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1、Section I：ISO 9000Bases RequirementsManagement Responsibility Element4.1Quality Policy-4.1.1 The 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
2、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. Organization-4.1.2 Responsibility and Authority-4.1.2The responsibility, authority and the i
3、nterrelation 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
4、 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 produce, process and quality system；c)initiate, recommend or provide solutions though desig
5、nated channels；d)verify the implementation of solutions；e)control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.f)represent the needs of the customer in internal functions in addressing QS-9000 requirements(e
6、.g selection of special characteristics, setting quality objectives, training, corrective & preventive actions, product design and development).Resources-4.1.2.2 The supplier shall identify resource requirements and provide adequate resources, including the assignment of trained personnel (see 4.18)
7、.for management, performance of work and verification activities including internal quality audits.Management representative-4.1.2.3The supplier s management with executive responsibility shall appoint a member of the supplier s own management who, irrespective of other responsibilities, shall have
8、defined authority for a)ensuring that a quality system is established, implemented and maintained in accordance with this international Standard, andb)reporting on the performance of the quality system to the supplier s management for review and as a basis for improvement of the quality system.管理责任
9、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。组织 4.1.2责任与授权 4.1.2.1从事影响品质之管理、执行与验证等工作人员均应了以界定和明文记载其责任，授权与相互关系，尤其是那些需要组织赋予自由度和授权以从事下列活动之人员：a)发起行动以预防任有关产品、流程、品质系统不合格情事的发生；备注： 建议负有品质责任的人员，如需处理品质问题时，可被授予停止生产的权限。b)鉴定并记录任何有关产品、流程及品质系统的问题
10、：c)循既定管道发起、建议或提供解决d)验证解决方案之执行；e)管制不合格产品被进一步加工、交货或安装，直到缺点或不满意情况被矫正为止。f)在内部组织机能中代表顾客的需求以对应QS-9000 的要求 ( 即管制特性的选择， 设定品质目标，训练，矫正与预防行动，产品设计与发展 ) 。资源 4.1.2.2供货商应鉴定资源的需求，并提供适当资源包括指派经训练的人员( 参阅 4.18) 以从事管理、执行工作与包含内部品质稽核在内的各项验证活动管理代表 4.1.2.3供货商负经营责任之管理阶层应指派供货商管理阶层其中一员，明定其授权且不受其它职务责任影响以从事下列活动a)确保品质系统依本国际标准建立、实
11、施与维持，及b)将品质系统的运作成效向供货商管理阶层报告以供其审查，并作为品质系统改精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 1 页，共 36 页 - - - - - - - - - - 善之依据。NOTE 5 ：The responsibility of a management representative may also include liaison with external parties on matters relating to the suppliers quality sys
12、tem.Organizational Interfaces 4.1.2.4The supplier shall have systems in place to ensure management of appropriate activities during concept development through production to Advanced Product Quality Planning and Control Plan reference manual). The supplier shall use a multi-disciplinary approach for
13、 decision-making and have the ability to communicate necessary information and data in the customer-prescribed format. NOTE ：Typical functions to be included are: Engineering/Technical Manufacturing/Production Industrial Engineering Purchasing/Materials Management Quality/ReliabilityCost Estimating
14、Product Service Management Information Systems/Data Processing Packaging Engineering Tooling Engineering/MaintenanceMarketing and SalesSubcontractors, as necessaryInformation to Management-4.1.2.5Management with responsibility and authority for corrective action shall be promptly informed of product
