Microsoft Word - ISO-TS16949-COIRUBBER MANUAL

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1 ISO/TS16949:2009 技术规范 TECHNICAL SPECIFICATION 质量管理体系 汽车生产件及相关服务件组织应用 ISO9001:2008 的特殊要求 Quality management systems Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations

2 目录 Contents 前言 Foreword 7 有关认证的说明 Remarks for certification 9 引言 Introduction 总则 General 过程方法 Process approach 与 ISO 9004 的关系 Relationship with ISO 与其他管理体系的相容性 Compatibility with other management systems 本技术规范的目的 Goal of this Technical Specification 15 1 范围 Scope 总则 General 应用 Application 17 2 引用标准 Normative reference 17 3 术语和定义 Terms and definitions 汽车行业术语和定义 Terms and definitions for the automotive industry 18 4 质量管理体系 Quality management system 总要求 General requirements 总要求 补充 General requirements Supplemental 文件要求 Documentation requirements 总则 General 质量手册 Quality manual 文件控制 Control of documents 工程规范 Engineering specifications 记录控制 Control of records 记录保存 Records retention 24 5 管理职责 Management responsibility 管理承诺 Management commitment 过程效率 Process efficiency 以顾客为关注焦点 Customer focus 质量方针 Quality policy 策划 Planning 质量目标 Quality objectives 质量目标 补充 Quality objectives Supplemental 质量管理体系的策划 Quality management system planning 职责 权限与沟通 Responsibility, authority and communication 职责和权限 Responsibility and authority 质量职责 Responsibility for quality 管理者代表 Management representative 顾客代表 Customer representative 内部沟通 Internal communication 管理评审 Management review

3 总则 General 质量管理体系绩效 Quality management system performance 评审输入 Review input 评审输入 补充 Review input Supplemental 评审输出 Review output 29 6 资源管理 Resource management 资源提供 Provision of resources 人力资源 Human resources 总则 General 能力 培训和意识 Competence, training and awareness 产品设计技能 Product design skills 培训 Training 岗位培训 员工的激励 Employee motivation and empowerment 基础设施 Infrastructure 工厂 设施和设备策划 Plant, facility and equipment planning 应急计划 Contingency plans 工作环境 Work environment 为达成产品要求符合性的人员安全 Personnel safety to achieve conformity product requirements 生产现场的清洁 Cleanliness of premises 32 7 产品实现 Product realization 产品实现的策划 Planning of product realization 产品实现的策划 补充 Planning of product realization Supplemental 接收准则 Acceptance criteria 保密性 Confidentiality 更改控制 Change control 与顾客有关的过程 Customer-related processes 与产品有关的要求的确 Determination of requirements related to the product 顾客指定的特殊特性 Customer-designated special characteristics 与产品有关的要求的评审 Review of requirements related to the product 与产品有关的要求的评审 补充 Review of requirements related to the produc Supplemental 组织制造可行性 Organization manufacturing feasibility 顾客沟通 Customer communication 顾客沟通 补充 Customer communication Supplemental 设计和开发 Design and development 设计和开发策划 Design and development planning 多方论证方法 Multidisciplinary approach 设计和开发输入 Design and development inputs 产品设计输入 Product design input 制造过程设计输入 Manufacturing process design input 39

4 特殊特性 Special characteristics 设计和开发输出 Design and development outputs 产品设计输出 补充 Product design outputs Supplemental 制造过程设计输出 Manufacturing process design output 设计和开发评审 Design and development review 监视 Monitoring 设计和开发验证 Design and development verification 设计和开发确认 Design and development validation 设计和开发确认 补充 Design and development validation Supplemental 样件计划 Prototype programme 产品批准过程 Product approval process 设计和开发更改的控制 Control of design and development changes 采购 Purchasing 采购过程 Purchasing process 法规符合性 Regulatory conformity 供方质量管理体系开发 Supplier quality management system development 顾客批准的供方 Customer-approved sources 采购信息 Purchasing information 采购产品的验证 Verification of purchased product 进货产品对要求的符合性 Incoming product conformity to requirements 对供方监视 Supplier monitoring 生产和服务提供 Production and service provision 生产和服务提供的控制 Control of production and service provision 控制计划 Control plan 作业指导书 Work instructions 作业准备验证 Verification of job setups 预防性和预见性维护 Preventive and predictive maintenance 生产工装的管理 Management of production tooling 生产计划 Production scheduling 服务信息反馈 Feedback of information from service 与顾客的服务协议 Service agreement with customer 生产和服务提供过程的确认 Validation of processes for production and service provision 生产和服务提供过程的确认 补充 Validation of processes for production and service provision Supplemental 标识和可追溯性 Identification and traceability 标识和可追溯性 补充 Identification and traceability Supplemental 顾客财产 Customer property 顾客所有的工装 Customer-owned production tooling 产品防护 Preservation of product 贮存和库存 Storage and inventory 监视和测量设备的控制 Control of monitoring and measuring equipment 52

