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    IATF 16949'16 English

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    Bruna Carvalho

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    AUTOMOTIVE IATF 16949 QUALITY MANAGEMENT SYSTEM STANDARD Quality management system requirements for automotive production and relevant service parts organizations International Automotive Task Force 1 Edition 1 October 2016 JATF copyright notice This Automotive Quality Management System Standard, known as [ATF 16949, is copyright protected by the members ofthe intematonal Automotive Task Force (IATF). The tte for this Automotive OMS ‘Standard “IATF 16949" is a registered trademark ofthe IATF. Except as permitted under the applicable laws of the user's country, neither this Automotive Quality Management System Standard nor any extract from it may be reproduced, stored in a retneval sysiem or transmitted in any form or by any means, electronic, photocopying, recording or othermise, without prior written permission being secured from the IAT Reproduction may be subject to royalty payments ora licensing agreement and violators are subject to legal prosecution. Requests for permission to reproduce andlor translate any part of this Aulomotive QMS Standard should be addressed to one of the folowing national automotive trade associations below Associazione Nazionale Filiera Industie Automobilistche (ANFIA / Italy) Automotive Industry Action Group (AIAG / USA) Fédération des Industries des Equipements pour Véhicules (FIEV / France) ‘Society of Motor Manufacturers and Traders Ltd. (SMMT / UK) ‘Verband der Automobilindustne eV. (VDA / Germany) Table of Contents TARE OF CONTENTS ope eae FOREWORD — AUTOMOTIVE OMS STANDARD. STORY eee _ 0.1. GENERAL oe (0.2 QUALITY MANAGEMENT PRINCIPLES. 0.3 PROCESS APPROACH. 0.3.1. GENERAL roe (0.3.2 PLAN-D0-CHECK-ACT CYCLE sono (0.3.3 RISK:BASED THINKING occ snnnonnnninnnnn ar) (0.4 RELATIONSHIP WITH OTHER MANAGEMENT SYSTEM STANDARDS onsen 8 QUALITY MANAGEMENT SYSTEMS — REQUIREMENTS ee ° 2 ScoPE.. 2. NORMATIVE REFERENCES 2.1 NORMATIVE AND INFORMATIVE RETERENCES., 2. TERMS AND DEFINITIONS... 23.1 TERMS AND DEANTIONS FOR THE AUTOMOTIVE INDUSTRY sn ict act “4 CONTEXT OF THE ORGANIZATION {1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT, 4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES sou: {3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM. 43.3. Determining the scope ofthe quay management system — supplemental. a 23.2 Customenspecfic requirements, - 4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES... co 16 BA mt a 44.24 Contormance of products and processes sos sme 4AL2 Pred ft oneon enim mnie ce AD MAB cassis paste remiss suas 1 (@AIAG, BANA, © FIEY, © SUMT, © VDA~2016~Ai nants reserved 5 LEADERSHIP 5. LEADERSHIP AND COMRATTMENT. 5.1. GENERAL... o Dabd.t Comporate responsi winnie tii TS Sab. Processeffectveness and fen umn i i SH 3 POCESS OWNET natn sd 5.1.2 CUSTOMER FOCUS.. 52 POUCY nennenr '5.2:1 ESTABLISHING THE QUALITY POLICY. 5.2.2 COMMUNICATING THE QUALITY POLICY. ‘5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES... 53.1 Organizational ols, responsibitis, and authortes — supplement nun 5.3.2 Responsbity and author fr product requirements and corectve acon. © PLANNING.. 16.1. ACTIONS TO ADORESS RISKS AND OPPORTUNITIES. O..2 ANDO.L2. EERE. RC nonin se 6.1.22 Preventive 90h nnsnannsnnnn 631.23 Contingency pla nnn {6.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM. 6.2.1 AND 6.2.2 6.22.4 aualty objectives and planing to achieve them — supplemetal wn 16.3 PLANNING OF CHANGES oneness 7 SUPPORT nnn —_ i TA RESOURCES oo oennesinnnennsnnninennninninnninnnnte DL AA GENERAL ictasstsoaeet atime AY TAA PEOPLE nn £13 INFRASTRUCTURE... 7.13.3 Pan, facity, and equipment planning es 77:14 ENVIRONMENT FOR THE OPERATION OF PROCESSES ec oesmnesn 7h Ervonmant for the operation F process — SuppOM tl mm mnnnnmnnninnntnn BB 7.1.5 MONITORING AND MEASURING RESOURCES 22 745.4 GENERAL ~ a ne 7415.11 Measurement systems anal — ee ss 2 7.15.2 MEASUREMENT TRACEABILITY (SAG, ANFIA, © FEV, © SMMT. € VDA 2016 Al fonts roared 2 74.521. Calbratonerticaton records. 7453 Laboratory requirement. 7.532 Ieternal laboratory 7.1532. extemal laboratory. 74.6 ORGANIZATIONAL KNOWLEDGE sovesnsineonnitnsininnnsnnnininsinninnnie A 7.2 COMPETENCE sn 72:4 Competence — supplemental non 7.2.2 Competence — on-thejob training. 72.3 internal autor competeney.. 724 Second party usttor competency 7. AWARENESS... 73.4 Awareness — supplement nse 73.2 Employee motnation and empowerment. 7.4 COMMUNICATION css ws 28 7.5 DOCUMENTED INFORMATION cence eres 155A. GENERAL ssn 26 7.5.11. Quslty management system documentation. 7.52. CREATING AND UPDATING.. 75.3 CONTROL OF DOCUMENTED INFORMATION 753.1 AND 7.5.3.2 753.24 Record retention 733.22. Engineering specticatons 5 OPERATION. 8.1 OPERATIONAL PLANNING AND CONTRO 18.1 Operational planning and control — supplement nen B12 COM GaN. one {8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES. 8.2.1 CUSTOMER COMMUNICATION... {82.1.1 Customer communication — supplemental 8.2.2 DETERMINING THE REQUIREMENTS FOR PRODUCTS ANO SERVICES. 182.2: Determining the requirements for products and services — supplemental 8.2.3 REVIEW OF THE REQUIREMENTS FOR PRODUCTS AND SERVICES onan aaa. {8.23.11 Revow ofthe requrament for products and services — supplemantal (822.12 Cuomer-desated specs characters. {8.2.1.3 Organization manufacturing fessioity 2.32. 