a%e conditions5 s(ecificall# =OT6 =O T6 A number or other identifier test equi(ment 0includin% em(lo#ee)o!ned covers soft!are5 includes en%ineerin% traceabl e to the device calibration equi(ment relevant for measurin%& chan%es affectin% measurement s#stems record meets the intent of requirement customer)o!ned equi(ment& or on)site c above su((lier)o!ned equi(ment needed to (rovide evidence of conformit# to internal ;62 3A?I2>ATIO=/>IFI3ATIO= >3O>:S requirements& le%islative and re%ulator# >ecords >ecor ds of the calibrat cali bration/ ion/veri verifica fication tion requirements& and customer)defined activi act ivit# t# for all %au%es& meas me asuri urin% n% and test tes t requirements shall be retained equi(ment& need ne eded ed to (rovide evidence of confo con formi rmit# t# of (roduct to determined The or%ani.ation shall ensure that requirements& includ inc ludin% in% em(lo# em( lo#ee) ee) and calibration/verification activities and customer)o!n ed equi(ment& shall include records shall include the follo!in% details+ in cludi din% n% the equi(ment identificati on& inclu .a3 revisions follo!in% en%ineerin% chan%es measur mea sureme ement nt standa sta ndard rd a%ain a% ainst st !hich !hi ch that im(act measurement s#stems5 the equi(ment equi (ment is calibrate calib rated& d& out)of)s( )s(eci ecific ficati ation on readin readin%s %s as .3 an# out)of revision revi sions s follo!in foll o!in% % en%ineeri en%in eerin% n% received for calibration/verification calibration/verification55 chan%es& assess ssme ment nt of the the ris8 ris8 of the the .c3 an asse out) of)s(ecif (ecificati ication on readin%s read in%s as an# out)of)s intended use of the (roduct caused b# received for calibration /verificatio n& the out)of)s(ecification condition5 as sess ssme ment nt of the th e im(a im (act ct of out) ou t)of of) ) an asse .d3 !hen a (iece of ins(ection s(ecification condition& measur measureme ement nt and test test equi(m equi(ment ent is sta tement ents s of confo con formi rmit# t# to foun found d to be out out of cali calibr brat atio ion n or statem s(ecifica s(eci fication tion after defective durin% its (lanned verification calibration/verification& and or cali calibr brat atio ion n or duri durin% n% its its use& use& notif not ifica icatio tion n to the custom cus tomer er if sus(e su s(ect ct documented information on the validit# (roduct or material mat erial has been shi((ed shi( (ed of (rev (revio ious us meas measur urem emen entt resu result lts s obtained obtained !ith this (iece of ins(ection ins(ection measurement and test equi(ment shall be retained& retained& includin% includin% the associated associated standardEs last calibration date and the next due date on the calibration re(ort5 .e3 notification to the customer if sus(ect (roduct or material has been been shi((ed5 .f3 statements of conformit# to s(ecification after calibration/verification5 .,3 verificati verification on that the soft!are soft!are version version used for (roduct and (rocess control is as s(ecified5 .h3 records of the calibration and maintenan maintenance ce activities activities for all %au%in% %au%in% 0includin% em(lo#ee)o!ned equi(ment& customer)o!ned equi(ment& or on)site
.i3
su((lier)o!ned equi(ment5 (roduction)related soft!are verification used for (roduct (roduct and (rocess (rocess control 0inc 0inclu ludi din% n% soft soft!a !are re inst instal alle led d on em(lo#ee)o!ned equi(ment& customer) o!ned o!ned equi(ment& equi(ment& or on)site on)site su((lier) su((lier) o!ned equi(ment
;1-7 ?aborator# >equirements The internal laboratory requirements are 1-71 Internal laborator# laborator# An or%ani.ationEs or%ani.ationEs internal laborator# facilit# facilit# essentially unchanged shall have a defined sco(e that includes its ca(abilit# to (erform the required ins(ection& test& or calibration services This laborator# sco(e shall be included in the qualit# mana%ement s#stem documentation ;68 ?A2O>ATO>C >"@I>$=TS The laborator# shall s(ecif# and im(lement& ;681 I=T>=A? ?A2O>ATO>C as a minimum& requirements for+ An or%ani.ationEs or%ani.ationEs internal laborato labo rator# r# .i.a3 adequa adequac# c# of the labora laborator tor# # techni technical cal facilit# faci lit# shall shal l have ha ve a defi de fine ned d sco( sc o(e e that th at (rocedures5 includ inc ludes es its ca(abi ca( abilit lit# # to (erform the .i.3 com(etenc# of the laborator# required ins(ection& test te st or calibr cal ibrati ation on (ersonnel5 services This Thi s labor lab orato ator# r# sco(e sc o(e shall sha ll be .i.c3 testin% of the (roduct5 includ inc luded ed in the qualit qua lit# # mana% ma na%em ement ent .i.d3 ca(abi ca(abilit lit# # to (erfor (erform m these these servic services es s#stem documentatio n The Th e labora lab orator tor# # correc correctl# tl#&& tracea traceable ble to the releva relevant nt shall s(ecif# s(e cif# and im(lemen im(l ement& t& as a (rocess standard 0such as AST$& =& minimum& technical requirem requ irements ents for etc5 !hen no national or international adequa ade quac# c# of the labora lab orator tor# # (rocedures& standard0s is available& the com (eten tenc# c# of the labora lab orator tor# # (ersonnel& or%ani.ation shall define and im(lement com(e test te stin in% % of the th e (roduct& a methodolo methodolo%# %# to verif# verif# measureme measurement nt ca(abi ca( abilit lit# # to (erform to (erform these services services s#stem ca(abilit#5 correctl#& trace tr aceab able le to the releva rel evant nt .i.e3 customer requirements& if an#5 (rocess standard standard 0such as AST$& AST$& .i.f3 revie! of the related records =& etc& and =OT Third)(art# accreditation to revie! rev ie! of the relate rel ated d record rec ords s ISO/I3 1*,- 0or equivalent ma# be Accreditation to ISO/I3 1*,=OT6 =O T6 used to demonstrate the or%ani.ationEs ma# ma # be used us ed to demo de mons nstr trat ate e the th e in)house laborator# conformit# to this or%ani.a or%a ni.ation tionEs Es in)hous in) house e laborat lab orator# or# requirement The external laboratory requirements are conformi conf ormit# t# to t o this thi s require requ irement ment but is not essentially unchanged 1-7, xternal laborator# mandator# xternal/commercial/inde(endent xternal/commercial/i nde(endent laborator# facilities used for ins(ection& test& or calibration services b# the or%ani.ation shall have a defined laborator# sco(e that
includes the ca(abilit# to (erform the ;682 T>=A? ?A2O>ATO>C required ins(ection& test& or calibration& and xternal/co mmercial/inde (endent either+ laborato labo rator# r# faciliti faci lities es used for ins(ectio ins(e ction& n& test te st or cali ca libr brat atio ion n serv se rvic ices es b# the th e L the laborator# shall be accredited to ISO/I3 1*,- or national equivalent or%ani.ati or%an i.ation on shall shal l have a defined and include the relevant ins(ection& laborator# sco(e that includes the test& or calibration service in the ca(abi ca( abili lit# t# to (erform the required sco(e of the accreditation ins(ection& test tes t or calibrat cali bration& ion& and either eith er 0certificate5 the certificate of there ther e shall shal l be eviden evi dence ce that tha t the exter ext ernal nal calibration or test re(ort shall labo la bora rato tor# r# is acce ac ce(t (tab able le to the th e include the mar8 of a national customer& or accreditation bod#5 or labo rator# r# shall be accr ac cred edit ited ed to the laborato L ther there e shal shalll be evid eviden ence ce that that the the ISO/I ISO /I3 3 1*,1* ,- or nation nat ional al equivalent extern external al labora laborator tor# # is acce(t acce(tabl able e to the customer =OT =OT 1 Such Suc h eviden evi dence ce ma# be =OT Such evidence ma# be demonstrated demonstr demo nstrate ated d b# customer cust omer assessme asse ssment& nt& b# customer assessment& for exam(le& or b# for exam(le& exam( le& or b# custom cus tomer) er)a(( a((ro roved ved customer) a((roved second)(art# secon sec ond) d) (art# assessment that the assessment that the laborator# meets the laborat or# meets the intent of ISO/I3 intent of ISO/I3 1*,- or national 1*,- or national equivalent equivalent The second)(art# assessment =OT =OT , Dhen Dh en a quali qu alifi fied ed labor lab orato ator# r# is ma# be (erformed b# the or%ani.ation not no t avai av aila labl ble e for fo r a %ive %i ven n (iece of assessin% the laborator# usin% a customer) equi(ment& cali ca libr brati ation on servic ser vices es ma# be a((roved method of assessment (erformed b# the equi(ment manufacturer 3alibration services ma# be (erformed b# In such suc h cases& cas es& the or%ani or% ani.at .ation ion shoul sho uld d the equi(ment manufacturer !hen a qualified ensur ens ure e that tha t the requi re quire remen ments ts liste lis ted d in laborator# is not available for a %iven (iece 671 6 71 have been met of equi(ment In such cases& the or%ani.ation shall ensure that the requirements listed in Section 1-71 have been met @se of calibration services& other than b# qualified 0or customer acce(ted laboratories& ma# be subect to %overnment re%ulator# confirmation& if required
Orani3ationa! no!" ;/1/6 $he or,ani-ation shall determine the 7nowled,e necessar for the o/eration of its /rocesses and to achiee conformit of /roducts and serices. $his 7nowled,e shall e maintained and e made aailale to the e)tent necessar. Bhen addressin, chan,in, needs and trends6 the or,ani-ation shall consider its current 7nowled,e and determine how to acquire or access an necessar additional 7nowled,e 7nowled ,e and required u/dates. 4O$5 4O $5 1 Or,a Or ,ani ni-a -ati tion onal al 7no 7nowl wled ed,e ,e is is 7nowled,e 7nowl ed,e s/ecific to the or,ani-ation it is ,ained e)/erience. It is information that is used and shared to achiee the or,ani-ations o;ecties. 4O$5 4O$ 5 Or,a Or,ani-a ni-ationa tionall 7nowled, 7nowled,e e can e ased on: a) internal sources 2e.,. intellectual /ro/ert 7nowled,e ,ained from e)/erience lessons learned from failures and successful /ro;ects ca/turin, and sharin, undocumented 7nowled,e and e)/erience e)/erienc e the results of im/roements in /rocesses6 /roducts and serices3 b) e)ternal sources 2e.,. standards academia conferences conferences ,atherin, 7nowled,e from customers or e)ternal /roiders3. H. (om/etence $he or,ani-ation shall: a) determine the necessar com/etence of /erson2s3 doin, wor7 under its control that affects the /erformance and effectieness effecti eness of the qualit mana,ement sstem
$here is no equialent clause in ISO9001:00*.
?ost clients do not hae an /rocess for ca/turin, this 7nowled,e other than e)ternal standards and s/ecifications. s/ecifications. Bill hae to consider estalishin, a lessons learned dataase to ca/ture trial 7nowled,e
(lients should consider how the or,ani-ation ca/tures the 7nowled,e ,ained when someone is sent to e)ternal trainin, or e)ternal trainin, is done internall
6/2
?'man rso'r+s
621 General
Personnel performing work affecting conformity to product requirements requirements shall be competent on the basis of appropriate appropriate education, training, skills and experience.
#wareness moed moed to ne)t clause H.8
b)ensure that these /ersons are com/etent on the asis of a//ro/riate education6 trainin,6 or e)/erience c) where a//licale6 ta7e actions to acquire the necessar com/etence6 and ealuate the effectieness of the actions ta7en d) retain a//ro/riate documented information as eidence of com/etence. 4O$5 #//licale actions can include6 for e)am/le6 the /roision of trainin, to6 the mentorin, of6 or the re assi,nment of currentl em/loed /ersons or the hirin, or contractin, of com/etent /ersons.
,1 ,1 3om(eten 3om(etence ce ; su((lementa su((lemental l The or%ani.ation shall establish and maintain a documented (rocess0es for identif#in% trainin% needs includin% a!areness 0see Section 71 and achievin% com(etence of all (ersonnel (erformin% activities affectin% conformit# to (roduct and (rocess requirements ersonnel (erformin% s(ecific assi%ned tas8s shall be qualified& as required& !ith (articular attention to the satisfaction of customer requirements ,, ,, 3om(etenc 3om(etence e ; on)the)ob on)the)ob trainin% trainin% The or%ani.ation shall (rovide on)the)ob trainin% 0!hich shall include customer requirements trainin% for (ersonnel in an# ne! or modified res(onsibilities affectin% conformit# to qualit# requirements& internal requirements& re%ulator# or le%islative requirements5 this shall include contract or a%enc# (ersonnel The level of detail required for on)the)ob trainin% shall be
4O$5 (onformit to /roduct requirements can e affected directl or indirectl /ersonnel /erformin, an tas7 within within the qualit mana,ement sstem.
Comptn+* trainin an" aarnss $he or,ani-ation shall a3 dete determin rmine e the nece necessa ssar r com/e com/etenc tence e for /ersonnel /erformin, wor7 affectin, conformit to /roduct requirements6 b) where a//licale6 /roide trainin, or ta7e other actions to achiee the necessar com/etence6 6/2/2
c)
ealuate the effectieness of the actions ta7en6
d) ensure that its /ersonnel are aware
of the releance and im/ortance of their actiities and how the contriute to the achieement of the qualit o;ecties6 and e) maintain a//ro/riate records of
education6 trainin,6 s7ills and e)/erience 2see '..'3. 6,, 6, ,1 1 T> T>AI AI=I= =I= The clause on Jroduct :esi%n S8illsK !as The or%ani.ati or%an i.ation on shall shal l establi sh and moved to clause <7,, maintain maint ain documented document ed (rocedures for identi f#in% trainin% trai nin% needs need s and achiev ac hievin% in% com(e com (ete tence nce of all (ersonnel all (ersonnel (erformin% (erformin% activitie acti vities s affecti aff ectin% n% conform con formit# it# to (roduct requirements ersonnel (erformin% ersonnel (erformin% s(ecifi s(ec ific c assi%ned assi %ned tas8s tas8 s shall shal l be qualified& Additional details in the on the ob trainin% as required requ ired& & !ith !i th (articular attention to the clause but no bi% chan%es satisfact sati sfaction ion of customer cust omer requireme requi rements nts =OT 1 This a((lies to all em(lo#e em (lo#ees es havin% hav in% an effe ef fect ct on quali t# at all levels leve ls of the or%ani.ation =OT =OT , An exam(l exa m(le e of the custo cu stomer mer) ) s(ecific requ irement s is the a((licati on of
commensurate !ith the level of education the (ersonnel (ossess and the com(lexit# of the tas80s the# are required to (erform for their dail# !or8 ersons !hose !or8 can affect qualit# shall be informed about the consequences of nonconformit# to customer requirements
di%iti.ed di%it i.ed mathemat math ematical icall# l# based base d data data %... T> T>AI AI=I =I= = O= TH TH LO LO2 2 The or%ani.ation shall (rovide on)the)ob trainin% for (ersonnel for (ersonnel in i n an# an # ne! ne ! or modified ob affectin% conformit# to (roduct to (roduct requirements& includ inc ludin% in% contra con tract ct or a%enc# a%e nc# (ersonnel ersonnel !ho ersonnel !hose se !or8 can affect qualit# quali t# shall shal l be info in form rmed ed abou ab outt the th e conseq con sequen uences ces to the custo cus tomer mer of nonconfo nonc onformit rmit# # to qualit# qual it# requirem requ irements ents
,7 ,7 Internal Internal auditor auditor com(etenc# com(etenc# The or%ani.ation shall have a documented (rocess0es to verif# that internal auditors are com(etent& ta8in% into account an# customer)s(ecific requirements For additional %uidance on auditor com(etencies& refer to ISO 19*11 The or%ani.ation shall maintain a list of qualified internal auditors "ualit# mana%ement s#stem auditors& manufacturin% (rocess auditors& and (roduct auditors shall all all be able to demonstrate the follo!in% minimum com(etencies+ a3 unde unders rsta tand ndin in% % of the the auto automo moti tive ve (rocess a((roach for auditin%& includin% ris8)based thin8in%5 3 understand understandin% in% of a((licabl a((licable e customer) customer) s(ecific requirements5 c3 understandin% of a((licable ISO 9**1 and IATF 16949 requirements related to the sco(e of the audit5 d3 understand understandin% in% of a((licabl a((licable e core tool requirements related to the sco(e of the audit5 e3 understand understandin% in% ho! to (lan& conduct& re(ort& and close out audit findin%s Additionall#& manufacturin% manufacturin% (rocess auditors shall demonstrate technical understandin% of the relevant manufacturin% (rocess0es to be audited& includin% (rocess ris8 anal#sis 0such as F$A and control (lan roduct auditors shall demonstrate com(etence in understandin% (roduct requirements and use of relevant measurin% and test
=e! detailed requirements for internal auditor com(etenc# includin% demonstration of com(etenc#
equi(ment to verif# (roduct conformit# Dhere trainin% is (rovided to achieve com(etenc#& documented information shall be retained to demonstrate the trainerEs com(etenc# !ith the above requirements $aintenance of and im(rovement in internal auditor auditor com(etenc com(etence e shall shall be demonstrate demonstrated d throu%h+ f3 executin% a minimum number of audits (er #ear& as defined b# the or%ani.ation5 and maintainin% n% 8no!led%e 8no!led%e of relevant relevant ,3 maintaini requ requir irem emen ents ts base based d on inte intern rnal al chan%es chan%es 0e%& 0e%& (rocess (rocess technolo%# technolo%#&& (roduct technolo%# and external chan%es 0e%& ISO 9**1& IATF 16949& core core tools& tools& and custom customer er s(ecif s(ecific ic requirements ,4 ,4 Second Second)(a )(art# rt# audito auditorr com(et com(etenc enc# # The or%ani.ation shall demonstrate the com(etence of the auditors underta8in% the second)(art# audits Second)(art# auditors shall meet customer s(ecific requirements for auditor qualification and demonstrate the minimum follo!in% core com(etencies& includin% understandin% of+ a3 the automo automotiv tive e (roces (rocess s a((roa a((roach ch to auditin%& includin% ris8 based thin8in%5 3 a((licabl a((licable e customer customer and or%ani.atio or%ani.ation n s(ecific requirements5 c3 a((lic a((licabl able e ISO 9**1 9**1 and IATF IATF 16949 16949 requirements related to the sco(e of the audit5 d3 a((licable manufacturin% (rocess0es to be audi audite ted& d& incl includ udin in% % F$ F$A A and and control (lan5 e3 a((l a((lic icab able le core core tool tool requ requir irem emen ents ts related to the sco(e of the audit5 f3 ho! to (lan& conduct& (re(are audit
:emonstration of the maintenance of auditor com(etenc#
=e! detailed requirements for second (art# auditor com(etenc# com(etenc# includin% demonstration of com(etenc#
re(orts& and close out audit findin%s
;8 #wareness ;8 #wareness $he or,ani-ation shall ensure that /ersons doin, wor7 under the or,ani-ations control are aware of: a) the qualit /olic b)releant qualit o;ectie o;ecties s
c) their contriution to the effecti effectieness eness of the qualit mana,ement sstem6 includin, the enefits of im/roed /erformance d) the im/lications of not conformin, with the qualit mana,ement sstem requirements.
58 " Qualit /olic 552 +
$hese awareness requirements were dis/ersed dis/ersed in seeral clauses /reiousl
622 " Our clients should consider includin, questions questions related to these requirement in their internal audits to hel/ ,a,e the awareness of their /ersonnel
%...8 $ $?OC ?OC $OT $OTIA IATI TIO= O= A=: 71 71 A!arenes A!areness s ; su((lement su((lemental al $OD>$=T The or%ani.ation shall maintain The or%ani.ation shall ha shall have ve a (rocess a (rocess to documented information that motiva mot ivate te em(lo# em( lo#ees ees to achiev ach ieve e qualit qua lit# # demonstrates that all em(lo#ees are obectives& to ma8e continual a!are of their im(act on (roduct qualit# im(rovements& and an d to crea cr eate te an and the im(ortance of their activities in environme envir onment nt to (romote (ro mote innovatio innov ation n The achievin%& maintainin%& and im(rovin% (rocess shall incl in clud ude e the th e (romotion of qualit#& includin% customer requirements qualit# quali t# and technolo tech nolo%ical %ical a!areness and the ris8s involved for the customer throu%ho thro u%hout ut the !hole or%ani.atio or%ani .ation n !ith nonconformin% (roduct 7, m(lo#ee motivation and em(o!erment The or%ani.ati or%an i.ation on shall shal l have ha ve a The or%ani.ation shall maintain a (roc (r oces ess s to meas me asur ure e the th e exte ex tent nt to documented (rocess0es to motivate !hic !h ich h its it s (ersonnel are are a!ar a! are e of em(lo#ees to achieve qualit# obectives& the th e rele re leva vanc nce e and an d im(o im (ort rtan ance ce of to ma8e continual im(rovements& and to thei th eirr acti ac tivi viti ties es and an d ho! ho ! the# th e# create an environment that (romotes contri con tribut bute e to the achiev ach ieveme ement nt of innovation The (rocess shall include the the qualit qua lit# # obect ob ective ives s Msee Mse e 6,, 6, , dN dN (romotion of qualit# and technolo%ical a!areness throu%hout the !hole or%ani.ation
;4 (ommunication
The organization shall determine the internal and external communications relevant to the quality management system, including on what it will communicate b)when to communicate! c) with whom to communicate!
d)how to communicate! e) who communicates communicates..
5.5.3 Internal communication Top management management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management management system.
The clause requirin% a (rocess to measure the extent to !hich (ersonnel are a!are of J has been re!orded to to Jmaintain documented information that demonstrates that K The clause on em(lo#ee motivation has been re!orded5 not si%nificant chan%es
#dditional detail6 detail6 ut no real chan,es
;5 Documented information ;51 nra!
$he or,ani-ations qualit mana,ement sstem shall include: a) documented information required this International Standard
b)documented information determined the or,ani-ation as ein, necessar for the effectieness effectieness of the qualit mana,ement sstem. 4O$5 $he e)tent of do document ed ed information for a qualit mana,ement sstem can ca n di diffe fferr fro from m one on e or or,a ,ani ni-a -ati tion on to an anot othe her r due to: " the si-e of or,ani-ation and its t/e of actiities6 /rocesses6 /roducts and serices
nra! 4/2/1 $he qualit mana,ement sstem documentation shall include a) documented statements of a qualit /olic and qualit o;ecties6 b)
a qualit manual6
documented /rocedures and records required this International Standard6 and
$here is no lon,er a requirement for s/ecific /rocedures
documents6 includin, records6 determined the or,ani-ation to e necessar to ensure the effectie effectie /lannin,6 o/eration and control of its /rocesses.
For e)am/le:
c)
d)
4O$5 1 Bhere the term Edocumented /rocedure a//ears within this International Standard6 this means that the /rocedure is estalished6 " the com/le)it of /rocesses and their documented6 im/lemented and maintained. # interactions sin,le document ma address the requirements " the com/etence of /ersons. for one or more /rocedures. # requirement for a documented /rocedure ma e coered more than one document. 4O$5 $he e)tent of the qualit qualit mana,ement - -1 11 1 "ual "ualit it# # mana mana%e %eme ment nt s#st s#stem em sstem documentation can differ from one documentation or,ani-ation to another due to
The or%ani.ationEs qualit# mana%ement s#stem shall be documented and include a qualit# manual& !hich can be a series of documents 0electronic or hard co(# The format and structure of the qualit# manual is at the discretion of the or%ani.ation and !ill de(end on the or%ani.ationEs si.e& culture& and com(lexit# If a series of documents is used& then a list shall be retained of the documents that com(rise the qualit# manual for the or%ani.ation
$he term Edocumented information is used to coer documents such as /rocedures and records.