5 测量系统分析 Measurement system analysis 校准 / 验证记录 Calibration/verification records 实验室要求 Laboratory requirements 内部实验室 Internal laboratory 外部实验室 External laboratory 54 8 测量 分析和改进 Measurement, analysis and improvement 总则 General 统计工具的确定 Identification of statistical tools 基础统计概念知识 Knowledge of basic statistical concepts 监视和测量 Monitoring and measurement 顾客满意 Customer satisfaction 顾客满意 补充 Customer satisfaction Supplemental 内部审核 Internal audit 质量管理体系审核 Quality management system audit 制造过程审核 Manufacturing process audit 产品审核 Product audit 内部审核计划 Internal audit plans 内审员资格 Internal auditor qualification 过程的监视和测量 Monitoring and measurement of processes 制造过程的监视和测量 Monitoring and measurement of manufacturing processes 产品的监视和测量 Monitoring and measurement of product 全尺寸检验和功能试验 Layout inspection and functional testing 外观项目 Appearance items 不合格品控制 Control of nonconforming product 不合格品控制 补充 Control of nonconforming product Supplemental 返工产品的控制 Control of reworked product 顾客通知 Customer information 顾客特许 Customer waiver 数据分析 Analysis of data 数据分析和使用 Analysis and use of data 改进 Improvement 持续改进 Continual improvement 组织的持续改进 Continual improvement of the organization 制造过程的改进 Manufacturing process improvement 纠正措施 Corrective action 解决问题的方法 Problem solving 防错 Error-proofing 纠正措施影响 Corrective action impact 拒收产品的试验 / 分析 Rejected product test/analysis 预防措施 Preventive action 64 附录 A 控制计划 Annex A (normative) Control plan 65 参考文献 Bibliography 67

6 - 6 - 前言 Foreword 国际标准化组织 (ISO) 是由各国标准化机构 (ISO 成员机构 ) 组成的世界性联合会 国际标准的拟定由 ISO 技术委员会负责 各成员机构若对某技术委员会所选定的主题感兴趣, 均有权参加该委员会的工作 与 ISO 保持联系的各国组织 ( 官方的或非官方的 ) 也可参加该项工作 ISO 与国际电器委员会 (IEC) 在电工技术标准化方面保持密切合作的关系 ISO (the International Organization for 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. 本国际标准是依照 ISO/IEC 导则第 2 部分中的规则制定的 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. 技术委员会的主要任务是制定国际标准 本国际技术标准草案已由技术委员会通过, 并传阅各成员机构一共投票表决 国际标准的公布需要至少 75% 的参加投票的成员团体批准 The main task of technical committees is to prepare 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. 在其它情况下, 特别是在市场急需某个文件时, 技术委员会可以决定出版其他形式的规范文件 : In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document: ISO 公布的可获得规范 (ISO/PAS) 代表一项在一个 ISO 工作小组内的技术专家达成的协议, 在相应委员会的成员的投票中有 50% 投票赞成后就可以出版发行 ; an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical 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; ISO 技术规范 (ISO/TS), 是技术委员会成员之间达成的协议, 在委员会成员所投票中有 2/3 投票赞成后就可以出版发行 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. ISO/TS 是由国际汽车工业特别行动小组 (IATF), 在 ISO/TC176 质量管理和质量保证技术委员会支持下制定的 ISO/TS was prepared by the International Automotive Task Force (IATF) with

7 - 7 - support from ISO/TC 176, Quality management and quality assurance. 通过根据 ISO9001 :2008 所作的技术修订, 第三版的 ISO/TS16949 取消并替代了第二版 (ISO/TS 16949:2002) This third edition of ISO/TS cancels and replaces the second edition (ISO/TS 16949:2002), which has been technically amended according to ISO 9001:2008. 方框内的文本是 ISO 9001:2008 的原文内容, 方框外是行业特殊补充的要求 Boxed text is original ISO 9001:2008 text. The sector-specific supplemental requirements are outside the boxes. 在本技术规范中, 应 (shall) 表示要求, 应当 (should) 表示建议 标示有 注 (NOTE) 的段落是对理解或澄清相关要求的指南 In this Technical Specification, the word shall indicates a requirement. The word should indicates a recommendation. Paragraphs marked NOTE are for guidance in understanding or clarifying the associated requirement. 所有用 例如 引出的建议都只具有指导性作用. Where the term such as is used, any suggestions given are for guidance only. 附录 A 是本技术规范的引用文件, 构成技术规范的一部分 Annex A forms a normative part of this Technical Specification. 有关认证的说明 Remarks for certification 按照 IATF 的认证方案 ( 见 IATF 认可规则 ) 所获取的本技术规范的认证, 包括任何的顾客特殊要求 ( 如果有 ), 将获得 IATF 的顾客成员的认可 详细情况可以从以下的国际汽车推动小组的当地监督办公室处获得 : 意大利汽车工业协会 (ANFIA) 美国国际汽车监督署 (IAOB) IATF-France 英国汽车制造与贸易商谢 (SMMT) 德国汽车工业协会 - 质量管理中心 (VDA-QMC) The certification to this Technical Specification, including customer-specific requirements if any, is recognized by the customer members of IATF when achieved according to the IATF certification scheme (see the Rules for achieving IATF recognition ). Details can be obtained at the addresses of the local oversight offices of IATF cited below: Associazione Nazionale Fra Industrie Automobilistiche (ANFIA) Web site: International Automotive Oversight Bureau (IAOB) Web site: IATF-France Web site: Society of Motor Manufacturers and Traders Ltd. (SMMT Ltd.) Web site: Verband der Automobilindustrie Qualit?tsmanagement Center (VDA-QMC) Web site:

8 引言 0.1 总则 Introduction 总则 General ISO9001:2008 质量管理体系要求 ISO 9001:2008 Quality management systems Requirements 引言 Introduction 0.1 总则 General 采纳质量管理体系是组织的一项战略性决策 一个组织的质量管理体系的设计和实施受下列因素的影响 : The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by: a) 组织的环境 该环境的变化或与该环境有关的风险 ; b) 组织不断变化的需求 ; c) 组织的具体目标 ; d) 组织所提供的产品 ; e) 组织所采用的过程 ; f) 组织的规模和组织结构 a) Its organizational environment, changes in that environment, and the risks associated with that environment; b) Its varying needs; c) Its particular objectives; d) The products it provides; e) The processes it employs; f) Its size and organizational structure. 统一质量管理体系的结构或文件不是本标准的目的 It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. 本标准规定的质量管理体系要求是对产品要求的补充 注 是理解和说明有关要求的指南 The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked. NOTE is for guidance in understanding or clarifying the associated requirement. 本标准能用于内部和外部 ( 包括认证机构 ) 评价组织满足顾客 适用于产品的法律法规要求和组织自身要求的能力 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. 本标准的制定已经考虑了 GB/T 和 GB/T 中所阐明的质量管理原则 The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.

9 过程方法 Process approach ISO9001:2008 质量管理体制体系 要求 ISO 9001:2008 Quality management systems Requirements 本标准鼓励在建立 实施质量管理体系以及在改进其有效性时采用过程方法, 通过满足顾客要求, 增强顾客满意度 This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. 为了使组织有效运行, 应确定和管理许多相互联系的活动 通过使用资源和管理, 将输入转换为输出的一项或一组活动, 可视为一个过程, 通常, 一个过程的输出直接形成下一个过程的输入 For an organization to function effectively, it has to determine 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. 为了产生期望的结果, 由过程组成的系统在组织内的应用, 连同这些过程的识别和相互作用, 以及对这些过程的管理, 可称之为 过程方法 The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the process approach. 过程方法的一个优点是对过程系统中单个过程之间的联系以及过程的组合和相互作用进行连续的控制 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. 在质量管理体系应用过程方法时, 强调以下方面的重要性 : a) 理解和满足要求 ; b) 需要从增值的角度考虑过程 ; c) 获得过程绩效和有效性的结果 ; d) 在客观测量的基础上, 持续改进过程 When used within a quality management system, such an approach emphasizes the importance of: a) Understanding and fulfilling requirements; b) The need to consider processes in terms of added value; c) Obtaining results of process performance and effectiveness; and d) Continual improvement of processes based on objective measurement. 图 1 所反映的以过程为基础的质量管理体系模式展示了第 4 章至第 8 章中所提出的过程联系 该图反映了在规定输入要求时, 顾客起着重要的作用 对顾客满意的监视, 要求组织对顾客关于组织是否已满足其要求的感受信息进行评价 该模式虽覆盖了本标准的所有要求, 但却未详细地反映各过程 The model of a process-based quality management system shown in Figure 1 illustrates

10 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. 注 : 此外, 称之为 PDCA 的方法可适用于所有过程 PDCA 模式可简述如下 : P- 策划 : 根据顾客的要求和组织的方针, 为提供结果建立必要的目标和过程 ; D- 实施 : 实施过程 ; C- 检查 : 根据方针 目标和产品要求, 对过程和产品进行监视和测量, 并报告结果 ; A- 处置 : 采取措施, 以持续改进过程业绩 NOTE: In addition, the methodology known as "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; 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

11 0.3 与 ISO9004 的关 系 Relationship with ISO

12 ISO9001:2008 质量管理体制体系 要求 ISO 9001:2008 Quality management systems Requirements 0.3 与 ISO9004 的关系 Relationship with ISO 9004 ISO9001 和 ISO9004 都是质量管理体系标准, 这两项标准相互补充, 但也可单独使用 ISO9001 and ISO9004 are quality management system standards which have been designed to complement each other, but can also be used independently. ISO9001 规定了质量管理体系要求, 可供组织内部使用, 也可用于认证或合同目的 ISO9001 所关注的是质量管理体系在满足顾客要求方面的有效性 ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements. 在本标准发布时,ISO9004 处于修订中 修订后的 ISO9004 将为组织在复杂 要求更高和不断变化的环境中获得持续成功提供管理指南 与 ISO9001 相比,ISO9004 关注质量管理的更宽范围 ; 通过系统和持续改进组织的绩效, 满足所有相关方的需求和期望 然而 ISO9004 不拟于用于认证 法律法规和合同的目的 At the time of publication of this International Standard, ISO 9004 is under revision. The revised edition of ISO 9004 will provide guidance to management for achieving sustained success for any organization in a complex, demanding, and ever changing, environment. ISO 9004 provides a wider focus on quality management than ISO 9001; it addresses the needs and expectations of all interested parties and their satisfaction, by the systematic and continual improvement of the organization s performance. However, it is not intended for certification, regulatory or contractual use. 注 : 应当由最高管理者在组织内宣传和贯彻 ISO9000:2005 和 ISO9004 中涉及的八项质量管理原则的知识及其应用 Note: The knowledge and use of the eight quality management principles referred to in the ISO 9000:2005 and ISO 9004 should be demonstrated and cascaded through the organization by top management. 0.4 与其它管理体系的相容性 Compatibility with other management systems ISO9001:2008 质量管理体制体系 要求 ISO 9001:2008 Quality management systems Requirements 0.4 与其它管理体系的相容性为方便使用者, 本标准在起草过程中适当的考虑了 ISO 标准的内容, 以增强两类标准的相容性 附录 A 表明了 ISO 与 ISO 之间的对应关系 During the development of this international standard, due consideration was given to the provision of ISO14001:2004 to enhance the compatibility of the two standards for benefit of the user community. Annex a shows the correspondence between ISO14001:2004. 本国际标准不包括其它管理体系所规定的要求, 例如环境管理, 职业健康和安全管