15、s or processes which become noncompliant with specified requirements.Management Review 4.1.3The supplier s management with executive responsibility shall review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of
16、 this international Standard and the supplier s stated quality policy and objectives.(See 4.1.1). Records of such reviews shall be maintained.(See 4.16).Management Review 4.1.3.1This Management Review requirement shall include all elements of the entire quality system, not only those specifically re
17、quired in other elements (e.g. 4.14.3.d).NOTE ：Management Review should be conducted with a multi-disciplinary approach(see Glossary).Business Plan 4.1.4The supplier shall utilize a formal, documented, comprehensive business plan. this Business Plan shall be a controlled document. The content of the
18、 Business plan is not subject to third party audit. This plan may typically include as applicable：Market-related issues Financial Planning and cost Growth projections Plant/facilities plans Cost objectives Human resource development R & D plans, projections, and projects with appropriate funding 备注
19、5 ：管理代表的责任亦可包含就供货商品质系统有关事务与外界团体的联系组织联系接口 - 4.1.2.4供货商于概念研发直到生产等阶段，应建立系统确保对各项适当活动的管理( 参考先期产品品质规划和管制计划参考手册) 。供货商决策时应采用跨功能群组讨论模式，且有能力使用顾客规定格式沟通必要的信息和数据。备注： 典型的组织机能包括：1.工程技术2.制造生产3.工业工程4.采购物料管理5.品质可靠度6.成本预估7.产品服务8.管理信息系统数据处理9.包装工程10.工模具工程保养11.市场及行销12.分包商 ( 必要时 )通知管理阶层 - 4.1.2.5当产品或制程无法符合特定要求时，该项信息应迅即通知负
20、责与授权矫正行动的管理阶层。管理审查 - 4.1.3供货商负经营责任之管理阶层每隔规定期间应审查品质系统，且其间隔应足以确保品质系统持续适切与有效符合本国际标准要求及供应既定之品质政策及目标( 参阅 4.1.1)。此项审查的记录应予维持 ( 参阅 4.16) 。管理审查 - 4.1.3.1本项管理审查应包括整体品质系统的所有要项，而非仅限于如4.14.3.d(预防行动 ) 要项中所特别指定者。备注： 管理审查需以跨功能的团队方式来举行( 参阅词汇 ) 。精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 2
21、页，共 36 页 - - - - - - - - - - 经营计划 - 4.1.4供货商必须应用一份正式明文规定且完整的经营计划。此项经营计划为管制文件。经营计划的内容不提供了第三者稽核。这个计划通常可能包含下列适用项目：1. 市场相关的事务2. 财务规划与成本3. 企业成长预期4. 工厂设施计划5. 成本目标6. 人力资源开发7. 研发计划，企业，项目及其适当的财源Projected sales figures Quality objectives Customer satisfaction plansKey internal quality and operational performa
22、nce measurable Health, Safety and Environmental issuesGoals and plans should cover short-term (1-2 years) and longer-term(3 years or more). The goals and plans should be based on analysis of competitive products and on benchmarking inside and outside the automotive industry and the supplier s commod
23、ity. Methods to determine current and future customer-expectations shall be in place. An objective process shall be used to define the scope and collection information, including the frequency and methods of collection.Methods to track, update, revise, and review the plan shall be documented to ensu
24、re that the plan is followed and communicated throughout the organization as appropriate. NOTE ：Data and information should drive process improvement plans. NOTE ： The supplier should provide means for employee empowerment in meeting business goals.Analysis and Use of Company Level Data 4.1.5The sup
25、plier shall document trends in quality, operational performance (productivity, efficiency, effectiveness, cost of poor quality) and current quality levels for key product and service features. These should be compared with those of competitors and/or appropriate benchmarks. Trends in data and inform
26、ation should be compared with progress toward overall business objectives and lead to action to support：1)Development of priorities for prompt solutions to customer-related 2)Determination of key customer-related trends and correlations to support status review, decision-making and longer-term plann