Instead of an internal audit /rocedure an or,ani-ation could /resent an internal audit schedule and audit forms&records that demonstrate audit criteria6 audit sco/e6 audit /lannin, /lannin, audit re/ortin, and correctie action on 4(Rs
(ontrols still required ut ma e a little more s/ecific or descri/tie descri/tie
a)
the si-e of or,ani-ation and t/e of actiities6 b) the com/le)it of /rocesses and their interactions6 and c) the com/etence of /ersonnel. 4O$5 8 $he documentation can e in an form or t/e of medium.
422 Qualit manual The The qual qualit it# # manu manual al shal shalll incl includ ude& e& at a $he or,ani-ation shall estalish and maintain minimum& the follo!in%+ a qualit manual that includes the sco(e of the qualit# mana%ement a3 2.2.b) the sco/e of the qualit s#stem& includin% details of and mana,ement sstem6 includin, ustification for an# exclusions5 exclusions5 details of and ;ustification ;ustification for an
IATF 16949 adds bac8 in the requirement requirement for a qualit# manual !ith some required content includin% (revious content !hich !as required
documented documented (rocesses (rocesses establishe established d
3
for
c3
d3
the qualit# mana%ement s#stem& or reference to them5 the or%ani.ationEs (rocesses and their sequence and interactions 0in(uts and out(uts& includin% t#(e and extent of control of an# outsourced (rocesses5 a document 0ie& matrix indicatin% !here !ithin the or%ani.ationEs qualit# mana%ement s#stem their customer)s(ecific requirements are addressed
e)clusions 2see 1.36 2.2.c) the documented /rocedures estalished for the qualit mana,ement sstem6 or reference to them6 and
a descri/tion of the interaction etween the /rocesses of the qualit mana,ement sstem. 2.2.d)
=OT A matrix of ho! the requirements of this Automotive "$S standard are addressed b# the or%ani.ationEs (rocesses ma# be used to assist !ith lin8a%es of the or%ani.ationEs (rocesses and this Automotive "$S Cratin an" 'p"atin ;/5/2 Bhen creatin, and u/datin, documented information6 the or,ani-ation shall ensure a//ro/riate: a) identification and descri/tion 2e.,. a title6 date6 author6 or reference numer3 b)format 2e.,. lan,ua,e6 software ersion6 ,ra/hics3 and media 2e.,. /a/er6 electronic3
c) reiew and a//roal for suitailit and adequac.
(ontrol of documented Information 7..!.1 Documented information required the qualit mana,ement sstem and this International Standard shall e controlled to ensure:
5.3.1.a)
it is aailale and suitale for
Contro! o "o+'mnts 4.2.! Documents required the qualit mana,ement sstem shall e controlled. Records are a s/ecial t/e t/e of document and shall e controlled accordin, to the requirements ,ien in '..'.
use6 where and when it is needed
5.3.1.b) it is adequatel /rotected 2e.,. from loss of confidentialit6 confidentialit6 im/ro/er use6 or loss of inte,rit3. ;582 For the control of documented information6 the or,ani-ation shall address address the followin, actiities6 as a//licale: a) distriuti distriution6 on6 access6 retrieal and use
b)stora,e and /reseration6 /reseration of le,iil le,iilit it
includin,
c) control of chan,es 2e.,. ersion control3 d) retention and dis/osition. Documented information of e)ternal ori,in determined the or,ani-ation to e necessar for the /lannin, and o/eration of the qualit mana,ement sstem shall e identified as a//ro/riate6 and e controlled. Documented information retained as eidence of conformit shall e /rotected from unintended unintende d alterations. 4O$5 #ccess can im/l a decision re,ardin, the /ermission to iew the documented information onl6 or the /ermission /ermission and authorit to iew and chan,e the documented information.
-7,1 >ecord retention The or%ani.ation shall define& document& and im(lement a record retention (olic# The control of records shall satisf# statutor#& re%ulator#& or%ani.ational& and customer requirements roduction (art a((rovals& toolin% records 0includin% maintenance and o!nershi(& (roduct and (rocess desi%n desi%n records& (urchase orders 0if a((licable& a((licable& or
# documented /rocedure /rocedure shall e estalished estalished to define the controls needed a) to a//roe documents for adequac /rior to issue6 b) to reiew and u/date as necessar and re a//roe documents6
to ensure that chan,es and c) the current reision status of documents are identified6 identified6 d) to ensure that releant ersions of a//licale documents are aailale at /oints of use6 e) to ensure that documents remain le,ile and readil identifiale6 f) to ensure that documents of e)ternal ori,in determined the or,ani-ation to e necessar for the /lannin, and o/eration of the qualit mana,ement sstem are identified and their distriution controlled6 and ,3 to /reent the unintended unintended use of osolete osolete documents6 and to a//l suitale identification to them if the are retained for IATF requires a documented record retention policy and defines retention for certain an /ur/ose. records for example PPAP records. Contro! o r+or"s 4/2/4 Records estalished to /roide eidence of conformit to requirements and of the effectie o/eration of the qualit mana,ement sstem shall e controlled. $he or,ani-ation shall estalish a documented /rocedure /rocedure to define the controls needed for the identification6 stora,e6 /rotection6 retrieal6 retention and dis/osition of records. Records shall remain le,ile6
contracts and amendments shall be retained for the len%th of time that the (roduct is active for (roduction (roduction and service requirements& (lus one calendar #ear& unless other!ise s(ecified b# the customer or re%ulator# a%enc# =OT roduction (art a((roval documented information ma# include a((roved (roduct& a((licable test equi(ment records& or a((roved test data
readil identifiale and retrieale. =OT 1 J:is(ositionK includes dis(osal =OT , J>ecordsK also include customer) s(ecified records 4,41 4, 41 >3O>:S >T >T=TIO= =TIO= The control cont rol of record rec ords s shall sha ll satisf sat isf# # statutor#& re%ul re% ulato ator# r# and custom cus tomer er requirements
4,71 =I=>I= S3IFI3ATIO=S The or%ani.atio or%an i.ation n shall ha have a (rocess to T( orani3ation s(a!! (av a "o+'mnt" assure ass ure the timel ti mel# # revie! rev ie!& & distribut distr ibution ion pro+ss "s+ri$in t( rvi* and "istri$'tion* an" imp!mntation o a!! im(lement im(le mentatio ation n of all customer +'stomr ninrin en%ineerin% standards/s( ecifications and stan"ar"s/sp+ii+ations stan"ar"s/sp+ii+at ions an" r!at" chan%es chan% es based on customer cust omer)req )require uired d rvisions $as" on +'stomr s+("'!s* schedule Tim T imel el# # revi re vie! e! shou sh ould ld be as as r)'ir" soon so on (n an ninrin as (ossible& as (ossible& and shall sha ll not no t exce ex ceed ed t!o t! o stan"ar"/sp+ii+ation +(an rs'!ts in a !or8in% !ee8s pro"'+t "sin +(an* rr to t( The or%ani.ati or%an i.ation on shall shal l maintai mai ntain n a record reco rd r)'irmnts in ISO 9001* S+tion -86 of the th e date da te on !hic !h ich h each ea ch chan ch an%e %e is (n an ninrin stan"ar"/sp+ii+ation +(an rs'!ts in a im(le im( lemen mente ted d in (roduction pro"'+t ra!i3ation pro+ss +(an* rr Im(lementatio n shall includ inc lude e u(date u(d ated d to t( r)'irmnts in S+tion -561 T( documents orani3ation s(a!! rtain a r+or" o t( =OT =O T A chan ch an%e %e in thes th ese e "at on (i+( a+( +(an is standard s/s(ecifi cations requires require s an imp!mnt" in pro"'+tion u(dat u(d ated ed recor re cord d of cust cu stome omerr (roduction Imp!mntation s(a!! in+!'" 'p"at" (art a((roval !hen these the se s(ecific s(ec ificatio ations ns "o+'mnts are ar e refe re fere renc nced ed on the th e desi de si%n %n reco re cord rd or if ,vi s(o'!" $ +omp!t" it(in 10 the# the # affec af fectt docu do cumen ments ts of (roduction (art orin "a%s o r+ipt o notii+ation o a((roval (rocess& such as control (lan& ninrin stan"ar"s/sp+ii+ation stan"ar"s/sp+ii+ations s F$As& etc +(ans OT> A +(an in t(s stan"ar"s/sp+ii+ations stan"ar"s/sp+ii+atio ns ma% r)'ir an 'p"at" r+or" o +'stomr pro"'+tion part approva! (n t(s sp+ii+ations ar rrn+" on t( "sin r+or" or i t(% a+t "o+'mnts o t( pro"'+tion part approva! pro+ss* s'+( as +ontro! p!an* ris
;5822 >ninrin sp+ii+ations
IATF requires a documented (rocess for controllin% en%ineerin% s(ecifications includin% quite a fe! detailed controls
ana!%sis As=* t+
- Opration *.1 O/erational /lannin, and control $he or,ani-ation shall /lan6 im/lement and control the /rocesses 2see '.'3 needed to meet the requirements for the /roision of /roducts and serices6 and to im/lement the actions determined in (lause %6 %6 : a) determinin, the requirements for the /roducts and serices
b)estalishin, criteria for: 1)
the /rocesses
;1 #!annin o pro"'+t ra!i3ation $he or,ani-ation shall /lan and deelo/ the /rocesses needed for /roduct reali-ation. =lannin, of /roduct reali-ation shall e consistent with the requirements of the other /rocesses of the qualit mana,ement sstem 2see '.13. In /lannin, /roduct reali-ation6 the or,ani-ation shall determine the followin,6 as a//ro/riate: a) qualit o;ecties and requirements for the /roduct
2)
the acce/tance of /roducts and serices c) determinin, the resources needed to achiee conformit to the /roduct and serice requirements d)im/lementin, control of the /rocesses in accordance with the criteria
e) determinin, and 7ee/in, documented information to the e)tent necessar: 1) to hae confidence that the /rocesses hae een carried out as /lanned 2) to demonstrate the conformit of /roducts and serices to their requirements. 4O$5 EMee/in, EMee/in, im/lies oth the m aintainin, and the retainin, of documented information. information.
b) the need to estalish /rocesses and
documents6 and to /roide resources s/ecific to the /roduct required erification6 alidation6 monitorin,6 measurement6 ins/ection ins/ection and test actiities s/ecific to the /roduct and the criteria for /roduct acce/tance d3 records needed to /roide eidence that the reali-ation /rocesses and resultin, /roduct meet requirements 2see '..'3. $he out/ut of this /lannin, shall e in a form suitale for the or,ani-ationGs method of o/erations. c)
4O$5 1 # document s/ecifin, the /rocesses of the qualit mana,ement sstem 2includin, the /roduct reali-ation reali-ation /rocesses3 and the resources to e a//lied to a s/ecific /roduct6 /ro;ect or contract can e referred to as a qualit /lan. 4O$5 $he or,ani-ation ma also a//l the requirements ,ien in H.8 to the deelo/ment of /roduct reali-ation /rocesses
$he out/ut of this /lannin, shall e suitale for the or,ani-ations o/erations. $he or,ani-ation shall control /lanned chan,es and reiew the consequences of =OT =OT Some So me unintended unintende d chan,es6ta7in, action to miti,ate mana% man a%eme ement nt an aderse effects6 as necessar necessar.. (lannin% as $he or,ani-ation shall ensure that outsourced reali.ation reali.ation /rocesses are controlled 2see *.'3. *.'3.
custom cus tomers ers refe re ferr to (roec (ro ect t or advanc adv anced ed (roduct qualit# a means to achieve (roduct Advance Adva nced d (roduct qualit#
$his /lannin, clause now includes a chan,e control requirement requirement and a reference to clause *.' for control of outsourced /rocesses
(lannin% embodies the conce(ts of error (revention and continual im(roveme im(r ovement nt as contrasted !ith error detection& and an d is based base d on a multidis mult idisci(l ci(lina inar# r# a((roach a((r oach ;11 ? ?A== A==I= I= OF >O:@ > O:@3T 3T >A?IPATIO >A?I PATIO= = ; S@ S@?$ ?$=TA? =TA? 3usto 3us tomer mer requi re quire remen ments ts and refere ref erence nces s to its technical tech nical s(eci fications shall be incl in clud uded ed in the th e (lannin% of (roduct <11 <11 O(era O(eratio tional nal (lannin% (lannin% and contro controll ; real re ali. i.at atio ion n as a com( co m(on onen entt of the th e qual qu alit it# # su((lemental (lan Dhen (lannin% for (roduct (roduct reali.ati reali.ation& on& the ;12 A33 A33TA=3 TA=3 3>IT>IA 3>IT>IA follo!in% to(ics shall be included+ Acce(tance Acce(tance criteria shall shal l be defi de fine ned d a3 customer customer (roduct (roduct requireme requirements nts and b# the or%ani or% ani.at .ation ion and& and & !her !h ere e technical s(ecifications5 require equ ired& d& a((rov a(( roved ed b# the custo cus tomer mer 3 lo%istics requirements5 For attribut attr ibute e data sam(lin% sam( lin%& & the the c3 manufacturin% feasibilit#5 acce(tance acce( tance level leve l shall be .ero d3 (roect (lannin% 0refer to ISO 9**1& defect def ects s Section <7,5 0see <,71 e3 acce(tance criteria The resources identified in ISO 9**1& Section <1 c& refer to the required verification& validation& monitorin%& 17 1 7 3O= 3O=FI: FI:=TI =TIA?IT A?ITC C measurement& ins(ection& and test The or%ani.ation shall ensure ensur e the activities s(ecific to the (roduct and the confident confi dentiali ialit# t# of customer) cust omer)cont contract racted ed criteria for (roduct acce(tance (roducts and (roects under <1, <1, 3onfid 3onfident ential ialit# it# develo(ment& and rela re late ted d (roduct The or%ani.ation shall ensure the information confidentialit# of customer)contracted (roducts and (roects under under develo(ment& includin% related (roduct information
There are a fe! additions 0lo%istics& (roect (lannin% (lannin% ?ess detail !ith res(ect to acce(tance criteria
The chan%e control clause 14 !as moved under the desi%n and develo(ment chan%e clause see <761 belo!
<, >equirements for (roducts and services -21 C'stomr +omm'ni+ation (ommunication (ommunicatio n with customers shall include: a) /roidin, information relatin, to /roducts and serices
b)handlin, enquiries6 contracts or orders6 includin, chan,es c) otainin, customer feedac7 relatin, to /roducts and serices6 includin, customer com/laints
7.2.! C'stomr +omm'ni+ation $he or,ani-ation or,ani-ation shall determine and im/lement effectie arran,ements for communicatin, with customers in relation to 2.3.a) /roduct information6
enquiries6 contracts or order handlin,6 includin, amendments6 and
2.3.b)
d)handlin, or controllin, customer /ro/ert esta ta li lish shin in, , s/ s/ec ecif ific ic re requ quir irem emen ents ts for e) es contin,enc actions6 when releant.
<,1 ,11 1 3usto ustom mer commu ommun nica ication tion su((lemental Dritten or verbal communication shall be in the lan%ua%e a%reed !ith the customer The or%ani.ation shall have the abilit# to communicate necessar# information& includin% data in a customer)s(ecified com(uter lan%ua%e and format 0e%& com(uter)aided desi%n data& electronic data interchan%e
1)
an a//licale statutor and
(ustomer communication added a cou/le of communication communication to/ics Some reor,ani-ation requirements
"
rewordin,
4ote on /ost delier actiities remoed
2.3.c) customer feedac76 includin,
customer com/laints. customer com/laints. $ore ex(licit callout concernin% the communication of data
;
-22 Dtrminin t( r)'irmnts r!at" to pro"'+ts an" srvi+s Bhen determinin, the requirements for the /roducts and serices to e offered to customers6 the or,ani-ation shall ensure that: a) the requirements for the /roducts and serices are defined6 includin,:
Rearran,ed order of suclauses
;281 3@STO$ 3@S TO$> > 3O$ 3O$$@=I $@=I3ATI 3ATIO= O= ; S@?$=TA? The or%ani.ati or%an i.ation on shall shal l have ha ve the th e abil ab ilit it# # to communica te necessar# information& includin% inclu din% data& in a custo cus tomer mer)) s(ecif s(e cified ied lan%ua lan %ua%e %e and forma for matt 0e% 0e % com(uter )aided )aid ed desi%n desi% n data& data & electronic electr onic data exchan%e excha n%e
;/2/1
Dtrmination o& r)'irmnts r!at" to t( pro"'+t $he or,ani-ation shall determine a) requirements s/ecified the customer6 includin, the requirements for delier and /ostdelier actiities6 b) requirements not stated the customer
ut necessar for s/ecified or intended
of
use6 where 7nown6
re,ulator requirements
2)
those considered necessar the or,ani-ation
b)the or,ani-ation can meet the claims for the /roducts and serices it offers.
c)
statutor and re,ulator requirements a//licale a//licale to the /roduct6 and
d) an additional requirements considered
necessar the or,ani-ation. =otes , and 7 are no! included in clause <,,1
<,, <,,1 1 :eterm :etermini inin% n% the requir requireme ements nts for 4O$5 =ostdelier actiities include6 for (roducts and services ; su((lemental e)am/le6 actions under warrant /roisions6 These requirements shall include contractual oli,ations such as rec#clin%& environmental im(act& and maintenance serices6 and su//lementar characteristics identified as a result of serices such as recclin, or final dis/osal. the or%ani.ationEs 8no!led%e of the (roduct and manufacturin% manufacturin% (rocesses =OT 1 ost)deli ost )deliver# ver# activitie acti vities s include incl ude 3om(liance to ISO 9**1& Section <,, item a an# after aft er)sa )sales les (roduct service (rovided 1& shall shall includ include e but not be limite limited d to the as (art of the customer contract or follo!in%+ (urchase order all all a((l a((lic icab able le %ove %overn rnme ment nt&& safe safet# t#&& and and envi enviro ronm nmen enta tall re%u re%ula lati tion ons s rela relate ted d to =OT , This requir req uiremen ementt inclu des acquis acquisiti ition& on& stora% stora%e& e& handli handlin%& n%& rec#cl rec#clin% in%&& rec#clin%& environmental im(a im (act ct and an d elimination& or dis(osal of material chara ch aract cteri erist stics ics ident ide ntifi ified ed as a resul re sultt of the th e or%ani.a or%a ni.ation tionEs Es 8no!led%e 8no!led% e of the (roduct the (roduct and manufact urin% (rocesses urin% (rocesses 0see 7,7 7,7 =OT =OT 7 3om(l 3om (lian iance ce to item it em c includ inc ludes es all a((licab a((l icable le %overnment& safe sa fet# t# and an d environmental re%ulations& a((l a( (lie ied d to acquisition& stora%e& handlin%& rec#clin%& eliminat ion or dis(osal of material mate rials s
-28 ,vi o r)'irmnts r!at" to pro"'+ts an" srvi+s *..8.1 $he or,ani-ation shall ensure that it has the ailit to meet the requirements for /roducts and serices to e offered to customers. $he or,ani-ation shall conduct a reiew efore committin, to su//l /roducts and serices to a customer6 to include: a) requirements s/ecified the customer6 includin, the requirements for delier and /ost delier actiities b)requirements not stated the customer6 ut necessar for the s/ecified or intended use6 when 7nown
c) requirements or,ani-ation
s/ecified
the
d)statutor and re,ulator requirements a//licale a//lical e to the /roducts and serices e) contract or order requirements differin, from those /reiousl e)/ressed. $he or,ani-ation shall ensure that contract or order requirements differin, from those /reiousl defined are resoled. $he customers requirements shall e confirmed the or,ani-ation efore acce/tance6 when the customer does not /roide a documented statement of their requirements. 4O$5 In some situations6 such as internet sales6 a formal reiew is im/ractical for each order. Instead6 the reiew can coer releant /roduct information6 such as catalo,ues or adertisin, material.
Reiew of requirements related to the /roduct $he or,ani-ation shall reiew the requirements related to the t he /roduct. / roduct. $his reiew shall e conducted /rior to the or,ani-ationGs commitment to su//l a /roduct to the customer 2e.,. sumission of tenders6 acce/tance of contracts or orders6 acce/tance of chan,es to contracts or orders3 and shall ensure that /roduct requirements are 2.2.a) defined6 contract or order requirements differin, from those /reiousl /reiousl e)/ressed are resoled6 and
2.2.b)
the or,ani-ation has the ailit to meet the defined requirements. Records of the results of the reiew and actions arisin, from the reiew shall e maintained 2see '..'3. Bhere the customer /roides no documented statement of requirement6 the customer requirements shall e confirmed the or,ani-ation efore acce/tance. 2.2.c)
Now specifically requires a record of the , ,1 >I ,,1 >ID D OF >"@I >"@I>$= >$=TS TS waiver >?A > ?AT T: : TO TH TH > >O: O:@3 @3T T; <, <,7 71 11 1 >evi >evie! e! of the the requ requir irem emen ents ts for for S@?$=TA? (roducts and services ; su((lemental Daiv Da ivin in% % the th e requ re quir irem emen entt stat st ated ed in , ,, , for fo r a The or%ani.ation shall retain documented formal revie! rev ie! 0see 0se e note not e shall sha ll requir req uire e evidence of a customer)authori.ed !aiver customer authori.ation for the requiremen requirements ts stated in ISO 9**1&
-8 Desi,n and deelo/ment of /roducts and serices -81 nra! $he or,ani-ation shall estalish6 im/lement and maintain a desi,n and deelo/ment /rocess that is a//ro/riate to ensure ensure the susequent /roision of /roducts and serices.
;8 Dsin an" "v!opmnt =OT6 =O T6
(lause introduction a//ears to require a desi,n /rocess
;81Dsin an" "v!opmnt p!annin
Suclauses for desi,n reiew6 desi,n erification and desi,n alidation were comined into a desi,n control suclause
The requir req uir ement eme nts s of 7 7 inclu inc lude de (roduct and manufacturin% (rocess manufacturin% (rocess desi%n desi %n and develo(men devel o(ment& t& and and focu fo cus s on error err or (revention (revention rather rather than detection
$he or,ani-ation shall /lan and control the desi,n and deelo/ment of /roduct. Durin, -811 :esi%n and develo(ment of (roducts the desi,n and deelo/ment /lannin,6 the and services ; su((lemental or,ani-ation shall determine The requirements of ISO 9**1& Section <71& shall a((l# to (roduct and a) the desi,n and deelo/ment sta,es6 manufacturin% (rocess desi%n and develo(ment and shall focus on error b) the reiew6 erification and alidation (revention rather than detection detection that are a//ro/riate to each desi,n and deelo/ment sta,e6 and The or%ani.ation shall document the desi%n and develo(ment (rocess c) the res/onsiilities and authorities Dsin an" "v!opmnt p!annin In determinin, the sta,es and controls for desi,n and deelo/ment6 the or,ani-ation shall consider: ".!.2
a) the nature6 duration and com/le)it of the desi,n and deelo/ment actiiti actiities es b)
the required /rocess sta,es6 includin, a//licale a//lical e desi,n and deelo/ment reiews
c)
the required desi,n and deelo/ment erification and alidation actiities
d)
the res/onsiilities and authorities inoled in the desi,n and deelo/ment /rocess
e) the internal and e)ternal resource needs for the desi,n and deelo/ment of /roducts and
for desi,n and deelo/ment. $he or,ani-ation shall mana,e the interfaces etween different ,rou/s inoled in desi,n and deelo/ment to ensure effectie communication and clear assi,nment of res/onsiilit.
