IATF 16949:2016 Automotive Quality Management System Standard PDF

AUTOMOTIVE IATF 16949:2016 QUALITY MANAGEMENT SYSTEM STANDARD Quality management system requirements for automotive production and relevant service parts organizations International Automotive Task Force 1st Edition 1 October 2016 IATF copyright notice This Automotive Quality Management System Standard, known as IATF 16949, is copyright protected by the members of the International Automotive Task Force (IATF). The title for this Automotive QMS Standard "IATF 16949" is a 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 written permission being secured from the IATF. Reproduction may be subject to royalty payments or a licensing agreement and violators are subject to legal prosecution. Requests for permission to reproduce and/or translate any part of this Automotive QMS Standard should be addressed to one of the following national automotive trade associations below : Associazione Nazionale Filiera Industrie Automobilistiche (ANFIA / Italy) Automotive Industry Action Group (AIAG / USA) Fédération des Industries des Equipementspour Véhicules (FIEV / France) Society of Motor Manufacturers and Traders Ltd. (SMMT / UK) Verband der Automobilindustrie e.V. (VDA / Germany) IATF 16949: 2016 1 Table of Contents Foreword – Automotive QMS Standard......................................................................................................................7 History...................................................................................................................................................................................... 7 Goal.................................................................................................................................................................... 7 Remarks for certification........................................................................................................................................................8 Introduction......................................................................................................................................................................................................... 9 0.1 General............................................................................................................................................................................... 9 0.2 Quality Management Principles....................................................................................................................................... 9 0.3 Process Approach............................................................................................................................................................... 9 0.3.1 General..........................................................................................................................................................................................9 0.3.2 Plan-Do-Check-Act Cycle................................................................................................................................. 9 0.3.3 Risk-Based Thinking................................................................................................ 0.4 Relationship With Other Management System Standards........................................................................................... 9 Quality Management Systems – Requirements...................................................................................................... 10 1 Scope................................................................................................................................................................................................10 1.1 Scope – automotive supplemental to ISO 9001:2015........................................................................... 10 2 Normative references.............................................................................................................................................10 2.1 Normative and informative references.................................................................................................. 10 3 Terms and definitions............................................................................................................................................ 10 3.1 Terms and definitions for the automotive industry......................................................................... 10 4 Context of the organization.....................................................................................................................................15 4.1 Understanding the organization and its context.............................................................................. 15 4.2 Understanding the needs and expectations of interested parties................................................... 15 4.3 Determining the scope of the quality management system..................................................................15 4.3.1 Determining the scope of the quality management system — supplemental......................................15 4.3.2 Customer-specific requirements..................................................................................................................15 4.4 Quality management system and its processes............................................................................... 15 4.4.1..............................................................................................................................................................................................................................................15 4.4.1.1 Conformance of products and processes..............................................................................................15 4.4.1.2 Product safety.............................................................................................................................................15 4.4.2...................................................................................................................................................................................................... 16 2 IATF 16949: 2016 5 Leadership...............................................................................................................................................................17 5.1 Leadership and commitment.......................................................................................................... 17 5.1.1 General................................................................................................................................................ 17 5.1.1.1 Corporate responsibility.................................................................................................................. 17 5.1.1.2 Process effectiveness and efficiency...............................................................................................17 5.1.1.3 Process owners....................................................................................................... 17 5.1.2 Customer focus.......................................................................................................... 17 5.2 Policy....................................................................................................................................................................17 5.2.1 Establishing the quality policy....................................................................................17 5.2.2 Communicating the quality policy..............................................................................17 5.3 Organizational roles, responsibilities and authorities........................................................................... 17 5.3.1 Organizational roles, responsibilities, and authorities — supplemental........................... 17 5.3.2 Responsibility and authority for product requirements and corrective actions................. 17 6 Planning........................................................................................................................................................ 19 6.1 Actions to address risks and opportunities..................................................................................... 19 6.1.1 and 6.1.2........................................................................................................................... 19 6.1.2.1 Risk analysis........................................................................................................... 19 6.1.2.2 Preventive action................................................................................................... 19 6.1.2.3 Contingency plans................................................................................................... 19. 6.2 Quality objectives and planning to achieve them................................................................................. 20 6.2.1 and 6.2.2................................................................................................................................... 20 6.2.2.1 Quality objectives and planning to achieve them — supplemental............................... 