AUTOMOTIVE ATF 16949 QUALITY MANAGEMENT SYSTEM STANDARD Quality management system requirements for automotive production and relevant service parts organizations International Automotive Task Force 1" Edition 1 Octaber 2016IATE copyright notice This Automotive Quality Management System Standard, known as IATF 16949, is copyright protected by the members ofthe Intemational Automotive Task Force (IATF). The tile fer this Automotive QMS. Standard “ATF 16249" isa registered trademark of the 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 retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, without prior ‘wnitten permission being secured from the [ATF Reproduction may be subject to royalty payments or a licensing agreement and violators are subject to legal prosecution Requests for permission to reproduce andlor translate any part of this Automotive QMS Standard should be addressed to one of the folowing national automobve trade associations below: Associazione Nazionale Filiera Industne Automobilistche (ANFIA / Italy) ‘Automotive Industry Action Group (AIAG / USA) Fédération des Industries des Equipements pour Vehicules (FIEV / France) Society of Motor Manufacturers and Traders Ltd. (SMMT / UK) ‘Verband der Automobilindustrie € V. (VDA Germany) Table of Contents FOREWORD ~ AUTOMOTIVE GMs STANDARD, HisToRY.. REMARKS FOR CERTIFICATION. (0.2 QUALITY MANAGEMENT PRINCIPLE. 0.3.4 GENERAL. (0.3.3 RISK BASED THINKIN ‘QUALITY MANAGEMENT SYSTENS — REQUIREMENTS. 1 score 2 NORMATIVE REFERENCES .2.3 NORMATIVE AND INFORWATIVE REFERENCES smn 10 23.1 TERMS ANOOEFINTIONS FOR THE AUTOMOTIVE DUSTY nnn 4 CONTEXT OF THE ORGANIZATION... UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT. 44.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES... 423 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM. 16 43:1 termining the scope ofthe uaity management system — supplemental os 6 43.2 Customerspeoti requirements se 16 42.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES. - 16 aaa 44.12 Conformance of products and processes y 44.12 Product safety. 1 BAG, @ANFIA.@FIEV,@ SMMT, 8 YDA~2016 Al i resewes 5 LEADERSHIP. ‘5.4. LEADERSHIP AND COMMITMENT, SALA corporate responstty, vot S12 brecetsetfestnenest an ettoaney . mB 5.1.2 CUSTOMER FOCUS 5.2 Pout. 5.2.1 ESTABLISHING THE QUALITY POLICY - - 15 5.2.2 COMMUNICATING THE QUALITY POLICY... - a8 5.3: Organzationa ols responsbitis, and authoties — supplemental os 5.12 responsi ard authatyfrpreductrequrements and comecave Scans 39 6 PLANNING. 6.41 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES 64.1 AND 6.12,6.4.1 AND6.A2.. 62.24 Riskenays 6.1.22 evento aztion. 61.23 contingency plans 20 6.2. QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM. 62.1 AND 622. 62.2 Quaity objectives and planning to ateve them — supplement 6. PLANNING OF CHANGES. 7 surpoRr.. 17.4 RESOURCES.. 7.4.2 PEOPL 72.4.3 INFRASTRUCTURE. 7.434 Plant fact and equioment lamin a 7.41 Environment fr the opraion of processes — supplemental ss 2 7.4.5 MONITORING AND MEASURING RESOURCES, 2.4.5.4 GENERAL.. 754 Measurementsstems alps snasnmmnmnnens son 7.4.5.2 MEASUREMENT TRACEABILITY. © AISG, @ANFIA, © FIEV, @SMAIT, BYDA~ 2010 — All rights reserved 75.21 celbraton/veiestion recor. 753 Laboratory requirements. nnn TSA Internal laboratory nnn 74532 Enerrallaborat0ry von nner ve os 7.4.6 ORGANIZATIONAL KNOWLEDGE 7.2 COMPETENCE. 7.21 Competence — Supple Metta nese ses na 722 Competence — onthe job rnng 2 723 Internal auitorcompatency, 25 724 Secondparty auditor competeney nn enn 25 7.3 AWARENESS... se 73: Awareness — supplemental ne se va 732 Employee motivation and empowerment 2. COMMUNICATION ono 7.5 DOCUMENTED INFORMATION. 75.2 GENERAL 75.1.1 Quay management 9st2m JOEUMENEON ons rnnmnn nnn 26 75.2 CREATING AND UPDATING.22 CONTROL OF DOCUMENTED INFORMATION, 2 2.1 AND7S.22. 27 75321 Recordretenton nnn 753.22. Engineering specteations.. 8 OPERATION... 8.4 OPERATIONAL PLANNING AND CONTROL. 8.11 Operational planing and cntrol — supplemental 28 B12 Confident nani o 28 8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES... - 28 8.2.1.1 customer communication — Supplemental nuns nimi 28 8.2.2 DETERMINING THE REQUIREMENTS FOR PRODUCTS AND SERVICES. 28 8.2.2.1 Determining the requirements for products and services — supplemental sue sons 1.2.3 REVIEW OF THE REQUIREMENTS FOR PRODUCTS AND SERVICES, - 2 aaa. ~ 29 1823.2: Review of the requrements for products and series — SURBIEMERA enn eB 22212 Customer dangnates specie enaractanence 33 1823.23 Crganzaton manufactunng fealty 23 8.2.3.2 nen 7 . 29 a (©AIAG, OANFIA,BFIEV, @ SMIMT, BVDA 20% —Al gh resenes 15.2.4 CHANGES TO REQUIREMENTS FOR PRODUCTS AND SERVICES 18.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES .. 8.3.1 GENERAL 30 12:1: Design and development of products and services — supolamantal. 20 {8.3.2 DESIGN AND DEVELOPMENT PLANNING. {8.3.2.1 Design and development planning — supplemental at ansnennnnnnnns 30 8.22 Product desgn smn nnn 3 3.323 Development of products with embedded software 30 8.3.3 DESIGN AND DEVELOPMENT INPUTS 3.33.1 Product design MPU a snnnnninninnninnminiinminimnnn 3A 833.2 Manufacturing process EIGN INPU osnvnrcnnnnnninnnnnnnnninnnnnnnn 3 3.33.3 Spedal characteristics canna 83.4 DESIGN AND DEVELOPMENT CONTROLS... - 2 8.34.1 MONON arcmin iin 23.42 Oanign and cevelopment vacation 32 3.3.4.3 Prototype PLOGFAMME nnn 2 18.8.4 Product epproVal FOCESS wu w-mnnnsrnnnnninminnnnnnnn 33 £8.35 DESIGN AND DEVELOPMENT OUTPUTS. 8.35.1 Design and development cutputs — supplemental 33 8.25.2 Manufacturing orocess design OUP nm8.3.6 DESIGN AND DEVELOPMENT CHANGES oo 12.6: Design and development changes — supplemental 8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES, 8.4.1 GENERAL. ~ - - ‘84.241 General — supplemental. ‘3.4.2 Suppller selection proces. BALL Customer-directed sources (als known as "Directed Buy" 8.4.2 TYPE AND EXTENT OF CONTROL 842.2 Type and extent of contol — supplemental ns o os 242.2 Startory ang raguatoryrequcemants 18.4.2. Supgller quality management system cevelopMENE nv. “ 184.23. automotive product lated software ox automone products wth embeded AM". 3.4.24 Suppller monorng 3204.1 Second-patty ate ennsnnmn ee 13.25 Supplier development cnn ennsenmnn ee 124.32 lnformation for extemal provisers— supplemental 8.5 PRODUCTION AND SERVICE PROVISION. {8.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION. AIAG, © ANFIA, © FEV. © SMT. ©VDA 2016 - AL gh resenea 35.14 Contal plan nnn 135.12 Stendardsed work — operator instructions and visu standards... 25:13 Venfeston ofjob setupt 2514 Vanfeston ater sntdo4 on : ns : . sn {35.15 Total productive maintenance were {35.16 Management of production talng and manclacturing, tes, nepection tooling and equlpmet 517 Brecuctin shedulng 125.2: Wentfestn and tracesity — suplementel 8.5.3 PROPERTY BELONGING TO CUSTOMERS OR EXTERNAL PROVIDERS, 8.5.4 PRESERVATION, {35.44 Preservation — supplemental 8.5.5 POST-DELIVERY ACTIVITIES. 185.5 Feedback information from scm 18552 Seniceagreement wth eust0Met nen . . : os 85.6 CONTROL OF CHANGES '85.6. Control of ehanges — supplement ‘85.6.1 Temporary change of process cont O 8.6 RELEASE OF PRODUCTS AND SERVICES. 8.6.1 Release of products and services — supplemental 6.2 Layout nspection and functional testing 86.3 Appecrance tems 864 Verfication and acceptance of conformity of externally provided products and services. 86.5 Statutory and regulatory CONfONMIY nnn a 38 28.6.6 Acceptonce critero 8.7 CONTROL OF NONCONFORMING OUTPUTS. ana {8.74.4 Customer authorzation fo €0002880N ms {874.2 Control of nenconforming product — customer speed PIECSS ssn 2.7.13 Control of suspect produc. 8.7.14 Control afreuerked proc [87.15 Control Ofrepared PrODUCwnwnnrnn nnn 8.7.46 Customer noieation. bm 3.74.7 Nonconforming product dspestot ne smnnnnniinnnnine AT a7 ar {9 PERFORMANCE EVALUATION, ar ‘9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION. ar 9.14 GENERAL, . ar 9.14.1 Monitoring and measurement of manufacturing processes sein AT 3.4.1.2 Identification of tata 12018 nennmnnnninusninnninnsnnnnnnen 5 (© AIAG, @ANFIA.G FIEV, © SMIMT, © VOA™2016 —Al ngs reserved 9.2.13 Applicaton of statistical concepts ne nntnnnnntiinniiiiinninin 9.1.2 CUSTOMER SATISFACTION vse 48 9.1.2.1 Customer satisfaction — supplement un ee 9.1.3 ANALYSIS AND EVALUATION. 