论质量体系要求样本.doc

QS9000Quality System RequirementsThird Edition质量体系要求第三版FOREWORD TO THIRD EDITION第三版序言Nearly 500,000 copies of QS-9000 in five languages are distributed in at least 63 countries. 迄今QS-9000最少在63个国家用5种语言文字发行了近500，000册。Chrysler, General Motors and certain Ford locations worldwide require QS-9000 third party 世界范围内克莱斯勒、通用汽车企业和一些福特整车厂要求其供方进行第三方QS-9000registration for suppliers. Supplier survey results indicate the benefits of QS-9000 registration include:注册， 对于供方调查结果表明QS-9000注册有以下益处：improved quality, e.g. reduced PPM from pre-registration levels, less scrap and rework改善质量，比如降低PPM，较少废品和返工improved efficiency提升了效率improved delivery改善了交付能力improved company morale改善了企业经营情况improved internal and external communications改善了企业内外部交流 Certification bodies/registrars are required to promptly report QS-9000 registrations to ASQ, 要求认证机构快速地把QS-9000注册报至美国质量学会（ASQ），Formerly ASQC, (see below), the administrator of the sanctioned QS-9000 Worldwide Registered 原名为美国质量管理学会（ASQC）。ASQ负责管理世界范围内认可QS-9000注册企业数Company Database. A quarterly directory is available, and the information can be accessed for a fee 据库。 每三个月汇报能够查到， 只要付一定费用还可在互联网ASQ主页on the ASQ Internet Web Page (http:asq.org/9000). This database also lists the recognized http:asq.org/9000下查到相关信息。 此数据库还包含授权认可机构和含有资格accreditation and QS-9000-qualified certification body/registrar offices.QS-9000注册机构办公室。Changes made in the Third Edition are summarized in the revised QS-9000 Appendix F, Change 修订QS-9000附录F：更改概要中概述了第三版所进行更改。Summary. A two-column workbook, showing the QS-9000 Second Edition text in the left column, and 在QS-9000工作手册中有两个栏目，左栏是QS-9000第二版正文， 右栏the Third Edition text changes in the right column, is available from AIAG and Carwin Continuous 是第三版对应更改内容。 此手册可从汽车工业行动集团（AIAG）和(see below).Carwin Continuous(见下面)得到。All previous editions of the International Automotive Sector Group (IASG) Sanctioned QS-9000 在QS-9000第二版作废同时，国际汽车行业工作组（IASG）认可全部版QS-9000Interpretations will be obsolete at the same time as the QS-9000 Second Edition becomes obsolete. 解释作废。These Sanctioned Interpretations have been incorporated as appropriate into the Third Edition. The 这些经认可解释已经编入QS-9000第三版中。Sanctioned Interpretations were intended to provide clarification regarding field related questions in 这些认可解释意在对QS-9000问世以来来自相关方面很多问题提供说明。the launch of QS-9000. Some interpretations, which provided clarification, are not needed after 提供说明一些解释，在编入QS-9000第三版后便不再需要。migration to the QS-9000 Third Edition is complete. Any IASG Sanctioned QS-9000 Interpretations 在第三版发行后可能公布、和要求QS-9000which may be issued subsequent to the release of the Third Edition and which specify applicability to 第三版适用范围任何IASG认可QS-9000解释对QS-9000注册/符合性是含有约束力，QS-9000 Third Edition are binding for QS-9000 registration/compliance stakeholders.以满足QS-9000注册/符合性需要。The QS-9000 Third Edition may be used immediately for QS-9000 compliance/registration QS-9000第三版可立即用于QS-9000符合性/注册工作。efforts. The Second Edition may continue to be used until January 1, 1999 at which time it becomes 若用户无另外通知，第二版可继续使用到其作废时间1999年1月1日。obsolete, unless otherwise notified by the customer.Further harmonization discussions with the French, German and Italian OEMs are continuing. 和法国、德国和意大利OEMS深入协调讨论在不停进行之中。Agreement was reached in 1996 to revise the current manuals to provide reciprocal recognition for 1996年达成一致协议， 修改现在手册，就“内部审核”（QS-9000要素4.17）internal audit (QS-9000 element 4.17) and subcontractor development (QS-9000 clause 4.6.2.1). Thus 和“分承包方开发”（QS-90004.6.2.1款）提供相互认可。it is acceptable for a supplier to use the revised AVSQ, EAQF or VDA6 manuals for internal auditing 所以，能够接收供方使用已修订AVSQ、EAQF或VDA6手册进行内部审核和分承包方and subcontractor development to satisfy QS-9000 third-party registration requirements regarding 开发，以满足相关要素4.17和4.6.2（见附录I）QS-9000第三方注册要求。elements 4.17 and 4.6.2 (See Appendix I). Reciprocal recognition does not extend further, e.g. 相互认可不能深入延伸，如AVSQ、EAQFregistration to AVSQ, EAQF or VAD6 is not equivalent to QS-9000 registration. Additional 或VDA6注册不等同于QS-9000注册。