3 (© AJAG.© ANFIA © FEV, © SMMAT.© VDA ~2016 Al mots resonod 8.2.4 CHANGES TO REQUIREMENTS FOR PRODUCTS AND SERVICES, {8.3 DESIGN AND DEVELOPMENT OF PRODLICTS AND SERVICES. 8.3.1 GENERAL. {5.3.14 Design and development of products and sances Supplement eunninnnniininnnnnnnin 0 8.3.2 DESIGN AND DEVELOPMENT PLANNING {83.2.1 Design and development planning — Supplemental annnonnnnnanininninnnnnte 30 ‘8522 Prot beren SiR iinet OD 183.23 Development of products with bedded SORWA!® vn nnnnnnnnnitnannnn 3D 8.3.3 DESIGN AND DEVELOPMENT INPUTS. 183.2: Prost design npat su at 183.32 Manufacturing process designinput cn oo en 83.33 Special characteristics sae ian atc 32 DESIGN AND DEVELOPMENT CONTROLS. 834A. Monitoring enn 183.42 Design and development valaton 83.4.3 Prototype progamme.. 183.44 Product approval proces 8.3.5 DESIGN AND DEVELOPMENT OUTPUTS. son {83.51 Design and development outputs — SuppleMEMtA wanna 38 {83.5.2 Monifaturing process desi OU nner 38 8.3.6 DESIGN AND DEVELOPMENT CHANGES.. 83.6: Design and velopment changes — supplement cen ce 8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES. 8.4.1 GENERAL. 8.4.1.1 General — supplemental 8.4.1.2 Supple selection frOCES nun nnnanns B41. Customer directed sources (60 moun 85 "DFECEE BUY nnn nner 8.4.2 TYPE AND EXTENT OF CONTROL... 342.1 Typeand extent of control — supplemental a : ilaeeah 18422 Statutory and regulatory requirements en = co 3B {84.2.3 Suppter quality management system JevelODMEN nvm nnn nnennentetnnn 38 342.11 Automotive procuct-elated softwar or automotive products with embedded software. 38 8424 Suppler MONON enrrennennnnnnin eaten BT 8.42.1 Second pany aud 8.425 Supper development 8.4.3 INFORMATION FOR EXTERNAL PROVIDERS.. 8.4.3.1 tnformation fr external providers —supplemetal cnet 8 {8.5 PRODUCTION AND SERVICE PROVISION. 8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION. OAIAG, OANFIA € FEV, © SMMT,©VDA-2016— Al rigs reserved 4 85.1.1 Conte! £5112 Starred work operator instructions ad val stand. £85.13 Verification of ob set-ups. nn 7 25.14 Verticatonafter shutdown... 83.15 Total productive maintenance. at asis stomped minis erg iepaton cel aat a 85.17 Production shedding nnn {8.5.2 IDENTIFICATION AND TRACEABIUTY ou 85.2. Wentieaton and raceabty — supplemental 15.2 PROPERTY BELONGING TO CUSTOMERS OR EXTERNAL PROVIDERS... sn 8.5.4 PRESERVATION... {85.4.1 Presenation — supplemental. 85.5 POST-DELIVERY ACTIVITIES ns 85.5.1 Feedback of formation from serdot nn 85.5.2 Service ageemert uth customer. 8.5.6 CONTROL OF CHANGES 85.63 Control of changes — supplemental. {85.6.1 Temporary change of process controls. 8.6 RELEASE OF PRODUCTS AND SERVICES. 186.1 Release of products and services — supplemental 126.2 Loyout inspection and functional sting ac 8.6.3 AppEOrONCE eM enone {26.4 Verification nd acceptance of conformity of external provided products and services. 186.5 Statutory and regulatory conform. 86.6 Acceptance criteria 8.7 CONTROL OF NONCONFORMING OUTPUTS a it 87.1.1 Customer autheraton fo conee0 een ee oA a7a2 Coot roanomrg pot — cna paid ces ne cA 87.1.3 Contolof suspect produ. nnn = 6 87.1.8 Control of reworked product, A 87.15 Contol of repaired product. 26 874.5 Customer notification een non a 87.17 Norconoring rod dopstion. a 72 9 PERFORRMANCE EVALUATION, AT 9.4 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION een? 9.2.1 GENERAL.. 9.1.41 Montonrg and measurement of manufacturing processes. 9.1.12 Wenttiatlon of sancteal toc. ' 5 @ AIAG, @ANFA, ® FEV, @ MMT. VOA ~ 2016 Al maha reseed 9.1.13 Appleationo statistical CONCEP nennnennnn 9.1.2 CUSTOMER SATISFACTION... 24.2.1 Customer satisfaction — supeementa. 9.1.3, ANALYSIS AND EVALUATION wns 9.2.31 Prontaton 9.2 INTERNAL AUDIT... 9.2.1 AND 9.2 9.2.2.1 tnteral aud programe enn 9222 Qualty management sctem au... 9.223 Manufacturing process Btu 5 9224 Product aud co cn on = 9.3. MANAGEMENT REVIEW oon rai ari 9.2.1 GENERAL. 93.2.1 Managerent review — supplemental 9.3.2 MANAGEMENT REVIEW INPUTS .cec ce =e 93.2.1 Managerent review inputs — supplemental. . 9.3.3. MANAGEMENT REVIEW OUTPUTS. . {93.3.1 Management review outputs — supplemental nannies 10 IMPROVEMENT 10.1 GENERAL... 10.2 NONCONFORMITY AND CORRECTIVE ACTION... 10.2.1 aND 102.2 10.23 problem solving. 10.24 Error proofing 402.5 waranty management stem 302.6 Customer complains an el alice tes rays. 40. CONTINUAL IMPROVEMENT . 10.3.1 Continual improvement — supplement ne ANNEX A: CONTROL PLAN ALL PRASES OFTHE CONTROLPLAN 2. ELEMENTSOF THE CONTROLPLAN “ANNEX ILOGRAPHY ~ SUPPLEMENTAL AUTOMOTIVE. AIG. @ANFA.