QS9000 3rd EditionQuality System Requirements（DOC 39）.doc

QS-9000 3rd Edition 1998-08-06QS-9000 3rd EditionQuality System RequirementsIntroductionGoalThe goal for Quality System Requirements QS-9000 is the development of fundamental quality systems that provide for continuous improvement, emphasizing defect prevention and the reduction of variation and waste on the supplier chain.目的QS-9000品质系统要求其目的乃于供应体系中发展品质系统的基础, 以提供持续改善, 强调预防不良, 减低变异与浪费.PurposeQS-9000 defines the fundamental quality system expectations of Chrysler, Ford, General Motors, Truck Manufacturers and other subscribing companies for internal and external supplier of production and service parts and materials. These companies are committed to working with The supplier to ensure customer satisfaction beginning with conformance to quality requirements, and continuing with reduction of variation and waste to benefit the final customer, the supply base, and themselves.意图QS-9000定义Chrysler, Ford, GM, 卡车制造厂及其它采用本要求的公司对其内部外部提供量产及服务性材料与零件的供货商所建立品质系统基础的期望. 上述公司承诺与其供货商合作以确保顾客的满意始于品质要求的符合, 与持续减低变异与浪费, 止于最终顾客, 供应体系, 及上述公司均有所获益.ApproachQS-9000 is a harmonization of Chrysler's Supplier Quality Assurance Manual, Ford's Q-101 Quality System Standard, and General Motors' NAO Target for Excellence, with input from the Truck Manufacturers. ISO9001:1994 Section 4 has been adopted as the foundation for QS-9000 and is printed in Section I in italic type. Interpretations and supplemental quality system requirements have been harmonized and are printed in normal type. While other companies may adopt this document, Chrysler, Ford, and General Motors retain full control over the content except for ISO9001:1994, of which copyright remains with the International Organization for Standardization.The word "shall" indicates mandatory requirements. The word "should" indicates a mandatory requirement with some flexibility allowed in compliance methodology. The supplier choosing other approaches to satisfy a "should" must be able to show that their approach meets the intent of QS-9000. All QS-9000 requirements shall be addressed in the quality system documentation, but not necessarily by individual procedures.Where "typical", "example", or "e.g." are used, any suggestions given are for guidance only.The references to "this International Standard" in the ISO text of 4.1.2.3, .4.1.3, 4.2.1, 4.2.2, 4.5.1, and Note 17 (4.11.1) shall be understood for the purposes of QS-9000 to refer to QS-9000 requirements, and not just ISO 9001 or ISO 9002requirements.Paragraphs marked "NOTE" are for guidance in understanding or clarifying the associated requirement. The word, "should," appearing in a NOTE is for guidance only.The Glossary contains information which should be used for purposes of compliance/registration to QS-9000. Where inconsistent terminology exists between QS-9000 and ISO 8402 (or other similar documents, e.g., ISO A-3), QS-9000 takes precedence for QS-9000 registration.a方式QS-9000是调和Chrysler的Supplier Quality Assurance, Ford的Q-101 Quality System Standard, 及北美GM的Target for Excellence等各项要求, 加上卡车制造厂的意见, 并采用ISO9001:1994第四段而构成QS-9000的基础, 而以斜体字表示于第一章. 有关品质系统要求的诠释及额外要求则被统合后以正楷字表示. 至于其它公司采用本文件时, 除却ISO9001:1994部份, Chrysler, Ford与GM仍全权掌握所有内容, 而ISO9001:1994则归属于国际标准组织. 本文中"SHALL"字眼指强制性要求. "SHOULD"亦指强制性要求但在执行方式容许较大的弹性. 供货商选择其它方式以满足"SHOULD"要求时, 必须展示其作法符合QS-9000的意图. 所有QS-9000的要求皆须被品质系统文件所包含, 但无需逐一制定程序书.当文中使用"typical", "example", 或"e.g."时, 其所提示的内容仅作为参考指引.ISO原始条文中, 于4.1.2.3, 4.1.3, 4.2.1, 4.2.2, 4.5.1, 及备注17(4.11.1)叙述之"本国际标准", 在本QS-9000要求的应用上, 乃指QS-9000, 而非仅限于ISO9001或ISO9002.的要求."NOTE"备注栏是针对相关要求的澄清或了解的指引, 而出现在备注中的"should"亦仅为指引.