49 8.1.8.1 PHOMREALON smn 9.2 INTERNAL AUDIT, 9.2.1 AND 9.22. 9.22.1 Interna ausit programme 9.22.2 Qualty management stem anno 9.22.3 Manufacturing proces uit nnn 9.22. POGUE AU nnn 9.3. MANAGEMENT REVIEW. 50 9.3.1 GENERAL, so 9.3.4 Management review — supplemental nun senna 5D 9.3.2 MANAGEMENT REVIEW INPUTS... so 9.32.1 Management review inputs —suppleMeal asenninnnnnitniinnininin SL 9.3.3 MANAGEMENT REVIEW OUTPUTS, st 9.23.1 Management review outputs — Supplemental snmnimnnant10 IMPROVEMENT... 10.1. GENERAL, 110.2 NONCONFORMITY AND CORRECTIVE ACTION. 10.241 AND 10.2.2... st 10.23 Problem SONINg onus 2024 Exorprooting. 102.5 Warranty management ystems ns 10.2.6 custome coolants and eld fare test nays 410.3 CONTINUAL IMPROVEMENT on 53 10.3.1 Continual imorovement — supplemental. ANNEX A CONTROL PLAN. [AA Phases oF THe conTROLPLAN 1A. ELEMENTS OFTHE CONTROL PUN ANNEX 8: BIBLIOGRAPHY — SUPPLEMENTAL AUTOMOTIVE. a @ AIAG, @ANFIA, @FIEV, @ SIAMT, ©VDA~ 2016 -Allghts reserved 6 Foreword ~ Automotive QMS Standard This Automotive Quality Management System Standard, herein referred to as "Automotive QMS Standard’ or “IATF 18949," along with applicable automotive customer-specific requirements, ISO 9001-2015 requirements, and ISO 90002015 defines the fundamental quality management system requirements for automotive production and relevant service parts organizations. As such, this Automotive OMS Standard cannot be considered a stand-alone GMS Standard but has to be comprehended as a supplement to and used in conjunction with ISO 90012015. ISO 9001-2015 is published as a separate ISO Standard, IATF 16949-2016 (1st edition) represents an innovative document, given the strong orientation to the: customer, with inclusion of a number of consolidated previous customer specific requirements. Annex 8 is provided for guidance to implement the JATF 16949 requirements unless otherwise specified by customer specific requirements History ISO/TS 16949 (1st edition) was originally created in 1999 by the International Automotive Task Force (IATF) wath the aim of harmonizing the different assessment and certfication systems worldade in the supply chain for the automotive sector. Other revisions were created (2nd edition in 2002, and 3rd edition in 2009) as necessary for either automotive sector enhancements or ISO 9001 revisions. ISO/TS 16949, (along with supporting technical publications developed by otiginal equipment manufacturers [herein referred to as OEMs] and the national automotive trade associations) introduced a common set oftechniques and methods for common product and process development for automotive manufacturing worldwide. In preparation for migrating from ISO/TS 16949:2008 (2rd edition) to this Automotive QMS Standard, IATF 16949, feedback was solicited from cerification bodies, auditors, suppliers, and OEMs to create IATF 16949:2016 (1st edition), which cancels and replaces ISO/TS 16949:2000 (2rd edition. The IATF maintains strong cooperation with ISO by continuing liaison committee status ensuring continued alignment with ISO 9001 Goal The goal of this Automotive QMS standard is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and ‘waste inthe supply chain 1 2 AIAG, @ANFIA, © FIEV, @ SMNT.@ VDA ~20%6 — All nights reserved Remarks for certific nm Requirements for cerifcation to this Automotive QMS Standard are defined in the Rules fer achieving and maintaining |ATF recognition. Details can be obtained from the local Oversight Offices of the IATF cited below. Associazione Nazionale Fillera Industrie Automobilstche (ANFIA) Web site: wanw.anfia it ‘e-mail anfia@anfia i International Automotive Oversight Bureau (AOB) Web site: vam iaob org €-mal iat [email protected] IATF France: Web site: wwnw.iat-trance.com ‘e-mail iat(@iatefrance com Society of Motor Manufacturers and Traders Lid. (SMMT Lid) ‘Web ste: wwinv.smmtoversight.co.uk ‘e-mail atf16940@smmtco uk ‘Verband der Automobilindustrie ~ Qualitats Management Center (VDA QMC) Web site: vanw vea-qme de e-mail: info@vda-qmc. de All public information about the LATF can be found at the IATF website: wow iatfalobaloversight org@ AIAG, @ANFIA @ FIEV, © SMT, © VDA~2015 -Al oh reserved Introduction 0.4 General ‘See ISO 9001:2016 requirements. (0.2 Quality management principles ‘See ISO 901.2015 requirements, 0.3 Process approach 0.3.1 General ‘See ISO 901.2015 requirements, 0.3.2 Plan-Do-Check-Aet cycle ‘See ISO 9001:2015 requirements. 0.3.3 Risk-based thinking See ISO 9001-2015 requirements, 0.4 Relationship with other management system standards See ISO 9001-2016 requirements, (Quality management systems — Requirements 1 Scope See 180 9001:2015 requirements, 1.1 Scope ~ automotive supplemental to SO 9001:2015 This Automotive GM'S Standard defines the qualty management system requirements forthe design and evelopment, production and, when relevant, assembly, instalation, and services of aulemabve-elated products, including products wth embedded software. ‘This Automotive GMS Standard is applicable to sites ofthe organization where manufacturing of customer-speciied production pats, service pats, andior accessory parts occur ‘This Automotive GM'S Standard should be applied throughout the automotive supply chain ° @ AAG, @ANFIA @ FEY, @ SUNT, @ DA 2015 Anat2 Normative references ‘See ISO 9001-2018 requirements, 2.1 Normative and informative references ‘Annex (Control Plan) is a normative part ofthis Automotive QMS standard Annex B (Bibliography — automotive supplemental) is informative, which provides additonal information intended to assist the understanding or use of this Automotive OMS standard 3 Terms and definitions ‘See ISO 9001:2015 requirements, 3.1. Terms and definitions for the automotive industry accessory part customer-specified adultional components) that are either mechanically or electronically connected to the vehicle or powertrain before (or alter) delivery to the final customer (e.g., custom floor mats, truck bed liners, wheel covers, sound system enhancements, sunfoofs, spolle's, super-chargers, etc.) ‘advanced product quality planning (APQP) product quality planning process that supports development of a product or service that will satsty Customer requirements; APOP serves as a guide in the development process and also a standard way to share results between organizations and their customers, APOP covers design robustness, design testing and specification compliance, production process design, quality inspeetion standards, process Capability, production capacity, product packaging, product testing and operator training plan, among other items aftermarket part replacement partis) not procured or released by an OEM for service part applications, which may or may not be produced to criginal equipment specifications authorization documented permission for a person(s) specifying rights and responsiblties related to giving or denying permissions or sanctions within an erganization AIAG @ANFIA, @FIEV, © SMIIT, @VDA2018 Al rehisreseved 0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 functionality of an error-proofing device or check fitures (e.g., 90 / no-go gauging) control plan documented description of the systems and processes requited for controling the manufacturing of product (see Annex A) ‘customer requirements all requirements specified by the customer (2.9, technical, commercial, product and manufacturing process-related requirements, general terms and conditions, customer-specific requirements, etc.) ‘customer-specific requirements (CSRs) interpretations of or supplemental requirements linked to a specific clause(s) of this Automotive QMS Standard design for assembly (DFA) process by which products are designed with ease of assembly considerations. (e.g, if a product Contains fewer parts it will take lass time to assemble, thereby reducing assembly costs) design for manufacturing (DFM) integration of produet design and process planning to design a product that is easly and economically ‘manufactured design for manufacturing and assembly (DFMA) Combination of two methodologies: Design for Manufacture (DFM), which is the pracess of optimizing the design to be easier to produce, have higher throughput, and improved quality, and Design for ‘Assembly (DFA), which is the optimization of the design to reduce risk of