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  • IATF 16949.2016 - Inglés

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    IATF 16949.2016 - Inglés

    Cargado por

    PerezJhonatan
    IATF 16949.2016 - Inglés

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    Automotive IATF 16949 Quality Management System Standard Quality managment system requirements for automotive production and relevant service parts organizations &\_ International | Automotive Task Force 1*Edition 1 October 2016 AUTOMOTIVE IATF 16949 QUALITY MANAGEMENT SYSTEM STANDARD Quality management system requirements for automotive production and relevant service parts organizations International Automotive Task Force "Edition 1 Octaber 2016, ATF copyright notice “This Automotive Quafy Management Sytem Standard, known as ATF 16949, ls copyright protected by ‘he members of the Intemational Automaive Task Force (IATF. The tle fr this Automotive GMS ‘Standard ATF 16949" a registred trademark of the IATF. Except a8 permited under the applicable laws of to user's county, nether tis Automotive Qualty Monagement System Standard nor any extrac fro it may be reproduced, stored ina retrieval system or tranemited in any form or by any means, electron, photocopying, recorcng or otherwise without prior writen permission being secuted from the IATF. Reproduction may be subject to royalty payments ora licensing agreement and violators are subject to leg prosecution. Requests for permission to reproduce andlor translate any part of ths Automotive QMS Standard should be acoressed to one ofthe folowing national automotive trade associations below: ‘Assocaxone Nazionale Filer Indust Automobisiche (ANIA ty) ‘Automotive Indus Aetion Group (AIAG USA) Fédération des Industries des Eqipements pour Vehicles (FIEV France) Society of Motor Manufacturers and Traders Lid. (SMMT/ UK) Verband der Automebiindusin@ V (VDA Germany) Table of Contents. “TABLE OF CONTENTS. FOREWORD ~ AUTOMOTIVE QMS STANDARD... GOAL. REMARKS FOR CERTIFICATION. iwropucTion 102 GENERAL ne 102 QUALITY MANAGEMENT PRINCIPLES... 10.3 PROCESS APPROACH nn (0.3. GENERAL, (9.3.2 PLAN-DO-CHECKACT CYCLE ean (0.3.3 ISK-BASED THINKING ennennnnen (04 RELATIONSHIP WITH OTFER MANAGEMENT SYSTEM STANDARDS voc [QUALITY MANAGEMENT SYSTEMS ~ REQUIREMENTS ow 1 score. 111 Score—suromeTMe SuPREMENTALTO1SO 80012018 oh 22 NORMATIVE REFERENCES nconssninnnnn 2. Notre avo neon ERENCES a nc £3 TERMS AND DEFINITIONS nnn 23. Tens ano osparons ron i auroworwe mous. Boe aor) {4 CONTEXT OF THE ORGANIATION... 4.41 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT 16 {4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIE nc ssnnsnnnens “4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM. sen 432 castomerspetieregrements ae {44 QUALITY MANAGEMENTSYSTEM AND ITS PROCESSES. Seba! nas A Salle nnn 443.1 confoomance produ and proces Ss 7 $422 Prod SY 7 44.2 sna pee (©AAG, © ANIA © FEV, © SMAI, ©VOA 2016 AI its eared ' 5 LEADERSH 15.1 LEADERSHIP AND COMMITMENT... 5.1. GENERAL Se leeitc SES aal S421 corporate responsity.———-— ans att 51.12 proces effectiveness and fone. anaes 5 16 5.2 CUSTOMER FOCUS ee 52 poucr. 53.2. ESTABLISHING THE QUALITY POLY nn $5.22 DMMUNICATING THE QUALITY POLY ans ‘5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES ccnnaro 5:1 Oranltional oes responses, an autores -spoementl. samme” 5.2 Responsbity and authority fr product equcements and corrective aE 9 65 PLANNING. {6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES. 61ND 612 6222 kana os - a9 61.22 Preventive ation - a ae 61.23 comngerey ans 7 ian 20 {62 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM 62100622. 16221 ala objectives ae panning achieve them — pam nnnenn 2» (6.3 PLANNING OF CHANGES nn 7 support... 7 RESOURCES en TAA GENERAL 7.2 PEOPLE sen 73.3 INFRASTRUCTURE 71.3.1 Plan fact, and equment pring... a oy 7.1.4 ENVIRONMENT FOR THE OPERATION OF PROCESSES. 7.24 Envronment forthe opeatonct process — supplemental 17.4.5 MONITORING AND MEASURING RESOURCES von TAL. GENERAL nse 1.5.11 Mesuement sytem 26 on a "7.1.5.2 MEASUREMENT TRACEABILITY. 