13 理, 财务管理或风险管理 然而本国际标准能够使组织的质量管理体系与有关的管理体系要求相互结合或一体化 组织为了建立符合本国际标准要求的质量管理体系, 有可能会改变其现有的管理体系 This International Standard does not include requirements specific to other management 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 ISO/TS16949 的目的 Goal of this Technical Specification 的目的本技术规范的目标是在供应链中建立持续改进, 强调缺陷预防, 减少变差和浪费的质量管理体系 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. 本技术规范与适当的顾客特殊要求相结合, 规定了签署本文件顾客的基本质量管理体系要求 This Technical Specification, coupled with applicable customer-specific requirements, defines the fundamental quality management system requirements for those subscribing to this Technical Specification. 本技术规范旨在避免多重认证审核, 并为汽车生产件及服务件的组织建立质量管理体系提供了一个通用的方法 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 organizations. 质量管理体系 汽车行业生产件下相关服务件的组织实施 ISO9001:2008 的特殊要求

14 Quality management systems Particular requirements for the application of ISO 9001:2008 for automotive production, and relevant service part organizations Scope 1 范围 1.1 总则 General ISO9001:2008 质量管理体系 要求 ISO 9001:2008 Quality management systems Requirements 本标准为有下列需求的组织规定了质量管理体系要求 : a) 需要证实其具有稳定地提供满足顾客和适用的法律法规要求的产品的能力 ; b) 通过体系的有效应用, 包括体系持续改进的过程的有效应用, 以及保证符合顾客与适用的法律法规要求, 旨在增强顾客满意 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 and applicable regulatory requirements. 注 1: 在本标准中, 术语 产品 仅适用于 : a) 预期提供给顾客的或顾客所要求的产品 ; b) 产品实现过程所产生的任何预期输出 注 2: 法律法规要求可称作法定要求 NOTE1: In this International Standard, the term product only applies to: a) product intended for, or required by, a customer; b) And intended output resulting from the product realization processes. Note2: Statutory and regulatory requirements can be expressed as legal requirements. 本技术规范与 ISO9001:2008 相结合, 规定了质量管理体系要求, 用于汽车相关产品的设计和开发 生产, 相关时, 也适用于安装和服务 This Technical Specification, in conjunction with ISO 9001:2008, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products. 本技术规范适用于组织进行顾客指定产品和 / 或服务零件的制造现场 This Technical Specification is applicable to sites of the organization where customer-specified parts, for production and/or service,are manufactured. 支持功能, 无论其在现场或外部场所 ( 如设计中心 公司总部及分销中心 ), 由于它们对现场的支持性而构成现场审核的一部分, 但不能获得本技术规范的认证 Supporting functions whether on-site or remote (such as design centers, corporate headquarters and distribution centers), form part of the site audit as they support the site,but cannot obtain stand-alone certification to this Technical Specification. 本技术规范可适用于整个汽车供应链 This Technical Specification can be applied throughout the automotive supply chain.

15 1.2 应用 应用 Application ISO9001:2008 质量管理体制体系 要求 ISO 9001:2008 Quality management systems Requirements 1.2 应用 Application 本标准规定的所有要求是通用的, 旨在适用于各种类型 不同规模和提供不同产品的组织 All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. 当本标准的任何要求因组织及其产品的特点不适用时, 可以考虑对其进行删减 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. 如果进行删减, 应仅限于本标准第 7 章的要求, 并且这样的删减不影响组织提供满足顾客要求和适用法律法规要求的产品的能力或责任, 否则不能声称符合本标准 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. 本技术规范仅允许组织在没有产品设计和开发责任的情况下删减与 7.3 有关的内容不允许删减制造过程设计 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 规范性引用文件 Normative reference ISO9001:2008 质量管理体制体系 要求 ISO 9001:2008 Quality management systems Requirements 下列文件的条款通过本标准的引用而成为本标准的条款 凡是注日期的引用文件, 其随后所有的修改单 ( 不包括勘误的内容 ) 或修订版均不适用于本标准, 然而, 鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本 凡是不注日期的引用文件, 其最新版本适用于本标准 ISO 质量管理体系 基础和术语 The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO9000:2005 Quality management systems Fundamentals and vocabulary. 3 术语和定义 Terms and definitions ISO9000:2008 质量管理体系 要求 ISO 9001:2008 Quality management systems Requirements 本标准采用 ISO9000 中所确立的术语和定义