20 6.3 Planning Of Changes.......................................................................................................................................... 20 7 Support........................................................................................................................................................... 21 7.1 Resources........................................................................................................................................................................ 21 7.1.1 General..................................................................................................................................... 21 7.1.2 People....................................................................................................................................... 21 7.1.3 Infrastructure................................................................................................................... 21 7.1.3.1 Plant, facility, and equipment planning.................................................................. 21 7.1.4 Environment for the operation of processes.............................................................. 21 7.1.4.1 Environment for the operation of processes — supplemental................................ 21 7.1.5 Monitoring and measuring resources....................................................................... 21 7.1.5.1 General......................................................................................................................... 21 7.1.5.1.1 Measurement system analysis............................................................................. 22 7.1.5.2 Measurement traceability..................................................................................... 22 IATF 16949: 2016 3 7.1.5.2.1 Calibration/verification records................................................................................ 22 7.1.5.3 Laboratory requirements....................................................................................... 23 7.1.5.3.1 Internal laboratory.............................................................................................. 23 7.1.5.3.2 External laboratory.............................................................................................. 23 7.1.6 Organizational knowledge......................................................................................... 23 7.2 Competence........................................................................................................................................................ 23 7.2.1 Competence — supplemental..................................................................................................................... 24 7.2.2 Competence — on-the-job training............................................................................................................. 24 7.2.3 Internal auditor competency........................................................................................................................ 24 7.2.4 Second-party auditor competency............................................................................................................... 25 7.3 Awareness.................................................................................................................................................. 25 7.3.1 Awareness — supplemental....................................................................................................................... 25 7.3.2 Employee motivation and empowerment................................................................................................. 25 7.4 Communication......................................................................................................................................... 25 7.5 Documented information......................................................................................................................... 25 7.5.1 General........................................................................................................................................................................ 25 7.5.1.1 Quality management system documentation......................................................................................... 25 7.5.2 Creating and updating................................................................................................................................... 26 7.5.3 Control of documented information............................................................................................................ 26 7.5.3.1 and 7.5.3.2...............................................................................................................................................................................26 7.5.3.2.1 Record retention...................................................................................................................................... 26 7.5.3.2.2 Engineering specifications..................................................................................................................... 26 8 Operation......................................................................................................................................................................................... 27 8.1 Operational planning and control............................................................................................................ 27 8.1.1 Operational planning and control — supplemental................................................................................ 27 8.1.2 Confidentiality................................................................................................................................................. 27 8.2 Requirements for products and services................................................................................................. 27 8.2.1 Customer communication............................................................................................................................ 27 8.2.1.1 Customer communication — supplemental........................................................................................... 27 8.2.2 Determining the requirements for products and services........................................................................ 27 8.2.2.1 Determining the requirements for products and services — supplemental....................................... 27 8.2.3 Review of the requirements for products and services........................................................................... 27 8.2.3.1.............................................................................................................................................................................................................................................27 8.2.3.1.1 Review of the requirements for products and services — supplemental...................................... 28 4 IATF 16949: 2016 8.2.3.1.2 Customer-designated special characteristics..................................................................................... 28 8.2.3.1.3 Organization manufacturing feasibility................................................................................................. 28 8.2.3.2....................................................................................................................................................................................................28 8.2.4 Changes to requirements for products and services............................................................................... 28 8.3 Design and development of products and services.........................................................................28 8.3.1 General.........................................................................................................................................................................28 8.3.1.1 Design and development of products and services — supplemental.................................................... 28 8.3.2 Design and development planning.............................................................................................................. 28 8.3.2.1 Design and development planning — supplemental........................................................................... 28 8.3.2.2 Product design skills................................................................................................................................... 29 8.3.2.3 Development of products with embedded software............................................................................ 29 8.3.3 Design and development inputs.................................................................................................................. 29 8.3.3.1 Product design input.................................................................................................................................. 29 8.3.3.2 Manufacturing process design input...................................................................................................... 