@FIEV, 8 SMUT, € VDA~2018—Allngnts eserves 6 Foreword — Automotive QMS Standard ‘This Automotive Quality Management System Standard, herein referred to as “Automotive GMS Standard” or "IATF 16949,” along with applicable automotive customer-specific requirements, ISO ‘9001-2015 requirements, and ISO 9000°2015 defines the fundamental quality management system ‘requirements for automotive production and relevant service parts organizations. As such, this ‘Aulomiotve QMS Standard cannot be considered a stand-alone OMS Standard but has to be comprehended as a supplement to and used in eanjuncton with ISO 9001:2015. ISO 9001-2015 is published as a separate ISO Standard LATE 16949-2016 (1st ection) represents an innovative document, given the strong orientation to the customer, with inclusion of a number of consolidated previous customer specific requirements, ‘Annex B is provided for guidance to implement the [ATF 16949 requirements unless otherwise specified by customer specific requirements. History ISO/TS 16949 (1st ection) was orignaly created in 1999 by the Intemational Automotive Task Force (ATE) withthe aim of harmonizing the diferent assessment and certfcation systems worldwide inthe supply chain forthe aulomotve sector. Other revisions were created (2nd editon n 2002, and Srd edition in 2008) as necessary for either automobve sector enhancements or SO 8001 revisions. ISO/TS 18849 {along with supporting technical publications developed by orginal equipment manufacturers (herein {eferred to as OEMs] and the natonal aulomotive trade associabons) inoduced a common set of techniques and methods for common product and process devetoprnent for automotve manufacturing worldwide In preparation for migrating from ISO/TS 169422009 (3rd edition) to this Automotive OMS Standard, ATF 16949, feedback was sobcited from certfication bodies, auditors, suppliers, and OEMs to create ATF 16949.2016 (1st eaiton), which cancels and replaces ISO/TS 16948.2008 (2rd edition). The IATF maintains strong cooperation with ISO by continuing liaison committee status ensuring continued alignment wih ISO 9001, Goal “The goal ofthis Automotve OMS standard s the development of a quality management system that ‘provides for continual improvement, emphasizing defect prevention and the reduction of variation and. waste in the supply chain, , AIAG, © ANFIA, © FEV, @ SMT, @ VDA 2018 Al nght eserves Remarks for certification Requirements for cerfication to this Automotive QMS Standard are defined in the Rules for achieving ‘and maintaining IATF recognition, Details can be obtained from the local Oversight Offces of the IATF cited below: Associazione Nazionale Fiera Industie Automobilstiche (ANFIA) Web site: wwiw.anfia i e-mail: anfia@anfia it Intemational Automotive Oversight Bureau ((AOB) Web site: www iaob og e-mail: iat 1694feedback@iaob org IATE France Web site: www iatffrance.com e-mail. ati@iatlfrance com Society of Motor Manufacturers and Traders Ltd. (SMMT Ltd) Web site: wnw.smmtoversightco.uk e-mail: iatf16949@smmtco uk ‘Verband der Automobilindustrie ~ Qualitats Management Center (VDA QMC) Web site: www. vdagme de e-mail: info@vda-qme de {All public information about the IATF can be found at the IATF website: www iatfglobaloversight ora (© AIAG, @ ANFIA, © FIEV, © SNOUT, OVDA— 2016 Al hts esenea Introduction 04 General ‘See 1S0 9001-2016 requirements 0.2 Quality management principles ‘See 1S0 9001-2015 requirements 0.3 Process approach 0.34 General ‘See 1S0 9001-2016 requirements 0.3.2 Plan-Do-Check-Aet eycle ‘See 1S0 9001-2015 requirements 0.33 Risk-based thinking ‘See 180 9001-2016 requirements (0.4 Relationship with other management system standards ‘See 1S0 8001-2015 requirements Quality management systems — Requirements. 1 Scope ‘See 180 9001-2015 requirements 1.4. Scope ~ automotive supplemental to 180 9001:2015 This Automotive QMS Standard defines the quality management system requirements for the design and development, production and, when relevant, assembiy, instalation, and services of automotve-related ‘Products, including produets with embedded software. ‘This Automotive GMS Standard is applicable to sites ofthe organization where manufacturing of customer-specifed production parts, service parts, and/or accessory parts occur. This Automotive QMS Standard should be applied throughout the automotive supply chain ° AIG © ANFIA, OFIEV,@ SMNT, @VDA- 2016 Al igh resend 2 Normative references ‘See 180 900122015 requirements 2.1 Normative and informative references ‘Annex A (Control Plan) is a normative part ofthis Automotive GMS standard. Annex B (Bibliography — automotive supplemental) is informative, which provides addtional informaton Intended to assist he understanding or use ofthis Automative GMS standard, 8 Terms and definitions ‘See 180 9001-2015 requirements 3.1. Terms and definitions for the automotive industry ‘accessory part customer specified additonal component(s) that are either mectianically or electronically connected to the vehicle oF powertrain before (or after) deivery to the final customer (e.g., custom ficor mats, truck bed liners, wheel covers, sound system enhancements, sunroofs, spoilers, super-chargers, et.) ‘advanced product quality planning (APP) product quality planving process that supports development of a product or service that will satisfy Customer requirements; APOP serves as a quide i the development process and also a standard way to share results between organizations and their customers; APQP covers design robustness, design testing and specification compliance, production process design, qualify inspection standards, process Capability, production capacity, product packaging, product testing and operator training plan, among other items aftermarket part replacement part(s) not procured or released by an OEM for service part applications, which may or ‘may not be produced to onginal equipment specifications ‘authorization documented permission for a person(s) specifying rights and