16 For the purposes of this document the terms and definitions given in ISO 9000 apply. 本标准中所有出现的术语 产品 之处, 也可指 服务 Throughout the text of this International Standard, wherever the term product occurs, it can also mean service. 3.1 汽车行业术语和定义 Terms and definitions for the automotive industry 本文件应用了 ISO9001:2005 以及下列内容中所确立的术语和定义 For the purposes of this document, the terms and definitions given in ISO9000: 2005 and the following apply 控制计划 控制计划 control plan 对控制产品所要求的系统和过程的形成文件的描述 注 : 见附录 A Documented description of the systems and processes required for controlling product. Note: see annex A 具有设计责任的组织 design responsible organization 有权制定一个新的或更改现有的产品规范的组织 Organization with authority to establish a new or change an existing product specification. 注 : 该职责包括在顾客指定的应用范围内试验并验证设计性能 NOTE:This responsibility includes testing and verification of design performance within the customer s specified application 防错 error proofing 为防止制造不合格产品而进行的产品和制造过程的设计和开发 Product and manufacturing process design and development to prevent manufacture of non-conforming products 实验室 laboratory 实验室进行检验 试验和校准的设施, 其范围包括但不限于化学 冶金 尺寸 物理 电性能或可靠性试验 facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional, physical, electrical or reliability testing 实验室范围 laboratory scope 受控文件包括 : 实验室有资格进行的特定试验, 评价和校准 ; 用来进行上述活动的设备清单, 以及 用来进行上述活动的方法和标准的清单 Controlled document containing: specific tests, evaluations and calibrations that a laboratory is qualified to perform; a list of the equipment which it uses to perform the above; and a list of methods and standards to which it performs the above. 制造 manufacturing 制造 以下制作或加工的过程 : 生产材料 ;

17 生产或服务件 ; 装配, 或 热处理 焊接 喷漆 电镀或其他表面处理 Process of making or fabricating: production materials, production or service parts, assemblies, or heat treating, welding, painting, plating or other finishing services. 预测性维护 predictive maintenance 预测性维护基于针对通过预测可能的失效模式的过程数据而避免维护问题的活动 Activities based on process data aimed at the avoidance of maintenance problems by prediction of likely failure modes 预防性维护 preventive maintenance 预防性维护为消除设备失效和生产的计划外中断的原因而策划的措施, 它是制造过程设计的一项输出 planned action to eliminate causes of equipment failure and unscheduled interruptions to production, as an output of the manufacturing process design 额外运费 premium freight 在合同约定的交付之外发生的超出成本或费用 注 : 可因方法 数量 未按计划或延迟交付等原因引起 Extra costs or charges incurred additional to contracted delivery. NOTE: this can be caused by method, quantity, unscheduled or late deliveries. ect. 外部地点 remote location 外部地点 支持现场, 且不存在生产过程的场所 ocation that supports sites and at which non-production processes occur. 现场 site 现场 发生增值的制造过程的场所 ocation at which value-added manufacturing processes occur 特殊特性 特殊特性 special characteristic 产品特性或制造过程参数, 可能影响产品的安全性或法规的符合性 配合 功能 性能或其后续过程的产品特性或制造过程参数 product characteristic or manufacturing process parameter which may affect safety or compliance with regulations, fit, function, performance or subsequent processing of product. 4 质量管理体系 Quality management system 4.1 总要求 General requirements ISO9001:2008 质量管理体系 要求 ISO 9001:2008 Quality management systems Requirements 4 质量管理体系 Quality management system 4.1 总要求 General requirements 组织应按本标准的要求建立质量管理体系, 形成文件, 加以实施和保持, 并持续改进其有效性

18 The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. 组织应 : a) 确定质量管理体系所需要的过程及其在整个组织中的应用 ( 见 1.2); b) 确定这些过程的顺序和相互作用 ; c) 确定所需的准则和方法, 以确保这些过程的运作和控制有效 ; d) 确保可以获得必要的资源和信息, 以支持这些过程的有效运行和监视 ; e) 监视 测量 ( 适用时 ) 和分析这些过程 ; f) 实施必要的措施, 以实现对这些过程所策划的结果和对这些过程的持续改进 The organization shall: a) determine 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 information necessary to support the operation and monitoring of these processes; e) monitor, measure where applicable and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. 组织应按本标准的要求管理这些过程 These processes shall be managed by the organization in accordance with the requirements of this International Standard. 组织如果选择将影响产品符合要求的任何过程外包, 应确保对这些过程的控制 对此类外包过程的控制类型和程度应在质量管理体系中加以规定 注 1: 上述质量管理体系所需的过程应当包括与管理活动 资源提供 产品实现和测量 分析和改进有关的过程 注 2: 外包过程 是为了质量管理体系的需要, 由组织选择, 并由外部方实施的过程 注 3: 组织确保对外包过程的控制, 并不免除其满足所有顾客要求和法律法规要求的责任 对外包过程控制的类型和程度可受诸如下列因素的影响 : a) 外包过程对组织提供满足要求的产品的能力的潜在影响 ; b) 对外包过程控制的分担程度 ; c) 通过应用 7.4 条款实现所需控制的能力 Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system. NOTE1: Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement analysis and improvement.

