ISO9001-200828中英文29共33页.doc

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1、【精品文档】如有侵权，请联系网站删除，仅供学习与交流ISO9001-200828中英文29共33页.精品文档.ISO 9001:2008English Chinese BilingualQuality management system Requirement质量管理体系 要求Copyright reserved, for reference to Intertek systems certification customersonlyISO 9001:2008 Introduction引言0.1 General 总则The adoption of a quality management s

2、ystem should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced bya) its organizational environment, changes in that environment, and the risks associated with that environment,b) its varying needs,c) its particular o

3、bjectives,d) the products it provides,e) the processes it employs,f) its size and organizational structure.采用质量管理体系应当是组织的一项战略性决策。一个组织质量管理体系的设计和实施受下列因素的影响：a) 组织的业务环境、该环境的变化或与该环境有关的风险，b) 组织的不同需求，c) 组织的特定目标，d) 所提供的产品，e) 所采用的过程，f) 组织的规模和组织结构。It is not the intent of this International Standard to imply u

4、niformity in thestructure of quality management systems or uniformity of documentation.统一质量管理体系的结构或文件不是本标准的目的。The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding

5、 or clarifying the associated requirement.本标准所规定的质量管理体系要求是对产品要求的补充。“注”是帮助理解、澄清有关要求的参考性信息。This International Standard can be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, statutory and regulatory requirements applicable to

6、 the product, and the organizations own requirements.本标准能用于内部和外部各方（包括认证机构）评定组织满足顾客要求、适用的产品的法律法规要求和组织自身要求的能力。The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.本标准的制定已经考虑了ISO 9000和ISO 9004中所阐明的质量管理

7、原则。0.2 Process approach过程方法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.本标准鼓励在建立、实施质量管理体系以及改进其有效性时采用过程方法，旨在通过满足顾客要

8、求，增强顾客满意。For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities 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 proce

9、ss directly forms the input to the next.为使组织有效运行，需确定和管理众多相互关联的活动。通过使用资源和实施管理，将输入转化为输出的一项或一组活动，可以视为一个过程。通常，一个过程的输出可直接形成下一个过程的输入。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 de

10、sired outcome, can be referred to as the “process approach”.为了产生期望的结果，组织内诸过程组成的系统的应用，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”。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 the

11、ir combination and interaction.过程方法的一个优点就是实现了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。When used within a quality management system, such an approach emphasizes the importance ofa) understanding and meeting requirements,b) the need to consider processes in terms of added value,c) obtaining results of proce

12、ss performance and effectiveness, andd) continual improvement of processes based on objective measurement.在质量管理体系中应用过程方法时，该方法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) 基于客观的测量，持续改进过程。The model of a process-based quality management system shown in Figure 1 illustrates the process linka

13、ges 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 requireme

14、nts. The model shown in Figure 1 covers all therequirements of this International Standard, but does not show processes at a detailed level.图1所反映的以过程为基础的质量管理体系模式展示了48章中所提出的过程联系。该展示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对顾客关于组织是否已满足其要求的感受的信息进行评价。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。NOTE In addition, the methodology

15、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: monitor a

16、nd measure processes and product against policies, objectives and requirements for the product and report the results.Act: take actions to continually improve process performance.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，建立实现结果所必需的目标和过程；D做：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

17、：采取措施，以持续改进过程绩效。0.3 Relationship with ISO 9004 与ISO 9004 的关系ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.ISO 9001 和ISO 9004 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。ISO 9001 specifies requirements for a qualit

18、y 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.ISO 9001 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。ISO 9001 所关注的是质量管理体系在满足顾客要求方面

19、的有效性。At the time of publication of this International Standard, ISO 9004 is under revision. Therevised 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

20、 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 organizations performance. However, it is not intended forcertification, regulatory or contractual use.与ISO 9001 相比，ISO 9

21、004 对质量管理体系更宽范围的目标提供了指南，除了有效性，该标准还特别关注持续改进一个组织的总体绩效与效率。对于最高管理者希望超越ISO 9001 要求，追求绩效持续改进的那些组织，推荐ISO 9004 作为指南。然而，用于认证或合同不是ISO 9004 的目的。Continual improvement of the quality management system质量管理体系的不断改进Customer 顾客Customer 客户Requirements 要求Satisfaction 满意Management Responsibility 管理职责Resource Management

22、资源管理Measurement, analysis and Improvement 测量、分析和改进Product Realization 产品实现Product 产品Output 输出Input 输入0.4 Compatibility with other management systems与其他管理体系的相容性During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compati

23、bility of the two standards for the benefit of the user community. Annex A shows the correspondence between ISO 9001:2008 and ISO 14001:2004.为了使用者的便利，本标准在制定过程中适当考虑了ISO 14001:2004 标准的内容，以增强两个标准的相容性。附录A 表明了ISO 9001:2008 与ISO 14001:2004 之间的对应关系。This International Standard does not include requirements