词汇部份的内容也需被使用以符合/登录QS-9000, 当QS-9000及ISO8402 (或类似文件, 如ISO A-3)其中的术语解释不一致时, 针对QS-9000的登录, 则QS-9000的解释具优先性.ApplicabilityQS-9000 applies to all internal and external supplier sites of: a) production materials, b) production or service parts, or c)heat treating, painting, plating or other finishing services directly to OEM customers subscribing to this document.QS-9000 applies to providers of: 1) semiconductors in conjunction with the Semiconductor Supplement issued by Chrysler, Ford and Delco Electronics; 2) tooling and equipment in conjunction with the Tooling and Equipment (TE) Supplement issued by Chrysler, Ford and General Motors. Availability of third party registration to the TE Supplement will be announced by Chrysler, Ford and/or General Motors as appropriate."Site" (see Glossary) is defined as a location at which value-added production processes occur (see Glossary). Remote locations, e.g. engineering, purchasing, internal off-site warehouses, shall be audited as they support a site. Remote locations cannot obtain independent QS-9000 registration. Remote locations shall be included in the initial audit and then be included in the normal surveillance plan and at a regular frequency. Remote locations where design functions is performed shall undergo surveillance audits at least once within each consecutive 12-month period.Service parts and materials applicability does not include aftermarket (see Glossary) parts or supplier.If in doubt regarding QS-9000 applicability, contact your customer.Only those suppliers meeting the "Applicability" definition are required to achieve compliance/registration. Any "site" may elect to pursue third party registration; however, such "sites" shall have demonstrated capability to comply with all QS-9000 requirements as evidenced by records (see 4.16) except for customer approval of the PPAP Part Submission Warrant. Only 4.19: Servicing (and 4.4: Design Control for ISO 9002) may be determined as not applicable by the certification body / registrar. Commercial/independent laboratory facilities cannot be registered to QS-9000.This document supersedes all editions of Chrysler's Supplier Quality Assurance Manual, Ford's Q-101 Quality System Standard, General Motors' NAO Targets for Excellence, General Motors' Europe General Quality Standard for Purchased Materials and the Truck Manufacturers' quality system manuals dated prior to 1995.ImplementationChrysler, Ford, General Motors, the Truck Manufacturers and the other subscribing companies require that suppliers establish, document, and implement effective quality systems based on QS-9000 in accordance with timing requirements established by their customers. All requirements of QS-9000 are to be incorporated in the supplier's quality system and described in the supplier's quality manual (see Glossary). QS-9000 is an input document for development of a quality manual. See the Quality System Documentation Progression on page 6 for an illustration of the typical levels of documentation. a适用QS-9000适用于下列所有直接交货给采用本文件OEM顾客的内部外部供货商其场所: a) 量产材料, b) 量产或服务零件, c) 热处理, 喷漆, 电镀或其它表面处理.QS-9000适用于下列厂商: 1) 半导体业, 合并应用Chrysler, Ford及Delco Electronics所发行的半导体补充要求; 2) 工模具及设备业, 合并应用Chrysler, Ford及GM所发行的工模具及设备(TE)补充要求. 对于TE补充要求的第三者登录将由Chrysler, Ford 及GM 于适当时机宣布."Site"场所的定义(参阅词汇)是指具附加价值生产制程发生的地点(参阅词汇), 诸如工程, 采购, 内部离线库房等远距地点, 乃支持"Site"的运作, 皆应被稽核, 但这些远距地点无法取得独立的QS-9000登录.初次评鉴及定期追查计画都应包括各个远距地点, 如果远距地点是属于设计功能者, 则每12个月期间应最少执行定期追查乙次.服务零件及材料其适用性并不包括后修市场(参阅词汇)零件或供货商.如对QS-9000的用性有所疑问时, 请联络您的顾客.只有那些契合本段"适用"定义的供货商被要求达成QS-9000的符合/登录.任一"site"场所都可选择进行第三者登录, 而这样的场所应有品质记录(参阅4.16)为左证以展示具备能力满足所有QS-9000的要求, 但记录中的PPAP零件送样申请书除外. 