information regarding future quality system requirement developments will be communicated as 需要时，将会交流相关以后质量体系要求发展更多信息。appropriate.Acknowledgments for this effort are due to: the numerous European OEM representatives, 谨此， 感谢： 欧洲OEM代表，汽车工业行动集团（AIAG）Automotive Industry Action Group Truck Advisory Group members, Chrysler, Ford, General Motors 卡车用户部组员， 克莱斯勒、福特、通用汽车公and supplier company reviewers, and the International Auto Sector Group members. Special 司和供方企业代表和IASG组员。 尤其感谢acknowledgment is given to Tripp Martin, the ASQ Automotive Division Task Force Liaison, for ASQ汽车部尤其工作组联络人Tripp Martin在编写第三版中给帮助。assistance in preparing the Third Edition. Thanks are also given to these organizations which have 同时还要感谢在QS-9000公布中给克莱斯勒、福特supported Chrysler, Ford, and General Motors in the QS-9000 launch worldwide:和通用汽车企业大力支持下列各相关机构： Task Force administrative support,尤其工作组管理支持，distribution of manuals and sanctioned training delivery Automotive Industry Action Group (AIAG)手册发行和认可培训汽车工业行动集团（AIAG） 01-248-358-3003 QS-9000/QSA Overview TrainingQS-9000/QSA认知培训APQP Overview Training APQP认知培训PPAP/FMEA Overview TrainingPPAP/FMEA认知培训QS-9000 Internal Auditing QS-9000内部审核Tooling and Equipment Supplement Overview Training工装和设备补充件认知培训APQP“How to” WorkshopQS-9000 Registrar Auditor TrainingQS-9000认证机构审核员培训Reality Interactive QS-9000 CD-ROM Compliance Series相互相关QS-9000 CD-ROM符合性系列Chrysler, Ford, General Motors and Plexus Modules:克莱斯勒、福特、通用汽车企业和品士（Plexus）企业培训课程Understanding QS-9000了解QS-9000QS-9000 Quality System DocumentationQS-9000质量体系文件化Implementing QS-9000 Internal Auditing实施QS-9000内部审核Implementing QS-9000 Quality Planning实施QS-9000质量策划Implementing FMEA实施FMEAImplementing SPC实施SPCImplementing MSA实施MSAUnderstanding TE Supplement了解TE补充件Auditing TE Supplement审核TE补充件R&M TrainingR&M培训QS-9000 Merchandise Program: 01-248-333-1679 (U.S. Only:1888-746-3003)QS-9000业务项目：01-248-333-1679（只在美国：1888-746-3003）Administration and delivery of sanctioned training Bureau Veritas管理和提供认可培训 Bureau Veritas (BV) 33-01-42915291QS-9000/QSA Overview TrainingQS-9000/QSA认知培训QS-9000 Internal AuditingQS-9000内部审核Administration of worldwide sanctioned QS-9000 Train the Trainer program and development of 世界范围内认可QS-9000培训师培训项目标管理QS-9000 training and other sanctioned materials Carwin Continuous和QS-9000培训及其它认可培训材料开发品士企业 01-612-644-4900 Distribution of manuals (Europe) Carwin Continuous 手册发行（欧洲）Carwin Continuous 44-Distribution of manuals (Australia) Federal Automotive Parts Manufacturers (FAPM)手册发行（澳大利亚）联帮汽车零件制造商（FAPM） 传真：61-6-257-4651Worldwide QS-9000 Certified Company Database American Society for Quality (ASQ)世界范围内QS-9000已认证企业数据库美国质量学会（ASQ） 01-414-272-8575 (North America Only: 1-800-248-1946) 01-414-272-8575（北美：1-800-248-1946 March, 1998 1998年3月Table of Contents目 录Introduction-引言- Goal- 目标- Purpose- 目标- Approach- 路径- Applicability- 适用范围- Implementation- 实施- Quality System Documentation Progression- 质量体系文件序列- Quality System Requirements Categories- 质量体系要求分类-Section I: ISO 9000-Based Requirements -第I部分 以ISO 9000为基础要求-Management Responsibility Element 4.1管理职责要素4.1 - Quality Policy- 4.1.1- 质量方针4.1.1 -Organization 4.1.2-组织4.1.2 -Management Review 4.1.3-管理评审4.1.3 -Business Plan4.1.4-业务计划4.1.4 -Analysis and Use of Company Level Data 4.1.5-企业级数据和资料分析和使用4.1.5 -Customer Satisfaction 4.1.6-用户满意度4.1.6 -Quality System Element 4.2-质量体系要素4.2 -General 4.2.1 -总则4.2.1 -Quality System Procedures 4.2.2-质量体系程序4.2.2 -Quality Planning 4.2.3-质量策划4.2.3 -Product Approval Process4.2.4-生产件同意程序4.2.4 -Continuous Improvement4.2.5 -连续改善4.2.5 -Facilities and Tooling Management4.2.6 -设施和工装管理4.2.6 -Contract Review Element 4.3-协议评审要素4.3 - General 4.3.1- 总则4.3.1 - Review 4.3.2 - 评审4.3.2 - Amendment to a Contract 4.3.3- 协议修订4.3.3 - Records4.3.4- 统计4.3.4 -Design Control Element 4.4-设计控制要素4.4 - General4.4.1-总则4.4.1 -Design and Development Planning 4.2.2-设计和开发策划4.2.2 -Organizational and Technical Interfaces 4.4