error, lowering costs, and ‘making it easier to assemble " @AIAG, © ANFIA,@FIEV, @SMINT, OVOA~2016— Alright reserveddesign for six sigma (DFSS) systematic methadolagy, 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 quaity level esign-responsible organization ‘organization with authorty to establish a new, or change an existing, product specification NOTE This responsibilty includes testing and venfication of design performance within the customer's specified application error proofing pproduct 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 analysie (FTA) deductive failure analysis methodology in which an undesired state of a system is analysed, faut tree ‘analysis maps the relationship between faults, subsystems, and redundant design elements by creating a logic diagram ofthe overall system laboratory facility for inspection, test, or calibration that may include but is not limited to the following: chemical, ‘metallurgical, mensional, physical, electrical, or reliability testing laboratory scope controlled document containing ~ specific tests, evaluatons, and calibrations that a laboratory is qualied to perform = alistof the equipment thatthe laboratory uses to perform the above; and = allistof methods and standards to which the laboratory performs the abovemanufacturing process of making or fabreating = production materials = production parts or service parts; assemblies, or ~ reat treating, welding, painting, plating, or other finishing services manufacturing feasibility fan analysis and evaluation of a proposed project to determine if it is technically feasible to manufacture the product to meet customer requirements. This includes but 's not limited to the following (as applicable). within the estimated costs, and ifthe necessary resources, facilities, tooling, capacity, software, and personnel with required skill, including support functions, are or are planned tobe available manufacturing services ‘companies that test, manufacture, distribute, and provide repair services for components and assemblies rmulti-diseiplinary approach method to capture input from all interested parties who may influence how a process is administered by a team whose members include personnel from the organization and may include customer and ‘supplier representatives, team members may be internal or external to the ofganization, ether 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 manufacturer, meets all the requirements of "good part’ (also referred to as “No Fault Found” ‘or "Trouble Not Found”) ‘outsourced process Portion ofan organization's function (ar processes) thats performed by an extemal organization 8 @ AAG, CANFIA, © FIEV, © SMT, © VDA—2016 Al rahtereservedperiodic 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 proactively taken out of service and disassembled, repaired, parts replaced, reassembled, and then retumed to sevice predictive maintenance fan approach and set of techniques to evaluate the condition of in-service equipment by performing periodic or continuous monitenng of equipment conditions, in order to predict when maintenance should be performed premium freight extra costs or charges incurred in addition to contracted delivery NOTE This can be caused by method, quantity, unscheduled or late deliveries, ete preventive maintenance planned activites at regular intervals (time-based, periodic inspection, and overhaul) to eliminate causes of equipment failure and unscheduled interruptions to production, as an output of the ‘manufacturing process design produet applies to any intended output resulting from the preduct realization pracess product safety standards relating to the design and manufacturing of products to ensure they do not represent harm or hazards to customers production shutdown condition where manufacturing processes are idle; ime span may be a few hours to a few months reaction plan action or series of steps prescribed in a control plan in the event abnormal or nonconforming events are detected © AIAG, @ANFIA @FIEV, @ SUNT, @ VDA 2016 Al nights reserves os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 ar released by the OEM for service part applications, ineluding remanufactured parts site location at which value-added manufacturing processes occur special characteristic Classification of a product charactenstic cr manufacturing process parameter that can affect safety or compliance with regulations, fi, function, performance, requirements, or subsequent processing of product special status notification of 2 customeridentified classification assigned to an organization where one or more customer requirements are not being satisfied due toa significant quality or delivery issuetrade-off process methodology of developing and using trade-off curves for products and their performance characteristics that establish the customer, tachnical, and economic relationship between design alternatives 4 Context ofthe organization 4.1 Understanding the organization and its context ‘See ISO 900-2016 requirements, 4.2 Understanding the needs and expectations See ISO 9001-2015 requirements, 4.3 Determining the scope of the quality management system See ISO 9001-2015 requirements, 4.3.1 Determining the scope of the quality management system — supplemental support function non-production activity (conducted on site or at a remote location) that supports ene (or mare) ‘manufacturing sites of the same organizaton total productive maintenance fa system of maintaining and improving the integrity of production and quality systems through machines, equipment, processes, and employees that add value to the organization ade-off curves tool to understand and communicate the relationship of various design characteristics of a product to each other, a product's performance on one characteristic is mapped on the Y-axis and another on the «axis, then a curve is plotted to illustrate product performance relative to the two characteristics (© AIAG, © ANFIA.@ FIEV, © SMMT, @ VOA 2016 —Al rights reservedtrade-off process methodology of developing and using tradeoff curves for products and their performance characteristics that establish the customer, technical, and economic relalonship between design atematives 4 Context of the organization 4.1 Understanding the organization and its context ‘See ISO 9001-2016 requirements. 4.2 Understanding the needs and expectations of interested parties ‘See |SO 9001:2016 requirements. 4.3 Determining the scope of the quality management system See ISO 9007-2015 requirements 4.3.4 Determining the scope of the quality management system — supplemental ‘Supporting functions, whether on-site or remote (such as design centres, corporate headquarters, and distribution centres), shall be included in the scope of the Quality Management System (QMS). The only permitted exclusion for this Automotive QMS Standard relates to the product design and development requirements within ISO 9001, Section 8.3. The exclusion shall be justified and maintained as documented information (see ISO 9001, Section 7.5). Permitted exclusions do not include manufacturing process design 4.3.2. Customer-speeifie requirements Customer-specitic requirements shall be evaluated and included in the scope of the organization's quality management system, 4.4 Quality management system and its processes, aad ‘See ISO 9001-2016 requirements @AIAG, @ANFIA, © FIEV, @ SMT, OVDA~2018 — Al rights reserved 644.1.4 Conformance of products and processes ‘The organization shall ensure conformance of all products and processes, including service parts and those that are outsourced, to all applicable customer, statutory, and regulatory requirements (see Section 8422), 4441.2 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 to the folovaing, where applicable: 2) Identification by the organization of statutory and regulatory product-safety requirements; b) customer notification of requirements in tem a), ©) special approvals for design FMEA 4) dentifcation of product safety-related charactenstics; €) identification and controls of safety-related characteristes of product and at the point of ‘manufacture; 4) special approval of control plans and process FMEAS; 19}, reaction plans (see Section 9.1.1.1) hh) defined responsibilities, defintion of escalation process and flow of information, including top management, and custamer notification; |) training identified by the organization or customer for personnel involved in product-safety related products and associated manutacturing processes; |) changes of praduct or process shall be appraved prior to implementation, including evaluation of potential effects on product safety fram process and product changes (see |SO 8001, Section 836) k) transfer of requirements with regard to product safety throughout the supply chain, including customer-designated sources (see Section 8.4.3.1); 1) product traceability by manufactured lot (at a minimum) throughout the supply chain (see Section 8521), 'm) lessons learned for new product introduction NOTE: Special approval is an additional approval by the function (typically the customer) that is responsible fo approve such documents with safety-related content. 