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1、technicalspecificationiso/ts16949second edition2002-03-01quality management systems particular requirements for the applicationof iso 9001:2000 for automotive productionand relevant service part organizationssystmes de management de la qualit exigences particulires pour lapplication de liso 9001:200
2、0 pour laproduction de srie et de pices de rechange dans lindustrie automobilereference numberiso/ts 16949:2002(e) iso 2002中华人民共和国国家标准gb/t18305-2003/iso/ts16949:2002 代替 gb/t18305-2001 质量管理体系 汽车生产件及相关维修零件组织应用gb/t19001-2000的特别要求quality management systemsparticular requirements for the applicationof is
3、o 9001:2000 for automotive productionand relevant service part organizations 2003-01-17发布 2003-06-01实施 中 华 人 民 共 和 国国家质量监督检验检疫总局 发布iso/ts 16949:2002(e)pdf disclaimerthis pdf file may contain embedded typefaces. in accordance with adobes licensing policy, this file may be printed or viewed but shall
4、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.ado
5、be is a trademark of adobe systems incorporated.details of the software products used to create this pdf file can be found in the general info relative to the file; the pdf-creation parameters were optimized for printing. every care has been taken to ensure that the file is suitable for use by iso m
6、ember bodies. in the unlikely event that a problem relating to it is found, please inform the central secretariat at the address given below. 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
7、mechanical, including photocopying and microfilm, without permission in writing from either iso at the address below or isos member body in the country of the requester. iso copyright officecase postale 56 ch-1211 geneva 20tel. + 41 22 749 01 11fax + 41 22 749 09 47e-mail copyrightiso.ch web www.iso
8、.ch printed in switzerlandthe 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, v
9、da (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
10、prior written permission being secured.requests for permission to reproduce and/or translate non-boxed text should be addressed to one of the addressesbelow:international automotive oversight bureau (iaob/usa)associazione nazionale fra industrie automobilistiche (anfia/italy)comit des constructeurs
11、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) iso 2002 all rights reserved anfia, ccfa/fiev, smmt, vda, daimlerchrysl
12、er, ford motor company, general motors corp. all rights reservediso/ts16949:2002 second editionpdf disclaimercontentsforewordremarks for certificationintroduction0.1 general0.2 process approach0.3 relationship with iso 9004 0.3.1 iatf guidance to iso/ts 16949:20000.4 compatibility with other managem
13、ent systems 0.5 goal of this technical specification 1 scope 1.1 general1.2 application 2 normative reference 3 terms and definitions3.1 terms and definitions for the automotive industry4 quality management system 4.1 general requirements 4.1.1 general requirements supplemental 4.2 documentation req
14、uirements4.2.1 general 4.2.2 quality manual 4.2.3 control of documents engineering specifications4.2.4 control of records records retention5 management responsibility 5.1 management commitment5.1.1 process efficiency5.2 customer focus 5.3 quality policy 5.4 planning 5.4.1 quality obje
15、ctives quality objectives supplemental5.4.2 quality management system planning 5.5 responsibility, authority and communication 5.5.1 responsibility and authority responsibility for quality5.5.2 management representative customer representative5.5.3 internal communication 5.6 m
16、anagement review 5.6.1 general quality management system performance page12378 9991111111112121212131314141414141515151616161616161617171717171717171818181818目 次gb/t18305-2003代替 gb/t18305-2001 1目录 3前言7iso前言7关于认证的说明8引言90.1 总则90.2过程方法90.3与gb/t 19004 的关系110.3.1iatf关于iso/ts16949:2002的指南110.4与其他管
17、理体系的相容性110.5本标准的目标111范围121.1总则121.2应用122规范性引用文件123术语和定义123.1汽车行业的术语和定义134质量管理体系144.1总要求144.1.1总要求 补充144.2文件要求144.2.1总则144.2.2质量手册154.2.3文件控制工程规范154.2.4质量记录控制记录保存165管理职责165.1管理承诺165.1.1过程效率165.2以顾客为关注焦点165.3质量方针165.4策划175.4.1质量目标质量目标 补充175.4.2质量管理体系策划175.5职责、权限与沟通175.5.1职责和
18、权限质量职责175.5.2管理者代表顾客代表185.5.3内部沟通185.6管理评审185.6.1总则质量管理体系业绩185.6.2 review input review input supplemental 5.6.3 review output 6 resource management6.1 provision of resources6.2 human resources 6.2.1 general 6.2.2 competence, awareness and training product d