=lannin, out/ut shall e u/dated6 as a//ro/riate6 as the desi,n and deelo/ment /ro,resses.
4O$5 Desi,n and deelo/ment reiew6 erification and alidation hae distinct /ur/oses. $he can e conducted and recorded se/aratel se/aratel or in an comination6 comination6 as suitale suitale for the /roduct and the or,ani-ation .
4ew e)/licit requirement to consider /otential consequences of failure due to the nature of the /roducts " serices an as/ect of ris7 identification in the desi,n /rocess IATF 16949 requires a documented desi%n and develo(ment (rocess
serices
f) the need to control interfaces etween /ersons inoled in the desi,n and deelo/ment /rocess g)
the need for inolem inolement ent of customers and users in the desi,n and deelo/ment /rocess
h)
the requirements for susequent /roision of /roducts and serices
i)
the leel of control e)/ected for the desi,n and deelo/ment /rocess customers and other releant interested /arties the documented information needed to demonstrate that desi,n and deelo/ment requirements hae een met.
Additional detail added added to desi%n and ;811 $@?TI:I $@?TI:IS3I?I S3I?I=A>C =A>C A>OA3H develo(ment (lannin%& for exam(le The or%ani.ati or%an i.ation on shall us use a (roect mana%ement5 and and su((l# chain multidisci(linar# a((r a( (roa oach ch to (re(are to (re(are for (roduct for (roduct reali.ation reali.ation&& includin% develo(m deve lo(ment/ ent/final finali.at i.ation ion and monitorin monit orin% % of s(ecia s(e cial l characteristics& <7,1 <7,1 :esi%n :esi%n and develo(ment develo(ment (lannin% (lannin% ; dev elo(me (ment nt and revie! rev ie! of F$As& F$ As& develo su((lemental includ inc ludin% in% action act ions s to reduce red uce (otential (otential The or%ani.ation shall ensure that desi%n ris8s& and and develo(ment (lannin% includes all develo dev elo(me (ment nt and revie! rev ie! of contr con trol ol affected sta8eholders !ithin the (lans or%ani.ation and& as a((ro(riate& its su((l# chain xam(les of areas for usin% such a multidisci(linar# a((roach include A multidisci(linar# a((roach t#(icall# =OT6 =OT6 but are not limited to the follo!in%+ incl udes the or%ani.at or%an i.ationEs ionEs desi%n& desi %n& a3 (roect mana%ement 0for exam(le& manufacturin%& en%ineerin%& qualit#& (roduction and other other a((ro(riate (ersonnel a((ro(riate (ersonnel A" or :A)>A5 :A)>A5 3 (roduct and manufacturin% (rocess desi%n activities 0for exam(le& :F$ and :FA& such as consideration of the use of alternative desi%ns and manufacturin% (rocesses5 c3 develo(ment and revie! of (roduct desi%n ris8 anal#sis 0F$As& includin% actions to reduce (otential ris8s5 d3 develo(ment and revie! of manufacturin% (rocess ris8 anal#sis
)
0for exam(le& F$As& (rocess flo!s& control (lans& and standard !or8 instructions =OT A multidisci(linar# a((roach t#(icall# includes the or%ani.ationEs desi%n& manufacturin%& en%ineerin%& qualit#& (roduction& (urchasin%& su((lier& maintenance& and other a((ro(riate functions
<7,, <7,, roduct roduct desi%n desi%n s8ills s8ills The or%ani.ation shall ensure that (ersonnel !ith (roduct desi%n res(onsibilit# are com(etent to achieve desi%n requirements and are s8illed in a((licable (roduct desi%n tools and techniques A((licable tools and techniques shall be identified b# the or%ani.ation
%...1 >O >O:@3T :@3T :S :SI= I= SQI SQI??S ??S The or%ani.ati or%an i.ation on shall shal l ensu en sure re that th at (ersonnel !ith !i th (roduct desi%n res(on res (onsib sibili ilit# t# are com(et com (etent ent to achiev ach ieve e desi%n des i%n requi re quire remen ments ts and are s8ille s8i lled d in a((licab a((l icable le tools tool s and techniqu tech niques es A((licable tools tools and techniques techniques shall be iden id enti tifi fied ed b# the th e or%ani.ation
=OT An exam(le of (roduct desi%n s8ills is the a((licatio a((lication n of di%iti.ed di%iti.ed mathemati mathematicall# call# based data
<7 <7, ,7 7 :eve :evelo lo(m (men entt of (rod (roduc ucts ts !ith !ith embedded soft!are The or%ani.ation shall use a (rocess for qualit# assurance for their (roducts !ith internall# develo(ed embedded soft!are A soft!are develo(ment develo(ment assessment methodolo%# shall be utili.ed to assess the or%ani.ationEs soft!are develo(ment (rocess @sin% (rioriti.ation (rioriti.ation based on ris8 and (otential im(act to the customer& the or%ani.ation shall retain documented information of a soft!are develo(ment ca(abilit# self)assessment The or%ani.ation shall include soft!are develo(ment !ithin the sco(e of their internal audit (ro%ramme 0see Section 9,,1
A ne! clause addressin% addressin% soft!are develo(ment for embedded soft!are and qualit# assurance for embedded soft!are
Dsin an" "v!opmnt Inp'ts $he or,ani-ation shall determine the requirements essential for the s/ecific t/es of /roducts and serices to e desi,ned and deelo/ed. $he or,ani-ation shall consider:
".!.!
3.3.a) functional and /erformance requirements 3.3.b) information deried from /reious similar desi,n and deelo/ment actiities 3.3.c) statutor and re,ulator requirements 3.3.d) standards or codes of /ractice that the or,ani-ation has committed to im/lement 3.3.e) /otential consequences of failure due to the nature of the /roducts and serices. In/uts shall e adequate for desi,n and deelo/ment /ur/oses6 com/lete and unami,uous. (onflictin, desi,n and deelo/ment in/uts shall e resoled. $he or,ani-ation shall retain documented information on desi,n and deelo/ment in/uts.
<771 <771 roduct roduct desi%n desi%n in(ut in(ut The or%ani.ation shall identif#& document& and revie! (roduct desi%n in(ut requirements as a result of contract revie! roduct desi%n in(ut requirements include but are not limited to the follo!in%+
;82 Dsin an" "v!opmnt "v!opmnt inp'ts In/uts relatin, to /roduct requirements shall e determined and records maintained maintained 2see '..'3. $hese in/uts shall include a)functional and /erformance requirements6 b) a//licale a//licale statutor and re,ulator requirements6 c)
where a//licale6 information deried from /reious similar desi,ns6 and
d) other requirements essential for
desi,n and deelo/ment. $he in/uts shall e reiewed for adequac. Requirements shall e com/lete6 unami,uous and not in conflict with each other. S(ecial characte ristics 0see ,11 =OT6 =O T6 S(ecial characte are included in this requirement require ment
H.8..1 >O >O:@3T :@3T :S :SI= I= I= I=@T @T The or%ani.ati or%an i.ation on shall shal l identif#& docume do cument nt and an d revi re vie! e! the th e (roduct desi%n in(ut requirements& includin incl udin% % the follo!in% follo !in%++ cust omer requirem requ irements ents 0contrac 0con tractt customer revie! rev ie! such suc h as s(ecia s(e cial l character char acter istics istic s 0see 7,7& 7, 7& identification& tracea tra ceabi bilit lit# # and (ac8a%in%5 us e of info in form rmat atio ion+ n+ the th e use or%ani.ati or%an i.ation on shall ha have a (rocess to de(lo# de( lo# infor inf ormat mation ion %ained %ai ned from fr om (revious (revious desi%n (roects& desi%n (roects& com(etitor anal#sis& su((l s u((lier ier
The desi%n in(ut clause no! includes a tie to the feasibilit# anal#sis and requires a (rocess for de(lo#in% information from (revious (roects5 benchmar8in%5 benchmar8in%5 su((lier feedbac8
a3 (roduct s(ecifications includin% but not limited limited to s(ecial s(ecial characteri characteristics stics 0see Section <7775 boundar# and interface requirements+ 3 c3 iden identi tifi fica cati tion on&& trac tracea eabi bili lit# t#&& and and (ac8a%in%+ d3 consideration of desi%n alternatives5 assessment of ris8s !ith the in(ut e3 requirements and the or%ani.ationEs abilit# to miti%ate/mana%e the ris8s& includin% from the feasibilit# anal#sis5 f3 tar%ets for conformit# to (roduct requirements includin% (reservation& reliabilit#& durabilit#& serviceabilit#& health& safet#& environmental& develo(ment timin%& and cost5 a((licable statutor# and re%ulator# ,3 requirements of the customer) identified countr# of destination& if (rovided5 h3 embedded soft!are requirements
The or%ani.ation shall have a (rocess to de(lo# information %ained from (revious desi%n (roects& com(etitive (roduct anal#sis 0benchmar8in%& su((lier feedbac8& internal in(ut& field data& and other relevant sources for current and future (roects of a similar nature
feedbac8& internal in(ut& field fie ld data& and other oth er releva rel evant nt sour so urces ces&& for fo r curr cu rren entt and an d futu fu ture re (roects (roects of a similar simi lar nature5 natu re5 tar%et tar %ets s for confor conf ormit mit# # to (roduct to (roduct requirements& life& reliabilit#& durabilit#& maintainabilit#& maintainabilit#& timin% ti min% and cost
rror)(roofin% no! out of the note and (art of the clause
H.8.. $A= $A=@FA @FA3T@ 3T@>I= >I= >O3 >O3SS SS
=OT One a((roach for considerin% desi%n :SI = I= I=@T @T alternatives is the use of trade)off curves The or%ani.ati or%an i.ation on shall shal l identif#& docume do cument nt and revie! rev ie! the manufa man ufact cturi urin% n% (rocess desi%n desi %n in(ut in(u t requirem requ irements& ents& includin% <77, <77, $anufactu $anufacturin% rin% (rocess (rocess desi%n in(ut (roduct desi%n desi%n out(ut data& The or%ani.ation shall identif#& ta r%et ets s for fo r (roductivit#& (roductivit#& (rocess (rocess tar% document& and revie! manufacturin% ca(abilit ca(ab ilit# # and cost& cost & (rocess desi%n in(ut requirements requirements an #& and customer s requirement s& if an#& includin% but not limited to the ex(eri ex( erienc ence e from fr om (revious (revious follo!in%+ develo(ments a3 (roduct desi%n out(ut data includin% s(ecial characteristics5 tar% tar%et ets s for for (rod (roduc ucti tivi vit# t#&&
3
(roc (roces ess s
=OT6 =O T6
The manufact manu fact urin% urin % (rocess desi%n
A fe! ne! in(uts in(uts listed includin% technolo%ical alternatives& ne! materials5 (roduct handlin% and er%onomics er%onomics
inclu in clu des the use of err or) (roof (r oofin in% % met hods hod s to ca(abilit#& timin%& and cost5 de% ree a((r o(r iat e to the ma%nit ma% nit ude of the manufacturin% technolo%# a de%ree (roblems and commensurate commensurate !ith the ris8s alternatives5 encountered customer requirements& if an#5 d3 e3 ex(erience from (revious develo(ments5 f3 ne! materials5 (roduct handlin% and er%onomic ,3 requirements5 and desi%n for manufacturin% and desi%n h3 for assembl# The manufacturin% (rocess desi%n shall include the use of error)(roofin% methods to a H.8..8 S3IA? 3HA>A3T 3HA>A3T>ISTI3 >ISTI3S S de%ree a((ro(riate to the The or%ani.ati or%an i.ation on shall identif# ident if# s(ecial s(eci al ma%nitude of the (roblem0s and characte char acterist ristics ics Msee 77 dN and commensurate !ith the ris8s incl ude all s(ecial charac cha racter terist istics ics in the include encountered control (lan& (lan& com(l# com( l# !ith custome cus tomer)s r)s(eci (ecified fied definiti defi nitions ons and s#mbols& s#mb ols& and <777 S(ecial characteristics iden tif# (rocess (roc ess control contr ol documen do cuments ts identif# The or%ani.ation shall use a includin% incl udin% dra!in%s& dra! in%s& F$As& control multidisci(linar# a((roach to establish& document& and im(lement its (rocess0es (lans& and o(erat o(e rator or instru ins tructi ctions ons to identif# s(ecial characteristics& !ith !it h the custo cus tomer merEs Es s(ecia s(e cial l includin% those determined b# the characterist ic s#mbol or or the customer and the ris8 anal#sis (erformed or%ani.ati or%an i.ationRs onRs equivalent equiv alent s#mbol s#mbo l or or b# the or%ani.ation& and shall include the notat not ation ion to inclu inc lude de those tho se (rocess (rocess follo!in%+ ste(s ste (s that tha t affec aff ectt s(ecia s(e cial l h.a3 documentation of all s(ecial characteristics charac character terist istics ics in the dra!in dra!in%s %s 0as required& ris8 anal#sis 0such as F$A& control (lans& and standard !or8/o !or8/o(er (erato atorr instru instructi ctions ons55 s(ecia s(ecial l =OT6 charact cha ract eristi eri stics cs can incl ude =OT6 S(ecial characteristics and (rocess (arameters (rocess (arameters char charac acte teri rist stic ics s are are iden identi tifi fied ed !ith !ith (roduct characteristics s(ecif s(ecific ic mar8in mar8in%s %s and are cascad cascaded ed throu%h each of these documents5 h.3 develo(ment of control and monitorin% strate%ies for s(ecial characteristics of (roducts and (roduction (rocesses5 (rocesses5 h.c3 custom customer) er)s(e s(ecif cified ied a((rov a((rovals als&& !hen !hen required5 h.d3 com(lianc com(liance e !ith customer)s customer)s(ecif (ecified ied defin efinit itio ions ns and and s#mbo #mbols ls or the the c3
Identification of s(ecial characteristics no! tied to ris8 anal#sis
$his clause now contains desi,n reiews6 desi,n erification and desi,n alidation
or%ani.ati or%ani.ationEs onEs equivalen equivalentt s#mbols s#mbols or nota notati tion ons& s& as defi define ned d in a s#mb s#mbol ol conversion table The s#mbol Desi,n and deelo/ment reiew sstematic reiews reiews of conversion table shall be submitted to #t suitale sta,es6 sstematic desi,n and deelo/ment shall e /erformed the customer& if required in accordance with /lanned arran,ements 2see H.8.13 3.4.a) to ealuate the ailit of the Dsin an" "v!opmnt ".!.4 results of desi,n and deelo/ment to +ontro!s $he or,ani-ation shall meet requirements6 and a//l controls to the desi,n and deelo/ment /rocess to ensure that:
a) the results to e achieed are defined b)reiews are conducted to ealuate the ailit of the results of desi,n and deelo/ment to meet requirements c) erificati erification on actiities are conducted to ensure that the desi,n and deelo/ment out/uts meet the in/ut requirements d)alidation actiities are conducted to ensure that the resultin, /roducts and serices meet therequirements for the s/ecified a//lication or intended use e) an necessar actions are ta7en on /rolems determined durin, the reiews66 or erification andalidation reiews actiities f) documented information of these actiities is retained. 4O$5 Desi,n and deelo/ment reiews6 erification and alidation alidation hae distinct /ur/oses. $he can e conducted se/aratel or in an comination6 as is suitale for the /roducts /roduct s and serices of the or,ani-ation.
<74 <741 1 $onito $onitorin rin% % $easurements at s(ecified sta%es durin% the
controls
to identif an /rolems and /ro/ose necessar actions.
3.4.b)
=artici/ants in such reiews shall include re/resentaties of functions concerned with the desi,n and deelo/ment sta,e2s3 ein, reiewed. Records of the results of the reiews and an necessar actions shall e maintained 2see '..'3.
=OT6 =O T6 These The se revie! rev ie!s s are ar e nor mall# mal l# coord coo rdin inate ated d !ith !it h the th e desi% des i%n n (hases and include incl ude manufact manu facturi urin% n% (rocess (rocess desi%n and develo(ment
;841 MOITO,I $easur $ea sureme ements nts at s(ecif s(e cified ied sta%es sta %es of desi%n des i%n and develo dev elo(me (ment nt shall sha ll be defined& defi ned& anal#s ana l#sed ed and re(ort re( orted ed !ith !it h sum s umma mar# r# result res ults s as an in(ut in (ut to mana% man a%eme ement nt revie! rev ie! These measurem meas urement ents s include incl ude =OT6 =O T6 qualit# ris8s& costs& lead)times& critical (aths (aths and others& othe rs& as a((ro(r a(( ro(r iate iate
7.!.
Dsin an"
=o! includes activit# re(ortin% to the customer as required
desi%n and develo(ment of (roducts and (rocesses shall be be defined& anal#sed& and re(orted !ith summar# results as an in(ut to mana%ement revie! 0see Section 97,1
"v!opmnt "v!opmnt vrii+ation Nerification shall e /erformed in accordance with /lanned arran,ements 2see H.8.13 to ensure th that th the desi,n and deelo/ment out/uts hae met the desi,n and deelo/ment in/ut requirements. Records of the results of the erification and an necessar actions shall e maintained 2see '..'3.
Dhen required b# the customer& measurements of the (roduct and (rocess develo(me develo(ment nt activit# activit# shall be re(orted re(orted to the customer at sta%es s(ecified& or a%reed to& b# the customer =OT Dhen a((ro(riate& these measurements ma# include qualit# ris8s& costs& lead times& critical (aths& and other measurements
Dsin an" "v!opmnt va!i"ation Desi,n and deelo/ment alidation shall e /erformed in accordance with /lanned arran,ements arran,ements 2see 2see H.8.13 H.8.13 to ensure that the resultin, /roduct is ca/ale of meetin, the <74, <74, :esi%n :esi%n and develo(ment develo(ment validation validation requirements for the s/ecified a//lication or :esi%n and develo(ment validation shall be intended use6 where 7nown. Bhereer (erformed in accordance accordance !ith customer requirements& includin% an# a((licable /racticale6 alidation shall e com/leted industr# and %overnmental a%enc#)issued /rior to the the delier delier or im/lementation of re%ulator# standards The timin% of desi%n the /roduct. Records of the results of and develo(ment validation shall be (lanned alidation alidation and an necessar necessar actions shall in ali%nment !ith customer)s(ecified timin%& e maint ained 2see '..'3. as a((licable =OT 1 The validatio valid ation n (rocess (roc ess normall# norm all# Dhere contractuall# a%reed !ith the includes incl udes an anal#sis anal# sis of field fiel d re(orts re(o rts for customer& this shall include evaluation of the similar simi lar (roducts (roducts interaction of the or%ani.ationEs (roduct& includin% embedded soft!are& !ithin the =OT , The requirements of 7- and 76 s#stem of the final customerEs (roduct above abo ve a((l# a(( l# to both bo th (rod (r oduct uct and 7.!.#
manufacturin% (rocesses ;861 D>SI AD D>@>O#M>T
@AIDATIO SB##>M>TA :esi%n :esi% n and develo(m deve lo(ment ent validati vali dation on shall shal l be (erformed be (erformed in accordance !ith customer requirements& includ in cludin% in% (ro%ramme timin%
;862 ;86 2 #,O #,OTOT TOT#> #> #,O #,O,A ,AMM> MM>
Added a((licable a((licable re%ulator# requirements& coordination !ith customer timin%& and the interaction of the (roduct !ith the customerRs (roduct to the validation clause
<747 <747 rotot#(e rotot#(e (ro%ra (ro%ramme mme Dhen required b# the customer& the or%ani.ation shall have a (rotot#(e (ro%ramme and control (lan (lan The or%ani.ation shall use& !henever (ossible& the same su((liers& toolin%& and manufacturin% (rocesses as !ill be used in (roduction
Dhen Dh en requir req uired ed b# the custo cus tomer mer& & the or%ani.ati or%an i.ation on shall ha have a (rotot#(e (rotot#(e (ro%ramme and control (lan (lan The or%ani.ation shall use& !herev !h erever er (ossible& (ossible& the same su((liers& toolin % and manufact manu facturin urin% % (rocesses as !ill !ill be be used se d in (roduction in (roduction All (erformance)testin% (erformance)testin% activities activities shall be shall be monitore moni tored d for timel# time l# com(letio com(l etion n and conformi t# to requirements Dhile Dh ile servic ser vices es ma# be outsou out source rced& d& the th e or%ani.ati or%an i.ation on shall shal l be res( re s(on onsi sibl ble e for fo r the th e outsourced services& includin% technical leadershi(
All (erformance)testin% activities shall be moni monito tore red d for for time timel# l# com( com(le leti tion on and and conformit# to requirements Dhen Dhen serv servic ices es are are outs outsou ourc rced ed&& the the or%ani.ati or%ani.ation on shall shall include include the t#(e and extent of control in the sco(e of its qualit# mana mana%e %eme ment nt s#st s#stem em to ensu ensure re that that outsour ce ced services conform to requirements 0see ISO 9**1& Section <4
<744 roduct a((roval (rocess The or%ani.ation shall establish& im(lement& and maintain a (roduct and manufacturin% a((roval (rocess conformin% to requirements defined b# the customer0s The or%ani.ation shall a((rove externall# (rovided (roducts and services services (er ISO 9**1& Section <47& (rior to submission of their (art a((roval to the customer The or%ani.ati or%ani.ation on shall obtain obtain documente documented d (roduct a((roval (rior to shi(ment& if required b# the customer >ecords of such a((roval shall be retained
The a((lication of (roduct a((roval to su((liers is moved out of the note and into >O:@3T A>O A>OA? A? the clause requirements
;868 >O3SS Have to have documented a((roval The or%ani.ati or%an i.ation on shall shal l conf co nfor orm m to a (roduct and manufacturi manufac turin% n% (rocess (rocess a((roval a((roval (rocedure reco%ni.ed reco%ni.ed b# the the customer =OT roduct a((roval should should be subsequen t to the verification of the manufacturin% (rocess This Th is (roduct (roduct and manufacturin% manufacturin% (rocess (rocess a((roval (rocedure (rocedure shall shall also al so be a((lie a(( lied d to su((liers
=OT ro roduct a((roval should subs subseq eque uent nt to the the veri verifi fica cati tion on of manufacturin% (rocess
be the the
-85 Dsin an" "v!opmnt o'tp'ts $he or,ani-ation shall ensure that desi,n and deelo/ment out/uts:
a) meet the in/ut requirements b)are adequate for the susequent /rocesses for the /roision of /roducts and serices c) inclu include de or reference monitorin, and measurin, requirements6 as a//ro/riate6 and acce/tance criteria
;88 Dsin an" "v!opmnt "v!opmnt o'tp'ts $he out/uts of desi,n and deelo/ment shall e in a form suitale for erification a,ainst the desi,n and deelo/ment in/ut and shall e a//roed /rior to release. Desi,n and deelo/ment out/uts shall meet the in/ut requirements for desi,n and deelo/ment6
a)
b) /roide a//ro/riate a//ro/riate information for
/urchasin,6 /roduction and serice /roision6 d)s/ecif the characteristics of the /roducts and serices that are c) contain or reference reference /roduct acce/tance essential for their intended criteria6 and /ur/oseand their safe and /ro/er /roision. d) s/ecif the characteristics of the /roduct $he or,ani-ation shall retain documented that are essential for its safe and /ro/er information on desi,n and deelo/ment use. out/uts. <7- <7-1 1 :esi% :esi%n n and develo(m develo(ment ent out(uts out(uts ; 4O$5 Inf ormation for /roduction and serice su((lemental /roision can include details for the The list of (roduct desi%n out(uts is The (roduct desi%n out(ut shall be /reseration of /roduct. ex(ressed in terms that can be verified and no! more extensive validated a%ainst (roduct desi%n in(ut requirements The (roduct desi%n out(ut >O:@3 :@3T T :S :SI= I= O@T O@T@T @TS S ; ;881 >O shall include but is not limited to the follo!in%& as a((licable+ S@?$=TA? a3 desi%n ris8 anal#sis 0F$A5 The (roduct desi%n out(ut shall be shall be 3 reliabilit# stud# results5 ex(res ex( ressed sed in term te rms s that tha t can be verifi ver ified ed c3 (roduct s(ecial characteristics5 characteristics5 and valid val idate ated d a%ain a%a inst st (roduct desi%n d3 resu result lts s of (rod (roduc uctt desi desi%n %n erro error) r) in(ut requirement s The (roduct desi%n (roofin%& such as :FSS& :FSS& :F$A& and FTA5 out(ut out( ut shall include e3 (roduct definition includin% includin% 7: models& desi%n desi %n F$A& reliabilit # results& technical data (ac8a%es& (roduct (roduct s(ecial charac ch aracteri teristic stics s and manufacturin% information& and s(ecifications& %eometric dimensionin% G tolerancin% (roduct error)(roofin%& error)(roofin%& as a((ro(riat e& 0:GT5 f3 ,: dra!in%s& (roduct manufacturin% (roduct definition includin% dra!in%s or information& and %eometric mathemat math ematicall icall # based data& data &
dimensionin% G tolerancin% 0:GT5 results& and (roduct desi%n revie!s results& (roduct desi%n revie! results5 results5 dia% nostic ic %uidelines& !here a((licable dia%nost h3 servic service e dia%no dia%nosti stic c %uidel %uideline ines s and re(air and serviceabilit# instructions5 i3 service (art requirements5 (ac8a%in% and labelin% requirements for shi((in% =OT Interim desi%n out(uts should include an# en%ineerin% (roblems bein% resolved throu%h a tradeoff (rocess ,3
The list of (rocess desi%n out(uts is no! more extensive <7-, <7-, $anufactur $anufacturin% in% (rocess (rocess desi%n out(ut The or%ani.ation shall document the manufacturin% (rocess desi%n out(ut in a manner that enables verification a%ainst the manufacturin% (rocess desi%n in(uts The $A=@FA3T@>I= T@>I= >O3SS ;882 $A=@FA3 or%ani.ation shall verif# the out(uts a%ainst :SI= :SI = O@T O@T@T @T manufacturin% (rocess desi%n in(ut The manufac turin% turi n% (rocess desi%n out(ut requirements The manufacturin% (rocess shall be ex(r ex (res esse sed d in term te rms s that th at can ca n be desi%n out(ut shall include but is not limited verified veri fied a%ainst a%ai nst manufact man ufacturin urin% % (rocess to the follo!in%+ desi%n desi% n in(ut in(u t requirem requ irements ents and validated valid ated s(ecifications and dra!in%s5 a3 The manufac turin% turi n% (rocess desi%n out(ut 3 s(ecial characteristics for (roduct shall include and manufacturin% (rocess5 s(ec ificatio ations ns and dra!in%s& dra!i n%s& c3 identi identific ficati ation on of (roces (rocess s in(ut in(ut s(ecific manufact manu facturin urin% % (rocess flo! variables that im(act characteristics5 d3 toolin% and equi(ment for (roduction chart/la#out& and control& includin% ca(abilit# manu facturin urin% % (rocess F$As& F$As& manufact studies of equi(ment and (lan 0see -11& -11& control (lan (rocess0es5 !or8 instructio ns& e3 manu manufa fact ctur urin in% % (roc (roces ess s flo! flo! a((roval acce(tance criteria& charts/la#out& includin% lin8a%e of (roduct& (rocess a((roval data dat a for qualit qua lit#& #& reliabilit#& (rocess& and toolin%5 maintainabil it# and measurabilit# & f3 ca(acit# anal#sis5 ,3 manufacturin% (rocess F$A5 resu lts of error)(r erro r)(roofi oofin% n% activitie activ ities& s& as results h3 maintenance (lans and a((ro(riate& and instructions5 meth me thod ods s of ra(i ra (id d dete de tect ctio ion n and an d i3 control (lan 0see Annex A5 feed fe edba bac8 c8 of (roduct/manufacturin% (roduct/manufacturin% standard !or8 and !or8 !or8 instructions5 (rocess nonconformities nonconformities 8 (rocess a((roval acce(tance criteria5 I data for qualit#& reliabilit#& maintainabilit#& and measurabilit#5 m results results of error)(roof error)(roofin% in% identifica identification tion and verification& as a((ro(riate5
n methods of ra(id detection& feedbac8& and correction of (roduct/manufacturin% (rocess nonconformities nonconformities
Dsin an" "v!opmnt +(ans -/8/6 $he or,ani-ation shall identif6 reiew and control chan,es made durin,6 or susequent to6 the desi,n and deelo/ment of /roducts and serices6 to the e)tent necessar to ensure that there is no aderse im/act on conformit to requirements. $he or,ani-ation shall retain documented information on:
a) desi,n and deelo/ment chan,es b)the results of reiew reiews s c) the authori-ation of the chan,es d)the actions ta7en to /reent aderse im/acts.