442 ‘See |SO 9001-2015 requirements w BAAG, @ANFIA GFIEV, SMT, 8 VDA~2015~Al noms reserves5 Leadership 541 Leadership and commitment 544 General See I$0 9001:2018 requirements 5.4.1.1 Corporate responsibility The organization shall define and implement corporate responsibilly policies, including at a minimum an anti-bribery policy, an employee code of conduct. and an ethics escalation policy (‘whistle-blowing policy’). 5.1.1.2 Process effectiveness and efficiency Top management shall review the product realization processes and support processes fo evaluate and Improve their effectiveness and efficiency. The results of the process review activities shall be included as input fo the management review (see Section 9.8.2.1.) 5.1.1.3 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 oles and be competent to perform those roles (see ISO 9001, Section 7.2) 54.2 Customer focus ‘See 150 9001:2018 requirements. 52 Policy 5.2.1 Establishing the quality policy See ISO 9001-2015 requirements 5.2.2 Communicating the quality polley See ISO 9001 2016 requirements 5.3 Organizational roles, responsibilities and authorities See ISO 901.2016 requirements, 5.3.1 Organizational roles, responsibilities, and authorities — supplemental Top management shall assign personnel with the responsibilty and authority to ensure that customer requicements are met. These assignments shall be documented, This includes but is nat limited ta the selection of special characteristics, seting quality obyectives and related traning, corrective and (©AIAG, © ANFIA @ FIEY, © SUMT, VDA 2016 — Al ints eservod 8preventive actions, product design and development, capacity analysis, logistics information, customer scorecards, and customer portals, 5.3.2 Responsibility and authority for product requirements and corrective actions Top management shall ensure that a). personnel responsible for conformity to praduct requirements have the authority to 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. b) personnel with authonty and responsiblity for corrective action are promptly informed of products oF processes that do not conform to requirements to ensure that nonconforming product is not Shipped ta 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 responsibility for, ensuring conformity to product requirements, 6 Planning 6:1 Actions to address risks and opportuniti BAA and 6.4.2 See ISO 9001:2015 requirements. 6.1.2.1 Risk analysis ‘The organization shall include in is risk analysis, at a minimum, lessons learned from product recalls, product audits, feld returns and repairs, complaints, scrap, and rework. ‘The organization shall retain documented information as evidence of the results of risk analysis. 6.1.2.2 Preventive action “The organization shall determine and implement action(s) to eliminate the causes of potential ‘nenconformiies in order to prevent their occurrence. Preventive actions shall be appropriate to the severiy ofthe potential issues ‘The organization shall establish a process to lessen the impact of negative effects of risk including the followang: 2). determining potential nonconformities and their causes; 'b)_ evaluating the need for action to prevent eccurrence of nonconfomities; ©) determining and implementing action needed 4) documented information of aeton taken: 9 ®AIAG, @ANFIA.S FIEV, © SMT, 8 VDA 2018 Alright resewed)_ reviewing the effectiveness of the preventive acton taken; 4) _ulilzing lessons leamed to prevent recurrence in similar processes (see ISO 9001, Section 7.1.6) 6.1.23 Contingency plans The organization shall 1) identify and evaluate intemal and external risks to all manufacturing processes and infrastructure ‘equipment essential to maintain production output and to ensure that customer requirements are met b) define contingency plans according ta risk and impact to the customer: ¢) prepare contingency plans for continuity of supply in the event of any of the following: key equipment failures (also see Section 8.5.6.1.1), interruption from extemally provided products, processes, and services, recurring natural disasters, fire, utility interruptions, labour shortages, or infrastructure disruptions; 9) include, as a supplement to the contingency plans, a notification process to the customer and other interested pares for the extent and duration of any situation impacting customer operations; ©) periodically test the contingency plans for effectiveness (e.g. simulations, as appropriate) 1) conduct contingency plan reviews (at @ minimum annually) using a multidisciplinary team incluaing top management, and update as required: 19) document the contingency plans and retain documented information describing any revision(s), including the person(s) who authorized the change(s) The contingency plans shall include provisions to validate thatthe manufactured product continues to meet customer specifications after the re-start of production following an emergency in which production was stopped and if the regular shutdown processes were not followed, 6.2 Quality ebjectives and planning to achieve them 6.24 and6.22 ‘See ISO 900.2015 requirements. 6.221 Quality objectives and planning to achieve them — supplemental Top management shall ensure that qualiy objectives fo meet customer requirements are defined, established, and maintained for relevant functions, processes, and levels throughout the organization The results ofthe organization's review regarding interested parties and their relevant requirements shal be considered when the organization establishes its annual (at a minimum) qualiy objectives and related performance targets (internal and external). ARG, @ ANFIA @ FIV, @SUMT, € VDA~2016—Al riots reseves 2»6.3 Planning of changes ‘See 180 9001.2015 requirements. 7 Support 7A Resources TAA General ‘See ISO 9001 2016 requirements 7A.2 People ‘See ISO 9001:2015 requirements 7.4.3 Infrastructure ‘See ISO 9001:2015 requirements 7.4.3.4 Plant, facility, and equipment planning ‘The organization shall use a mulidisciplinary approach including risk identification and risk mitigation methods for developing ana improving plant, facility, and equipment plans. In designing plant layouts, the organization shall 2) optimize material flow, material handling, and value-added use of floor space including control of Ronconferming product, and b) faciliate synchronous material flow, as applicable. Methods shall be developed and implemented to evaluate manufacturing feasibly for new product or new operations Manufacturing feasibilly assessments shall include capacity planning. These methods shall also be applicable for evaluating proposed changes to existing operations, The organization shall maintain process effectiveness, including periodic re-evaluation relative to risk, to incorporate any changes made during process approval, contol plan maintenance (see Section 8.5.1.1), and venfication of job set-ups (see Section 8.5.1.3). Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to management reviews (see |S0 9001, Section 9.2). NOTE 1 These requirements should include the application of lean manufacturing principles. NOTE 2. These requirements should apply to on-site supplier activities, as applicable AIAG, OANFIA, © FIEY, © S/T, © VDA~20%0~Al gh reserves7.4.4 Environment for the operation of processes. See 180 9001:2018 requirements. NOTE Where third-party certification to [SO 45001 (or equivalent) is recognized, it may be used to demonstrate the organization's conformity to the personnel safety aspects of this requirement, 7.4.4.1 Environment for the operation of processes — supplemental ‘The organization shall maintain its premises ina state of order, cleanliness, and repair that is consistent with the product and manufacturing process needs 7.4.5 Monitoring and measuring resources 7 4 General ‘See ISO 9001-2018 requirements, 7.1.5.1.1 Measurement systems analysis Statistical studies shall be conducted to analyse the variation present inthe results of each type of inspection, measurement, and test equipment system identified in the contvol plan. The analytical methods and acceptance criteria used shall conform to thse in reference manuals on measurement systems analyss. Other analytical methods and acceptance criteria may be used if approved by the customer. Records of customer acceptance of alternative methods shall be retained along with results from altemative measurement systems analysis (see Section 9.1.1 1) NOTE Prioritization of MSA studies should focus on ertieal or special product or process characteristics, 7.4.5.2 Measurement traceability ‘See 150 9001:2016 requirements, NOTE number or another identifier traceable to the device calibration record meets the intent ofthe requitements in SO 8001-2015, 748.21 Calibration/verification records ‘The organization shall have a documented process for managing calbrationivenication records. Records ofthe calibration/verification actwity for al gauges and measuring and test equipment (including ‘Employee-owned equipment relevant for measuring, customer-cwned equipment, of an-ste supplier @AIAG, @ANFIA, © FEV, © SMMT, @VDA~2010—Al igh reserved 2‘owned equipment) needed to provide evidence of conformity to internal requirements, legislative and regulatory requirements, and customer-defined requirements shall be retaines The organization shall ensure that calibration/verification activities and records shall include the following etals )_ revisions following engineering changes that impact measurement systems, b)_any out-of specification readings as received for calibration! venfication, ©) an assessment ofthe risk of the intended use of the product caused by the out-of-specification condition: dd) when a piace of inspection measurement and test equipment is found to be out of calibration or defective during its planned verification or calibration or during ts use, documented information on the validity of previous measurement resuils 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, €)_notifeation to the customer if suspect product or material has been shipped; 1) statements of conformity to specification after calibration’ verification; 9) ventcation that the software version used for product and process control is as specified, hh) records of the calibration and maintenance activities for all gauging (including employee-owmed equipment, customer-ovmed equipment, or on-site supplier-owned equipment), |) produetion-related software verification used for product and process control (including sofware instaled on employee-cwned equipment, customer-cwned equipment, or on-site supplie-owmed equipment) 7.4.5.3 Laboratory requirements 7.1.5.3.4 Intemal laboratory ‘An organization's intemal laboratory facility shall have a defined scope that includes its capabiliy to perform the required inspection, test, or calibration services, This laboratory scope shall be included in ‘the quality management system documentation. The laboratory shall specify and implement, as 2 minimum, requirements for a) adequacy of the laporatary technical procedures; bb) competency of the laboratory personnel €)_ testing ofthe product, 4) capability to perform these services correctly traceable to the relevant process standard (such as ASTM, EN, etc. when no national or international standard(s) 's available, the organization shall ‘define and implement a methodology to verily measurement system capabiity, ©) customer requirements, f any, 4) review of the related records, NOTE Third-party accreditation to ISO/IEC 17025 (or equivalent] may be used to demonstrate the organization's in-house laboratory conformity to this requirement a ©AIAG, BANFIA, @FIEV, © SMIT, @VDA2016 —Allnghts eserves7.1.8.3.2 External laboratory Externalcommercialindependent laboratory facilities used for inspection, test, or calibration services by the organization shall have a defined laboratory scope that includes the capabilty fa perform the requited inspection, test, of calibration, and eter. — the laboratory shall be accredited to ISOVIEC 17025 or national equivalent and include the relevant inspection, test, or calibration service in the scope ofthe accreditation (certificate), he Cerificate of calibration or test report shall include the mark of a national accreditation body, or — there shall be evidence that the external laboratory is acceptable to the customer NOTE Such evidence may be demonstrated by customer assessment, for example, or by customer ‘approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national ‘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 qualified laboratory is not available fora given piece of equipment. In such cases, the oxganization shall ensure that the requirements isted in Section 7.1.5.3.1 have been met Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject to ‘government regulatory confirmation, i required. 7A.6 Organizational knowledge ‘See ISO 9001:2015 requirements. 1.2 Competence ‘See 150 9001:2015 requirements, 7.2.1 Competence — supplemental ‘The erganization shall establish and maintain a documented process(es) for identifying training needs including awareness (see Secton 7.3.1) and achieving competence ofall personnel performing actities affecting conformity to product and process requirements. Personnel performing specific assigned tasks shall be qualified, as required, with paricular attention to the satisfaction of customer requirements 7.22 Competence — on-the:job training ‘The organization shall provide on-the-job training (which shall include customer requirements training) for personnel in any new or modified responsibilities affecting conformity to quality requirements, intemal Fequicements, regulatory or legislate requirements; this shall include contract or agency personnel. The level of detail required for on-the-job training shall be commensurate with the level of education the ‘personnel possess and the complexty of the task(s) they are required to perform for their daily work Persons whose work can affect quality shall be informed about the consequences of nonconformity customer requirements, AIG, @ANFIA @FIEV,@ SWAT, YOK 2015— Ai nats eserves ao7.2.3 Internal auditor competency ‘The organization shall have a decumented process(es) to verify that intemal ausitors are competent, taking into account any customer-specifie requirements. For additional guidance on auditor competencies, refer to ISO 19011. The organization shall maintain a ist of qualtied internal auditors, Quality management system auditors, manufacturing process auditors, and product auditors shall all be able to demonstrate the fellowing minimum competencies: 2) understanding of the automotive process approach for auditing, including risk-based thinking, b) understanding of applicable customer specific requirements, ¢) understanding of applicable ISO $001 and IATF 16949 requirements related to the scope of the audit 4). understanding of applicable core tool requirements related to the scope of the audit 2). understanding how to plan, conduct, report, and clase out aust findings Additionally, manufacturing provess auuitors shall demonstrate technical understanding of the relevant ‘manufacturing process(es) to be audited, including process risk analysis (such as PFMEA) and control plan. Product auditors shall demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity ‘Where training is provided to achieve competency, documented information shall be retained to ‘demonstrate the trainer's competency with the above requirements Maintenance of and improvement in internal auctor competence shall be demonstrated through 4) executing a minimum number of audits per year, as defined by the organization; and g) maintaining knowledge of relevant requirements based on internal changes (eg., process technology, product technology) and external changes (@.a., ISO 9001, IATF 16948, core tools, and customer specifi requirements) 7.24 Second:party auditor competency ‘The organization shall demonstrate the competence of the aueltors undertaking the second-party audits Second- party audiors shall meet customer speci requirements for auctor qualiication and ‘demonstrate the minimum following core competencies, including understanding of 2) the automotive process approach to auditing, including risk based thinking: ') applicable customer and organization specific requirements, ©) applicable ISO 8001 and IATF 16949 requirements related to the scope of the audit 4) applicable manufacturing process(es) to be audited, including PFMEA and control plan 2) applicable core tool requirements related to the scope of the aussi, ) howto pian, conduct, prepare audit reports, and close out aueit findings. 