只有4.19的服务或是ISO9002系统中的4.4设计管制可经认证团体认定为不适用. 商业/独立的实验设施无法取得QS-9000登录. 本文件取代1995之前下列厂商公布的各项标准: Chrysler的Supplier Quality Assurance Manual, Ford的Q-101 Quality System Standard, 北美GM的Target for Excellence, 欧洲GM的General Quality Standard for Purchased Materials及卡车制造厂的品质系统手册.应用Chrysler, Ford, GM, 卡车制造厂及其它采用本文件的公司要求各供货商依据其顾客的时间表建立执行一个基于QS-9000的有效品质系统, 并将其书面化. 供货商的品质系统应结合QS-9000的所有要求并将其书于供货商的品质手册(参阅词汇). QS-9000于供货商发展其品质手册时为其依据文件之一. 参阅第六页的品质系统文件发展图以了解文件的典型阶层.Conformance to QS-9000 will be evaluated using the process described in Appendix A. Each customer will continue to develop unique supplier ratings.Third party registration to QS-9000 will be accepted and will be required by some customers (refer to Section II: Customer-Specific Requirements). Verification of conformance to ISO 9001 (or ISO 9002 for suppliers that are not responsible for the design of any product supplier to any customer subscribing to this document) is a necessary condition for registration to QS-9000. Registration to ISO 9001, however, may not be sufficient for the companies using QS-9000, since this document contains additional requirements for these companies. Subcontractor third party registration to QS-9000 is not required by Chrysler, Ford or General Motors at this time.Suppliers and subcontractors shall deploy QS-9000 as appropriate. Any company may require QS-9000 registration of its suppliers, regardless of the company's position in the supply chain, e.g. Tier 2 and below.使用附录A所描述的过程以评估品质系统对QS-9000的符合性. 每一顾客将持续发展其独特的评分制度.有些顾客会接受及要求QS-9000的第三者登录(参阅第二章的顾客特定要求). 登录为QS-9000时亦须验证符合ISO9001 (或是ISO9002, 如供货商无须对任何采用本文件的顾客其任何产品负设计责任者). 但是登录为ISO9001的供货商并不意味就足以引用QS-9000, 因为QS-9000尚包含其它额外要求. 目前Chrysler, Ford 或GM并不要求分包商进行QS-9000的第三者登录.供货商与其分包商应适当展开QS-9000, 任何公司都可要求其供货商取得QS-9000登录, 而不论该公司在整个供应体系的位阶, 亦即二阶厂商及更下阶厂商.The third registration scope must include all products and services being supplied to one or more of the companies subscribing to this document, unless specifically waived by the customer.The term QS-9000 is a copyright protected property of Chrysler, Ford and General Motors. Only those third party certification bodies/ registrars qualified for QS-9000 by a Chrysler, Ford and General Motors recognized accreditation body are permitted to issue a registration certificate with the term QS-9000.The related QS-9000 manuals are available from AIAG, Garwin Continuous or FAPM (see Foreword for phone numbers). The related manuals (with latest edition number and date at time of publication) are shown below. For document control purposes, use the edition number/dates. "Printing dates" do not represent revisions to these documents except for PPAP Second Edition.Quality System Assessment- Second Edition, dated March 1998Measurement System Analysis Reference Manual- Second Edition, February 1995Statistical Process Control Reference Manual- First Edition, 1992Potential Failure Mode and Effect Analysis Reference Manual- Second Edition, February 1995Production Part Approval Process- Second Edition, Second Printing, July 1995Advanced Product Quality Planning and Control Plan Reference Manual- First Edition, June 1994Semiconductor Supplement- First Edition, April, 1995AEC-A100: QSA Semiconductor Edition- First Edition, April 1995Tooling and Equipment Supplement- First Edition, July 1996- Hotline in USA: 1-800-444-2810- Hotline outside USA: 01-248-358-3003- TE Training Information: 01-248-799-4228a供货商第三者登录的范围应含盖所有提供给任一采用本文件顾客的产品及服务, 否则需取得顾客的特准.QS-9000一词乃为Chrysler, Ford 及GM版权保护的财产, 只有那些被Chrysler, Ford 及GM承认的验证团体所认可的认证团体才可以颁发所谓QS-9000的认可证书.QS-9000相关的手册可自AIAG, Garwin Continuous或FAPM购得, (本文前言中有他们的电话). 