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TS16949中英对照


Foreword
ISO (the International Organization for

前言
ISO(国际标准组织)系国家标准机构之全球性联 盟(ISO 会员机构)。国际标准之准备工作系透过 ISO 技术委员会正常地执行。任一会员机构对技 术委员会已建立之主题有兴趣者皆有权利参加 该委员会。与 ISO 有联系之国际组织,无论是官 方或非官方亦可参与此项工作。ISO 组织于所有 电工标准化之事务方面,与国际电工协会(IEC) 有密切合作。

Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International

Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. The main task of technical committees is to pre pare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other type of normative document. an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical 某些情形下, 尤其是市场上对此类文件有迫切要 求时, 技术委员会可以决定出版另一种型态的规 范文件: --ISO公用规范(ISO/PAS)表示ISO工作小组的技 术专家之间已达成协议,且经过原委员会投票, 50%的会员同意可以出版。 --ISO技术规范(ISO/TS) 表示技术委员会会员之 间已达成协议, 且经过委员会投票, 2/3的会员同 意可以出版。 国际标准系依据ISO/IEC指令, 第3部份之准则所 编拟。 技术委员会的主要工作是拟定国际标准。 技术委 员会采用之国际标准草案须传递至各会员国投 票。欲公布出版为国际标准,最少需要 75%之会 员机构投票赞成。

experts in an ISO working group and is accepted for publication if it is approved by 50% of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS)

represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote.

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An ISO/PAS or ISO/TS is reviewed after three years with a view to deciding whether it can be conformed for a further three years, revised to become an International Standard, or withdraws. In the case of a

ISO/PAS 或 ISO/TS 在三年后会重新检讨以决定 其是否再确认三年、修订成为国际标准或者废 止。若结果是再确认,则六年后会重新检讨,届 时只能够置换为国际标准或者废止。

confirmed ISO/PAS or ISO/TS, it is reviewed again after six years at which time it has to be either transposed into an International Standard or withdrawn. ISO/TS 16949:2002 was prepared by the International Automotive Task Force (IATF) and Japan Automobile Manufacturers Association Inc. (JAMA), with support from ISO/TC 176, Quality management and quality assurance. This second edition of ISO/TS 16949 cancels and replaces the first edition (ISO/TS 16949:1999), which has been technically revised. Boxed text is original ISO 9001:2000 text. The sector-specific supplemental requirements are outside the boxes. In this Technical Specification, the word ―shall‖ indicates a requirement. a recommendation. The word ―should‖ indicates 本技术规范中〝须〞代表强制要求, 〝应〞代表 建议。标示〝备注〞的章节则仅为指导纲要,目 的在解释或澄清相关的要求。 本文中框线中的文字为 ISO 9001:2000 的内容, 框线外文字则为汽车业增加的要求。 ISO/TS 16949 第二版公布后,第一版(ISO/TS 16949:1999) 即被取消并取代。 ISO/TS 16949:2002 是由 “国际汽车产业工作小 组(IATF)”和“日本汽车制造商协会”(JAMA) 所共同制定, ISO/TC 176 “品质管理与品质保证” 委员会支持。

Paragraphs marked ―NOTE‖ are

for guidance in understanding or clarifying the associated requirement. Where the term ―such as‖ is used, any suggestions given are for guidance only. Annex A forms a normative part of this Technical Specification. Remarks for certification (skip) 验证说明 (此部份内容略过) 当用到〝譬如(例如或比如)〞时,所提供的建议 都仅为指导纲要。 附录 A 为本技术规范的规范性部分。

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0. Introduction
0.1 General The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an is

0. 简介
0.1 概述 品质管理系统之采用应为一个组织的策略决策。 一个 组织品质管理系统之设计及实施, 受到组织之不同需 求、特殊目标、所提供的产品、所使用的过程,以及 其规模大小与架构所影响。 本国际标准并无隐含品质 管理系统架构之一致性或文件之一致性的意图。

organization's quality management system

influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are

本标准所订的品质管理系统要求,与产品之要求互 补。 加注“备注”之信息是提供了解或厘清相关要求之 指引。

complementary to requirements for products. Information marked ―NOTE‖ is for guidance in understanding requirement. The adoption of a quality management system needs to be a strategic decision of the organization. The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, regulatory and the organization's own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into or clarifying the associated

品质管理系统的采用有必要成为组织的策略决定。 一 个组织的品质管理系统的设计与实施, 受到组织不同 需求、特殊目标、提供产品、组织规模大小与结构而 影响。 这并非意味着本国际标准涵盖品质管理系统的 架构一致性或文件一致性。

本国际标准可被内部及外部团体(包括验证机构)使 用,以评鉴组织符合顾客、法规及组织本身要求的能 力。

当发展本国际标准时,ISO 9000 及 ISO 9004 所叙述 之品质管理系统原则已加以考虑。 iii

consideration during the development of this International Standard. 0.2 Process approach 0.2 流程导向 This International Standard promotes the adoption of a process approach when developing, 当开发、实施及改进品质管理系统之有效性时时,本 国际标准鼓励采用过程导向, 以藉由符合顾客要求提 高顾客满意。

implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their

一组织为使功能有效, 其必须识别及管理许多相连结 之活动。一项使用资源,及加以管理以便可将输入转 换为输出之活动,可视为一个过程。通常一个过程之 输出可直接地成为下一过程之输入。

组织内各过程系统之应用, 与这些过程之识别及相互 作用,以及其管理,通常可被称为“过程导向”。

management, can be referred to as the ―process approach‖. An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. When used within a quality management system, such an approach emphasizes the importance of a) understanding and meeting requirements, b) the need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness, and c) 获得过程绩效与有效性的结果,及 当使用于品质管理系统内时, 此一导向强调下列各项 之重要性 a) 了解及符合要求, b) 考虑以过程附加价值为观点之需求, 过程导向之利益为提供过程系统内个别过程间进行 中的管制,以及有关于其组合与相互作用之连结。

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d) continual improvement of processes based on objective measurement. The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level.
NOTE In addition, the methodology known as

d) 以目标量测为基础之过程的持续改进。

图 1 所显示以过程为基础之品质管理系统模式, 展示 条款 4 到 8 过程连结的图解。 此图解显示在界定要求 成为输入之过程中,顾客扮演一个重要之角色。不论 组织是否符合顾客要求,顾客满意度之监督,需要评 估顾客感受的有关信息。 1 显示之模式包含本国际 图 标准之全部要求,但并不展现细部阶层之过程。

备注: 此外,已知之“计划-执行-检查-行动” (PDCA) 方法,可应用于所有过程。PDCA 可以简单地 描述如下:

―Plan-Do-Check-Act‖ (PDCA) can be applied to all processes. PDCA can be briefly described as follows. Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies. Do: implement the processes.

计划:依照顾客要求及组织政策,建立必要之目标及 过程以交付结果。

执行:实施此过程。

Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results. Act: take actions to continually improve process performance.

检查:针对产品之政策、目标及要求,监督及量测过 程与产品,以及报告其结果。

行动:采行措施以持续改进过程绩效。

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Continual improvement of

the quality management systems

Management responsibility Customer Measurement, analysis and improvement

Customer

Resource management

Satisfaction

Requirement s

Input

Product realization

Output Product

Key Value-adding activities Information flow Figure 1 — Model of a process-based quality management system

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图例 加值活动 信息流 图 1 – 以过程为基础之品质管理系统模式

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0.3 Relationship with ISO 9004 The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to complement each other, but can also be used independently. Although the two

0.3 与 ISO 9004 之关系 ISO 9001 及 ISO 9004 之目前版本,已经发展成为品 质管理系统标准的一致性配对,其已被设计为互补, 但亦可以单独地使用。 虽然此两个国际标准各有不同 之范围,但为了易于使用,却有类似之架构,以协助 其成为一致性配对之应用。

International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair. ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement performance of and an organization's as well overall as its ISO 9004 赋予一品质管理系统目标之范围,较 ISO 9001 更广泛的指引,特别是在持续地改进组织之全 盘绩效,包括效率及其有效性。组织之高阶管理阶层 期望超越 ISO 9001 之要求及追求绩效之持续改进时, ISO 9004 被建议作为一项指引。 无论如何, 其并不意 图作为验证或为合约之目的。

efficiency,

effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes. NOTE The knowledge and use of the eight quality management principles referred to in ISO 9000:2000 and ISO 9004:2000 should be demonstrated and cascaded through the organization by top management. 0.3.1 IATF Guidance to ISO/TS 16949 : 2002 "IATF Guidance to ISO/TS 16949: 2002‖ is a document containing recommended automotive industry practices, examples, illustrations and explanations, and provides assistance in the application to conform to the requirements of this Technical Specification. This IATF Guidance documents is not intended for certification or for contractual purposes

备注

八项品质管理原则 (参考 ISO 9000:2000 和 ISO 9004:2000) 的知识和应用, 应由高阶管理阶层 加以示范并展开至整个组织。

0.3.1 IATF ISO/TS 16949 : 2002 指导纲要 「IATF ISO/TS 16949 : 2002 指导纲要」是一份包含 建议的汽车业做法、范例、实例及说明的文件,可以 提供一些应用方法以协助符合本技术规范的要求。

此份 IATF 指导纲要文件不作为验证或合约用途。

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0.4

Compatibility systems

with

other

management

0.4 与其它管理系统之兼容性

This International Standard has been aligned with ISO 14001:1996 in order to enhance the

为 了 使 用 者 共 同 之 利 益 , 本 国 际 标 准 已 与 ISO 14001:1996 相调和,以强化两个标准之兼容性。

compatibility of the two standards for the benefit of the user community. This International Standard does not include requirements specific to other management 本国际标准并不包含其它管理系统所订之要求, 例如 特别是环境管理、职业卫生与安全管理、财务管理或 风险管理。无论如何,本国际标准使组织能够与相关 之管理系统要求,调和或整合其本身之品质管理系 统。组织采用其现行管理系统,以建立符合本国际标 准要求之品质管理系统是可能的。

systems, such as those particular to environmental management, occupational health and safety management, financial management or risk

management. However, this International Standard enables an organization to align or integrate its own quality management system with related

management system requirements. It is possible for an organization to adapt its existing

management system(s) in order to establish a quality management system that complies with the requirements of this International Standard. 0.5 Goal of this Technical Specification The goal of this Technical Specification is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. This Technical Specification, coupled with applicable customer-specific requirements, defines the fundamental quality management system requirements for those subscribing to this document. This Technical Specification is intended to avoid multiple certification audits and provide a common approach to a quality management system for automotive production, and relevant service part organization. 本技术规范希望可避免重复验证, 并提供生产性和相 关服务性汽车零组件组织, 一个建构品质管理系统的 共通途径。 本技术规范,伴随适用的顾客特定要求,界定了采用 本文件之业者的基本品质管理系统要求。 0.5 本技术规范的目的 本技术规范的目的在于发展一套品质管理系统, 可提 供整个供应链体系的持续改善、强调缺点的预防、减 少变异及浪费。

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Quality management systems requirements 9001:2000 for for the

– Particular of ISO and

application

automotive

production

品质管理系统—生产性和与相关服务性汽 车零组件之组织使用 ISO 9001:2000 之特殊 要求

relevant service part organizations 1.Scope 1.1 General This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer requirements. NOTE In this International Standard, the term 备注:在本国际标准内,名词“产品”仅适用于顾客所 期望,或所要求之产品。 and applicable regulatory b) 藉由系统之有效应用,朝向提高顾客之满意,包 括系统过程之持续改进及符合顾客与适用法规要 求之保证。 a) 需要展示其一致地提供产品的能力,并符合顾客 与适用法规要求,及 1. 范围 1.1 概述 本国际标准所订之品质管理系统要求,使一个组织:

―product‖ applies only to the product intended for, or required by, a customer. This Technical Specification, in conjunction with ISO 9001:2000, defines the quality management system requirements for the design and development, production and, when relevant, installation and servicing of automotive-related products. This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. Supporting functions, where on-site or remote (such as design centres, corporate headquarters and distribution centres), form part of the site audit as they support the site, but cannot obtain stand-alone

本技术规范,结合 ISO 9001:2000,明定汽车业相关 产品从设计/开发、生产和(当相关时)安装/服务的 品质管理系统要求。

本技术规范适用于顾客指定的生产性和/或服务性零 组件的组织的生产场所。支持性质的单位/功能,不 论是和生产场所位于同一场所或是远距场所 (譬如设 计中心、 公司总部和配送中心) 因其支持生产场所, , 因此也要接受稽核, 但不可单独取得本技术规范之认 证。

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certification to this Technical Specification. This Technical Specification can be applied throughout the automotive supply chain. 1.2 Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development. Permitted exclusions do not include manufacturing process design. 2. The Normative reference following normative document contains 2. 参考标准 本技术规范唯一允许可以排除之项目落在 7.3 节 , 条件是当组织不负责产品设计与开发时。 允许排除的 项目不得包括制程设计。 当决定排除项目时,除非这些排除被限制于条款第 7 节之要求,且此等排除不影响组织的能力或责任,符 合本国际标准之宣称将不可接受, 以便提供符合顾客 及适用法规要求之产品。 由于组织及其产品之特质, 本国际标准之任何要求不 适用时,可考虑予以排除。 本国际标准之全部要求是一般性的,且不论类型、规 模大小及所提供之产品,意图适用于所有组织。 本技术规范适用于整个汽车业的供应链体系。 1.2 适用性

下列标准文件所包含之条款,被引用作为本文,及组 成本技术规范之条款。就加注日期之引用标准言,任 何这些版本后续之修正或改版并不适用。无论如何, 以本技术规范为协议基础之团体, 被鼓励调查应用下 列所述标准文件之最新版本的可能性。 对于无日期之 引用标准言,应参考使用标准文件之最后版本。ISO 及 IEC 之会员仍维持最新有效之国际标准登录。

provisions, which, through reference in this text, constitute provisions of this Technical Specification. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this Technical Specification are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies.