2 AIAG. @ANFIA @ FEV, © MNT, @ VDA 200 -Alrichsreeoved7.3 Awareness See ISO 9001-2018 requirements. 7.3.1 Awareness — supplemental The organization shall maintain documented information that demonstrates that all employees are aware of their impact an product quality and the importance oftheir actuties in achieving, maintaining, and improving quality, including customer requirements and the nsks involved for the customer with non- conforming product, 7.2.2 Employee motivation and empowerment The organization shall maintain a documented process(es) to motivate employees to achieve quality objectives, 0 make continual improvements, and to create an environment that promotes innovation. The process shall include the promotion of qualiy and technological awareness throughout the whole organization, 7.4 Communication ‘See ISO 9001-2015 requirements, 7.8 Documented information 7.84 General ‘See 180 9001 2018 requirements 7.5.1.1 Quality management system documentation The organization's quality management system shall be documented and include a quality manual, which can be a series of documents (electronic or hard copy) The format and structure of the quality manuals at the discretion of the organization and will depend on the organization's size, culture, and complexity. Ifa series of documents fs used, then a list shall be retained of the documents that comprise the quality manual forthe organization. The quality manual shall include, at a minimum, the folowing: a) the scope of the quality management system, including details of and justification for any exclusions; b) documented processes established for the quality management system, or reference to them, ¢) the organization's processes and their sequence and interactions (Inputs and outputs), including {ype and extent of control of any outsourced processes, 4) 2 document (Le., matrix) indicating where within the organization's quality management system their customer-specifie requirements are addressed. © AAG, © ANFIA, © FEV, © SMMT,@VDA~2016— Al ns reserved 2NOTE A matrix of how the requirements ofthis Automotive QMS standard are addressed by the organization's processes may be used ta assist with linkages of the organization's processes and this, Automotive QMS. 7.8.2 Creating and updating ‘See ISO 90012016 requirements. 7.83 Control of documented information 788A and 7.5.32 ‘See ISO 9001:2015 requirements. 7.8.3.2.1 Record retention The organization shall define, document, and implement a record retention policy. The control of records shall salisly statutory, regulatory, organizational, and customer requirements, Production part approvals, tooling records (Including maintenance and ownership), product and process design records, purchase orders (if applicable), or contracts and amendments shall be retained for the length of tme that the procuct is active for production and service requirements, plus one calendar year, Unless otherwise specified by the customer or regulatory agency. NOTE Production part approval documented information may include approved product, applicable test ‘equipment records, or approved test data 7.83.22 Enginooring specifications The organization shall have a documented process describing the review, distribution, and implementation ofall customer engineering standards/specifications and related revisions based on customer schedules, as required. \When an engineering standard/specification change results in 2 product design change, refer to the requirements in [SO 9001, Section 8 36. When an engineering standardispecifcation change results in a product realization process change, refer to the requitements in Section 8.6.6.1. The organization shall reiain a record of the date on which each change is implemented in production. Implementation shall include updated documents Review should be completed within 10 working days of receipt of notification of engineering standards/specifications changes. NOTE A change in these standards/specifications may require an updated record of customer ppreduction part approval when these specifications are referenced on the design record orf they affect, documents ofthe production part approval process, such as control plan, risk analysis (such as FIMEAS), etc 2 AIAG, OANFIA, © FIEV. ©SMIMT, @VDA~ 2016 All rais reserved8 Operation 8.1 Operational planning and control See ISO 9001-2015 requirements. 8.4.1 Operational planning and control — supplemental \When planning for product realization, the folowing topies shall be included: 1a). customer product requirements and technical specifications; logistics requirements; ) manufacturing feasibility d)_ project planning (refer to ISO 8001, Section 8.32); e) acceptance enteria. ‘The resources identified in ISO 9001, Section 8.1), refer to the required verification, validation ‘monitoring, measurement, inspection, and test activites specific to the product and the criteria for product acceptance. 8.1.2 Confidentiality ‘The organization shall ensure the confidentiality of customer-contracted products and projects under development, including related product information. 8.2 Requirements for products and servi 8.2.4 Customer communieation See ISO 9001-2015 requirements, 8.2.1.1 Customer communication — supplemental \Writen o¢ verbal communication shall be in the language agreed with the customer. The organization shall have the ability to communicate necessary information, including data in a customer-speciied computer language and format (¢ g., computer-aided design data, electronic data interchange) 8.2.2 Determining the requirements for products and services See ISO 90012015 requirements, (© AIAG, @ANFIA BEV, @SMMIT © VDA—2048— lings reserves 24.2.2.1 Determining the requirements for products and services — supplemental ‘These requirements shall include recycling, environmental impact, and characteristics identified as a result of the organization's Knowledge of the product and manufacturing processes. Compliance to ISO 9001, Section 82.2 item a) 1), shall include but net be limited to the following: all applicable government, safety, and environmental regulations related to acquistion, storage, handling, recycling, elimination, or disposal of material 8.2.3 Review of the requirements for products and services 82.3.4 ‘See ISO 9001-2015 requirements, 4.2.3.1.1 Review of the requirements for products and services — supplemental ‘The organization shall retain documented evidence of a customer-authorized waiver for the requirements stated in ISO 9001, Section 8.2.3.1, for a formal review. 4.2.3.1.2 Customer-designated special characteristics The organization shall conform to customer requirements for designation, approval documentation, and control of special charactensics. 8.2.3.1.3 Organization manufacturing feasibility ‘The organization shall utilize a mutidiseipinary approach to conduct an analysis to determine if itis ‘feasible that the organization's manufacturing processes are capable of consistently producing product ‘hat meets all of the engineering and capacity requirements specified by the customer. The organization shall conduct ths feasibility analysis for any manufactunng or product technology new to the organization and for any changed manufacturing process or product design ‘Adaitionally, the organization should validate through production runs, benchmarking studies, or other appropriate methods, their abilty to make product to specifications at the required rate. 3232 ‘See ISO 901.2016 requirements, 8.2.4 Changes to requirements for products and services ‘See ISO 901.2016 requirements, Pry AAG © ANFA, © FIEV, @ SUNT, @VDA—20%8 — Al nhs reserved8.3 Design and development of products and services, 8.3.1 General See ISO 9001:2015 requirements, 2.3.1.1 Design and development of products and services — supplemental The requirements of ISO $001, Section & 31, shall apply to product and manufacturing process design {and development and shall focus on error prevention rather than detection ‘The organization shall document the design and development process. 