公司企业企业经营管理（中英文）

1、Section I：ISO 9000Bases RequirementsManagement ResponsibilityElement Quality The suppliers 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 suppliers

2、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. Responsibility and responsibility, authority and the interrelation of personnel who manage, perform and verify

3、 work affecting quality shall be defined and documented, particularly for personnel who need the organizational freedom and authority to：initiate action to prevent the occurrence of any nonconformities relating to product, process and quality system；NOTE：It is recommended that the personnel responsi

4、ble 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；initiate, recommend or provide solutions though designated channels； verify the implementation of solutions； contr

5、ol further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.represent the needs of the customer in internal functions in addressing QS-9000 requirements selection of special characteristics, setting quality objectives,

6、training, corrective & preventive actions, product design and development). The supplier shall identify resource requirements and provide adequate resources, including the assignment of trained personnel (see .for management, performance of work and verification activities including internal quality

7、 audits.Management suppliers management with executive responsibility shall appoint a member of the suppliers own management who, irrespective of other responsibilities, shall have defined authority for ensuring that a quality system is established, implemented and maintained in accordance with this

8、 international Standard, andreporting on the performance of the quality system to the suppliers management for review and as a basis for improvement of the quality system.管理责任品质政策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。组织责任与授权从事影响品质之管理、执行

9、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：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。鉴定并记录任何有关产品、流程及品质系统的问题：循既定管道发起、建议或提供解决 验证解决方案之执行；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。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)。资源供货商应鉴定资源的需求，并提供适当资源包括指派

10、经训练的人员(参阅以从事管理、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确保品质系统依本国际标准建立、实施与维持，及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 qualit

11、y system.Organizational Interfaces 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 decis

12、ion-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 Product

13、 Service Packaging Engineering Tooling Engineering/MaintenanceMarketing and SalesSubcontractors, as necessaryInformation to with responsibility and authority for corrective action shall be promptly informed of products or processes which become noncompliant with specified requirements.Management Rev

14、iew suppliers 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 this international Standard and the suppliers stated quality policy and objectives.(See Reco

15、rds of such reviews shall be maintained.(See .Management Review Management Review requirement shall include all elements of the entire quality system, not only those specifically required in other elements . ：Management Review should be conducted with a multi-disciplinary approach(see Glossary).Busi

16、ness Plan supplier shall utilize a formal, documented, comprehensive business plan. this Business Plan shall be a controlled document. The content of the Business plan is not subject to third party audit. This plan may typically include as applicable： Market-related issues Financial Planning and cos

17、t Growth projections Plant/facilities plans Cost objectives Human resource development R & D plans, projections, and projects with appropriate funding 备注 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 - 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

18、织机能包括：工程技术制造生产工业工程采购物料管理品质可靠度成本预估产品服务管理信息系统数据处理包装工程工模具工程保养市场及行销分包商(必要时)通知管理阶层 - 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责与授权矫正行动的管理阶层。 管理审查 - 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 。此项审查的记录应予维持(参阅 。管理审查 - 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)。经营计划 -

19、 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 performance measurable Health, Safety and Environmental

20、 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 suppliers commodity. Methods to determine current and future cus

21、tomer-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 ensure that the plan is followed and communicated th

22、roughout 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 supplier shall document trends in quality, operational performa

23、nce (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 information should be compared with progress toward overall busine

24、ss objectives and lead to action to support：Development of priorities for prompt solutions to customer-related Determination of key customer-related trends and correlations to support status review, decision-making and longer-term planning.Customer Satisfaction The supplier shall have a documented p

25、rocess 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 and supported by objective information. These trends should be compared

26、 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 supplier shall notify their certification body/registrar in writing within five (5) working da

27、ys 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(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

28、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 - 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：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。顾客满意 - 供

29、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 - 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：Chrysler “Needs Improvement”Fork Q-1 RevocationGeneral Motors Level II ContainmentQuality System Element General

30、 supplier shall establish, document and maintain a quality system 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 qua

31、lity system procedures and outline the structure of the documentation used in the quality system.NOTE 6：Guidance on quality manuals is given in ISO 10013.Quality System Procedures supplier shallprepare documented procedures consistent with the requirements of the International Standard and the suppl

