1、ISO9001质量管理体系标准要素详解 ISO9001质量管理体系标准要素详解 ISO9001:2000 Quality management systems Requirements (Third edition 2000-12-15)一合理的简化 2000版ISO9000标准将其简化为以下五个标准1. ISO90002000质量管理体系-基本原理和朮语取代了ISO8402标准和ISO9000-1。2. ISO9001: 2000质量管理体系-要求取代了94版的3个质量保证标准。3. ISO90042000质量管理体系-业绩改进指南取代现行的ISO90041,-2,-3,-4标准。4. IS
2、O19011质量和环境审核指南取代了现行的ISO10011 (包括3个分标准) 和ISO14010ISO14011ISO14012 标准。5. ISO10012测量控制系统取代现行的ISO10012-1, -2标瘁 94版的ISO9001有20个要素现改为4个部份相互新闻系如下图ISO 9001:2000ISO 9001:19941.适用范围11.1一般规定1.2 Application应用2.参考标准23.朮语及定义34.质量管理系统4.1一般要求4.2.14.2文件要求4.2.24.2.1 概述4.5.24.5.34.2.2 品质手册4.2.14.2.3 文件的管制4.5.1+4.5.2+
3、4.5.34.2.4 质量记录的管制4.165.管理责任5.1管理承诺4.1+4.1.2.2+4.2.15.2以顾客为中心4.3.25.3质量政策4.1.15.4规划5.4.1质量目标4.1.1+4.2.15.4.2质量管理系统规划4.2.35.5责任、职权、沟通5.5.1责任与职权4.1.2.15.5.2管理代表4.1.2.35.5.3内部沟通5.6管理审查4.1.35.6.1概述4.1.35.6.2审查输入4.1.35.6.3审查输出4.1.36资源管理6.1资源的提供4.1.2.26.2人力资源6.2.1概述4.1.2.2+4.2.3+4.186.2.2培训意识和能力4.186.3资源结
4、构4.1.2.2+4.96.4工作环境4.97 产品实现7.1 产品实现的规划4.2.3+4.9+4.10.17.2 客户相关流程7.2.1 产品有关需求的决定4.3.2+4.4.47.2.2 产品有关需求的审查4.3.2+4.3.3+4.3.47.2.3 客户沟通4.3.27.3设计与开发7.3.1设计与开发规划4.4.2+4.4.3+4.4.6+4.4.7+4.4.87.3.2设计与开发输入4.4.47.3.3设计与开发输出4.4.57.3.4设计与开发审查4.4.67.3.5设计与开发验证4.4.77.3.6设计与开发确认4.4.87.3.7设计的管制与开发变更4.4.97.4采购7.4
5、.1采购过程4.6.1+4.6.27.4.2采购信息4.6.37.4.3采购产品的验证4.6.4+4.10.2+4.10.3+4.10.47.5生产及服务作业7.5.1生产与服务准许备管制4.9+4.10.3+4.15.6+4.197.5.2过程的确认4.97.5.3鉴别与追溯4.8+4.10.5+4.127.5.4客户产品4.77.5.5产品的保存4.15.2+4.15.3+4.15.4+4.15.5+4.15.67.6量测与监控仪器的管制4.11.1+4.11.28量测、分析及改善8.1概括4.10+4.20.18.2量测与监控8.2.1客户满意8.2.2内部稽核4.178.2.3流程的监
6、控与量测4.9+4.20.18.2.4产品的量测与监控4.10.2+4.10.3+4.10.4+4.10.5+4.208.3不合格品的管制4.13.1+4.13.28.4资料分析4.14.2+4.14.3+4.208.5改善8.5.1持续改善之规划4.1.38.5.2矫正措施4.14.1+4.14.28.5.3预防措施4.14.1+4.14.3二词语的使用更加准确或符合组织的习惯1.用 “质量管理体系”取代了 “质量保证体系”2.用 “文件控制” 取代了 “文件和数据控制”3.用 “顾客的财产”取代了 “顾客提供的产品”4.供应链由 “承包方-供方-顾客” 改为 “供方-组织-顾客”5.用 “
7、最高管理者”取代 “负有执行职责的管理者”。三更方便地适用于各种产品类型和规模的组织1.以过程模式代替20个要素的模式。 将20个要素的形式变成四部分这种结构具有普遍的适用性。但其并不强求组 织更改其质量管理体系的结构或其文件以和本国际标准的结构保持一致组织 的质量管理体系文件的规定应适合于其特有的活动方式。2.强调根据组织的具体情况设计适用的质量管理体系。 文件的要求有了较大的灵活性a.标准要求必须建立程序文件的共有6处文件控制记录控制内部审核不合格品控制纠正措施预防措施b.别一类的组织要求的文件主要指产品实现过程所需的文件。四标准要求NOTE In addition, the method
8、ology 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 organizations policies.Do: implement the processes.Check: mon
9、itor 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.Figure 1 Model of a process-based quality management systemQuality management systems Requirements1 Scope 范围1.1 Gen
10、eral 总则This International Standard specifies requirements for a quality management system where an organization本国际标准规定的质量管理体系要求组织a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and 需证实其持续提供符合客户需求及适用法规要求产品的能力。b) aims to e
11、nhance 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. 目的在于通过系统的有效运作以达到客户的满意包括持续改善系统的流程和确保符合客户满及适用 法规的需求。NOTE In this International S
12、tandard, the term “product” applies only to the product intended for, or required by, a customer.备注在本国际标准中述语产品指的是客户订购或客户需求的产品。1.2 Application 应用All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product pro
13、vided.本国际标准规定的是一般和通用的要求适用于所有组织不论其类型规模和提供的产品如何。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.本国际标准的要求会因组织或产品的特性因素而不适用可以考虑排除。Where exclusions are made, claims of conformity to this In
14、ternational Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.组织可以排除的条款仅限于条款7中的要求并且仅可以排除不影响组织提供
15、符合客户和适用的法律要求的产品的能力和责任的要求。否则就不能声称符合本国际标准。2 Normative reference 引用标准The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publicatio
16、ns do not apply. However, parties to agreements based on this International Standard 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.