8.3.2 Design and development planning ‘See 180 9001:2015 requirements. 8.3.2.1 Design and development planning — supplemental ‘The organization shall ensure that design and development planning includes all affected stakeholders within te organization and, as appropriate, its supply chain. Examples of areas for using such a rmultidscipinary approach inelude but are not limited to the following; 2) project management (foc example, APOP or VDA-RGA), b) product and manufacturing process design activities (for example, DFM and OFA), such as consideration of the use of alternative designs and manufacturing processes; ©) development and review of product design risk analysis (FMEAS), including actions to reduee potential risks, 1) development and review of manufacturing process risk analysis (for example, FMEAS, process flows, contol plans, and standard work instructions) NOTE A muttidiscipinary approach typically includes the organization's design, manufacturing engineering, quality, production, purchasing, supplier, maintenance, and other appropriate functions. 8.3.2.2 Product design skills The organization shall ensure that personnel with product design responsibilty are competent to achieve design requirements and are skilled in applicable product design tools and techniques. Applicable tools and techniques shall be identtied by the organization. NOTE An example of product design skils is the application of digitized mathematically based data 4.3.2.3 Development of products with embedded software The erganization shall use a process for quality assurance for their products with internally developed embedded software. A software development assessment methodology shall be utlized to assess the organization's software development process. Using priontization based on risk and potential impact to the customer, the organization shall retain documented information of a software development capability self-assessment. AIAG, @ ANFIA, OFIEV, © SMUT, ©VOA~2016~Al rights reservedThe organization shall include softvare development within the scope of their internal audit programme (see Section 9 2.2 1), 8.3.3 Design and development inputs ‘See ISO 9001 2015 requirements, 8.3.3.1 Product design input The organization shall identify, document, and review product design input requirements as a result of contra 2) b ° ° °) 2 by ct review. Preduct design input requirements include but are not limited to the following product specifications including but not limited to special characteristics (see Section 8.3.3.3), boundary and interface requirements; identifcation, taceabilty, and packaging consideration of design alternatives assessment of risks with the input requirements and the organization's ability to mitigatelmanage the risks, including from the feasibilty analysis, targets for conformity to product requirements including preservation, reliability, durabilty, serviceability, health, safety, environmental, development timing, and cost applicable statutory and regulatory requirements ofthe customer-identified country of destination, if provided: ‘embedded sofware requirements ‘The organization shall have a pracess to deploy information gained from previous design projects, competitive product analysis (benchmarking), supplier feedback, internal nput, fed data, and other relevant NOTE 83.32 sources for current and future projects of a similar nature (One approach for considering design alternatives is the use of trade-off curves: Manufacturing process design input The organization shall identity, decument, and review manufactunng process design input requirements including but not limited tothe following a) b) °) 4) 2) 4) 9 ») product design output data including special characteristics; targets for productivity, process capabilty, timing, and cost, manufacturing technology alternatives, customer requirements, itary, experience from previous developments; new matenals product handling and ergonomic requirements, and design for manufacturing and design for assembly. ‘The manufacturing process design shall include the use of error-proofing methods toa degree appropri * jate to the magnitude of the problem(s) and commensurate with the risks encountered AIAG, 6 ANFIA, © FIEV, B® SWIT, 8 VDA ~ 2016 ~All reserved8.3.3.3 Special characteristics ‘The organization shall use a muftidsciplnary approach to establish, document, and implement its pracess(es) to entity special characteristics, including those determined by the customer and the risk Analysis performed by the organization, and shall include the following ) documentation of all special characteristics in the drawings (as required), sk analysis (such as FMEA), control plans, and standard work/operator instructions, special characteristics are Identined with specific markings and are cascaded through each of these documents; b) development of control and monitoring strategies for special characteristics of produets and production processes, ©) custamer-specitied approvals, when require: ) compliance with customer-specified definitions and symbols or the organization's equivalent symbols of notations, as defined in a symbol conversion table. The symbol conversion table shall be submitted to the customer, if required 8.3.4 Design and development controls ‘See ISO 9001 2018 requirements. 8.34.1 Monitoring Measurements at specified stages during the design and development of products and processes shall bbe defined, analysed, and reported with summary results as an input fo management review (see Section 9321) When required by the customer, measurements of the product and pracess development activity shall be reported to the customer at stages specified, or agreed to, by the customer. NOTE When appropriate, these measurements may include quality risks, costs, lead tes, critical paths, and other measurements, 8.3.4.2 Design and development validation Design and development validation shall be performed in accordance with customer requirements, Including any applicable industry and governmental agency-issued regulatory standards. The timing of design and development validation shall be planned in alignment with customer-specified timing, as applicable, Where contractually agreed withthe customer, this shall include evaluation ofthe interaction ofthe ‘organization's product, including embedded software, within the system of the inal customer's product 8.3.4.3 Prototype programme When required by the customer, the organization shall have a protctype programme and control plan ‘The organization shall use, whenever possible, the same supplies, tooling, and manufacturing processes a wil be used in production. All performanee-testing activites shall be monitored for timely completion and conformity to requirements. (BAG, © ANFIA @ FIEV, © SUM, ©VDA 2016 —Al ight reserved 2When services are outsourced, the organization shall include the type and extent of control in the scope ofits quality management system to ensure that outsourced services conform to requirements (see ISO 9001, Section 8.4). 8.3.4.4 Product approval process ‘The organization shall establish, implement, and maintain a product and manufacturing approval process conforming to requirements defined by the custamer(s) ‘The organization shall approve externally provided products and services per ISO 9001, Section 8.4.3, prior to submission of their part approval to the customer. ‘The organization shall obtain documented product approval prior to shipment, if required by the customer. Records of such approval shall be retained. NOTE Product approval should be subsequent to the verification of the manufacturing process. 