AUTOMOTIVE QUALITY MANAGEMENT SYSTEM STANDARD
IATF 16949
Quality managmnt !y!tm "#ui"mnt! $%" aut%m%ti& '"%(u)ti%n an( "l&ant !"&i) 'a"t! %"gani*ati%n!
International Automotive Task Task Force F orce
1st Edition 1 October 2016 自尊
IATF copyright notice This Automotive Quality Management System Standard, known as IATF 16949, is o!yright !roteted "y the mem"ers o# the International Automotive Task Fore $IATF%& The title #or this Automotive QMS Standard 'IATF 16949' is a registered trademark o# the IATF& ()e!t as !ermitted under the a!!lia"le laws o# the user*s ountry, neither this Automotive Quality Management System Standard nor any e)trat #rom #rom it may "e "e re!rodued, re!rodued, stored stored in a retrieval retrieval system or or transmitted transmitted in any #orm or "y any means, eletroni, !hotoo!ying, reording r eording or otherwise, otherwise, without without !rior written !ermission !er mission "eing seured #rom the IATF& IATF& +e!rodution may "e su"et to royalty !ayments or a liensing agreement and violators are su"et to legal !roseution&
+e5uests #or !ermission to re!rodue andor translate any !art o# this Automotive QMS Standard should "e addressed to one o# the #ollowing national automotive trade assoiations "elow7 Assoia8ione /a8ionale Filiera Industrie Automo"ilistihe Automo"ilistihe $A/FIA Italy% Italy% Automotive Automotiv e Industry Ind ustry Ation .rou! $AIA. I SA% Federation des Industries des (5ui!ements !our 0ehiules $FI(0 Frane% Soiety o# Motor Manu#aturers and Traders :td& $SMMT ;% 0er"and 0er"and der Automo"ilindustrie e&0& $0A .ermany%
+e5uests #or !ermission to re!rodue andor translate any !art o# this Automotive QMS Standard should "e addressed to one o# the #ollowing national automotive trade assoiations "elow7 Assoia8ione /a8ionale Filiera Industrie Automo"ilistihe Automo"ilistihe $A/FIA Italy% Italy% Automotive Automotiv e Industry Ind ustry Ation .rou! $AIA. I SA% Federation des Industries des (5ui!ements !our 0ehiules $FI(0 Frane% Soiety o# Motor Manu#aturers and Traders :td& $SMMT ;% 0er"and 0er"and der Automo"ilindustrie e&0& $0A .ermany%
Ta+l %$ ,%ntnt! TABLE BLE OF CONT CONTEN ENTS.............. TS........................ .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... ................... ......... .... 1 FOREWORD FOREWORD A!TO"OTI# A!TO"OTI#E E $"S STANDARD.................. STANDARD............................ .................... .................... .................... .................... .................... .................... ................ ........... ..... ......... ..... ......... ..... . % &ISTOR &ISTOR'........ 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ON....................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .......... ........ ..... ... * INTR INTROD! OD!CT CTION ION............. ............................. ............................... .............................. .............................. .............................. .............................. .............................. .............................. ........................................... ............................ ... + ,.1 ,.1 (ENE (ENERA RAL........... L.......................... .............................. .............................. .............................. .............................. .............................. .............................. .............................. .............................. .............................. ........................ ......... + ,.- $!ALIT' "ANA(E"ENT "ANA(E"ENT RINCILES................. RINCILES................................ .............................. .............................. .............................. ............................... ............................... ........................... ............ + ,./ ROCE ROCESS SS ARO AROAC AC&........... &.......................... .............................. .............................. .............................. .............................. .............................. .............................. ................................................ ................................. + ,./.1 ,./.1 (ENERA (ENERAL.............. L............................. .............................. .............................. .............................. .............................. .............................. .............................. .............................. .............................. .............................. .................. ... + ,./.,./.- LAN0D LAN0DO0C& O0C&EC) EC)0AC 0ACT T C'CLE....... C'CLE...................... .............................. .............................. .............................. .............................. .............................. ................................................... .................................... + ,././ RIS)0BASED RIS)0BASED T&IN)IN( T&IN)IN(............... .............................. ............................... ............................... .............................. .............................. .............................. .............................. ..................................... ...................... + ,. RELATIONS&I WIT& OT&ER "ANA(E"ENT S'STE" STANDARDS................. STANDARDS........................... .................... .................... .................... ................... ............. ...... .. + $!ALIT' "ANA(E"ENT "ANA(E"ENT S'STE"S RE$!IRE"ENTS............ RE$!IRE"ENTS...................... .................... .................... .................... .................... .................... .................... .................... ................. ......... + 1 SCOE....................... SCOE...................................... .............................. .............................. .............................. .............................. .............................. .............................. .............................. .............................. ................................. .................. + 1&1 S<=>( S<=>( ? AT=M=TI0 AT=M=TI0( ( S>>:(M(/T S>>:(M(/TA: A: T= T= IS= 91731@&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 91731@&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&& &&&&&& &&&&&& && 9
- NOR"A NOR"ATI TI#E #E REFEREN REFERENCES... CES.................. .............................. .............................. .............................. .............................. .............................. .............................. .............................. .................................. ................... 1, 3&1/=+MATI0( TI0(A/ I/F=+MA I/F=+MATI0( TI0( +(F(+(/ +(F(+(/<(S&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& <(S&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&& &&&& 1
/ TER"S AND DEFINITIONS............ DEFINITIONS........................... .............................. .............................. .............................. .............................. .............................. .............................. ........................................ ......................... 1, &1T(+MS T(+MS A/ A/ (FI/I (FI/ITI= TI=/S /S F=+ F=+ TB(AT=M= AT=M=TI0 TI0( ( I/ST I/ST+C&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& +C&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&& 1
CONTE2T CONTE2T OF T&E OR(ANI3A OR(ANI3ATIO TION............ N........................... .............................. .............................. .............................. .............................. .............................. .............................. ........................... ............ 14 .1 !NDERSTANDIN( T&E OR(ANI3ATION OR(ANI3ATION AND ITS CONTE2T......... .................... .......... .................... .................... .................... .................... .................... ................ ...... 14 .- !NDERSTANDIN( T&E NEEDS AND E2ECTATIONS OF INTERESTED ARTIES.....................................................14 ./ DETER"ININ( T&E SCOE OF T&E $!ALIT' "ANA(E"ENT S'STE"...................................................................14 4&&1 etermining the so!e o# the 5uality management management system ? su!!lement su!!lemental&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& al&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 16 4&&3
4-4 QUALITY MANAGEMENT SYSTEM AND ITS .RO,ESSES------------------------------------------------------------16 4-44-4-1---------------------1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------ -- 16 4&4&1&1 4&4&1&1
rodut sa#ety &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&& 1D
4-44-4-/---------------------/------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ------------ -- 10
LEADERS2I.
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13 -1 LEADERS2I. AND ,OMMITMENT---------------------------------------------------------------------------------------------13 -1-1 GENERAL-----------------------------------------------------------------------------------------------------------------------------13 @&1&1&1
&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 1E
@&1&1&3 >roess e##etiveness and e##iieny&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&& 1E @&1&1& >roessowners&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 1E
-1-/ ,USTOMER FO,US--------------------------------------------------------------------------------------------------------------- 13 / .OLI,Y--------------------------------------------------------------------------------------------------------------------- ------------ 13 -/-1 ESTA5LIS2ING T2E QUALITY .OLI,Y-------------------------------------------------------------------------------------13 -/-/ ,OMMUNI,ATING T2E QUALITY .OLI,Y-------------------------------------------------------------------------------13 - ORGANI7ATIONAL ROLES RES.ONSI5ILITIES AND AUT2ORITIES----------------------------------------------13 @ & & 1 = r g a n i 8 a t i o n a l r o l e s , r e s ! o n s i " i l i t i e s , a n d a u t h o r i t i e s ? su ! ! l e m e n t a l
1E
@&&3 +es!onsi"ility and authority #or !rodut re5uirements and orretive ations &&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&& &&& 19
6 .LANNING----------------------------------------------------------------------------------------------------------------------- --------- 19 6-1 A,TIONS TO ADDRESS RIS8S AND O..ORTUNITIES-----------------------------------------------------------------19 6-1-1 AND 6-1-/---------------------------------------------------------------------------------------------------------------------------- 19 6
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6-/ QUALITY O5E,TIVES AND .LANNING TO A,2IEVE T2EM--------------------------------------------------------/: 6-/-1 AND 6-/-/---------------------------------------------------------------------------------------------------------------------------- /: 6 & 3 & 3 & 1 Q u a l i t y o " e t i v e s a n d ! l a nn i n g t o a h i e v e th e m ? s u ! ! l e m e n t a l
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6- .LANNING OF ,2ANGES---------------------------------------------------------------------------------------------- ----------- /1 0 SU..ORT--------------------------------------------------------------------------------------------------------------------------------- /1 0-1 RESOUR,ES--------------------------------------------------------------------------------------------------------------------------- /1 0-1-1 GENERAL----------------------------------------------------------------------------------------------------------------- ------------ /1 0-1-/ .EO.LE-------------------------------------------------------------------------------------------------------------------------------/1 0-1-
INFRASTRU,TURE-----------------------------------------------------------------------------------------------------------------/1 D&1&&1 >lant, #aility, and e5ui!ment !lanning&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&& 31
0-1-4 ENVIRONMENT FOR T2E O.ERATION OF .RO,ESSES-------------------------------------------------------------// D&1&4&1 (nvironment #or the o!eration o# !roesses ? su!!lemental&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 33
0-1- MONITORING AND MEASURING RESOUR,ES-------------------------------------------------------------------------// D&1&@&1
.(/(+A:&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 33 D&1&@&1&1 Measurement systems analysis &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 33
0-1--/ MEASUREMENT TRA,EA5ILITY------------------------------------------------------------------------------------------//
D&1&@&3&1
7.1.6 ORGANIZATIONALKNOWLEDGE............................................................................................................................................................24 7.2
COMPETENCE...........................................................................................................................................................................................24 D&3,1
7.3 AWARENESS................................................................................................................................................................................................26 D&&1 Awareness ? su!!lemental&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&
36
D&&3 (m!loyee motivation and em!owerment&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 36
7.4
COMMUNICATION...................................................................................................................................................................................26
7.5 DOCUMENTED INFORMATION ................ ........ .................... ........ . ..... .... ........ .................................... ....... ..................................................................26 7.5.1
GENERAL.................................................................................................................................................................................................26 D&@&1&1 Quality management system doumentation &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&& &&&& & &&&&&&&&&&&&&&&&&&&&&&& 36
7.5.2 CREATINGANDUPDATING.......................................................................................................................................................................2 7 7.5.3 CONTROL OF DOCUMENTED INFORMATION........................................................................................................................................27 7.5.3.1AND7.5.3.2...................................................................................................................................................................................... ...... ...... 27 D&@&&3&1 +eord retention&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&
3D
D&@&&3&3 (ngineering s!ei#iations &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 3D
8
OPERATION...................................................................................................................................................................................................28
8.1 OPERATIONALPLANNINGANDCONTROL...............................................................................................................................................28 E&1&1 =!erational !lanning and ontrol ? su!!lemental&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 3E E&1&3
8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES.....................................................................................................................................28 8.2.1 CUSTOMERCOMMUNICATION.............................................................................................................................................................2 8 E,3&1&1
8.2.2 DETERMININGTEREQUIREMENTSFOR PRODUCTSANDSERVICES................................................................................................28 E&3,3&1 etermining the re5uirements #or !roduts and servies ? su!!lemental&&&&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&&&&& &&&&&& &&&& &&&& &&&& &&& &&& 39
8.2.3REVIEWOFTEREQUIREMENTSFORPRODUCTSANDSERVICES......................................................................................................2 ! 8.2.3.1
.................................................................................................................................................................................................................2! E&3&&1&1 +eview o# the re5uirements #or !roduts and servies ? su!!lemental &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& && 39 E&3&&1&3
8.2.3.2
.................................................................................................................................................................................................................2!
3-/-4 ,2ANGES TO REQUIREMENTS FOR .RODU,TS AND SERVI,ES------------------------------------------------/9 3- DESIGN AND DEVELO.MENT OF .RODU,TS AND SERVI,ES------------------------------------------------------: 3--1 GENERAL----------------------------------------------------------------------------------------------------------------------------- : E&&1&1 esign and develo!ment o# !roduts and servies
—
su!!lemental&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
3--/ DESIGN AND DEVELO.MENT .LANNING------------------------------------------------------------------------ ------- : E&&3&1 esign and develo!ment !lanning ? su!!lemental&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& E&&3&3 >rodut design skills &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&& E&&3& evelo!ment o# !roduts with em"edded so#tware&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
3-- DESIGN AND DEVELO.MENT IN.UTS---------------------------------------------------------------------- ------------- 1 E&&&1 >rodut design in!ut&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 1 E&&&3 Manu#aturing !roess design in!ut&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 1 E&&& S!eial harateristis &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& & 3
3--4 DESIGN AND DEVELO.MENT ,ONTROLS-------------------------------------------------------------------------- ----- / E&&4&1 Monitoring &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 3 E&&4&3 esign and develo!ment validation&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 3 E&&4& >rototy!e !rogramme&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 3 E&&4&4 >roduta!!roval !roess &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
3-- DESIGN AND DEVELO.MENT OUT.UTS--------------------------------------------------------------------------------- E&&@&1 esign and develo!ment out!uts ? su!!lemental&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&& E&&@&3 Manu#aturing !roess design out!ut &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&
3--6 DESIGN AND DEVELO.MENT ,2ANGES---------------------------------------------------------------------------------4 E&&6&1 esign and develo!ment hanges — su!!lemental &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 4
3-4 ,ONTROL OF E;TERNALLY .ROVIDED .RO,ESSES .RODU,TS AND SERVI,ES--------------------------4 3-4-1 GENERAL----------------------------------------------------------------------------------------------------------------------------- 4 E&4&1&1 .eneral ? su!!lemental &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&& & @ E&4&1&3 Su!!lier seletion !roess &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&& @ E&4&1&
3-4-/ TY.E AND E;TENT OF ,ONTROL------------------------------------------------------------------------------------------- E&4&3&1 Ty!e and e)tent o# ontrol ? su!!lemental&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 6 E&4&3&3 Statutory and regulatory re5uirements&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& & 6 E&4&3& Su!!lier5uality management system develo!ment &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& && 6 E&4&3&&1 Automotive !rodut2related so#tware or automotive !roduts with em"edded so#tware&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&& 6 E&4&3&4 Su!!lier monitoring&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&& D E&4&3&4&1 Seond2!arty audits &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&& D E&4&3&@ Su!!lier develo!ment &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& E
3-4- INFORMATION FOR E;TERNAL .ROVIDERS---------------------------------------------------------------------------3 E&4&&1 in#ormation #or e)ternal !roviders
—
su!!lemental &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& E
3- .RODU,TION AND SERVI,E .ROVISION----------------------------------------------------------------------------------3 3--1 ,ONTROL OF .RODU,TION AND SERVI,E .ROVISION-----------------------------------------------------------3
E&@&1&1 rodution sheduling &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& && 41
*.5.- IDENTIFICATION AND TRACEABILIT'........................................................................................................................ 1 E&@&3&1 Identi#iation and traea"ility ? su!!lemental&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 41
*.5./ ROERT' BELON(IN( TO C!STO"ERS OR E2TERNAL RO#IDERS...................................................... ............ *.5. RESER#ATION............................................................................................................................................................ E&@&4&1 >reservation ? su!!lemental&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 43
*.5.5 OST0DELI#ER' ACTI#ITIES........................................................................................................................................ E&@&@&1 Feed"ak o# in#ormation #rom servie &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 4 E&@&@&3 Servie agreement with ustomer&&&&&&&& &&&&&&
&&&&&&&&&&&
&&&&& &&&&& &&&&&&&&&&&&&& H &&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&4
*.5.4 CONTROL OF C&AN(ES.............................................................................................................................................. / E&@&6&1
*.4 RELEASE OF ROD!CTS AND SER#ICES................................................................................................... ..... .............. 8.6.1 Release of products and services — supplemental....................................................................................................................................44 8.6.2 Layout inspection and functional testing .................................................................................................................................................44 8.6.3 Appearance items ....................................................................................................................................................................................45 8.6.4 erification and acceptance of conformity of e!ternally provided products and services......................................................................45 8.6.5 "tatutory and regulatory conformity.........................................................................................................................................................45 8.6.6 Acceptance criteria .................................................................................................................................................................................45
*.% CONTROL OF NONCONFOR"IN( O!T!TS.............................................................................................................. 5 *.%.1....................................................................................................................................................................................... 5 E&D&1&1
*.%.-....................................................................................................................................................................................... % + ERFOR"ANCE E#AL!ATION.......................................................................................................................................... % +.1 "ONITORIN(6 "EAS!RE"ENT6 ANAL'SIS AND E#AL!ATION.......................................................................... ..... .. % +.1.1 (ENERAL...................................................................................................................................................................... % 9&1&1&1 Monitoring and measurement o# manu#aturing !roesses&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 4D 9&1&1&3 Identi#iation o# statistial tools&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& 4E
9&1&1& A!!liation o# statistial one!ts&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
4E
9-1-/ ,USTOMER SATISFA,TION------------------- --------------9&1&3&1
43 &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
&&&&&& &&&&&&&&
4E
9-1- ANALYSIS AND EVALUATION------------------------------9&1&&1
49
>rioriti8ation&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
49
9-/ INTERNAL AUDIT---------------------------------------------------
49
9-/-1 AND 9-/-/------------------------------------------------------------
49
9&3&3&1 Internal audit !rogramme
49
9&3&3&3 Quality management system audit&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
@
9&3&3& Manu#aturing !roess audit&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
@ @
9&3&3&4 >rodut audit&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &
9- MANAGEMENT REVIE<------------------------------------------
+"-1 GENERAL 9&&1&1
# 5 1 . ! " # # $ 3 2 # #
..... --------------------
Management review ? su!!lemental
%%%" " 4
------
&'&"("(&&)
................