27、ing.Customer Satisfaction 4.1.6 The supplier shall have a documented process for determining customer satisfaction, including frequency of determination, and how objectivity and validity are assured. Trends in customer satisfaction and key indicators of customer dissatisfaction shall be documented a
28、nd supported by objective information. These trends should be compared to those of competitors, or appropriate benchmarks, and reviewed by senior management. NOTE ： Consideration should be given to internal, external and final CustomersCertification Body/Registrar Notification 4.1.6.1A supplier shal
29、l notify their certification body/registrar in writing within five (5) working days when a customer places the site in any of the following statuses：Chrysler “Needs Improvement ”Fork Q-1 RevocationGeneral Motors Level II Containment 8. 预期销售成果9. 品质目标10. 顾客满意计划11. 内部品质和作业绩效的主要指针12. 安全卫生及环保议题目标和计划须包含短程
30、(1-2年) 和长程 (3 年或以上) 。这些目标和计划的拟定需依据竞争产品的分析，汽车工业内外的标竿以及供货商自身的商品。须建立衡量目前和未来顾客期望的方法。应采用客观的流程来定义范围及收集信息，包括收集信息的频次及方式。追踪，检讨，更新及修订计划的方法应以明文规定，以确保该计划在整体组织中被适当的贯彻与沟通。备注： 数据和信息需促进流程的改善计划。备注： 供货商为达成经营目标可赋予员工充分的授权。公司层级数据的分析和应用 - 4.1.5供货商针对品质， 作业绩效 ( 生产力、效率、效益、低劣品质的成本) 及产品和服务主要特性目前的品质水准，明文记载其趋势。并以此与竞争者和或适当企业标竿来比
31、较。数据和信息中所显示之趋势应与整体经营目标的的进展相比较，转化成据以行动的信息以支持：1)顾客相关问题解决方案的优先级。2) 决定与顾客相关的重要趋势和对等比较以支持现状检讨、决策及长规划。精品资料 - - - 欢迎下载 - - - - - - - - - - - 欢迎下载 名师归纳 - - - - - - - - - -第 3 页，共 36 页 - - - - - - - - - - 顾客满意 - 4.1.6供货商应制定一套决定顾客满意的书面程序，程序包括决定的频次及如何确保其客观性和有效性。顾客满意的趋势以及顾客不满意的主要指针，应书面记载且具客观信息予以证实。这些趋势需与竞争厂商，或适
32、当的企业标竿来比标，并经高层管理阶层审查。备注： 顾满意考量可顾及内部，外部和最终顾客。通知认证团体 - 4.1.6.1当顾客将处所(site)置于下列状态时，供货商应于(5)个工作天内以书面通知他的认证团体：1)Chrysler “Needs Improvement”2)Fork Q-1 Revocation3)General Motors Level II ContainmentQuality System Element 4.2 General 4.2.1The supplier shall establish, document and maintain a quality syste
33、m as amines of ensuring that product conforms to specified requirements. The supplier shall prepare a quality manual covering the requirements of this International Standard. The quality manual shall include or make reference to the quality system procedures and outline the structure of the document
34、ation used in the quality system.NOTE 6 ：Guidance on quality manuals is given in ISO 10013.Quality System Procedures 4.2.2The supplier shalla)prepare documented procedures consistent with the requirements of the International Standard and the supplier s -stated quality policy, and b)effectively impl
35、ement the quality system and its documented procedures.For the purposes of this International Standard, the range and detail of the procedures that form part of the quality system shall be dependent upon the complexity of the work, the methods used, and the skills and training needed by personnel in
36、volved in carrying out the activity. NOTE 7 ：Documented procedures may make reference to work instructions that define how an activity is performed. Quality Planning 4.2.3The supplier shall define and document how the requirements for quality will be met. Quality planning shall be consistent with al
37、l other requirements of a supplier s quality system and shall be documented in a format to suit the suppliers method of operation. The supplier shall give consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects or contracts：a.the prepar
38、ation of quality plans：b.the identification and acquisition of any controls, processes, equipment (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality：c.ensuring the compatibility of the design, the production process, installat