32、iers-stated quality policy, and effectively implement 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, a

33、nd the skills and training needed by personnel involved in carrying out the activity. NOTE 7：Documented procedures may make reference to work instructions that define how an activity is performed. the preparation of quality plans： the identification and acquisition of any controls, processes, equipm

34、ent (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality： ensuring the compatibility of the design, the production process, installation, servicing, inspection and test procedures and the applicable documentation; the updating a

35、s necessary of quality control, inspection and testing techniques, including the development of new instrumentation; the identification of any measurement requirement involving capability the needed capability to be developed;the identification of suitable verification at appropriate stages in the r

36、ealization of product;the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element;品质系统 概述 - 供货商应建立与维持一个书面化的品质系统做为确保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 - 供货商应

37、：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。品质规划 - 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：拟定各项品质计划；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

38、技术；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；必要时，得更新质量管理、检验与测试技术，含新仪器的开发；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；在产品实现的各适当阶段鉴定其适切的验证；厘清所有性能与要求的允收标准，包括那些具主观因素者；the identification and preparation of quality records (see NOTE 8:The quality plans referred to see may be in the form of a reference to the appropr

39、iate documented procedures that form integral part of the suppliers quality system.Advanced Product Quality Planning 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

40、changed products. These teams should use appropriate techniques identified in the Advanced Product Quality Planning and Control Plan reference manual. Similar techniques that accomplish the intent are acceptable. Team actions should include： Development/finalization of special characteristics (see A

41、ppendix C)Development and review of FMEAsEstablishment of actions to reduce the potential failure modes with high risk priority numbers Development or review of Control PlansSpecial Characteristics suppliers process control guidelines and similar documents FMEAs, Control Plans, Operation Instruction

42、s) shall be marked with the customers special characteristic symbol (or the suppliers 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：Init

43、ially, the customer may determine Special Characteristics and identify them. Special Characteristics may be identified from any product characteristics category, dimensional, material, appearance, performance.)Feasibility Reviews supplier shall investigate and confirm the manufacturing feasibility o

44、f 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.Fe

45、asibility reviews should be documented using the Team feasibility commitment in the Advanced Product Quality Planning and Control Plan Reference manual.Product Safety care and product safety shall be considered in the suppliers design control (element and process control (element policies and practi

46、ces. The supplier should promote internal awareness of safety consideration relative to the suppliers product. h. 品质记录之鉴别与调制(参阅 备注8：上述之品质计划成参阅 其形式可以构成供货商品质系统之适当书面程序对照的方式表示。先期产品品质规划 供货商应建立和实施先期产品品质规划流程。供货商须召集内部的跨功能小组，以准备新产品或变更产品的量产。这些小组须采用规定在先期产品品质规划和管制计划参考手册的各种适当的技术。但也可采用能达成本项意图的类似技术。小组的工作须包括：1.各项管制

47、特性的发展定案(见附录C)。2.各项失效模式与效应分析的发展和检讨。3.制定行动方案以降低高风险优先指数的潜在失效模式。4.各项管制计划的发展和检讨。管制特性 当顾客的设计记录(参阅词汇)有标明管制特性时，供货商的各项制程管制指导书及类似的档-(FMEA、管制计划，操作说明)，使用顾客指定的管制特性符号(或者供货商对等的符号或标记)来标明那些会影响管制特制的制程步骤(参见附录C)。备注：初期时，顾客可能会确定管制特性并加以标识。管制特性可能来自任何产品特性的种类，即尺寸、材质、外观,功能。可性审查 供货商在签定合约以生产产品之前，应对所规划的产品探讨及确认制造的可行性。可行性是指在既定的统计制

48、程能能力，产能且符合所有工程要求的前提下，评定某特定产品其设计、材料或生产制程的迫切性。可行性审查结果的记载须使用先期产品品质规划和管制计划参考手册里的小组可行性承诺书。产品安全性 供货商的设计管制及制程管制，其政策与实务应考量关注产品的安全性。供货商需在内部推广对其产品安全性考量的认知。Process Failure Mode and Effects Analysis (Process FMEAs) Process FMEAs shall consider all Special Characteristics. Efforts shall be taken to improve the p