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Members of ISO and IEC maintain registers of currently valid International Standards. ISO 9000:2000, Quality management systems — Fundamentals and vocabulary. 3. Terms and definitions For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply. The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used: supplier ? organization? customer The term ―organization‖ replaces the term ―supplier‖ used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term ―supplier‖ now replaces the term ―subcontractor‖. Throughout the text of this International Standard, wherever the term ―product‖ occurs, it can also mean ―service‖. 3.1 Terms and definitions for the automotive industry 3.1 汽车业名词和定义 For the purposes of this Technical Specification, the terms and definitions given in ISO 9000: 2000 and the following apply. 3.1.1 control plan documented descriptions of the systems and processes required for controlling product (see annex A) 3.1.1 管制计划 说明控制产品所需之系统与制程的文件(参考附录 A) 。 ISO 9000:2000 内所订之与下述之名词和定义均适用 于本技术规范。 本国际标准之全部本文,无论何处所出现之名词―产 品‖,其也可表示―服务‖之意。 供货商?组织?顾客 名词―组织‖取代 ISO 9001:1994 所使用之名词―供应 者‖,且参照至应用此国际标准的单位。同样地,名 词―供应者‖目前取代名词―分包商‖。 3. 名词和定义 ISO 9000:2000 所列之各项名词及定义均可适用本 国际标准。 以下在本版次 ISO 9001 所用以描述供应链之名词, 已经加以变更,以反映目前所使用之字汇: ISO 9000:2000,品质管理系统 – 原理及词汇。

3.1.2 design responsible organization

3.1.2 负设计责任的组织 有权力制定新的产品规格或者更改现有产品规格的

organization with authority to establish a new, or change 组织 an existing, product specification NOTE This responsibility includes testing and verification of design performance within the customer's specified application 3.1.3 error proofing 3.1.3 防错法 为了预防产生不良品所从事之产品与制程的设计与

备注

此(设计)责任包含在顾客规定的应用范围内测 试与验证设计的表现/绩效。

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开发。 product and manufacturing process design and development to prevent manufacture of

nonconforming products. 3.1.4 laboratory facility for inspection, test or calibration that may include, but not limited to, chemical, metallurgical, dimensional, physical, electrical or reliability testing 3.1.6 laboratory scope controlled document containing – specific tests, evaluations and calibrations that a laboratory is qualified to perform, – list of the equipment which it uses to perform the above, and – list of methods and standards to which it performs the above 3.1.6 manufacturing process of making or fabricating – production materials, – production or service parts, – assemblies, or – heat treating, painting, plating or finishing services. 3.1.7 predictive maintenance 3.1.7 预测保养 以制程资料为基础的活动, 目的在借由预测可能的不 other 3.1.6 制造 产出下列项目的流程 – 生产性材料, – 生产性或服务性零组件, – 组装,或 – 热处理、涂装、电镀或其它表面处理服务。 3.1.6 实验室范围 是一管制文件, 其内容含: – 实验室有资格执行的特定测试、评估和校正, – 执行上述项目所需用到的设备清单,以及 – 执行上述项目的方法与标准清单。 3.1.4 实验室 进行检验、测试或校正的设施/场所,可能包括(但 不限于)化性、金相、尺寸、物性、电性或可靠度测 试。

activities based on process data aimed at the avoidance 良模式以避免发生(设备)保养问题。 of maintenance problems by prediction of likely failure modes 3.1.8 preventive maintenance planned action to eliminate causes of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design 3.1.9 . Premium freight 3.1.9 额外的运费 交货合约以外发生的额外费用或成本 3.1.8 预防保养 有计划的行动, 目的在消除设备故障和非计划性之生 产中断,并为制程设计的输出项目之一。

xii

extra costs or charges incurred additional to contracted delivery NOTE This can be caused by method, quantity, unscheduled or late deliveries, etc. 3.1.10 remote location location that supports sites and at which non-production processes occur 3.1.11 site 3.1.11 生产场所 发生附加价值的制造过程的场所 备注:额外运费发生的原因可能是因为方法、数量、 计划外的交货、或是延迟交货等。 3.1.10 远距场所 无生产制/流程发生,目的在支持「生产场所」的一 个场所。

location at which value-added manufacturing processes occur
3.1.12 special characteristics product characteristics or manufacturing process parameters which can affect safety or compliance with regulations, fit, function, performance or subsequent processing of product 3.1.12 管制特性 产品特性或制程参数,这些特性/参数很有可能会影 响到安全或法规、产品的安装、功能、性能或后续的 产品处理之符合性。

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4. Quality management system 4.1 General requirements The organization shall establish, document,

4.品质管理系统 4.1 一般要求 组织须依照本国际标准之要求,建立、文件化、实施 与维持一品质管理系统,及持续改进其有效性

implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this

International Standard. The organization shall: a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and d) 确保必要资源与信息之可取用性,以支持过程的 运作与监督, c) 决定所需之准则与方法,以确保此等过程的运作 与管制两者均有效, b) 决定此等过程之顺序与交互作用, 组织须: a) 鉴别此品质管理系统与其应用于整个组织所需之 过程(参照第 1.2 节),

information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organization in accordance with the requirements of this International Standard. Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. NOTE Processes needed for the quality f)

e) 监督、量测与分析此等过程,及

实施必要措施,以达成此等过程所规划的结果与 持续改进。

此等过程须由组织依照本国际标准之要求加以管理。

当组织选择来自外部会影响产品要求符合性之任何 过程时,组织须确保此等过程的管制。此等来自外部 过程之管制,须在品质管理系统内加以鉴别。

备注:品质管理系统所需之过程参考上述,应包括管 理阶层活动、资源之提供、产品实现及量测之 过程。

management system referred to above should include processes for management activities, provision of resources, product realization and measurement.

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4.1.1 General requirements—Supplemental Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all customer requirements. NOTE See also 7.4.1 and 7.4.1.3

4.1.1 一般要求—补述 确保对外包过程的控制, 不能免除组织符合顾客所有 要求的责任。

备注

请同时参照第 7.4.1 节和第 7.4.1.3 节。

4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this

4.2 文件化要求 4.2.l 概述 品质管理系统文件须包括

a) 品质政策与品质目标之书面叙述,

b) 品质手册, c) 本国际标准要求之书面程序,

International Standard, d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see 4.2.4). NOTE 1 Where the term ―documented procedure‖ appears within this International Standard, this means that the procedure is 备注 1: 本国际标准内所出现之名词―书面程序‖,系 指此程序被建立、文件化、实施及维持。 e) 本国际标准要求之纪录(参照第 4.2.4 节)。 d) 组织为确保其过程之有效规划、运作与管制所需 的文件,

established, documented, implemented and maintained. NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personnel. NOTE 3 The documentation can be in any form or type of medium. 4.2.2 Quality Manual The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, a) 品质管理系统之范围,包括任何排除之细节及调 4.2.2 品质手册 组织须建立及维持一品质手册,并包括下述 c) 人员之能力。 备注 3: 文件可以为任何形式或型态之媒体。 b) 过程与其交互作用之复杂性,及 a) 组织之规模大小与活动之型态, 备注 2: 品质管理系统文件之程度, 各组织间可由于 下列而有所不同

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including details of and justification for any exclusions (see 1.2), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system. 4.2.3 Control of documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4. A documented procedure shall be established to define the controls needed a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 4.2.3.1 Engineering specifications The organization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on customer-required schedule. Timely review should be as soon as possible, and shall not exceed two working weeks. f) c) b)

整(参照第 1.2 节),

品质管理系统所建立之书面程序或对其之引用, 及

品质管理系统各项过程间交互作用的描述。

4.2.3 文件管制 品质管理系统所需之文件须加以管制。 记录是文件之 一种特殊型态,其须依照第 4.2.4 节所定的要求加以 管制。

书面程序须建立,以界定所需之管制

a) 在文件发行前批准其适宜性,

b) 在必要时,审查与更新以及重新批准文件,

c) 确保文件之变更与最新修订状况,已加以识别,

d) 确保在使用场所可取用相关版本之适用文件,

e) 确保文件易于阅读与容易识别,

确保外来之文件已加以识别,并对其分发加以管 制,及

g) 防止失效文件被误用,以及这些文件若为任何目 的而保留时,须加以适当之识别。

4.2.3.1 工程规格 组织须有一套流程以确保对所有顾客的工程标准/ 规格,及其变更,得以根据顾客要求的时程,适时的 审查、分发及执行。适时的审查应尽快执行,且不得 超过二个工作周。

The organization shall maintain a record of the date on which each change is implemented in

组织须保存一份记载每项生产变更生效日期的记录。 所谓「执行」 ,须包括更新相关文件。

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production.
NOTE

Implementation shall include
备注 当这些规格是被设计资料所参考或当其会影响 生产性零件核准程序的文件(例如管制计划,FMEA 等)时,这些标准/规格的变更,需要同时更新顾客 生产性零件核准的记录。

updated documents.
A change in these standards/specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc. 4.2.4 Control of records Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality 4.2.4 记录管制 记录须加以建立及维持, 以提供品质管理系统符合要 求及有效运作之证据。记录须易于阅读、容易识别及 取用。为了记录之鉴别、储存、保护、取用、保存期 限及处理, 书面程序须加以建立, 以界定所需之管制。

management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. NOTE 1: ―Disposition‖ above includes disposal. NOTE 2: ―Records‖ also include customer-specified records. 4.2.4.1 Records retention The control of records shall satisfy regulatory and customer requirements. 5. Management responsibility 5.1 Management commitment Top management shall provide evidence of its commitment to the development and

备注 1 上述之「处理」包括废弃。 备注 2 「记录」亦包括顾客指定之记录。

4.2.4.1 记录保存 记录之管制须满足法规和顾客之要求。

5.管理责任 5.1 管理承诺 高阶管理阶层须藉由下列各项, 提供其对品质管理系 统发展与实施,以及对有效性持续改进承诺的证据

implementation of the quality management system and continually improving its effectiveness by a) communicating to the organization the a) 在组织内传达符合顾客,以及法令与法规要求之 重要性,

importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources. 5.1.1 Process efficiency

b) 建立品质政策, c) 确保品质目标已加以建立, d) 执行管理阶层审查,及 e) 确保资源之可取用性。 5.1.1 流程效率

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Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency. 5.2 Customer focus Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). 5.3 Quality policy

高阶管理阶层须审查产品实现流程和支持流程, 以确 保其有效性和效率。

5.2 顾客导向 高阶管理阶层须确保顾客要求已被决定与符合, 并提 高顾客满意的目标(参照第 7.2.1 及 8.2.1 节)。

5.3 品质政策

Top management shall ensure that the quality policy a) is appropriate to the purpose of the organization, b) includes a commitment to comply with