<761 :esi%n and develo(ment chan%es ; su((lemental The or%ani.ation shall evaluate all desi%n chan%es after initial (roduct a((roval& includin% those (ro(osed b# the or%ani.ation or its su((liers& for (otential im(act on fit& form& function& (erformance& and/or durabilit# These chan%es shall be validated a%ainst customer requirements and a((roved internall#& (rior to (roduction im(lementation im(lementation If required b# the customer& the or%ani.ation shall obtain documented a((roval& or a documented !aiver& from the customer (rior to (roduction im(lementation For (roducts !ith embedded soft!are& the
;8; Contro! o "sin an" "v!opmnt +(ans Desi,n and deelo/ment chan,es shall e identified and records maintained. $he chan,es shall e reiewed6 erified and alidated6 as a//ro/riate6 and a//roed efore im/lementation. $he reiew of desi,n and deelo/ment chan,es shall include ealuation of the effect of the chan,es on constituent /arts and /roduct /roduct alread deliered. Records of the results of the reiew of chan,es and an necessar actions shall e maintained 2see '..'3. :esi%n :es i%n and an d develo dev elo(me (ment nt chan% cha n%es es =OT6 =O T6 include incl ude all chan%es durin% duri n% the (roduct (ro duct (ro%ramme life 0see 0see 14 ;14 3HA= 3O=T>O 3O=T>O? ? The or%ani.ati or%an i.ation on shall shal l ha have a (rocess to control and reac re actt to chan ch an%e %es s that th at im(a im (act ct (roduct reali.ation The effec eff ects ts of an# chan%e& includ inc ludin% in% those tho se chan%e cha n%es s caused cau sed b# an# su((lier su(( lier& & shall be assessed asse ssed& & and verifica veri fication tion and valid ation atio n activiti acti vities es shall be defined& defi ned& to ensure ensu re com(lia com (liance nce !ith customer requirements 3han%es 3han %es shall shal l be validated before im(lementati on For Fo r (ro(rietar# desi%ns& im(ac im (actt on form fo rm&& fit and functi fun ction on 0incl 0in cludi udin% n% (erformance and/or and/o r durabilit dura bilit# # shall shal l be rev r evie ie!e !ed d !ith !i th the th e cust cu stom omer er so that th at all al l effe ef fect cts s can ca n be (ro(erl# evaluated evaluated Dhen Dh en requir req uired ed b# the custo cu stomer mer& & additional verification /identificat ion requirements & such su ch as thos th ose e requ re quir ired ed for fo r ne! n e! (roduct (roduct introduction& shall be met me t =OT =OT 1 An# (roduct reali.ation chan%e affecti affe ctin% n% custome cust omerr require requ irement ments s requires requ ires notificat noti ficat ion to& and a%reemen a%re ementt from& fro m& the customer
or%ani.ation shall document the revision level of soft!are and hard!are as (art of the chan%e record
-4 Contro! o xtrna! provision provision o oo"s an" srvi+s *.'.1 eneral $he or,ani-ation shall ensure that e)ternall /roided /rocesses6 /roducts and serices conform to requirements. requirements. $he or,ani-ation shall determine the controls to e a//lied to e)ternall /roided /rocesses6 /roducts and serices when: a) /roducts and serices from e)ternal /roiders are intended for incor/oration into the or,ani-ations own /roducts and serices b)/roducts and serices are /roided directl to the customer2s3 e)ternal /roiders on ehalf of the or,ani-ation c) a /rocess6 or /art of a /rocess6 is /roided an e)ternal /roider as a
=OT , The above abov e require requ irement ment a((lies to (roduct and manufactu rin% (rocess chan%es
;4 #'r+(asin ;/4/1
#'r+(asin pro+ss
$he or,ani-ation shall ensure that /urchased /roduct conforms to s/ecified s/ecified /urchase requirements. requirements. $he t/e and e)tent of control a//lied to the su//lier and the /urchased /roduct shall e de/endent u/on the the effect of of the /urchased /roduct on susequent susequent /roduct reali-ation or the final /roduct. $he or,ani-ation shall ealuate and select su//liers ased on their ailit to su//l /roduct in accordance accordance with the or,ani-ationGs requirements. (riteria for selection6 ealuation and reealuation shall e estalishe d. Records of the results of ealuations and an necessar actions arisin, from the ealuation shall
(lause roadened to s/ecificall coer e)ternall /roided /rocesses6 /roduct and serices A more clearl coers outsourced /rocesses
?ore clearl a//lies to /roduct related /roducts6 /rocesses and serices serices
result of a decision the or,ani-ation. $he or,ani-ation shall determine and a//l criteria for the ealuatio ealuation6 n6 selection6 monitorin, of /erformance6 and re ealuation of e)ternal /roiders6 ased on their ailit to /roide /rocesses or /roducts and serices in accordance with requirements. $he or,ani-ation shall retain documented information of these actiities and an necessar actions arisin, from the ealuations.
<411 <411 eneral eneral ; su((lemen su((lemental tal The or%ani.ation shall include all (roducts and services that that affect customer requirements such as subassembl#& sequencin%& sortin%& re!or8& and calibration services in the sco(e of their definition of externall# (rovided (roducts& (rocesses& (rocesses& and services
<41, <41, Su((lier Su((lier selection selection (rocess (rocess The or%ani.ation shall have a documented su((lier selection (rocess The selection selection (rocess shall include+ a3 an assessment of the selected su((lierEs ris8 to (roduct conformit# and uninterru(ted su((l# of the or%ani.ationEs (roduct to their customers5 3 rel relevan evantt quali ualit# t# and and deli deliv ver# er# (erformance5 an evaluation of the su((lierEs qualit# c3 mana%ement s#stem5 multidisc multidisci(lin i(linar# ar# decision decision ma8in%5 ma8in%5 d3 and an assessment of soft!are e3 develo(ment ca(abilities& if a((licable Other su((lier selection criteria that should
e maintained maintained 2see '..'3.
=OT 1 urchase urc hased d (roducts above include incl ude all (roducts all (roducts and services that affect aff ect custom cus tomer er requ re quire ireme ments nts such suc h as sub) assembl#& assem bl#& sequencin%& sortin%& re!or8 and calibra tion services =OT , Dhen Dhe n there ther e are mer%ers& mer% ers& acquisit acqu isitions ions or affilia aff iliation tions s associat asso ciated ed !ith su((liers& the or%ani or% ani.at .ation ion shoul sh ould d verif# ver if# the th e contin cont inuit uit# # of the su((li su( (lier erEs Es qualit qua lit# # mana%eme mana %ement nt s#stem s#st em and its effective effec tiveness ness
=ote 1 is no! in the su((lemental requirements clause <411
=ote , is no! in the su((lemental requirements clause <41,
>equires a documented su((lier selection (rocess includin% more details concernin% to(ics considered
be considered include the follo!in%+ volu volume me of auto automo moti tive ve busi busine ness ss L 0absol 0absolute ute and as a (ercen (ercenta% ta%e e of total total business5 L financial stabilit#5 (urchased (roduct& material& or L service com(lexit#5 requ requir ired ed tech techno nolo lo%# %# 0(ro 0(rodu duct ct or L (rocess5 adequac# of available resources 0e%& L (eo(le& infrastructure5 desi%n and develo(ment ca(abilities L 0includin% (roect mana%ement5 manufacturin% ca(abilit#5 L L chan%e mana%ement (rocess5 business business continuit# continuit# (lannin% (lannin% 0e%& 0e%& L disa disast ster er (re( (re(ar ared edne ness ss&& cont contin in%e %enc nc# # (lannin%5 L lo%istics (rocess5 L customer service
H.'.1.8 3@STO$>)A>O: SO@>3S -418 3usto 3ustomer mer)di )direc rected ted source sources s 8no!n as ':irected)2u#' Dhen s(ecified b# the customer& the or%ani.ation shall (urchase (roducts& materials& or services from customer) directed sources
0also 0also
All requirements of Section <4 0exce(t the requ requir irem emen ents ts in IATF IATF 1694 16949& 9& Sect Sectio ion n <41, are a((licable to the or%ani.ationEs contro controll of custom customer) er)dir direct ected ed source sources s unless s(ecific a%reements are other!ise defi define ned d b# the the cont contra ract ct bet! bet!ee een n the the or%ani.ation and the customer
Dhe re s(ecif s(e cifie ied d b# the contr con tract act 0e% 0e % customer cust omer en%ineer en%i neerin% in% dra!in%& dra!i n%& s(ecification& the or%ani.ati or%an i.ation on shall shal l (urchase (roducts& (urchase (roducts& materi mat erials als or servi ser vices ces from fro m a((roved a((r oved sources sour ces The use of customer cust omer)des )desi%na i%nated ted sources& sour ces& includin incl udin% % tool/%au tool /%au%e %e su((lier su(( liers& s& does do es not no t reli re liev eve e the th e or%a or %ani ni.at .atio ion n of the t he res(on res (onsib sibili ilit# t# for fo r ensuri ens urin% n% the qualit qua lit# # of (urchased (roducts
=ote that the requirements in <41, !ith res(ect to su((lier selection do not a((l# to directed bu# sources
T%p an" xtnt o +ontro! -/4/2 $he or,ani-ation shall ensure that e)ternall /roided /rocesses6 /roducts and serices do not adersel affect the or,ani-ations ailit to consistentl delier conformin, /roducts and serices to its customers. $he or,ani-ation shall: a) ensure that e)ternall /roided /roided /rocesses remain within the control of its qualit mana,ement sstem
b)define oth the controls that it intends to a//l to an e)ternal /roider and those it intends to a//lto the resultin, out/ut
@rii+ation o p'r+(as" ;/4/8 pro"'+t $he or,ani-ation shall estalish and im/lement the ins/ection or other actiities actiities necessar for ensurin, that /urchased /roduct meets s/ecified /urchase requirements. Bhere the or,ani-ation or its customer intends to /erform erification at the su//lierGs /remises6 the or,ani-ation shall state the intended erification arran,ements and method of /roduct release in the /urchasin, information.
$/e " e)tent of control se/arated into new clause and erification of /urchased /roduct incor/orated into this clause
4ew requirements Eto ensure that e)ternall /roided /rocesses remain within the control of its Q?S A we "o not intrprt this to mean that an or,ani-ation hain, an outsource Process cannot drop ship to the c!stomer
c) ta7e into consideration: 1)
the /otential im/act of the e)ternall /roided /rocesses6 /roducts and serices on the or,ani-ations ailit to consistentl meet customer and a//licale statutor and re,ulator requirements
2)
the effectieness of the controls a//lied the e)ternal /roider
d)determine the erification6 or other actiities6 necessar to ensure that the e)ternall /roided /rocesses6 /roducts /roducts and serices meet requirements
<4, 4,1 T#(e T#(e and and exte extent nt of contr ontrol ol ; su((lemental The or%ani.ation shall have a docum ocumen ente ted d (ro (roces cess to ident dentif if# # outsourced (rocesses and to select the t#(es t#(es and extent extent of contro controls ls used used to
=eed a documented (rocess to select and control outsourced (rocesses
verif# conformit# of externall# (rovided (roducts& (rocesses& and services to internal internal 0or%ani.at 0or%ani.ational ional and external external customer requirements The (rocess shall include the criteria and actions to escalate or reduce the t#(es and extent of controls and develo(ment activities based on su((lier (erformance and assessment of (roduct& material& or service ris8s
;411 STATBTO, AD ,>BATO, COFO,MIT All (urchased All (urchased (roducts or materials use us ed in (roduct shall conf co nfor orm m to a((l icable le statutor stat utor# # and re%ulator# re%ulat or# <4,, Statutor# and re%ulator# a((licab requirements requirements The or%ani.ation shall document their (rocess to ensure that (urchased (roducts& (rocesses& and services services conform to the current a((licable statutor# and re%ulator# requirements in the countr# of recei(t& the countr# of shi(ment& and the customer) identified countr# of destination& if (rovided If the customer defines s(ecial controls for certain (roducts !ith statutor# and re%ulator# requirements& the or%ani.ation shall ensure the# are im(lemented and maintained as defined& includin% at su((liers
x(anded su((lemental clause requirin% a documented (rocess for ensurin% re%ulator# com(liance and associated customer com(liance b# the su((l# chain
The su((lier "$S develo(ment has been clarified5 no! includes second (art# H.'.1. SB##I>, 7BAIT MAA>M>T audits5 ISO9**1 certification b# SST>M D>@>O#M>T accredited 325 325 the (rocess sequence sequence The or%ani.ati or%an i.ation on shall (erform su((lier leads to certification to IATF 16949 qualit# qual it# mana%eme mana %ement nt s#stem develo( ment !ith !i th the %oal of su((li su( (lier er conf c onfor ormi mit# t# !ith !it h <4,7 <4,7 Su((lier Su((lier qualit# qualit# mana%ement mana%ement s#stem this Technic Tec hnical al S(ecification 3onformi 3onf ormit# t# develo(ment The or%ani.ation shall require their !ith !i th ISO IS O 9**1 9* *1+, +,** **< < is the th e firs fi rstt ste( st e( in su((liers of automotive (roducts and achiev ach ievin% in% this thi s %oal services to develo(& im(lement& and =OT6 =O T6 The Th e (rioriti.ation (rioriti.ation of su((liers for im(rove a qualit# mana%ement s#stem develo(me devel o(ment nt de(ends de(e nds u(on& u(on & for exam(le& exam (le& certified to ISO 9**1& unless other!ise authori.ed b# the customer Me%& item a the th e su((li su( (lierE erEs s quali qua lit# t# (erformance and belo!N& !ith the ultimate obective of the th e im(or im( orta tance nce of the (roduct the (roduct su((lied becomin% certified to this Automotive "$S Standard @nless other!ise s(ecified b# the @nl ess other !ise !is e s(ecif s(e cified ied b# the customer& the follo!in% sequence should be @nless customer& su((li su( (liers ers to the or%ani or% ani.at .ation ion a((lied to achieve this requirement+
a3 3
c3
d3
e3
com( com(li lian ance ce to ISO ISO 9**1 9**1 thro throu% u%h h shall be thir th ird d (art#& re%i re %ist ster ered ed to ISO I SO second)(art# audits5 9**1+, 9** 1+,**< **< b# an accre acc redit dited ed third thi rd)(a )(art# rt# certification to ISO 9**1 throu%h third) certificati on bod# (art# audits5 unless other!ise s(ecified b# the the cust custom omer er&& su(( su((li lier ers s to the the or%a or%ani ni.a .ati tion on shal shalll demo demons nstr trat ate e conformit# to ISO 9**1 b# maintainin% a third) third) (art# (art# certif certifica icatio tion n issued issued b# a certification bod# bearin% the accreditation mar8 of a reco%ni.ed IAF $?A 0International Accreditation Forum $ultilate $ultilateral ral >eco%niti >eco%nition on Arran%eme Arran%ement nt member member and !here !here the accred accredita itatio tion n bod#Es main sco(e includes mana%e mana%emen mentt s#stem s#stem certif certifica icatio tion n to ISO/I3 1*,15 certification to ISO 9**1 !ith com(lianc com(liance e to other customer)d customer)define efined d "$S requirements requirements 0such as $inimum $inimum Automotive "ualit# $ana%ement S#st S#stem em >equ >equir irem emen ents ts for for Sub) Sub)Ti Tier er Su((li Su((liers ers M$A"$S M$A"$S>N >N or equiva equivalen lent t throu%h second)(art# audits5 certification to ISO9**1 !ith com(liance to IATF IATF 16949 16949 throu% throu%h h second second)(a )(art# rt# audits5 certif certifica icatio tion n to 16949 16949 throu% throu%h h third) third) (art# audits 0valid third)(art# certif certifica icatio tion n of the su((li su((lier er to IATF IATF 16949 b# an lATF)reco%ni.ed certification bod#
-4281 Autom Automoti otive ve (roduc (roduct)r t)rela elated ted soft soft!a !are re or auto automo moti tive ve (rod (roduc ucts ts !ith !ith embedded soft!are The or%ani.ation shall require their su((liers of automotive (roduct)related soft!are& or automotive (roducts !ith embedded soft!are& to im(lement and maintain a (rocess for soft!are qualit# assurance for their (roducts A soft!are develo(ment develo(ment assessment methodolo%# shall be utili.ed to assess
=e! clause requirin% su((liers of (roduct !ith embedded soft!are to have a soft!are "A (ro%ram for their (roducts and to use a soft!are soft!are develo(ment assessment methodolo%# in assess their s#stem
the su((lierEs soft!are develo(ment (rocess @sin% (rioriti.ation (rioriti.ation based on ris8 and (otential im(act to the customer& the or%ani.ation shall require the su((lier to retain documented information of a soft!are develo(ment ca(abilit# self) assessment
-424 Su((lier -424 Su((lier monitorin% The or%ani.ation shall have a documented (rocess and criteria to evaluate su((lier (erformance in order to ensure ensure conformit# of externall# (rovided (roducts& (rocesses& and services services to internal and external customer requirements At a minimum& the follo!in% su((lier (erformance indicators shall shall be monitored+ deli delive vere red d (rod (roduc uctt conf confor ormi mit# t# to e.a3 requirements5 customer disru(tions at the receivin% e.3 (lant& includin% #ard holds holds and sto( shi(s5 deliver# schedule (erformance5 e.c3 e.d3 number number of occurrence occurrences s of (remium frei%ht If (rovided b# the customer& the or%ani.ation shall also include the follo!in%& as a((ro(riate& in their su((lier (erformance monitorin%+ e.e3 s(ecial status customer notifications related to qualit# or deliver# issues5 e.f3 dealer returns& !arrant#& field actions& and recalls -4241 Second)(art# -4241 Second)(art# audits The or%ani.ation shall include a second) (art# audit (rocess in their su((lier mana%ement a((roach Second)(art# audits ma# be used for the follo!in%+ e.f.a3 su((lier ris8 assessment5 su((lier monitorin%5 e.f.3 e.f.c3 su((lier "$S develo(ment5
H.'.8. SB##I>, MOITO,I Su((lier Su((l ier (erformance (erformance shall be moni mo nito tore red d throu%h thro u%h the follo!in foll o!in% % indicato indi cators+ rs+ deli vered d (roduct conformit# to to delivere requirements5 customer disru(tion s& includ inc ludin% in% field fie ld returns5 delive del iver# r# schedu sch edule le (erformance (erformance 0inclu 0in cludin din% % incid in cident ents s of (remium of (remium frei%ht5 frei%ht5 status st atus customer cust omer notifica noti fication tions s s(ecial relat re lated ed to qualit qua lit# # or deliv del iver# er# issues iss ues The or%ani.ati or%an i.ation on shall (romote shall (romote su((lier moni mo nito tori rin% n% of the th e (erformance of their manufactur manuf actur in% (rocesses in% (rocesses
This ne! clause requires a second (art# audit (rocess of su((liers
(roduct audits5 (rocess audits 2ased on a ris8 anal#sis& includin% (roduct safet#/re%ulator# safet#/re%ulator# requirements& (erformance of the su((lier& su((lier& and "$S certification level& at a minimum& the or%ani.ation shall document the criteria for determinin% the need& t#(e& frequenc#& and sco(e of second)(art# audits The or%ani.ation shall retain records of the second)(art# audit re(orts If the sco(e of the second)(art# audit is to assess the su((lierEs qualit# mana%ement s#stem& then the a((roach shall be consistent !ith the automotive (rocess a((roach =OT uidance ma# be found in the IATF Auditor uide and ISO ISO 19*11 e.f.d3 e.f.e3
-425 Su((lier -425 Su((lier develo(ment The or%ani.ation shall determine the (riorit#& t#(e& extent& and and timin% of required su((lier develo(ment actions for its active su((liers :etermination in(uts shall include but are not limited to the follo!in%+ e.f.e.a3 (erformance issues identified throu%h throu%h su((lier su((lier monitorin% monitorin% 0see Section Section <4,45 e.f.e.3 second second)(a )(art# rt# audit audit findin findin%s %s 0see 0see Section <4,415 e.f.e.c3 thir third) d)(a (art rt# # qual qualit it# # mana mana%e %eme ment nt s#stem certification status5 e.f.e.d3 ris8 anal#sis The or%ani.ation shall im(lement actions necessar# to resolve o(en 0unsatisfactor# (erformance issues and and (ursue o((ortunities for continual im(rovement
Su((lier develo(ment has to include (erformance monitorin%& second second (art# audits and ris8 anal#sis !ith issues identified and follo!ed to effective com(letion
. -48 Inormation or xtrna! provi"rs $he or,ani-ation shall ensure the adequac of requirements /rior to their communication to the e)ternal /roider. $he or,ani-ation shall communicate to e)ternal /roiders /roiders its requirements requirements for:
a) the /rocesses6 /roducts and serices to e /roided
;/4/2 ;/4/2 #'r+ #'r+(a (asi sin n in&or in&orma matio tion n =urchasin, information information shall descrie the /roduct to e /urchased6 includin,6 where a//ro/riate6 a)
b) requirements for qualification of
/ersonnel6 and
b)the a//roal of: 1)
/roducts and serices
2)
methods6 /rocesses and equi/ment
3)
the release of /roducts and serices
c) com/etence6 includin, an required qualification of /ersons
requirements for a//roal of /roduct6 /rocedures6 /rocesses and equi/ment6
c)
qualit mana,ement sstem requirements.