responsibiliies related to giving or denying permissions or sanctions within an organization SAG, @ANFIA, FIEV, © SIMMT, VDA 2016 Al gts e8erV2 10 “ challenge (master) part part(s) of known specification, calibrated and traceable to standards, with expected results (pass or fail) that are used to validate the functonalty of an eor-procfing device or check fixtures (2.0, 90 / ‘no-go gauging) control plan ‘documented descripton of the systems and processes required for controling the manufacturing of product (see Annex A) ‘customer requirements all requirements specified by the customer (e.g, technical, commercial, product and manufacturing rocess-telated requirements, general terms and conditions, customer-specific requirements, et.) ‘customer-specific requirements (CSRs) Interpretations of or supplemental requirements linked to a specific clause{s) of this Automotive OMS Standard ‘design for assembly (DFA) process by which products are designed with ease of assembly considerations. (e.9,, if a product ‘contains fewer parts it wil take less time to assemble, thereby reducing assembly costs) design for manufacturing (OFM) integration of product design and process planning to design a product that's easily and economically manufactured design for manufacturing and assembly (DFMA) ‘combination of two methodologies: Design for Manufacture (OFM), which is the process of optimizing the design to be easier to produce, have higher throughput, and improved quality; and Design for Assembly (OFA), which is the optimization ofthe design to reduce risk of ertor, lowering costs, and making it easier to assemble AIAG, OANFIA, © FEV, © SMMT, @VDA~ 2016 Al igisresewed design for six sigma (DFSS) systematic methodology, tools, and techniques with the aim of being a robust design of products or processes that meets customer expectations and can be produced at a six sigma quality level design-responsible organization ‘organization with authonty to establish a new, or change an existing, product specification NOTE This responsibilty includes testing and verifeation of design performance within the customer's specified application, ‘error proofing product and manufacturing process design and development to prevent manufacture of nonconforming products ‘escalation process process used to highlight or flag certain issues within an organization so that the appropriate personnel can respond to these situations and monitor the resolutions fault tree analysis (FTA) deductive fale analysis methodology in which an undesired state of a system is analysed; fault tree analysis maps the relationship between faults, subsystems, and redundant design elements by creating a logic diagram of the averall system laboratory facility for inspecton, test, or calibration that may include but is not limited to the folowing: chemical, metallurgical, dimensional, physical, electncal, or reliability testing laboratory scope controled doc ument containing = specific tests, evaluations, and calibrations that a laboratory is qualified to perform; ~ _alistofthe equipment that the laboratory uses to perform the above; and ~ alist of methods and standards to which the laboratory performs the above (©.AIAG @ANFIA,@ FEV, OSMOMT, @VDA~ 2016 Al ights reserved 2 manufacturing. process of making or fabricating production materials; production parts or seviee parts ~ assemblies; oF heat treating, welding, painting, plating, or other fishing services manufacturing feasibility ‘an analysis and evaluation of @ proposed project to determine if it is technically feasible to rmanufactufe the product to mest customer requirements. This includes but is not limited to the following (as applicable). within the estimated costs, and ifthe necessary resources, facies, tooling, capacity, software, and personnel with required skils, including support functions, are or are planned tobe available manufacturing services companies that test, manufacture, distribute, and provide repair services for components and assemblies ‘multi-disciplinary approach ‘method to capture input from all interested parties who may infuence how a process is administered by a team whese members include personnel from the organization and may include customer and supplier representatives; team members may be intemal or external to the orgarizaton; either existing teams or ad hoc teams may be used as circumstances warrant; input to the team may include both organization and customer inputs ‘no trouble found (NTF) designation applied to a part replaced during a service event that, when analysed by the vehicle or parts manufactuter, meets all the requtements of a “good part (also referred to as “No Fauit Found” oF "Trouble Not Found") ‘outsourced process portion of an organization's function (or provesses) that is performed by an external organization, (©AAG,© ANFIA, © FIEV, © SIT, © VDA 2016 Aros vesonod periodie overhaul maintenance methodology to prevent a major unplanned breakdown where, based on fault or interruption history, a piece of equipment, or subsystem of the equipment, is proactvely taken out of service and disassembled, repaired, parts replaced, reassembled, and then retuimed to service predictive maintenance ‘an approach and set of techniques to evaluate the concliion of in-service equipment by performing periodic or continuous monitoring of equipment