&&&&&&&&&&&&&&&&&&
: %1 6 %8 8 $ 2 5 # # # # 6 1 . 1 7 " " #
-----
&&&&&&&&&&&&&&&&&
&"*(("&+ .........
&&@
&&&&&&&&&&
&&&&&&&& & & & &&&&&&& &&&&&& &&&&&&& &&&&&& &&&& &&&& &&&& &&& @
9--/ MANAGEMENT REVIE< IN.UTS-------------------------------------------------------
:
9&&3&1 Management review in!uts ? su!!lemental&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&& @1
9-- MANAGEMENT REVIE< OUT.UTS-----------------------------------------------------
1
9&&&1 Management review out!uts ? su!!lemental&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &
@1
1: IM.ROVEMENT------------------------------------------------------------------------------------
1
1:-1 GENERAL------------------------------------------------------------------------------------------
1
1:-/ NON,ONFORMITY AND ,ORRE,TIVE - --------A,TION ----------------- ---------- - -------------------- --------1:-/-1 AND 1:-/-/-------------------------------------------------------------------------------------
.....
---- 1 1
1&3& >ro"lem solving&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
@3
1&3,4 (rror2!roo#ing &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
@3
1&3&@ Jarranty management systems&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& &&&&& @3 1&3&6
1:- ,ONTINUAL IM.ROVEMENT--------------------------------------------------------------
10.3.1 Continual improvement — supplemental.....................................................
53
ANNE; A= ,ONTROL .LAN-------------------------------------------------------------------------
4
A&1
>BAS(S =F TB( <=/T+=: >:A/ &&& &&&&& &&&&& &&&&& &&&&& &&&&& &&&&& &&&& &&&&& &&&&& &&&&& &&&&& &&&&& &&&&& &&&& &&&&& &&&&& &&&&& &&&&& &&&&& &&&&& &&&&& &&&& && && && && &&
&@4
A&3
(:(M(/TS =F TB( <=/T+=: >:A/&&&& &&&&& &&&&& &&&&& &&&& &&&&& &&&&& &&&&& &&&&& &&&&& &&&&& &&&& &&&&& &&&&& &&&&& &&&&& &&&&& &&&&& &&&& &&&&& &&&&& &&& && && && && && &
@4
ANNE; 5= 5I5LIOGRA.2Y SU..LEMENTAL AUTOMOTIVE----------------------------
6
F%">%"( ? Aut%m%ti& QMS Stan(a"( This Automotive Quality Management System Standard herein re!erred to as "Automotive QMS Standard" or "#AT$ 16%&%" along 'ith a((licable automotive customer)s(eci!ic re*uirements #SO %001+201, re*uirements and #SO %000+201, de!ines the !undamental *uality management system re*uirements !or automotive (roduction and relevant service (arts organi-ations. As such this Automotive QMS Standard cannot be considered a stand)alone QMS Standard but has to be com(rehended as a su((lement to and used in con/unction 'ith #SO %001+201,. #SO %001+201, is (ublished as a se(arate #SO Standard. #AT$ 16%&%+2016 1st edition re(resents an innovative document given the strong orientation to the customer 'ith inclusion o! a number o! consolidated (revious customer s(eci!ic re*uirements. Anne 3 is (rovided !or guidance to im(lement the #AT$ 16%&% re*uirements unless other'ise s(eci!ied by customer s(eci!ic re*uirements.
2i!t%"y #SO4TS 16%&% 1st edition 'as originally created in 1%%% by the #nternational Automotive Tas5 $orce #AT$ 'ith the aim o! harmoni-ing the di!!erent assessment and certi!ication systems 'orld'ide in the su((ly chain !or the automotive sector. Other revisions 'ere created 2nd edition in 2002 and rd edition in 200% as necessary !or either automotive sector enhancements or #SO %001 revisions. #SO4TS 16%&% along 'ith su((orting technical (ublications develo(ed by original e*ui(ment manu!acturers 7herein re!erred to as OEMs8 and the national automotive trade associations introduced a common set o! techni*ues and methods !or common (roduct and (rocess develo(ment !or automotive manu!acturing 'orld'ide. #n (re(aration !or migrating !rom #SO4TS 16%&%+200% rd edition to this Automotive QMS Standard #AT$ 16%&% !eedbac5 'as solicited !rom certi!ication bodies auditors su((liers and OEMs to create 1AT$ 16%&%+2016 1st edition 'hich cancels and re(laces #SO4TS 16%&%+200% rd edition. The #AT$ maintains strong coo(eration 'ith #SO by continuing liaison committee status ensuring continued alignment 'ith #SO %001.
G%al The goal o! this Automotive QMS standard is the develo(ment o! a *uality management system that (rovides !or continual im(rovement em(hasi-ing de!ect (revention and the reduction o! variation and 'aste in the su((ly chain.
Rma"@! $%" )"ti$i)ati%n +e5uirements #or erti#iation to this Automotive QMS Standard are de#ined in the +ules #or ahieving and maintaining IATF reognition& etails an "e o"tained #rom the loal =versight =##ies o# the IATF ited "elow7 Assoia8ione /a8ionale Filiera Industrie Automo"ilistihe $A/FIA% Je" site7 wvvw&an#ia&it e2mail7 an#iaKan#ia&it International Automotive =versight Gureau $IAG% Je" site7 www&iao"&org e2mail7 iat#16949#eed"akKiao"&org IATF Frane Je" site7 www&iat#2#rane&om e2mail7 iat#Kiat#2 #rane&om Soiety o# Motor Manu#aturers and Traders :td& $SMMT :td&% Je" site7 www&smmtoversight&o&uk e2mail7 iat#16949Ksmmt&o&uk 0er"and der Automo"ilindustrie ? Qualitats Management
All !u"li in#ormation a"out the IATF an "e #ound at the IATF we"site7 '''.iat!globaloversight.org
Int"%(u)ti%n :-1 Gn"al
See #SO %001+201, re*uirements.
:-/ Quality managmnt '"in)i'l! See #SO %001+201,
re*uirements.
:- ."%)!! a''"%a) :--1 Gn"al
See #SO %001+201, re*uirements.
:--/ .lan?D%?,)@?A)t )y)l
See #SO %001+201, re*uirements.
:-- Ri!@?+a!( tin@ing
See #SO %001+201, re*uirements. :-4 Rlati%n!i' >it %t" managmnt !y!tm !tan(a"(!
See #SO %001+201, re*uirements.
Quality managmnt !y!tm! B R#ui"mnt! 1 S)%'
See #SO %001+201, re*uirements.
1.1 Sco7e C automotive su77lemental to ISO +,,18-,15 This Automotive QMS Standard de!ines the *uality management system re*uirements !or the design and develo(ment (roduction and 'hen relevant assembly installation and services o! automotive)related (roducts including (roducts 'ith embedded so!t'are. This Automotive QMS Standard is a((licable to sites o! the organi-ation 'here manu!acturing o! customer)s(eci!ied (roduction (arts service (arts and4or accessory (arts occur. This Automotive QMS Standard should be a((lied throughout the automotive su((ly chain.
/ N%"mati& "$"n)! See IS= 91731@ re5uirements&
/-1 N%"mati& an( in$%"mati& "$"n)! Anne) A $lan% is a normative !art o# this Automotive QMS standard& Anne) G $Gi"liogra!hy? automotive su!!lemental% is in#ormative, whih !rovides additional in#ormation intended to assist the understanding or use o# this Automotive QMS standard&
T"m! an( ($initi%n! See IS= 91731@ re5uirements&
-1 T"m! an( ($initi%n! $%" t a ut%m%ti& in(u!t"y
a))!!%"y 'a"t ustomer2s!ei#ied additional om!onent$s% that are either mehanially or eletronially onneted to the vehile or !owertrain "e#ore $or a#ter% delivery to the #inal ustomer $e&g&, ustom #loor mats, truk "ed liners, wheel overs, sound system enhanements, sunroo#s, s!oilers, su!er2hargers, et&%
a(&an)( '"%(u)t #uality 'lanning A.Q. !rodut 5uality !lanning !roess that su!!orts develo!ment o# a !rodut or servie that will satis#y ustomer re5uirementsL A>Q> serves as a guide in the develo!ment !roess and also a standard way to share results "etween organi8ations and their ustomersL A>Q> overs design ro"ustness, design testing and s!ei#iation om!liane, !rodution !roess design, 5uality ins!etion standards, !roess a!a"ility, !rodution a!aity, !rodut !akaging, !rodut testing and o!erator training !lan, among other items
a$t"ma"@t 'a"t re!laement !art$s% not !roured or released "y an =(M #or servie !art a!!liations, whih may or may not "e !rodued to original e5ui!ment s!ei#iations
aut%"i*ati%n doumented !ermission #or a !erson$s% s!ei#ying rights and res!onsi"ilities related to giving or denying !ermissions or santions within an organi8ation
)allng ma!t" 'a"t !art$s% o# known s!ei#iation, ali"rated and traea"le to standards, with e)!eted results $!ass or #ail% that are used to validate the #untionality o# an error2!roo#ing devie or hek #i)tures $e&g&, go no2go gauging%
)%nt"%l 'lan doumented desri!tion o# the systems and !roesses re5uired #or ontrolling the manu#aturing o# !rodut $see Anne) A%
)u!t%m" "#ui"mnt! all re5uirements s!ei#ied "y the ustomer $e&g&, tehnial, ommerial, !rodut and manu#aturing !roess2related re5uirements, general terms and onditions, ustomer2s!ei#i re5uirements, et&%
)u!t%m"?!')i$i) "#ui"mnt! ,SR! inter!retations o# or su!!lemental re5uirements linked to a s!ei#i lause$s% o# this Automotive QMS Standard
(!ign $%" a!!m+ly DFA !roess "y whih !roduts are designed with ease o# assem"ly onsiderations& $e&g&, i# a !rodut ontains #ewer !arts it will take less time to assem"le, there"y reduing assem"ly osts%
(!ign $%" manu$a)tu"ing DFM integration o# !rodut design and !roess !lanning to design a !rodut that is easily and eonomially manu#atured
(!ign $%" manu$a)tu"ing an( a!!m+ly DFMA om"ination o# two methodologies7 esign #or Manu#ature $FM%, whih is the !roess o# o!timi8ing the design to "e easier to !rodue, have higher through!ut, and im!roved 5ualityL and esign #or Assem"ly $FA%, whih is the o!timi8ation o# the design to redue risk o# error, lowering osts, and making it easier to assem"le
(!ign $%" !i !igma DFSS systemati methodology, tools, and tehni5ues with the aim o# "eing a ro"ust design o# !roduts or !roesses that meets ustomer e)!etations and an "e !rodued at a si) sigma 5uality level
(!ign?"!'%n!i+l %"gani*ati%n organi8ation with authority to esta"lish a new, or hange an e)isting, !rodut s!ei#iation /=T( ustomer*s s!ei#ied a!!liation,
This res!onsi"ility inludes testing and veri#iation o# design !er#ormane within the
""%" '"%%$ing !rodut and manu#aturing !roess design and develo!ment to !revent manu#ature o# nonon#orming !roduts
!)alati%n '"%)!! !roess used to highlight or #lag ertain issues within an organi8ation so that the a!!ro!riate !ersonnel an res!ond to these situations and monitor the resolutions
$ault t" analy!i! FTA dedutive #ailure analysis methodology in whih an undesired state o# a system is analysedL #ault tree analysis ma!s the relationshi! "etween #aults, su"systems, and redundant design elements "y reating a logi diagram o# the overall system
la+%"at%"y #aility #or ins!etion, test, or ali"ration that may inlude "ut is not limited to the #ollowing7 hemial, metallurgial, dimensional, !hysial, eletrial, or relia"ility testing
la+%"at%"y !)%' ontrolled doument ontaining
−s!ei#i tests, evaluations, and ali"rations that a la"oratory is 5uali#ied to !er#ormL −a list o# the e5ui!ment that the la"oratory uses to !er#orm the a"oveL and −a list o# methods and standards to whih the la"oratory !er#orms the a"ove
manu$a)tu"ing !roess o# making or #a"riating !rodution materialsL !rodution !arts or servie !artsL assem"liesL or heat treating, welding, !ainting, !lating, or other #inishing servies
manu$a)tu"ing $a!i+ility an analysis and evaluation o# a !ro!osed !roet to determine i# it is tehnially #easi"le to manu#ature the !rodut to meet ustomer re5uirements& This inludes "ut is not limited to the #ollowing $as a!!lia"le%7 within the estimated osts, and i# the neessary resoures, #ailities, tooling, a!aity, so#tware, and !ersonnel with re5uired skills, inluding su!!ort #untions, are or are !lanned to "e availa"le
manu$a)tu"ing !"&i)! om!anies that test, manu#ature, distri"ute, and !rovide re!air servies #or om!onents and assem"lies
multi?(i!)i'lina"y a''"%a)A method to a!ture in!ut #rom all interested !arties who may in#luene how a !roess is administered "y a team whose mem"ers inlude !ersonnel #rom the organi8ation and may inlude ustomer and su!!lier re!resentativesL team mem"ers may "e internal or e)ternal to the organi8ationL either e)isting teams or ad ho teams may "e used as irumstanes warrantL in!ut to the team may inlude "oth organi8ation and ustomer in!uts
n% t"%u+l $%un( DNTFE designation a!!lied to a !art re!laed during a servie event that, when analysed "y the vehile or !arts manu#aturer, meets all the re5uirements o# a 'good !art' $also re#erred to as '/o Fault Found' or 'Trou"le /ot Found'%
%ut!%u")( '"%)!! !ortion o# an organi8ation*s #untion $or !roesses% that is !er#ormed "y an e)ternal organi8ation
'"i%(i) %&"aul maintenane methodology to !revent a maor un!lanned "reakdown where, "ased on #ault or interru!tion history, a !iee o# e5ui!ment, or su"system o# the e5ui!ment, is !roatively taken out o# servie and disassem"led, re!aired, !arts re!laed, reassem"led, and then returned to servie
'"(i)ti& maintnan) an a!!roah and set o# tehni5ues to evaluate the ondition o# in2servie e5ui!ment "y !er#orming !eriodi or ontinuous monitoring o# e5ui!ment onditions, in order to !redit when maintenane should "e !er#ormed
'"mium $"igt e)tra osts or harges inurred in addition to ontrated delivery /=T( This an "e aused "y method, 5uantity, unsheduled or late deliveries, et&
'"&nti& maintnan) !lanned ativities at regular intervals $time2"ased, !eriodi ins!etion, and overhaul% to eliminate auses o# e5ui!ment #ailu re and unsheduled interru!tions to !rodution, as an out!ut o# the manu#aturing !roess design
'"%(u)t a!!lies to any intended out!ut resulting #rom the !rodut reali8ation !roess
'"%(u)t !a$ty standards relating to the design and manu#aturing o# !roduts to ensure they do not re!resent harm or ha8ards to ustomers
'"%(u)ti%n !ut(%>n ondition where manu#aturing !roesses are idleL time s!an may "e a #ew hours to a #ew months
"a)ti%n 'lan ation or series o# ste!s !resri"ed in a ontrol !lan in the event a"normal or nonon#orming events are deteted
"m%t l%)ati%n loation that su!!orts manu#aturing sites and at whih non2!rodution !roesses our
!"&i) 'a"t re!laement !art$s% manu#atured to =(M s!ei#iations that are !roured or released "y the =(M #or servie !art a!!liations, inluding remanu#atured !arts
!it loation at whih value2added manu#aturing !roesses our
!')ial )Aa"a)t"i!ti) lassi#iation o# a !rodut harateristi or manu#aturing !roess !arameter that an a##et sa#ety or om!liane with regulations, #it, #untion, !er#ormane, re5uirements, or su"se5uent !roessing o# !rodut
!')ial !tatu! noti#iation o# a ustomer2identi#ied lassi#iation assigned to an organi8ation where one or more ustomer re5uirements are not "eing satis#ied due to a signi#iant 5uality or delivery issue
!u''%"t $un)ti%n non2!rodution ativity $onduted on site or at a remote loation% that su!!orts one $or more% manu#aturing sites o# the same organi8ation
t%tal '"%(u)ti& maintnan) a system o# maintaining and im!roving the integrity o# !rodution and 5uality systems through mahines, e5ui!ment, !roesses, and em!loyees that add value to the organi8ation
t"a(?%$$ )u"&! tool to understand and ommuniate the relationshi! o# various design harateristis o# a !rodut to eah otherL a !rodut*s !er#ormane on one harateristi is ma!!ed on the C2a)is and another on the )2a)is, then a urve is !lotted to illustrate !rodut !er#ormane relative to the two harateristis
t"a(?%$$ '"%)!!