$he or,ani-ation shall ensure the adequac of s/ecified /urchase requirements /rior to their communication to the su//lier.
Bordin, chan,e: ISO 9001:00* required that /urchasin, information 2=Os3 descrie requirements Ewhere a//ro/riate $hose word are not in the reised standard howeer the words are now Ecommunicate to e)ternal /roiders its requirements So if the do not hae such requirements there is nothin, to communicate. Our inter/retation is that there was no essential chan,e
d)the e)ternal /roiders interactions interactions with the or,ani-ation e) control and monitorin, of the e)ternal /roiders /erformance to e a//lied the or,ani-ation erification on or alidatio alidation n actiities that f) erificati the or,ani-ation6 or its customer6 intends to /erform at thee)ternal /roiders /remises.
-481 Information for external (roviders ; su((lemental The or%ani.ation shall (ass do!n all a((licable statutor# and re%ulator# requirements and s(ecial (roduct and
3lause requirin% flo!do!n of re%ulator# and s(ecial characteristics to su((liers and to su((l# chain
(rocess characteristics characteristics to their su((liers and require the su((liers to cascade all a((licable requirements do!n the su((l# chain to the (oint of manufacture
-5 #ro"'+tion an" srvi+ provision Contro! o pro"'+tion an" srvi+ provision $he or,ani-ation shall im/lement /roduction and serice /roision under controlle controlled d conditions. (ontrolled conditions shall include6 as a//licale: a) the aailailit of documented information that defines:
-/5/1
;51 Contro! o pro"'+tion pro"'+tion an" srvi+ provision $he or,ani-ation shall /lan and carr out /roduction and serice /roision under controlled conditions. (ontrolled conditions shall include6 as a//licale6 a)
1)
the characteristics of the /roducts to e /roduced6 the serices to e /roided6 or the actiities to e / erformed 2) the results to e achieed
b)the aailailit and use of suitale monitorin, and measurin, resources c) the im/lementation of monitorin, and measurement actiities at a//ro/riate sta,es to erif that criteria for control of /rocesses or out/uts6 and acce/tance criteria for /roducts and serices6 hae een met d)the use of suitale infrastructure and enironment for the o/eration of /rocesses e) the a//ointment of com/etent /ersons6 includin, an required qualification f) the alidation6 and /eriodic realidation6 of the ailit to achiee /lanned results of the /rocesses for /roduction /roduction and serice /roision6 where the resultin, out/ut cannot e erified susequent monitorin, or measurement g) the im/lementation of actions to /reent
the aailailit of information that descries the characteristics of the /roduct6
b) the aailailit of wor7 instructions6
as necessar6 c)
$he Es/ecial /rocess requirements are not in a se/arate clause the /rocess alidation requirements are now a ullet in the list
#dded requirements requirements #//ointment of com/etent /ersons A if clients do not hae a /rocess&actiit com/etence determination and matri) the need one
the use of suitale equi/ment6
d) the aailailit and use of monitorin,
and measurin, equi/ment6 e)
the im/lementation of monitorin, and measurement6 and
f)
the im/lementation of /roduct release6 delier and /ostdelier /ostdelier actiities.
Im/lementation Im/lementation of actions to /reent human error A nonconformin, /roduct customer com/laints should lead to at least consideration consideration of mista7e/roofin, mista7e/roofin, the /rocess
$he /rocess alidation requirements are now included in the main clause ;52 @a!i"ation or o& pro+sss pro"'+tion an" srvi+ provision $he or,ani-ation shall alidate an /rocesses for /roduction and serice /roision where the resultin, out/ut cannot e erified susequent monitorin, or measurement and6 as a consequence6 deficiencies ecome a//arent onl after the /roduct is in use or the or the serice has een deliered. Nalidation shall demonstrate the ailit of these /rocesses to achiee /lanned
human error
h)the im/lementation of release6 delier and /ostdelier actiities.
=OT Suitable infrastructure includes a((ro(riate manufacturin% equi(ment required to ensure (roduct com(liance $onitorin% and measurin% resources include a((ro(riate monitorin% and measurin% equi(ment required to ensure effective control of manufacturin% (rocesses
results. $he or,ani-ation shall estalish arran,ements for these /rocesses includin,6 as a//licale6 a) defined criteria for reiew and a//roal of the /rocesses6 b) a//roal of equi/ment and qualification
The se(arate clause requirin% validation of all (roduction G service (rovision use of s/ecific methods and /rocedures6 (rocesses is no lon%er lon%er in the standard of /ersonnel6
c)
d) requirements for records 2see '..'36 and
e3 rea reali lida dati tion on..
The requirements no! s(ecificall# reco%ni.e that famil# control (lans are OQ
-, ,1 1 A? A?I:A I:ATIO TIO= = OF >O >O3S 3SS SS S FO FO> > -511 3ontrol (lan The or%ani.ation shall develo( control (lans 0in accordance !ith Annex A at the the s#stem& subs#stem& com(onent& and/or material level for the relevant manufacturin% site and all (roduct ;511 su((lied& includin% those for (rocesses (roducin% bul8 materials materials as !ell as (arts Famil# control (lans are acce(table for bul8 material and similar (arts usin% a common manufacturin% (rocess The or%ani.ation shall have a control (lan for (re)launch and (roduction that sho!s lin8a%e and incor(orates information from the desi%n ris8 anal#sis 0if (rovided b# the customer& (rocess flo! dia%ram& and manufacturin% (rocess ris8 anal#sis out(uts 0such as F$A
>O:@3T >O :@3TIO= IO= A=: S S>I >I3 3 >O >OI ISIO SIO= =; S@?$=TA? The requir req uireme ements nts of -, - , shall sha ll a((l a( (l# # to all al l (rocesses for (roduction for (roduction and service (rovision 3O=T>O? ?A= The or%ani.ati or%an i.ation on shall deve lo( control cont rol (lans (lans 0see Annex Annex A develo( at the s#stem& s#ste m& subs#stem& com(onen com( onentt and/or and/ or material mate rial level for the (roduct su((lied& su((lied& includ in cludin% in% thos th ose e for fo r (rocesses (roducin% (rocesses (roducin% bul8 bul8 mater mat erial ials s as !ell !el l as as (arts& (arts& and hav e a contro con trol l (lan (lan for (re)launch for (re)launch have and (roduction nd (roduction that that ta8es into acco ac coun untt the th e desi de si%n %n F$A F$ A and an d manufact manu facturin urin% % (rocess F$A out(uts
The The or%ani.ation shall& if required b# the customer& (rovide measurement and conformit# data collected durin% execution of either the (re)launch or (roduction control (lans The or%ani.ation or%ani.ation shall include in the control (lan+ controls used for the e.f.e.d.a3 manufacturi manufacturin% n% (rocess (rocess control& control& includin% includin%
The requirements no! s(ecificall# include verifica tion of ob set) u(s and 1 st (iece ins(ections
control contr ol (lan (lan shall list li st the th e cont co ntro rols ls used us ed for fo r the th e manufactu manu facturin% rin% (rocess (rocess control& control& includ inc lude e method met hods s for fo r monito mon itorin rin% % of control exercis exe rcised ed over s(ecial s(eci al character char acter istics istic s 0see 7,7 defined defi ned b# both bo th the th e cust cu stom omer er and an d the th e or%ani.ation& include inclu de the customer) cust omer)requ required ired
verification of ob set)u(s5 information& if an#& an# & and first)off/last)off (art validation& initia ini tiate te the s(eci s(e cifie fied d reacti rea ction on (lan (lan as a((licable5 0see 0s ee <, < ,7 71 1 !hen !h en the th e (rocess methods for monitorin% of e.f.e.d.c3 beco be come mes s unst un stab able le or not no t control statisticall # ca(able exercised over s(ecial characteristics 0see 3ontrol (lans 3ontrol (lans shall be revi re vie! e!ed ed and an d Annex A defined b# b# both the customer and u(da u( date ted d !hen !h en an# an # chan ch an%e %e occu oc curs rs the or%ani.ation5 affecti aff ectin% n% (roduct& manufactur manufac turin% in% (rocess& e.f.e.d.d3 the customer)required measurement& lo%istics& su(( su ((l# l# sour so urce ces s or information& if an#5 The revie! and u(date of control (lans is F$A 0see 14 14 e.f.e.d.e3 s(ecified reaction (lan 0see no! s(ecificall# required in conunction Annex A5 !hen nonconformin% (roduct =OT 3ustomer 3usto mer a((roval a((r oval ma# ma # be !ith nonconformin% (roduct and customer is detected& the (rocess becomes required after revie! or u(date of the com(laints statisticall# unstable or not statisticall# control (lan (lan ca(able The or%ani.ation shall revie! control (lans& and u(date as required& for an# of the follo!in%+ e.f.e.d.f3 the or%ani.ation determines it has shi((ed nonconformin% (roduct to the customer5 e.f.e.d.,3 !hen an# chan%e occurs affectin% (roduct& manufacturin% (rocess& measurement& measurement& lo%istics& su((l# sources& (roduction volume chan%es& or ris8 anal#sis 0F$A 0see Annex A5 e.f.e.d.h3 after a customer com(laint and im(lementation of the associated Dor8 instructions no! also should include corrective action& !hen a((licable5 rules for o(erator safet# e.f.e.d.i3 at a set frequenc# based on a ris8 anal#sis If required b# the customer& the or%ani.ation ;512 DO>Q I=ST> I=ST>@3TIO= @3TIO=S S shall obtain customer a((roval after revie! The or%ani.ati or%an i.ation on shall (re(are shall (re(are documented or revision of the control (lan e.f.e.d.3
!or8 !or 8 instr ins truct uction ions s for fo r all em(lo#e em(l o#ees es havin% hav in% -512 Standardised !or8 ; o(erator res(on res (onsib sibili ilitie ties s for fo r the o(erat o(e ration ion of instructions and visual standards (rocesses that im(act conformit# to The or%ani.ation shall ensure that (roduct requirements requirements These Th ese instructi instr uctions ons standardised !or8 documents are+ be acce ac cess ssib ible le for fo r use us e at the th e !or8 !o r8 e.f.e.d.i.a3 communicated to and shall unde unders rsto tood od b# the the em(l em(lo# o#ee ees s !ho !ho are are station res(onsible for (erformin% the !or85
le%ible5 (resented in the lan%ua%e0s understood b# the (ersonnel res(onsible to follo! them5 e.f.e.d.i.d3 acce access ssib ible le for for use use at the the desi%nated !or8 area0s The standardised !or8 documents shall also include rules for o(erator safet# e.f.e.d.i.3 e.f.e.d.i.c3
These Thes e instruct inst ructions ions shall shal l be deri de rive ved d from fr om sour so urce ces s such su ch as the th e qual qu alit it# # (lan& the the control (lan (lan and the (roduct the (roduct reali.ation reali.ation
erification of ob set)u(s no! s(ecificall# referenc refe rences es 1st (iece ins(ections and requires records
(rocess ;518 >I >IFI3ATI FI3ATIO= O= OF LO2 ST) ST)@S @S Lob set)u set )u(s (s shall sha ll be verifi ver ified ed !henev !he never er
(erformed& such as an initial ru r un of a ob& -518 erification of ob set)u(s material chan% ch an%eov eover er or ob or ob chan%e The or%ani.ation shall+ e.f.e.d.i.d.a3 veri verif# f# ob ob set)u et)u(s (s !hen hen Dor 8 instruct inst ructions ions shall be avai av aila labl ble e for fo r (erformed& such as an initial run of a Dor8 set)u( set )u( (ersonnel The Th e or%ani.ati or%an i.ation on shall ob& material chan%eover& or ob chan%e that requires a ne! set)u(5 use statisti stat istical cal methods meth ods of verific ver ificatio ation& n& e.f.e.d.i.d.3 maintain documented !here a((licable information for set)u( (ersonnel5 e.f.e.d.i.d.c3 use use stat statis isti tica call meth method ods s of =OT ?ast)of ?as t)off)( f)(art art com(aris com( arisons ons are verification& !here a((licable5 recommended e.f.e.d.i.d.d3 (erform first)off/last)off (art vali valida dati tion on&& as a((l a((lic icab able le55 !her !here e a((ro(riate a((ro(riate&& first)off first)off (arts should be retained for com(arison !ith the last)off erification after shutdo!n is a ne! sub) (arts5 !here a((ro(riate& last)off)(arts clause should be retained for com(arison !ith first)off (arts in subsequent runs5 e.f.e.d.i.d.e3 retain records of (rocess and (roduct a((roval follo!in% set)u( and first)off/last)off (art validations .
<-14 <-14 erificati erification on after after shutdo!n shutdo!n The or%ani.ation shall define and im(lement the necess necessar# ar# action actions s to ensure ensure (roduc (roduct t com( com(li lian ance ce !ith !ith requ requir irem emen ents ts afte afterr a (lanned or un(lanned (roduction shutdo!n (eriod ;514 > > =TI =TI A=: >:I3 > :I3TI TI $AI=T=A=3 <-1<-1- Total (roduct (roductive ive maintenan maintenance ce The or%ani.ati or%an i.ation on shall shal l iden i dentif tif# # 8e# (rocess The or%ani.atio or%ani.ation n shall develo(& develo(& im(lement& im(lement& equi(m equ i(ment ent and (rovide resources for and maintain a documented total (roductive machine/ mach ine/equi equi(ment (ment mainte ma intenance nance and maintenance s#stem dev elo( ( an effec eff ectiv tive e (lanned total At a minimum& the s#stem shall include the develo
follo!in%+ (reventive maintenance maintenance s#stem As a identific ficati ation on of (roces (rocess s equi(m equi(ment ent minimum& this a3 identi thi s s#stem s#st em shall sha ll inclu inc lude de the th e $aintenance obectives are no! an in(ut to nece necess ssar ar# # to (rod (roduc uce e conf confor ormi min% n% follo!in%+ mana%ement revie! (roduct at the required volume5 volume5 (lanned maintenance maintenance activities5 activities5 3 availabilit# of re(lacement (arts for the and (reservation of (ac8a%in% equi(ment identified in item a5 equi(ment& tool to olin in% % and an d %au%in%5 c3 (rovision of resource for machine& avai labilit# it# of re(laceme re(l acement nt (arts for 8e# availabil equi(ment& and facilit# maintenance5 manufacturin % equi(ment5 d3 (ac8a%in% and (reservation of documentin%& evalua eva luati tin% n% and im(ro im( rovin vin% % equi(ment& toolin%& and %au%in%5 maintenance obectives e3 a((licable customer)s(ecific >evie! of the maintenance (lan and requirements5 The or%ani.ati or%an i.ation on shall utili. uti li.e e (redictive obectives no! s(ecificall# s(ecificall# required f3 documented documented maintenanc maintenance e obective obectives& s& maintenan maint enance ce methods metho ds to continua cont inuall# ll# for exam(le+ exam(le+ O 0Overall 0Overall qui(ment qui(ment im(ro im( rove ve the effect eff ective ivenes ness s and the ffe ffect ctiv iven enes ess s&& $T2F $T2F 0$ea 0$ean n Time Time effici eff icienc enc# # of (roduction of (roduction equi(ment equi(ment 2et!een Failure& and $TT> 0$ean Time To >e(air& and reventive $aintenance com(liance metrics erformance to the maintenan maintenance ce obective obectives s shall form an in(ut into mana%ement revie! 0see ISO 9**1& Section 975 ,3 re%ular revie! of maintenance (lan and obect obective ives s and a docume documente nted d action action (lan to address corrective actions !here obectives are not achieved5 h3 use of (reve reven ntiv tive maint ainten enan ance ce methods5 i3 use of (redictive maintenance methods& as a((licable5 ;3 (eriodic overhaul ;515 $A= $A=A A$= $=T T OF >O >O:@3T :@3TIO= IO= TOO?I= <-16 <-16 $ana%emen $ana%ementt of (roduction (roduction The or%ani.ati or%an i.ation on shall (rovide shall (rovide toolin% and manufacturin%& test& resour res ources ces for tool too l and an d %au%e %au% e desi%n& desi %n& ins(ection toolin% and equi(ment fabricat fabr ication ion and verificat veri ficat ion activiti acti vities es The or%ani.ation shall (rovide resources The or%ani.ati or%an i.ation on shall estab es tablis lish h and for tool and %au%e desi%n& fabrication& and im(l im (lem emen entt a s#st s# stem em for fo r (roduction verification activities for (roduction and toolin% mana%ement includ in%+ service materials and for bul8 materials& as mainte mai ntenan nance ce and re(air re( air facili fac ilitie ties s and a((licable (ersonnel5 The or%ani.at or%ani.ation ion shall establish establish and stora%e stor a%e and recover# reco ver#55 im(lem im(lement ent a s#stem s#stem for (roduc (roductio tion n set)u(5 toolin% toolin% mana%ement mana%ement&& !hether !hether o!ned tool)cha tool )chan%e n%e (ro%rammes for (erishable b# the or%ani.ati or%ani.ation on or the customer& customer&
includin%5 tools5 maintenance and re(air facilities and tool a3 desi%n modifica modi fication tion document docu mentatio ation& n& (ersonnel5 includin incl udin% % en%ineeri en%in eerin% n% chan%e chan %e level5 leve l5 stora%e and recover#5 3 tool modif mo difica icatio tion n and revisi rev ision on to c3 set)u(5 documentation5 tool)chan%e (ro%rammes for d3 tool identification& defini de finin% n% the status& statu s& (erishable tools5 s u c h as (roduction& as (roduction& re(air re(a ir or dis(osal dis( osal tool desi%n modification e3 The or%ani.atio or%an i.ation n shall shal l im(le im( lemen ment t a s#stem s#s tem docum document entati ation& on& includ includin% in% en%ine en%ineeri erin% n% to moni mo nito torr thes th ese e acti ac tivi viti ties es if an# an # !or8 !o r8 is chan%e level of the (roduct5 outsourced f3 tool tool modi modifi fica cati tion on and and revi revisi sion on to documentation5 =OT This requirem requ irement ent also a((lies a((l ies to ,3 tool identification& such as serial or the availabili availa bilit# t# of tools too ls for vehicle servi ce asset number5 the status& such as (arts (roduction& re(air or dis(osal5 dis(osal5 o!nershi(5 and location ;541 ;54 1 CBSTOM>,.O> CBSTOM>, .O>D D #,ODBCTIO The The or%a or%ani ni.a .ati tion on shal shalll veri verif# f# that that TOOI customer)o!ned tools& manufacturin% C'stomr.on " too!s* man'a+t'rin* tst* equi equi(m (men ent& t& and and test test/i /ins ns(e (ect ctio ion n insp+ ins p+ti tion on too!i too !in n an" )'ipm )' ipmnt nt s(a!! s(a !! $ equi(ment are (ermanentl# mar8ed in prman pr mannt nt!% !% mar ma r" " so t(at t(a t t( onrs on rs(ip (ip a visible location so that the o!nershi( and a((licat a((lication ion of each each item item can be o a+( itm it m is visi$! vis i$!* * an" +an $ determined "trmin" The or%ani.ation shall im(lement a s#stem to monitor these activities if an# !or8 is outsourced ;516 >O:@3TIO= S3H:@?I= roducti rod uction on shall be schedu sch eduled led in order ord er to <-1 <-1 roduction roduction schedu schedulin% lin% meet customer cust omer requirem requ irements ents& & suc su ch as The or%ani.ation shall ensure that ust) (roduction is scheduled scheduled in order to meet in)tim in) time e su((or su( (orted ted b# an infor in format mation ion customer orders/demands such as Lust)In) s#stem Time 0LIT and is su((orted b# an that th at (ermits access to (roduction to (roduction information s#stem that (ermits access to info in form rmat atio ion n at 8e# 8e # sta% st a%es es of the th e (rocess (roduction information at 8e# 8e# sta%es of the and is order or der drive dri ven n (rocess and is order driven driven The or%ani.ation shall include relevant (lannin% information durin% (roduction schedulin%& e%& customer orders& su((lier on)time deliver# (erformance& ca(acit#& shared loadin% 0multi)(art station& lead time& inventor# level& (reventive maintenance& and calibration
-52 Identification Identific ation and traceailit $he or,ani-ation shall use suitale means to identif out/uts when it is necessar to ensure the conformit of /roducts and serices. $he or,ani-ation shall identif the status of out/uts with res/ect to monitorin, and measurement requirements throu,hou throu,houtt /roduction and serice serice /roision. $he or,ani-ation shall control the unique identification of the out/uts when traceailit is a requirement6 and shall retain the documented information necessar to enale traceailit.
I"ntii+ation I"ntii+ation an" 7..! tra+a$i!it% Bhere a//ro/riate6 a//ro/riate6 the or,ani-ation shall identif the /roduct suitale means throu,hout /roduct reali-ation. $he or,ani-ation shall identif the /roduct status with res/ect to monitorin, and measurement requirements throu,hout /roduct reali-ation. Bhere traceailit is a requirement6 the or,ani-ation shall control the unique identification identification of the /roduct and maintain records 2see '..'3. 4O$5 In some industr sectors6 confi,uration mana,ement is a means which identification and traceailit are maintained.