30 8.3.3.3 Special characteristics............................................................................................................................... 30 8.3.4 Design and development controls............................................................................................................... 30 8.3.4.1 Monitoring............................................................................................................................................................... 30 8.3.4.2 Design and development validation........................................................................................................ 30 8.3.4.3 Prototype programme.............................................................................................................................. 31 8.3.4.4 Product approval process........................................................................................................................ 31 8.3.5 Design and development outputs.............................................................................................................. 31 8.3.5.1 Design and development outputs — supplemental............................................................................. 31 8.3.5.2 Manufacturing process design output................................................................................................... 32 8.3.6 Design and development changes............................................................................................................. 32 8.3.6.1 Design and development changes — supplemental............................................................................ 32 8.4 Control of externally provided processes, products and services........................................... 32 8.4.1 General........................................................................................................................................................................ 32 8.4.1.1 General — supplemental..........................................................................................................................32 8.4.1.2 Supplier selection process.........................................................................................................................33 8.4.1.3 Customer-directed sources (also known as "Directed–Buy")...............................................................33 8.4.2 Type and extent of control............................................................................................................................ 33 8.4.2.1 Type and extent of control — supplemental.......................................................................................... 33 8.4.2.2 Statutory and regulatory requirements.................................................................................................... 34 8.4.2.3 Supplier quality management system development............................................................................. 34 IATF 16949: 2016 5 8.4.2.3.1 Automotive product-related software or automotive products with embedded software.............................................................................................................................. 34 8.4.2.4 Supplier monitoring............................................................................................................................................... 34 8.4.2.4.1 Second-party audits.................................................................................................................................35 8.4.2.5 Supplier development................................................................................................................................35 8.4.3 Information for external providers............................................................................................................... 35 8.4.3.1 Information for external providers — supplemental............................................................................. 35 8.5 Production and service provision............................................................................................. 36 8.5.1 Control of production and service provision..............................................................................................36 8.5.1.1 Control plan.................................................................................................................................................36 8.5.1.2 Standardised work — operator instructions and visual standards....................................................... 36 8.5.1.3 Verification of job set-ups........................................................................................................................... 37 8.5.1.4 Verification after shutdown....................................................................................................................... 37 8.5.1.5 Total productive maintenance................................................................................................................... 37 8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment.......................................................................................................................... 37 8.5.1.7 Production scheduling............................................................................................................................... 38 8.5.2 Identification and traceability...................................................................................................................... 38 8.5.2.1 Identification and traceability — supplemental...................................................................................... 38 8.5.3 Property belonging to customers or external providers........................................................................... 39 8.5.4 Preservation.................................................................................................................................................... 39 8.5.4.1 Preservation — supplemental.................................................................................................................. 39 8.5.5 Post-delivery activities.................................................................................................................................... 39 8.5.5.1 Feedback of information from service..................................................................................................... 39 8.5.5.2 Service agreement with customer............................................................................................................ 39 8.5.6 Control of changes......................................................................................................................................... 40 8.5.6.1 Control of changes — supplemental...................................................................................................... 40 8.5.6.1.1 Temporary change of process controls................................................................................................ 40 8.6 Release of products and services..................................................................................................... 41 8.6.1 Release of products and services — supplemental.................................................................................41 8.6.2 Layout inspection and functional testing....................................................................................................41 8.6.3 Appearance items..........................................................................................................................................41 8.6.4 Verification and acceptance of conformity of externally provided products and services.............................................................................................................................................42 6 IATF 16949: 2016 8.6.5 Statutory and regulatory conformity............................................................................................................ 42 8.6.6 Acceptance criteria......................................................................................................................................... 42 8.7 Control of nonconforming outputs.......................................................................................................... 42 8.7.1.......................................................................................................................................................................... 42 8.7.1.1 Customer authorization for concession................................................................................................... 42 8.7.1.2 Control of nonconforming product — customer-specified process................................................... 42 8.7.1.3 Control of suspect product........................................................................................................................ 42 8.7.1.4 Control of reworked product..................................................................................................................... 