methodology o! develo(ing and using t rade)o!! curves !or (roducts and their (er!ormance characteristics that establish the customer technical and economic relationshi( bet'een design alternatives
4 ,%ntt %$ t %"gani*ati%n 4-1 Un("!tan(ing t %"gani*ati%n an( it! )%ntt
See #SO %001+201, re*uirements.
4-/ Un("!tan(ing t n(! an( ')tati%n! %$ int"!t( 'a"ti!
See #SO %001+201, re*uirements.
4- Dt"mining t !)%' %$ t #uality managmnt !y!tm
See #SO %001+201, re*uirements.
4.3.1 Determining the scope of the quality management system — supplemental
Su((orting !unctions 'hether on)site or remote such as design centres cor(orate head*uarters and distribution centres shall be included in the sco(e o! the Quality Management System QMS. The only (ermitted eclusion !or this Automotive QMS Standard relates to the (roduct design and develo(ment re*uirements 'ithin #SO %001 Section 9.. The eclusion shall be /usti!ied and maintained as documented in!ormation see #SO %001 Section :.,. ;ermitted eclusions do not include manu!acturing (rocess design.
4.3.2 Customerspecific requirements
See #SO %001+201, re*uirements
4.4.1.1 Conformance of pro!ucts an! processes The organi8ation shall ensure on#ormane o# all !roduts and !roesses, inluding servie !arts and those that are outsoured, to all a!!lia"le ustomer, statutory, and regulatory re5uirements $see Setion E&4&3&3%&
4.4.1.2 "ro!uct safety The organi8ation shall have doumented !roesses #or the management o# !rodut2sa#ety related !roduts and manu#aturing !roesses, whih shall inlude "ut not "e limited to the #ollowing, where a!!lia"le7
a)identi#iation "y the organi8ation o# statutory and regulatory !rodut2sa#ety re5uirementsL b)ustomer noti#iation o# re5uirements in item a%L c)s!eial a!!rovals #or design FM(AL d)identi#iation o# !rodut sa#ety2related harateristisL e)identi#iation and ontrols o# sa#ety2related harateristis o# !rodut and at the !oint o# manu#atureL f)s!eial a!!roval o# ontrol !lans and !roess FM(AsL g)reation !lans $see Setion 9&1&1&1%L h)de#ined res!onsi"ilities, de#inition o# esalation !roess and #low o# in#ormation, inluding to! management, and ustomer noti#iationL i)training identi#ied "y the organi8ation or ustomer #or !ersonnel involved in !rodut2sa#ety related !roduts and assoiated manu#aturing !roessesL
j)hanges o# !rodut or !roess shall "e a!!roved !rior to im!lementation, inluding evaluation o# !otential e##ets on !rodut sa#ety #rom !roess and !rodut hanges $see IS= 91, Setion E&&6%L
k)trans#er o# re5uirements with regard to !rodut sa#ety throughout the su!!ly hain, inluding ustomer2designated soures $see Setion E&4&&1%L
l) !rodut traea"ility "y manu#atured lot $at a minimum% throughout the su!!ly hain $see Setion E&@&3&1%L m)lessons learned #or new !rodut introdution& /=T(7 S!eial a!!roval is an additional a!!roval "y the #untion $ty!ially the ustomer% that is res!onsi"le to a!!rove suh douments with sa#ety2related ontent&
..See IS= 91731@ re5uirements&
La("!i' -1 La("!i' an( )%mmitmnt -1-1 Gn"al See IS= 91731@ re5uirements&
#.1.1.1 Corporate responsi$ility The organi8ation shall de#ine and im!lement or!orate res!onsi"ility !oliies, inluding at a minimum an anti2"ri"ery !oliy, an em!loyee ode o# ondut, and an ethis esalation !oliy $'whistle2"lowing !oliy'%,
-1-1-/ "rocess effecti%eness an! efficiency To! management shall review the !rodut reali8ation !roesses and su!!ort !roesses to evaluate and im!rove their e##etiveness and e##iieny& The results o# the !roess review ativities shall "e inluded as in!ut to the management review $see Setion 9&&3&1&%&
#.1.1.3 "rocess o&ners To! management shall identi#y !roess owners who are res!onsi"le #or managing the organi8ation*s !roesses and related out!uts& >roess owners shall understand their roles and "e om!etent to !er#orm those roles $see IS= 91, Setion D&3%&
-1-/ ,u!t%m" $%)u! See IS= 91731@ re5uirements&
-/ .%li)y -/-1 E!ta+li!ing t #uality '%li)y See IS= 91731@ re5uirements&
-/-/ ,%mmuni)ating t #uality '%li)y See IS= 91731@ re5uirements&
- O"gani*ati%nal "%l! "!'%n!i+iliti! an( aut%"iti! See IS= 91731@ re5uirements&
#.3.1 'rgani(ational roles) responsi$ilities) an! authorities — supplemental To! management shall assign !ersonnel with the res!onsi"ility and authority to ensure that ustomer re5uirements are met& These assignments shall "e doumented& This inludes "ut is not limited to the seletion o# s!eial harateristis, setting 5uality o"etives and related training, orretive and
!reventive ations, !rodut design and develo!ment, a!aity analysis, logistis in#ormation, ustomer soreards, and ustomer !ortals&
#.3.2 *esponsi$ility an! authority for pro!uct requirements an! correcti%e actions To! management shall ensure that7
a) !ersonnel res!onsi"le #or on#ormity to !rodut re5uirements have the authority to sto! shi!ment and sto! !rodution to orret 5uality !ro"lemsL /=T( ue to the !roess design in some industries, it might not always "e !ossi"le to sto! !rodution immediately& In this ase, the a##eted "ath must "e ontained and shi!ment to the ustomer !revented
b) !ersonnel with authority and res!onsi"ility #or orretive ation are !rom!tly in#ormed o# !roduts or !roesses that do not on#orm to re5uirements to ensure that nonon#orming !rodut is not shi!!ed to the ustomer and that all !otential nonon#orming !rodut is identi#ied and ontainedL
c) !rodution o!erations aross all shi#ts are sta##ed with !ersonnel in harge o#, or delegated res!onsi"ility #or, ensuring on#ormity to !rodut re5uirements&
6 .lanning 6-1 A)ti%n! t% a(("!! "i!@! an( %''%"tuniti! 6-1-1 an( 6-1-/ See IS= 91731@ re5uirements&
+.1.2.1 *is, analysis The organi8ation shall inlude in its risk analysis, at a minimum, lessons learned #rom !rodut realls, !rodut audits, #ield returns and re!airs, om!laints, sra!, and rework& The organi8ation shall retain doumented in#ormation as evidene o# the results o# risk analysis&
+.1.2.2 "re%enti%e action The organi8ation shall determine and im!lement ation$s% to eliminate the auses o# !otential nonon#ormities in order to !revent their ourrene& >reventive ations shall "e a!!ro!riate to the severity o# the !otential issues& The organi8ation shall esta"lish a !roess to lessen the im!at o# negative e##ets o# risk inluding the #ollowing7
a)determining !otential nonon#ormities and their ausesL b)evaluating the need #or ation to !revent ourrene o# nonon#ormitiesL c)determining and im!lementing ation neededL d)doumented in#ormation o# ation takenL
e)reviewing the e##etiveness o# the !reventive ation takenL f)utili8ing lessons learned to !revent reurrene in similar !roesses $see IS= 91, Setion D&1&6%&
+.1.2.3 Contingency plans
The organi8ation shall7 evaluate internal and e)te e)ternal rnal risks to all manu#aturing manu#aturing !roesses and in#rastruture in#rastruture e5ui!ment essential essentia l to maintain maintain !rodution !rodution a)identi#y and evaluate out!ut and to ensure that ustomer re5uirements re5uirements are metL me tL
b)de#ine ontingeny !lans aording to risk and im!at to the ustomerL !re!are onting ontingeny eny !lans !lans #or ontin ontinuity uity o# su!!ly su!!ly in the event event o# any o# the #ollowi #ollowing7 ng7 key e5ui! e5ui!me ment nt #ai #ailu lure ress $als $also o see see Set Setio ion n c) !re!are E&@&6&1&1%L interru!tion #rom e)ternally !rovided !roduts, !roesses, !roesses, and serviesL reurring natural natural disastersL disastersL #ireL utility utility interru!tionsL interru!tionsL la"our shortag shortagesL esL or in#rastruture in#r astruture disru!tionsL
d)inlude, as a su!!lement to the ontingeny !lans, a noti#iation !roess to the ustomer and other interested !arties #or the e)tent and duration o# any situation im!ating ustomer o!erationsL !eriodially ally test the ontinge ontingeny ny !lan !lanss #or #or e##et e##etiven iveness ess $e&g&, $e&g&, simu simulat lations ions,, as a!!ro!ri a!!ro!riate%L ate%L e) !eriodi
f)ondut ontingeny !lan reviews $at a minimum annually% using a multidisi!linary team inluding to! management, and u!date as re5uiredL doumented in#ormation desri"ing any revision$s%, inluding the !erson$s% who authori8ed g)doument the ontingeny !lans and retain doumented the hange$s%& The ontingeny !lans shall inlude !rovisions to validate that the manu#atured !rodut ontinues to meet ustomer ustomer s!ei#iation s!ei#iationss a#ter the re2start o# !rodution #ollowing an emergeny in whih !rodution was sto!!ed and i# the regular shutdown !roesses were not #ollowed&
6-/ Quality %+)ti&! an( 'lanning t% a)i& tm 6/-1 an( 6-/-/ See IS= 91731@ re5uirements&
+.2.2.1 -uality o$ecti%es an! planning to achie%e them — supplemental To! management shall ensure that 5uality o"etives to meet ustomer re5uirements are de#ined, esta"lished, and maintained #or relevant #untions, !roesses, and levels throughout the organi8ation& The results o# the organi8ation*s review regarding interested !arties and their relevant re5uirements shall "e onsidered onsidered when when the the organi8at organi8ation ion esta"lishes its its annual $at a minimum% minimum% 5uality 5uality o"etives o"etives and related related !er#ormane !er# ormane targets $internal $in ternal and an d e)ternal%& e)tern al%&
6- .lanning %$ )ang! See IS= 91731@ re5uirements&
0 Su''%"t 0-1 R!%u")! 0-1-1 Gn"al See IS= 91731@ re5uirements& 0-1-/ .%'l See IS= 91731@ re5uirements& 0-1-
In$"a!t"u)tu" See IS= 91731@ re5uirements&
/.1.3.1 "lant) facility) an! equipment planning The organi8ation organi8a tion shall use u se a multidisi!linary a!!roah inluding in luding risk identi#iation and risk mitigation methods methods #or develo! develo!ing ing and and im!rovi im!roving ng !lan !lant, t, #ai #aili lity ty,, and and e5ui e5ui!m !men entt !lan !lans& s& In desi design gnin ing g !lan !lantt lay layouts outs,, the the org organ ani8 i8at atio ion n shal shall7 l7 inluding ontrol o# nonon#or non on#orming ming !rodut, !ro dut, and a nd a)o!timi8e material #low, material handling, and value2added use o# #loor s!ae inluding
b)#ailitate synhronous material #low, as a!!lia"le& Methods shall "e develo!ed and im!lemented to evaluate manu#aturing #easi"ility #or new !rodut or new o!erations& Manu#aturing #easi"ility #easi"ility assessments shall inlude a!aity !lanning& !lanning& These methods shall also "e a!!lia"le #or evaluating !ro!osed hanges to e)isting o!erations& The organi8ation shall maintain !roess e##etiveness, inluding !eriodi re2evaluation relative to risk, to inor!orate any hanges made during !roe !roess ss a!!r a!!rova oval, l, ont ontrol rol !lan !lan main mainte tena nane ne $see $see Set Setio ion n E&@& E&@&1& 1&1% 1%,, and and veri veri#i #iat atio ion n o# o" o" set2 set2u! u!ss $see $see Seti Setion on E&@& E&@&1& 1&%& %& Assessments o# manu#aturing #easi"ility and evaluation o# a!aity a!aity !lanning shall "e in!uts to management managemen t reviews review s $see IS= I S= 91, 91 , Setion 9&%& /=T( /=T( 1 These These re5ui re5uirem rement entss shoul should d inl inlude ude the the a!!l a!!li iati ation on o# lean lean man manu#a u#at turi uring ng !rini !rini!le !les& s&
/=T( 3 These These re5uireme re5uirements nts should should a!!ly a!!ly to on2sit on2sitee su!!li su!!lier er ativi ativitie ties, s, as as a!!li a!!lia"l a"le& e&
0-1-4 En&i"%nmnt $%" t %'"ati%n %$ '"%)!!! See IS= 91731@ re5uirements& /=T( /=T( Jher Jheree thi third2! rd2!ar arty ty ert erti# i#i iat atio ion n to IS= IS= 4@ 4@1 1 $or $or e5ui e5uiva vale lent nt%% is reo reogn gni8 i8ed ed,, it may may "e used used to demo demons nstr trat atee the the orga organi ni8a 8ati tion on*s *s on#ormity to the !ersonnel sa#ety as!ets o# this re5uirement&