高阶管理阶层须确保品质政策

a) 对组织之目的是适切的, b) 包括品质管理系统符合要求与有效性持续改进 之承诺,

requirements and continually improve the effectiveness system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability. of the quality management

c) 提供一个建立与审查品质目标之架构,

d) 在组织内已被沟通与了解,及

e) 审查其持续的适用性。 5.4 规划 5.4.1 品质目标

5.4 Planning 5.4.1 Quality objectives Top management including for shall ensure that to a]], quality meet are

高阶管理阶层须确保品质目标, 包括产品符合要求之 需求[参照第 7.1 a]节],已在组织内相关部门及阶层 加以建立。品质目标须可量测,且与品质政策一致。

objectives,

those

needed [see 7.1

requirements

product

established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. 5.4.1.1 Quality objective--Supplemental Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy. NOTE Quality objectives should address customer expectations and be achievable within a defined time period. 5.4.2 Quality management system planning 5.4.2 品质管理系统规划 xviii 5.4.1.1 品质目标—补述 高阶管理阶层须定义品质目标和量度指针, 且须将其 纳入经营计划,并运用该目标和指针来展开品质政 策。 备注 品质目标应强调顾客的期望,且应是在预定期 间内可以达成的。

Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management implemented. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Top management shall ensure that responsibilities and authorities are defined and communicated within the organization. 5.5.1.1 Responsibility for quality Managers with responsibility and authority for corrective action shall be promptly informed of products or processes which do not conform to requirements. Personnel responsible for quality shall have the authority to stop production to correct quality problems. Production operations across all shifts shall be staffed with personnel in charge of, or delegated responsibility for, ensuring product quality. 5.5.2 Management representative Top management shall appoint a member of management responsibilities, who, shall irrespective have of other and system are planned and

高阶管理阶层须确保 a) 品质管理系统规划已加以完成,以符合第 4.1 节 所定要求与品质目标,及

b) 当规划与实施品质管理系统变更时,品质管理系 统完整性仍得以维持。

5.5 职责、权限与沟通 5.5.1 职责与权限 高阶管理阶层须确保职责及权限, 已在组织内加以界 定及沟通。

5.5.1.1 品质责任 负有权责执行矫正措施的管理人员, 须被立即告知不 符合规定的产品或制程。

品质负责人员须被授权停止生产以矫正品质问题。

跨越所有班次之生产线(作业)均须配置负责产品品质 之人员 (e.g. QA 人员) 。 5.5.2 管理代表 高阶管理阶层须在管理阶层中指派一员担任管理代 表,其不受其它职责所影响,明订其职责及权限,此 职责及权限包括

responsibility

authority that includes a) ensuring that processes needed for the quality management system are established, a) 确保品质管理系统所需之过程,已加以建立、实 施及维持,

implemented and maintained, b) reporting to top management on the b) 向高阶管理阶层报告品质管理系统之绩效与改 进之任何需求,及

performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer organization. requirements throughout the

c) 确保促进组织全盘认知顾客之要求。

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NOTE

The

responsibility

of

a

management

备注:管理代表之职责,可包括与外部团体在品质管 理系统相关事务之联系。

representative can include liaison with external parties on matters relating to the quality management system. 5.5.2.1 Customer representative Top management shall designate personnel with responsibility and authority to ensure that customer requirements are addressed. This includes

5.5.2.1 顾客代表 高阶管理阶层须指定人员, 并赋予其权责用以确保顾 客的要求受到重视。本项包括管制特性的选择,设定 品质目标及相关训练,矫正及预防措施,产品的设计 与开发。

selection of special characteristics, setting quality objectives and related training, corrective and preventive development. 5.5.3 Internal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system. 5.6 Management review 5.6.1 General Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained (see 4.2.4).. 5.6.1.1 Quality management system performance These reviews shall include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process. Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see 8.4.1 and 8.5.1). actions, product design and

5.5.3 内部沟通 高阶管理阶层须确保组织内已建立适当的沟通过程, 以及进行与品质管理系统有效性有关的沟通。

5.6 管理审查 5.6.1 概述 高阶管理阶层须在规划之期间内, 审查组织品质管理 系统,以确保其持续的适用、适切及有效。审查须包 括改进时机之评估,以及品质管理系统,包括品质政 策及品质目标,变更的需求。

管理阶层审查纪录须加以维持(参照第 4.2.4 节)

5.6.1.1 品质管理系统绩效 此等审查须包括品质管理系统的所有要求及其绩效 趋势,因其为持续改善流程的重要部分。

管理审查的部分内容须为品质目标的监督, 以及不良 品质成本的定期报告和评估(参考第 8.4.1 节及第 8.5.1 节) 。

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These results shall be recorded to provide, as a minimum, evidence of the achievement of the quality objectives specified in the business plan, and customer satisfaction with product supplied. 此等结果须加以纪录,至少可以提供作为下述成果 (达成)的左证: --经营计划规定的品质目标,以及 --供应产品之顾客满意度。 5.6.2 审查输入 管理阶层审查输入须包括下列信息

5.6.2 Review input The input to management review shall include information on a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality

a) 稽核之结果, b) 顾客之回馈, c) 过程绩效与产品符合性, d) 预防及矫正措施之状况, e) 先前管理阶层审查之跟催措施, f) 可能影响品质管理系统之变更,及 g) 改进之建议。

management system, and g) recommendations for improvement.

5.6.2.1 Review input-Supplemental Input to management review shall include an analysis of actual and potential field-failures and their impact on quality, safety or the environment. 5.6.3 Review output The output from the management review shall include any decisions and actions related to a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs.

5.6.2.1 审查输入—补述 管理审查输入须包含对实际的与潜在的产品售后(使 用)失效之分析,以及这些失效对品质、安全或环境 的冲击分析。 5.6.3 审查输出 管理阶层审查之输出须包括下列有关之任何决定及 措施 a) 品质管理系统与其过程有效性之改进, b) 顾客要求有关产品之改进,及 c) 资源之需求。

6. Resource management 6.1 Provision of resources The organization shall determine and provide the resources needed a) to implement and maintain the quality

6. 资源管理 6.1 资源提供 组织须决定及提供所需之资源,

a) 以实施与维持品质管理系统,以及持续改进其有 效性,及

management system and continually improve its effectiveness, and

xxi

b) to enhance customer satisfaction by meeting customer requirements. 6.2 Human resources 6.2.1 General Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. 6.2.2 Competence, awareness and training The organization shall a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience (see 4.2.4). 6.2.2.1 Product design skills The organization shall ensure that personnel with product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques. Applicable tools and techniques shall be identified by the organization. 6.2.2.2 Training The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks shall be qualified, as required, with particular attention to the satisfaction of customer requirements. NOTE 1 This applies to all employees having an effect on quality at all levels of the

b) 以藉由符合顾客要求提高顾客满意度。

6.2 人力资源 6.2.1 概述 执行会影响产品品质工作的人员,须以适当之教育、 训练、技术及经验为基准,胜任其工作。

6.2.2 能力、认知与训练 组织须 a) 决定执行会影响产品品质工作之人员必要的能 力,

b) 提供训练或采行其它措施以满足这些需求,

c) 评估所采行措施之有效性, d) 确保人员认知其从事之活动的关连性与重要性, 以及他们如何在品质目标之达成有所贡献,及

e) 维持适当之教育、 训练、 技术及经验的纪录(参照 第 4.2.4 节)。 6.2.2.1 产品设计技术 组织须确保负产品设计责任之人员有能力达到设计 要求,且对需要的应用工具和技术十分娴熟。

组织须界定需要的应用工具和技术

6.2.2.2 训练 组织须制定并维持一套用于鉴定训练需求以及使影 响产品品质之所有人员可以胜任其工作之书面程序。 对执行特定工作之人员须依需求审定其资格, 尤其须 特别注意满足顾客的要求。

备注 1 上述要求适用于组织内各阶层所有会影响品 质的员工。

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organization. NOTE 2 An example of the customer specific requirements is the application of 备注 2 顾客特定要求的例子比如数字化数学资料 的应用。

digitized mathematically based data. 6.2.2.3 Training on the job The organization shall provide on-the-job training for personnel in any new or modified job affecting product quality, including contract or agency personnel. Personnel whose work can affect 6.2.2.3 职前(在职)训练 组织须提供会影响产品品质的人员, 包括约聘人员或 代理人员,任何新作业或变更的作业的职前(在职) 训练。 担任会影响品质工作的人员须被告知当不合格 发生时对顾客造成的影响(后果)。

quality shall be informed about the consequences to the customer of nonconformity to quality requirements. 6.2.2.4 Employee motivation and empowerment The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an 6.2.2.4 员工激励和授权 组织须有一套流程以激励员工达成品质目标、 进行持 续改善以及塑造创新之环境。 此流程须包含整个组织 的品质与科技意识的宣导。

environment to promote innovation. shall include the promotion of

The process quality and

technological awareness throughout the whole organization. The organization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives [see 6.2.2 d?]. 6.3 Infrastructure The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a) b) buildings, workspace and associated utilities, process equipment (both hardware and a) 建筑物、工作空间与相关之公共设施, b) 过程设备(硬件与软件两者) ,及 6.3 基础架构 组织须决定、提供及维持所需之基础架构,以达成符 合产品要求。适用时,基础架构包括 组织须有一套流程以衡量其人员对所担任业务的相 关性与重要性的认知程度, 以及其对达成品质目标的 贡献度(参考第 6.2.2 节 d?项) 。

software), and c) supporting services (such as transport or communication). 6.3.1 Plant, facility and equipment planning The organization shall use a multidisciplinary approach (see 7.3.1.1) for developing plant, facility 6.3.1 工厂、设施及设备规划 组织须采用跨功能小组的做法(参考第 7.3.1.1 节),以 制定工厂,设施及设备计划。( i.e.与先期产品品质规 c) 支持服务(诸如输送或通讯) 。

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and equipment plans.

Plant layouts shall optimize

划程序相结合)。工厂的配置须使物料流动、搬运和 现场空间使用附加价值达到最佳化, 且须促进同步物 流。 须制定及实施一套方法以评估及监督现行作业的 有效性。

material travel, handling and value-added use of floor space, and shall facilitate synchronous material flow. implemented Methods shall be developed and to evaluate and monitor the

effectiveness of existing operations. NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness system. 6.3.2 Contingency plans The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns. 6.4 Work environment The organization shall determine and manage the work environment needed to achieve conformity to product requirements. 6.4.1 Personnel safety to achieve product quality Product safety and means to minimize potential risks to employees shall be addressed by the organization, development especially process in and the in design and 6.4.1 为达成产品品质之人员安全 组织须强调产品安全和减少员工潜在危机的方法, 特 别在设计与开发流程以及制造流程活动中。 6.4 工作环境 组织须决定及管理工作环境所需, 以达成符合产品要 求。 6.3.2 紧急应变计划 组织须准备应变计划以便在紧急事件中 (例如设施中 断、劳工短缺、主要设备故障和产品售后/使用退货) 能满足顾客要求。 of the quality management 备注 此等要求应强调精简生产原则以及与品质管 理系统有效性之连结。

manufacturing

process activities. 6.4.2 Cleanliness of premises The organization shall maintain its premises in a state of order, cleanliness and repair consistent with the product and manufacturing process needs. 7. Product realization 7.1 Planning of product realization The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1). In planning product realization, the organization shall determine the following, as appropriate: 在规划产品实现时,适当时,组织须决定下列: 7. 产品实现 7.1 产品实现之规划 组织须规划及开发产品实现所需之过程。 产品实现之 规划,须与品质管理系统其它过程的要求一致(参照 第 4.1 节) 。 6.4.2 工作场所(环境)之整洁 组织须保持其工作环境处于一种与其产品和制程需 要相称的、井然有序、干净且维修良好的状态。

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a) quality objectives and requirements for the product; b) the need to establish processes, documents, and provide resources specific to the product; c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4). The output of this planning shall be in a form suitable for the organization's method of

a)

产品之品质目标及要求;

b)

建立过程、文件之需求及提供产品特定之资源;

c)

产品所需之特定的查证、确认、监督、检验与测 试活动,以及产品允收标准;

d)

所需之纪录, 以提供证明实现过程及最终产品达 成要求(参照第 4.2.4 节) 。

规划的结果须为适合于组织运作方法之一种形式。

operations. NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. NOTE 2 The organization may also apply the requirements development processes. NOTE Some customers refer to project management or advanced product quality planning as a means to achieve product realization. Advanced product quality 备注 某些顾客采用项目管理或先期产品品质规划作 为达成产品实现的方式。相对于侦测错误,先 期产品品质规划体现了预防错误与持续改善 的观念,并且是以跨功能小组方法为基础。 given of in 7.3 to the 备注 2: 对于产品实现过程之开发,组织亦可应用 备注 1: 一份规定品质管理系统过程(包括产品实

现过程)及资源,应用于某一特定产品、项 目或合约的文件,可视为一份品质计划。

第 7.3 节所定之要求。

product

realization

planning embodies the concepts of error prevention and continual improvement as contrasted with error detection, and is based on a multidisciplinary approach. 7.1.1 Planning of product realization--Supplemental Customer requirements and references to its technical specifications shall be included in the planning of product realization as a component of the quality plan. 7.1.2 Acceptance criteria Acceptance criteria shall be defined by the organization and, 7.1.2 允收标准 组织须界定允收标准 (Note: 通常是在 APQP 时界 7.1.1 产品实现之规划—补述 顾客要求以及其引申之技术规格要求, 须被纳入产品 实现计划之中,以作为品质计划的一部份。

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where required, approved by the customer. For attribute data sampling, 8.2.3.1). 7.1.3 Confidentiality The organization shall ensure the confidentiality of the acceptance level shall be zero defects (see

定!), 并且, 若需要时,须取得顾客核准。 对于计数值抽样, 允收标准须为零缺点。 (参照第 8.2.3.1 节) 。 7.1.3 机密性 组织对于已与顾客签约之开发中的产品和项目, 以及

customer-contracted products and projects under development, 与产品相关的信息,须确保其机密性。 and related product information. 7.1.4 Change control The organization shall have a process to control and react to changes that impact product 7.1.4 变更管制 组织须有一套流程来管制及反应会影响产品实现的 变更。任何变更所造成的影响,包括那些由供货商所 引起的变更,都须加以评估,且须界定验证与验收的 作业,以确保符合顾客的要求。变更在实施之前须加 以验收完成。

realization.