42 8.7.1.5 Control of repaired product....................................................................................................................... 43 8.7.1.6 Customer notification..................................................................................................................................43 8.7.1.7 Nonconforming product disposition........................................................................................................ 43 8.7.2.......................................................................................................................................................................................................................... 43 9 Performance evaluation......................................................................................................................................... 44 9.1 Monitoring, measurement, analysis and evaluation........................................................................44 9.1.1 General.........................................................................................................................................................................44 9.1.1.1 Monitoring and measurement of manufacturing processes.............................................................. 44 9.1.1.2 Identification of statistical tools.................................................................................................................. 44 9.1.1.3 Application of statistical concepts............................................................................................................ 44 9.1.2 Customer satisfaction..................................................................................... 45 9.1.2.1 Customer satisfaction — supplemental................................................................................................. 45 9.1.3 Analysis and evaluation.................................................................................. 45 9.1.3.1 Prioritization................................................................................................................................................ 45 9.2 Internal audit................................................................................................................................................................... 45 9.2.1 and 9.2.2.......................................................................................................................................................................................................45 9.2.2.1 Internal audit programme.....................................................................................................................................45 9.2.2.2 Quality management system audit........................................................................................................... 46 9.2.2.3 Manufacturing process audit................................................................................................................... 46 9.2.2.4 Product audit............................................................................................................................................... 46 9.3 Management review.......................................................................................................................................... 46 9.3.1 General.........................................................................................................................................................................46 9.3.1.1 Management review — supplemental.................................................................................................... 46 9.3.2 Management review inputs.......................................................................................................................... 46 9.3.2.1 Management review inputs — supplemental........................................................................................ 46 9.3.3 Management review outputs....................................................................................................................... 47 9.3.3.1 Management review outputs — supplemental..................................................................................... 47 IATF 16949: 2016 7 10 Improvement................................................................................................................................................................................ 48 10.1 General........................................................................................................................................................................... 48 10.2 Nonconformity and corrective action................................................................................................... 48 10.2.1 and 10.2.2..................................................................................................................................................................................................48 10.2.3 Problem solving............................................................................................................................................ 48 10.2.4 Error-proofing........................................................................................................................................................... 48 10.2.5 Warranty management systems................................................................................................................ 48 10.2.6 Customer complaints and field failure test analysis................................................................................ 48 10.3 Continual improvement......................................................................................................................... 49 10.3.1 Continual improvement — supplemental............................................................................................... 49 Annex A: Control Plan...................................................................................................................................... 50 A.1 Phases of the control plan.............................................................................................................. 50 A.2 Elements of the control plan.......................................................................................................... 50 Annex B: Bibliography – supplemental automotive......................................................................................... 52 8 IATF 16949: 2016 Foreword — Automotive QMS Standard This Automotive Quality Management System Standard, herein referred to as "Automotive QMS Standard" or "IATF 16949," along with applicable automotive customer-specific requirements, ISO 9001:2015 requirements, and ISO 9000:2015 defines the fundamental quality m anagement system requirements for automotive production and relevant service parts organizations. As such, this Automotive QMS Standard cannot be considered a stand-alone QMS Standard but has to be comprehended as a supplement to and used in conjunction wi th ISO 9001:2015. 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 re quirements. Annex B is provided for guidance to implement the IATF 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 Forc e (IATF) with the aim of harmonizing the different assessment and certification systems worldwide 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 original 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 16949:2009 (3rd edition) to this Automotive QMS Standard, IATF 16949, feedback was solicited from certification bodies, auditors, suppliers, and OEMs to create IATF 16949:2016 (1st edition), which cancels and replaces ISO/TS 16949:2009 (3rd 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 in the supply chain. IATF 16949: 2016 9 Remarks for certification Requirements for certification to this Automotive QMS Standard are defined in the Rules for achieving and maintaining IATF recognition. Details can be obtained from the local Oversight Offices of the IATF cited below: Associazione Nazionale Filiera Industrie Automobilistiche (ANFIA) Web site: www.anfia.it e-mail: [email protected] International Automotive Oversight Bureau (IAOB) Web site: www.iaob.org e-mail: [email protected] IATF France Web site: www.iatf-france.com e-mail: [email protected] Society of Motor Manufacturers and Traders Ltd. (SMMT Ltd.) Web site: www.smmtoversight.co.uk e-mail: [email protected] Verband der Automobilindustrie — Qualilats Management Center (VDA QMC) Web site: www.vda-qmc.de e-mail: [email protected] All public information about the IATF can be found at the IATF website: www.iatfglobaloversight.org 10 IATF 16949: 2016 Introduction 0.1 General See ISO 9001:2015 requirements. 0.2 Quality management principles See ISO 9001:2015 requirements. 0.3 Process approach 0.3.1 General See ISO 9001:2015 requirements. 0.3.2 Plan-Do-Check-Act 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 9001:2015 requirements. IATF 16949: 2016 11 Quality management systems — Requirements 1 Scope See ISO 9001:2015 requirements. 