24、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 re

25、lated 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.本标准不包括针对其他管理体系的特定要求，例如环境管理、职业健康与安全管理、财务管理或风险管理有关的特定要求。然而本标准使组织能够将自身

26、的质量管理体系与相关的管理体系要求结合或一体化。组织为了建立符合本标准要求的质量管理体系，可能会改变现行的管理体系。.Quality management systems Requirements质量管理体系 要求1 Scope范围1.1 General总则This International Standard specifies requirements for a quality management system wherean organization本标准为有下列需求的组织规定了质量管理体系要求：a) needs to demonstrate its ability to consi

27、stently provide product that meets customer andapplicable statutory and regulatory requirements, andb) 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 app

28、licable statutory and regulatory requirements.a) 需要证实其有能力稳定地提供满足顾客和适用的法律法规要求的产品；b) 通过体系的有效应用，包括体系持续改进的过程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。NOTE 1 In this International Standard, the term “product” only applies toa) product intended for, or required by, a customer,b) any intended output resulting from the p

29、roduct realization processes.注1：在本标准中，术语“产品”仅适用于a) 预期提供给顾客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。NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.注2：法律法规要求可称作法定要求。1.2 Application应用All requirements of this International Standard are generic and are intended to be applicable

30、to all organizations, regardless of type, size and product provided.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。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.当本标准的任何要求由于组织及其产品的特点不适用时，可以

31、考虑对其进行删减。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 organizations ability, or responsibility, to provide product that meets customer and a

32、pplicable statutory and regulatory requirements.如果进行了删减，而且这些删减仅限于本标准第7 章的要求，同时不影响组织提供满足顾客和适用法律法规要求的产品的能力或责任, 方可声称符合本标准。2 Normative references规范性引用文件The following referenced documents are indispensable for the application of this document.For dated references, only the edition cited applies. For unda

33、ted references, the latest edition of the referenced document (including any amendments) applies.下列文件中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 9000:2005, Quality management systems Fundamentals and vocabularyISO9000

34、:2005 质量管理体系 基础和术语3 Terms and definitions术语和定义For the purposes of this document, the terms and definitions given in ISO 9000 apply.本标准采用ISO 9000 中所确立的术语和定义。Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.本标准中所出现的术语“产品”，也可指“服务”。4 Qual

35、ity management system质量管理体系4.1 General requirements总要求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。

36、The organization shalla) 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

37、 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, andf) implement actions necessary to achieve planned results and continual im

38、provement of these processes.组织应：a) 确定质量管理体系所需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) 确定为确保这些过程的有效运作和控制所需的准则和方法；d) 确保可以获得必要的资源和信息，以支持这些过程的运作和监视；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。These processes shall be managed by the organization in accordance with the requirements of this

39、 International Standard.组织应按本标准的要求管理这些过程。Where an organization chooses to outsource any process that affects product conformity to 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 with

40、in the quality management system.针对组织所选择的任何影响产品符合要求的外包过程，组织应确保对其实施控制。对此类外包过程控制的类型和程度应在质量管理体系中加以规定。NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvemen

41、t.注1：上述质量管理体系所需的过程包括与管理活动、资源提供、产品实现和测量、分析和改进有关的过程。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.注2：外包过程是经组织识别为质量管理体系所需的，但选择由组织的外部方实施的过程。NOTE 3 Ensuring control over o

42、utsourced processes does not absolve the organization of theresponsibility 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 asa) the potential impact of the outsourced proces

43、s on the organizations 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 7.4.注3：确保对外包过程的控制并不免除组织满足顾客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下列因素影响：a) 外包过程对组织提供满足要求

44、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。4.2 Documentation requirements文件要求4.2.1 General总则The quality management system documentation shall includea) documented statements of a quality policy and quality objectives,b) a quality manual,c) documented procedures and records required by this I

45、nternational Standard, andd) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.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) 本标准所要求的形成文件的程序和记录；d) 组织确定的为确保其过程有效策划、运作和控制所需的文件，包括记录。NOTE 1 Where the term “docu

46、mented 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 documentedprocedure may be covered by more than one docum

47、ent.注1：本标准出现 “形成文件的程序”之处，即要求建立该程序，形成文件，并加以实施和保持。一个文件可包括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 2 The extent of the quality management system documentation can differ from one organization to another due toa) the size of organization and type of activities,b) the complexity of processes and their int

48、eractions, andc) the competence of personnel.注2：不同组织的质量管理体系文件的多少与详略程度取决于：a) 组织的规模和活动的类型；b) 过程及其相互作用的复杂程度；c) 人员的能力。NOTE 3 The documentation can be in any form or type of medium.注3文件可采用任何形式或类型的媒体。4.2.2 Quality manual质量手册The organization shall establish and maintain a quality manual that includesa) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),b) the documented procedures established