$he note in reference to confi,uration mana,ement has een remoed
=OT Ins(ection and test status is not The revised requirements ex(ect the indicated b# the location of (roduct in the traceabilit# of (roduct so that (roduction flo! unless inherentl# obvious& nonconformin% (roduct can be clearl# such as material in an automated traced to allo! customer to contain (roduction transfer (rocess (rocess Alternatives nonconformin% (roduct esca(es are (ermitted if the status is clearl# -71 I:=TIFI3ATIO= I:=TIFI3ATIO = A=: identified& documented& and achieves the T>A3 T>A 3A2I A2I?I ?ITC TC ; desi%nated (ur(ose S@?$=TA? -521 Identi Identific ficati ation on and tracea traceabil bilit# it# ; su((lemental The requirements ex(ect a stud# of The !ords !or ds JDhe JD here re a((ro a(( ro(ri (riate ateK K in -7 - 7 shall sha ll customer and re%ulator# traceabilit# The (ur(ose of traceabilit# is to su((ort not a((l# identification of clear start and sto( (oints requirements and the definition of for (roduct received b# the customer or in a((ro(riate s#stems the field that ma# contain qualit# and/or safet#)related nonconformities Therefore& the or%ani.ation shall im(lement identification and traceabilit# (rocesses as described belo! The The or%a or%ani ni.a .ati tion on shal shalll cond conduc uctt an anal anal#s #sis is of inte intern rnal al&& cust custom omer er&& and and re%ulator# traceabilit# requirements for all automotive (roducts& includin% develo(in develo(in% % and documentin documentin% % traceabili traceabilit# t# (lans& based on the levels of ris8 or failure severit# severit# for em(lo#ees em(lo#ees&& customers& customers& and consumers These (lans shall define the
a((ro(riate traceabilit# s#stems& (rocesses& and methods methods b# (roduct& (rocess& and manufacturin% location that+ a3 enable enable the or%ani.ati or%ani.ation on to identif# identif# nonconformin% and/or sus(ect (roduct5 3 enable the or%ani.ation to se%re%ate nonconformin% and/or sus(ect (roduct5 c3 ensur nsure e the the abili bilitt# to meet meet the customer customer and/or and/or re%ulator# re%ulator# res(onse res(onse time requirements5 d3 ensure documented information is retained in the format 0electronic& hardco(#& archive that enables the or%ani.ation to meet the res(onse time requirements5 e3 ensure seriali.ed identification of individual (roducts& if s(ecified b# the customer or re%ulator# standards5 f3 ensure the identification and traceabilit# requirements are extended to externall# (rovided (roducts !ith safet#/re%ulator# safet#/re%ulator# characteristics #roprt% $!onin to "..! +'stomrs or xtrna! provi"rs $he or,ani-ation shall e)ercise care with /ro/ert elon,in, to customers or e)ternal /roiders while it is under the or,ani-ations control or ein, used the or,ani-a or,ani-ation. tion. $he or,ani-ation shall identif6 erif6 /rotect and safe,uard customers or e)ternal /roiders /ro/ert /roided for use or incor/oration into the /roducts and serices. Bhen the /ro/ert of a customer or e)ternal /roider is lost6 dama,ed or otherwise found to e unsuitale for use6 the or,ani-ation shall re/ort this to the customer or e)ternal /roider and retain documented information information on what has occurred. 4O$5 # customers or e)ternal /roiders /ro/ert can include material6 com/onents6 com/onents6 tools and equi/ment6 /remises6 intellectual /ro/ert and
;54 (ustomer /ro/ert $he or,ani-ation shall e)ercise care with customer /ro/ert while it is under the or,ani-ationGs or,ani-ationGs control control or ein, ein, used the or,ani-ation. $he or,ani-ation shall identif6 erif6 /rotect and safe,uard customer /ro/ert /roided for use use or incor/oration incor/oration into the /roduct. If an customer /ro/ert is lost6 dama,ed or otherwise found to e unsuitale for use6 the or,ani-ation or,ani-ation shall re/ort this to the customer and maintain records 2see '..'3. (ustomer /ro/ert can include 4O$5 intellectual /ro/ert and /ersonal data.
=ote =ot e broad br oadens ens the th e descri des cri(t (tion ion of the a((li a(( licab cabil ilit# it# of custo cus tomer mer o!ned o! ned (ro(ert# (ro(ert#
/ersonal data.
-5 -54 4 #rs #rsr rv vatio ation n $he or,ani-ation shall /resere the out/uts durin, /roduction and serice /roision6 to the e)tentnecessar to ensure conformit to requirements. 4O$5 =reseration ca can in include identification6 handlin,6 contamination control6 /ac7a,i /ac 7a,in,6 n,6 stora, sto ra,e6 e6 tra transm nsmiss ission ion or trans/ortation6 and /rotection.
-541 reservation ; su((lemental reservation shall include identification& handlin%& contamination control& (ac8a%in%& stora%e& transmission or trans(ortation& and (rotection reservation shall a((l# to materials and com(onents from external and/or internal (roviders from recei(t throu%h throu%h (rocessin%& includin% shi(ment and until deliver# to/acce(tance b# the customer In order to detect deterioration& the or%ani.ation shall assess at a((ro(riate (lanned intervals the condition of (roduct in stoc8& the (lace/t#(e of stora%e container& and the stora%e environment The or%ani.ation shall use an inventor# mana%ement s#stem to o(timi.e inventor# turns over time and ensure stoc8 rotation& such as 'first)in)first)out' 0FIFO The or%ani.ation shall ensure that obsolete (roduct is controlled in a manner similar to that of nonconformin% (roduct Or%ani.ations shall com(l# !ith (reservation& (ac8a%in%& (ac8a%in%& shi((in%& and labelin% requirements as (rovided b# their customers
H.!.! =reseration of /roduct $he or,ani-ation shall /resere /resere the /roduct durin, internal /rocessin, and delier to
$he e)am/les of /reseration were moed to a note.
the intended destination destination in order to maintain conformit to requirements. #s a//licale6 /reseration shall include identification6 handlin,6 /ac7a,in,6 stora,e and /rotection. =reseration shall also a//l to the constituent /arts of a /roduct.
--1 - -1 STO>A STO>A A=: I== I==TO>C TO>C The clause no! includes a definition of In order or der to detect det ect deteri det eriora oratio tion& n& the th e (reservation condit con dition ion of (roduct in stoc8 shall be asses as sesse sed d at a((ro a(( ro(ri (riate ate (lanned intervals The or%ani.ati or%an i.ation on shall use us e an inve in vent ntor or# # mana% man a%eme ement nt s#stem s#s tem to o(timi o(t imi.e .e inven inv entor tor# # turns tur ns over ove r time ti me and assure ass ure stoc8 st oc8 rotation rotat ion&& such as Jfirst)i Jfir st)in)fi n)first) rst)outK outK 0FIFO 0FI FO Obsolete Obsol ete (roduct shall be cont co ntro roll lled ed in a simil si milar ar manne ma nnerr to nonco nformi nfo rmin% n% (roduct
#ost."!ivr% a+tivitis $he or,ani-ation shall meet requirements for /ostdelier actiities associated with the /roducts and serices.
In ISO 9001:00* /ostdelier actiities were er riefl mentioned in Econtract reiew and E/roduction " serice /roision $his has een e)/anded to this suclause
In determinin, the e)tent of /ostdelier actiities that are required6 the or,ani-ation shall consider: a) statutor and re,ulator requirements
For most of our clients this suclause will not a//l A the /roal need to hae a discussion that will lead to e)clusion. If the do hae /ost delier actiities6 other than customer re;ected /roduct which is coered under nonconformin, /roduct and customer com/laints then the need to address this suclause
"..
b)the /otential undesired consequences associated associat ed with its /roducts and serices c) the nature6 use and intended lifetime of its /roducts and serices d)customer requirements e) customer feedac7. 4O$5 4O$ =os ost tde deli lie er r ac acti tii iti ties es ca can n in incl clud ude e actions under warrant /roisions6 contractual oli,ations oli,ati ons such as maintena maintenance nce serices6 and su//lementar su//leme ntar serices such as r ecclin, or final dis/osal.
<--1 <--1 Feedbac8 Feedbac8 of information information from service service The or%ani.ation shall ensure that a (rocess for communication communication of information on service concerns to manufacturin%& material handlin%& lo%istics& en%ineerin%& and desi%n activities is established& im(lemented& and maintained =OT 1 The intent of the addition of 'service concerns' to this sub)clause is to ensure that the or%ani.ation is a!are of nonconformin% (roduct0s and material0s that ma# be identified at the
;51; F:2A3 F :2A3Q Q OF I=F I=FO>$ O>$ATI ATIO= O= F>O F>O$ $ S>I3 A (rocess A (rocess for communication of inform inf ormati ation on on servic ser vice e concer con cerns ns to manufacturin%& manufacturin%& en%ine en% ineeri erin% n% and desi%n des i%n activitie acti vities s shall shal l be esta es tabl blis ishe hed d and an d maintained The Th e inte in tent nt of the th e addi ad diti tion on of =OT6 =O T6 Jser Js ervi vice ce conc co ncer erns nsK K to this th is subc su bcla laus use e is to ensu en sure re that th at the th e or%a or %ani ni.a .ati tion on is a!ar a! are e of nonconfo rmities that occur outside of its or%ani.ation .
customer location or in the field =OT , 'Service concerns' should include the results of field failure test anal#sis 0see Section 1*,6 !here a((licable
<--, <--, Service Service a%reement a%reement !ith customer customer ;51- S> S>I3 I3 A>$=T A> $=T DITH DIT H Dhen there is a service a%reement !ith the 3@STO$> customer& the or%ani.ation shall+ Dhen Dh en ther th ere e is a serv se rvic ice e a%re a% reem emen entt !ith !it h the th e a3 verif# that the relevant service centres customer& the th e or%ani.ati or%an i.ation on shall shal l verif # the com(l# !ith a((licable requirements5 effectiveness of 3 verif# the effectiveness of an# s(ecial an# or%ani.atio or%ani .ation n service serv ice centres& cent res& (ur(ose tools or measurement measurement equi(ment5 an# s(ecia s(e cial)( l)(ur( ur(ose ose tools too ls or c3 ensure that all service (ersonnel are measurem ent equi(ment& and trained in a((licable requirements the th e trai tr aini nin% n% of serv se rvic ice e (ersonnel
-/5/6
Contro! o +(ans
$he or,ani-ation shall reiew and control chan,es for /roduction or serice /roision6
#nother chan,e control suclause6 which oerla/s with chan,e requirements in clause *.1. #SR would hae hae e)/ected this chan,e chan,e control under ISO 9001:00*
to the e)tentnecessar to ensure continuin, continuin, conformit with requirements. $he or,ani-ation shall retain documented information descriin, the results of the reiew of chan,es6the /erson2s3 /erson2s3 authori-i authori-in, n, the chan,e6 and an necessar actions arisin, from the reiew. -561 3ontrol of chan%es ; su((lemental The or%ani.ation shall have a documented (rocess to control and react react to chan%es that im(act (roduct reali.ation The effects of an# chan%e& includin% those chan%es caused b# the or%ani.ation& the customer& or an# su((lier& shall be assessed The or%ani.ation shall+ c.a3 define define verifi verificat cation ion
and
valida validatio tion n
A (roduct reali.ation reali.ation chan%e (rocess that requires defined verification and validation5 (roduction trial run5 ris8 anal#sis5 records The requirements include a((lication to su((liers
acti activi viti ties es to ensu ensure re com( com(li lian ance ce !ith !ith customer requirements5 c.3 validate chan%es before im(lementation5 c.c3 document the evidence of related ris8 anal#sis5 c.d3 retain retain record records s of verifi verificat cation ion and validation 3han%es& includin% those made at su((liers& should require a (roduction trial run for verification of chan%es 0such as chan%es to (art desi%n& manufacturin% location& or manufacturin% (rocess to validate the im(act of an# chan%es on the manufacturin% (rocess Dhen hen req require uired d b# the the cust custom omer er&& the the or%ani.ation shall+ c.e3 notif# the customer of an# (lanned (roduct reali.ation chan%es chan%es after the most recent (roduct a((roval5 obtain documented a((roval& (rior to c.f3 im(lementation of the chan%e5 c.,3 com(lete additional verification or identification requirements& such as (roduction trial run and ne! (roduct validation -5611 Tem(orar# chan%e of (rocess controls The or%ani.ation shall identif#& document& and maintain a list of the (rocess controls& includin% ins(ection& measurin%& test& and error)(roofin% devices& that includes the (rimar# (rocess control control and the a((roved bac8)u( or alternate methods The or%ani.ation shall document the (rocess that mana%es mana%es the use of alternate control methods The or%ani.ation shall include in this (rocess& based on ris8 anal#sis 0such as F$A& severit#& and the internal a((rovals to be obtained (rior to (roduction im(lementation im(lementation of the alternate control method
This clause requires a documented (rocess to control tem(orar# tem(orar# chan%es includin% the alternate control methods5 a ris8 anal#sis and customer a((rovals
2efore shi((in% (roduct that !as ins(ected or tested usin% the alternate method& if required& the or%ani.ation shall obtain a((roval from the customer0s The or%ani.ation shall maintain and (eriodicall# revie! a list of a((roved alternate (rocess control methods that are referenced in the control (lan Standard !or8 instructions shall be available for each alternate (rocess control method The or%ani.ation shall revie! the o(eration of alternate (rocess controls on a dail# basis& at a minimum& to verif# im(lementation of standard !or8 !ith the %oal to return to the standard (rocess as defined b# the control (lan as soon as (ossible xam(le methods include but are not limited to the follo!in%+ c.,.a3 dail# dail# qualit qualit# # focuse focused d audits audits 0e%& 0e%& la#ered (rocess audits& as a((licable5 c.,.3 dail# leadershi( meetin%s >estart verification is documented for a defined (eriod based on severit# and confirmation that all features of the error) (roofin% device or (rocess (rocess are effectivel# reinstated The or%ani.ation shall im(lement traceabilit# of all (roduct (roduced !hile an# alternate (rocess control devices or (rocesses are bein% bein% used 0e%& verification and retention of first (iece and last (iece from ever# shift
DIs are required for the alternate control methods A dail# revie! of the alternate (rocess controls is required
>equired traceabilit# of the (roduct (roduced !hile the alternate alternate (rocess is used
-6 ,!as o pro"'+ts pro"'+ts an" srvi+s $he or,ani-ation shall im/lement /lanned arran,ements6 at a//ro/riate sta,es6 to erif that the /roduct and serice requirements hae een met. $he release of /roducts and serices to the customer shall not /roceed until the /lanned arran,ements hae een satisfactoril com/leted6 unless otherwise a//roed a releant authorit and6 as a//licale6 the customer. $he or,ani-ation shall retain documented information on the release of /roducts and serices. $he documented information shall include: a) eidence of conformit with the acce/tance criteria b)traceailit to the /erso /erson2s3 n2s3 authori-in, the release.
-24 Monitorin an" mas'rmnt o pro"'+t $he or,ani-ation shall monitor and measure the characteristics of the /roduct to erif that /roduct requirements hae een met. $his shall e carried out at a//ro/riate sta,es of the /roduct reali-ation /rocess in accordance with the /lanned arran,ements 2see H.13. 5idence of conformit with the acce/tance criteria shall e maintained. Records shall indicate the /erson2s3 authori-in, authori-in, release of /roduct for delier to the customer 2see '..'3.
$he release of /roduct and delier of serice to the customer shall not /roceed until the /lanned arran,ements arran,ements 2see H.13 hae een satisfactoril com/leted6 unless otherwise a//roed a releant authorit and6 where a//licale6 the -61 >elease >elease of (roducts (roducts and services services ; customer. su((lemental The or%ani.ation shall ensure that the (lanned arran%ements to verif# that the (roduct and service requirements requirements have been met encom(ass the control (lan and are documented as s(ecified in the control (lan 0see Annex A The or%ani.ation shall ensure that the (lanned arran%ements for initial release of (roducts and services services encom(ass (roduct or service a((roval a((roval The or%ani.ation shall ensure that (roduct or service a((roval is accom(lished after chan%es follo!in% initial release&
>elease of (roducts no! s(ecificall# tied to the control (lan Dhen Dh en select sel ectin% in% (roduct =OT6 =O T6 (arameters to monitor com(liance to s(ecifie d internal and external exte rnal requirements& the or%ani.at or%a ni.ation ion determin dete rmines es the th e t#(e t# (es s of (roduct of (roduct characteristics& leadin% to t#(e s of measure meas urement ment&& the t#(es suit able measure meas urement ment means& mean s& and suitable ca(a bilit# t# and s8ills s8il ls require requ ired d the ca(abili
accordin% to ISO 9**1& Section <-6
-62 ?a#o ?a#out ut testin%
ins( ins(ec ecti tion on
and and
func functi tion onal al ?AC -241 ?ACO@T O@T I=S I=S 3TI 3TIO= O= A=: F@=3 F@=3TIO TIO=A? =A? TSTI= A la#out ins(ection and a functional =o chan%es to the la#out A la#out ins(ection ins(ection and a functional verifica veri fication tion to a((licable a((li cable customer cust omer ins(ection/functional testin% verification to a((licable customer en%ineerin% material and and (erformance en%ineerin% material and (erformance standards shall be (erformed for each standard stan dards s shall shal l be (erformed for each (roduct as s(ecified in the control (lans (roduct as s(ecified in the control (lans control (lans >esults shall be available for customer >esults >esul ts shall shal l be availa ava ilable ble for custo cu stomer mer revie! revie! =OT 1 ?a#out ins(ection is the com(lete measurement of all (roduct dimensions sho!n on the desi%n record0s
=OT ?a#out ?a#o ut ins(ect ins( ection ion is the com(lete com( lete measurement of all (roduct (rod uct dimensio ns sho!n on the desi%n records recor ds
=OT , The frequenc# of la#out ins(ection is determined b# the customer
-242 AA>A=3 AA>A=3 IT$S IT$S For or%ani.atio or%an i.ations ns manufact manu facturin urin% % (arts =o chan%es to the a((earance items For or%ani.ations manufacturin% (arts desi de si%n %nat ated ed b# the th e cust cu stom omer er as clause desi%nated b# the customer as Ja((earance itemsK& the or%ani or% ani.at .ation ion 'a((earance items&' the or%ani.ation shall shall (rovide (rovide (rovide the follo!in%+ resources& includ in cludin% in% a3 a((ro( a((ro(ria riate te resour resources ces&& includ includin% in% a((ro(riate li%htin%& for evaluation& li%htin%& for evaluation5 mast ers for colour& colo ur& %rain& %loss& metalli meta llic c masters 3 masters for colour& %rain& %loss& metallic brilliance& texture& brilliance& texture& distinc dis tinctnes tness s of ima%e ima% e distinctness of ima%e 0:OI& and 0:OI& as a((ro(riat e& ha(tic technolo%#& as a((ro(riate5 maintenan main tenance ce and control cont rol of a((ear a(( earanc ance e c3 maintenance and control of masters mast ers and evaluatio evalu ation n equi(ment& equi( ment& and a((e a((ear aran ance ce mast master ers s and and eval evalua uati tion on verifica veri fication tion that (ersonnel ma8in% equi(ment5 a((ear a(( earanc ance e evalua eva luatio tions ns are com(et com (etent ent verifi verificat cation ion that that (erson (ersonnel nel ma8in% ma8in% d3 and an d qual qu alif ifie ied d to do so so a((earance evaluations are com(etent and -68 A((earance items
qualified to do so
H.'.8.1 ICOMI #,ODBCT COFO,MIT -64 erif erifiicati catio on and and acce acce(t (tan ance ce of TO ,>7BI,>M>TS =o chan%es to the verification of externall# conformit# conformit# of externall# externall# (rovided (roducts (roducts The or%ani.ati or%a ni.ation on shall shal l ha have a (rocess to (rovided (roducts and services services clause and services assu as sure re the th e qual qu alit it# # of (urchased (roduct (urchased (roduct
The or%ani.ation shall have a (rocess to 0see 0s ee 4 47 7 util ut ili. i.in in% % one on e or more mo re of the th e ensure the qualit# of externall# (rovided follo!in% methods + (rocesses& (roducts& and and services utili.in% recei(t rece i(t of& and evalua eva luatio tion n of& of & statistical one or more of the follo!in% methods+ data dat a b# the or%ani or% ani.at .ation ion55 a3 recei(t recei(t and evaluation evaluation of statistic statistical al receivin rece ivin% % ins(ectio ins(e ction n and/or and/o r testin%& test in%& data data (rov (rovid ided ed b# the the su(( su((li lier er to the the such su ch as sam( sa m(li lin% n% base ba sed d on or%ani.ation5 (erformance5 receivin% ins(ection ins(ection and/or and/or testin%& testin%& second) 3 receivin% seco nd) or third)(a thir d)(art# rt# assessme asse ssments nts such as sam(lin% based on (erformance5 or audits aud its of su((li su( (lier er sites& sit es& !hen !h en c3 second)(art# or third)(art# cou(l cou (led ed !ith records recor ds of acce(t acc e(tabl able e assessments or audits of su((lier delivere deli vered d (roduct conformit# to to sites !hen cou(led !ith records of requirements5 acce(table delivered (roduct evaluation b# a desi%nated desi%nated (art evaluation conformance to requirements5 laborator#5 d3 (art evaluation b# a desi%nated anot an othe herr meth me thod od a%re a% reed ed !ith !i th the th e laborator#5 customer e3 anot anothe herr meth method od a%re a%reed ed !ith !ith the the customer -65 Statutor# and re%ulator# conformit# rior to release of externall# (rovided (roducts into its (roduction flo!& the or%ani.ation shall confirm and be able to (rovide evidence that that externall# (rovided (rocesses& (roducts& and and services conform to the latest a((licable statutor#& re%ulator#& and other requirements in the countries !here the# are manufactured and in the customer)identified countries of destination& if (rovided -66 Acce(tance criteria criteria Acce(tance criteria criteria shall be defined b# the the or%ani.ation and& !here a((ro(riate or required& a((roved b# the customer For attribute data sam(lin%& the acce(tance level shall be .ero defects 0see Section 9111
This is a ne! clause to verif# re%ulator# conformit# of externall# (rovided (roducts !ith evidence
H.1. A33T A33TA=3 A=3 3>IT>IA 3>IT>IA Acce(tance Acce(tance criteria shall shal l be defi de fine ned d b# the or%ani or% ani.at .ation ion and& and & !her !h ere e require equ ired& d& a((rov a(( roved ed b# the custo cus tomer mer For attribut attr ibute e data sam(lin% sam( lin%& & the the acce(tance acce( tance level leve l shall be .ero defect def ects s 0see <,71
=o chan%e to the acce(tance criteria clause
-; Contro! o non+onormin o'tp'ts *.H.1 $he or,ani-ation shall ensure that out/uts that do not conform to their requirements are identified and controlled to /reent their unintended use or delier.
$he or,ani-ation shall ta7e a//ro/riate action ased on the nature of the nonconformit and its effect on the the conformit of /roducts and serices. $his shall also a//l to nonconformin, /roducts and serices detected after delier of /roducts6 durin, or after the /roision of serices. $he or,ani-ation shall deal with nonconformin, out/uts in one or more of the followin, was:
a3correction b)se,re,ation6 containment6 return or sus/ension of /roision of /roducts and serices
Bhere a//licale6 the or,ani-ation shall deal with nonconformin, /roduct one or more of the followin, was: ta7in, action to eliminate a) the detected nonconformit b) authori-in, its use6 release or acce/tance under concession a releant authorit and6 where a//licale6 the customer c) ta7in, action to /reclude its ori,inal intended use or a//lication
c) informin, the customer d)otainin, authori-ation for acce/tance under concession. (onformit to the requirements shall e erified when nonconformin, out/uts are corrected.
