TS16949中英文对照版.pdf

1 Reference number ISO/TS 16949:2002(E) ISO 2002 TECHNICAL SPECIFICATION ISO/TS 16949 Second edition 2002-03-01 Quality management systems Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations Systmes de management de la qualit Exigences particulires pour lapplication de lISO 9001:2000 pour la production de srie et de pices de rechange dans lindustrie automobile ISO/TS 16949:2002(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. 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CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland The content inside the boxed text of this document is ISO 9001:2000 text and is 2 protected by the above copyright statement. The text outside the boxes has been originated by the International Automotive Task Force. Copyright for this text is held by ANFIA, CCFA/FIEV, SMMT, VDA (see below) and the car manufacturers DaimlerChrysler, Ford Motor Company, General Motors Corp. Neither this Technical Specification nor any extract from it may be reproduced in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise without prior written permission being secured. Requests for permission to reproduce and/or translate non-boxed text should be addressed to one of the addresses below: International Automotive Oversight Bureau (IAOB/USA) Associazione Nazionale Fra Industrie Automobilistiche (ANFIA/Italy) Comit des Constructeurs Franais dAutomobiles (CCFA/France) Fdration des Industries des quipements pour Vhicules (FIEV/France) Society of Motor Manufacturers and Traders (SMMT/UK) Verband der Automobilindustrie - Qualittsmanagement Center (VDA-QMC/Germany) Contents Page Foreword 7 Remarks for certification 8 Introduction 10 0.1 General 10 0.2 Process approach 10 0.3 Relationship with ISO 9004 12 0.3.1 IATF Guidance to ISO/TS 16949:2000 12 0.4 Compatibility with other management systems 13 0.5 Goal of this Technical Specification 13 1 Scope 14 1.1 General 14 1.2 Application 15 2 Normative reference 15 3 Terms and definitions 16 3.1 Terms and definitions for the automotive industry 16 4 Quality management system 18 4.1 General requirements 18 3 4.1.1 General requirements Supplemental 1 8 4.2 Documentation requirements 19 4.2.1 General 19 4.2.2 Quality manual 19 4.2.3 Control of documents 20 Engineering specifications 20 4.2.4 Control of records 21 Records retention 21 5 Management responsibility 22 5.1 Management commitment 22 5.1.1 Process efficiency 22 5.2 Customer focus 22 5.3 Quality policy 22 5.4 Planning 23 5.4.1 Quality objectives 23 Quality objectives Supplemental 23 5.4.2 Quality management system planning 23 5.5 Responsibility, authority and communication 23 5.5.1 Responsibility and authority 23 Responsibility for quality 24 5.5.2 Management representative 24 Customer representative 24 5.5.3 Internal communication 24 5.6 Management review 25 5.6.1 General 25 Quality management system performance 25 5.6.2 Review input 25 Review input Supplemental 26 5.6.3 Review output 26 6 Resource management 27 6.1 Provision of resources 27 6.2 Human resources 27 6.2.1 General 27 6.2.2 Competence, awareness and training 27 Product design skills 27 Training 28 Training on the job 28 Employee motivation and empowerment 28 6.3 Infrastructure 28 6.3.1 Plant, facility and equipment planning 29 6.3.2 Contingency plans 29 6.4 Work environment 29 6.4.1 Personnel safety to achieve product quality 29 6.4.2 Cleanliness of premises 29 4 7 Product realization 30 7.1 Planning of product realization 30 7.1.1 Planning of product realization Supplemental 30 7.1.2 Acceptance criteria 31 7.1.3 Confidentiality 31 7.1.4 Change control 31 7.2 Customer-related processes 31 7.2.1 Determination of requirements related to the product 31 Customer-designated special characteristics 32 7.2.2 Review of requirements related to the product 32 Review of requirements related to the product Supplemental 33 Organization manufacturing feasibility 3 3 7.2.3 Customer communication 33 Customer