/.1.4.1 0n%ironment for the operation of processes — supplemental The organi8ation shall maintain its !remises in a state o# order, leanliness, and re!air that is onsistent with the !rodut and manu#aturing !ro !roess ess need needs& s&
0-1- M%nit%"ing an( ma!u"ing "!%u")! 0-1--1 Gn"al See IS= 91731@ re5uirements&
/.1.#.1.1 easurement systems analysis Statistial studies shall "e onduted to analyse the variation !resent in the results o# eah ty!e o# ins!etion, measurement, and test e5ui!ment system identi#ied in the ontrol !lan& The analytial methods methods and ae!tane riteria riteria used shall on#orm to those in re#erene manuals manuals on measurement systems analysis& =ther analytial methods and ae!tane riteria may "e used i# a!!roved "y the ustomer& +eords o# ustomer ae!tane o# alternative methods shall "e retained along with results #rom alternative measurement systems analysis $see Setion 9&1&1&1%& /=T( /=T( >rior >riorit iti8 i8at atio ion n o# MSA MSA stud studie iess shou should ld #ous #ous on riti ritia all or s!e s!eia iall !rodu !rodut t or !roe !roess ss hara harat ter eris isti tis s&&
0-1--/ Ma!u"mnt t"a)a+ility See IS= 91731@ re5uirements& /=T( /=T( A num" num"er er or anot anothe herr iden identi ti#i #ier er trae raea" a"le le to the the devi devie e ali ali"r "rat atio ion n reo reord rd meet meetss the the inte intent nt o# the the re5 re5ui uire reme ment ntss in IS= IS= 91 9173 731 1@& @&
/.1.#.2.1 Cali$ration%erification recor!s The organi8atio o rgani8ation n shall sh all have ha ve a doumented doumen ted !roess !r oess #or managing ali"rationveri# ali"ratio nveri#iation iation reords& reord s& +eords +eords o# o# the the al ali"r i"rat ation ionve veri# ri#ia iatio tion n ativity #or all gauges and measuring and test e5ui!ment $inluding em!loyee2owned e5ui!ment relevant #or measuring, ustomer2owned e5ui!ment, or on2site su!!lier2
owned e5ui!ment% needed to !rovide evidene o# on#ormity to internal re5uirements, legislative and regulatory re5uirements, and ustomer2 de#ined re5uirements shall "e retained& The organi8ation shall ensure that ali"rationveri#iation ativities and reords shall inlude the #ollowing details7
a)revisions #ollowing engineering hanges that im!at measurement systemsL b)any out2o#2s!ei#iation readings as reeived #or ali"rationveri#iationL c)an assessment o# the risk o# the intended use o# the !rodut aused "y the out2o#2s!ei#iation onditionL d)when a !iee o# ins!etion measurement and test e5ui!ment is #ound to "e out o# ali"ration or de#etive during its !lanned veri#iation or ali"ration or during its use, doumented in#ormation on the validity o# !revious measurement results o"tained with this !iee o# ins!etion measurement and test e5ui!ment shall "e retained, inluding the assoiated standard*s last ali"ration date and the ne)t due date on the ali"ration re!ortL
e)noti#iation to the ustomer i# sus!et !rodut or material has "een shi!!edL f)statements o# on#ormity to s!ei#iation a#ter ali"rationveri#iationL g)veri#iation that the so#tware version used #or !rodut and !ro ess ontrol is as s!ei#iedL h)reords o# the ali"ration and maintenane ativities #or all gauging $inluding em!loyee2owned e5ui!ment, ustomer2owned e5ui!ment, or on2site su!!lier2owned e5ui!ment%L
i) !rodution2related so#tware veri#iation used #or !rodut and !roess ontrol $inluding so#tware installed on em!loyee2owned e5ui!ment, ustomer2owned e5ui!ment, or on2site su!!lier2owned e5ui!ment%&
/.1.#.3 a$oratory requirements /.1.#.3.1 Internal la$oratory An organi8ation*s internal la"oratory #aility shall have a de#ined so!e that inludes its a!a"ility to !er#orm the re5uired ins!etion, test, or ali"ration servies& This la"oratory so!e shall "e inluded in the 5uality management system doumentation& The la"oratory shall s!ei#y and im!lement, as a minimum, re5uirements #or7
a)ade5uay o# the la"oratory tehnial !roeduresL b)om!eteny o# the la"oratory !ersonnelL c)testing o# the !rodutL d)a!a"ility to !er#orm these servies orretly, traea"le to the relevant !roess standard $suh as
ASTM& (/, et&%L when no national or
international standard$s% is availa"le, the organi8ation shall de#ine and im!lement a methodology to veri#y measurement system a!a"ilityL
e)ustomer re5uirements, i# anyL f)+eview o# the related reords& /=T( Third2!arty areditation to IS=I(< 1D3@ $or e5uivalent% may "e used to demonstrate the organi8ation*s in2house la"oratory on#ormity to this re5uirement&
/.1.#.3.2
0ternal la$oratory
()ternalommerialinde!endent la"oratory #ailities used #or ins!etion ，test，or ali"ration servies "y the organi8ation shall have a de#ined la"oratory so!e that inludes the a!a"ility to !er#orm the re5uired ins!etion ，test ，or ali"ration ， and either7 the la"oratory shall "e aredited to IS=I(< 1D3@ or national e5uivalent and inlude the r elevant ins!etion ，test ， or ali"ration servie in the so!e o# the areditation $erti#iate%L the erti#iate o# ali"ration or test re!ort shall inlude the mark o# a national areditation "odyL or there shall "e evidene that the e)ternal la"oratory is ae!ta"le to the us tomer& /=T( Suh evidene may "e demonstrated "y ustomer assessment, #or e)am!le, or "y ustomer a!!roved seond2 !arty assessment that the la"oratory meets the intent o# IS=I(< 1D3@ or national e5uivalent& The seond2!arty assessment may "e !er#ormed "y the organi8ation assessing the la"oratory using a ustomer2a!!roved method o# assess ment&
0-1-6 O"gani*ati%nal @n%>l(g
See #SO %001+201, re*uirements.
0-/ ,%m'tn)
See #SO %001+201, re*uirements.
7.2.1 Competence , supplemental The organi8ation shall esta"lish and maintain a doumented !roess$es% #or identi#ying training needs inluding awareness $see Setion D&&1% and ahieving o m!etene o# all !ersonnel !er#orming ativities a##eting on#ormity to !rodut and !roess re5uirements& >ersonnel !er#orming s!ei#i assigned tasks shall "e 5uali#ied ，as re5uired，with !artiular attention to the satis#ation o# ustomer re5uirements&
7.2.2 Competence B on-the-job training The organi8ation shall !rovide on2the2o" training $whih shall inlude ustomer re5uirements training% #or !ersonnel in any new or modi#ied res!onsi"ilities a##eting on#ormity to 5uality re5uirements, internal re5uirements, regulatory or legislative re5uirementsL this shall inlude ontrat or ageny !ersonnel& The level o# detail re5uired #or on2the o" training shall "e ommensurate with the level o# eduation the !ersonnel !ossess and the om!le)ity o# the task$s% they are re5uired to !er#orm #or their daily work& >ersons whose work an a##et 5uality shall "e in#ormed a"out the onse5uenes o# nonon#ormity to ustomer re5uirements&
7.2.3 Internal auditor competency The organi8ation shall have a doumented !roess$ es% to veri#y that internal auditors ar e om!etent, taking into aount any ustomer2s!ei#i re5uirements& For additional guidane on auditor
a)
understanding o# the automotive !roess a!!roah #or auditing ，inluding risk2"ased thinkingL
b)
understanding o# a!!lia"le ustomer2s!ei#i re5uirementsL
c)
understanding o# a!!lia"le IS= 91 and IATF 16949 re5uirements related to the so!e o# the auditL
d)
understanding o# a!!lia"le ore tool r e5uirements related to the so!e o# the auditL
e)
understanding how to !lan ，ondut ，re!ort，and lose out audit #indings
Additionally ，manu#aturing !roess auditors shall demonstrate tehnial understanding o# the relevant manu#aturing !roess$es% to "e audited ，inluding !roess risk analysis $suh as >FM(A% and ontrol >lan. >rodut auditors shall demonstrate om!etene in understanding !rodut re5uirements and use o# relevant measuring and test e5ui!ment to veri#y !rodut on#ormity& Jhere training is !rovided to ahieve om!eteny ，doumented in#ormation shall "e retained to demonstrate the trainer*s om!eteny with the a"ove re5uirements& Maintenane o# and im!rovement in internal auditor om!etene shall "e demonstrated through7
f)
e)euting a minimum num"er o# audits !er year ，as de#ined "y the organi8ationL and
g)
maintaining knowledge o# relevant re5uirements "ased on internal hanges $e&g . !roess tehnology, !rodut tehnology% and e)ternal hanges $e&g&, IS= 91 IATF 16949 ore tools and ustomer s!ei#i re5uirements%
7.2.4 Second-party auditor competency The organi8ation shall demonstrate the om!etene o# the auditors undertaking the seond2!arty audits& Seond2!arty auditors shall meet ustomer s!ei#i re5uirements #or auditor 5uali#iation and demonstrate the minimum #ollowing ore om!etenies ，inluding understanding o#7
a)
the automotive !roess a!!roah to auditing ，inluding risk "ased thinkingL
b)
a!!lia"le ustomer and organi8ation s!ei#i re5uirementsL
c)
a!!lia"le IS= 91 and IATF 16949 re5uirements related to the so!e o# the auditL
d)
a!!lia"le manu#aturing !roess$es% to "e audited ，inluding >FM(A and ontrol !lanL
e)
a!!lia"le ore tool re5uirements related to the s o!e o# the auditL
f)
how to !lan ，ondut ， !re!are audit re!orts，and lose out audit #indings&
0- A>a"n!!
See #SO %001+201, re*uirements.
7.3.1 Awareness , supplemental The organi8ation shall maintain doumented in#ormation that demonstrates that all em!loyees are aware o # their im!at on !rodut 5uality and the im!ortane o# their ativities in ahieving, maintaining, and im!roving 5uality, inluding ustomer re5uirements and the risks involved #or the ustomer with non2on#orming !rodut&
7.3.2 Employee motivation and empowerment The organi8ation shall maintain a doumented !roess$es% to motivate em!loyees to ahieve 5uality o"etives, to make ontinual im!rovements, and to reate an environment that !romotes innovation& The !roess shall inlude the !romotion o# 5uality and tehnologial awareness throughout the whole organi8ation&
7.4 ,%mmuni)ati%n See #SO %001+201, re*uirements.
7.5 D%)umnt( in$%"mati%n 0--1 Gn"al See #SO %001+201, re*uirements.
7.5.1.1 Quality management !y!tm documentation The organi8ation*s 5uality management system shall "e doumented and inlude a 5uality manual ，whih an "e a series o# douments $eletroni or hard o!y% The #ormat and struture o# the 5uality manual is at the disretion o# the organi8ation and will de!end on the organi8ation*s si8e，ulture，and om!le)ity& I# a series o# douments is used，then a list shall "e retained o# the douments that om!rise the 5uality manual #or the organi8ation& The 5uality manual shall inlude ，at a minimum ，the #ollowing7
a)
the so!e o# the 5uality management system ， inluding details o# and usti#iation #or any e)lusionsL
b)
doumented !roesses esta"lished #or the 5uality management system ，or re#erene to themL
c)
the organi8ation*s !roesses and their se5uene and interations $in!uts and out!uts% ，inluding ty!e and e)tent o# ontrol o# any outsoured !roessesL
d)
a doument $i&e&,matri)% indiating where within the organi8ation*s 5uality management system their ustomer2s!ei#i re5uirements are addressed&
/=T( A matri) o# how the re5uirements o# this Automotive QMS standard are addressed "y the organi8ation*s !roesses may "e used to assist with linkages o# the organi8ation*s !roesses and this Automotive QMS
7.5.2 ,"ating an( u'(ating See #SO %001+201, re*uirements.
7.5.3
,%nt"%l %$ (%)umnt( in$%"mati%n
0--6-1 an( 0--6-/ See #SO%001+201, re*uirements.
7..!.".#
$ecord retention
The organi8ation shall de#ine ，doument ，and im!lement a reord retention !oliy& The ontrol o# reords shall satis#y statutory， regulatory ，organi8ational ，and ustomer re5uirements& >rodution !art a!!rovals, tooling reords $inluding maintenane and ownershi!%,!rodut and !roess design reords ， !urhase orders $i# a!!lia"le% ，or ontrats and amendments shall "e retained #or the length o# time that the !rodut is ative #or !rodution and servie re5uirements , !lus one alendar year, unless otherwise s!ei#ied "y the ustomer or regulatory ageny /=T( >rodution !art a!!roval doumented in#ormation may inlude a!!roved !rodut ，a!!lia"le test e5ui!ment reords ，or a!!roved test data&
0--6-/-/
Engin"ing !')i$i)ati%n!