The effects of any change, including

those changes caused by any supplier, shall be assessed, and verification and validation activities shall be defined, to ensure compliance with customer requirements. Changes shall be

validated before implementation. For proprietary designs, impact on form, fit and function (including performance, and/or durability) shall be reviewed 关于专属的设计,举凡形状、安装、功能(包括性能 及/或耐久性的)的影响,都须跟顾客一起商议,以

with the customer so that all effects can be properly evaluated. 便能进行正确的评估。 When required by the customer, additional 当顾客提出要求时,须符合所增加的查证/识别要 求,譬如:新产品引进之要求。

verification/identification requirements, such as those required for new product introduction, shall be met. NOTE 1 Any product realization change affecting customer requirements requires

备注 1 任何会影响顾客要求的产品实现变更都需要 通知顾客,并取得顾客同意

notification to, and agreement from, the customer. NOTE 2 The above requirement applies to product and manufacturing process changes. 7.2 Customer-related processes 7.2.1 Determination of requirements relating to the product The organization shall determine a) requirements specified by the customer, 组织须决定 a) 顾客所定之要求,包括交货与交货后活动的要 求, 7.2 顾客相关作业流程 7.2.1 产品有关要求的决定 备注 2 上述要求适用于产品变更与制程变更。

including the requirements for delivery and post-delivery activities, b) requirements not stated by the customer but necessary for specified or intended use, where

b) 非顾客所陈述之要求,但为已知特定用途或为预 期用途所必须者,

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known, c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization. NOTE 1 Post-delivery activities include any 备注 1 交货后活动包括属于与客户的合约或购买订 单一部份的任何产品售后服务活动。 d) 组织所决定之任何附加的要求。 c) 与产品有关之法令与法规要求,及

after-sales product service provided as part of the customer contract or purchase order. NOTE 2 This requirement includes recycling, environmental impact and

备注 2 上述要求包括回收、环境冲击以及根据组织 对产品与制程的了解所鉴别出之特性。 (参 照第 7.3.2.3 节) 。

characteristics identified as a result of the organization’s knowledge of the product and manufacturing processes (see 7.3.2.3) NOTE 3 Compliance to item c) includes all applicable government, safety and 备注 3

上述 c)项之符合应包括将适用的政府法令、

安全与环保法规,适用 于材料的取得、 储存、搬运、 回收、 废弃或处理。

environmental regulations, applied to acquisition, storage, handling,

recycling, elimination or disposal of materials. 7.2.1.1 Customer-designated special characteristics The organization shall demonstrate conformity to customer requirements for designation, documentation and control of special characteristics. 7.2.1.1 顾客指定的管制特性 组织须展现能符合客户对管制特性之「指定/命名」 (e.g. 赋予持定符号…等), 「文件化」及「管制」之要 求。

7.2.2 Review of requirements relating to the product The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that a) product requirements are defined, b) contract or order requirements differing from those previously expressed are resolved, and

7.2.2 产品要求审查

组织须审查与产品有关之要求。 此审查须在组织承诺 供应给顾客一项产品之前执行(例如:标单之送出、 合约或订单之接受、合约或订单变更之接受) ,且须 确保

a) 产品要求已加以界定, b) 与先前表达不同之合约或订单要求已加以解决, 及

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c) the organization has the ability to meet the defined requirements. Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4). Where the customer provides no documented statement requirements of requirement, shall be the customer by the

c) 组织有能力符合所界定之要求。

审查结果及审查产生措施之纪录,均须予以维持(参 照第 4.2.4 节) 。

当顾客提供非书面叙述之要求时, 组织在接受顾客要 求前须加以确认。

confirmed

organization before acceptance. Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material. 7.2.2.1 Review of requirements related to the product--Supplemental Waiving the requirement stated in 7.2.2 for a formal review (see note) shall require customer 7.2.2.2 组织的制造可行性 组织在合约审查过程中须针对提议之产品进行调查, 确认与记录其制造可行性,包括风险分析。 7.2.2.1 产品要求审查—补述 免除第 7.2.2 节中叙及的正式审查(参照备注) ,需 要有顾客的授权。 备注: 在某些情况, 诸如网际网络之销售, 正式的审 查对每一订单言, 可能并不实际。 替代之审查 可包含相关的产品信息, 诸如型录、 广告资料 等。 当产品要求变更时,组织须确保相关文件已加以修 订,以及将变更之要求知会相关人员。

authorization. 7.2.2.2 Organization manufacturing feasibility The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis. 7.2.3 Customer communication The organization shall determine and implement effective arrangements for communicating with customers in relation to a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer complaints. 7.2.3.1 Customer communication-Supplemental The organization shall have the ability to 7.2.3.1 顾客沟通—补述 组织须具备以顾客规定的语言与格式沟通必要信息 feedback, including customer c) 顾客回馈,包括顾客抱怨。 a) 产品信息, b) 查询、合约或订单之处理,包括修订时,及 7.2.3 顾客沟通 组织须决定及实施有效的安排, 以便就下列相关项目 与顾客沟通

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communicate necessary information, including data, in a customer-specified language and format (e.g. computer-aided design data,

的能力(例如计算机辅助设计资料、电子资料交 换) 。

electronic data exchange). 7.3 Design and development NOTE The requirements of and manufacturing 7.3 include product design and 7.3 设计和开发 备注 第 7.3 节的要求包括产品与制程的设计与开发, 并应将焦点放在预防错误而非侦测错误。

process

development, and focus on error prevention rather than detection. 7.3.1 Design and development planning The organization shall plan and control the design and development of product. During the design and development planning, the organization shall determine a) the design and development stages, b) the review, verification and validation that are appropriate to each design and development stage, and c) the responsibilities and authorities for design and development. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses. 7.3.1.1 Multidisciplinary approach The organization shall use a multidisciplinary approach to prepare for product realization, including development/finalization and monitoring of special characteristics, development and review of FMEAs, including actions to reduce potential risks, and development and review of control plans. A multidisciplinary approach typically 备注 典型的跨功能小组成员包括组织内的设计、制 造、工程、品质、生产和其它适当人员。 – 7.3.1.1 跨功能小组的方式 组织须利用跨功能小组的方式筹备产品实现,包括: – – 各项管制特性的建立/定案和监督, 各项失效模式与效应分析的建立和审查, 包含降低潜在风险之各种行动方案,以及 各项管制计划的建立和审查。 适当时, 在设计及开发过程中, 规划输出须加以更新。 组织须管理参与设计及开发之不同小组间的接口, 以 确保有效的沟通与职责的明确指派。 c) 设计及开发之职责与权限。 a) 设计及开发阶段, b) 审查、查证与确认活动,对每一个设计及开发阶 段是适切的,以及 当设计及开发规划时,组织须决定 7.3.1 设计和开发规划 组织须规划与及管制产品之设计及开发。

NOTE

includes the organization’s design, manufacturing, engineering, quality, production and other

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appropriate personnel. 7.3.2 Design and development inputs Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include a) b) functional and performance requirements, applicable requirements, c) where applicable, information derived from previous similar designs, and d) other requirements essential for design and development. These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other. NOTE Special characteristics (see 7.2.1.1) are included in this requirement. 7.3.2.1 Product design input The organization shall identify, document and review the product design inputs requirements, including the following: customer requirements (contract review) such as special characteristics (see 7.3.2.3), – 备注 管制特性(参照第 7.2.1.1 节)亦包含于上述要 求。 7.3.2.1 产品设计输入 组织须对产品设计输入的要求加以鉴别、 文件化和审 查,包括下列项目: – 顾客要求(合约审查) :例如管制特性(参 照第 7.3.2.3 节) 、识别、追溯性和包装; 信息的使用:组织须备有一流程以便将得 自先前设计项目、竞争者分析、供货商回馈、内 部输入、产品售后(使用)资料和其它相关来源的 信息,应用到具类似性质的现有及未来项目之 中。 – 产品品质、寿命、可靠度、耐久性、可维 护性、时效性和成本的目标。 此等输入之适切性须加以审查。要求应完整、明确及 不会互相矛盾。 d) 其它设计及开发所不可或缺之要求。 c) 当适用时,源自以往类似设计之信息,及 statutory and regulatory a) 功能与绩效之要求, b) 适用的法令与法规之要求, 7.3.2 设计和开发输入 与产品要求相关之输入, 须加以决定及纪录加以维持 (参照第 4.2.4 节) 。此等输入须包括

identification, traceability and package; use of information: the organization shall have a process to deploy information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data, and other relevant sources, for current and future projects of a similar nature; targets for product quality, life, reliability, durability, maintainability, timing and cost. 7.3.2.2 Manufacturing process design input The organization shall identify, document and review the manufacturing process design input requirements, including product design output data, targets for productivity, process capability and

7.3.2.2 制程设计输入 组织须对制程设计输入的要求加以鉴别、 文件化和审 查,包括 – – – 产品设计输出资料, 生产力、制程能力和成本的目标, 顾客的要求(若有的话) ,和

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cost, customers requirements, if any, and experience from previous developments.



先前开发案的经验。

NOTE The manufacturing process design includes the use of error-proofing methods to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered. 7.3.2.3 Special characteristics The organization shall identify special

备注 制程设计包括视问题的大小程度及所面对风险 的相当性采用适切的防错法。

7.3.2.3 管制特性 组织须鉴别出管制特性(参照第 7.3.3 d 节) ,并且 ? ? ? 将所有管制特性纳入管制计划中 遵照顾客规定的定义和标志,并且 在制程管制文件上 (包括图面、FMEA's,管 制计划,作业指导书)标记顾客的管制特性符号或 组织的相对等符号或注记, 用以清楚指出那些会影 响管制特性的制程步骤。

characteristics [see 7.3.3 d?] and include all special characteristics in the control plan, comply with customer-specified definitions and symbols, and identify process control documents including drawings, FMEAs, control plans, and operator instructions with the customer’s special

characteristics symbol or the organization’s equivalent symbol or notation to include those process steps that affect special

characteristics. NOTE Special characteristics can include product characteristics and process parameters. 7.3.3 Design and development outputs 7.3.3 设计和开发输出 备注 管制特性可能包括产品特性和制程参数。

The outputs of design and development shall be provided 设计及开发之输出, 须以一种能够查验设计及开发输 in a form that enables verification against the design and 入之形式加以提供,以及在发行前须加以核准。 development input and shall be approved prior to release. Design and development outputs shall a) meet the input requirements for design and development, b) provide appropriate information for purchasing, production and for service provision, c) contain or reference product acceptance criteria, and d) specify the characteristics of the product that are essential for its safe and proper use.. 7.3.3.1 Product design outputs –Supplemental 7.3.3.1 产品设计输出—补述 d) 规定产品之安全及适合使用的必要特性。 c) 包含或引用产品之允收标准,及 b) 提供采购、生产及服务提供之适当信息, 设计及开发输出须 a) 符合设计及开发输入之要求,

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The product design output shall be expressed in terms that can be verified and validated against product design input requirements. design output shall include design FMEA, reliability results, product special characteristics and specifications, product error-proofing, as appropriate, product definition including drawings or mathematically based data, product design reviews results, and diagnostic guidelines where applicable. The product