相关手册 (及其发行版次与日期) 条列如下. 请使用发行版次与日期以为文件管制的依据, 除PPAP第二版之外, 印刷日期并不代表这些文件的修订.Tooling & Equipment QSA-TE- First Edition, July 1996Reliability and Maintainability Guidelines for Manufacturing Machinery and Equipment- First Edition, 1993- Published by SAE 01-412-776-4841 &National Center for Manufacturing Sciences, Inc.01-313-995-0300Additional Information on quality systems can be found in the following documents: ISO 8402:1994 Quality Management and Quality Assurance - Vocabulary ISO 8601:1988 Data elements and interchange formats - Information interchange - Representation of dates and times ISO 9000-1:1994 Quality Management and Quality Assurance Standard - Part 1: Guidelines for selection and use ISO 9000-2:1993 Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003 ISO 9004-1:1994 Quality Management and Quality System Elements - Part 1: Guidelines ISO 9004-4:1993 Part 4: Guidelines for quality improvement ISO 10011-1:1990 Guidelines for Auditing Quality Systems - Part 1: Auditing ISO 10011-2:1991 Part 2: Qualification criteria for quality system auditors ISO 10011-3:1991 Part 3: Management of audit programmes. ISO 10012-1:1992(E) Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation system for measuring equipment. ISO/IEC Guide 25 -1990 General requirements for the competence of calibration and testing laboratories at the time of publication, ISO/IEC Guide 25 is under revision ISO/IEC Guide 62:1996(E), General requirements for bodies operating assessment and certification/registration of quality systems IAF Guidance on the Application of ISO/IEC Guide 62:1996, issue 1, 2 June, 1997 AVSQ '94 ANFIA Valutazione Sistemi Qualita, Edizione 3, Febbraio 1995 + Addendum QS-9000 all'ASVQ, Edizione marzo 1997 italian Automotive Industry Quality Requirements EAQF94 Evaluation Qualite Fournisseur, 1994 Edition plus QS-9000 Appendix to EAQF March 1997 Edition, French Automotive Industry Quality Requirements VDA6.1 Qualitatsmanagement in der Automobilindustrie - QM-Systemaudit 3. Vollstandig uberarbeitete Auflage 1996/1, July, 1996 German Automotive Industry Quality Requirements a品质系统的额外信息可参考下列文件:Section I : ISO 9000 - Bases RequirementsManagement Responsibility - Element 4.1Quality Policy - 4.1.1The supplier's management with executive responsibility shall define and document its policy for quality, including objectives for quality and its commitment to quality. The quality policy shall be relevant to the supplier's organizational goals and the expectations and needs of its customers. The supplier shall ensure that this policy is understood, implemented and maintained at all levels of the organization.管理责任 - 4.1品质政策 - 4.1.1供货商负经营责任之管理阶层应界定并明文记载其对品质所持之政策,包含品质目标与对品质之承诺。 该品质政策必须相关于供货商之组织目标与顾客需求与期望。供货商应确保该组织内之所有阶层均了解、实施与维持此品质政策。Organization - 4.1.2Responsibility and Authority - 4.1.2.1The responsibility, authority and the interrelation of personnel who manage, perform and verify work affecting quality shall be defined and documented, particularly for personnel who need the organizational freedom and authority to :a)initiate action to prevent the occurrence of any nonconformities relating to product, process and quality system;NOTE: It is recommended that the personnel responsible for quality have the authority to stop production, if necessary to correct quality problems.b)identify and record any problems relating to the product, process and quality system;c)initiate, recommend or provide solutions through designated channels; d)verify the implementation of solutions;e) control further processing, delivery or installation of nonconforming product until the defi