2 OAKS, ANE © FEV, © SHAT, © VOR 2018 hs resort 145.24 Callrioerieaton rtd. 753. abortoryreqtemett enn 2ASA1 ner lbortong ae 71532 Gaeralabortary. fa 7.4.6 ORGANIZATIONAL KNOWLEDGE. V2 COMPETENCE enn 2.24 Competence supplement oo 2 7. Competence —on-theje ang au - 20 1723 itera autor competency ao as 724 Secondary aude eompeteney nnn eet 73 AWARENESS... Seat 73.1 awareness~suppleenel aaa ee 173.2 employee motaton and emgowermer®. 25 174 COMMUNICATION vn 26 7.5 DOCUMENTED INFORMATION. 754 GENERAL, 751.1 Quay management stem documentation. 175.2 CREATING AND UPDATING. 7.5.3 CONTROL OF DOCUMENTED INFORMATION. TSBAAND 753.2 753.21 Recordset, ie een 753.22. Egnetingspectiatons i ” 8 OPERATION. eel sn 1. OPERATIONAL PLANNING AND CONTROL nnn 28 1.1 Operational planning and contol — spleen nn 2 1822 confident, oe Seeeh alll 28 ‘8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES. 18.2.1 CUSTOMER COMMUNICATION nnn 82:11 Cstoma ommanietion — supplement nnn 28 18.2.2 DETERMINING THE REQUIREMENTS FOR PRODUCTS AND SERVICES neeeensnnncneereen 28 1422.1 Determining he rearemen or products and serves - epee ao = '8.2.3 REVIEW OF THE REQUIREMENTS FOR PRODUCTS AND SERVICES... 82.2. 1:23.11 Review of the reaurmers for produc and sve — spleen 29 823.12 Catomerdesrated spec haaeH nn nenrnnnnnnnnnnnnnnnnnen 182313 Orgenaaton manutactungfensiay tata (GAAS, ©ANFIA OEY, ©SUMT, 8 VDA=2016- Arena a 1.24 CHANGES TO REQUIREMENTS FOR PRODUCTS AND SERVICES. |8.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICE nna 1.3.1 GENERAL nacre 183.11 Deen and development of produ ad serves pment : {8.3.2 DESIGN AND DEVELOPMENT PLANNING... 1.321 Desensnd development panning -suplenent 12322 Predict deg i mn £1323 bevelpment of rodace with embedded War v-msninn ie 183.3 DESIGN AND DEVELOPMENT INPUTS 123.1 rode etn ap 8222 Manufacturing proces design now a 2333 spell chara none {1.3.4 DESIGN AND DEVELOPMENT CONTROLS nnn 2.1 Motoring ~ ———————— at 13.42 Desgnand development ato. acc Seiichi 143 Protane ogame : ae 2 a 44 Prodi ppv poe =a 18.35 DESIGN AND DEVELOPMENT OUTPUTS nnn 1.35.1 Design and development xtpts—supoemental oma 12352 Manutctuting proces Sesh LA nmr pi ee {8.36 DESIGN AND DEVELOPMENT CHANGES. nnn 1.264 sgn and development hangs supplement nnn 1.8 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES nnnnnnnnnnne 38 B48 GENERAL nnn pn 3 ‘4422 Supper secton proces. S 8 has catomerareced sources abo known 4 -DYesed-Buf)snnnneennnmnem 3B {8.4.2 TYPE AND EXTENT OF CONTROL ewsnnnnn 14421 Type ad extent of contrat supplement om 13422 Stator and egutor relearn 18.423 Supple unity management rte development nnn $133.2 Rlcmcone pdocrctee softwere orautomative produc win ened stmt monn 38 8424 Super mantorng. - en i) 84241 second 2 ~ : delat 12425 Supper devapment. 7 saree Triana] {4.43 INFORMATION FOR EXTERNAL PROVIDERS 14431 lformation for enteral providers super w {15 PRODUCTION AND SERVICE PROVISION.. 185.1 CONTROL OF PRODUCTION AND SERVICE PROVISION nsnnsnronsnnnn 4 AAG, @ ANF, FEY, © SAT. OA = 20 18512 Sundries work operator itructons nd wal onder 155.13 Verran fob setups. ee 8515 Teal posse matanance —— 135.6 Noragenent of rodutin tooling and manufacturing, es nspection toon {5.7 Patueton een en {85.2 IDENTIFICATION AND TRACEABILITY nes 15.21 leeeton and waceaby — Sup hMeN nnn {85.3 PROPERTY BELONGING TO CUSTOMERS OR EXTERNAL PROVIDERS enna 82 185.4 PRESERVATION. 5.42 Prsration supplemental nn 85.5 POST-DELIVERY ACTIVITIES vente {855 Fesdbackol formation omer. aah 18552 seviee agreement with eutomet nnn {85.6 CONTROL OF CHANGES enn 18563 comodo hanges-supemettal nae nnn 185.611 Temporary ang of proces conto si 18.6 RELEASE OF FRODUCTS AND SERVICES enn 136: Rlese of product and serves — suet en {262 Lape incon and Neto ttn 63 Apparanc aman 1364 Veriaton and acceptance of contro een pred products anders {455 Stator and reply onary z, 66 Aceptacecrtera - 87 CONTROL OF NONCONFORMING OUTPUTS. 1171.2 Conrl of ancorforing product ~estmersece roe 8713 Conrlofspet produ. . ~ 8715 Conrl orp produ. 8718 comer notteaton. pa ar 187.7 Nencoorming prodit depot 802 ennai '9 PERFORMANCE EVALUATION. 19.