产品设计输出须以一种能够查验或验收产品设计输 入要求的语句加以表达。产品设计输出须包括 – – – – – – 设计 FMEA、可靠度结果; 产品的管制特性和规格; 适当时,产品的防错法; 产品定义,包括图面或数学资料; 产品的设计审查结果;以及 适用时,诊断指导纲要。

7.3.3.2 Manufacturing process design output The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated. The manufacturing process design

7.3.3.2 制程设计输出 制程设计输出须以一种能够查验制品设计输入要求 和验收的语句加以表达。制程设计输出须包括 – 规格和图面; – 制造流程图/平面布置图; – 制程 FMEA; – 管制计划(参照第 7.5.1.1 节) ; – 作业指导书; – 制程认可的允收标准; – 品质、可靠度、可维护性和可量测性的资料; – 适当时,防错法活动的结果;以及 – 快速侦测与回馈产品/制程不良的方法。

output shall include specification and drawings, manufacturing process flowchart/layout, manufacturing process FMEAs, control plan (see 7.5.1.1) work instructions, process approval acceptance criteria, data for quality, reliability, maintainability and measurability, results of error-proofing activities, as appropriate, and methods of rapid detection and feedback of product/manufacturing process nonconformities. 7.3.4 Design and development review At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1) a) to evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose necessary

7.3.4 设计和开发审查 在适当阶段, 须依照所规划之安排 (参照第 7.3.1 节) 执行设计及开发之系统性审查,

a) 以评估设计及开发结果符合要求之能力,及

b) 以鉴别任何问题及提出必要之措施。

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actions. Participants in such reviews shall include 参与此审查者, 须包括与被审查之设计及开发阶段有 关部门的代表。审查结果及任何必要措施之纪录,均 须加以维持(参照第 4.2.4 节) 。

representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4). NOTE These reviews are normally coordinated with the design phases and include manufacturing process design and development. 7.3.4.1 Monitoring Measurements at specified stages of design and development shall be defined, analysed and reported with summary results as an input to management review. NOTE These measurements include quality risks, costs, lead-times, critical paths and others, as appropriate. 7.3.5 Design and development verification Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements.

备注 此等审查通常需要配合设计之各个不同阶段且应含
制程设计与开发。

7.3.4.1 监测 于特定的设计与开发阶段必须执行的衡量须加以界 定、 分析, 并报告总结结果, 以作为管理审查的输入。

备注 此等衡量包含品质风险、成本、前置时间、关 键路径和其它适切项目。

7.3.5 设计及开发查证 查证须依照所规划之安排(参照第 7.3.1 节)执行, 以确保设计及开发输出符合设计及开发输入要求。 查 证结果及任何必要措施之纪录,均须加以维持(参照 第 4.2.4 节) 。

Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4). 7.3.6 Design and development validation Design and development validation shall be performed in accordance with planned 7.3.6 设计和开发验收 设计及开发验收须依照所规划的安排(参照第 7.3.1 节)执行,以确保产品之结果有能力符合已知特定应 用或预期用途的要求。当可行时,确认须在产品交货 或实施之前予以完成。 确认结果及任何必要措施之纪 录,均须加以维持(参照第 4.2.4 节) 。

arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4). NOTE 1 The validation process nromally include an analysis of field reports for similar products. NOTE 2 The requirements of 7.3.5 and 7.3.6 above

备注 1 验收过程通常包含类似产品的 「产品售后(使 用)」报告分析。 备注 2 上述第 7.3.5 节和第 7.3.6 节的要求同时适用

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apply to both product and manufacturing processes. 7.3.6.1 Design and development

于产品与制程。

7.3.6.1 设计和开发验收—补述 设计和开发验收的执行须根据顾客要求 (包含顾客的 方案中对时程的要求) 。

validation-Supplemental Design and development validation shall be performed in accordance with customer

requirements including programme timing. 7.3.6.2 Prototype programme When required by the customer, the organization shall have a prototype progrmme and control plan. The organization shall use, wherever possible, the same suppliers, tooling and manufacturing 所有的性能测试活动须监测是否及时的完成和符合 要求。 7.3.6.2 原型样品方案 顾客要求时, 组织须有一份原型样品方案与管制计划 。组织须尽可能使用与正式生产时相同的供货商,工 模具和制程。

processes as will be used in production. All performance testing activities shall be monitored for timely completion and conformity to

requirements. While services shall may be be outsourced, for the the 当上述服务可能外包时,组织须对外包的服务负责, 包括提供技术指导。

organization outsourced leadership.

responsible including

services,

technical

7.3.6.3 Product approval process The organization shall conform to a product and manufacturing process approval procedure

7.3.6.3 产品核准流程 组织须符合顾客认可之「产品和制程核准程序」 。

recognized by the customer. NOTE Product approval should be subsequent to the verification of the manufacturing process. This product and manufacturing process approval procedure shall also be applied to suppliers. 7.3.7 Control of design and development changes Design and development changes shall be 7.3.7 设计和开发变更管制 设计及开发变更须加以鉴别与纪录应加以维持。 变更 须加以审查、查证及确认,适当时,在实施前须加以 核准。设计及开发变更之审查,须包括变更对构成零 组件及已交运产品之影响的评估。 此种产品和制程核准程序也须适用于供货商。 备注 产品核准须在制程查证之后。

identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.

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Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4). NOTE 1 Design and development changes include all changes during the product progrmme life (see 7.1.4) 7.4 Purchasing 7.4.1 Purchasing process The organization shall ensure that purchased product conforms to specified purchase

变更审查结果及任何必要措施之纪录, 均须加以维持 (参照第 4.2.4 节) 。

备注 1 设计和开发变更包含规划的产品寿命期间所 有的变更(参照第 7.1.4 节) 。

7.4 采购 7.4.1 采购流程 组织须确保所采购之产品符合采购规定要求。 对供应 者及所采购产品使用之管制方式与程度, 须视所采购 产品对后续产品实现或最终产品的影响而定。

requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product

realization or the final product. The organization shall evaluate and select 组织须以供应者依照组织之要求供应产品的能力为 基础,来评估及选择供应者。选择、评估及再评估之 标准须予以建立。 评估结果及评估所产生之任何必要 措施的纪录,均须加以维持(参照第 4.2.4 节) 。

suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4). NOTE 1 Purchased products above includes all products customer and services that such affect as

备注 1 上述要求提及的采购之产品包含会影响顾客 要求之所有产品与服务,例如小组装、配送、筛选、 重工及校正服务。

requirements

sub-assembly,

sequencing,

sorting, 备注 2 当供货商有合并、购并或分割的情形时,组 织应验证供货商的品质管理系统及其有效性之持续 性。

rework and calibration services. NOTE 2 When there are mergers, acquisitions or affiliations associated with suppliers, the organization should verify the continuity of the supplier’s quality management system and its effectiveness. 7.4.1.1 Regulatory conformity All purchased products or materials used in product shall conform to applicable regulatory 7.4.1.1 法规之符合 所有采购之产品或用于产品的材料须符合适用的法 规要求。

requirements. 7.4.1.2 Supplier quality management system 7.4.1.2 供货商品质系统的开发(建立)

development

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The organization shall perform supplier quality management system development with the goal of supplier conformity with this Technical Specification. Conformity with ISO 9001:2000 is

组织须以供货商符合本技术规范为目标来执行供货 商品质管理系统的开发(建立)。符合 ISO 9001:2000 的要求是达成目标的第一步

the first step in achieving this goal. NOTE The prioritization of suppliers for 备注 供货商开发的优先级视其,举例而言,品质表 现和所提供的产品的重要性而定。

development depends upon, for example, the supplier’s quality performance and the importance of the product supplied. Unless otherwise specified by the customer,

除非顾客另有规定,否则组织的供货商须取得由「国 际 承 认 的 」 第 三 者 认 证 公 司 所 认 证 通 过 的 ISO 9001:2000 认证。

suppliers to the organization shall be third party registered to ISO 9001:2000 by an accredited thirdparty certification body. 7.4.1.3 Customer-approved sources Where specified by the contract (e.g. customer engineering drawing, specification), the organization shall purchase products, materials or services from approved sources. The use of customer-designated sources, including tool/gauge suppliers, does not relieve the

7.4.1.3 顾客核准的来源 当合约中(例如顾客的工程图面、规范)要求时,组 织须自核准的来源采购所需的产品、材料或服务。

采用顾客指定来源,包括工具/检具供货商,并不能 免除组织确保采购产品的品质的责任。

organization of the responsibility for ensuring the quality of purchased products. 7.4.2 Purchasing information Purchasing information shall describe the product to be purchased, including where appropriate a) requirements for approval of product,

7.4.2 采购信息 采购信息须描述所采购之产品,适当时包括

a)

产品、程序、过程及设备要求之核准,

procedures, processes and equipment, b) c) requirements for qualification of personnel, and quality management system requirements. b) c) 人员资格之要求,及 品质管理系统之要求。

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 7.4.3 Verification of purchased product

采购规定要求传达给供应者前,组织须确保其适切 性。

7.4.3 采购产品的验证

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The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. here the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

组织须建立及实施必要之检验或其它活动, 以确保所 采购产品符合采购规定要求。 当组织或其顾客意图在供应者场所执行查证时, 组织 须于采购信息中, 叙述所计划之查证安排及产品放行 之方法。

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7.4.3.1 Incoming product quality The organization shall have a process to assure the quality of purchased product (see 7.4.3) utilizing one or more of the following methods:

7.4.3.1 进厂产品的品质 组织须备有一套流程以确保采购产品之品质 (参照第 7.4.3节),并须采用下列的一项或多项方法:

-

receipt of, and evaluation of, statistical data by the organization;



由组织接收并评估(由供货商所提供的)统 计数据;

-

receiving inspection and/or testing such as sampling based on performance;



接收检验与/或测试(譬如:依据进料品 质表现之优劣来决定抽样松紧) ;

-

second- or third-party assessments or audits of supplier sites, when coupled with records of acceptable delivered product quality;

– – –

在供货商处执行第二者或第三者的评鉴或 稽核,且须搭配可接受的交货产品品质纪录; 委由指定的实验室所实施的零组件评估; 其它经顾客同意的方法。

-

part evaluation by a designated laboratory; another method agreed with the customer.

7.4.3.2 Supplier monitoring Supplier performance shall be monitored through the following indicators: delivered product quality; customer disruptions including field returns;

7.4.3.2 供货商监测 供货商的绩效(表现)须透过下列指针加以监测: – – 已交货产品的品质 顾客(生产) 干扰/停顿,含产品售后(使用) 退回(退货) 交期表现(含发生超额运费之事件) ; 因品质或交期问题所造成之「特别状况之 通知客户」

delivery schedule performance (including incidents of – premium freight); –

-

special status customer notifications related to quality or delivery issues.

The organization shall promote supplier monitoring of the 组织须鼓励供货商监测其制程绩效(表现)。 performance of their manufacturing processes. 7.5 Production and service provision 7.5.1 Control of production and service provision The organization shall plan and carry out 7.5 生产与服务提供 7.5.1 生产及服务提供之管制 组织须在管制之情况下规划及完成生产及服务提供。 当适用时,管制情况须包括

production and service provision under controlled conditions. Controlled conditions shall include, as applicable a) the availability of information that describes the characteristics of the product, b) the availability of work instructions, as

a) 描述产品特性之信息的可取用性,

b) 工作说明书之可取用性,当必要时,

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necessary, c) d) the use of suitable equipment, the availability and use of monitoring and measuring devices, e) the implementation of monitoring and e) 监督及量测之实施,及 c) 适当设备的使用, d) 监督及量测装置之可取用性及使用,

measurement, and f) the implementation of release, delivery and post-delivery activities. 7.5.1.1 Control plan The organization shall – develop control plans (see annex A) at the system, subsystem, component and/or material level for the product supplied, including those for processes producing bulk materials as well as parts, and – have a control plan for pre-launch and production – that takes into account the design FMEA and manufacturing process FMEA outputs, The control plan shall – list the controls used for the manufacturing process control, – include methods for monitoring of control exercised over special characteristics (see 7.3.2.3) defined by both the customer and the organization, 管制计划须 – 列出制程管制中所使用的管制方法; – 包含监测顾客与组织自行界定的管制特性(参照 第 7.3.2.3 节)之控制方法; – 包含顾客要求之信息(若有的话) ;以及 7.5.1.1 管制计划 组织须 – 对所供应的产品按照系统、子系统、组件 及(或)物料的级别研拟适当的管制计划(参照 附录 A) ,包含生产散装物质的制程以及生产零 组件的制程;以及 备有量产前与量产阶段的管制计划,此管 制计划需将设计 FMEA 与制程 FMEA 的输出纳 入考虑。 f) 放行、交货及交货后活动之实施。

– include the customer-required information, if any, and – 规定当制程变得不稳定或能力不足时须采取的 – initiate the specified reaction plan (see 8.2.3.1) when the process becomes unstable or not statistically capable. Control plans shall be reviewed and updated when any change occurs affecting product, manufacturing process, 当任何变更会影响到产品, 制程, 量测, 后勤补给, measurement, logistics, supply sources or FMEA (see 7.1 .4). 物料供应来源或 FMEA 时, 管制计划须予以检讨及更 新(参照第 7.1.4 节) 。 反应计划(参照第 8.2.3.1 节) 。

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NOTE Customer approval may be required after review or update of the control plan.