The organi8ation shall have a doumented !roess desri"ing the review ，distri"ution ，and im!lementation o# all ustomer engineering standardss!ei#iations and related revisions "ased on ustomer shedules ，as re5uired& Jhen an engineering standards!ei#iation hange results in a !rodut design hange ，re#er to the re5uirements in IS=91, Setion E&&6& Jhen an engineering standards!ei#iation hange results in a !rodut reali8ation !roess hange ， re#er to the re5uirements in Setion E&@&6&1& The organi8ation shall retain a reord o# the date on whih eah hange is im!lemented in !rodution& Im!lementation shall inlude u!dated douments& +eview should "e om!leted within 1 working days o# reei!t o# noti#iation o# engineering standardss!ei#iations hanges& /=T( A hange in these standardss!ei#iations may re5uire an u!dated reord o# ustomer !rodution !art a!!roval when these s!ei#iations are re#erened on the design reord or i# they a##et douments o# the !rodution !art a!!roval !roess ， suh as ontrol !lan，risk analysis $suh as FM(As% ， et
3 O'"ati%n 3-1 O'"ati%nal 'lanning an( )%nt"%l See #SO %001+201, re*uirements
固
8.1.1 %perational planning and control supplemental -
Jhen !lanning #or !rodut reali8ation, the #ollowing to!is shall "e inluded7
a)
ustomer !rodut re5uirements and tehnial s!ei#iationsL
b)
logistis re5uirementsL
c)
manu#aturing #easi"ilityL
d) !roet !lanning $re#er to IS= 91, Setion E&&3%L e)
ae!tane riteria.
The resoures identi#ied in IS= 91, Setion E&1 %, re#er to the re5uired veri#iation, validation, monitoring, measurement, ins!etion, and test ativities s!ei#i to the !rodut and the riteria #or !rodut ae!tane .
8.1.2 Con&identiality The organi8ation shall ensure the on#identiality o# ustomer2ontrated !roduts and !roets under develo!ment ， inluding related !rodut in#ormation&
3-/ R#ui"mnt! $%" '"%(u)t! an( !"&i)! 3-/.1 ,u!t%m" )%mmuni)ati%n See ISO 9001:2015 requirements.
'.".#.# Customer communication , supplemental Jritten or ver"al ommuniation shall "e in the language agreed with the ustomer& The organi8ation shall have the a"ility to ommuniate neessary in#ormation, inluding data in a ustomer2s!ei#ied om!uter language and #ormat $e.g&，om!uter2aided design data, eletroni data interhange%&
3-/-/ Dt"mining tA "#ui"mnt! $%" '"%(u)t! an( !"&i)! See #SO %001+201, re*uirements.
5.2.2.1 Determining the requirements for pro!ucts an! ser%ices 6 supplemental These re5uirements shall inlude reyling, environmental im!at, and harateristis identi#ied as a result o# the organi8ation*s knowledge o# the !rodut and manu#aturing !roesses&
3-/- R&i> %$ t "#ui"mnt! $%" '"%(u)t! an( !"&i)! 3-/--1 See IS= 91731@ re5uirements&
5.2.3.1.1 *e%ie& of the requirements for pro!ucts an! ser%ices — supplemental The organi8ation shall retain doumented evidene o# a ustomer2authori8ed waiver #or the re5uirements stated in IS= 91, Setion E&3&&1, #or a #ormal review&
5.2.3.1.2 Customer!esignate! special characteristics The organi8ation shall on#orm to ustomer re5uirements #or designation, a!!roval doumentation, and ontrol o# s!eial harateristis&
5.2.3.1.3 'rgani(ation manufacturing feasi$ility The organi8ation shall utili8e a multidisi!linary a!!roah to ondut an analysis to determine i# it is #easi"le that the organi8ation*s manu#aturing !roesses are a!a"le o# onsistently !roduing !rodut that meets all o# the engineering and a!aity re5uirements s!ei#ied "y the ustomer& The organi8ation shall ondut this #easi"ility analysis #or any manu#aturing or !rodut tehnology new to the organi8ation and #or any hanged manu#aturing !roess or !rodut design& Additionally,the organi8ation should validate through !rodution runs, "enhmarking studies, or other a!!ro!riate methods, their a"ility to make !rodut to s!ei#iations at the re5uired rate&
3-/--/ See IS= 91731@ re5uirements&
3-/-4 ,ang! t% "#ui"mnt! $%" '"%(u)t! an( !"&i)! See IS= 91731@ re5uirements&
3- D!ign an( (&l%'mnt %$ '"%(u)t! an( !"&i) ! 3--1 Gn"al See IS= 91731@ re5uirements&
5.3.1.1 Design an! !e%elopment of pro!ucts an! ser%ices — supplemental The re5uirements o# IS= 91, Setion E&&1, shall a!!ly to !rodut and manu#aturing !roess design and develo!ment and shall #ous on error !revention rather than detetion& The organi8ation shall doument the design and develo!ment !roess&
3--/ D!ign an( (&l%'mnt 'lanning See IS= 91731@ re5uirements&
5.3.2.1 Design an! !e%elopment planning — supplemental The organi8ation shall ensure that design and develo!ment !lanning inludes all a##eted stakeholders within the organi8ation and, as a!!ro!riate, its su!!ly hain& ()am!les o# areas #or using suh a multidisi!linary a!!roah inlude "ut are not limited to the #ollowingL
a) !roet management $#or e)am!le, A>Q> or 0A2+.A%L b) !rodut and manu#aturing !roess design ativities $#or e)am!le, FM and FA%, suh as onsideration o# the use o# alternative designs and manu#aturing !roessesL
c)develo!ment and review o# !rodut design risk analysis $FM(As%, inluding ations to redue !otential risksL d)develo!ment and review o# manu#aturing !roess risk analysis $#or e)am!le, FM(As, !roess #lows, ontrol !lans, and standard work instrutions%& /=T( A multidisi!linary a!!roah ty!ially inludes the organi8ation*s design, manu#aturing, engineering, 5uality, !rodution, !urhasing, su!!lier, maintenane, and other a!!ro!riate #untions&
5.3.2.2 "ro!uct !esign s,ills The organi8ation shall ensure that !ersonnel with !rodut design res!onsi"ility are om!etent to ahieve design re5uirements and are skilled in a!!lia"le !rodut design tools and tehni5ues& A!!lia"le tools and tehni5ues shall "e identi#ied "y the organi8ation& /=T( An e)am!le o# !rodut design skills is the a!!liation o# digiti8ed mathematially "ased data& 5.3.2.3 De%elopment
of pro!ucts &ith em$e!!e! soft&are The organi8ation shall use a !roess #or 5uality assurane #or their !roduts with internally develo!ed em"edded so#tware& A so#tware develo!ment assessment methodology shall "e utili8ed to assess the organi8ation*s so!t'are develo(ment !roess& sing !rioriti8ation "ased on risk and !otential im!at to the ustomer, the organi8ation shall retain doumented in#ormation o# a so#tware develo!ment a!a"ility sel#2assessment&
The organi8ation shall inlude so#tware develo!ment within the so!e o# their internal audit !rogramme $see Setion 9&3&3&1%&
3-- D!ign an( (&l%'mnt in'ut! See IS= 91731&@ re5uirements&
5.3.3.1 "ro!uct !esign input The organi8ation shall identi#y,doument, and review !rodut design in!ut re5uirements as a result o# ontrat review& >rodut design in!ut re5uirements inlude "ut are not limited to the #ollowing7
a) !rodut s!ei#iations inluding "ut not limited to s!eial harateristis $see Setion E&&&%L b) "oundary and inter#ae re5uirementsL c)identi#iation, traea"ility, and !akagingL d)onsideration o# design alternativesL e)assessment o# risks with the in!ut re5uirements and the organi8ation*s a"ility to mitigatemanage the risks, inluding #rom the #easi"ility analysisL
f)targets #or on#ormity to !rodut re5uirements inluding !reservation, relia"ility, dura"ility, serviea"ility, health, sa#ety, environmental, develo!ment timing, and ostL
g)a!!lia"le statutory and regulatory re5uirements o# the ustomer2identi#ied ountry o# destination, i# !rovidedL h)em"edded so#tware re5uirements& The organi8ation shall have a !roess to de!loy in#ormation gained #rom !revious design !roets, om!etitive !rodut analysis $"enhmarking%, su!!lier #eed"ak, internal in!ut, #ield data, and other relevant soures #or urrent and #uture !roets o# a similar nature& /=T( =ne a!!roah #or onsidering design alternatives is the use o# trade2o## urves& 5.3.3.2
anufacturing process !esign input The organi8ation shall identi#y, doument, and review manu#aturing !roess design in!ut re5uirements inluding "ut not limited to the #ollowing7
a) !rodut design out!ut data inluding s!eial harateristisL b)targets #or !rodutivity, !roess a!a"ility, timing, and ostL c)manu#aturing tehnology alternativesL d)ustomer re5uirements, i# anyL e)e)!eriene #rom !revious develo!mentsL f)new
materialsL
g) !rodut handling and ergonomi re5uirementsL and h)design #or manu#aturing and design #or assem"ly& The manu#aturing !roess design shall inlude the use o# error2!roo#ing methods to a degree a!!ro!riate to the magnitude o# the !ro"lem$s% and ommensurate with the risks enountered&
5.3.3.3 7pecial characteristics The organi8ation shall use a multidisi!linary a!!roah to esta"lish, doument, and im!lement its !roess$es% to identi#y s!eial harateristis, inluding those determined "y the ustomer and the risk analysis !er#ormed "y the organi8ation, and shall inlude the #ollowing7
a)doumentation o# all s!eial harateristis in the drawings $as re5uired%, risk analysis $suh as FM(A%, ontrol !lans, and standard worko!erator instrutionsL s!eial harateristis are identi#ied with s!ei#i markings and are asaded through eah o# these doumentsL
b)develo!ment o# ontrol and monitoring strategies #or s!eial harateristis o# !roduts and !rodution !roessesL c)ustomer2s!ei#ied a!!rovals, when re5uiredL d)om!liane with
ustomer2s!ei#ied de#initions and sym"ols or the organi8ation*s e5uivalent sym"ols or notations, as
de#ined in a sym"ol onversion ta"le& The sym"ol onversion ta"le shall "e su"mitted to the ustomer, i# re5uired&
3--4 D!ign an( (&l%'mnt )%nt"%l! See IS= 91731@ re5uirements&
5.3.4.1 onitoring Measurements at s!ei#ied stages during the design and develo!ment o# !roduts and !roesses shall "e de#ined, analysed, and re!orted with summary results as an in!ut to management review $see Setion 9&&3&1%& Jhen re5uired "y the ustomer, measurements o# the !rodut and !roess develo!ment ativity shall "e re!orted to the ustomer at stages s!ei#ied, or agreed to, "y the ustomer& /=T( Jhen a!!ro!riate, these measurements may inlude 5uality risks, osts, lead times, ritial !aths, and other measurements&
5.3.4.2 Design an! !e%elopment %ali!ation esign and develo!ment validation shall "e !er#ormed in aordane with ustomer re5uirements, inluding any a!!lia"le industry and governmental ageny2issued regulatory standards& The timing o# design and develo!ment validation shall "e !lanned in alignment with ustomer2s!ei#ied timing, as a!!lia"le& Jhere ontratually agreed with the ustomer, this shall inlude evaluation o# the interation o# the organi8ation*s !rodut, inluding em"edded so#tware, within the system o# the #inal ustomer*s !rodut&
5.3.4.3 "rototype programme Jhen re5uired "y the ustomer, the organi8ation shall have a !rototy!e !rogramme and ontrol !lan& The organi8ation shall use, whenever !ossi"le, the same su!!liers, tooling, and manu#aturing !roesses as will "e used in !rodution& All !er#ormane2testing ativities shall "e monitored #or timely om!letion and on#ormity to re5uirements&
Jhen servies are outsoured, the organi8ation shall inlude the ty!e and e)tent o# ontrol in the so!e o# its 5uality management system to ensure that outsoured servies on#orm to re5uirements $see IS= 91, Setion E&4%&
5.3.4.4 "ro!uct appro%al process The organi8ation shall esta"lish, im!lement, and maintain a !rodut and manu#aturing a!!roval !roess on#orming to re5uirements de#ined "y the ustomer$s%& The organi8ation shall a!!rove e)ternally !rovided !roduts and servies !er IS= 91, Setion E&4&, !rior to su"mission o# their !art a!!roval to the ustomer& The organi8ation shall o"tain doumented !rodut a!!roval !rior to shi!ment, i# re5uired "y the ustomer& +eords o# suh a!!roval shall "e retained& /=T( >rodut a!!roval should "e su"se5uent to the veri#iation o# the manu#aturing !roess&
3-- D!ign an( (&l%'mnt %ut'ut! See IS= 91731@ re5uirements&
5.3.#.1 Design an! !e%elopment outputs — supplemental The !rodut design out!ut shall "e e)!ressed in terms that an "e veri#ied and validated against !rodut design in!ut re5uirements& The !rodut design out!ut shall inlude "ut is not limited to the #ollowing, as a!!lia"le7
a)design risk analysis $FM(A%L b)relia"ility study resultsL c) !rodut s! eial har ateristisL d)results o# !rodut design error2!roo#ing, suh as FSS, FMA, and FTAL e) !rodut de#inition inluding models, tehnial data !akages, !rodut manu#aturing in#ormation, and geometri dimensioning toleraning $.T%L
f)
3 drawings, !rodut manu#aturing in#ormation, and geometri dimensioning toleraning $.T%L
g) !rodut d esign review resultsL h)servie diagnosti guidelines and re!air and serviea"ility instrutionsL i)servie !art re5uirementsL j) !akaging and la"eling re5uirements #or shi!!ing& /=T( Interim design out!uts should inlude any engineering !ro"lems "eing resolved through a tradeo## !roess&
5.3.#.2 anufacturing process !esign output The organi8ation shall doument the manu#aturing !roess design out!ut in a manner that ena"les veri#iation against the manu#aturing !roess design in!uts& The organi8ation shall veri#y the out!uts against manu#aturing !roess design in!ut re5uirements& The manu#aturing !roess design out!ut shall inlude "ut is not limited to the #ollowing7
a)s!ei#iations and drawingsL b)s!eial harateristis #or !rodut and manu#aturing !roessL c)identi#iation o# !roess in!ut varia"les that im!at harateristisL d)tooling and e5ui!ment #or !rodution and ontrol, inluding a!a"ility studies o# e5ui!ment and !roess$es%L
e)manu#aturing !roess #low hartslayout, inluding linkage o# !rodut, !roess, and toolingL f)a!aity analysisL g)manu#aturing !roess FM(AL h)maintenane !lans and instrutionsL i)ontrol !lan $see Anne) A%L j)standard work and work instrutionsL k) !roess a!!rova l ae!tane riteriaL I% data #or 5uality, relia"ility, maintaina"ility, and measura"ilityL
m)results o# error2!roo#ing identi#iation and veri#iation, as a!!ro!riateL n)methods o# ra!id detetion, #eed"ak, and orretion o# !rodutmanu#aturing !roess nonon#ormities&
3--6 D!ign an( (&l%'mnt )ang! See IS= 91731@ re5uirements&
5.3.+.1 Design an! !e%elopment changes — supplemental The organi8ation shall evaluate all design hanges a#ter initial !rodut a!!roval, inluding those !ro!osed "y the organi8ation or its su!!liers, #or !otential im!at on #it, #orm, #untion, !er#ormane, andor dura"ility& These hanges shall "e validated against ustomer re5uirements and a!!roved internally, !rior to !rodution im!lementation& I# re5uired "y the ustomer, the organi8ation shall o"tain doumented a!!roval, or a doumented waiver, #rom the ustomer !rior to !rodution im!lementation& For !roduts with em"edded so#tware, the organi8ation shall doument the revision level o# so#tware and hardware as !art o# the hange reord&
3-4 ,%nt"%l %$ t"nally '"%&i(( '"%)!!! '"%(u)t! an( !"&i)! 3-4-1 Gn"al See IS= 91731@ re5uirements&
5.4.1.1 8eneral — supplemental The organi8ation shall inlude all !roduts and servies that a##et ustomer re5uirements suh as su"assem"ly, se5uening, sorting, rework, and ali"ration servies in the so!e o# their de#inition o# e)ternally !rovided !roduts, !roesses, and servies&
5.4.1.2 7upplier selection process The organi8ation shall have a doumented su!!lier seletion !roess& The seletion !roess shall inlude7
a)an assessment o# the seleted su!!lier*s risk to !rodut on#ormity and uninterru!ted su!!ly o# the organi8ation*s !rodut to their ustomersL
b)relevant 5uality and delivery !er#ormaneL c)an evaluation o# the su!!lier*s 5uality management systemL d)multidisi!linary deision makingL and e)an assessment o# so#tware develo!ment a!a"ilities, i# a!!lia"le& =ther su!!lier seletion riteria that should "e onsidered inlude the #ollowing7