<11 3ustomer author i. i.ation concession The or%ani.ation shall obtain a customer concession or deviation (ermit (rior to further (rocessin% (rocessin% !henever the (roduct or manufacturin% (rocess is different from that !hich is currentl# a((roved
-8 Contro! o non+onormin non+onormin pro"'+t $he or,ani-ation shall ensure that /roduct which does not conform to /roduct requirements is identified identified and controlled controlled to /reent its unintended use or delier. # documented /rocedure shall e estalished to define the the controls and and related res/onsiilities res/onsiilities and authorities for dealin, with nonconformin, /roduct.
d) ta7in, action a//ro/riate to the effects6 or /otential effects6 of the nonconformit when nonconformin, /roduct is detected after delier or use has started.
Bhen nonconformin, /roduct is corrected for it shall e su;ect to reerification reerification to demonstrate conformit to the requirements. Records of the nature of nonconformities and an susequent actions ta7en6 includin, concessions otained6 shall e
#SR inter/retation A correction includes not onl correctin, the nonconformin, /roduct ut also includes re,radin, or a//roin, the /roduct for an alternate use
Informin, the customer 2ullet c3 a//lies to nonconformin, /roduct that has alread shi//ed
The or%ani.ation shall obtain customer authori.ation (rior to further (rocessin% for 'use as is' and re!or8 dis(ositions of nonconformin% (roduct If sub) com(onents are reused in the manufacturin% (rocess& that sub) com(onent reuse shall be clearl# communicated to the customer in the concession or deviation (ermit The or%ani.ation shall maintain a record of the ex(iration date or quantit# authori.ed under concession The or%ani.ation shall also ensure com(liance !ith the ori%inal or su(ersedin% s(ecifications and requirements !hen the authori.ation ex(ires $aterial shi((ed under concession shall be (ro(erl# identified on each shi((in% container 0this a((lies equall# to (urchased (roduct The or%ani.ation shall a((rove an# requests from su((liers before submission to the customer
maintained 2see '..'3.
-81 COT,O COT,O OF OCOFO,MI OCO FO,MI #,ODBCT SB##>M>TA roduct rod uct !ith unidenti unid entified fied or sus(ect sus( ect status stat us shall be classi cla ssifie fied d as noncon non confor formin min% % (roduct 0see -7 -7 -82 COT,O COT,O OF ,>O, ,>O,>D >D #,ODBCT #,ODBCT Instructions for re!or8& includin % re) ins(ection requirement s& shall be acce ac cess ssib ible le to and an d util ut ili. i.ed ed b# the th e a((ro(ri a((r o(riate ate (ersonnel (ersonnel -88 -8 8 CBST CBSTOM>, OM>, IFO,MAT IFO,MATIO IO 3ustomer 3ust omers s shall shal l be inform info rmed ed (rom(tl# (rom(tl# in the event eve nt that tha t noncon non confor formin min% % (roduct has been been shi((ed
-84 4 CBS CBSTOM> TOM>, , AI@>, AI@>, <1, <1, 3ontrol 3ontrol of nonconformin nonconformin% % (roduct (roduct ; -8 The or%ani.ati or%an i.ation on shall shal l obta ob tain in a cust cu stom omer er customer)s(ecified (rocess The or%a r%ani.a ni.ati tion on sha shall com( com(l# l# !ith conces con cessio sion n or deviat dev iation ion (ermit (ermit (rior (rior to a((licabl a((licable e customer)s customer)s(ecif (ecified ied controls controls for furthe fur therr (rocessin% !henever !henever the (roduct the (roduct nonconformin% (roduct0s or manufa man ufactu cturin rin% % (rocess is different different from that tha t !hich !hi ch is curren cur rentl tl# # a((ro a( (roved ved The or%ani.ati or%a ni.ation on shall shal l mainta mai ntain in a record rec ord of <17 <17 3ontrol 3ontrol of sus(ect sus(ect (roduct (roduct the ex(ira ex( iratio tion n date dat e or quanti qua ntit# t# author aut hori.e i.ed d The or%ani.ation shall ensure that (roduct The or%ani.ati or%an i.ation on shall shal l also ensure ensu re !ith unidentified or sus(ect status is com(lian com( liance ce !ith the ori%inal ori% inal or classified and controlled as su(ersedin% nonconformin% (roduct The or%ani.ation s(ecifica s(eci fication tions s and requirem requ irements ents !hen the shall ensure that all a((ro(riate authori.ation ex(ires $aterial shi((e d on manufacturin% (ersonnel receive trainin% an authori. auth ori.atio ation n shall shal l be (ro(erl# for containment of sus(ect and identified nonconformin% (roduct on each shi((in% shi( (in% container conta iner This Th is a((l a( (lie ies s equa eq uall ll# # to (urchased to (urchased (roduct (roduct The or%ani.ati or%an i.ation on shall shal l a((r a( (rov ove e an# an # <14 <14 3ontrol 3ontrol of re!or8ed re!or8ed (roduc (roduct t
The or%ani.ation shall utili.e ris8 anal#sis 0such as F$A methodolo%# to assess ris8s in the re!or8 (rocess (rior to a decision to re!or8 the (roduct If required b# the the customer& the or%ani.ation shall obtain a((roval from the customer (rior to commencin% re!or8 of the (roduct
requests requ ests from su((liers su((l iers before befo re submissi subm ission on to the customer cust omer
=e! requirement to use ris8 anal#sis 0F$A to assess ris8s in the re!or8 (rocess
The or%ani.ation shall have a documented (rocess for re!or8 confirmation in accordance !ith the control (lan or other relevant documented information to verif# com(liance to ori%inal s(ecifications Instructions for disassembl# or re!or8& includin% re)ins(ection and traceabilit# requirements& shall be accessible to and utili.ed b# the a((ro(riate (ersonnel The or%ani.ation shall retain documented information on the dis(osition of re!or8ed (roduct includin% quantit#& dis(osition& dis(osition date& and a((licable traceabilit# information <1<1- 3ontrol 3ontrol of re(aired re(aired (roduct (roduct The or%ani.ation shall utili.e ris8 anal#sis 0such as F$A methodolo%# to assess ris8s in the re(air (rocess (rior to a decision to re(air the (roduct The or%ani.ation or%ani.ation shall obtain a((roval from the customer before commencin% re(air of the (roduct The or%ani.ation shall have a documented (rocess for re(air confirmation confirmation in accordance !ith the control (lan or other relevant documented information Instructions for disassembl# or re(air& includin% re)ins(ection and traceabilit# requirements& shall be accessible to and utili.ed b# the a((ro(riate
=e! clause on re(air of (roduct >e!or8 is defined 0ISO 9*** definition as action to ensure the (roduct meets requirements >e(air is defined 0ISO 9*** definition as action to ensure the (roduct meets intended use
:ocumented re(air (rocess and re(air instructions :ocumented customer authori.ation for concession
(ersonnel The or%ani.ation shall obtain a documented customer authori.ation for concession for the (roduct to be re(aired The or%ani.ation shall retain documented information on the dis(osition of re(aired (roduct includin% quantit#& quantit#& dis(osition& dis(osition date& and a((licable traceabilit# information
<16 <16 3ustomer 3ustomer notificati notification on The or%ani.ation shall immediatel# notif# the customer0s in the event that nonconformin% (roduct has been shi((ed Initial communication shall be follo!ed !ith detailed documentation of the event
<1 <1 =onconform =onconformin% in% (roduct dis(osition dis(osition The or%ani.ation shall have a documented (rocess for dis(osition of nonconformin% (roduct not subect to re!or8 re!or8 or re(air For (roduct not meetin% requirements& requirements& the or%ani.ation shall verif# that the (roduct to be scra((ed is rendered unusable (rior to dis(osal The or%ani.ation shall not divert nonconformin% (roduct to service or other use !ithout (rior customer a((roval *.H.
$he or,ani-ation shall documented information that: a) descries the nonconformit nonconformit
retain
b)descries the actions ta7en c) descries an concessions otained d)identifies the authorit decidin, the action
=e! requirements to render scra( unusable and controls on divertin% nonconformin% (roduct to other uses
in res/ect of the nonconformit.
9 #rorman+ va!'ation 9.1 ?onitorin,6 measurement6 analsis and ealuation 9.1.1 eneral $he or,ani-ation shall determine: what needs to e a) and measured monitored
b)
c)
- Mas'rmnt* Mas'rmnt* ana!%sis an" improvmnt -1 nra!
$he or,ani-ation shall /lan and im/lement the monitorin,6 measurement6 analsis and im/roement /rocesses needed to demonstrate conformit to /roduct requirements6 the methods for monitorin,6 measurement6 analsis and ealuation needed to ensure b) to ensure conformit of the qualit mana,ement alid results sstem6 and to continuall im/roe the effectieness of the when the monitorin, and measurin, shall qualit mana,ement sstem. e /erformed $his shall include determination of a//licale d) when the results from methods6 includin, statistical techniques6 and monitorin, and measurement the e)tent of their use. shall e analsed and ealuated.
$he or,ani-ation shall ealuate the /erformance and the effectieness of the qualit mana,ement sstem. $he or,ani-ation shall retain a//ro/riate documented information as eidence of the
-28 Monitorin an" mas'rmnt o pro+sss $he or,ani-ation shall a//l suitale methods for monitorin, and6 where a//licale6 measurement of the qualit mana,ement sstem /rocesses. $hese methods shall demonstrate the ailit of the /rocesses to achiee /lanned results. Bhen /lanned results are not achieed6 correction and correctie action shall e ta7en6 as a//ro/riate. 4O$5 Bhen determinin, suitale methods6 it is adisale that the or,ani-ation consider the t/e and e)tent of monitorin, or measurement a//ro/riate a//ro/riate to each of its /rocesses in relation to their im/act on the conformit to /roduct requirements and on the effectieness of the qualit mana,ement sstem. 9111 $onito $onitorin rin% % and measur measureme ement nt manufacturin% (rocesses The or%ani.ation shall (erform (rocess studies on all ne! manufacturin% 0includin% assembl# or sequencin% (rocesses to verif# (rocess (rocess ca(abilit# and to (rovide additional in(ut for (rocess control& includin% includin% those for s(ecial characteristics =OT For some manufacturin% (rocesses& it ma# not not be (ossible to demonstrate (roduct com(liance throu%h (rocess ca(abilit# For For those (rocesses& alternate methods such as batch conformance to s(ecification ma# be used The or%ani.ation shall maintain manufacturin% (rocess ca(abilit# or (erformance results as s(ecified b# the customerEs (art a((roval (rocess
of -28 -281 1 $O= $O=IT ITO>I O>I= = A=: $A $AS@> S@>$ $=T =T OF $A=@FA3 $A=@FA3T@>I= T@>I= >O3S >O3SSS SS The or%ani.atio or%an i.ation n shall shal l (erform (rocess studies on all al l ne! n e! manufactu manuf acturin% rin% 0includi 0inc ludin% n% assembl# or sequen seq uencin cin% % (rocesses to verif# (rocess ca(a ca (abi bili lit# t# and an d to (rovide additional in(u in (utt for (rocess control The T he resu re sult lts s of (rocess studies stud ies shall shal l be document docu mented ed !ith s(ecifications& s(ecifications& !here a((licable a((li cable&& for mean me ans s of (roduction& measurem meas urement ent and test& test & and maintenance instruction s These documents shall include incl ude obectiv obe ctives es for manufac man ufacturi turin% n% (rocess ca(abilit#& ca(abilit#& reliabilit#& maintaina main tainabili bilit# t# and availabilit#& as !ell !e ll as acce(tan acce (tance ce criteria crit eria
requirements The or%ani.ation shall The or%ani.ati or%a ni.ation on shall shal l maintai main tain n verif# that the (rocess flo! dia%ram& manufacturin% F$A& and control (lan are (rocess ca(abilit# or (erformance as im(lemented& includin% adherence to the s(ecified follo!in%+ b# the th e cust cu stom omer er (art a((roval (rocess a((roval (rocess a3 measurement techniques5 requirements The Th e or%ani.ati or%an i.ation on shall 3 sam(lin% (lans5 ensure c3 acce(tance criteria5 that tha t the contro con trol l (lan (lan and (rocess flo! d3 reco record rds s of actu actual al meas measur urem emen ent t dia%ram dia%r am are im(lement im(l emented& ed& includ in cludin% in% values values and/or and/or test test result results s for variab variable le adherence data5 s(eci fied reacti tion on (lan (lans s and and esca escala lati tion on to the s(ecified e3 reac measurem ent techniques& (rocess !hen acce(tance criteria are not met sam(lin% sam( lin% (lans& (lans& Si%nif Si%nifica icant nt (roces (rocess s events events&& such such as acce(tance criteria& and tool chan%e or machine re(air& shall be reac tion (lans !hen acce(tance criteria reaction recorded and retained as documented are ar e not no t met me t information Si%nifica Si%n ificant nt (rocess events& such su ch as tool to ol chan%e chan %e or The or%ani.ation shall initiate a reaction machine mach ine re(air& re(a ir& shall be recorded (lan indicated on the control (lan and evaluated for im(act on com(liance to The or%ani.ati or%an i.ation on shall init i nitiat iate e a reacti rea ction on s(ecifications for characteristics that are (lan from the control (lan for either not statisticall# ca(able or are chara cha racte cteris ristic tics s that tha t are either eit her not unstable These reaction (lans shall include containment of (roduct and 1** statisti stat isticall call# # ca(able ca(a ble or are unstable unsta ble (ercent ins(ection& as a((ro(riate A These Th ese reacti rea ction on (lans shall includ inc lude e corrective action (lan shall be develo(ed contai con tainme nment nt of (roduct and 1** and im(lemented b# the or%ani.ation ins(ection& as a((ro(ri a((r o(riate ate A correc cor rectiv tive e indicatin% s(ecific actions& timin%& and action act ion (lan (l an shall sh all the t hen n be com( co m(le lete ted d b# assi%ned res(onsibilities to ensure that the (rocess becomes stable and the or%ani.ati or%an i.ation& on& indicatin% s(ecifi c statisticall# ca(able The (lans shall be timin% tim in% and assi%n ass i%ned ed res(on res (onsib sibili ilitie ties s to revie!ed !ith and a((roved b# the assu as sure re that th at the th e (rocess becomes stable customer& !hen required and ca(able ca(a ble The Th e (lans shall be revi re vie! e!ed ed The or%ani.ation or%ani.ation shall maintain maintain records records of !ith !i th and an d a((r a( (rov oved ed b# the th e cust cu stom omer er !hen !h en effective dates of (rocess chan%es so required The or%ani.ati or%an i.ation on shall shal l maint ma intain ain record rec ords s of effec ef fecti tive ve dates dat es of (rocess of (rocess chan%es chan%es
9112 Identification of statistical tools The or%ani.ation shall determine the a((ro(riate use of statistical tools The or%ani.ation shall verif# that a((ro(riate statistical tools are included as (art of the advanced (roduct qualit# (lannin% 0or equivalent (rocess and included in the desi%n ris8 anal#sis 0such as :F$A 0!here a((licable& the (rocess ris8 anal#sis 0such as F$A& and the control (lan
9118 A((lication 9118 A((lication of statistical statistical conce(ts Statistical conce(ts& such as variation& control control 0stabilit# 0stabilit#& & (rocess (rocess ca(abilit# ca(abilit#&& and the the con consequ sequen ence ces s of over over) ) adustment adustment&& shall shall be understood understood and used used b# em(lo# em(lo#ees ees involv involved ed in the collection collection&& anal#sis& anal#sis& and mana%ement mana%ement of statistical data
-11 I:=TIFI3A I:=T IFI3ATIO= TIO= OF STAT STATISTI ISTI3A? 3A? TOO?S A((ro(riate A((ro(riate statistical too t ools ls for fo r each ea ch (rocess shall shal l be determ det ermine ined d durin% dur in% advanc adv ance e qualit qua lit# # (lannin% and included included in the control contr ol (lan (lan
-12 Q=OD? Q=O D?: : OF 2AS 2ASI3 I3 ST STATI ATISTI STI3A? 3A? 3O=3TS 2asic statistic stati stical al conce(ts& suc such h as variation& control c ontrol 0stabilit#& (roces (ro cess s ca(abilit# and over)adustment shall be shall be unders und erstoo tood d and utili. uti li.ed ed throu% thr ou%hou houtt the or%ani.ation
-/2/1 $.1.2
(ustomer satisfaction
$he or,ani-ation shall monitor customers /erce/tions of the de,ree to which their needs and e)/ectations hae een fulfilled. $he or,ani-ation shall determine the methods for otainin,6 monitorin, and reiewin, this information. 4O$5 5)am/les of monitorin, monitorin, customer customer /erce/tions /erce/tio ns can include customer customer sures6 customer feedac7 ondeliered /roducts and serices6 meetin,s with customers6 mar7et share analsis6 com/liments6 warrant claims
C'stomr satisa+tion
#s one of the measurements measurements of the /erformance /erformance of the qualit mana,ement sstem6 the or,ani-ation shall monitor information relatin, to customer /erce/tion as to whether the or,ani-ation has met customer requirements. $he methods for otainin, and usin, this information information shall e determined.
4O$5 ?onitorin, customer /erce/tion can include otainin, in/ut from sources such as customer satisfaction sures6 customer data
The use of statistical tools is no! tied to the ris8 anal#sis and F$As
and dealer re/orts.
on deliered /roduct qualit6 user o/inion sures6 lost usiness analsis6 com/liments6 warrant claims claims and dealer re/orts.
3onsidera 3onsi deration tion shoul d be %ive %i ven n to =OT6 =OT6 both internal intern al and external exte rnal customers -211
CBSTOM>, CBSTOM >, SATISFAC SATISFACTIO TIO SB##>M>TA 9121 3ustomer satisfaction ; 3ustom 3us tomer er satisf sat isfact action ion !ith !it h the or%ani or% ani.at .ation ion su((lemental shall be monitore moni tored d throu%h thro u%h continua cont inual l 3ustomer satisfaction !ith the evalua eva luatio tion n of (erformance of the or%ani.ation shall be monitored throu%h reali.atio reali .ation n (rocesses erformance continual evaluation of internal and indicato indi cators rs shall shal l be base ba sed d on obe ob ect ctiv ive e external (erformance indicators to ensure data dat a and includ inc lude& e& but not no t be lim l imit ited ed to+ to + com(liance to the (roduct and (rocess delivere deli vered d (art qualit# (erformance& qualit# (erformance& s(ecifications and other customer requirements customer disru(tions& includi incl udin% n% field fie ld returns& erformance indicators shall be based del iver# r# schedu sch edule le (erformance delive on obective evidence and include but 0inclu 0in cludin din% % incide inc idents nts of (remium frei%ht& not be limited to the follo!in%+ and e.a3 delivered (art qualit# (erformance5 cus tomer mer notifi not ificat cation ions s relate rel ated d to qualit qua lit# # custo e.3 customer disru(tions5 e.c3 field field return returns& s& recall recalls& s& and !arran !arrant# t# or deliver# deli ver# issues 0!here a((licable5 The or%ani.ati or%an i.ation on shall monit mon itor or the th e e.d3 deli delive ver# r# sche schedu dule le (erf (erfor orma manc nce e (erformance of manufacturin% (rocesses manufacturin% (rocesses 0includin% incidents of (remium frei%ht5 to demons dem onstra trate te com(li com (lianc ance e !ith !it h e.e3 cust custom omer er noti notifi fica cati tion ons s rela relate ted d to customer cust omer requirement requir ements s for (roduct for (roduct qual qualit it# # or deli delive ver# r# issu issues es&& incl includ udin in% % qual qu alit it# # and an d effi ef fici cien enc# c# of the th e (rocess s(ecial status 3ustomer satisfaction no! includes a The or%ani.ation shall monitor the s(ecific reference to online customer (erformance of manufacturin% manufacturin% (rocesses to scorecards and customer (ortals demonstrate com(liance !ith customer requirements for (roduct qualit# and (rocess *.' Ana!%sis o "ata efficienc# The monitorin% shall include the revie! of customer (erformance data $he or,ani-ation shall determine6 collect includin% online customer (ortals and and analse a//ro/riate data to customer scorecards& !here (rovided demonstrate the suitailit and effectieness of the qualit mana,ement sstem and to ealuate where continual and ealuation of data data $.1.! #nalsis and im/roement of the eff ectieness of the
$he or,ani-ation shall analse and ealuate a//ro/riate data and information arisin, from monitorin, and measurement. $he results of analsis shall e used to ealuate:
a) conformit of /roducts and serices b)the de,ree of customer satisfaction
qualit mana,ement mana,ement sstem can e made. $his shall include data ,enerated as a result of monitorin, and measurement measurement and from other releant sources.
$he analsis of data shall /roide information relatin, to a) customer satisfaction 2see *..136
c) the /erformance and effectieness of the qualit mana,ement sstem
b)conformit to /roduct requirements 2see
d)if /lannin, has een im/lemented effectiel
c) characteristics and trends of
e) the effectieness of actions ta7en to address ris7s and o//ortunities f) the /erformance of e)ternal /roiders
*..'36
/rocesses and /roducts6 includin, o//ortunities for /reentie action 2see *..8 and *..'36 and su//liers 2see H.'3.
g) the need for im/roements to the qualit mana,ement sstem. ?ethods to analse data can 4O$5 include statistical techniques.
9181 rioriti.ation Trends in qualit# and o(erational (erformance shall be com(ared !ith (ro%ress to!ard obectives obectives and lead to action to su((ort (rioriti.ation of actions for im(rovin% customer satisfaction
-41 AASIS AD BS> OF DATA Trend Tr ends s in qualit qua lit# # and o(erat o(e ratio ional nal (erformance shall be com( co m(ar ared ed !ith !i th (ro%ress to!ard obectives obectives and lead to action act ion to su((or su( (ortt the follo! fol lo!in% in%++ develo dev elo(me (ment nt of (riorities of (riorities for (rom(t for (rom(t solution solu tions s to customer cust omer)rel )related ated (roblems5 (roblems5 dete rminatio ation n of 8e# customer cust omer) ) determin relate rel ated d trend tr ends s and correl cor relati ation on for status stat us revie!& revi e!& decision) d ecision) ma8in% and an d lon%e lon %err term te rm (lannin%5 (lannin%5 an info in form rmat atio ion n s#st s# stem em for fo r the th e time ti mel# l# re(or re( ortin tin% % of (roduct of (roduct information information arisin% from usa%e :ata :at a should sho uld be com(a co m(are red d !ith !it h =OT6 =O T6 those of com(etito rs and/or a((ro (riate benchmar8s
9.2 Internal #udit 9.2.1
$he or,ani-ation shall conduct internal audits at /lanned interals to /roide information on whether the qualit mana,ement sstem: a) conforms to:
1)
the or,ani-ations own requirements for its qualit mana,ement sstem
2)
the requirements of this International Standard 3 is ef effe fect cti iel el im/ im/le leme ment nted ed an and d maintained.
$he or,ani-ation shall: 9.2.2 a) /lan6 estalish6 im/lement and maintain an audit /ro,ramme2s3 includin, the frequenc66 methods6 res/onsiilities6 frequenc res/onsiilities6 /lannin, requirements and re/ortin,6 which shall ta7e into consideration the im/ortance of the /rocesses concerned6 chan,es affectin, the or,ani-ation6 and
*.. Internal audit $he or,ani-ation shall conduct internal audits at /lanned interals to determine whether the qualit mana,e ment sstem sstem a)
conforms to the /lanned arran,ements 2see H.136 to the requirements of this International Standard and to the qualit mana,ement sstem requirements estalished the or,ani-ation6 and
b) is effectiel im/lemented and maintained. #n audit /ro,ramme /ro,ramme shall e /lanned6
ta7in, into consideration the status and im/ortance of the /rocesses /rocesses and areas to e audited6 as well as the results of /reious audits. $he audit criteria6 sco/e6 frequenc and methods shall e defined. $he selection of auditors and conduct of audits shall ensure o;ectiit o;ectiit and im/artialit of the audit /rocess. #uditors shall not audit their own wor7.