1.1 Scope – automotive supplemental to ISO 9001:2015 This Automotive QMS Standard defines the quality management system requirements for the design and development, production and, when relevant, assembly, installation, and services of automotive-related products, including products with embedded software. This Automotive QMS Standard is applicable to sites of the organization where manufacturing of customer-specified production parts, service parts, and/or accessory parts occur. This Automotive QMS Standard should be applied throughout the automotive supply chain. 2 Normative references See ISO 9001:2015 requirements. 2.1 Normative and informative references Annex A (Control Plan) is a normative part of this Automotive QMS standard. Annex B (Bibliography – automotive supplemental) is informative, which provides additional information intended to assist the understanding or use of this Automotive QMS standard. 3 Terms and definitions See ISO 9001:2015 requirements. 3.1 Terms and definitions for the automotive industry accessory part customer-specified additional component(s) that are either mechanically or electronically connected to the vehicle or powertrain before (or after) delivery to the final customer (e.g., custom floor mats, truck bed liners, wheel covers, sound system enhancements, sunroofs, spoilers, super-chargers, etc.) advanced product quality planning (APQP) product quality planning process that supports development of a product or service that will satisfy customer requirements; APQP serves as a guide in 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, quality 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 original equipment specifications authorization documented permission for a person(s) specifying rights and responsibilities related to giving or denying permissions or sanctions within an organization 12 IATF 16949: 2016 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 fixtures (e.g., go / no-go gauging) control plan documented description of the systems and processes required for controlling the manufacturing of product (see Annex A) customer requirements all requirements specified by the customer (e.g., technical, commercial, product and m anufacturing 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 less time to assemble, thereby reducing assembly costs) design for manufacturing (DFM) integration of product design and process planning to design a product that is easily and economically manufactured design for manufacturing and assembly (DFMA) combination of two methodologies: Design for Manufacture (DFM), which is the process 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 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 authority to establish a new, or change an existing, product specification NOTE This responsibility includes testing and verification 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 IATF 16949: 2016 13 fault tree analysis (FTA) deductive failure 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 overall system laboratory facility for inspection, test, or calibration that may include but is not limited to the following: chemical, metallurgical, dimensional, physical, electrical, or reliability testing laboratory scope controlled document containing  specific tests, evaluations, and calibrations that a laboratory is qualified to perform;  a list of the equipment that the laboratory uses to perform the above; and  a list of methods and standards to which the laboratory performs the above manufacturing process of making or fabricating  production materials;  production parts or service parts;  assemblies; or  heat treating, welding, painting, plating, or other finishing services manufacturing feasibility an 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 is not limited to the following (as applicable): within the estimated costs, and if the necessary resources, facilities, tooling, capacity, software, and personnel with required skills, including support functions, are or are planned to be 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 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 organization; 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 manufacturer, meets all the requirements of a "good part" (also referred to as "No Fault Found" or "Trouble Not Found") 14 IATF 16949: 2016 outsourced process portion of an organization's function (or processes) that is performed by an external organizat ion 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 returned to service predictive maintenance an approach and set of techniques to evaluate the condition 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 addition to contracted delivery NOTE This can be caused by method, quantity, unscheduled or late deliveries, etc. preventive maintenance planned activities 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 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 condition where manufacturing processes are idle; time 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 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 location at which value-added manufacturing processes occur IATF 16949: 2016 15 special characteristic classification of a product characteristic or manufacturing process parameter that can affect safety or compliance with regulations, fit, function, performance, requirements, or subsequent processing of product special status notification of a customer-identified classification assigned to an organization where one or more customer requirements are not being satisfied due to a significant quality or delivery issue support function non-production activity (conducted on site or at a remote location) that supports o ne (or more) manufacturing sites of the same organization total productive maintenance a 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 characteristics of a product to each other; a product's performance on one characteristic is mapped on the Y -axis and another on the x- axis, then a curve is plotted to illustrate product performance relative to the two characteristics trade-off process methodology of developing and using trade-off curves for products and their performance characteristics that establish the customer, technical, and economic relations hip between design alternatives 16 IATF 16949: 2016 4 Context of the organization 4.1 Understanding the organization and its context See ISO 9001:2015 requirements. 4.2 Understanding the needs and expectations of interested parties 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 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-specific requirements Customer-specific requirements shall be evaluated and included in the scope of the organization's quality management system. 4.4 Quality management system and its processes 4.4.1 See ISO 9001:2015 requirements 4.4.1.1 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 8.4.2.2). 4.4.1.2 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 following, where applicable: a) identification by the organization of statutory and regulatory product-safety requirements; b) customer notification of requirements in item a); c) special approvals for design FMEA; d) identification of product safety-related characteristics; e) identification and controls of safety-related characteristics of product and at the point of manufacture; f) special approval of control plans and process FMEAs; g) reaction plans (see Section 9.1.1.1); IATF 16949: 2016 17 h) defined responsibilities, definition of escalation process and flow of information, including top management, and customer notification; i) training identified by the organization or customer for personnel involved in product-safety related products and associated manufacturing processes; j) changes of product or process shall be approved prior to implementation, including evaluation of potential effects on product safety from process and product changes (see ISO 9001, Section 8.3.6); k) transfer of requirements with regard to product safety throughout the supply chain, including customer-designated sources (see Section 8.4.3.1); l) product traceability by manufactured lot (at a minimum) throughout the supply chain (see Section 8_5.2.1); m) lessons learned for new product introduction. NOTE: Special approval is an additional approval by the function (typically the customer) that is responsible to approve such documents with safety-related content. 4.4.2 See ISO 9001:2015 requirements. 18 IATF 16949: 2016 5 Leadership 5.1 Leadership and commitment 5.1.1 General See ISO 9001:2015 requirements. 5.1.1.1 Corporate responsibility The organization shall define and implement corporate responsibility 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 to evaluate and improve their effectiveness and efficiency. The results of the process review activities shall be included as input to the management review (see Section 9.3.2.1.). 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 roles and be competent to perform those roles (see ISO 9001, Section 7.2). 5.1.2 Customer focus See ISO 9001:2015 requirements. 