conditions, in order to predict when maintenance should be performed premium freight ‘extra costs or charges incurred in addktion to contracted delivery NOTE This can be caused by method, quantity, unscheduled or late deliveries, etc Preventive maintenance Planned activities at regular intervals (Ume-based, periodic inspection, and ovettiau) to eliminate ‘causes of equipment failure and unscheduled interruptions to production, 2s an output of the ‘manufacturing process design product applies to any intended output resulting from the product realization process product safety standards relating to the design and manufacturing of products to ensure they do not represent harm ‘or hazards to customers production shutdown cconditon where manufacturing processes are idle; time span may be a few hours toa few months reaction plan _acton or series of steps prescribed in a contro plan in the event abnormal or nonconforming events are detected ‘© AIG, CANFA © FEV, @ SMMT, © VDA 2016 At gts reseed 1“ remote location location that supports manufacturing sites and at which non-production processes occur service part replacement part(s) manufactured to OEM specifications that are procured or released by the OEM for ‘service part applications, including remanufactured parts site Jocation at which value-added manufacturing processes occur ‘special characteristic classification of a product charactetistc or manufacturing process parameter that can affect safety or compliance with regulations, ft, funeton, perfomance, requirements, or subsequent processing of product special status notfication of a customer identfied classification assigned 1o an organization where one oF more: ‘customer requirements are not being satisfied due toa significant quality or delivery issue ‘support function on-production activity (conducted on site of at a remote location) that supports one (or more) manufacturing sites ofthe same organization total productive maintenance system of maintaining and improving the integrity of production and quality systems through machines, equipment, processes, and employees that add value to the organization trade-off curves, tool to understand and communicate the relationship of various design characterists of a product to ‘each other; a product's performance on one charactensbe 's mapped on the Y-axis and another on the x-axis, then a curve is plotted to ilustrate product performance relative o the two characteristics AIAG, OANFIA, © FEV, © SMM, @ VOA~2016— Alot resend trade-off process, methodology of developing and using trade-off curves for products and their performance characteristics that establish the customer, technical, and economic relatonship between design aliematives 4 Context of the organization 4.4 Understanding the organization and its context ‘See 1S0 9007-2015 requirements 4.2 Understanding the needs and expectations of interested parties See 1S0 9001:2015 requirements 43 Determining the scope of the quality management system See ISO 9001:2015 requirements. 43.1 Determining the scope of the quality management system — supplemental ‘Supporting functions, whether on-site or remote (such a5 design centres, corporate headquarters, and distibution cenises), shall be included in the scope of the Quality Management System (QMS). The only permitied exclusion for this Automotive QMS Standard relates to the product design and development requirements within ISO 9001, Section 8.3. The exclusion shall be justfled and maintained ‘as documented information (see ISO 9001, Section 7.5). Permitted exclusions do not include manufacturing process design, 43.2 Customer-specific requirements ‘Gustomer-speciti requirements shall be evaluated and included inthe scope ofthe organizatbon’s quality management system. 4.4 Quality management system and its processes, 44a See 1S0 9001-2016 requirements (©.AIAG, © ANFA, © FIEY, © SNRAT. © VDA 2016 At ign rosorved 6 441.4 Conformance of products and processes “The organization shall ensure conformance of al products and processes, including service parts and those that are outsourced, to all applicable customer, statutory, and regulatory requirements (see Section 8422). 4412 Product safety “The organization shall have documented processes for the management of product-safety related products and manufacturing processes, which shall include but not be limited tothe following, where applicable. )_identfication by the organization of statutory and regulatory product-safety requirements; bb). customer notification of requirements in item a); ©) special approvals for design FMEA; 4d) identification of product safety-related charactersstes, ©) identification and controls of safety-elated characteristics of product and at the point of ‘manufacture; )_spocial approval of control plans and process FIMEAS; 9) reaction plans (see Section 9.1.1.1); hh) defined responsibiities, definition of escalation process and flow of information, including top ‘management, and customer notficabon; |) training identified by the organization or customer for personnel involved in product safety related products and associated manufacturing processes; |) changes of product or process shall be approved prior o implementation, including evaluation of potential effects on product safety from process and product changes (see ISO 9001, Section 836); ky) transfer of requirements with regard to product safety throughout the supply chain, including customer-designated sources (see Section 8.4.3.1), product traceability by manufactured lot (at a minimum) throughout the supply chain (see Section 8521), rm) lessons leamed for new product introduction NOTE: Special approval is an additonal approval by the function (ypicaly he customer) thats responsible fo approve such documents with safety-related content. 