备注

管制计划检讨及更新后,可能需要经过顾客 的核准。

7.5 1.2 Work instructions The organization shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product quality.

7.5.1.2 作业指导书 组织须为负责会影响产品品质之制程作业的所有员 工,准备书面的作业指导书。这些指导书在工作场所 须很容易被取得及使用(在不会造成工作中断之情况

These instructions shall be accessible for use at the work 下)。 station.

These instructions shall be derived from sources such as the quality plan, the control plan and the product realization process.

这些指导书须取材自比如品质计划、 管制计划和产品 实现流程等来源。

7.5.1.3 Verification of job set-ups Job set-ups shall be verified whenever performed, such as an initial run of a job, material changeover or job change. Work instructions shall be available for set-up personnel. The organization shall use statistical methods of verification where applicable.

7.5.1.3 作业条件设定的验证 只要是执行作业条件的设定(例如每一工作起始时, 原料转换,工作变更)就须验证作业条件的设定。 有关的指导书须提供给执行设定之人员。凡适用时, 组织须进行统计方法的验证。

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NOTE

Last-off-part comparisons are

备注

建议采用〝末件零组件的比较〞。

recommended. 7.5.1.4 Preventive and predictive maintenance The organization shall identify key process equipment and provide resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system. As a minimum, this system shall include the following: - planned maintenance activities, - packaging and preservation of equipment, tooling and gauging, - availability of replacement parts for key manufacturing equipment, - documenting, evaluating and improving maintenance objectives. The organization shall utilize predictive maintenance 组织须运用预测保养的方法以持续改善生产设备的 - 计划排定的保养活动; - 设备、工模具及量具之包装及保存; - 主要制造设备的替换零件的可获得性; - 保养目标的文件化,评估及改善。 7.5.1.4 预防及预测保养 组织须鉴定那些是主要的制程设备,并且提供资源, 以维护这些机器/设备, 同时制定一套有效规划的全 面预防保养制度。该项制度至少须包括:

methods to continually improve the effectiveness and the 有效性和效率。 efficiency of production equipment. 7.5.1.5 Management of production tooling The organization shall provide resources for tool and gauge design, fabrication and verification activities. 7.5.1.5 生产用工模具之管理 组织须提供资源,以从事工模具和量具之设计、制造 和验证活动。

The organization shall establish and implement a system 组织须制定和执行一套生产用工模具的管理制度, 内 for production tooling management including : 容包括:

- maintenance and repair facilities and personnel; - storage and recovery; - set-up; - tool-change programmes for perishable tools, tool design modification documentation, including engineering change level, tool modification and revision to documentation, tool identification, defining the status, such as production, repair or disposal.
?

– 保养和修理的设施和人员; – 储存和修复; – 设定(调定)条件; – 损耗性工模具的汰换计划; – 工模具设计变更之文件化,包含工程变更; – 工模具修改及文件的更新; – 工模具标示以鉴别其状态,例如可用、待修或报 废。

The organization shall implement a system to monitor these activities if any work is outsourced.

如果任何这方面之作业系属外包性质者,组织须 有一套监测的系统。

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NOTE This requirement also applies to the availability of 备注 tools for vehicle service parts. 7.5.1.6 Production scheduling

上述要求亦适用汽车服务性零件的工模具之

取得。 7.5.1.6 生产排程 统支持下的及时性生产, 该系统允许在制程的重要阶 段取得生产信息,而且生产排程应是订单导向。

例如信息系 Production shall be scheduled in order to meet customer 生产进度须妥善安排以符合顾客的要求, requirements, such as just-in-time supported by an information system that permits access to production information at key stages of the process and is order driven. 7.5.1.7 Feedback of information from service A process for communication of information on service concerns to manufacturing, engineering and design activities shall be established and maintained. NOTE The intent of the addition of ―service concerns" to this subclause is to ensure that the organization is aware of nonconformities that occur external to its organization. 备注 于此要项中增加〝售后服务关切事项〞的目 的是为确保组织知道发生在自己组织外部的 不符合事项。 7.5.1.7 服务信息的回馈 须制定并维持一套沟通流程将有关售后服务关切事 项的信息,通报给制造、工程及设计单位。

7.5.1.8 Service agreement with customer

7.5.1.8 与顾客之服务协议

When there is a service agreement with the customer, the 当与顾客有服务协议时, 组织须确认下列项目的有效 organization shall verify the effectiveness of - any organization service centres, - any special-purpose tools or measurement equipment, and - the training of service personnel. 7.5.2 Validation of production and service provision processes The organization shall validate any processes for production and service provision where the 组织须确认输出结果无法经由后续的监督或量测加 以查证之任何生产及服务提供的过程。 此包括唯有在 产品使用后或服务已交货后, 才会显现缺陷之任何过 程。 7.5.2 生产及服务提供过程之确认 性: – 组织的服务中心; – 特殊用途的工模具或量测设备;以及

– 服务人员的训练。

resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results. The organization shall establish arrangements for these processes including, as applicable a) defined criteria for review and approval of the processes,

确认须展示这些过程达成规划结果之能力。

组织须建立这些过程之安排,当适用时,包括

a)

界定过程审查及核准之标准,

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b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records (see 4.2.4), and e) revalidation.

b)

设备之核准及人员之资格,

c) d) e)

特定方法及程序之使用, 要求之纪录(参照第 4.2.4 节) ,及 再确认。

7.5.2.1 Validation of processes for production and service 7.5.2.1 生产及服务提供过程之确认—补述 provision -- Supplemental 第 7.5.2 节的要求须适用于所有的生产及服务提供流 The requirements of 7.5.2 shall apply to all processes for 程。 production and service provision. 7.5.3 Identification and traceability Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the 当追溯性为一要求时, 组织须管制及记录产品之唯一 识别(参照第 4.2.4 节) 。 组织须对有关于监督及量测要求之产品状况加以鉴 别。 7.5.3 识别和追溯性 适当时,组织须藉由适宜之方法,对产品实现全盘加 以鉴别。

organization shall control and record the unique identification of the product (see 4.2.4). NOTE In some industry sectors, configuration management identification maintained. NOTE Inspection and test status is not indicated by the location of product in the production flow unless inherently obvious, such as material in an automated production transfer process. Alternatives are permitted, if the status is clearly identified, documented and achieves the designated purpose. 7.5.3.1 Identification and traceability - Supplemental The words "Where appropriate" in 7 5.3 shall not apply. 7.5.4 Customer property The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard is a means by which are

备注: 在某些产业领域, 型态管理系藉由识别及追溯 性加以维持之一种方法。

and

traceability

备注

产品在正常生产流中的位置, 并不能作为检验 与测试状况的适当指针,除非为先天明显易见 者(例如:在自动生产的转换过程中的物料) 。 除了自动生产的转换过程之外,若测试状况可 清楚地识别、文书化并能达到指定的目的,则 其它替代方式是被允许的。

7.5.3.1 识别和追溯性—补述 上述第 7.5.3 节中的〝适当时〞不适用本规范。 7.5.4 顾客财产 当顾客财产在组织之管制下,或正由组织使用时,组 织须确实加以管理。组织对提供作为使用,或组合成 为产品之顾客财产, 须加以识别、 查证、 保护及防护。 假如任何顾客财产发生遗失、 损坏或发现不适合使用 时,须向顾客报告及纪录须加以维持(参照第 4.2.4

customer property provided for use or incorporation

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into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4). NOTE Customer property can include intellectual property. NOTE Customer-owned returnable packaging is included in this clause. 7.5.4.1 Customer-owned production tooling Customer-owned inspection tooling tools, and manufacturing, equipment shall test, be

节) 。

备注:顾客财产可包括智能财产。 备注 本要项包括那些属于顾客之可回收的包装材 料。 7.5.4.1 顾客拥有的生产用工模具 属于顾客的工具、制造用工模具、测试、检验量具和 设备须予以永久标记,使每一对象的所有权,能够一 目了然且能够确定。

permanently marked so that the ownership of each item is visible, and can be determined. 7.5.5 Preservation of product The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product. 7.5.5.1 Storage and inventory

7.5.5 产品防护 组织须在内部过程及交货至计划目的地之期间, 防护 产品之符合性。此防护须包括识别、运搬、包装、储 存及保护。防护也须适用于构成一项产品之零组件。

7.5.5.1 储存和存货

In order to detect deterioration, the condition of product in 为测知库存品之变质状况,库存品须适时作定期评 stock shall be assessed at appropriate planned intervals. 鉴。 The organization shall use an inventory 组织须使用一套存货管理系统, 以使存货周转时间达 到最佳化,同时确保存货的周转,例如”先进先出”。 过期之产品须比照不良品的方式管制。

management system to optimize inventory turns over time and assure stock rotation, such as "first-in-first-out" (FIFO). Obsolete product shall be controlled in a similar manner to nonconforming product.

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7.6 Control of monitoring and measuring devices The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).

7.6 监督和量测仪器之管制 组织须决定所从事之监督及量测, 及所需的监督及量 测装置,以提供所定产品符合性要求之证据(参照第 7.2.1 节) 。

The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results,

组织须建立过程以确保监督及量测可加以完成, 并且 以与监督及量测要求一致之一种方式完成。

当为确保有效结果所必须,量测设备须

measuring equipment shall a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international standards; or national no such a) 在规定期间及使用前,针对追溯至国际或国家量 测标准之量测标准,加以校正或查证;若无此等 标准存在,亦须将所使用之校正或查证基准加以 记录;

measurement

where

standards exist, the basis used for calibration or verification shall be recorded; b) be adjusted or re-adjusted as necessary; c) be identified to enable the calibration status to be determined; d) be safeguarded from adjustments that would invalidate the measurement result; e) be protected from damage and deterioration during handling, maintenance and storage. In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4). When used in the monitoring and measurement of 当使用于规定要求之监督及量测时, 计算机软件满足 d) 加以防护,以免于不当之调整而使其量测结果失 效; e) 加以保护,以免在运搬、维护及储存时损坏及变 质。 除此之外,当设备被发现不符要求时,组织须评估及 记录先前量测结果之有效性。 组织须对此设备及任何 被影响之产品,采行适当之措施。校正及查证结果之 纪录须加以维持(参照第 4.2.4 节) 。 b) 当必要时加以调整或重调整; c) 加以识别,使校正状况可以判定;

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specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. NOTE See ISO 10012-1 and ISO 10012-2 for guidance. NOTE A number or other identifier traceable to the device calibration record meets the intent of requirement c) above. 7.6.1 Measurement system analysis Statistical studies shall be conducted to analyse the

预期用途之能力,须加以确认。此须在初次使用前着 手完成,及必要时予以再确认。

备注:参照 ISO 10012-1 及 ISO 10012-2 作为指引。

备注

使用可追溯至该仪器校正记录的序号的作法, 符合上述 c) 项规定的精神。

7.6.1 量测系统分析 须实施适当的统计研究, 以分析每一种形式的量测及

variation present in the results of each type of measuring 试验设备系统的结果中所呈现的变异。 这项要求须适 and test equipment system. This requirement shall apply 用于管制计划里所列的量测系统。 所采用的分析方法 to measurement systems referenced in the control plan. 和允收标准, 须符合顾客有关量测系统分析参考手册

The analytical methods and acceptance criteria used shall 中的规定。若顾客核准,可使用其它的分析方法和允 conform to those in customer reference manuals on measurement systems analysis. Other analytical 收标准。

methods and acceptance criteria may be used if approved by the customer. 7.6.2 Calibration/Verification records Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide evidence of conformity of product to determined requirements, including employee- and customer-owned equipment, shall include - equipment identification, including the measurement standard against which the equipment is calibrated, - revisions following engineering changes, - any out-of-specification readings as received for calibration/verification, - an assessment of the impact of out-of-specification condition, - statements of conformity to specification after calibration/verification, and - notification to the customer if suspect product or material has been shipped. – 设备的识别,包含该设备校正所依据的量测标准 , – 根据各工程变更所作之修正, – 校正/验证接收当时 (亦即调整前)任何超出允收 标准的读值, – 超出允收标准状况的影响评估, – 校正/验证后,符合允收标准的说明, – 当可疑的物料或产品可能已经出货时,通知顾客 的记录。 7.6.2 校正/验证记录 提供产品符合既定要求证据所需的所有量具、 量测及 试验设备,,包括员工自己的量具和属于顾客的量具 在内,其校正/验证活动的记录须包括下列各项:

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7.6.3 Laboratory requirements 7.6.3.1 Internal laboratory An organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement, as a minimum, technical requirements for - adequacy of the laboratory procedures, - competency of the laboratory personnel, - testing of the product,

7.6.3 实验室的要求 7.6.3.1 内部实验室 组织的内部实验室设施须界定其执行被要求的检验、 测试或校正服务的能力范围。 实验室能力范围须纳入 品质管理系统的文件中。 实验室须规定和执行下述的 技术要求(至少) :

– 实验室程序的适切性; – 实验室人员的胜任性; – 产品的测试;

- capability to perform these service correctly, traceable to – 正确执行此等服务的能力、且能追溯至相关标准 the relevant process standard (such as ASTM, EN, etc.), and, - review of the related records. NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate supplier in-house laboratory conformity to this requirement but is not mandatory. 7.6.3.2 External laboratory External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either there shall be evidence that the external laboratory is – 须有证据显示顾客接受该外部实验室,或 acceptable to the customer, or the laboratory shall be accredited to ISO/IEC 17025 or national equivalent. NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by customerapproved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. NOTE 2 When a qualified laboratory is not available for a 备注 2 当某一设备,并无合格的实验室可提供校正 given piece of equipment, calibration services may be performed by the equipment manufacturer. In such 服务时,可由原设备制造商执行。在此情形 下,组织须确保符合第 7.6.3.1 节的要求。 备注 1 举例而言,上述所提之证据可以是顾客的评 鉴或是顾客认可的第二者的评鉴, 以证明该实验室符 合 ISO/IEC 17025 或相对等的国家标准的精神。 7.6.3.2 外部实验室 组织所使用的外部的/营业的/独立的实验室设施须界 定其执行被要求的检验、测试或校正服务的能力范 围,并符合下述两者之一的要求: 备注 供货商的室内实验室取得 ISO/IEC 17025 的认 证符合上述要求,但取得认证并非必要。 (例如ASTM, EC等) ;以及

– 相关记录的审查。

– 实验室须取得ISO/IEC 17025或相对等的国家标
准的认证。

cases, the organization should ensure that the requirements listed in 7 6.3.1 have been met.

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8. Measurement, analysis and improvement

8. 量测、分析和改善

8.1 General The organization shall plan and implement the monitoring, measurement, analysis and

8.1 概述 组织须规划及实施所需之监督、量测、分析及改善过 程

improvement processes needed a) to demonstrate conformity of the product, b) to ensure conformity of the quality management system, and c) to continually improve the effectiveness of the quality management system. This shall include determination of applicable methods, including statistical techniques, and the extent of their use.. 8.1.1 Identification of statistical tools Appropriate statistical tools for each process shall be determined during advance quality planning and included in the control plan. 8.1 2 Knowledge of basic statistical concepts Basic statistical concepts, such as variation, control (stability), process capability and over-adjustment shall be understood and utilized throughout the organization. 8.2 Monitoring and measurement 8.2.1 Customer satisfaction As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. NOTE Consideration should be given to both internal and external customers. 8.2.1.1 Customer satisfaction -- Supplemental Customer satisfaction with the organization shall be 8.2.1.1 顾客满意度—补述 顾客对组织的满意度须透过实现过程绩效的持续评 备注 应同时顾及内部和外部顾客。 8.2 监督和量测 8.2.1 顾客满意度 不论组织是否符合顾客要求, 组织须监督与顾客感受 有关之信息,以作为品质管理系统绩效的一种量测。 取得及使用此信息之方法,须加以决定。 8.1.2 基本统计概念的知识 基本统计概念,譬如变异、管制状态(稳定性) 、制 程能力及过度调整, 须为组织内的全体人员周知并使 用。 8.1.1 统计工具的鉴别 在先期品质规划阶段期间,须先针对每项制程,决定 适当的统计工具,并须纳入管制计划内。 此须包括适当方法,含统计技术,及其使用程度之决 定。 c) 以持续改善品质管理系统之有效性。 a) b) 以展示产品的符合性, 以确保品质管理系统之符合性,及

monitored through continual evaluation of performance of 估加以监测。绩效的指针须根据客观资料且包括(但 the realization processes. Performance indicators shall be 不限于)下述资料: based on objective data and include, but not be limited to: – 交货品质表现, xlviii

-

delivered part quality performance, customer disruption including field returns,

– 顾客(生产)干扰/停顿,含产品售后(使用)退回(退 货),

, delivery schedule performance (including incidents of – 交期表现(含发生超额运费之事件) premium freight), and – 因品质或交期问题所造成之「特别状况之通知客 户」 。 组织须监测制程的表现以展现符合顾客对产品品质 与制程效率的要求。

-

customer notifications related to quality or delivery issues.

The organization shall monitor the performance of manufacturing processes to demonstrate

compliance with customer requirements for product quality and efficiency of the process. 8.2.2 Internal audit The organization shall conduct internal audits at planned intervals to determine whether the quality management system a) conforms to the planned arrangements (see 7.1), to the requirements of this International a) 符合所规划之安排(参照第 7.1 节) 、本国际标准 之要求及组织所建立之品质管理系统要求,以及 8.2.2 内部稽核 组织须在规划之期间内执行内部稽核, 以决定品质管 理系统是否

Standard and to the quality management system requirements established by the

organization, and b) is effectively implemented and maintained. b) 有效地实施及维持。 稽核计划须加以规划, 并考虑被稽核之过程与区域的 状况与重要性, 以及先前稽核结果。 稽核准则、 范围、 频率及方法须加以界定。稽核员之遴选及稽核之执 行,须确保稽核过程的客观性及公正性。稽核员不得 稽核其本身之工作。

An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure. The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).

规划与执行稽核,及报告结果与维持纪录(参照第 4.2.4 节)之职责与要求,须以书面程序加以界定。

被稽核区域管理阶层之责任, 须确保采行措施没有不 当之延误,以消除所发现之不符合及其原因。后续跟 催活动须包括所采行措施之查证, 及查证结果之报告 (参照第 8.5.2 节) 。

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NOTE

See ISO 10011-1, ISO 10011-2 and ISO

备注:参照 ISO 10011-1、ISO 10011-2 及 ISO 10011-3 作为指引。 8.2.2.1 品质管理系统的稽核 组织须稽核其品质管理系统以确认符合本技术规范 以及任何额外的品质管理系统的要求。

10011-3 for guidance.. 8.2.2.1 Quality management system audit The organization shall audit its quality management system to verify compliance with this Technical Specification and any additional quality

management system requirements. 8.2.2.2 Manufacturing process audit The organization shall audit each manufacturing process to determine its effectiveness. 8 2.2.3 Product audit The organization shall audit products at appropriate 8.2.2.3 产品的稽核 组织须在生产与交货的适当阶段, 按照界定的频率稽 8.2.2.2 制程的稽核 组织须稽核每一个制造流程以确定其有效性。

以确认符合所有规定的要求, 例如产品尺寸、 stages of production and delivery to verify conformity to all 核产品, specified requirements, such as product dimensions, functionality, packaging and labeling, at a defined frequency. 8.2.2.4 Internal audit plans 8.2.2.4 内部稽核计划 次,并且须按照年度计划安排稽核时程。 当发生内部/外部不符合事项或顾客抱怨时, 须适当 nonconformities or 地增加稽核频率。 活动和班 Internal audits shall cover all quality management related 内部稽核须涵盖所有品质管理相关的流程、 processes, activities and shifts, and shall be scheduled according to an annual plan. When internal/external 功能、包装、卷标。

customer complaints occur, the audit frequency shall be appropriately increased. NOTE Specific checklists should be used for each audit. 8.2.2.5 Internal auditor qualification The organization shall have internal auditors who are qualified to audit the requirements of this Technical Specification ( see 6.2.2.2). 8.2.3 Monitoring and measurement of processes The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product. 8.2.3 过程的监督和量测 组织须使用适当的方法监督及,当适用时,量测品质 管理系统过程。此等方法须展示过程之能力,以达成 所规划之结果。当所规划结果无法达成时,须采行改 正及矫正措施,当适当时,以确保产品之符合性。 8.2.2.5 内部稽核人员的资格 组织内须有具备稽核本技术规范资格的内部稽核人 员(参照第 6.2.2.2 节) 。 备注 特定的查核表必应为每次内部稽核所使用。

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8.2.3.1 Monitoring and measurement of manufacturing processes

8.2.3.1 制程的监测与测量

The organization shall perform process studies on all new 组织须对所有的新制程(包括组装或配送)执行制程 manufacturing (including assembly or sequencing) processes to verify process capability and to provide 研究以确认制程能力, 并提供做为制程管制的额外输 入。可行时,这些制程研究的结果须予以转成书面之

additional input for process control. The results of process 规格,以做为生产方式,量测方式和保养说明书之用 studies shall be documented with specifications, where applicable, for means of production, measurement and test, and maintenance instructions. These documents shall include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria. The organization shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organization shall ensure that the control plan and process flow diagram are implemented, including adherence to the specified - measurement techniques, - sampling plans, - acceptance criteria, and reaction plans when acceptance criteria are not met.
? ? ? ?

( i.e 转成书面化之 process specs)。 此等文件须包括制 程能力、可靠度、可维护度和可用度的目标以及允收 标准。

组织须维持顾客于零组件核准程序(e.g. PPAP )要求 中核定的制程能力或绩效。 组织须确保管制计划和制 造流程图被执行,包括遵守规定的:

量测技术; 抽样计划; 允收标准;以及 当不符合允收标准时的反应计划。

Significant process events, such as tool change or machine repair, shall be recorded. The organization shall initiate a reaction plan from the control plan for characteristics that are either not statistically capable or are unstable. These reaction plans shall include containment of product and 100% inspection as appropriate. A corrective action plan shall then be completed by the organization, indicating specific timing and assigned responsibilities to assure that the process becomes stable end capable. The plans shall be reviewed with and approved by the customer when so required. The organization shall maintain records of effective dates of process changes.

发生重大之制程事件 (例如: 换模, 机器维修) 须加 以记录。 当制程能力不足或不稳定时, 组织须由管制计划中 采取包括「阻隔(不良)」(containment of product)及全检 等适当之反应计划。 后续采取之「矫正措施计划」 (corrective action plan) 须包括明确之时程及权责, 以 确保制程恢复稳定及足够之制程能力。 当顾客要求 时, 这些计划 (含反应计划及矫正措施计划) 需由客 户审查及核准。

组织须保存制程变更生效日期的记录。

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8.2.4 Monitoring and measurement of product The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned

8.2.4 产品的监督和量测 组织须监督及量测产品之特性, 以查证产品要求已符 合。此须在产品实现过程之适当阶段,依照所规划之 安排予以完成(参照第 7.1 节) 。

arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product (see 4.2.4). Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless 除非相关权责人员及,当适当时,顾客之核准,否则 须直到全部所规划的安排(参照第 7.1 节)已经完全 满意,才可进行产品放行及服务交运。 符合性与允收标准之证据,须予以维持。纪录须显示 产品放行人员之授权(参照第 4.2.4 节) 。

otherwise approved by a relevant authority and, where applicable, by the customer. NOTE When selecting product parameters to monitor compliance to specified internal and external requirements, the organization determine the types of product characteristics, leading to - the types of measurement, - suitable measurement means, and - the capability and skills required. 8.2.4.1 Layout inspection and functional testing A layout inspection and a functional verification to applicable customer engineering material and performance standards shall be performed for each product as specified in the control plans. Results shall be available for customer review. – 测量的类型; – 合适的测量方法; 备注 当选择产品参数以监测是否符合内部与外部规 定时,组织应(先)决定产品特性之种类,因其会导致 于下列事项的决定:

– 需要的能力与技能。
8.2.4.1 全尺寸检查与性能测试 每个产品均须根据管制计划的规定, 按照适用的顾客 工程物料和性能标准,实施全盘尺寸检验和机能验 证。检查结果须可随时供顾客审查。

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NOTE Layout inspection is the complete measurement of all product dimensions shown on the design records 8.2.4.2 Appearance items

备注 「全尺寸检查」 是指对设计资料上标示的所有 产品尺寸全部加以检查。

For organizations manufacturing parts designated by the 8.2.4.2 外观件(品目) customer as "appearance items", the organization shall provide – appropriate resources including lighting for evaluation, – masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as appropriate, – maintenance and control of appearance 凡组织制造的零件,被顾客认定属于〝外观件(品目) 〞时,组织须提供: – (外观)评鉴用之适当资源(包含照明亮度); – 适当地设置评估颜色、纹理、光泽、金属亮度、 质地及影像差别(DOI)的比对标准件; – 外观比对标准件和评鉴设备的维护保养与管制; – 从事外观评鉴作业的人员可以胜任且已具有担 任该项工作资格的验证合格资料。

masters and evaluation equipment, and

– verification that personnel making appearance
evaluations are competent and qualified to do so.