# documented /rocedure /rocedure shall shall e
# /rocedure is no lon,er lon,er required6 ut ou ou do need to hae documented eidence of the im/lementation of the internal audit /ro,ramme 2for e)am/le: schedule audit sco/es6 audit criteria6 chec7lists3 and of the audit results
the results of /reious /reious audits audits b)define the audit criteria and sco/e for each audit
c) select auditors and conduct audits to ensure o;ectiit and the im/artialit of the audit /rocess d)ensure that the results of the audits are re/orted to releant mana,ement e) ta7e a//ro/riate correction and correctie actions without undue dela f) retain documented information as eidence of the im/lementation of the audit /ro,ramme and the audit results. 4O$5
See ISO 19011 for ,uidance.
estalished estalished to define the res/onsiilities and requirements for /lannin, and conductin, audits6 estalishin, records and re/ortin, results.
Records of the audits and their results shall e maintained 2see '..'3. $he mana,ement res/onsile for the area ein, audited shall ensure that an necessar corrections and correctie actions are ta7en without undue dela to eliminate detected nonconformities and their causes. Followu/ actiities shall include the erification of the actions ta7en and the re/ortin, of erification results 2see *.!.3.
9221 Internal audit (ro%ramme 4O$5 See ISO 19011 for ,uidance. The or%ani.ation shall have a documented internal audit (rocess The (rocess shall include the develo(ment and im(lementation of an internal audit (ro%ramme that covers -221 "@A?IT "@A?ITC C $A=A $A=A$=T $=T SCST SCST$ $ A@:IT the entire qualit# mana%ement s#stem The or%ani.ati or%an i.ation on shall audi au ditt its it s qual qu alit it# # includin% qualit# mana%ement s#stem audits& mana%eme mana %ement nt s#stem to verif# manufacturin% (rocess audits& and (roduct com(lian com( liance ce !ith this Technica Tech nical l audits S(ecific S(ec ificatio ation n and an# addition addi tional al qualit qua lit# # The audit (ro%ramme shall be (rioriti.ed based u(on ris8& internal and external (erformance trends& and criticalit# of the (rocess0es Dhere the or%ani.ation is res(onsible for soft!are develo(ment& the or%ani.ation shall include soft!are develo(ment ca(abilit# assessments in their internal audit (ro%ramme
mana%emen t s#stem requiremen ts
IATF requires a documented (rocess
Formall# requires basin% the (ro%ramme on (riorities from ris8 anal#sis
Includes soft!are develo(ment if -222 $A=@FA3 $A=@FA3T@>I= T@>I= >O3S >O3SS S A@:IT or%ani.ation is res(onsible for soft!are develo(ment The or%ani.ati or%an i.ation on shall audi au ditt each ea ch manufact manu facturin urin% % (rocess to determine determine its effectiveness
-228 >O:@3 >O:@3T T A@:IT The or%ani.ati or%an i.ation on shall audit aud it (roducts (roducts at
The frequenc# of audits shall be revie!ed and& !here a((ro(riate& adusted based on occurrence of (rocess chan%es& internal and external nonconformities& and/or customer com(laints The effectiveness of the audit (ro%ramme shall be revie!ed revie!ed as a (art of mana%ement revie! 9,,, 9,,, "ualit# "ualit# mana%emen mana%ementt s#stem audit audit The or%ani.ation shall audit all qualit# mana%ement s#stem (rocesses over each three)#ear calendar (eriod& accordin% to an annual (ro%ramme& usin% the (rocess a((roach to verif# com(liance !ith this Automotive "$S Standard Inte%rated !ith these audits& the or%ani.ation shall sam(le customer)s(ecific qualit# mana%ement s#stem requirements for effective im(lementation 9,,7 9,,7 $anufactu $anufacturin% rin% (rocess (rocess audit The or%ani.ation shall audit all manufacturin% (rocesses over each three)#ear calendar (eriod to determine their effectiveness and efficienc# usin% customer)s(ecific required a((roaches for (rocess audits Dhere not defined b# the customer& the or%ani.ation shall determine the a((roach to be used
a((ro( a(( ro(ria riate te sta%es sta %es of (roduction of (roduction and deliver# deli ver# to verif# veri f# conform conf ormit# it# to all s(ecified requ requir irem emen ents ts&& such such as (roduct dimensions& functionalit #& (ac8a%in% an d labellin%& at "$S audits s(ecifies an annual (r%ramme a and so that all "$S (rocesses are audited defined frequenc# over a three #ear calendar (eriod Also requires sam(lin% of customer s(ecific -224 I=T I=T>=A? >=A? A@:IT ?A=S "$S requirements for effectiveness Internal audits aud its shall shal l cover cov er all qualit qua lit# # mana%eme mana %ement nt related rela ted (rocesses& activiti acti vities es and shifts& shi fts& and shall sha ll be sched sc hedule uled d accord acc ordin% in% to an annual ann ual (lan (lan Dhen Dhe n internal inte rnal/exte /external rnal nonconfo nonc onformit rmities ies or customer cust omer com(la c om(laints ints o ccur& ccur & the audit aud it $anufacturin% (rocess audits B audit all of frequenc freq uenc# # shall shal l be a((ro( a(( ro(ri riate atel# l# them over the the three #ear (eriod5 determine determine increased effectiveness and efficienc# usin% =OT S(ecific chec8list s should be used customer s(ecified a((roaches for each eac h audit aud it Include audit of the (rocess ris8 anal#sis F$A and 3ontrol lan -225 I=T I=T>= >=A? A? A@:ITO A@: ITO> > "@A?IFI3ATIO= The or%ani.atio or%ani .ation n shall have internal inte rnal audi au dito tors rs !ho !h o are ar e qual qu alif ifie ied d to audi au ditt the th e requirem requ irements ents of this Technica Tech nical l S(ecificatio n0 see 6,,,
Dithin each individual audit (lan& each manufacturin% (rocess shall be audited on all shifts !here it occurs& includin% the a((ro(riate sam(lin% of the shift handover The manufa manufactu cturin rin% % (roces (rocess s audit audit shall shall include an audit of the effective im(l im(lem emen enta tati tion on of the the (roc (roces ess s ris8 ris8 anal#sis anal#sis 0such as F$A& F$A& control control (lan& and associated documents 9,, 9,,4 4 roduc roductt audit audit The or%ani.ation shall audit (roducts usin% customer)s(ecific required
roduct audits usin% customer s(ecific a((roaches
a((roaches at a((ro(riate sta%es of (roduction and deliver# deliver# to verif# conformit# to s(ecified requirements Dhere not defined b# the customer& the or%ani.ation shall define the a((roach to be used
9.3 ?ana,ement reiew ?ana,ement reiew 981 eneral $o/ mana,ement shall reiew the 56 561 1 n nra ra!! or,ani-ations qualit mana,ement sstem6 $o/ mana,ement shall reiew the at /lanned interals6 to ensure its continuin, or,ani-ationGs qualit mana,ement sstem6 at suitailit6 adequac6 effectieness and /lanned interals6 to ensure its continuin, ali,nment with the strate,ic direction of the suitailit6 adequac and effectieness. $his or,ani-ation. reiew shall include assessin, o//ortunities 9811 $ana%ement revie! ; su((lemental for im/roement im/roement and the need for chan,es to $ana%emen $ana%ementt revie! revie! shall shall be conducted conducted the qualit mana,ement sstem6 includin, the at leas leastt annu annual all# l# The The freq freque uenc nc# # of qualit /olic and qualit o;ecties. mana%ement revie!0s shall be increased base based d on ris8 ris8 to com( com(li lian ance ce !ith !ith Records from mana,ement reiews shall e customer customer requiremen requirements ts resultin% resultin% from maintained 2see '..'3. internal internal or external external chan%es chan%es im(actin% im(actin% the qualit qualit# # mana%e mana%emen mentt s#stem s#stem and (erformance)related issues issues $.!.2 ?ana,ement Reiew In/uts 5611 "@A? "@A?ITC ITC $A=A $A=A$ $=T =T SCS SCST T$ $ $he mana,ement reiew shall e /lanned and >FO>$A=3 carried out ta7in, into consideration: These Thes e revie!s revi e!s shall shal l include inc lude all a) th the e stat status us of act actio ions ns fro from m /reious requir req uireme ements nts of the qualit qua lit# # mana%e man a%emen mentt s#stem s#s tem and its (erformance its (erformance trends as an
?ana,ement reiew now needs to ali,n with the strate,ic direction of the or,ani-ation
?ana,ement reiew in/uts now include su//lier /erformance effectieness of actions to address ris7s adequac of resources chan,es in internal and e)ternal issues
Annual mana%ement mana%ement revie!s revie!s required required !ith frequenc# increased based on ris8 to com(liance to customer requirements resultin% from chan%es and (erformance issues
mana,ement reiews
b)chan,es in e)ternal and internal issues that are releant to the qualit mana,ement sstem c) information on the /erformance and effectieness of the qualit mana,ement sstem6 includin, trends in: 1)
customer satisfaction satisfaction and feedac7 from releant interested /arties
2)
the e)tent to which qualit o;ecties o;ecti es hae een met
3)
/rocess /erformance and conformit of /roducts and serices
4)
nonconformities and correctie actions
5)
monitorin, and measurement results
")
audit results
7)
the /erformance of e)ternal /roiders
d)the adequac of resources e) the effectieness of actions ta7en to address ris7s and o//ortunities 2see %.13 f) o//ortunities for im/roement.
essential (art (a rt of the contin con tinual ual im(rovement (rocess art ar t of the mana% man a%eme ement nt revie! rev ie! shall sha ll be the monito mon itori rin% n% of qualit qua lit# # obect ob ective ives& s& and an d the th e re%u re %ula larr re(o re (ort rtin in% % and an d evalu eva luat atio ion n of the th e cos co st of (oor qualit# 0see 0see <41 and <-1 <-1 These Thes e results resu lts shall shal l be reco re cord rded ed to (rovide& to (rovide& as a mini mi nimu mum& m& evide ev idence nce of the achiev ach ieveme ement nt of the qualit# quali t# obect ob ective ives s s(ecif s(e cified ied in the the busine bus iness ss (lan& (lan& and a nd customer cust omer satisfac tion !ith !i th (roduct (roduct su((lied su((lied
,vi inp't .#.2 $he in/ut to mana,ement reiew shall include information on a) results of audits6 b) customer feedac76 c) /rocess
/erformance conformit6
and
/roduct
d) status of /reentie and correctie actions6 e) followIu/
actions from mana,ement reiews6
/reious
f) chan,es that could affect the qualit
mana,ement sstem6 and 9821 $ana%ement revie! in(uts ; g) recommendations for im/roement. su((lemental In(ut to mana%ement revie! shall include+ >ID D I=@ I=@T T ; S@ S@?$ ?$=TA? =TA? There is no! a list of additional !.%..1 >I a3 cost of (oor qualit# 0cost of internal In(ut In( ut to mana% man a%eme ement nt revie! rev ie! shall sha ll incl in clud ude e an mana%ement revie! in(uts and external nonconformance5 anal#s ana l#sis is of actual act ual and an d (otential field)failur field)f ailures es 3 measures of (rocess effectiveness5 and their the ir im(ac im (actt on qual q ualit# it#& & safe sa fet# t# or the th e c3 measures of (rocess efficienc#5 environment d3 (roduct conformance5 e3 assessments of manufacturin% feasibilit# made for chan%es to existin% o(erations and for ne! facilities or ne! (roduct 0see Section 1715 f3 customer satisfaction 0see ISO 9**1& Section 91,5 ,3 revi revie! e! of (erf (erfor orma manc nce e a%ai a%ains nst t maintenance obectives5 h3 !arra arrant nt# # (erf (erfor orm mance ance 0!h 0!here ere a((licable5 i3 revie! of customer scorecards 0!here a((licable5 identification of (otential field failures identified throu%h ris8 anal#sis 0such as F$A5 8 actual field failures and their im(act on safet# or the environment 9.8.8 ?ana,ement Reiew Out/uts $he out/uts of the mana,ement reiew shall ,vi o'tp't $he out/ut from the mana,ement reiew shall include decisions decisions and actions related to: include an decisions and actions related to a) o//ortunities for im/roement ".3.a) im/roement of the b)an need for chan,es to the qualit effectieness of the qualit mana,ement sstem and its
mana,ement sstem
c) resource needs. $he or,ani-ation shall retain documented information as eidence of the results of mana,ement reiews.
/rocesses6 im/r im/ro oem eme ent of /roduct related customer requirements6 and
".3.b)
".3.c)
resource needs. An action (lan is required as a mana%ement revie! out(ut !hen customer (erformance tar%ets are not met
9771 $ana%ement revie! out(uts ; su((lemental To( mana%ement shall document and im(lement an action (lan !hen customer (erformance tar%ets are not met 10 Im/roement 10.1 10.1 eneral ene ral
* Im/roement *.!.1 (ontinual im/roement im/roement
$he or,ani-ation shall determine and select o//ortunities for im/roement and im/lement an necessar actions to meet customer requirements and enhance customer satisfaction.
$he or,ani-ation shall continuall im/roe the effectieness of the qualit mana,ement sstem throu,h the use of the qualit /olic6 qualit o;ecties6 audit results6 analsis analsis of data6 correctie and /reentie actions and mana,ement reiew.
$hese shall include: a) im/roin, /roducts and serices to meet requirements as well as to address future needs and e)/ectations -511
b)correctin,6 /reentin, or reducin, undesired effects c) im/roin, the /erformance and effectieness effecti eness of the qua lit mana,ement sstem. 4O$5 5)am/les of im/roement can include correction6 correctie action6 continual im/roement6 rea7throu,h chan,e6 innoation innoation and re or,ani-ation.
to
3O=TI= 3O= TI=@A? @A? I$ I$>O >O$ $=T =T OF TH O>A=IPATIO= The or%ani.ati or%an i.ation on shall defi de fine ne a (rocess for continua cont inual l im(rovement
4ow need to select s/ecific o//ortunities for im/roement and ta7e actions
10. 4onconformit 10. 4onconformit and correctie correctie action 1021 Bhen a nonconformit occurs6 includin, an arisin, from com/lai com/laints6 nts6 the or,ani-ation shall:
a) react to the nonconformit and6 as a//licale: 1)
ta7e action to control and correct it
2)
deal with the consequences
b)ealuate the need for action to eliminate the cause2s3 of the nonconformit6 in order that it does not recur or occur elsewhere6 :
-52 Corr+tiv a+tion $he or,ani-ation shall ta7e action to eliminate the causes of nonconformities in order to /reent recurrence. (orrectie actions shall e a//ro/riate to the effects of the nonconformities nonconformities encountered.
# documented /rocedure /rocedure shall shall e estalished to define requirements for a)
reie iewin, in, nonc nonco onfor nformi miti tie es customer com/laints36
reiewin, and anal-in, the reiewin, nonconformit
b) determinin, the causes of
2)
determinin, the causes of the nonconformit
c)
3)
determinin, if similar nonconformities e)ist6 or could /otentiall occur
d) dete determ rmin inin,an in,and d
1)
c) im/lement an action needed d)reiew the effectieness of an correctie action ta7en e) u/date ris7s and o//ortunities determined durin, f) /lannin,6 if necessar g) ma7e chan,es to the qualit mana,ement sstem6 if nece ne cess ssar ar .
2inc 2inclu lud din, in,
nonconformities6 ealuatin, the need for action to ensure that nonconformities do not recur6 im/le im/leme ment ntin in, ,
action
needed6 e)
records of the results of action ta7en 2see '..'36 and
f)
reiewin, the effectieness of the correctie action ta7en.
# /rocedure is no lon,er required do need documented eidence
10/2/2 $he or,ani-ation shall retain documented information as eidence of: a) the nature of the nonconformities and an susequent actions ta7en
b)the results of an correctie action. -521 >O2? >O2?$ $ SO?I SO?I= = 1*,7 1*,7 roblem roblem solvin solvin% % The or%ani.ati or%an i.ation on shall have ha ve a defi de fine ned d The or%ani.ation or%ani.ation shall have a documented documented (rocess for (roblem solvin% leadin% to (rocess0es for (roblem solvin% solvin% includin%+ root cause caus e identifi iden tificati cation on and eliminat elim ination ion cus tomer er)(r )(resc escrib ribed ed (roblem)solv (roblem)solvin% in% a3 defined a((roaches for various t#(es If a custom and scale of (roblems 0e%& ne! format form at exists& exist s& the or%ani.ati or%an i.ation on shall shal l use the (roduct develo(ment& current (rescribed format format manufacturin% issues& field failures& audit findin%s5 3 containment& interim actions& and <-,, <- ,, >>O >>O>)> >)>OOFI OOFI= = related activities necessar# for The or%ani.ati or%an i.ation on shall use error)(roofin% error)(r oofin% control of nonconformin% out(uts method met hods s in their the ir correc cor rectiv tive e action act ion (rocess (rocess 0see ISO 9**1& Section <5 c3 root cause anal#sis& methodolo%# 3orrective action im(act is no! included used& anal#sis& and results5 -528 3O>>3 3O>>3TI TI A3TIO= I$A3T in the roblem Solvin% clause d3 im(lementation of s#stemic The or%ani.atio or%an i.ation n shall shal l a(( a ((l# l# to othe ot herr corrective actions& includin% simila sim ilarr (rocesses and (roducts the consideration of the im(act on correcti corr ective ve action& actio n& and controls cont rols similar (rocesses and (roducts5 im(lemented& in orde or derr to elim el imin inat ate e the th e e3 verification of the effectiveness of caus ca use e im(lemented corrective actions5 of a nonconfo nonc onformit rmit# # f3 revie!in% and& !here necessar#& u(datin% the a((ro(riate documented information 0e%& F$A& control (lan Dhere the customer has s(ecific (rescribed (rocesses& tools& or s#stems for (roblem solvin%& the or%ani.ation or%ani.ation shall use those (rocesses& tools& or s#stems unless other!ise a((roved b# the customer 1*,4 1*,4 rror)(roofi rror)(roofin% n% The or%ani.ation shall have a documented documented (rocess to determine determine the use use of a((r a((ro( o(ri riat ate e erro error) r)(r (roo oofi fin% n% method methodolo olo%ie %ies s :etail :etails s of the method method used shall be documented in the (rocess
rror)roofin% is in the clause belo! 01*,4 A documented (rocess is required $ethodolo%ies to be documented in the F$A The testin% of error)(roofin% devices is required and records of the testin% are required
ris8 anal#sis 0such as F$A and test frequencies shall be documented in the control (lan The (rocess shall include the testin% of error)(roofin% devices for failure or simulated failure >ecords shall be maintained 3hallen%e (arts& !hen used& shall be identified& controlled& verified& and calibrated !here feasible rror)(roofin% device failures shall have a reaction (lan This !arrant# mana%ement s#stem is a ne! clause and a((lies !hen the or%ani.ation is required to (rovide !arrant# for their (roducts
1*,1*,- Darrant# Darrant# mana%ement mana%ement s#stems s#stems Dhen the or%ani.ation is required to (rovide !arrant# for their their (roduct0s& the or%ani.ation shall im(lement a !arrant# mana%ement (rocess The or%ani.ation shall include in the (rocess a method for !arrant# (art anal#sis& includin% =TF 0no trouble found Dhen s(ecified b# the customer& the or%ani.ation shall im(lement the required !arrant# mana%ement (rocess
1*,6 1*,6 3ustomer 3ustomer com(laints com(laints and field failure failure test anal#sis The or%ani.ation shall (erform anal#sis on custom customer er com(la com(laint ints s and field field failur failures& es& includ includin% in% an# return returned ed (arts& (arts& and shall shall initia initiate te (roble (roblem m solvin solvin% % and correc correctiv tive e action to (revent recurrence Dhere Dhere reques requested ted b# the custom customer& er& this this shall include anal#sis of the interaction of embedded embedded soft!are soft!are of the or%ani.ati or%ani.ationEs onEs (roduct !ithin the s#stem of the final customerEs (roduct The or%ani.ation shall communicate the results of testin%/anal#sis to the customer and also !ithin the or%ani.ation
-524 >L3T >L 3T: : >O:@3 >O :@3T T TST/A=A?CSIS The c#cle time requirement has been The or%ani.ati or%an i.ation on shall anal#s ana l#se e (arts removed reected reec ted b# the customer cust omerEs Es manufact manu facturin urin% % (lants& en%ineeri en%in eerin% n% faciliti faci lities es and The revised clause includes anal#sis of the dealershi(s The or%ani.ati or%an i.ation on shall shal l interaction of embedded soft!are mini mi nimi mi.e .e the th e c#cl c# cle e time ti me of this th is (rocess >ecor >ec ords ds of these the se anal#s ana l#ses es shal s hall l be 8e(t 8e (t and made mad e availa ava ilable ble u(on u(o n reque re quest st The or%ani.ation shall (erform (erform anal#sis anal#sis and initia ini tiate te corre co rrecti ctive ve actio ac tion n to (revent to (revent recurrence 3#cle 3#c le time tim e relat rel ated ed to reec re ected ted =OT6 =O T6 (roduct anal#sis should be consistent !ith !it h the th e deter det ermin minat ation ion of root ro ot cause& cau se& corrective ac tion and monit orin% the
effectiveness of im(lement ation
108 Contin'a! improvmnt $he or,ani-ation shall continuall im/roe the suitailit6 adequac and effectieness of the qualit mana,ement sstem. $he or,ani-ation shall consider the results of analsis and ealuation6 and the out/uts from mana,ement reiew6 reiew6 to determine if there are needs or o//ortunities that shall e addressed as /art of continual im/roement. 1081 3ontinual im(rovement ; su((lemental The or%ani.ation shall have a documented (rocess for continual im(rovement The or%ani.ation shall include in this (rocess the follo!in%+ a3 identification of the methodolo%# used& obectives& measurement& effectiveness& and documented information5 3 a manufacturin% (rocess im(rovement action (lan !ith em(hasis on the reduction of (rocess variation and !aste5 c3 ris8 anal#sis 0such as F$A =OT 3ontinual im(rovement is im(lemented once manufacturin% (rocesses are statisticall# statisticall# ca(able and stable or !hen (roduct characteristics are (redictable and meet customer customer requirements
3O=TI=@A I=@A? ? I$ I$>O >O$ $=T =T OF TH *.!.1.1 3O=T O>A=IPATIO= The or%ani.ati or%an i.ation on shall shal l defi de fine ne a (rocess for continual im(rovement
$A=@FA3T@>I= T@>I= >O3 >O3SS SS *.!.1. $A=@FA3 I$>O$=T $anufactu $anuf acturin% rin% (rocess (rocess im(rovement shall shall continual conti nuall# l# focus focu s u(on control cont rol and an d reduct red uction ion of variat var iation ion in (roduct in (roduct character char acteristi istics cs and manufact manu facturin urin% % (rocess (arameters =OT 1 3ontrolled characte ristics are documente d in the control (lan (lan =OT , 3ontinual im(ro im( rovem vement ent is im(lemen im(l emented ted once manufact manu facturi urin% n% (rocesses are ca(able and stable& or (roduct characteristics are (redictable are (redictable and meet customer cust omer require requ irement ments s
>equires a documented 3I (rocess includin% methodolo%#5 obectives5 effectiveness5 manufacturin% (rocess im(rovement (lan