442 ‘See 180 9001-2015 requirements w (@AIAG, BANA, © FIEY, © SUMT, 6 VDA~2016—Ai nants reserved 8 Leadership 8.4 Leadership and commitment S44 General See ISO 9007-2018 requirements. 5.1.1.1 Corporate responsibitity The organization shall define and implement corporate responsibility palicies, including at a minimum an ant-bnbery policy, an employee code of conduct, and an ettues escalation palicy (whisle-biowing policy). 5.1.1.2 Process effectiveness and efficiency ‘Top management shall review the product realization processes and support processes to evaluate and Improve thesr effectiveness and efficiency. The results of the process review actvties shall be mcluded. as input to the management review (see Section 9.3.2.1.) 5.4.1.3 Process owners “Top management shall identify process owners who are responsible for managing the organization's processes and related outputs. Process owners shall understand their roles and be competent to perfoc those roles (see ISO 9001, Section 7-2). 5.1.2 Customer focus See ISO 9001:2016 requirements 5.2 Policy 5.2.1 Establishing the quality policy See ISO 9001:2016 requirements. 5.2.2 Communicating the quality policy See ISO 9001.2016 requirements 5.3 Organizational roles, responsibilities and authorities, See ISO 8001-2015 requirements 5.3.1 Organizational roles, responsibilities, and authorities — supplemental ‘Top management shall assign personne! with the responsibity and authority to ensure that customer equirements are met. These assignments shall be documented, This includes but isnot limited to the selection of special characteristics, setting quality objectives and related traning, comectve and ©AIAG,O ANAA OEY, ¢ SMT, ©VDA 2016 Alsons resend 1 preventive actions, product design and development, capacity analysis, agisties information, custamer ‘Scorecards, and customer portals. 45.3.2 Responsibility and authority for product requirements and corrective actions “Top management shall ensure that: ‘2)_ personnel responsible for conformity to product requirements have the authority o stop shipment ‘and stop production to correct quality problems; NOTE Due to the process design in some industries, it might not always be possible to stop production immediately. In this case, the affected batch must be contained and shipment to the ‘customer prevented ») personne! with authority and responsibilty for corrective action are promptly informed of products fr processes that do not conform to requirements to ensure that nonconforming product is not ‘shipped to the customer and that all potential nonconforming product is identified and contained, ©) production operations across all shifts are staffed with personnel in charge of, or delegated responsibilty for, ensuring conformity to product requirements. 6 Planning 6.1 Aetions to address risks and opportunities, BAA and 6.4.2 ‘See ISO 90012015 requirements. 6.1.2.1 Risk analysis The organization shall include in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field retums and repairs, complaints, scrap, and rework. ‘The organization shall retain documented information as evidence of the results of sk analysis, 6.1.2.2 Preventive action ‘The organizaton shall determine and implement action(s) to eliminate the eauses of patental ‘nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the seventy of the potential issues. ‘The organization shall establish a process to lessen the impact of negative effects of risk including the folowing: 2), determining potential nonconformities and their causes; evaluating the need for action to prevent cecurrence of noneonforites, {)_ determining and implementing action needed; ©) documented information of action taken; 19 (SNAG, @ ANF © FEV, @SYMMT. @ VDA 2016~ Al ons reserved 2). reviewing the effectiveness of the preventive action taken; 1) tilzing lessons leamed to prevent recurrence in similar processes (see ISO 9001, Section 7.1.8). 6.1.23 Contingency plans ‘The organization shal: ‘) identfy and evaluate intemal and extemal risks to all manufacturing processes and infrastructure equipment essential to maintain production output and to ensure that customer requirements are met, ')_ define contingency plans according o risk and impact to the customer; €) prepare contingency plans for continuity of supply in the event of any of the following: key Squlpment:llises Gist see, Settlon 8.5 5.11), eemuiion fom Sxemaly provided products; processes, and services; recurring natural disasters; fre; ublity inleruptions; labour shortages, or infrastructure disruptions; 4d) include, as a supplement fo the contingency plans, @ notification process to the customer and other interested parties for the extent and duration of any situation impacting customer operabons; ©) periodically test the contingency plans for effectiveness (e.g, simulations, as appropriate); 1) conduct confngency plan reviews (at @ minimum annually) using a