5.2 Policy 5.2.1 Establishing the quality policy See ISO 9001:2015 requirements. 5.2.2 Communicating the quality policy See ISO 9001:2015 requirements. 5.3 Organizational roles, responsibilities and authorities See ISO 9001:2015 requirements. 5.3.1 Organizational roles, responsibilities, and authorities — supplemental Top management shall assign personnel with the responsibility and authority to ensure that customer requirements are met. These assignments shall be documented. This includes but is not limited to the selection of special characteristics, setting quality objectives and related training, corrective and 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 product requirements have the authority to stop shipment and stop production to correct quality problems; IATF 16949: 2016 19 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 authority and responsibility for corrective action are promptly informed of products or 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; c) production operations across all shifts are staffed with personnel in charge of, or delegated responsibility for, ensuring conformity to product requirements. 20 IATF 16949: 2016 6 Planning 6.1 Actions to address risks and opportunities 6.1.1 and 6.1.2 See ISO 9001:2015 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 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 nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the severity of the potential issues. The organization shall establish a process to lessen the impact of negative effects of risk including the following: a) determining potential nonconformities and their causes; b) evaluating the need for action to prevent occurrence of nonconformities; c) determining and implementing action needed; d) documented information of action taken; e) reviewing the effectiveness of the preventive action taken; f) utilizing lessons learned to prevent recurrence in similar processes (see ISO 9001, Section 7.1.6). 6.1.2.3 Contingency plans The organization shall: a) identify and evaluate internal 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 to risk and impact to the customer; c) 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 externally provided products, processes, and services; recurring natural disasters; fire; utility interruptions; labour shortages; or infrastructure disruptions; d) include, as a supplement to the contingency plans, a notification process to the customer and other interested parties for the extent and duration of any situation impacting customer operations; e) periodically test the contingency plans for effectiveness (e.g., simulations, as appropriate); f) conduct contingency plan reviews (at a minimum annually) using a multidisciplinary team including top management, and update as required; g) document the contingency plans and retain documented information describing any revision(s), including the person(s) who authorized the change(s). IATF 16949: 2016 21 The contingency plans shall include provisions to validate that the m anufactured 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 objectives and planning to achieve them 6.2.1 and 6.2.2 See ISO 9001:2015 requirements. 6.2.2.1 Quality objectives and planning to achieve them — supplemental Top management shall ensure that quality objectives to meet customer requirements are defined, established, and maintained for relevant functions, processes, and levels throughout the organization. The results of the organization's review regarding interested parties and their relevant requirements shall be considered when the organization establishes its annual (at a minimum) quality objectives and related performance targets (internal and external). 6.3 Planning of changes See ISO 9001:2015 requirements. 22 IATF 16949: 2016 7 Support 7.1 Resources 7.1.1 General See ISO 9001:2015 requirements. 7.1.2 People See ISO 9001:2015 requirements. 7.1.3 Infrastructure See ISO 9001:2015 requirements. 7.1.3.1 Plant, facility, and equipment planning The organization shall use a multidisciplinary approach including risk identification and risk mitigation methods for developing and improving plant, facility, and equipment plans. In designing plant layouts, the organization shall: a) optimize material flow, material handling, and value-added use of floor space including control of nonconforming product, and b) facilitate synchronous material flow, as applicable. Methods shall be developed and implemented to evaluate manufacturing feasibility for new product or new operations. Manufacturing feasibility assessments shall include capacity planning. These methods shall also be applicable for evaluating proposed changes to existi ng operations. The organization shall maintain process effectiveness, including periodic re-evaluation relative to risk, to incorporate any changes made during process approval, control plan maintenance (see Section 8.5.1.1), and verification 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 ISO 9001, Section 9.3). NOTE 1 These requirements should include the application of lean manufacturing principl es. NOTE 2 These requirements should apply to on-site supplier activities, as applicable. 7.1.4 Environment for the operation of processes See ISO 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 safety aspects of this requirement. 7.1.4.1 Environment for the operation of processes — supplemental The organization shall maintain its premises in a state of order, cleanliness, and repair that is consistent with the product and manufacturing process needs. 7.1.5 Monitoring and measuring resources 7.1.5.1 General See ISO 9001:2015 requirements. IATF 16949: 2016 23 7.1.5.1.1 Measurement system analysis Statistical studies 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 criteria used shall conform to those in reference manuals on measurement systems analysis. 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 alternative measurement systems analysis (see Section 9.1.1.1). NOTE Prioritization of MSA studies should focus on critical or special product or process characteristics. 7.1.5.2 Measurement traceability See ISO 9001:2015 requirements. NOTE A number or another identifier traceable to the device calibration record meets the intent of the requirements in ISO 9001:2015. 7.1.5.2.1 Calibration/verification records The organization shall have a documented process for managing calibration/verification records. Records of the calibration/verification activity for all gauges and measuring and test equipment (including employee-owned equipment relevant for measuring, customer-owned equipment, or on-site supplier-owned equipment) needed to provide evidence of conformity to internal requirements, legislative and regulatory requirements, and customer-defined requirements shall be retained. The organization shall ensure that calibration/verification activities and records shall include the following details: a) revisions following engineering changes that impact measurement systems; b) any out-of-specification readings as received for calibration/verification; c) 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 verification or calibration or during its use, documented information on 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; e) notification to the customer if suspect product or material has been shipped; f) statements of conformity to specification after calibration/verification; g) verification that the software version used for product and process control is as specified; h) records of the calibration and maintenance activities for all gauging (including employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment); i) production-related software verification used for product and process control (including software installed on employee-owned equipment, customer-owned equipment, or on-site supplier-owned equipment). 24 IATF 16949: 2016 7.1.5.3 Laboratory requirements 7.1.5.3.1 Internal laboratory An organization's internal laboratory facility shall have a defined scope that includes its capability 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 a minimum, requirements for: a) adequacy of the laboratory technical procedures; b) competency of the laboratory personnel; c) testing of the product; d) capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.); when no national or international standard(s) is available, the organization shall define and implement a methodology to verify measurement system capability; e) customer requirements, if any; f) 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. 7.1.5.3.2 External laboratory External/commercial/independent laboratory facilities used for inspection, 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 shall be accredited to ISO/IEC 17025 or national equivalent and include the relevant inspection, test, or calibration service in the scope of the accreditation (certificate); the certificate 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 for a given piece of equipment. In such cases, the organization shall ensure that the requirements listed 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, if required. 