49、rocess to achieve defect prevention rather than defect detection. Certain customers have FMEA review and approval requirements that shall be met prior to production part approval (see Section II). Refer to the Potential Failure Mode and Effects Analysis reference manual.Mistake Proofing The supplier

50、 shall utilize appropriate mistake proofing methodologies during the planning of processes, facilities, equipment and tooling.The Control Plan supplier shall develop Control Plans at the system, subsystem, component and or material level, as appropriate for the product supplied. The Control Plan sha

51、ll include the information required in the Control plan form in Appendix J. The Control Plan requirement encompasses process producing bulk materials . steel, plastic resin, paint)as well as those producing parts.The output of the advanced quality planning process, beyond the development of robust p

52、rocesses, is a Control Plan. Control Plans shall be revised or updates when products or processes differ significantly from those in current production.The Control Plan should list the controls used for processes control (see .The Control Plan shall cover three distinct phases as appropriate：Prototy

53、pe A description of the dimensional measurements and materialand performance tests that will occur during Prototype build (see APQP reference manual). The supplier shall have a prototype control plan if there are required by the customer.Pre-launch A description of the dimensional measurements and m

54、aterial and performance tests that will occur Prototype and before full Production.Production Documentation of product/process characteristics, process controls, tests, and measurement systems that occur during mass production. The supplier shall use a multi-disciplinary approach to develop Control

55、Plans.NOTE：A multi-disciplinary approach typically includes the suppliers Design, manufacturing, engineering, quality, production, and other Appropriate personnel. For external suppliers, it may include the customers Purchasing, quality, Engineering customer plant personnel as well as subcontractors

56、.Control Plans shall be reviewed and updated as appropriate when any of thefollowing occur：The product is changed. The processes are changed. The processes become unstable. The process become non-capable. Inspection method, frequency, etc. is revised. Refer to the Production Part Approval Process ma

57、nual. 制程的失效模式与效应分析 制程的失效模式与效应分析应考虑所有的管制特性，应致力于改善制程，以做到预防不良胜于找出不良。某些顾客要求在产品认可核准前要先完成FMEA审查及核准(参阅雇客特定要求章节)。参考潜在失效模式与效应分析参考手册。错误防止 供货商应于制程，设施，仪器，工模具等规划过程中，使用适当的错误防止方法论。管制计划 供货商应对所供应产品的系统、子系统、组件及(或)物料等各层次适当的制定管制计划。管制计划包含附录J管制计划表格内的所有信息(细项)。此项管制计划要求含盖生产散装材料的制程(譬如：钢铁、塑料树脂、油漆)及零组件生产。除了稳健制程的开发以外，管制计划亦是先期品质规

58、划流程的结果。当产品或制程显著不同于现行量产时，则管制计划应加以修订或更新。管制计划需列出制程管制(参照所使用的各项管制，管制计划应涵括下列三种不同阶段：原型样品说明在原型样品试制期间，所发生的各项尺寸量测、材料及性能测试等(参阅APQP参考手册)。顾客如是要求时，供货商应有原型样品管制计划。量产前说明介于原型样品和全面量产之间，所发生的各项尺寸量测、材料及性能测试等。量产完整描述在大量生产过程中，所涉及的各项产品制程特性、制程管制、测试和量测系统等的文件。供货商应运用跨功能团的方式以发展管制计划。备注：跨功能小组的成员，通常须包括供货商的设计、制造工程、品质、生产及其它相关人员。对于外部供货

59、商，也可包括顾客的采购、品质、产品工程、顾客工厂人员和分包商的人员。当下列任何一项情况发生时，管制计划应进行适当地检诗和更新：产品变更时制程变更时制程不稳定时制程能力不足时检验方法，频度等被变更参照量产零组件核准程序手册Product Approval Process General The supplier shall fully comply with all requirements set forth in the Production Part Approval Process (PPAP) manual.Subcontractor Requirements should utili

60、ze a part approval process . PPAP) for Subcontractors (see Glossary).NOTE：Certain customers require their supplier use PPAP with Their subcontractors (see Section II) Engineering Change Validation supplier shall verify that changes are properly validated See , And PPAP NOTE：This applies equally to s