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1、TECHNICALISO/TSSPECIFICATION 16949Second Edition20020301质量管理体系汽车行业生产件和相关服务件的组织实施ISO 9001:2000的特殊要求Quality management systems Particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizationsInternational Automotive Task ForceReference numb
2、erISO/TS 16949:2002 (B) ISO 2002All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISOs member body in the co
3、untry of the requester.The content inside the boxed text of this document is ISO 9001:2000 text and is 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
4、(see below) and the car manufacturers DaimIerChrysler, 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 pr
5、ior written permission being secured.Requests for permission to reproduce and/or translate nonboxed text should be addressed to one of the addresses below:International Automotive Oversight Bureau (IAOB/USA)Associazione Nazionale Fra Industrie Automobilistiche (ANFIA/Italy)Comite des Constructeurs F
6、ranais dAutomobiles (CCFA/France)Fdration des Industries des Equipements pour Vhicules (FIEV/France)Society of Motor Manufacturers and Traders (SMMT/UK)Verband der Automobilindustrie Qualitatsmanagement Center (VDAOMC/Germany)ContentsPageForeword前言Remarks for certification有关认证的说明Introduction引言0.1 Ge
7、neral总则0.2 Process approach过程方法0.3 Relationship with ISO 9004 与ISO 9004的关系0.3.1 IATF Guidance to ISO/TS 16949:2002 IATF关于ISO/TS 16949:2002的指南0.4 Compatibility with other management systems与其他管理体系的相容性0.5 Goal of this Technical Specification本技术规范的目的1 Scope范围1.1 General总则1.2 Application应用2 Normative re
8、ference引用标准3 Terms and definitions术语和定义3.1Terms and definitions for the automotive industry汽车行业的术语和定义4 Quality management system4.1 General requirements4.1.1 General requirements - Supplemental4.2 Documentation requirements4.2.1 General4.2.2 Quality manual4.2.3 Control of documents4.2.3.1 Engineerin
9、g specifications4.2.4 Control of records4.2.4.1 Records retention5 Management responsibility5.1 Management commitment5.1.1 Process efficiency5.2 Customer focus5.3 Quality policy5.4 Planning5.4.1 Quality objectives5.4.1.1 Quality objectives Supplemental5.4.2 Quality management system planning5.5 Resp
10、onsibility, authority and communication5.5.1 Responsibility and authority5.5.1.1 Responsibility for quality5.5.2 Management representative5.5.2 1 Customer representative5.5.3 Internal communication5.6 Management review5.6.1 General5.6.1.1 Quality management system performance5.6.2 Review input5.6.2.
11、1 Review input Supplemental5.6.3 Review output6 Resource management6.1 Provision of resources6.2 Human resources6.2.1 General6.2.2 Competence, awareness and training6.2.2.1 Product design skills6.2.2.2 Training6.2.2.3 Training on the job6.2.2.4 Employee motivation and empowerment6.3 Infrastructure6.
12、3.1 Plant, facility and equipment planning6.3.2 Contingency plans6.4 Work environment6.4.1 Personnel safety to achieve product quality6.4.2 Cleanliness of premises7 Product realization7.1 Planning of product realization7.1.1 Planning of product realization Supplemental7.1.2 Acceptance criteria7.1.3
13、Confidentiality7.1.4 Change control7.2 Customerrelated processes7.2.1 Determination of requirements related to the product7.2.1.1 Customerdesignated special characteristics7.2.2 Review of requirements related to the product7.2.2.1 Review of requirements related to the product Supplemental7.2.2.2 Org
14、anization manufacturing feasibility7.2.3 Customer communication7.2.3.1 Customer communication Supplemental7.3 Design and development7.3.1 Design and development planning7.3.1.1 Multidisciplinary approach7.3.2 Design and development inputs7.3.2.1 Product design input7.3.2.2 Manufacturing process desi
15、gn input7.3.2.3 Special characteristics7.3 3 Design and development outputs7.3.3.1 Product design outputs Supplemental7.3.3.2 Manufacturing process design output7.3.4 Design and development review7.3.4.1 Monitoring7.3.5Design and development verification7.3.6 Design and development validation7.3.6.1
16、 Design and development validation Supplemental7.3.6.2 Prototype programme7.3.6.3 Product approval process7.3.7 Control of design and development changes7.4 Purchasing7.4.1 Purchasing process7.4.1.1 Regulatory conformity7.4.1.2 Supplier quality management system development7.4.1.3 Customerapproved s
17、ources7.4.2 Purchasing information7.4.3 Verification of purchased product7.4.3.1 Incoming product quality7.4.3.2 Supplier monitoring7.5 Production and service provision7.5.1 Control of production and service provision7.5.1.1 Control plan7.5.1.2 Work instructions7.5.1.3 Verification of job setups7.5.