19、esign skills training training on the job employee motivation and empowerment 6.3 infrastructure6.3.1 plant, facility and equipment planning6.3.2 contingency plans 6.4 work environment6.4.1 personnel safety to achieve product quality 6.4.2 cleanliness of premises 7 product rea
20、lization7.1 planning of product realization7.1.1 planning of product realization supplemental 7.1.2 acceptance criteria 7.1.3 confidentiality 7.1.4 change control7.2 customer-related processes 7.2.1 determination of requirements related to the product customer-designated special characterist
21、ics7.2.2 review of requirements related to the product review of requirements related to the product supplemental organization manufacturing feasibility 7.2.3 customer communication customer communication supplemental7.3 design and development7.3.1 design and development plannin
22、g multidisciplinary approach7.3.2 design and development inputs product design input manufacturing process design input special characteristics 7.3.3 design and development outputs product design outputs supplemental manufacturing process design output 7.3
23、.4 design and development review monitoring7.3.5 design and development verification 7.3.6 design and development validation design and development validation supplemental18181819191919191919191920202020202020202121212121212122222222222222232323232324242424252525255.6.2评审输入评
24、审输入 补充185.6.3评审输出186资源管理196.1资源提供196.2人力资源196.2.1总则196.2.2能力、意识和培训产品设计技能培训岗位培训员工激励和授权196.3基础设施206.3.1工厂、设施和设备策划206.3.2应急计划206.4工作环境206.4.1与实现产品质量相关的人员安全206.4.2生产现场的清洁207产品实现207.1产品实现的策划207.1.1产品实现的策划 补充217.1.2接收准则217.1.3保密217.1.4更改控制217.2与顾客有关的过程217.2.1与产品有关的要求的确定
25、顾客指定的特殊特性217.2.2与产品有关的要求的评审与产品有关的要求的评审 补充组织制造可行性227.2.3顾客沟通顾客沟通 补充227.3设计和开发227.3.1设计和开发的策划多方论证方法237.3.2设计和开发输入产品设计的输入制造过程设计输入特殊特性237.3.3设计和开发输出产品设计输出 补充制造过程设计输出247.3.4设计和开发评审监视257.3.5设计和开发验证257.3.6设计和
26、开发确认2设计和开发确认 补充2 prototype programme product approval process 7.3.7 control of design and development changes 7.4 purchasing7.4.1 purchasing process regulatory conformity supplier quality management system development customer-approved sources 7.4.2 purc
27、hasing information7.4.3 verification of purchased product incoming product quality supplier monitoring7.5 production and service provision 7.5.1 control of production and service provision control plan work instructions verification of job set-ups preven
28、tive and predictive maintenance management of production tooling production scheduling feedback of information from service service agreement with customer 7.5.2 validation of processes for production and service provision validation of processes for production
29、 and service provision supplemental 7.5.3 identification and traceability identification and traceability supplemental7.5.4 customer property customer-owned production tooling 7.5.5 preservation of product storage and inventory 7.6 control of monitoring and measuring devices7.
30、6.1 measurement system analysis 7.6.2 calibration/verification records 7.6.3 laboratory requirements internal laboratory external laboratory 8 measurement, analysis and improvement8.1 general8.1.1 identification of statistical tools8.1.2 knowledge of basic statistical concepts 8.2 mo
31、nitoring and measurement 8.2.1 customer satisfaction customer satisfaction supplemental 8.2.2 internal audit quality management system audit manufacturing process audit product audit 252525262626262626272727272727282828282929292929292930303030303131313131323232323232323
32、233333样件计划2产品批准过程257.3.7设计和开发更改的控制257.4采购267.4.1采购过程2法规的符合性2供方质量管理体系的开发2顾客批准的供货来源267.4.2采购信息267.4.3采购产品的验证2进货产品的质量2对供方的监视277.5生产和服务提供277.5.1生产和服务提供的控制2控制计划2作业指导书2作业准备的验证2预防性和预见性维护2生产工装的管理2生产计划297.
33、5.1.7服务信息反馈2与顾客的服务协议297.5.2生产和服务提供过程的确认2生产和服务提供过程的确认 补充297.5.3标识和可追溯性2标识和可追溯性 补充297.5.4顾客财产30顾客所有的生产工装307.5.5产品防护30贮存和库存307.6监视和测量装置的控制307.6.1量测系统分析317.6.2校准/验证记录317.6.3实验室要求3内部实验室3外部实验室318测量、分析和改进328.1总则328.1.1统计工具的确定328.1.2基础统计概念知识328.2监视和测量328
34、.2.1顾客满意3顾客满意 补充328.2.2内部审核3质量管理体系审核3制造过程审核3产品审核3 internal audit plans internal auditor qualification 8.2.3 monitoring and measurement of processes monitoring and measurement of manufacturing processes8.2.4 monitoring and measurement of product
35、 layout inspection and functional testing appearance items 8.3 control of nonconforming product 8.3.1 control of nonconforming product supplemental 8.3.2 control of reworked product 8.3.3 customer information 8.3.4 customer waiver 8.4 analysis of data 8.4.1 analysis and use of data 8.