? volume o# automotive "usiness $a"solute and as a !erentage o# total "usiness%L ? #inanial sta"ilityL ? !urhased !rodut, material, or servie om!le)ityL ? re5uired tehnology $!rodut or !roess%L ? ade5uay o# availa"le resoures $e&g&, !eo!le, in#rastruture%L ? design and develo!ment a!a"ilities $inluding !roet management%L ? manu#aturing a!a"ilityL ? hange management !roessL ? "usiness ontinuity !lanning $e&g&, disaster !re!aredness, ontingeny !lanning%L ? l ogistis
!roessL
? ustomer
servie&
5.4.1.3 Customer!irecte! sources 9also ,no&n as :Directe!—;uy:<
Jhen s!ei#ied "y the ustomer, the organi8ation shall !urhase !roduts, materials, or servies #rom ustomer2direted soures& All re5uirements o# Setion E&4 $e)e!t the re5uirements in IATF 16949, Setion E&4&1&3% are a!!lia"le to the organi8ation*s ontrol o# ustomer2direted soures unless s!ei#i agreements are otherwise de#ined "y the ontrat "etween the organi8ation and the ustomer&
3-4-/ Ty' an( tnt %$ )%nt"%l See IS= 91731@ re5uirements&
5.4.2.1 Type an! etent of control supplemental The organi8ation shall have a doumented !roess to identi#y outsoured !roesses and to selet the ty!es and e)tent o# ontrols used to veri#y on#ormity o# e)ternally !rovided !roduts, !roesses, and servies to internal $organi8ational% and e)ternal ustomer re5uirements& The !roess shall inlude the riteria and ations to esalate or redue the ty!es and e)tent o# ontrols and develo!ment ativities "ased on su!!lier !er#ormane and assessment o# !rodut, material, or servie risks&
5.4.2.2 7tatutory an! regulatory requirements The organi8ation shall doument their !roess to ensure that !urhased !roduts, !roesses, and servies on#orm to the urrent a!!lia"le statutory and regulatory re5uirements in the ountry o# reei!t, the ountry o# shi!ment, and the ustomer2identi#ied ountry o# destination, i# !rovided& I# the ustomer de#ines s!eial ontrols #or ertain !roduts with statutory and regulatory re5uirements, the organi8ation shall ensure they are im!lemented and maintained as de#ined, inluding at su!!liers&
5.4.2.3 7upplier quality management system !e%elopment The organi8ation shall re5uire their su!!liers o# automotive !roduts and servies to develo!, im!lement, and im!rove a 5uality management system erti#ied to IS= 91, unless otherwise authori8ed "y the ustomer Ne&g&, item a% "elowO, with the ultimate o"etive o# "eoming erti#ied to this Automotive QMS Standard& nless otherwise s!ei#ied "y the ustomer, the #ollowing se5uene should "e a!!lied to ahieve this re5uirement7
a)om!liane to IS= 91 through seond2!arty auditsL b)
erti#iation to IS= 91 through third2!arty auditsL unless otherwise s!ei#ied "y the ustomer, su!!liers to the organi8ation shall demonstrate on#ormity to IS= 91 "y maintaining a third2!arty erti#iation issued "y a erti#iation "ody "earing the areditation mark o# a reogni8ed IAF M:A $International Areditation Forum Multilateral +eognition Arrangement% mem"er and where the areditation "ody*s main so!e inludes management system erti#iation to IS=I(< 1D31L
c)erti#iation to IS= 91 with om!liane to other ustomer2de#ined QMS re5uirements $suh as Minimum Automotive Quality Management System +e5uirements #or Su"2Tier Su!!liers NMAQMS+O or e5uivalent% through seond2!arty auditsL
d)erti#iation to IS 91 with om!liane to IATF 16949 through seond2!arty auditsL e)erti#iation to 16949 through third2!arty audits $valid third2!arty erti#iation o# the su!!lier to IATF 16949 "y an IATF2 reogni8ed erti#iation "ody%&
5.4.2.3.1 Automoti%e pro!uctrelate! soft&are or automoti%e pro!ucts &ith em$e!!e! soft&are The organi8ation shall re5uire their su!!liers o# automotive !rodut2related so#tware, or automotive !roduts with em"edded so#tware, to im!lement and maintain a !roess #or so#tware 5uality assurane #or their !roduts& A so#tware develo!ment assessment methodology shall "e utili8ed to assess the su!!lier*s so#tware develo!ment !roess& sing !rioriti8ation "ased on risk and !otential im!at to the ustomer, the organi8ation shall re5uire the su!!lier to retain doumented in#ormation o# a so#tware develo!ment a!a"ility sel#2assessment&
5.4.2.4 7upplier monitoring The organi8ation shall have a doumented !roess and riteria to evaluate su!!lier !er#ormane in order to ensure on#ormity o# e)ternally !rovided !roduts, !roesses, and servies to internal and e)ternal ustomer re5uirements& At a minimum, the #ollowing su!!lier !er#ormane indiators shall "e monitored7
a)delivered !rodut on#ormity to re5uirementsL b)ustomer disru!tions at the reeiving !lant, inluding yard holds and sto! shi!sL c)delivery shedule !er#ormaneL d)num"er o# ourrenes o# !remium #reight& I# !rovided "y the ustomer, the organi8ation shall also inlude the #ollowing, as a!!ro!riate, in their su!!lier !er#ormane monitoring7
e)s!eial status ustomer noti#iations related to 5uality or delivery issuesL f)dealer returns, warranty, #ield ations, and realls& 5.4.2.4.1 7econ!party au!its The organi8ation shall inlude a seond2!arty audit !roess in their su!!lier management a!!roah& Seond2!arty audits may "e used #or the #ollowing7
a)su!!lier risk assessmentL b)su!!lier monitoringL c)su!!lier QMS develo!mentL d) !r od u t
au di ts L
e) ! ro e ss
aud its &
Gased on a risk analysis, inluding !rodut sa#etyregulatory re5uirements, !er#ormane o# the su!!lier, and QMS erti#iation level, at a minimum, the organi8ation shall doument the riteria #or determining the need, ty!e, #re5ueny, and so!e o# seond2!arty audits& The organi8ation shall retain reords o# the seond2!arty audit re!orts& I# the so!e o# the seond2!arty audit is to assess the su!!lier*s 5uality management system, then the a!!roah shall "e onsistent with the automotive !roess a!!roah& /=T( .uidane may "e #ound in the IATF Auditor .uide and IS= 1911
5.4.2.# 7upplier !e%elopment The organi8ation shall determine the !riority, ty!e, e)tent, and timing o# re5uired su!!lier develo!ment ations #or its ative su!!liers& etermination in!uts shall inlude "ut are not limited to the #ollowing7
a) !er#ormane issues identi#ied through su!!lier monitoring $see Setion E&4&3&4%L b)seond2!arty audit #indings $see Setion E&4&3&4&1%L c)third2!arty 5uality management system erti#iation statusL d)risk
analysis&
The organi8ation shall im!lement ations neessary to resolve o!en $unsatis#atory% !er#ormane issues and !ursue o!!ortunities #or ontinual im!rovement&
3-4- In$%"mati%n $%" t"nal '"%&i("! See IS= 91731@ re5uirements&
5.4.3.1 Information for eternal pro%i!ers — supplemental The organi8ation shall !ass down all a!!lia"le statutory and regulatory re5uirements and s!eial !rodut and !roess harateristis to their su!!liers and re5uire the su!!liers to asade all a!!lia"le re5uirements down the su!!ly hain to the !oint o# manu#ature&
3- ."%(u)ti%n an( !"&i) '"%&i!i%n 3--1 ,%nt"%l %$ '"%(u)ti%n an( !"&i) '"%&i!i%n See IS= 91731@ re5uirements& /=T( Suita"le in#rastruture inludes a!!ro!riate manu#aturing e5ui!ment re5uired to ensure !rodut om!liane& Monitoring and measuring resoures inlude a!!ro!riate monitoring and measuring e5ui!ment re5uired to ensure e##etive ontrol o# manu#aturing !roesses&
5.#.1.1 Control plan The organi8ation shall develo! ontrol !lans $in aordane with Anne) A% at the system, su"system, om!onent, andor material level #or the relevant manu#aturing site and all !rodut su!!lied, inluding those #or !roesses !roduing "ulk materials as well as !arts& Family ontrol !lans are ae!ta"le #or "ulk material and similar !arts using a ommon manu#aturing !roess& The organi8ation shall have a ontrol !lan #or !re2launh and !rodution that shows linkage and inor!orates in#ormation #rom the design risk analysis $i# !rovided "y the ustomer%, !roess #low diagram, and manu#aturing !roess risk analysis out!uts $suh as FM(A%&
The organi8ation shall, i# re5uired "y the ustomer, !rovide measurement and on#ormity data olleted during e)eution o# either the !re2 launh or !rodution ontrol !lans& The organi8ation shall inlude in the ontrol !lan7
a)ontrols used #or the manu#aturing !roess ontrol, inluding veri#iation o# o" set2u!sL b)#irst2o##last2o##, !art validation, as a!!lia"leL c)methods #or monitoring o# ontrol e)erised over s!eial harateristis $see Anne) A% de#ined "y "oth the ustomer and the organi8ationL
d)the ustomer2re5uired in#ormation, i# anyL e)s!ei#ied reation !lan $see Anne) A%L when nonon#orming !rodut is deteted, the !roess "eomes statistially unsta"le or not statistially a!a"le& The organi8ation shall review ontrol !lans, and u!date as re5uired, #or any o# the #ollowing7
f)the organi8ation determines it has shi!!ed nonon#orming !rodut to the ustomerL g)when any hange ours a##eting !rodut, manu#aturing !roess, measurement, logistis, su!!ly soures, !rodution volume hanges, or risk analysis $FM(A% $see Anne) A%L
h)a#ter a ustomer om!laint and im!lementation o# the assoiated orretive ation, when a!!lia"leL i)at a set #re5ueny "ased on a risk analysis& I# re5uired "y the ustomer, the organi8ation shall o"tain ustomer a!!roval a#ter review or revision o# the ontrol !lan&
5.#.1)2 7tan!ar!i(e! &or, —operator instructions an! %isual stan!ar!s The organi8ation shall ensure that standardi8ed work douments are7
a)ommuniated to and understood "y the em!loyees who are res!onsi"le #or !er#orming the workL b)legi"le, c) !resented in the language$s% understood "y the !ersonnel res!onsi"le to #ollow themL d)aessi"le #or use at the designated work area$s%& The standardi8ed work douments shall also inlude rules #or o!erator sa#ety&
5.#.1.3 =erification of o$ setups The organi8ation shall7
a)veri#y o" set2u!s when !er#ormed, suh as an initial run o# a o", material hangeover, or o" hange that re5uires a new set2u!L b)maintain doumented in#ormation #or set2u! !ersonnelL c)use statistial methods o# veri#iation, where a!!lia"leL d) !er#orm #irst2o##last2o## !art validation, as a!!lia"leL where a!!ro!riate, #irst2o## !arts should "e retained #or om!arison with the last2o## !artsL where a!!ro!riate, last2o##2!arts should "e retained #or om!arison with #irst2o## !arts in su"se5uent runsL
e)retain reords o# !roess and !rodut a!!roval #ollowing set2u! and #irst2o##last2o## !art validations& 5.#.1.4 =erification after shut!o&n The organi8ation shall de#ine and im!lement the neessary ations to ensure !rodut om!liane with re5uirements a#ter a !lanned or un!lanned !rodution shutdown !eriod&
5.#.1.# Total pro!ucti%e maintenance The organi8ation shall develo!, im!lement, and maintain a doumented total !rodutive maintenane system& At a minimum, the system shall inlude the #ollowing7
a)identi#iation o# !roess e5ui!ment neessary to !rodue on#orming !rodut at the re5uired v olume, b)availa"ility o# re!laement !arts #or the e5ui!ment identi#ied in item a> c) !rovision o# resoure #or mahine, e5ui!ment, and #aility maintenaneL d) !akaging and !reservation o# e5ui!ment, tooling, and gaugingL e)a!!lia"le ustomer2s!ei#i re5uirementsL f)doumented maintenane o"etives, #or e)am!le7 =(( $=verall (5ui!ment (##etiveness%, MTGF $Mean Time Getween Failure%, and MTT+ $Mean Time To +e!air%, and >reventive Maintenane om!liane metris& >er#ormane to the maintenane o"etives shall #orm an in!ut into management review $see IS= 91, Setion 9&%L
g)regular review o# maintenane !lan and o"etives and a doumented ation !lan to address orretive ations where o"etives are not ahievedL
h)use o# !reventive maintenane methodsL i)use o# !reditive maintenane methods, as a!!lia"leL j) !e ri od i
ov er ha ul &
5.#.1.+ anagement of pro!uction tooling an! manufacturing) test) inspection tooling an! equipment The organi8ation shall !rovide resoures #or tool and gauge design, #a"riation, and veri#iation ativities #or !rodution and servie materials and #or "ulk materials, as a!!lia"le& The organi8ation shall esta"lish and im!lement a system #or !rodution tooling management, whether owned "y the organi8ation or the ustomer, inluding7
a)maintenane and re!air #ailities and !ersonnelL b)storage and reoveryL c)set2u!L d)tool2hange !rogrammes #or !erisha"le toolsL e)tool design modi#iation doumentation, inluding engineering hange level o# the !rodutL f)tool modi#iation and revision to doumentationL g)tool identi#iation, suh as serial or asset num"erL the status, suh as !rodution, re!air or dis!osalL ownershi!L and loation& The organi8ation shall veri#y that ustomer2owned tools, manu#aturing e5ui!ment, and testins!etion e5ui!ment are !ermanently marked in a visi"le loation so that the ownershi! and a!!liation o# eah item an "e determined& The organi8ation shall im!lement a system to monitor these ativities i# any work is outsoured& 5.#.1./ "ro!uction
sche!uling The organi8ation shall ensure that !rodution is sheduled in order to meet ustomer ordersdemands suh as Pust2In2Time $PIT% and is su!!orted "y an in#ormation system that !ermits aess to !rodution in#ormation at key stages o# the !roess and is order driven& The organi8ation shall inlude relevant !lanning in#ormation during !rodution sheduling, e&g&, ustomer orders, su!!lier on2time delivery !er#ormane, a!aity, shared loading $multi2!art station%, lead time, inventory level, !reventive maintenane, and ali"ration&
3--/ I(nti$i)ati%n an( t"a)a+ility See IS= 91731@ re5uirements& /=T( Ins!etion and test status is not indiated "y the loation o# !rodut in the !rodution #low unless inherently o"vious, suh as material in an automated !rodution trans#er !roess& Alternatives are !ermitted i# the status is learly identi#ied, doumented, and ahieves the designated !ur!ose&
5.#.2.1 I!entification an! tracea$ility — supplemental The !ur!ose o# traea"ility is to su!!ort identi#iation o# lear start and sto! !oints #or !rodut reeived "y the ustomer or in the #ield that may ontain 5uality andor sa#ety2related nonon#ormities& There#ore, the organi8ation shall im!lement identi#iation and traea"ility !roesses as desri"ed "elow& The organi8ation shall ondut an analysis o# internal, ustomer, and regulatory traea"ility re5uirements #or all automotive !roduts, inluding develo!ing and doumenting traea"ility !lans, "ased on the levels o# risk or #ailure severity #or em!loyees, ustomers, and onsumers& These !lans shall de#ine the
a!!ro!riate traea"ility systems, !roesses, and methods "y !rodut, !roess, and manu#aturing loation that7
a)ena"le the organi8ation to identi#y nonon#orming andor sus!et !rodutL b)ena"le the organi8ation to segregate nonon#orming andor sus!et !rodutL c)ensure the a"ility to meet the ustomer andor regulatory res!onse time re5uirementsL d)ensure doumented in#ormation is retained in the #ormat $eletroni, hardo!y, arhive% that ena"les the organi8ation to meet the res!onse time re5uirementsL
e)ensure seriali8ed identi#iation o# individual !roduts, i# s!ei#ied "y the ustomer or regulatory standardsL f)ensure the identi#iation and traea"ility re5uirements are e)tended to e)ternally !rovided !roduts with sa#etyregulatory harateristis&
3-- ."%'"ty +l%nging t% )u!t%m"! %" t"nal '"%&i("! See IS= 91731@ re5uirements&
3--4 ."!"&ati%n See IS= 91731@ re5uirements&
5.#.4.1 "reser%ation — supplemental