19 NOTE 2: An outsourced process is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as: a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements; b) the degree to which the control for the process is shared; c) the capability of achieving the necessary control through the application of 总要求 补充 General requirements Supplemental 确保外包过程的控制不能免除组织对符合所有顾客要求的职责 注 : 另见 和 Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all customer requirements. NOTE See also and 文件要求 Documentation requirements 总则 General ISO9001:2008 质量管理体系 要求 ISO 9001:2008 Quality management systems Requirements 质量管理体系文件应包括 : a) 形成文件的质量方针和质量目标 ; b) 质量手册 ; c) 本国际标准所要求的程序文件和记录 ; d) 组织为确保其过程有效策划 运行和得到控制所需要的文件, 包括记录 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 International Standard, and d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes. 注 1: 本标准出现 形成文件的程序 之处, 即要求建立程序, 形成文件, 并加以实施和保持 ; 一个文件可包括对一个或多个程序的要求 一个形成文件的程序的要求可以被包含在多个文件中 NOTE 1: Where the term documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.

20 注 2: 不同组织的质量管理体系文件的多少与详略程度可以不同, 取决于 : a) 组织的规模和活动类型 ; b) 过程及其相互作用的复杂程度 ; c) 人员的能力 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. 注 3: 文件可采用任何形式或类型的媒体 NOTE 3: The documentation can be in any form or type of medium 质量手册 质量手册 Quality manual ISO9001:2008 质量管理体系 要求 ISO 9001:2008, Quality management systems Requirements 组织应编制和保持质量手册, 质量手册包括 : a) 质量管理体系的范围, 包括任何删减的细节和正当的理由 ( 见 1.2); b) 为质量管理体系而建立的形成文件的程序或对其引用 ; c) 质量管理体系过程之间相的互作用的描述 The organization shall establish and maintain a quality manual that includes: a) the scope of the quality management system, 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 文件控制 文件控制 Control of documents ISO9001:2008 质量管理体系 要求 ISO 9001:2008 Quality management systems Requirements 文件控制 Control of documents 质量管理体系所要求的文件应予以控制 记录是一种特殊类型的文件, 应根据 的要求进行控制 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 应编制形成文件的程序, 以规定以下方面所需的控制 : a) 为使文件是充分与适宜的, 文件发布前得到批准 ; b) 必要时对文件进行评审与更新, 并再次批准 ; c) 确保文件的更改和现行修订状态得到识别 ; d) 确保在使用处可获得适用文件的有关版本 ;

21 e) 确保文件保持清晰 易于识别 ; f) 确保组织所规定的策划和运行质量管理体系所需的外来文件得到识别 ; 并控制其分发 ; g) 防止作废文件的非预期使用, 若因任何原因而保留作废文件时, 对这些文件进行适当的标识 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 determined by the organization to be necessary for the planning and operation of the quality management system 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 工程规范 工程规范 Engineering specifications 组织应有一个过程, 以保证按顾客要求的时间安排及时评审 发放和实施所有顾客工程标准 / 规范及其更改 及时评审应当尽快进行, 不应超过两个工作周 组织应保存每项更改在生产中实施日期的记录 实施应包括对文件的更新 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. The organization shall maintain a record of the date on which each change is implemented in production. Implementation shall include updated documents. 注 : 当设计记录引用了这些规范或这些规范影响生产件批准过程的文件, 例如 : 控制计划,FMEAs 等时, 这些标准 / 规范的更改要求对顾客的生产件批准记录进行更新 NOTE: 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 记录的控制 ISO9001:2008 Control of records 质量管理体系 要求 ISO 9001:2008 Quality management systems Requirements 记录的控制 Control of records 为提供符合要求和质量管理体系有效运行的证据而建立的记录, 应得到控制 组织应编制形成文件的程序, 以规定记录的标识 贮存 保护 检索 保存期限和处置所需的控制

22 记录应保持清晰 易于识别和检索 Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. Records shall remain legible, readily identifiable and retrievable. 注 1: 以上 处置 包括废弃 注 2: 记录 还包括顾客指定的记录 NOTE 1: "Disposition" above includes disposal. NOTE 2: "Records" also include customer-specified records 记录保存 Records retention 记录控制应满足满足法规和顾客的要求 The control of records shall satisfy regulatory and customer requirements. 5 管理职责 Management responsibility 5.1 管理承诺 Management commitment ISO9001:2008 质量管理体系 要求 ISO 9001:2008 Quality management systems Requirements 最高管理者应通过以下活动, 对其建立 实施质量管理体系并持续改进其有效性的承诺提供证据 : a) 向组织传达满足顾客和法律 法规要求的重要性 ; b) 制定质量方针 ; c) 确保质量目标的制定 ; d) 进行管理评审 ; e) 确保资源的获得 Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by: a) communicating to the organization the 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 过程绩效 过程绩效 Process efficiency 最高管理应评审产品实现过程和支持过程, 以确保它们的有效性和效率 Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency

23 以顾客为关注焦点 Customer focus ISO9001:2008 质量管理体系 要求 ISO 9001:2008 Quality management systems Requirement 5.2 以顾客为关注焦点 Customer focu 最高管理者应以增进顾客满意为目的, 确保顾客的要求得到确定并予以满足 ( 见 和 8.2.1) Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction (see and 8.2.1). 5.3 质量方针 Quality policy ISO9001:2008 质量管理体系 要求 ISO 9001:2008 Quality management systems Requirements 5.3 质量方针 Quality policy 最高管理者应确保质量方针 : a) 与组织的宗旨相适应 ; b) 包括对满足要求和持续改进质量管理体系有效性的承诺 ; c) 提供制定和评审质量目标的框架 ; d) 在组织的得到沟通和理解 ; e) 在持续适宜性方面得到评审 Top management shall ensure that the quality policy: a) is appropriate to the purpose of the organization; b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management 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. 5.4 策划 Planning 质量目标 Quality objectives 质量目标 ISO9001:2008 质量管理体系 要求 ISO 9001:2008 Quality management systems Requirements 5.4 策划 Planning 质量目标 Quality objectives 最高管理者应确保在组织的相关职能和层次上建立质量目标, 质量目标包括满足产品要求所需的内容 ( 见 7.1 a)) 质量目标应是可测量的, 并与质量方针保持一致 Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1) are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy 质量目标 补充 Quality objectives Supplemental 最高管理者应确定质量目标及测量要求, 并应包含在经营计划中, 用于质量方针的

24 展开 注 : 质量目标应体现顾客期望并在规定的时间内是可以实现的 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 质量管理体系策划 Quality management system planning ISO9001:2008 质量管理体系 要求 ISO 9001:2008 Quality management systems Requirements 质量管理体系策划 Quality management system planning 最高管理者应确保 : a) 对质量管理体系进行策划, 以满足质量目标以及 4.1 的要求 ; b) 在对质量管理体系的变更进行策划和实施时, 保持质量管理体系的完整性 ; 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 system are planned and implemented. 5.5 职责 权限和沟通 Responsibility, authority and communication 职责与权限 Responsibility and authority ISO9001:2008 质量管理体系 要求 5.5 职责 权限和沟通 Responsibility, authority and communication 职责与权限 Responsibility and authority 最高管理者应确保组织内的职责 权限得到规定和沟通 Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization 质量职责 质量职责 Responsibility for quality 不符合要求的产品或过程应立即通知给负有纠正措施职责和权限的管理者 负责产品要求符合性的人员, 应有权停止生产, 以纠正质量问题 所有班次的生产作业, 应安排有负责确保产品要求符合性的人员, 或指定其代理人员 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 conformity to product requirement 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 conformity to product requirement.

25 5.5.2 管理代表 ISO9001:2008 Management representative 质量管理体系 要求 管理代表 Management representative 最高管理者应在本组织管理层中指定一名管理者, 无论该成员在其他方面的职责如何, 应具有以下方面的职责和权限 : a) 确保质量管理体系所需的过程得到建立 实施和保持 ; b) 向最高管理者报告质量管理体系的业绩和任何改进的需求 ; c) 确保在整个组织内提高满足顾客要求的意识 注 : 管理者代表的职责可包括与质量管理体系有关事宜的外部联络 Top management shall appoint a member of the organization s management who, irrespective of other responsibilities, shall have responsibility and authority that includes a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout the organization. NOTE:The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system 顾客代表 Customer representative 顾客代表最高管理者应指定人员, 赋予其职责和权限, 以确保顾客要求得到体现, 包括特殊特性的选择 制定质量目标和相关的培训 纠正和预防措施 产品设计和开发 Top management shall designate personnel with responsibility and authority to ensure the customer requirements are addressed, this includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development 内部沟通 ISO9001:2008 Internal communication 质量管理体系 要求 内部沟通 Internal communication 最高管理者应确保在组织内建立适当的沟通过程, 并确保对质量管理体系的有效性进行沟通 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 管理评审 Management review

26 5.6.1 总则 General ISO9001: 质量管理体系 要求 5.6 管理评审 Management review 总则 General 最高管理者应按策划的时间间隔评审质量管理体系, 以确保其持续的适宜性 充分性和有效性 评审应包括评价质量管理体系的改进机会和变更的需要, 包括质量方针和质量目标 应保持管理评审的记录 ( 见 4.2.4) 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) 质量管理体系绩效 Quality management system performance 作为持续改进过程的必不可少的部分 这些评审应包括对质量管理体系的所有要求及其绩效趋势的评审 对质量目标进行监视及对不良质量成本的定期报告和评价应是管理评审的一部分内容 ( 见 和 ) 这些结果应予以记录, 至少能为以下方面的成绩提供证据 : a) 经营计划中规定的质量目标 ; b) 顾客对提供产品的满意度 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 and 8.5.1). These results shall be recorded to provide, as a minimum, evidence of the achievement of: a) the quality objectives specified in the business plan, and b) customer satisfaction with product supplied 评审输入 ISO9001:2008 Review input 质量管理体系 要求 评审输入 Review input 管理评审的输入应包括以下方面的信息 : a) 审核结果 ; b) 顾客反馈 ; c) 过程表现和产品符合性 ; d) 预防和纠正措施的状况 ;