7.1.6 Organizational knowledge See ISO 9001:2015 requirements. 7.2 Competence See ISO 9001:2015 requirements. IATF 16949: 2016 25 7.2.1 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 all personnel performing activities affecting conformity to product and process requirements. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements. 7.2.2 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, internal requirements, regulatory or legislative 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 complexity 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 to customer requirements. 7.2.3 Internal auditor competency The organization shall have a documented process(es) to verify that internal auditors are competent, taking into account any customer-specific requirements. For additional guidance on auditor competencies, refer to ISO 19011. The organization shall maintain a list of qualified internal auditors. Quality management system auditors, manufacturing process auditors, and product auditors shall all be able to demonstrate the following minimum competencies: a) understanding of the automotive process approach for auditing, including risk-based thinking; b) understanding of applicable customer-specific requirements; c) understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit; d) understanding of applicable core tool requirements related to the scope of the audit; e) understanding how to plan, conduct, report, and close out audit findings. Additionally, manufacturing process auditors 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 auditor competence shall be demonstrated through: f) executing a minimum number of audits per year, as defined by the organization; and g) maintaining knowledge of relevant requirements based on internal changes (e.g., process technology, product technology) and external changes (e.g., ISO 9001, IATF 16949, core tools, and customer specific requirements). 26 IATF 16949: 2016 7.2.4 Second-party auditor competency The organization shall demonstrate the competence of the auditors undertaking the second-party audits. Second-party auditors shall meet customer specific requirements for auditor qualification and demonstrate the minimum following core competencies, including understanding of: a) the automotive process approach to auditing, including risk based thinking; b) applicable customer and organization specific requirements; c) applicable ISO 9001 and IATF 16949 requirements related to the scope of the audit; d) applicable manufacturing process(es) to be audited, including PFMEA and control plan; e) applicable core tool requirements related to the scope of the audit; f) how to plan, conduct, prepare audit reports, and close out audit findings. 7.3 Awareness See ISO 9001:2015 requirements. 7.3.1 Awareness — supplemental The organization shall maintain documented information that demonstrates that all employees are aware of their impact on product quality and the importance of their activities in achieving, maintaining, and improving quality, including customer requirements and the risks involved for the customer with nonconforming product. 7.3.2 Employee motivation and empowerment The organization shall maintain a documented process(es) to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment that promotes innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization. 7.4 Communication See ISO 9001:2015 requirements. 7.5 Documented information 7.5.1 General See ISO 9001:2015 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 manual is at the discretion of the organization and will depend on the organization's size, culture, and complexity. If a series of documents is used, then a list shall be retained of the documents that comprise the quality manual for the organization. The quality manual shall include, at a minimum, the following: 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; IATF 16949: 2016 27 c) the organization's processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes; d) a document (i.e., matrix) indicating where within the organization's quality management system their customer- specific requirements are addressed. NOTE A matrix of how the requirements of this Automotive QMS standard are addressed by the organization's processes may be used to assist with linkages of the organization's processes and this Automotive QMS. 7.5.2 Creating and updating See ISO 9001:2015 requirements. 7.5.3 Control of documented information 7.5.3.1 and 7.5.3.2 See ISO 9001:2015 requirements. 7.5.3.2.1 Record retention The organization shall define, document, and implement a record retention policy. The control of records shall satisfy 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 time that the product 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. 7.5.3.2.2 Engineering specifications The organization shall have a documented process describing the review, distribution, and implementation of all customer engineering standards/specifications and related revisions based on customer schedules, as required. When an engineering standard/specification change results in a product design change, refer to the requirements in ISO 9001, Section 8.3.6. When an engineering standard/specification change results in a product realization process change, refer to the requirements in Section 8.5.6.1. The organization shall retain 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 production part approval when these specifications are referenced on the design record or if they affect documents of the production part approval process, such as control plan, risk analysis (such as FMEAs), etc. 28 IATF 16949: 2016 8 Operation 8.1 Operational planning and control See ISO 9001:2015 requirements. 8.1.1 Operational planning and control — supplemental When planning for product realization, the following topics shall be included: a) customer product requirements and technical specifications; b) logistics requirements; c) manufacturing feasibility; d) project planning (refer to ISO 9001, Section 8.3.2); e) acceptance criteria. The resources identified in ISO 9001, Section 8.1 c), refer to the required verification, validation, monitoring, measurement, inspection, and test activities 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 services 8.2.1 Customer communication See ISO 9001:2015 requirements. 8.2.1.1 Customer communication — supplemental Written or 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-specified computer language and format (e.g., computer-aided design data, electronic data interchange). 8.2.2 Determining the requirements for products and services See ISO 9001:2015 requirements. 8.2.2.1 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 8.2.2 item a) 1), shall include but not be limited to the following: all applicable government, safety, and environmental regulations related to acquisition, storage, handling, recycling, elimination, or disposal of material. 8.2.3 Review of the requirements for products and services 8.2.3.1 See ISO 9001:2015 requirements. IATF 16949: 2016 29 8.2.3.1.1 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. 8.2.3.1.2 Customer-designated special characteristics The organization shall conform to customer requirements for designation, approval documentation, and control of special characteristics. 8.2.3.1.3 Organization manufacturing feasibility The organization shall utilize a multidisciplinary approach to conduct an analysis to determine if it is feasible that the organization's manufacturing processes are capable of consistently producing product that meets all of the engineering and capacity requirements specified by the customer. The organization shall conduct this feasibility analysis for any manufacturing or product technology new to the organization and for any changed manufacturing process or product design. Additionally, the organization should validate through production runs, benchmarking studies, or other appropriate methods, their ability to make product to specifications at the required rate. 8.2.3.2 See ISO 9001:2015 requirements. 8.2.4 Changes to requirements for products and services See ISO 9001:2015 requirements. 8.3 Design and development of products and services 8.3.1 General See ISO 9001:2015 requirements. 