mulidisciplinary team including top management, and update as required; 9) document the contingency plans and retain documented information descriting any revision(s), Including the person(s) who authonzed the change(s) The contingency plans shail include provisions to validate that the manufactured product continues to meet customer specificatons after the re-start of producton following an emergency in which production Was stopped and i the regular shutdown processes were not followed 6.2 Quality objectives and planning to achieve them 8.24 and 6.2.2 ‘See 1S0 9001-2016 requirements, 6.22.1 Quality objectives and planning to achieve them — supplemental ‘Top management shall ensure that quality objectives to meet customer requitements are defined, ‘established, and maintained for relevant functons, processes, and levels throughout the arganizatton. “The results of the organization's review regarding interested parties and their relevant requirements shal bbe considered when the organization establishes its annual (at a minimum) quality objectives and related performance targets (internal and extemal) AIG, @ANFIA, CFIEV, ©SMIMT, © VDA 2016 Al ints eseved 2» 633 Planning of changes See ISO 9001:2015 requirements 7 Support 7A Resources TAA General ‘See 10 9001:2015 requirements. 74.2 People ‘See 1S0 9001:2015 requirements. 74.3 Infrastructure See 1SO 901.2018 requitements 7.1.3.4 Plant, facitty, and equipment planning ‘The organization shail use a muitdisciplinary approach including risk identification and risk mitigation methods for developing and improving plant, facility, and equipment plans. In designing plant layouts, the ‘organization shal 3) optimize material flow, material handling, and value-added use of floor space including control of rronconforring product, and ) faciitate synchronous material fow, as applicable. Methods shall be developed and implemented to evaluate manufacturing feasibility for new product of ‘new operations. Manufacturing feasiolity assessments shall include capacity planning, These metnods shall also be applicable for evaluating proposed changes to existing operations. ‘The organization shail maintain process effectiveness, including periodic re-evaluation relative to nsk, to incorporate any changes made during process approval, contrl plan maintenance (see Section 8.5.1.1), ‘and verfication of job set-ups (see Section 8.5.1.3) ‘Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to imianagement reviews (see ISO 2001, Secton 9.3) NOTE 1 These requirements should include the application of lean manufacturing principles. NOTE2 These requirements should apply to on-site supplier activites, as applicable. a CAING, OANFLA, ©FIEV, © SMMT, ©VDA 2016 A age resowo 7.1.4 Environment for the operation of processes See 1S 9001:2015 requirements NOTE Where third-party certification to ISO 45001 (or equivalent) is recognized, it may be used to demonstrate the organization's conformity to the personnel safely aspects of this requirement z 1 Environment for the operation of processes — supplemental ‘The erganization shall maintain its premises in a state of arder, cleanliness, and repair thats consistent with the product and manufacturing process needs. 7.4.5 Monitoring and measuring resources: ABA General See ISO 9001:2015 requirements 7ADA4 Measurement systems analysis Statistcal stucies shall be conducted to analyse the variation present in the results of each type of Inspection, measurement, and test equipment system identified in the control plan. The analytical methods and acceptance enteria used shall conform to those in reference manuals on measurement systems analys's. Other analytical methods and acceptance enteria may be used if approved by the customer. Recards of customer acceptance of alternative methods shall be retained along with results from alternative measurement systems analysis (see Section 9.1.1.1) NOTE _Priritzation of MSA studies should focus on critical or special product or process charactensties. 74.8.2 Measurement traceability See 180 9001-2015 requirements. NOTE _A number or another identifier traceable tothe device calibration record meets the intent of the requirements in ISO 90012015, 7.15241 Calibration/verification records The organization shall have a documented process for managing calibration/veriication records, Records ofthe calibraionvenifcation activity for all gauges and measuring and test equipment (including ‘employee-owned equipment relevant for measunng, customer-ouned equipment, or on-site suppler- (©.AIAG, © ANFA.© FEV, © SHIT. @VOA 2016 — Argh raserved 2 ‘owned equipment) needed to provide evidence of conformity to internal requirements, legistative and regulatory requirements, and customer defined requirements shall be retained. The organization shall ensure that calibration verification activites and records shall include the following details revisions following engineering changes that impact measurement systems; )_any out-of specification readings as received for calibrationverifcation; ©) an assessment of the risk of the intended use of the product caused by the out-of specification condition; d) when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned verifcaton or calibration of during is use, documented information fon the validity of previous measurement results obtained with this piece of inspection measurement and test equipment shall be retained, including the associated standard’s last calibration date and the next due date on the calibration report, €)_ottication to the customer i suspect product or material has been shipped; £) statements of conformity to specification after calibration/verfication, 9) verfication that the software version used for product and process controls as specified; hh) records of the calibration and maintenance activites for all gauging (including employee-owned equipment, customer-owned equipment, of on-site supplier-owned equipment), j)_production-related software verification used for product and process control (including software installed on employee-owned equipment, customer-owned equipment, or on-site suppiier-owned ‘equipment. 