27 e) 以往管理评审的跟踪措施 ; f) 可能影响质量管理体系的变更 ; g) 改进建议 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 management system, and g) recommendations for improvement 评审输入 --- 补充 Review input Supplemental 管理评审的输入应包括实际的和潜在的使用现场失效以及他们对质量 安全或环境的影响分析 Input to management review shall include an analysis of actual and potential field-failures and their impact on quality, safety, or the environment 评审输出 ISO9001:2008 Review output 质量管理体系 要求 评审输出 Review output 管理评审的输出应包括与以下方面有关的任何决定和措施 : a) 质量管理体系有效性及其过程有效性的改进 ; b) 与顾客要求有关的产品改进 ; c) 资源需求 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 6. 资源管理 Resource management 6.1 资源的提供 Provision of resources ISO9001:2008 质量管理体系 要求 6 资源管理 Resource management 6.1 资源的提供 Provision of resources 组织应确定并提供以下方面所需资源, 以 : a) 实施 保持质量管理体系并持续改进其有效性 ;

28 b) 通过满足顾客要求, 增强顾客满意 The organization shall determine and provide the resources needed a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements. 6.2 人力资源 总则 Human resources General ISO9001:2008 质量管理体系 要求 6.2 人力资源 Human resources 总则 General 基于适当的教育 培训 技能和经验, 从事影响产品要求符合性工作的人员应是能够胜任的 注 : 在质量管理体系中承担任何任务的人员都可能直接或间接地影响产品要求符合性 Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience NOTE:Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system 能力 培训和意识 Competence, training and awareness ISO9001:2008 质量管理体系 要求 能力 培训和意识 Competence, training and awareness 组织应 : a) 确定从事影响产品要求符合性的工作的人员的必要的能力 ; b) 适用时, 提供培训或采取其他措施以满足这些需求 ; c) 评价采取措施的有效性 ; d) 确保员工意识到所从事活动的相关性和重要性, 以及如何为实现质量目标做出贡献 ; e) 保持教育 培训 技能和经验的适当记录 The organization shall: a) determine the necessary competence for personnel performing work affecting conformity to product requirements. b) where applicable, provide training or take other actions achieve the necessary competence. 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)

29 产品设计技能 Product design skills 产品设计技能组织应确保具有产品设计责任人员有达到设计要求的能力, 并熟练地掌握适用的工具和技术 组织应识别适用工具和技术 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 培训 Training 培训组织应建立并保持形成文件的程序, 识别培训需求并使所有从事对产品要求符合性有影响的人员具备能力 承担特定任务的人员应按要求进行资格认可, 在满足顾客要求方面给予特别的关注 注 1: 本要求适用于组织各层次内所有影响质量的员工 注 2: 顾客特殊要求的范例之一是使用数字化的数学数据 The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting conformity to product requirement. 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 organization. NOTE 2:An example of the customer specific requirements is the application of digitized mathematically based data 岗位培训 Training on the job 岗位培训对影响产品要求符合性的岗位, 组织应对新的或调整工作岗位的人员提供岗位培训 包括合同工和代理工作人员 应将不符合要求给顾客带来的后果告知对质量有影响的人员 The organization shall provide on-the-job training for personnel in any new or modified job affecting conformity to product requirements, including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements 员工的鼓励 员工的鼓励 Employee motivation and empowerment 组织应建立一个激励员工实现质量目标 进行持续改进和建立促进创新的环境的过程 该过程应促进提高整个组织对质量和技术的认知 组织应有一个过程, 以测量员工对于所从事活动的相关性和重要性, 以及如何为实现质量目标作出贡献 ( 见 d) 的认知程度 The organization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole organization. The organization shall have a process to measure the extent to which its personnel are

30 aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives (see d). 6.3 基础设施 Infrastructure ISO9001:2008 质量管理体系 要求 6.3 基础设施 Infrastructure 组织应确定 提供并维护为达到产品符合要求所需的基础设施 适用时, 基础设施包括 : a) 建筑物 工作场所和相应的设施 ; b) 过程设备 ( 硬件和软件 ); c) 支持性服务 ( 如运输和通讯或信息系统 ) The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a) buildings workspace and associated utilities, b) process equipment,( both hardware and software ), and c) supporting services ( such as transport or communication or information systems ) 工厂 设施和设备策划 Plant, facility and equipment planning 组织应采用多方论证的方法 ( 见 ) 来开发工厂 设施和设备的计划 工厂的布局应最大限度地减少材料地交转和搬运, 以及最大限度地增值使用场地空间, 便于材料的同步流动 应开发并实施对现有操作有效性进行评价和监视方法 注 : 这些要求应着重于精益制造原则, 并与质量管理体系的有效性相关联 The organization shall use a multidisciplinary approach (see ) for developing plant, facility and equipment plans. Plant layouts shall optimize material travel, handling and value-added use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations. NOTE:These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system 应急计划 应急计划 Contingency plans 组织应准备应急计划, 以在紧急事件下满足顾客的要求, 例如 : 公用事业供应中断 劳动力短缺, 关键设备故障和使用现场退货等 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 工作环境 ISO9001:2008 质量管理体系 要求 Work environment