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION enone SAL taal 9.1.13 Montorng nd mesuremen of manUtciting POC 95113 Aptcaton of ast cones. BRE (© NAG, © ANFA, © FEV, SHAT, 8VOA 2015 hes eared 5 9.1.2 CUSTOMER SATISFACTION 92.23 customer sttacton sepia. 9.1.3 ANALYSIS AND EVALUATION renner 9.2 INTERNAL AUDI 9.24 AND 8.2.2 cnonnenneneen 92.22 tera aud pep ce 9222 aly maragenent system aud 9223 Manufacurng protest 2u8t on 9224 Product alt ne 9.3 MANAGEMENT REVIEW wrovnnnss 93.1 GENERAL nc 92.1. Management cele -spplmen 9.3.2. MANAGEMENT REVIEW INPUTS von 92.21 Management review inputs supple nn 9.3.3 MANAGEMENT REVIEW OUTPUTS ene 933.1 Management reew ovo. supplemental feel s 310.2 AND 1022 ener 1023 Probie song eee 2 302.4 tor gen = ee “2 2025 Wacranty management systems nnn a 1025 Customer complaints ad a alure test nly. eee. 3033 CONTINUAL IMPROVEMENT sneenenn 1034 Contiralimorovemart -sulemen nv els ANNEX A: CONTROL PUAN A PAHS THECONTROLPA nnn o A2 ftewentsor meconmno. na ‘ (SHAG, SAFI, FEV, SMMMT.© VDA 2016 Aight rena Foreword ~ Automotive QMS Standard ‘This Automative Qualty Management System Standard, herein referred to as “Aulomatve QMS Standard or "IATF 16849," long wih applicable automoWve customer-epectic requirements, ISO 8001:2016 requirements, and 'SO 9000-2015 defines the fundamental qualty management aystem requirements for automotive production and relevant service parts organizations. As such, te ‘Audomotive OMS Standard cannot be considered a stand-alone OMS Standard but has © bs ‘comprehended asa supplement to and used in conjuncton with ISO 8001-2016, 150 900%:2015is, published as a separate ISO Standard IATE 16949:2016 (1s eto) represents an innovative document, given the strong orentation tothe ‘customer, with inclusion ofa numberof consolidated previous customer specicrequrements, ‘Annex B is provided for guidance to implement the IATF 16949 requirements unless otherwise speciied by customer specific requirements. History 'SOMTS 16949 st edton) was orginally created in 1999 bythe Intemational Automotive Task Force (ATF) with the aim of harmenizing the aferent assessment and certicaion systoms worldwide the Supply chain for the automotive acta. Other revisions were created (2nd ealton in 2002, and 2d eatin in 2003) as necessary for etter automotive sector enhancements or ISO 9001 revisions. ISO/TS 16049, (along wih supporting technical publications developed by orginal equipment manufacturers [herein Fefered to as OEMs] and the national automotive rade associations) introduced a common set techniques and methods for common product and process development for automotive manufacuing words In preparation for migrating from ISOTS 16949:2009 (rd edtion) to his Automotive QMS Standard, IATE 16949, feadback was soled fom certfcaion bodies, austors, suppliers, and OEMs to create \ATF 10949:2016 (1st econ), which cancels and replaces ISOITS 1634-2009 (3d ealton), ‘The IATE maintains strong cooperation with ISO by conthuingHalson committe status ensuring continued alignment wit ISO 8004, Goal “The goal ofthis Automotive QMS standard is the development of a qualty management system that provides fr continual improvement, emphasizing defect prevention and the reduction of vaiton and ‘waste nthe supply chain, Remarks for certification Requirements for certification to this Automotive QMS Standard ae defined inthe Rules for achieving land maintaining IATF recognition ‘Details can be obiained from the local Oversight Offices of the [ATF cited below: ‘Associazine Nazionale Flora Industrie Automobilsche (ANFIA) Wed sto: wwwaanfait emal arfa@ania Intemational Automotive Oversight Bureau (ADB) Web ste: ww jaab.org e-mail at 1604feecback@laob org IATE France eo ste: ww iat-srance.com ema iat@iat-trance.com Society of Motor Manufacturers and Traders Lid. (SMMT Lid.) Web site: www.smmtoversight co.uk ‘e-mail iat 6949@smmit.co uk \Verband der Automoblinduste — Qualtats Management Center (VDA MC) Web site: wow veanqme de ‘emai info@vda-qme.ce ‘Al public information about Ure IATF can be found atthe IAT website: yn Jatfolobalaversighora ° (AIAG, © ANF, FIV, © SMIMT.