7483 Laboratory requirements 7.1.6.3.1 Intems! laboratory ‘An organization's intemal laboratory facil shall have a defined scope thatincludes its capability to perform the required inspection, fest, or calibration services. This laboratory scope shall be included in ‘the quality management system documentation, The laboratory shall specify and implement, as a ‘minimum, requirements for. a) adequacy of the laboratory technical procedures; b)_ competency of the laboratory personnel €) testing of te product, d)_capabilly to perform these services correctly, traceable to the relevant process standard (such as ‘ASTM, EN, eft ); when no national or intemational standard(s)'s avaiable, the organization shall {define and implement 2 methodology to venfy measurement system capabilty; €) customer requirements, if any; 1) rewew of the related records. NOTE Third-party accreditation to ISO/IEC 17025 (or equivalent) may be used to demonstrate the ‘organizabon's in-house laboratory conformity to this requirement. 2 (© AIAG. @ ANFIA, © FEV, © SMMT. @ VOA—2016~ Al ghis reserved 74832 External laboratory Extemal/commercialindependent laboratory facilities used for inspecton, test, or calibration services by the organization shall have a defined laboratory scope that includes the Capability to perform the required Inspection, test, or calibration, and either — the laboratory shal be accredited to ISO/IEC 17026 or national equivalent and include the relevant inspection, tes, or calibration service in the scope of the accreditation (certificate); the certificate of calibration or test report shall include the matk of a national accreditation body; oF — there shall be eviience that the extemal laboratory is acceptable to the customer. NOTE Such evidence may be demonstrated by customer assessment, for example, or by customer- approved second-party assessment thatthe laboratory meets the intent of ISOIEC 17025 or natonal equivalent. The second-party assessment may be performed by the organization assessing the laboratory using a customer-approved method of assessment. Calibration services may be performed by the equipment manufacturer when a qualifed laboratory is not avaiable for a given piece of equipment. In such cases, the organczabon shall ensure that the requirements listed in Section 7.16 3.1 have been met Use of calibration services, otter than by qualified (or customer accepted) laboratories, may be subject 10 government regulatory confirmation, f required. 7.4.8 Organizational knowledge See 150 90012018 requirements 7.2 Competence See 1S0 9001-2015 requirements 72.1 Competence — supplemental The organization shall establish and maintain a documented process(es) for identifying training needs including awareness (see Section 7.3.1) and achieving competence of al personnel performing activites affecting conformity to product and process requirements. Personnel performing specific assigned tasks shal be qualified, as required, with paricular attention tothe satisfaction of customer requirements 7.22 Competence — on-thejob taining ‘The organization shall provide on-the-job training (which shall include customer requirements training) for personnel in any new or modifed responsiblifes affecting conformity to quality requirements, intemal ‘equirements, regulatory or legislative requirements; ths shall include contract or agency personnel. The level of detal requited for on-the.jb training shall be commensurate withthe level of education the personnel possess and tne complexity of the task(s) they are required to perform for their daily work. Persons whose work ean affect quay shall be informed about the consequences of nonconformity to customer requirements. (© AAG, BANFIA, © FEY, @ SMT, @VDA~ 2016 — Al ights reserves 2 7.23 Internal auditor competency ‘The organization shall have a documented process(es) o verify that intemal aucitors are competent, taking into account any customer-specifc requirements. For additonal guidance on auditor competencies, refer to ISO 19011. The organization shall maintain a list of qualified intenal auchtors. {Quality management system aucitors, manufacturing process auditors, and product auditors shall all be able 10 demonstrate the folowing minimum competencies: )_ understanding ofthe automotive process approach for auditing, including risk-based thinking; )_ understanding of applicable customer specific requirements; €) understanding of applieable ISO 9001 and IATF 16949 requirements related to the scope of the audit,

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