communication Supplemental 33 7.3 Design and development 33 7.3.1 Design and development planning 33 Multidisciplinary approach 34 7.3.2 Design and development inputs 34 Product design input 35 Manufacturing process design input 35 Special characteristics 35 7.3.3 Design and development outputs 36 Product design outputs Supplemental 36 Manufacturing process design output 3 6 7.3.4 Design and development review 37 Monitoring 7 7.3.5 Design and development verification 37 7.3.6 Design and development validation 37 Design and development validation Supplemental 38 Prototype programme 38 Product approval process 38 7.3.7 Control of design and development changes 38 7.4 Purchasing 39 7.4.1 Purchasing process 39 Regulatory conformity 39 Supplier quality management system development 40 Customer-approved sources 40 5 7.4.3 Verification of purchased product 40 Incoming product quality 41 Supplier monitoring 41 7.5 Production and service provision 41 7.5.1 Control of production and service provision 41 Control plan 42 Work instructions 42 Verification of job set-ups 42 Preventive and predictive maintenance 4 3 Management of production tooling 43 Production scheduling 43 Feedback of information from ser and service provision vice 4 4 Service agreement with customer 44 7.5.2 Validation of processes for production 44 Validation of processes for production and service provision Supplemental 45 7.5.3 Identification and traceability 45 Identification and traceability Supplemental 45 7.5.4 Customer property 45 Customer-owned production tooling 46 7.5.5 Preservation of product 46 Storage and inventory 46 7.6 Control of monitoring and measuring devices 46 7.6.1 Measurement system analysis 47 7.6.2 Calibration/verification records 47 7.6.3 Laboratory requirements 48 Internal laboratory 4 8 External laboratory 48 8 Measurement, analysis and improvement 50 8.1 General 50 8.1.1 Identification of statistical tools 50 8.1.2 Knowledge of basic statistical concepts 5 0 8.2 Monitoring and measurement 50 Customer satisfaction Supplement 8.2.1 Customer satisfaction 50 al 5 0 8.2.2 Internal audit 51 Quality management system audit 52 Manufacturing process audit 52 Product audit 52 Internal audit plans 52 7.4.2 Purchasing information 40 6 Internal auditor qualification 5 2 8.2.3 Monitoring and measurement of processes 52 manufacturing processes 52 8.2.4 Monitoring and measurement of product 5 3 Layout inspection and functional testing 54 Appearance items 54 548.3 Control of nonconforming product 8.3.1 Control of nonconforming product Supplemental 55 8.3.2 Control of reworked product 55 8.3.3 Customer information 5 5 8.3.4 Customer waiver 55 8.4 Analysis of data 56 8.4.1 Analysis and use of data 56 8.5 Improvement 56 8.5.1 Continual improvement 56 Continual improvement of the organization 57 Manufacturing process improvement 5 7 8.5.2 Corrective action 57 Problem solving 58 Error-proofing 58 Corrective action impact 58 Rejected product test/analysis 58 8.5.3 Preventive action 60 Annex A (normative) Control plan 61 A.1 Phases of the control plan 61 A.2 Elements of the control plan 61 Bibliography 61 NOTE In this table of contents, ISO 9001:2000 headings are normal type face, IATF headings are in italics. Monitoring and measurement of 7 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years with a view to deciding whether it should be confirmed for a further three years, revised to become an International Standard, or withdrawn. In the case of a confirmed ISO/PAS 前言 前言 国际标准化组织(ISO)是由各国标准化机构 (ISO 成员机构)组成的世界性的联合会。制定 国际标准工作通常由 ISO 的技术委员会完成。 各成员团体若对某项目感兴趣，就有权派代表 参加为该项目而成立的技术委员会的工作。与 ISO 保持联系的各国组织 （官方的或非官方的） 也可参加有关工作。ISO 与国际电工委员会 （IEC） 在电工技术标准化方面保持密切合作的 关系。 国际标准是根据 ISO/IEC 导则第 3 部分的规 则起草的。 技术委员会的主要任务是制定国际标准。由技 术委员会通过的国际标准草案提交各成员团体 投票表决。国际标准的公布需要至少 75的参 加投票的成员团体批准。 在其他情况下，特别是当存在对标准化文件的 紧急市场需求时，技术委员会可以决定发布其 它类型的标准化文件： ISO 公布的可获得的规范（ISO/PAS）代表 一项由一个 ISO 工作组内的技术专家达成的协 议，如果它已获得至少 50%委员会成员的表决 通过，就可以得到公布许可。 