@VDA — 201A rene Introduction 04 General ‘See ISO 9001:2015 requrements 02 Quality management principles ‘See ISO 8001-2018 requirement, 103 Process approach 103.4 General ‘See ISO 9001-2015 requirements 1032 Plan-Do-check-Act eycle ‘See ISO 9001:2015 requirements. 1033 Risk-based thinking ‘See ISO 9001:2015 requirements 0.4 Relationship with other management system standards, ‘Sem 180 9001:201S requrements ‘Quality management systems - Requirements 4 Scope ‘See ISO 9001:2015 requirements 41 Scope ~ automotive supplemental to ISO 9001:2015 ‘This Automotive QMS Standard defines the quality management system requrements fr the design and development, production and, when relevant, assembly instalaon, and service of automotve-elated products, including products with embedded software. This Automotive QMS Standard is applicable to sites ofthe organization where manufacturing of customer-spectied productior pats, serdce pats, andlor accessory parts occu. “This Automate GMS Standerd shouls be apple troughout me automotive supply chain. OAAG, CANA, OFEY, © SHNT, © VDA 2018 At eg sare 2 Normative refernnces ‘See ISO 9001 2015 requirements. 2.1 Normative and informative references. [Annex (Conte Plan) it arematvn part af this Automotive OMS standard ‘Annex B (Bibiography— automotive supplemental is informative, which provides adional information Intended to assist the understanding or use of his Automotive GMS standare 3 Terms and definitions ‘See ISO £001:2015 requirements 3.1 Terms and definitions for the automotive industry ‘accessory part ‘customer epeciie additonal component(s that are either mechanicaly or electronically connected to the vehicle or powartrin before (rafter) delivery tothe final customer (6.9, custom fer mats, tuck bed liners, wheel covers, sound system enhancements, sunroofs, epolers, super-chargers, et.) ‘advanced product quality planning (APP) product quelty planning process that supports development of @ product or service that wil satisfy customer raquitements; APOP serves as a guide n the development process and algo a standard way to share resuls between organizations and thelr custorars; APP covers design robushess, design testing and specication compiiance, production process design, qusity inspection standard, process capability, production capac, product packeging,procuc testing and operator taining plan, among other tems aftermarket part replacement part(s) not procured or tleased by an OEM for service part appleations, which may oF ‘may net be produced to orignal equipment specications authorization documented permission for a person(s) spectving rights end responsbities relates to giving or «denying permissions or sanctions wenin an organization 0 “SHAG, OANFIA GE, © SINT, VOR ~ 278 ~ AUN ana challenge (master) part pat(s) of known specication, calibrated and traceable to standards, with expected results (pass or fal) hat are used to validate the functonalty of an error-procing device or check fatues (@9., 90° no-go gausing) control plan documented description ofthe systems and processes requied for controting the manufacturing of product (see Annex A) customer requirements requirements specified by the customer (eg, technical, commercial, product and manufacturing process-elated requirements, gneral terms and conditions, csstome-pecif requirements, etc.) ‘customer specifi requirements (CSRs) Interpretations of or supplemental requirements inked to a specific clause(s) ofthis Automotive QMS. Standard design for assembly (OFA) ‘process by which products are designed with ease of assembly considerations, (e.g. Ha product ‘contains fewer parts wil ake lass time to assemble, thereby reducing assembly costs) design for manufacturing (OFM) Integration of product design and process planning to design a product that is easly and economically manufactured ‘management reviews (see 1SO 9001, Sacton 93) NOTE 1 These requirements shoul include the application of lean manufacturing principles. NOTE2 These requirements should apply o on-site supplier actives, as applicable, SAG, ©ANFIA OFEV, © SMT, © VDA~2016- Arges ane ” 7.14 Environment for the operation of processes ‘See ISO 9001:2018 requirements, NOTE Where