18、1.4 Preventive and Predictive maintenance7.5.1.5 Management of production tooling7.5.1.6 Production scheduling7.5.1.7 Feedback of information from service7.5.1.8 Servicing agreement with customer7.5.2 Validation of processes for production and service provision7.5.2.1 Validation of processes for pro
19、duction and service provision Supplemental7.5.3 Identification and traceability7.5.3.1 Identification and traceability Supplemental7.5.4 Customer property7.5.4.1 Customerowned production tooling7.5.5 Preservation of product7.5.5.1 Storage and inventory7.6 Control of monitoring and measuring devices7
20、.6.1 Measurement system analysis7.6.2 Calibration/Verification records7.6.3 Laboratory requirements7.6.3.1 Internal laboratory7.6.3.2 External laboratory8 Measurement, analysis and improvement8.1 General8.1.1 Identification of statistical tools8.1.2 Knowledge of basic statistical concepts8.2 Monitor
21、ing and measurement8.2.1 Customer satisfaction8.2.1.1 Customer satisfaction Supplemental8.2.2 Internal audit8.2.2.1 Quality management system audit8.2.2.2 Manufacturing process audit8.2.2.3 Product audit8.2.2.4 Internal audit plans8.2.2.5 Internal auditor qualification8.2.3 Monitoring and measuremen
22、t of processes8.2.3.1 Monitoring and measurement of manufacturing processes8.2.4 Monitoring and measurement of product8.2.4.1 Layout inspection and functional testing8.2.4.2 Appearance items8.3 Control of nonconforming product8.3.1 Control of nonconforming product Supplemental8.3.2 Control of rework
23、ed product8.3.3 Customer information8.3.4 Customer waiver8.4 Analysis of data8.4.1 Analysis and use of data8.5 Improvement8.5.1 Continual improvement8.5.1.1 Continual improvement of the organization8.5.1.2 Manufacturing process improvement8.5.2 Corrective action8.5.2.1 Problem solving8.5.2.2 Errorpr
24、oofing8.5.2.3 Corrective action impact8.5.2.4 Rejected product test/analysis8.5.3 Preventive actionAnnex A (normative) Control Plan附录A (标准的) 控制计划A.1 Phases of the control plan/控制计划的阶段A.2 Elements of the control plan/控制计划的要素Bibliography/引用文献NOTE In this table of contents, ISO 9001:2000 headings are n
25、ormal type face, IATF headings are in italics.注：在本目录中，ISO 9001:2000的标题是正体字，IATF的标题是斜体字。Foreword前言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
26、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 nongovernmental, in liaison with ISO, also take part in the work. ISO colla
27、borates closely with the International Electrotechnical Commission (IEC) on all matters of Electrotechnical standardization.国际标准化组织（ISO）是由各国标准化团体（ISO成员团体）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。各成员团体若对某技术委员会确定的项目感兴趣，均有权参加该委员会的工作。与ISO保持联系的各国际组织（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。Internat
28、ional Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.国际标准遵照ISO/IEC导则第3部分的规则起草。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
29、 for voting. Publication as an International Standard requires approval by at least 75% of the member bodies casting a vote.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，需取得了至少75%参加表决的成员团体的同意，才能作为国际标准正式发布。In other circumstances, particularly when there is an urgent market requirement for such documents, a technical co
30、mmittee 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 50 % of the members of the parent committee casting a vot
31、e;- 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
32、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 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
33、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.ISO/TS 16949:2002是由国际汽车推动小组(IATF)和日本汽车制造商协会(JAMA)，在ISO/TC 176，质量管理和质量保证技术委员会的支持下共同制定的。This second edition
34、 of ISO/TS 16949 cancels and replace the first edition (ISO/TS 16949:1999), which has been technically revised.本第二版ISO/TS 16949取代经技术性修订的第一版ISO/TS 16949 (ISO/TS 16949:1999)。Boxed text is original ISO 9001:2000 text. The sectorspecific supplemental requirements are outside the boxes.方框内的文字是ISO 9001:20
35、00原文。方框外的文字是行业特殊补充要求。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. 在本技术规范中，“必须”(shall)表示要求。“应该”(should)表示推荐。标有“注”(NOTE)的段落是理解或澄清
36、相关要求的指导性解释。Where the term such as is used, any suggestions given are for guidance only.所有用“如”(such as)引出的建议仅具有指导性作用。Annex A forms a normative part of this Technical Specification. 附录A构成本技术规范的一部分。Remarks for certification/有关认证的说明The certification to this Technical Specification, including customerspe
37、cific 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).按照IATF的认证安排获得本技术规范的认证，包括顾客特殊要求（如果有），将获得IATF顾客成员的承认。参见“获得IATF认可的规则”。Details can be obtained at the addresses of the local ov
38、ersight bodies of IATF cited below:Associazione Nazionale Fra Industrie Automobilistiche (ANFIA)Web site: www.anfia.itemail: anfiaanfia.itInternational Automotive Oversight Bureau (IAOB)Web site: www.iaob.orgemail: qualityiaob.orgFederation des Industries des Equipements pour Vehicules (FIEV)Comite
39、des Constructeurs Francais dAutomobiles (CCFA)Web site: www.iatfemail: iatfiatfFSociety of Motor Manufacturers and Traders Ltd. (SMMT Ltd.)Web site: www.smmt.co.ukemail: qualitysmmt.co.ukVerband der Automobilindustrie (VDA) Qualitatsmanagement Center (QMC)Web site: www.vdaqmc.deemail: infovdaqmc.deI
40、ntroduction引言0.1 General总则ISO 9001:2000, Quality management systems RequirementsIntroduction引言0.1 General总则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 varyi
41、ng 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.采用质量管理体系应当是组织的一项战略性决策。一
42、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或文件不是本标准的目的。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 req
43、uirement.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。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.本标准能用于内部和外部（包括认证机构）评定组织满足顾客、法律法规和组织自身要求
44、的能力。The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.本标准的制定已经考虑了GB/T 19000和GB/T 19004中所阐明的质量管理原则。0.2 Process approach过程方法ISO 9001:2000, Quality management systems Requirements0.2 Process approac
45、h过程方法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.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。For an organiz
46、ation to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.为使组织有
47、效运作，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视为过程。通常，一个过程的输出直接形成下一个过程的输入。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 approach”.组织内诸过程的系统的应用，连同这些过程的识别和相互作用及其管理，可称之为“过程方法”。An advantage of the process approach is the ongoing control that it provides over the linkage between the