>reservation shall inlude identi#iation,handling, ontamination ontrol, !akaging, storage, transmission or trans!ortation, and !rotetion& >reservation shall a!!ly to materials and om!onents #rom e)ternal andor internal !roviders #rom reei!t through !roessing, inluding shi!ment and until delivery toae!tane "y the ustomer& In order to detet deterioration, the organi8ation shall assess at a!!ro!riate !lanned intervals the ondition o# !rodut in stok, the !laety!e o# storage ontainer, and the storage environment& The organi8ation shall use an inventory management system to o!timi8e inventory turns over time and ensure stok rotation, suh as '#irst2in2#irst2out' $FIF=%& The organi8ation shall ensure that o"solete !rodut is ontrolled in a manner similar to that o# nonon#orming !rodut& =rgani8ations shall om!ly with !reservation, !akaging, shi!!ing, and la"eling re5uirements as !rovided "y their ustomers&
3-- .%!t?(li&"y a)ti&iti! See IS= 91731@ re5uirements&
5.#.#.1 Fee!$ac, of information from ser%ice The organi8ation shall ensure that a !roess #or ommuniation o# in#ormation on servie onerns to manu#aturing, material handling, logistis, engineering, and design ativities is esta"lished, im!lemented, and maintained& /=T( 1 The intent o# the addition o# 'servie onerns' to this su"2lause is to ensure that the organi8ation is aware o# nonon#orming !rodut$s% and material$s% that may "e identi#ied at the ustomer loation or in the #ield& /=T( 3 'Servie onerns' should inlude the results o# #ield #ailure test analysis $see Setion 1&3&6% where a!!lia"le&
5.#.#.2 7er%ice agreement &ith customer Jhen there is a servie agreement with the ustomer, the organi8ation shall7
a)veri#y that the relevant servie entres om!ly with a!!lia"le re5uirementsL b)veri#y the e##etiveness o# any s!eial !ur!ose tools or measurement e5ui!mentL c)ensure that all servie !ersonnel are trained in a!!lia"le re5uirements&
8.5.6 C(+*-( (/ 0&+
See IS= 91731@ re5uirements&
5.#.+.1 Control of changes — supplemental The organi8ation shall have a doumented !roess to ontrol and reat to hanges that im!at !rodut reali8ation& The e##ets o# any hange, inluding those hanges aused "y the organi8ation, the ustomer, or any su!!lier, shall "e assessed& The organi8ation shall7
a)de#ine veri#iation and validation ativities to ensure om!liane with ustomer re5uirementsL b)validate hanges "e#ore im!lementationL c)doument the evidene o# related risk analysisL d)retain reords o# veri#iation and validation&
e)noti#y the ustomer o# any !lanned !rodut reali8ation hanges a#ter the most reent !rodut a!!rovalL f)o"tain doumented a!!roval, !rior to im!lementation o# the hangeL g)om!lete additional veri#iation or identi#iation re5uirements, suh as !rodution trial run and new !rodut validation&
5.#.+.1.1 Temporary change of process controls The organi8ation shall identi#y, doument, and maintain a list o# the !roess ontrols, inluding ins!etion, measuring, test, and error2 !roo#ing devies, that inludes the !rimary !roess ontrol and the a!!roved "ak2u! or alternate methods& The organi8ation shall doument the !roess that manages the use o# alternate ontrol methods, The organi8ation shall inlude in this !roess, "ased on risk analysis $suh as FM(A%, severity, and the internal a!!rovals to "e o"tained !rior to !rodution im!lementation o# the alternate ontrol method& Ge#ore shi!!ing !rodut that was ins!eted or tested using the alternate method, i# re5uired, the organi8ation shall o"tain a!!roval #rom the ustomer$s%& The organi8ation shall maintain and !eriodially review a list o# a!!roved alternate !roess ontrol methods that are re#erened in the ontrol !lan& Standard work instrutions shall "e availa"le #or eah alternate !roess ontrol method& The organi8ation shall review the o!eration o# alternate !roess ontrols on a daily "asis, at a minimum, to veri#y im!lementation o# standard work with the goal to return to the standard !roess as de#ined "y the ontrol !lan as soon as !ossi"le& ()am!le methods inlude "ut are not limited to the #ollowing7
a)daily 5uality #oused audits $e&g,, layered !roess audits, as a!!lia"le%L b)daily
leadershi! meetings&
+estart veri#iation is doumented #or a de#ined !eriod "ased on severity and on#irmation that all #eatures o# the error2!roo#ing devie or !roess are e##etively reinstated& The organi8ation shall im!lement traea"ility o# all !rodut !rodued while any alternate !roess ontrol devies or !roesses are "eing used $e&g&, veri#iation and retention o# #irst !iee and last !iee #rom every shi#t%&
3-6 Rla! %$ '"%(u)t! an( !"&i)! See IS= 91731@ re5uirements&
3-6-1 Rla! %$ '"%(u)t! an( !"&i)! B !u''lmntal The organi8ation shall ensure that the !lanned arrangements to veri#y that the !rodut and servie re5uirements have "een met enom!ass the ontrol !lan and are doumented as s!ei#ied in the ontrol !lan $see Anne) A%& The organi8ation shall ensure that the !lanned arrangements #or initial release o# !roduts and servies enom!ass !rodut or servie a!!roval& The organi8ation shall ensure that !rodut or servie a!!roval is aom!lished a#ter hanges #ollowing initial release, aording to IS= 91, Setion E,@&6&
3-6-/ Lay%ut in!')ti%n an( $un)ti%nal t!ting A layout ins!etion and a #untional veri#iation to a!!lia"le ustomer engineering material and !er#ormane standards shall "e !er#ormed #or eah !rodut as s!ei#ied in the ontrol !lans& +esults shall "e availa"le #or ustomer review&
/=T( 1 :ayout ins!etion is the om!lete measurement o# all !rodut dimensions shown on the design reord$s%& /=T( 3 The #re5ueny o# layout ins!etion is determined "y the ustomer& 3-6-
A''a"an) itm!
For organi8ations manu#aturing !arts designated "y the ustomer as 'a!!earane items,' the organi8ation shall !rovide the #ollowing7
a)a!!ro!riate resoures, inluding lighting, #or evaluationL b)masters #or olour, grain, gloss, metalli "rilliane, te)ture, distintness o# image $=I%, and ha!ti tehnology, as a!!ro!riateL
c)maintenane and ontrol o# a!!earane masters and evaluation e5ui!mentL d)veri#iation that !ersonnel making a!!earane evaluations are om!etent and 5uali#ied to do so& 3-6-4
V"i$i)ati%n
an( a))'tan) %$ )%n$%"mity %$ t"nally '"%&i(( '"%(u)t! an( !"&i)!
The organi8ation shall have a !roess to ensure the 5uality o# e)ternally !rovided !roesses, !roduts, and servies utili8ing one or more o# the #ollowing methods7
a)reei!t and evaluation o# statistial data !rovided "y the su!!lier to the organi8ationL b)reeiving ins!etion andor testing, suh as sam!ling "ased on !er#ormaneL c)seond2!arty or third2!arty assessments or audits o# su!!lier sites when ou!led with reords o# ae!ta"le delivered !rodut on#ormane to re5uirementsL
d) !art evalua tion "y a design ated l a"or ator yL e)another method agreed with the ustomer& 3-6- Statut%"y an( "gulat%"y )%n$%"mity >rior to release o# e)ternally !rovided !roduts into its !rodution #low, the organi8ation shall on#irm and "e a"le to !rovide evidene that e)ternally !rovided !roesses, !roduts, and servies on#orm to the latest a!!lia"le statutory, regulatory, and other re5uirements in the ountries where they are manu#atured and in the ustomer2identi#ied ountries o# destination, i# !rovided&
3-6-6 A))'tan) )"it"ia Ae!tane riteria shall "e de#ined "y the organi8ation and, where a!!ro!riate or re5uired, a!!roved "y the ustomer& For attri"ute data sam!ling, the ae!tane level shall "e 8ero de#ets $see Setion 9&1&1&1%&
3-0 ,%nt"%l %$ n%n)%n$%"ming %ut'ut! 3-0-1 See IS= 91731@ re5uirements&
5./.1.1 Customer authori(ation for concession The organi8ation shall o"tain a ustomer onession or deviation !ermit !rior to #urther !roessing whenever the !rodut or manu#aturing !roess is di##erent #rom that whih is urrently a!!roved& The organi8ation shall o"tain ustomer authori8ation !rior to #urther !roessing #or 'use as is' and rework dis!ositions o# nonon#orming !rodut& I# su"2om!onents are reused in the manu#aturing !roess, that su"2om!onent reuse shall "e learly ommuniated to the ustomer in the onession or deviation !ermit& The organi8ation shall maintain a reord o# the e)!iration date or 5uantity authori8ed under onession& The organi8ation shall also ensure om!liane with the original or su!erseding s!ei#iations and re5uirements when the authori8ation e)!ires& Material shi!!ed under onession shall "e !ro!erly identi#ied on eah shi!!ing ontainer $this a!!lies e5ually to !urhased !rodut%& The organi8ation shall a!!rove any re5uests #rom su!!liers "e#ore su"mission to the ustomer&
5./.1.2 Control of nonconforming pro!uct customerspecifie! process The organi8ation shall om!ly with a!!lia"le ustomer2s!ei#ied ontrols #or nonon#orming !rodut$s%& 5./)1.3 Control of
suspect pro!uct The organi8ation shall ensure that !rodut with unidenti#ied or sus!et status is lassi#ied and ontrolled as nonon#orming !rodut& The organi8ation shall ensure that all a!!ro!riate manu#aturing !ersonnel reeive training #or ontainment o# sus!et and nonon#orming !rodut&
5./.1.4 Control of re&or,e! pro!uct The organi8ation shall utili8e risk analysis $suh as FM(A% methodology to assess risks in the rework !roess !rior to a deision to rework the !rodut& I# re5uired "y the ustomer, the organi8ation shall o"tain a!!roval #rom the ustomer !rior to ommening rework o# the !rodut& The organi8ation shall have a doumented !roess #or rework on#irmation in aordane with the ontrol !lan or other relevant doumented in#ormation to veri#y om!liane to original s!ei#iations& Instrutions #or disassem"ly or rework, inluding re2ins!etion and traea"ility re5uirements, shall "e aessi"le to and utili8ed "y the a!!ro!riate !ersonnel& The organi8ation shall retain doumented in#ormation on the dis!osition o# reworked !rodut inluding 5uantity, dis!osition, dis!osition date, and a!!lia"le traea"ility in#ormation&
5./.1.# Control of repaire! pro!uct The organi8ation shall utili8e risk analysis $suh as FM(A% methodology to assess risks in the re!air !roess !rior to a deision to re!air the !rodut& The organi8ation shall o"tain a!!roval #rom the ustomer "e#ore ommening re!air o# the !rodut& The organi8ation shall have a doumented !roess #or re!air on#irmation in aordane with the ontrol !lan or other relevant doumentedin#ormation& Instrutions #or disassem"ly or re!air, inluding re2ins!etion and traea"ility re5uirements, shall "e aessi"le to and utili8ed "y the a!!ro!riate !ersonnel& The organi8ation shall o"tain a doumented ustomer authori8ation #or onession #or the !rodut to "e re!aired&
The organi8ation shall retain doumented in#ormation on the dis!osition o# re!aired !rodut inluding 5uantity, dis!osition, dis!osition date, and a!!lia"le traea"ility in#ormation&
5./.1.+ Customer notification The organi8ation shall immediately noti#y the ustomer$s% in the event that nonon#orming !rodut has "een shi!!ed& Initial ommuniation shall "e #ollowed with detailed doumentation o# the event&
5./.1./ >onconforming pro!uct !isposition The organi8ation shall have a doumented !roess #or dis!osition o# nonon#orming !rodut not su"et to rework or re!air& For !rodut not meeting re5uirements, the organi8ation shall veri#y that the !rodut to "e sra!!ed is rendered unusa"le !rior to dis!osal& The organi8ation shall not divert nonon#orming !rodut to servie or other use without !rior ustomer a!!roval&
3-0-/ See IS= 91731@ re5uirements&
9 ."$%"man) &aluati%n 9-1 M%nit%"ing ma!u"mnt analy!i! an( &aluati%n 9-1-1 Gn"al See IS= 91731@ re5uirements&
?.1.1.1 onitoring an! measurement of manufacturing processes The organi8ation shall !er#orm !roess studies on all new manu#aturing $inluding assem"ly or se5uening% !roesses to veri#y !roess a!a"ility and to !rovide additional in!ut #or !roess ontrol, inluding those #or s!eial harateristis& /=T( For some manu#aturing !roesses, it may not "e !ossi"le to demonstrate !rodut om!liane through !roess a!a"ility& For those !roesses, alternate methods suh as "ath on#ormane to s!ei#iation may "e used& The organi8ation shall maintain manu#aturing !roess a!a"ility or !er#ormane results as s!ei#ied "y the ustomer*s !art a!!roval !roess re5uirements& The organi8ation shall veri#y that the !roess #low diagram, >FM(A, and ontrol !lan are im!lemented, inluding adherene to the #ollowing7
a)measurement tehni5uesL b)sam!ling
!lansL
c)ae!tane riteriaL d)reords o# atual measurement values andor test results #or varia"le dataL e)reation !lans and esalation !roess when ae!tane riteria are not met& Signi#iant !roess events, suh as tool hange or mahine re!air, shall "e reorded and retained as doumented in#ormation& The organi8ation shall initiate a reation !lan indiated on the ontrol !lan and evaluated #or im!at on om!liane to s!ei#iations #or harateristis that are either not statistially a!a"le or are unsta"le& These reation !lans shall inlude ontainment o# !rodut and 1 !erent ins!etion, as a!!ro!riate& A orretive ation !lan shall "e develo!ed and im!lemented "y the organi8ation indiating s!ei#i ations, timing, and assigned res!onsi"ilities to ensure that the !roess "eomes sta"le and statistially a!a"le& The !lans shall "e reviewed with and a!!roved "y the ustomer, when re5uired& The organi8ation shall maintain reords o# e##etive dates o# !roess hanges& ?.1.1.2
I!entification of statistical tools The organi8ation shall determine the a!!ro!riate use o# statistial tools& The organi8ation shall veri#y that a!!ro!riate statistial tools are inluded as !art o# the advaned !rodut 5uality !lanning $or e5uivalent% !roess and inluded in the design risk analysis $suh as FM(A% $where a!!lia"le%, the !roess risk analysis $suh as >FM(A%, and the ontrol !lan&
?.1.1.3 Application of statistical concepts Statistial one!ts, suh as variation, ontrol $sta"ility%, !roess a!a"ility, and the onse5uenes o# over2adustment, shall "e understood and used "y em!loyees involved in the olletion, analysis, and management o# statistial data&
9-1-/ ,u!t%m" !ati!$a)ti%n See IS= 91731@ re5uirements&
?.1.2.1 Customer satisfaction — supplemental
>er#ormane indiators shall "e "ased on o"etive evidene and inlude "ut not "e limited to the #ollowing7
a)delivered !art 5uality !er#ormaneL b)ustomer disru!tionsL c)#ield returns, realls, and warranty $where a!!lia"le%L d)delivery shedule !er#ormane $inluding inidents o# !remium #reight%L e)ustomer noti#iations related to 5uality or delivery issues, inluding s!eial status& The organi8ation shall monitor the !er#ormane o# manu#aturing !roesses to demonstrate om!liane with ustomer re5uirements #or !rodut 5uality and !roess e##iieny& The monitoring shall inlude the review o# ustomer !er#ormane data inluding online ustomer !ortals and ustomer soreards, where !rovided&
9-1- Analy!i! an( &aluati%n See IS= 91731@ re5uirements&
?.1.3.1 "rioriti(ation Trends in 5uality and o!erational !er#ormane shall "e om!ared with !rogress toward o"etives and lead to ation to su!!ort !rioriti8ation o# ations #or im!roving ustomer satis#ation&
9-/ Int"nal au(it 9-/-1 AND 9-/-/ See IS= 91731@ re5uirements&
?.2.2.1 Internal au!it programme The organi8ation shall have a doumented internal audit !roess& The !roess shall inlude the develo!ment and im!lementation o# an internal audit !rogramme that overs the entire 5uality management system inluding 5uality management system audits, manu#aturing !roess audits, and !rodut audits& The audit !rogramme shall "e !rioriti8ed "ased u!on risk, internal and e)ternal !er#ormane trends, and ritiality o# the !roess$es%& Jhere the organi8ation is res!onsi"le #or so#tware develo!ment, the organi8ation shall inlude so#tware develo!ment a!a"ility assessments in their internal audit !rogramme& The #re5ueny o# audits shall "e reviewed and, where a!!ro!riate, adusted "ased on ourrene o# !roess hanges, internal and e)ternal nonon#ormities, andor ustomer om!laints& The e##etiveness o# the audit !rogramme shall "e reviewed as a !art o# management review&
? 2 2.2 -uality management system au!it .