8.3 Control of nonconforming product The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related

8.3 不合格品之管制 组织须确保不合格产品要求之产品已加以识别及管 制,以防止其被误用或交货。此项管制与处理不合格 品有关之职责及权限,须以书面程序加以界定。

responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. The organization shall deal with nonconforming product by one or more of the following ways: a) by taking action to eliminate the detected nonconformity; b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c) by taking action to preclude its original intended use or application. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4). When nonconforming product is corrected it shall be subject to re-verification to demonstrate 当不合格品已矫正, 其须予以重新查证以展示符合要 求。 不符合特质之纪录及任何后续采行措施, 包括特采之 获准,均须加以维持(参照第 4.2.4 节) 。 c) 采行措施以防止其被误用或应用。 b) 由相关权责人员,及当适当时顾客之核准,授权 其使用、放行或特采允收; a) 采行措施以消除所发现之不符合; 组织须藉由下列一项或数项方法,处理不合格品:

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conformity to the requirements. When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity. 8.3.1 Control of nonconforming product- Supplemental Product with unidentified or suspect status shall be classified as nonconforming product (see 7.5.3). 8.3.2 Control of reworked product Instructions for rework, including re-inspection requirements, shall be accessible to and utilized by the appropriate personnel. 8.3.3 Customer information Customers shall be informed promptly in the event that nonconforming product has been shipped. 8.3.4 Customer waiver The organization shall obtain customer concession or 8.3.4 顾客的特采 无论何时,只要产品或制程跟目前核准者不一致时, 8.3.3 通知顾客 当不合格品已经出货时,须立即通知顾客。 8.3.1 不合格品之管制—补述 未识别或是处于可疑状态的产品都须被归类为不合 格品。 8.3.2 重新加工品的管制 重新加工之指导书,包括重新检验的要求,须让适当 人员很容易地取得及使用。 当不合格品在交货或开始使用后才被发现, 组织须对 不符合之影响,或可能之影响,采行适当的措施。

deviation permit prior to further processing whenever the 组织均需于进行下一流程步骤前,获得顾客的特采 product or manufacturing process is different from that which is currently approved. (concession)或核准(deviation permit)。 组织须维持一份此项特采或核准的有效期限或被授

组织也须确保当被授权的有效期限届 The organization shall maintain a record of the expiration 权数量的记录。 date or quantity authorized. The organization shall also ensure compliance with the original or superseding specifications and requirements when the authorization expires. Material shipped on an authorization shall be properly identified on each shipping container. This applies equally to purchased product. The organization shall agree with any requests from suppliers before submission to the customer. 8.4 Analysis of data The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality 8.4 资料分析 组织须决定、搜集及分析适当之资料,以展示品质管 理系统的适用性及有效性, 以及评估品质管理系统之 有效性何处可完成持续改进。 此须包括从监督及量测 之结果,以及其它相关来源所产生之资料。 满时,恢复跟原来的或替代的规格与要求一致。在这 种授权情况下所交运的物料,其每件交运的容器,都 须适当标示。此项要求也适用于(对供货商)采购的产 品。在提交任何特采要求给顾客之前,组织须同意供 货商的任何(特采)请求。

management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other

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relevant sources. The analysis of data shall provide information relating to a) b) customer satisfaction (see 8.2.1), conformity to product requirements (see 7.2.1), a) 顾客满意度(参照第 8.2.1 节) , b) 符合产品要求(参照第 7.2.1 节) , c) 过程及产品之特性与趋势,包括预防措施之时 机,及 资料分析须提供与下列相关之信息

c) characteristics and trends of processes and products including opportunities for preventive action, and d) suppliers.

d) 供应者。 8.4.1 资料的分析与使用 品质与营运绩效之趋势须与经营目标的进度相比较, 并且导引出行动支持下列事项:

8.4.1 Analysis and use of data Trends in quality and operational performance shall be compared with progress toward objectives and lead to action to support the following: - development of priorities for prompt solutions to customer-related problems, - determination of key customer-related trends and correlation for status review, decision making and longer term planning, - an information system for the timely reporting of product information arising from usage. NOTE Data should be compared with those of competitors and/or appropriate benchmarks. 8.5 Improvement

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针对顾客相关的问题方面,研究出迅速解决此等 问题的优先级,

– 找出与顾客相关的主要趋势和相互关系,以协助
检讨现状、作成决策以及进行长程规划, – 发展一套信息系统,可以及时报告产品使用时的 信息。 备注 资料应与竞争对手和/或适当的标竿比较。

8.5 改善

8.5.1 Continual improvement The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. 8.5.1.1 Continual improvement of the organization The organization shall define a process for continual improvement (see examples in annex B of ISO 9004 : 2000). 8.5.1.2 Manufacturing process improvement Manufacturing process improvement shall continually focus upon control and reduction of variation in product characteristics and manufacturing process parameters.

8.5.1 持续改善 组织须建藉由品质政策、品质目标、稽核结果、资料 分析、矫正及预防措施,以及管理阶层审查之使用, 持续改进品质管理系统之有效性。

8.5.1.1 组织的持续改善 组织须定义一套流程以进行持续改善 (参考 ISO 9004:2000 附录 B 之例子) 。

8.5.1.2 制程改善 制程改善的重点须持续放在控制与降低产品特性与 制程参数的变异。

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NOTE 1 Controlled characteristics are documented in the control plan. NOTE 2 Continual improvement is implemented once manufacturing processes are capable and stable, or product characteristics are predictable and meet customer requirements.

备注 1 需要控制的特性于管制计划中须已列出。

备注 2 一旦制程的能力已足够且呈现稳定,或者产 品特性是可预测又符合顾客要求的情况时, 可以进行持续改善。

8.5.2 Corrective action The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken (see 4.2.4), and f) reviewing corrective action taken. 8.5.2.1 Problem solving The organization shall have a defined process for problem solving leading to root cause identification and elimination. If a customer-prescribed problem-solving format exists, the organization shall use the prescribed format. 8.5.2.2 Error-proofing The organization shall use error-proofing methods in their corrective action process. 8.5.2.3 Corrective action impact The organization shall apply to other similar processes and products the corrective action, and controls implemented, to eliminate the cause of a nonconformity.

8.5.2 矫正措施 为了防止再发,组织须采行措施以消除不符合之原 因。矫正措施须与所遭遇不符合之影响相适切。 书面程序须加以建立,以界定下列各项要求

a) b) c) d) e) f)

审查不符合(包括顾客抱怨) , 判定不符合之原因, 评估措施之需求,以确保不符合不再发生, 决定及实施所需之措施, 所采行措施结果之纪录(参照第 4.2.4 节) ,及 审查所采行之矫正措施。

8.5.2.1 解决问题 组织须界定出能够鉴定并消除根本原因的解决问题 的流程。

当顾客有规定解决问题的格式时, 组织须按照规定格 式来处理。

8.5.2.2 防错法 组织于其矫正措施流程中须使用防错法。

8.5.2.3 矫正措施之影响 组织须将(为消除不良之原因而)提出的矫正措施以及 已实施的管制,应用到其它类似的制程和产品,以消 除不良之根本原因( i.e.水平/横向展开)。 8.5.2.4 退 回产品的测试/分析

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8.5.2.4 Rejected product test/analysis The organization shall analyse parts rejected by the customer's manufacturing plants, engineering facilities and dealerships. The organization shall minimize the cycle time of this process. Records of these analyses shall be kept and made available upon request. The organization shall perform analysis and initiate corrective action to prevent recurrence. NOTE Cycle time related to rejected product analysis should be consistent with the determination of root cause, corrective action and monitoring the effectiveness of implementation. 8.5.3 Preventive action The organization shall determine action to

组织须分析从顾客的制造工厂、 工程单位及经销商处 退回的零组件。 组织须尽可能使处理流程花费的时间 达到最短。这些分析的记录,须予以保存且于要求时 即可提供。组织须实施分析并主动提出矫正措施,以 防止再发。

备注 与退回产品分析相关的处理时间须包含从确定 根本原因、矫正措施到监测实施成效的时间。

8.5.3 预防措施 组织须决定措施,以消除潜在不符合之原因,以防止 其发生。预防措施须与潜在问题之影响相适切。

eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for a) determining potential nonconformities and their causes, b) evaluating the need for action to prevent occurrence of nonconformities, c) determining and implementing action needed, d) records of results of action taken (see 4.2.4), and e) reviewing preventive action taken.

书面程序须加以建立,以界定下列各项要求

a) 判定潜在不符合及其原因,

b) 评估措施之需求,以预防不符合之发生,

c)

决定及实施所需之措施,

d) 所采行措施结果之纪录(参照第 4.2.4 节) ,及 e) 审查所采行之预防措施。

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Annex A (normative) Control Plan A.1 Phases of the control plan The control plan shall cover three distinct phases as appropriate. a) Prototype: a description of the dimensional measurements, material and performance tests that will occur during building of the prototype. The organization shall have a prototype control plan if required by the customer. b) Pre-launch: a description of the dimensional measurements, material and performance tests that occur after prototype and before full production. Pre-launch is defined as a production phase in the process of product realization which may be required after prototype build. c) Production: documentation of product/process

附录 A 管制计划 A.1 管制计划的阶段 管制计划须适当地涵括三种不同的阶段:
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原型样品-说明在原型样品制作期间,所发生各 项尺寸量测、材料及性能测试等。如顾客要求时 ,组织须建立原型样品的管制计划。

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量产前-说明介于原型样品制作和全面量产之 间,所发生的各项尺寸量测、材料及性能测试。 「 量产前」是指于产品实现流程中可定义为建立原 型样品后所需的一个生产阶段。

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量产-书面记载在大量生产期间,所发生的各项 产品/制程特性、制程管制、测试和量测系统。

每个单一产品须有其个别的管制计划, 但是许多情形 下, 可以使用系列产品共享的管制计划来涵盖许多共

管制计划是品质计划 characteristics, process controls, tests, and measurement 通制程下生产出来的类似产品。 的输出之一。 systems that occur during mass production. Each part shall have a control plan but, in many cases, family control plans may cover a number of similar parts produced using a common process. Control plans are an output of the quality plan. A.2 Elements of the control plan The organization shall develop a control plan that includes, as a minimum, the following contents. a) General data - control plan number, - issue date, and revision date, if any, - customer information (see customer requirements), - organization’s name/site designation, -part number(s), -part name/description, -engineering change level, -phase covered (prototype, pre-launch, production), -key contact, -part/process step number, -process name/operation description. b) Product control b) 产品的管制项目 A.2 管制计划的项目 组织须制定一套管制计划,至少包括以下的内容: a) 基本资料 --管制计划编号 --发行日期与修订日期(若有的话) --顾客信息(参见顾客要求) --组织的名称/场所称号 --零件编号 --零件名称/说明 --工程变更阶段 --涵盖的阶段(原型样品、量产前、量产) --主要联络人 --零件/制程步骤编号 --制程名称/作业内容说明

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- product-related special characteristics, - other characteristics for control (number, product or process), - specification/tolerance. c) Process control - process parameters, - process-related special characteristics, -machines, jigs, fixtures, tools for manufacturing. d) Methods - evaluation measurement technique, - error-proofing, - sample size and frequency, - control method e) Reaction plan and corrective actions - reaction plan (include or reference), - corrective action.

--产品相关的管制特性 --其它需管制的特性(编号、产品或制程) --规格/公差

c) 制程的管制项目 --制程参数 --制程相关的管制特性 --制造用的机器、治具、夹具、工模具 d) 管制的方法 --评估的测量技术 --防错法 --抽样数量和频率 --管制方式 e) 响应计划和矫正措施 --响应计划(包含在管制计划内,或被引申) --矫正措施

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