third-party certification to ISO 45001 (or equivalent is recognizes it may be used to Sortonsrat he organization's Conformty othe personel safety aspects ofthis requirement 1444 Environment forthe operation of processes ~ supplermental “The organization shal maintain ts premises ina state of order, cleanliness, and repair thats consistent ‘withthe product and manufacturing process need 7.18 Monitoring and measuring resources ‘TASA General ‘See ISO 9001-2016 requirements 74.8.4.4 Measurement system analysis Statistical studes shal be conducted to analyse the variation present inthe resus ofeach type of inapecion. measurement, and test equipment system identified in he conto plan. The analytical fhetnods and acceptance cftela used shal conform to those in reference manuals on measurement [ystems analysis, Other analytical mathods and acceptance crterla may be used f approved by the customer. Records of customer acceptance of atemative methods shal be retaned along wit resuts fem ‘atemative measurement systems analysis (see Section 8.1.1.1). NOTE. Prioriization of MSA studies should focus on etical or special product or process Characters. 74.52 Measurement traceability ‘See 1S0 8001:2015 requirements, NOTE A number or another identifier traceable tothe device calloration record meets the intent ofthe Fequirements in ISO 9001208. 74.524 Calbrationverification records “The organization shall have a documented process for managing calbrationverifcation records. . Records ofthe catbraton/verficaion activ fr al gauges and measuring an test equipment (incuding fomployes-owned equipment relevant far measuring customer-owned equloment, or or-e Suppir- 2 OAAG, @ANEU, OFIEY, SMM, © A ~Z18 Ari ‘owned equipment) needed to provide evidence of conformity to intemal requirements, legislative and regulatory requirements, and customer defined requemants shal bereaved. “The organization shall ensue that calbration!veriicaton activites and records shall incude the following etal 2) revisions folowing engineering changes tht impact measurement systems; 1) any outo-speciicaton readings as received for callbraontverction; )_ an assessment ofthe risk of he Intended use ofthe product caused by the out ot speciication condition: 4) when a piece of nszecion measurement and tst equipments found to be out of ckbraion or defecve during its planned verification or calibration or during is use, documented Information fon the valisty of previous measurement resuts oblained with tis piece of inspection ‘measurement and ‘st equipment shal be retained, Including the associated standards lat ) competency ofthe laboratory personnel; ©) ‘testing ofthe product; 4) capabilty to perform these serdces comectl, traceable tothe relevant process standard (such as ASTM, EN, ete): when no national or international standard(s) Is avallable, the organization shall ‘define and implementa methodology to verty measurement system capabiliy: ©) customer requiements, if any; 1) reviow ofthe related records. NOTE Third-party accretion to ISO/IEC 17025 (or aquivalent) may be used to demonstrate the ‘xgenization’ in-house laboratory conformity to his requirement (©AAG, © ANFIA @ FE, ©'SMIMT.© VDA 2016 Alois eared a 74832 Extemal laboratory Extemalcommerialindependent laboratory facies used for inspection, tet, or calibration services by ‘he organization shall have a defined laboratory scope that includes the capably to perform the required Inspection, test, or calfbration, and ether. = the laboratory shall be accrodted to ISOVIEC 17026 or national equivalent and include the Telovantinepection, tes, of calbration service ia the scope ofthe acredtaion (cerca): the Cerificate of calibration o est epor shall include the mark of a national accrediation Body; oF = there shall be evidence thatthe extemal laboratory is acceptable to the customer. NOTE Such erence may be demonstrated by customer assessment, for example, or by customer- ‘approved secont-party assessment tha the laboratory meets the intent of ISO/IEC 17025 or national ‘Squvalent. The second-party assessment may be performed by the organization assessing the laboratory using a customer-approved method of assessment, CCalbration series may be performed bythe equipment manufacturer when 2 quaified laboratory isnot _avalable fora given piece of equipment. in such cases, the organization shall ensure thatthe ‘equirements listed in Socton 7-15 3.1 have boon met Use of calsration services, cer than by qualified (or customer accepted) laboratories, may be subject to ‘government regulatory confirmation, f required. 