.
The organi8ation shall audit all 5uality management system !roesses over eah three2year alendar !eriod, aording to an annual !rogramme, using the !roess a!!roah to veri#y om!liane with this Automotive QMS Standard& Integrated with these audits, the organi8ation shall sam!le ustomer2s!ei#i 5uality management system re5uirements #or e##etive im!lementation&
?.2.2.3 anufacturing process au!it The organi8ation shall audit all manu#aturing !roesses over eah three2year alendar !eriod to determine their e##etiveness and e##iieny using ustomer2s!ei#i re5uired a!!roahes #or !roess audits& Jhere not de#ined "y the ustomer, the organi8ation shall determine the a!!roah to "e used& Jithin eah individual audit !lan, eah manu#aturing !roess shall "e audited on all shi#ts where it ours, inluding the a!!ro!riate sam!ling o# the shi#t handover& The manu#aturing !roess audit shall inlude an audit o# the e##etive im!lementation o# the !roess risk analysis $suh as >FM(A%, ontrol !lan, and assoiated douments&
?.2.2.4 "ro!uct au!it The organi8ation shall audit !roduts using ustomer2s!ei#i re5uired a!!roahes at a!!ro!riate stages o# !rodution and delivery to veri#y on#ormity to s!ei#ied re5uirements& Jhere not de#ined "y the ustomer, the organi8ation shall de#ine the a!!roah to "e used&
9- Managmnt "&i> 9--1 Gn"al See IS= 91731@ re5uirements&
?.3.1.1 anagement re%ie& — supplemental Management review shall "e onduted at least annually& The #re5ueny o# management review$s% shall "e inreased "ased on risk to om!liane with ustomer re5uirements resulting #rom internal or e)ternal hanges im!ating the 5uality management system and !er#ormane2related issues&
9--/ Managmnt "&i> in'ut! See IS= 91731@ re5uirements&
?.3.2.1 anagement re%ie& inputs — supplemental In!ut to management review shall inlude7
a)ost o# !oor 5uality $ost o# internal and e)ternal nonon#ormane%L b)measures o# !roess e##etivenessL c)measures o# !roess e##iienyL d) !rodut on#orma neL e)assessments o# manu#aturing #easi"ility made #or hanges to e)isting o!erations and #or new #ailities or new !rodut $see Setion D&1&&1%L
f)ustomer satis#ation $see IS= 91, Setion 9&1&3%L g)review o# !er#ormane against maintenane o"etivesL h)warranty !er#ormane $where a!!lia"le%L i)review o# ustomer soreards $where a!!lia"le%L j)identi#iation o# !otential #ield #ailures identi#ied through risk analysis $suh as FM(A%L k)atual #ield #ailures and their im!at on sa#ety or the environment&
+././ "ana9ement revie: out7uts See IS= 91731@ re5uirements&
?.3.3.1 anagement re%ie& outputs — supplemental To! management shall doument and im!lement an ation !lan when ustomer !er#ormane targets are not met&
1, Im7rovement 1,.1 (eneral See IS= 91L31@ re5uirements&
1,.- Noncon;ormit< an= corrective action 1,.-.1 an= 1,.-.See IS= 91731@ re5uirements&
[email protected] "ro$lem sol%ing The organi8ation shall have a doumented !roess$es% #or !ro"lem solving inluding7
a)de#ined a!!roahes #or various ty!es and sale o# !ro"lems $e&g&, new !rodut develo!ment, urrent manu#aturing issues, #ield #ailures, audit #indings%L
b)ontainment, interim ations, and related ativities neessary #or ontrol o# nonon#orming out!uts $see IS= 91, Setion E&D%L
c)root ause analysis, methodology used, analysis, and resultsL d)im!lementation o# systemi orretive ations, inluding onsideration o# the im!at on similar !roesses and !rodutsL e)veri#iation o# the e##etiveness o# im!lemented orretive ationsL f)reviewing and, where neessary, u!dating the a!!ro!riate doumented in#ormation $e&g&, >FM(A, ontrol !lan%& Jhere the ustomer has s!ei#i !resri"ed !roesses, tools, or systems #or !ro"lem solving, the organi8ation shall use those !roesses, tools, or systems unless otherwise a!!roved "y the ustomer&
[email protected] 0rrorproofing The organi8ation shall have a doumented !roess to determine the use o# a!!ro!riate error2!roo#ing methodologies& etails o# the method used shall "e doumented in the !roess risk analysis $suh as >FM(A% and test #re5uenies shall "e doumented in the ontrol !lan& The !roess shall inlude the testing o# error2!roo#ing devies #or #ailure or simulated #ailure& +eords shall "e maintained&
[email protected].# arranty management systems Jhen the organi8ation is re5uired to !rovide warranty #or their !rodut$s%, the organi8ation shall im!lement a warranty management !roess& The organi8ation shall inlude in the !roess a method #or warranty !art analysis, inluding /TF $no trou"le #ound%& Jhen s!ei#ied "y the ustomer, the organi8ation shall im!lement the re5uired warranty management !roess&
[email protected].+ Customer complaints an! fiel! failure test analysis The organi8ation shall !er#orm analysis on ustomer om!laints and #ield #ailures, inluding any returned !arts, and shall initiate !ro"lem solving and orretive ation to !revent reurrene& Jhere re5uested "y the ustomer, this shall inlude analysis o# the interation o# em"edded so#tware o# the organi8ation*s !rodut within the system o# the #inal ustomer*s !rodut& The organi8ation shall ommuniate the results o# testinganalysis to the ustomer and also within the organi8ation&
1#.3 C(+*+& '-('+*
See IS= 91731@ re5uirements&
1#.3.1 C(+*+& '-('+* 9 '+*&
The organi8ation shall have a doumented !roess #or ontinual im!rovement& The organi8ation shall inlude in this !roess the #ollowing7
a)identi#iation o# the methodology used, o"etives, measurement, e##etiveness, and doumented in#ormationL b)a manu#aturing !roess im!rovement ation !lan with em!hasis on the redution o# !roess variation and wasteL c)risk analysis $suh as FM(A%& /=T(
Anne> A8 Control .lan
.?ases o; t?e control 7lan
A.1
A control (lan covers three distinct (hases as a((ro(riate+ ，
a) P-(*(*:; a desri!tion o# the dimensional measurements ，material ，and !er#ormane tests that will our during "uilding o# the !rototy!e& The organi8ation shall have a !rototy!e ontrol !lan ，i# re5uired "y the ustomer ， b) P-,I&+0; a desri!tion o# the dimensional measurements ， material ， and !er#ormane tests that our a#ter !rototy!e and "e#ore #ull !rodution& >re2Iaunh is de#ined as a !rodution !hase in the !roess o# !rodut reali8ation that may "e re5uired a#ter !rototy!e "uild&
c) P-(<0*(+; doumentation o# !rodut!roess harateristis !roess ontrols, tests, and measurement systems that our during mass !rodution&
?OTE 1 It is reommended that the organi8ation re5uire its su!!liers to meet the re5uirements o# this Anne)& /=T( 3 For some "ulk materials, the ontrol !lans do not list most o# the !rodution in#ormation& This in#ormation an "e #ound in the orres!onding "ath #ormulationrei!e details&
Elements o; t?e control 7lan
A.2
A ontrol !lan inludes ，as a minimum ，the #ollowing ontents7 G+-& <&*&
a)
ontrol !lan num"erL
b)
issue date and revision date ，i# anyL
c)
ustomer in#ormation $see ustomer re5uirements%L
d)
organi8ation*s namesite designationL
e) !a 叫 num"er$s%L f) !art namedesri!tionL g)
engineering hange levelL
h) !hase overed $!rototy!e ， !re2Iaunh ， !rodution%L i) %
key ontatL !art!roess ste! num"erL
k) !roess nameo!eration desri!tionL 1) #untional grou!area res!onsi"le
ro=uct control a) !rodut2related s!eial harateristisL b)
other harateristis #or ontrol $num"er ， !rodut or !roess%L
c)
s!ei#iationtolerane
rocess control a) !roess !arameters $inluding !roess settings and toleranes%L b) !roess related s!eial harateristisL c) mahines, igs #i)tures, tools #or manu#aturing $inluding identi#iers ，as a!!ro!riate%L
"et?o=s a)
evaluation measurement tehni5ueL
b)
error2!roo#ingL
c)
sam!le si8e and #re5uenyL
d)
ontrol method
Reaction 7lan a% reation !lan $inlude or re#erene%&
ANNE2 B8 Bi@lio9ra7?< , su77lemental automotive
Internal au=it AIA. roess Audit roess7 Beat Treatment System Assessment roess7 >lating System Assessment roess7 roess7 Jelding System Assessment roess7 Soldering System Assessment roess7 Molding System Assessment roess7 roess Audit FI( 0
03& >rodution >roess Audit Manual
IAT Auditor .uide #or IATF 16949 F 0olume 6 !a 叫 >roess Audit 0= A
0olume 6 !art @ >rodut Audit
Noncon;ormit< an= corrective action AIA. ro"lem Solving >ratitioner .uide 0 A 0olume 'Audit standard #ield #ailure analysis' 0olume 'Field #ailures analys is"
"easurement s
气2
A/FIA AQ 34 MSA Measurement Systems Analysis 0A
0olume @ '
.ro=uct a77roval AIA. >rodution >art A!!roval >roess $>>A>% 0A
0olume 3 >rodution !roess and !rodut a!!roval $>>A% 0olume 19 >art 1 $'Ins!etion o# Tehnial artiulate art 3 $'Tehnial leanliness in assem"ly 2 (nvironment ，:ogistis ，>ersonnel and Assem"ly (5ui!ment'%
.ro=uct =esi9n AIA. A>Q> and lan otential Failure Mode (##ets Analysis $FM(A% A/FIA AQ 9 FM(A AQ 14 Manual o# ()!erimental esign AQ 3@ +elia"ility .uide 0A 0olume 4 rodut and >roess FM(A 0olume 0A2+.A 'Maturity :evel Assurane #or /ew >arts' 0olume '+o"ust >rodution >roess' 0olume S!eial
.ro=uction control
A#A@ MMO@4E Materials Management O(erational @uidelines 4 ogistics Evaluation SMMT #m(lementing Standardised Bor5
$ualit< mana9ement s
AQ 026 Managing and im(roving the (rocess #AT$ Cules !or achieving and maintaining #AT$ recognition Risk anal
DA Dolume & "Cing)binder" elementary aids ，ris5 analyses ，methods ，and (rocess models
So;t:are rocess Assessment
Statistical tools
A#A@ Statistical ;rocess
Su77lier ualit< mana9ement A#A@
#AT$ Minimum Automotive Quality Management System Ce*uirements !or Sub)Tier Su((liers MAQMSC
&ealt? an= sa;et< #SO #SO &,001 Occu(ational health and sa!ety management systems