39、ion, servicing, inspection and test procedures and the applicable documentation; d.the updating as necessary of quality control, inspection and testing techniques, including the development of new instrumentation; e.the identification of any measurement requirement involving capability the needed ca
40、pability to be developed;f.the identification of suitable verification at appropriate stages in the realization of product;g.the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element;品质系统 4.2概述 - 4.2.1供货商应建立与维持一个书面化的品质系统做为确保
41、产合规定要求的手段。供货商应准备一份涵盖本国际标准要求的品质手册。品质手册应包含或照品质系统的书面程序，并对品质系统所采用文件其架构予以概要说明。备注 6：品质手册的指导纲要请参阅ISO 10013品质系统程序 - 4.2.2供货商应：a. 拟定符合本国际标准要求与供货商既定品质政策之各项书面程序，及b. 有效实施品质系统及其各项书面程序。为达到本国际标准之目的，构成品质系统之程序其范围与详细程度，端赖工作复杂性、采用的方法及执行业务参与人员所需技巧与训练等因素而定。备注 7： 书面程序可参考对应那些界定作业如何执行的工作指导书。精品资料 - - - 欢迎下载 - - - - - - - -
42、- - - 欢迎下载 名师归纳 - - - - - - - - - -第 4 页，共 36 页 - - - - - - - - - - 品质规划 - 4.2.3供货商应界定与书面化各项品质要求是如何违成。品质规划应与供货商品质系统的所有其它要求一致，并以适合供货商作业方法的格式将其文书化。供货商应适当考量下列活动以达成产品、项目或合约的规定要求：a.拟定各项品质计划；b.鉴定与取得为违成需求品质所需之任何管制、流程、设备 ( 含检验及测试设备) 、 治具、资源及技术；c.确保设计、生产流程、安装、服务、检验与测试等程序，与适用文件间彼此之一致性；d.必要时， 得更新质量管理、检验与测试技术，含
43、新仪器的开发；e.鉴定任何量测需求其能力超出现有已知技术水准者，应有充裕的时间开发所需能力；f.在产品实现的各适当阶段鉴定其适切的验证；g.厘清所有性能与要求的允收标准，包括那些具主观因素者；h.the identification and preparation of quality records (see 4.16)NOTE 8:The quality plans referred to see 4.2.3a may be in the form of a reference to the appropriate documented procedures that form integ
44、ral part of the suppliers quality system.Advanced Product Quality Planning 4.2.3.1The supplier shall establish and implement an advanced product quality planning process. The supplier should convene internal multi-disciplinary teams to prepare for production of new or changed products. These teams s
45、hould use appropriate techniques identified in the Advanced ProductQuality Planning and Control Plan reference manual. Similar techniques that accomplish the intent are acceptable. Team actions should include：Development/finalization of special characteristics (see Appendix C)Development and review
46、of FMEAsEstablishment of actions to reduce the potential failure modes with high risk priority numbers Development or review of Control PlansSpecial Characteristics 4.2.3.2The supplier s process control guidelines and similar documents (e.g FMEA s, Control Plans, Operation Instructions) shall be mar
47、ked with the customers special characteristic symbol (or the supplier s equivalent symbol or notation) to indicate those process steps that affect Special characteristics, when Special Characteristics are identified on the customer design record (see Glossary) (see Appendix C)NOTE ：Initially, the cu
48、stomer may determine Special Characteristics and identify them. Special Characteristics may be identified from any product characteristics category, (e.g dimensional, material, appearance, performance.)Feasibility Reviews 4.2.3.3The supplier shall investigate and confirm the manufacturing feasibilit
49、y of proposed products prior to contracting to produce those products. Feasibility is an assessment of the suitability of a particular design, material, or process for production, while conforming to all engineering requirements at the required statistical process capability and at specified volumes
50、.Feasibility reviews should be documented using the Team feasibility commitment in theAdvanced Product Quality Planning and Control Plan Reference manual.Product Safety 4.2.3.4Due care and product safety shall be considered in the supplier s design control (element 4.4) and process control (element