17:18 Organizational knowledge ‘See ISO 8001:2015 requirements, 72 Competence ‘S00 180 0001:2015 requirements. 7.21 Competesce - supplemental ‘The organizator shall estabish and maintain a documented processes) for identifying training needs including awareress (see Section 7.3.1) and achieving competence of al personnel performing activites aftecting confomty to product and process requirements. Personnel performing specific asigned tasks Shall be qualfec, a require, with parila tenon tothe satisfaction of customer requirements, 7.22 Competence on-theJob training “The organizaior shal provide on-the-job training (which shal Include customer requirements training) for personnel in any new or mediedresponsoliies afin conformity to qualty requements intra Fequrements, regulatory or legislative requirements; his shall include corract or agency personnel, The level of detal required for on-theob training shall be commensurate wth the level of education the ‘Personnel possess and the complexity of te Tasks) they are require 1 perform for ther cay wok. Persons whose work can affect quality shall be informed about the consequences of ronconformity fo ‘customer requirements » (GAAS, BANE. © FE, © SHAT, © VOA 2015 Alsgi 17.23 Internal auditor competency The organizaton shall have a documented process(es) overt that intemal audios are competent, {aking into account any customer-specc requrements, For exdtonel guidance se seatoy, ‘competencies refer o SO 19011. The organization shall maintain & fst of @uafiedinarsal auditors, Quality management system auctors, manufacturing process auditors. and product suitors shal all be {ble to demonstrate the folowing minimum competencies 4) understanding of the automotve process approach fr audting incuing Ysk-based thinking: )_ understanding of appicable customer-pecic requirements; 1 understanding of applicable ISO 8001 and IATF 16949 requrementsrlated tothe scope of the au; 8) undortanding of appcable core tool requirements related tothe scape ofthe audit; ©) understanding how o plan, conduct, report, and close out audit fincngs. ‘Additonaly, manufacturing process auditors shall demonstrate tachical understanding ofthe relevant ‘manufacturing process(es) tobe audited, including process rick analysis (such as PFMEA) and covet Where training provided to achieve competency, documented information shal be reiained to «demonstrate the trainers competency with the above requrement, Maintenance ofan improvementin intemal auditor competence shal be deronstated through: 1) executing a minimum number of suc per year, 8 defined bythe organization; and 9) Mabtsning knowledge of relevant requirements based on internal changes (e.g, process ‘technology, product technology) and extemal changes (eg, ISO 900, IATF 16949, core tools, land customer specie requirements). 7.24 Secondparty auditor competency The organizator shall demonstrate the competence of the auditors undertaking the secon: party aud, ‘Second-party austors shall met customer specific requirements for autor qualifstion ane ‘demonstrate the minimum folowing core competencies, incucing understanding of 8) ‘the automotive process approach fo audting, including sk based thinking; )_appicabe customer and organization specc requirements; ©) applicabie ISO 9001 and ATF 16949 requirement related to the scope of he aut 4). applicable manufacturing process(es) to be audited, including PFMEA end contrl plan; ©) applicable core tool requirements related to the scope ofthe auc; howto pan, conduct, prepare aust reports, and close out aut fncngs. GARG, ©ANFA © FEV, © SMT. @VOA 2018 Ah rca 2s 17.2 Awareness ‘See 1$0 9001:2018 requirements. “The organization shall maintain document information that demonstrates thatal employees are aware Of their impact on product quality and the Importance of ther scivites in achievng, maining, and ‘proving ually, Incuding customer requrements and the risks involved forthe customer with non- ‘conforming product. 