8.3.5 Design and development outputs ‘See ISO 9001-2018 requirements, 8.3.5.1 Design and development outputs — supplemental ‘The product design output shall be expressed in terms that can be verified and validated against product design input requirements. The product design output shall include but is not limited to the following, as applicable. )- design risk analysis (FMEA) by rebabilty study results; €) product special charactensties; @) results of product design error-proofing, such as DFSS, DFMA, and FTA: ©) product definition including SD models, technical data packages, product manutactunng information, and geometric dimensioning & tolerancing (GD&T); 4) 2D drawings, product manufacturing information, and geometric dimensioning & tolerancing (epary ©) product design review resuts h) service diagnostic quidelines and repair and serviceabilty instructions; i) service part requirements; 1) packaging and labeling requirements for shipping. NOTE Interim design outputs should include any engineering problems being resolved through atrade- off process 8.3.5.2 Manufacturing process design output ‘The organization shall document the manufacturing process design output in 2 manner that enables verifieation against the manufacturing process design inputs. The organization shall very the outputs against manufacturing process design input requirements. The manufacturing process design output shall inelude but is not imitad tothe folowing s AKG, ANFIA, 5, @ MNT, € VDA ~20'6 ~All tas reserveda) specifications and drawings, b)_ special charactenstcs for product and manufacturing process ©) identification of process input variables that impact characteristics, 4) ‘tooling and equipment for production and control, including capability studies of equipment and pracess(es) 2) manufacturing process flow charts/layout, including linkage af product, process, and tooling 1) capacity analysis; (9) manufacturing process FMEA; fh). maintenance plans and instructions; 1) control plan (see Annex A); |) standard work and work instructions; K) process approval acceptance criteria, 1) data for quality, reliability, maintainabilly, and measurabily Im) results of error-proofing identification and verification, as appropriate, rn) methods of rapid detection, feedback, and correction of productimanufacturing process nonconformities. 3.8 Design and de ‘See ISO 9001:2015 requirements. lopment changes 8.3.6.1 Design and development changes — supplemental “The organization shall evaluate all design changes after initial product approval, including these proposed by the organization or ts suppliers, for potential mpact en fi, form, function, performance, and/or durability. These changes shall be valdated against customer requirements and approved internally, priar fo preduetion implementation Ifrequited by the customer, the organization shall obtain documented approval, or a documented waiver, ‘rom the customer prior to production implementation. For products with embedded software, the organization shall document the revision level of software and hardware as part of the change record 8.4 Control of externally provided processes, products and services 84.4 General ‘See ISO 9001:2018 requirements, ‘© AAG, ©ANFIA CFIEV, © SMT, VDA - 2016 AN fans reserved Pa8.4.1.1 General — supplemental The organization shall include all products and services that affect customer requirements such as sub- assembly, sequencing, sorting, rework, and calibration services in the scope of their definition of externally provided products, processes, and services, 4.4.1.2 Supplier selection process The organization shall have a documented supplier selection process. The selection process shall include: a) an assessment of the selected supplier's risk to produet conformity and uninterrupted supply of the organization's product to their customers; b) relevant quality and delivery performance; ©) an evaluation of the supplier's quality management system, 4) muttidisciplinary decision making, and ©) an assessment of software develooment capabilites, if applicable. Other supplier selection erteria that should be considered include the following: — volume of automotive business (absolute and as a percentage of total business) — financial stability — purchased product, material, or service complexity, — required technology (product or process); — adequacy of available resources (e.g, people, infrastructure), — design and development capabilities (including project management), — manufacturing capability — change management process; — business continuity planning (e.g, disaster preparedness, contingency planning); = logistics process — customer service. 8.41.3 Customendirected sources (also known as “Directed-Buy”) ‘When specified by the customer, the organization shall purchase products, materials, or services from customer-directed sources, All requirements of Section 8.4 (except the requirements in JATF 16949, Section 8.4.1.2) are applicable to the organization's control of cusiomer-directed sources unless specific agreements are otherwise defined by the contract between the organization and the customer 8.4.2 Type and extent of control See ISO 9001-2018 requirements 8 BAIAG, @ANFIA @ FEV, BSWMT, 8 OA~ 2076 Almas reserves8.4.2.1 Type and extent of contro! — supplemental ‘The organization shall have a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity of externally provided products, processes, and services to internal (organizational) and external customer requirements. ‘The process shall include the eriteria and actions to escalate or reduce the types and extent of contrals land development activities based on supplier performance and assessment of product, material, or service risks. 8.4.2.2 Statutory and regulatory requirements ‘The organization shall document their process to ensure that purchased products, processes, and seivices conform to the cutrent applicable statutory and regulatory requirements in the county of receipt, the countty of shipment, and the customer-identified country of destination, if provided. Ifthe customer defines special controls for certain products with statutory and requlatary requirements, the organization shall ensure they are implemented and maintained as defines, including at suppliers 8.4.2.3 Supplier quality management system development ‘The organization shall require their suppliers of automotive products and services to develop, implement, and improve a quality management system certified to ISO 9001, unless otherwise authorized by the customer [e.g., item a) below], with the ulimate objective of becoming certified to this Automotive QMS ‘Standard. Uniess otherwise specified by the customer, the following sequence should be applied to achieve this requirement a) compliance to ISO 9001 through second-party audits b) certification to 1S $001 through third-party auaits; unless othenvise specified by the customer, suppliers to the organization shall demonstrate conformity to ISO 9001 by maintaining a third- party certification issued by a cerlffcaton body bearing the accreditation mark of a recognized IAF MLA (Intemational Accreditation Forum Muliiateral Recognition Arrangement) member and where the accreditation body's main scope includes management system cerifcation to ISO/IEC. 7021; €) certification to ISO 9001 wrth compliance to other customer-defined QMS requirements (such as ‘Minimum Automobve Quality Management System Requirements for Sub-Tier Suppliers [MAGMSR] or equivalent) through second-party audits, 4). certification to ISO8001 with compliance to IATF 16949 thraugh second-pary audits; ©) certification to 16949 through third-party audits (valid third-party certification of the supplier to IATF 16949 by an (ATF-recognized certification body). 8.42.3.1 Automotive product-related software or automotive products with ombedded software The organization shall require their suppliers of automotive product-related software, or automotive products with embedded software, to implement and maintain a process for software quality assurance ‘or their products A software development assessment methodology shall be ullized to assess the supplier's software development process. Using prioritization based on risk and potential impact to the customer, the organization shall require the supplier to retan documented information of a software development capably self-assessment ©AIAG, @ANFIA, OFIEV, @ SMT, @VDA-2010-, rights eserves Fy