ISO 技术规范 ISO/TS 代表一项由一个技术 委员会成员达成的协议， 如果它已获得至少 2/3 委员会成员的表决通过，就可获得公布许可。 对 ISO/PAS 或 ISO/TS 三年后进行评审，以决 定是否可以再继续使用三年，或修订以成为国 标标准，或撤除。对决定继续使用的 ISO/PAS 或 ISO/TS.六年后再次评审。那时必须决定是 8 or ISO/TS, it is reviewed again after six years at which time it has to be either transposed into an International Standard or withdrawn. ISO/TS 16949:2002 was prepared by the International Automotive Task Force (IATF) and Japan Automobile Manufacturers Association, Inc. (JAMA), with support from ISO/TC 176, Quality management and quality assurance. This second edition of ISO/TS 16949 cancels and replaces the first edition (ISO/TS 16949:1999), which has been technically revised. Boxed text is original ISO 9001:2000 text. The sector-specific supplemental requirements are outside the boxes. In this Technical Specification, the word “shall” indicates a requirement. The word “should” indicates a recommendation. Paragraphs marked “NOTE” are for guidance in understanding or clarifying the associated requirement. Where the term “such as” is used, any suggestions given are for guidance only. Annex A forms a normative part of this Technical Specification. Remarks for certification The certification to this Technical Specification, including customer-specific requirements if any, is recognized by the customer members of IATF when achieved according to the IATF certification scheme (see the “Rules for achieving IATF recognition”). Details can be obtained at the addresses of the local oversight bodies of IATF cited below: Associazione Nazionale Fra Industrie Automobilistiche (ANFIA) Web site: www.anfia.it e-mail: anfiaanfia.it International Automotive Oversight Bureau (IAOB) Web site: e-mail: Fdration des Industries des quipements pour Vhicules (FIEV) Comit des Constructeurs Franais dAutomobiles (CCFA) Web site: www.iatf- e-mail: iatfiatf-F Society of Motor Manufacturers and Traders 否修订成为国际标准，还是要撤除。 ISO/TS16949 ： 2002 ISO/TS16949 ： 2002 由国际汽车推动小组 （IATF）IATF）和日本汽车制造商协会（JAMAJAMA）,在 ISO/TC176，ISO/TC176， 质量管理和质量保证技术委员会的 支持下共同制定的。 第二版 ISO/TS 16949ISO/TS 16949 取代经技术性修订的第一 版（ISO/TS 16949:1999ISO/TS 16949:1999）. 方框的文字是 ISO9001：2000ISO9001：2000 原文。方框外的 部分是行业特殊补充要求。 在本技术规范中， “必须” 表示要求。 “应该” 表示推荐。标有“注”的段落是对有关标准的 指导性解释或阐述。 所有用“例如”引出的建议都只仅起指导性作 用。 附录 A 是这个技术规范的标准化部分。 有关认证的说明 有关认证的说明 按照 IATF 认证计划获得的本技术规范的认证， 包括顾客的技术要求（如果有） ，将获得 IATF 顾客成员的承认。（见 获得 IATF 认可的规则 ） 详细资料可从以下国际汽车推动小组的监督机 构获得： 意大利汽车工业协会 ANFIA ANFIA Web site:www.anfia.it e-mail:anfiaanfia.it 国际汽车监督局 IAOB IAOB Web site: e-mail: 法国车辆设备工业联盟 FIEV FIEV 法国汽车制造商委员会 CCFA CCFA Web site:www.iatf- 9 Ltd. (SMMT Ltd.) Web site: www.smmt.co.uk e-mail: qualitysmmt.co.uk Verband der Automobilindustrie Qualittsmanagement Center (VDA-QMC) Web site: www.vda-qmc.de e-mail: infovda-qmc.de e-mail:iatfiatf-F 英国汽车与零部件厂商协会 SMMT Ltd SMMT Ltd Web site:www.smmt.co.uk e-mail:qualitysmmt.co.uk 德国汽车工业协会质量管理中心 QMC QMC Web site:www.vda-qmc.de e-mail:infovda-qmc.de 10 Introduction 0.1 General ISO 9001:2000, Quality management systems Requirements Introduction 0.1 General The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. This International Standard can be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, regulatory and the organizations own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard. 0.2 Process approach ISO 9001:2000, Quality management systems Requirements 0.2 Process approach This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation 引言 引言 0.1 总则 0.1 总则 ISO9001：2000，质量管理体系要求 ISO9001：2000，质量管理体系要求 0 引言 0 引言 0.1 总则0.1 总则 采用质量管理体系应该是一个组织的一项战略 性决策。一个组织质量管理体系的设计和实施 受各种需求、具体目标、所提供的产品、所采 用的过程以及该组织的规模和结构的影响。统 一质量管理体系的结构和文件不是本标准的目 的。 本标准所规定的质量管理体系要求是对产品要 求的补充。“注” 是理解和说明有关要求的指南。 本国际标准所规定的质量管理体系能被内部和 外部组织，包括认证机构，用来评定一个组织 满足顾客、法律法规和自身要求的能力。 本国际标准的制定已经考虑了 ISO9000 和 ISO9004 中所阐明的质量管理原则 0.2 过程方法 0.2 过程方法 ISO9001：2000 质量管理体系要求 ISO9001：2000 质量管理体系要求 0.2 过程方法0.2 过程方法 本标准鼓励在建立、实施质量管理体系以及改 进其有效性时，采用过程方法，通 过满足顾客要求，增强顾客满意。 为使组织有效运行，组织必须识别和管理众多 相互关联的活动，通过使用资源和管理，将输 入转化为输出的活动可以视为过程。通常，一 11 of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process appro