7.2 Employee motivation and empowerment “The ongenzation shall maintain a documented process(es) to motivate employees to achieve qualty bjectves, to make continual improvements, and o create an environment thetpromotes innovation. The: process shal include the promotion of qual and technological awareness treughout the whole ‘organization. 7A Communication ‘G20 160 9001:2016 roquiements. 7.5 Documented information 7.5 General ‘See ISO 8001:2016 requirements. 7.81.4 Quality management system documentation “The organization's qualty management systom shall be documented and include a quabty manual, which canbe 8 series of documents (lecroic or hard copy) “The format and structure of the quality manual is at the iscraton ofthe organization and wil depend on tha organizations siz, culur, and comple. Ifa series of documents fs used, then 8 Iist shall be ‘retained of te documents that comprise the quality manual for the organization. “The quality manual shal Include, at minimum, te folowing: a 1b) documented processes established forthe quality management system, of reference to ther; ) the organization's processes and ther sequence and Interactions (puts and outputs). including type and extent of contol a any outsourced processes; . ©) a document (i2., mattx)Inlcting where win the organization's qualty management system ‘their customer-speciicrequements are addressed, 3m "@ AAG. © ANFIA CFE, © SMUT, VOR 2018 gh NOTE Amatix of how the requremerts ofthis Automotive MS standard are addressed by he ‘organizato's processes may be used '» assist wth Inkages of he organization's processes ad this ‘Automotive OMS, 7.82 Creating and updating ‘S2e ISO 8001:2018 requirements, 7.533 Control of documented information 7.83.4 and 7.532 ‘See IS 9001:2018 requrements 7.83.24 Record retention ‘The organization shal define, document, and implementa record tetenon paicy. The control of records ‘hall saisty statutory, regulatory, organizational, and custome requirements, length of ime thatthe products active fr production and service requirements, plus one elender year, Unless otherwise spect by the customer or regulatory agency. NOTE _ Production part approval documented information may indude approved product, applicable test ‘equipment records, or approved test data, 7.53.22 Engineesing specications ‘The organization shal have a documented process deserting the review, distbution, and implementation of all customer engineering standards/specieatons and related revisions based on ‘customer schedules, a required. ‘When an engineering standard/specication change resuts in a product design change, afr to tho Fequrements in 'SO 8001, Secon 8.3.6. When an engineering standardispectcaion change rests ina Review should be completed within 10 working days of receipt of ntificatlon of engineering standerds/speciicaion changes, NOTE A change n hese standards/specicaions may require an updated record of customer ‘roduction part approval when these specications are referenced on the design reson or f ty affect ‘documents ofthe production part approval process, such as convo plan, risk analysis (such ae FMEA), ee "AAG, ©ANFIA,OFEV,©'SUNT, © VOA 2018 Agha a 18 Operation ‘Operational planning anc control ‘See 180 900%:2015 requirements, 8.4.1 Operational planning and contro! — supplemental _Wnen panning for product realization, the following topics shal be include: 1) customer product requirements and technica specications; 1b) logis requirements: ‘©)- manufacturing feasbity: 4) project planning (refer to [SO 9001, Section 8.3.2) (9) acceptance ceri. “The resources identiled in SO 9001, Section 8.1), refer to the required verification, validation, ‘TRinfonng, mesturemont, Inspection, and tet activites speci tothe product and the ertera fr product acceptance, 84.2 Confidentiality Tne organization shal ensure the confidentiality of customer-contraced products and projets under ovelopment, including related produc information. 