17、Members of ISO and IEC maintain registers of currently valid International Standards.下列相关国际标准所包含条文通过在本标准中引用而构成为本标准的条文由于引用的条文会逐渐过时陆续修正或改版造成引用的国际标准不再适用。然而使用本国际标准的各方应探讨使用下列相关国际标准之最新版本的可能性。IEC和ISO成员都持有现行有效的国际标准。ISO 9000:2000, Quality management systems Fundamentals and vocabulary.ISO 9000:2000质量管理体系-基础知
18、识和朮语3 Terms and definitions 朮语和定义For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.出于本国际标准的目的使用的朮语和定议在ISO9000中给出。The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently
19、used:在ISO90012000 描述供应链所使用的朮语被改变为组织普遍使用的词汇 Supplier organization customer 供方 组织 客户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”. 朮语组织取代了I
20、SO9001:1994版使用的朮语供方,意思是适用于本国际标准的单位。同样用朮语供方取代了朮语分供方。Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.在整个标准中所使用的朮语产品在这里同样包括服务。4 Quality management system 质量管理体系4.1 General requirements 一般要求The organization shall establish, document, imp
21、lement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.组织应建立执行并保持一个文件化的质量管理体系并持续改进其有效性使其与本国标标准要求相一至。The organization shall组织应a) identify the processes needed for the quality management system and th
22、eir application throughout the organization (see 1.2), 认别实施质量管理系统及应用于整个组织所需的流程。b) determine the sequence and interaction of these processes, 确定这些流程之顺序及相互关系。c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, 确定所需标准及方法以确保这些流程可达成有效作业
23、及管制。d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, 提供有效的资源和信息以支持这些流程的运行及管制。e) monitor, measure and analyse these processes, and 监控测量及分析这些流程。f) implement actions necessary to achieve planned results and continual improveme
24、nt of these processes. 执行所需要的活动来达成计划并持续改进这些流程。These processes shall be managed by the organization in accordance with the requirements of this International Standard.组织应对这些流程进行管理使其与本国际标准的要求相一至。Where an organization chooses to outsource any process that affects product conformity with requirements, t
25、he organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.当组织迁择会影响到产品符合要求的外部流程时组织应确保这些外部流程得到控制并在质量管理体系中对这些流程进行鉴别。NOTE Processes needed for the quality management system referred to above should include proc
26、esses for management activities, provision of resources, product realization and measurement.备注在上面所述的质量管理所需的流程包括管理活动资源提供产品实现及测量流程。4.2 Documentation requirements 文件需求4.2.1 General 一般要求The quality management system documentation shall include质量管理体系文件应包括a) documented statements of a quality policy and
27、quality objectives, 文件化的质量方针和质量目标。b) a quality manual, 质量手册。c) documented procedures required by this International Standard,本国际标准要求的程序文件。d)documents needed by the organization to ensure the effective planning, operation and control of its processes, and组织需求的确保流程得到有效的实施和控制的文件。e) records required by
28、this International Standard (see 4.2.4).本国际标准要求的记录。(见行条款4.2.4)NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.备注1要本国际标准中出现的朮语文件化程序是要求建立形成文件实施程序并予以保持。NOTE 2 The extent of the
29、quality management system documentation can differ from one organization to another due to备注2质量管理体系文件的范围可能因以下原因在组织间会有差异a) the size of organization and type of activities, 组织的规模和类型。b) the complexity of processes and their interactions, and 流程的复杂程度和相互作用。c) the competence of personnel. 人员的能力。NOTE 3 The
30、 documentation can be in any form or type of medium.备注3文件化的程序和文件可存在任何形式的媒体。4.2.2 Quality manual 质量手册The organization shall establish and maintain a quality manual that includes组织就建立并保持个质量手册包含以下内容a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2), 质量管理体系的范围包括详细内容及任何排除情况和原因。b) the documented procedures established for the quality management system, or reference to them, and 质量管理体系建立的文件化程序或其援引。c) a description of the interaction between the processes of the quality man
