QS9000 3rd EditionQuality System Requirements(DOC 39).doc
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1、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 was
2、te 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
3、 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
4、, 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 Chryslers Supplier Quality Assurance Manual, Fords Q-101 Quality System Standard, and General Motors NAO Target for Excellence,
5、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
6、 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
7、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 proc
8、edures.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, a
9、nd 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
10、 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
11、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typi
12、cal, 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-90
13、00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)
14、 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 Supp
15、lement 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
16、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
17、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 achi
18、eve 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
19、 (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 Chryslers Supplier Quality Assurance Manual, Fords Q-101 Quality Sy
20、stem 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 comp
21、anies 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 suppliers quality system and described in the suppliers quality
22、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-9
23、000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
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