8.2 Requirements for products and services 8.21 Customer communication ‘See ISO 9001:2015 requirements. 82.1.1 Customer communication — supplemental \Witten or verbal communication shal be In the language agreed withthe customer, The organization shall hve the ably to communicate necessary information, including data in a custemer-speciied ‘Computer language and format 2.9, computer-aided design data electronic data interchange), {8.2.2 Determining the requirements for products and services ‘S06 160 9001:2018 requirments 20 (SAAG, @ANFIA,@FIEV, © SHIT, OOK 218 Abin 8.22.4 Determining the requirements for products and services - supplemental ‘These requires lal ictude racying, envronmentlimpac, and characteristics Wentifed as a result of the organization's knowledge ofthe product and manufacturing processes. Compliance to ISO 9001, Section 8.2.2 tem a) 1), shall include but not be lmted othe following all appicable goverment, safety, and environmental regulations related to acqustion, storage, nandtng, ‘ecycing, elimination, or disposal of mate 8.2.3 Review of the requirements for products and services 8234 ‘See ISO 8001:2015 requirement, 8.2.1.1 Review of the requirements for products and services — supplemental ‘The organization shall retin documented evidence of a customer-auhorized waiver forthe requiements sated in ISO 8001, Secton 82.1, fora formal review. 8.23.4.2 Customerdesignated special characteristics ‘The organization shall conform to customer requirements for designation, approval documentation, and control of special characteristics. 8.2.1.3 Organization manufacturing feasibility ‘The organization shall lize a multcscptinary approach to canduct an analysis to determine # tis feasbie that the organization's manufacturing processes are capable of consistantly producing product that meets al ofthe engineering and capacty requirements spectieg by the customer, The orenizaton Shall conduct his feasbilty analysis for any manufacturing or product tachnology new tote ceganizaton ‘and for any changed manufacturing process or product design. ‘Additonal, the organization should validate through production runs, benchmarking studies, or other ‘appropriate methods, their ably to make producto specications atthe required rate. e232 ‘See ISO 8001:2018 requirements. 8.24 Changes to requirements for products and services ‘See ISO 8001:2015 requirements, 8 Aiko, © ANTI, OEY, © SUIT, VOA~2018 ~ A his reset a 18.3 Design and development of products and services 8.3.1 General ‘See 180 9001:2016 requirements, 8.3:14 Design and development of products and services - supplemental “The equrements of $0 9001, Secton 0.21, shell apply to product and manufacturing process desion _and development and shall focus on eroe prevention rather than detection, “The organization shall document the desi and development process. 18.32 Design and development planning ‘See ISO 9001:2015 requirements. {8.2.2.1 Design and development planning - supplemental “The organization shall ensue that design and development planning includes al affected sakeholders ‘iin he organization and 2s appropriate, ks supply chain. Examples of areas for using Sich 2 Tmutiaisopinery approach nelude bu are not imled tothe following: 2) project management for example, APOP or VDA-RGA}, ) product and manufacturing process design activities (for example, OFM and DFA), such as ‘consideration ofthe use of alemative designs and manufacturing processes; ©) development and review of product design risk analysis (FMEAS), Including acions to educa potential sks; 8) development and review of manufacturing process risk analysis (or example, FMEAS, process: ‘owe, conrl plans, and standard work instructions). NOTE Armuliziscipinary approach typically includes the orgaization's design, manufacturing, ‘engineering, quaiy, production, purchasing, supple, maintenance, and olher appropriate functions, 83.22 Product design skills “The organization shal ensure that personnel wth product design responsiity re competent o achieve

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