8.3.1.1 Design and development of products and services — supplemental The requirements of ISO 9001, Section 8.3.1, 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 ISO 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 the organization and, as appropriate, its supply chain. Examples of areas for using such a multidisciplinary approach include but are not limited to the following: a) project management (for example, APQP or VDA -RGA); b) product and manufacturing process design activities (for example, DFM and DFA), such as consideration of the use of alternative designs and manufacturing processes; c) development and review of product design risk analysis (FMEAs), including actions to reduce potential risks; 30 IATF 16949: 2016 d) development and review of manufacturing process risk analysis (for example, FMEAs, process flows, control plans, and standardised work instructions). NOTE A multidisciplinary 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 responsibility are competent to achieve design requirements and are skilled in applicable product design tools and techniques. Applicable tools and techniques shall be identified by the organization. NOTE An example of product design skills is the application of digitized mathematically based data. 8.3.2.3 Development of products with embedded software The organization shall use a process for quality assurance for their products with internally developed embedded software. A software development assessment methodology shall be utilized to assess the organization's software development process. Using prioritization based on risk and potential impact to the customer, the organization shall retain documented information of a software development capability self-assessment. The organization shall include software 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 contract review. Product design input requirements include but are not limited to the following: a) product specifications including but not limited to special characteristics (see Section 8.3.3.3); b) boundary and interface requirements; c) identification, traceability, and packaging; d) consideration of design alternatives; e) assessment of risks with the input requirements and the organization's ability to mitigate/ manage the risks, including from the feasibility analysis; f) targets forconformity toproduct requirements including preservation, reliability, durability, serviceability, health, safety, environmental, development timing, and cost; g) applicable statutory and regulatory requirements of the customer-identified country of destination, if provided; h) embedded software requirements. The organization shall have a process to deploy information gained from previous design projects, competitive product analysis (benchmarking), supplier feedback, internal input, field data, and other relevant sources for current and future projects of a similar nature. NOTE One approach for considering design alternatives is the use of trade-off curves. IATF 16949: 2016 31 8.3.3.2 Manufacturing process design input The organization shall identify, document, and review manufacturing process design input requirements including but not limited to the following: a) product design output data including special characteristics; b) targets for productivity, process capability, timing, and cost; c) manufacturing technology alternatives; d) customer requirements, if any; e) experience from previous developments; f) n ew ma teria ls ; g) product handling and ergonomic requirements; and h) design for manufacturing and design for assembly. The manufacturing process design shall include the use of error -proofing methods to a degree appropriate to the magnitude of the problem(s) and commensurate with the risks encountered. 8.3.3.3 Special characteristics The organization shall use a multidisciplinary approach to establish, document, and implement its process(es) to identify special characteristics, including those determined by the customer and the risk analysis performed by the organization, and shall include the following: a) documentation of all special characteristics in the drawings (as required), risk analysis (such as FMEA), control plans, and standardised work/operator instructions; special characteristics are identified with specific markings and are cascaded through each of these documents; b) development of control and monitoring strategies for special characteristics of products and production processes; c) customer-specified approvals, when required; d) compliance with customer-specified definitions and symbols or the organization's equivalent symbols or 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 9001:2015 requirements. 8.3.4.1 Monitoring Measurements at Specified stages during the design and development of products and processes shall be defined, analysed, and reported with summary results as an input to management review (see Section 9.3.2.1). When required by the customer, measurements of the product and process 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 times, 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 32 IATF 16949: 2016 design and development validation shall be planned in alignment with customer -specified timing, as applicable. Where contractually agreed with the customer, this shall include evaluation of the interaction of the organization's product, including embedded software, within the system of the final customer's product. 8.3.4.3 Prototype programme When required by the customer, the organization shall have a prototype programme and control plan. The organization shall use, whenever possible, the same suppliers, tooling, and manufacturing processes as will be used in production. All performance-testing activities shall be monitored for timely completion and conformity to requirements. When services are outsourced, the organization shall include the type and extent of control in the scope of its quality management system to ensure that outsourced services conform to re quirements (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 customer(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 9001:2015 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: a) design risk analysis (FMEA); b) reliability study results; c) product special characteristics; d) results of product design error-proofing, such as DFSS, DFMA, and FTA; e) product definition including 3D models, technical data packages, product manufacturing information, and geometric dimensioning & tolerancing (GD&T): f) 2D drawings, product manufacturing information, and geometric dimensioning & tolerancing (GD&T): g) p ro d u c t d es ig n re v ie w r es u l t s ; h) service diagnostic guidelines and repair and serviceability instructions; i) service part requirements; j) packaging and labeling IATF 16949: 2016 33 NOTE Interim design outputs should include any engineering problems being resolved through a trade-off process. 8.3.5.2 Manufacturing process design output The organization shall document the manufacturing process de sign output in a manner that enables verification against the manufacturing process design inputs. The organization shall verify the outputs against manufacturing process design input requirements. The manufacturing process design output shall include but is not limited to the following: a) specifications and drawings; b) special characteristics for product and manufacturing process; c) identification of process input variables that impact characteristics; d) tooling and equipment for production and control, including capability studies of equipment and process(es); e) manufacturing process flow charts/layout, including linkage of product, process, and tooling; f) capacity analysis; g) manufacturing process FMEA; h) maintenance plans and instructions; i) control plan (see Annex A); j) standardised work and work instructions; k) process approval acceptance criteria; l) data for quality, reliability, maintainability, and measurability; m) results of error-proofing identification and verification, as appropriate; n) methods of rapid detection, feedback, and correction of product/manufacturing process nonconformities. 8.3.6 Design and development changes See ISO 9001:2015 requirements. 8.3.6.1 Design and development changes — supplemental The organization shall evaluate all design changes after initial product approval, including those proposed by the organization or its suppliers, for potential impact on fit, form, function, performance, and/or durability. These changes shall be validated against customer requirements and approved internally, prior to production implementation. If required by the customer, the organization shall obtain documented approval, or a documented waiver, from the customer prior to production implementation. For products with embedded software, the organization sha ll document the revision level of software and hardware as part of the change record. 8.4 Control of externally provided processes, products and services 8.4.1 General See ISO 9001:2015 requirements. 8.4.1.1 General — supplemental The organization shall include all products and services that affect customer requirements such as 34 IATF 16949: 2016 sub-assembly, sequencing, sorting, rework, and calibration services in the scope of their definition of externally provided products, processes, and services. 8.4.1.2 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 product conformity and uninterrupted supply of the organization's product to their customers; b) relevant quality and delivery performance; c) an evaluation of the supplier's quality management system; d) multidisciplinary decision making; and e) an assessment of software development capabilities, if applicable. Other supplier selection criteria that should be considered include the following: volume of automotive business (absolute and as a percentage of

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