36、5 improvement 8.5.1 continual improvement continual improvement of the organization manufacturing process improvement 8.5.2 corrective action problem solving error-proofing corrective action impact rejected product test/analysis 8.5.3 preventive action
37、annex a (normative) control plan a.1 phases of the control plan a.2 elements of the control plan bibliography note in this table of contents, iso 9001:2000 headings are normal type face, iatf headings are in italics.3333333334343435353535353536363636363637373737373838383内部审核计划3内审员资格3
38、38.2.3过程的监视和测量3制造过程的监视和测量338.2.4产品的监视和测量3全尺寸检验和功能试验3外观项目348.3不合格品控制358.3.1不合格品控制 补充358.3.2返工品的控制358.3.3顾客通知358.3.4顾客特许358.4数据分析358.4.1数据的分析和使用368.5改进368.5.1持续改进3组织的持续改进3制造过程的改进368.5.2纠正措施3解决问题3防错3纠正措施影响3拒收产品的试验/分析378.5.3预防措施37附录
39、a(规范性附录)控制计划38a.1控制计划的阶段38a.2控制计划的要素38参考文献39 iso 2002 all rights reserved anfia, ccfa/fiev, smmt, vda, daimlerchrysler, ford motor company, general motors corp. all rights reserved iso/ts 16949:2002(e)forewordiso (the international organization for standardization) is a worldwide federation of natio
40、nal 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. internati
41、onal organizations, governmental and non-governmental, in liaison with iso, also take part in the work. iso collaborates closely with the international electro-technical commission (iec) on all matters of electro-technical standardization.international standards are drafted in accordance with the ru
42、les 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
43、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 agreemen
44、t 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
45、 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 co
46、nfirmed 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 was prepared by the international automotive task force (iatf) and japan automobile manufacturers association, inc. (jama), with
47、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 th
48、e 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 guidan
49、ce only.annex a forms a normative part of this technical specification.gb/t18305-2003/iso/ts16949:2002前 言本标准等同采用iso/ts16949:2002质量管理体系 汽车生产件及相关维修零件组织应用iso9001:2000的特别要求。本标准对gb/t 18305-2001(idt iso/ts16949:1999)质量体系 汽车供方质量体系要求作了技术性修订。本标准发布时,代替gb/t18305 2001。本标准的主要变化:1.由于gb/t190012000(idt iso 9001:200
50、0)质量管理体系 要求的发布与实施,对原以gb/t190011994(idt iso 9001:1994)为基础的gb/t 18305-2001进行了结构上的调整,标准的正文部分由原来的20要素变为8大条款;2.原gb/t 18305-2001中的“附录a(标准的附录)术语和定义”被取消,部分内容调整到新标准的第3章中;3.原gb/t 18305-2001中的“附录c(提示的附录)特殊特性”被取消本标准目录中的宋体字代表gb/t190012000质量管理体系 要求的内容,楷体字代表行业特别要求。本标准的附录a是规范性附录。本标准由全国汽车标准化技术委员会、全国质量管理和质量保证标准化技术委员会
51、提出并归口。本标准起草单位:中国汽车技术研究中心、中国标准研究中心。本标准主要起草人:李志颖、于洪涛、郑元辉、李仁良、 王卫东。iso前言国际标准化组织(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)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。国际标准根据iso/iec导则第3部分的规则起草。技术委员会的主要任务时制定国际标准。由技术委员会通过的国际标准草案提交各成员团
52、体投票表决。国际标准草案需取得了至少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。其他情况下,特别是市场对这样的文件有紧迫需求时,技术委员会可决定出版其他形式的标准化文件: iso公开规范(iso/pas)表明一个iso工作组内技术专家间已达成一致,如果上一级委员会的成员50投票同意则可被接受出版。 iso技术规范(iso/ts)表明技术委员会成员间已达成一致,如果委员会2/3的成员投票同意则可被接受出版。对iso/pas或iso/ts,三年后要进行一次评审,以决定它是否应当在下一个三年内获得确认,修订为国际标准或撤消。在iso/pas或iso/ts获得确认的情况下,六年后重新评审,最终确定转为国际标准或撤消。iso/ts16949:2002由国际汽车特别工作组(iatf)和日本汽车制造商协会(jama)在iso/tc176质量管理和质量保证委员会的支持下共同制定的。通过技术修订,取消第一版的iso/ts16949:1999,并由第二版iso/ts16949替代。方框内的文字是iso9001:2000原文。方框外的部分是行业特殊补充要求。在本技术规范中,“应”(shall)表示要求,“应当”(should)表示建议。标有“注”(note)的段落是对理解和解释
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