ISO9000
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质 量 管 理 体 系 要 求 Quality management systems — Requirements ISO前言 国际标准化组织(ISO)是各国标准化团体(ISO成员团体)组成的世界性的联合汇。制定国际标准工作通常由ISO的技术委员会完成。个成员团体若对某技术委员会确定的项目感兴趣，均由权参加该委员会的工作。与ISO保持联系的各国际组织(官方的或非官方的)也可参加有关工作。ISO与国际电工委员会(IEC)在电工技术标准化方面保持密切合作的关系。 国际标准是根据ISO/IEC导则第3部分的规则起草的。 由技术委员会通过的国际标准草案提交各成员团体投票表决，需取得了至少3/4参加表决的成员团体的同意，国际标准草案才能作为国际标准证实发布。 本标准中的某些内容有可能涉及一些专利权问题，这一点应引起注意，ISO不负责识别任何这样的专利权问题。 国际标准ISO9001是由ISO/TC176/SC2质量管理和质量保证技术委员会质量体系分技术委员会制定的。 由于ISO9001已做了技术性修订，ISO9001第三版取代第二版(ISO9001：1994)。ISO9002：1994和ISO9003：1994的内容已反映在本标准中，故本标准 Foreword 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. 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. Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 9001 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance,Subcommittee SC 2, Quality systems. This third edition of ISO 9001 cancels and replaces the second edition (ISO 9001:1994) together with ISO 9002:1994 and ISO 9003:1994. It constitutes a technical revision of these documents. Those organizations which have used ISO 9002:1994 and ISO 9003:1994 in the past may use this International Standard by excluding certain requirements in accordance with 1.2. 发布时，这两项标准将作废。原已使用ISO9002：1994和ISO9003：1994的组织只需按第1.2条的规定删减某些要求，仍可以使用本标准。 本版标准的名称发生了变化，不再有“质量保证”一词。这反映了本标准规定的质量管理体系要求除了产品质量保证之外，还旨在增强顾客满意。 本标准的附录A和附录B仅是提示的附录。 條目标题是...
[编辑] 章节1引言 0.1 总则 采用质量管理体系应当是组织的一项战略性决策。组织的质量管理体系的设计和实施受各种需求、具体的目标、所提供的产品、所采用的过程以及组织的规模和结构的影响。本标准无意统一质量管理体系的结构和文件。 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”是理解和澄清有关要求的指南。 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、法律法规和组织自身要求的能力。 本标准的制定已经考虑了GB/T 19000-2000中所阐明的质量管理原则。 0.2 过程方法 本标准鼓励组织在建立、实施质量管理体系以及改进其有效性时采用过程方法，通过满足顾客要求，增强顾客满意。 为使组织有效运行，组织必须识别和管理众多相互关联的活动。利用资源并通过管理，将输入转化为输出的活动，可以视为过程。通常，一个过程的输出可直接成为下一个过程的输入。 组织内诸过程组成的系统的应用，以及这些过程的识别和相互作用及对其管理，我们称之为“过程方法”。 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 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. 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. 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 9004 have been taken into consideration during the development of this International Standard. 0.2 Process approach 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. 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 过程方法的优点是对诸过程的组成的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。 过程方法在质量管理体系中应用时强调以下方面的重要性： a)理解和满足要求； b)需要考虑过程的增值； c)获得过程业绩和有效性的结果； d)基于客观的测量，持续改进过程。 图1所反映的以过程为基础的质量管理体系模式展示了4—8章所提出的过程联系。这种展示反映了组织在确定输入要求时，顾客起着重要的作用。顾客满意的监视需评价顾客对组织是否满足其要求的感受的相关信息。这种模式虽覆盖了本标准的所有要求，却没有详细地反映各过程。 注：此外，称之为“PDCA”的方法可适用于所有的过程。 PDCA模式可简述如下： P—策划：根据顾客的要求和组织的方针，建立提供结果所必要的目标和过程； 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—改进：采取措施，以持续改进过程业绩。 interactions of these processes, and their 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 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. 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 “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. 图1 以过程为基础的质量管理体系模式 0.3 与GB/T 19004-2000的关系 GB/T 19001-2000和GB/T 19004-2000已制定为一对协调一致的质量管理体系标准。这两项标准相互补充，但也可以单独使用。尽管两项标准具有不同的适用范围，但具有相似的结构，以便于使用。 GB/T 19001-2000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。在满足顾客要求方面，GB/T 19001-2000所关注的是质量管理体系的有效性。 与GB/T 19001-2000相比，GB/T 19004-2000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。为最高管理者希望通过追求业绩持续改进而超越GB/T 19001-2000要求的那些组织 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 International Standards have different scopes, they have similar structures in order to assist their application as a consistent pair. 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. ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization's overall performance and efficiency, as well as its effectiveness. GB/T 19004-2000推荐了指南。然而，GB/T 19004-2000无意用作认证或合同的目的。 0.4 与其它管理体系的相容性 为了使用者的利益，本标准与GB/T 24001-1996相互趋近，以增强两类标准的相容性。 本标准不包括针对其它管理体系的特定要求，例如环境管理，职业卫生与安全管理、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。组织为了建立与符合本标准要求的质量管理体系，可能会改变其现行的管理体系。 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. 0.4 Compatibility with other management systems This International Standard has been aligned with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community. 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. [编辑] 子章节 11 范围 1.1 总则 本标准为有下列需求的组织规定了质量管理体系的要求： 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，包括持续改进体系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。 注：在本标准中，术语“产品”仅适用于预期提供给顾客或顾客所要求的产品。 1.2 应用 本标准规定的所有要求都是通用的，意在适用于各种类型、不同规模和提供不同产品的组织。 当本标准的任何要求由于组织及其产品的特点而不适用时，可以考虑进行删减。 删减仅限于第7章中那些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的要求，否则不能声称符合本标准。 2 引用标准 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，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十分可以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。 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 and applicable regulatory requirements. NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer. 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 fulfils customer and applicable regulatory requirements. 2 Normative reference 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 publications do not apply. However, parties to agreements based on this International Standard are GB/T 19000-2000 质量管理体系－基础和术语(idtISO9000:2000)。 3 术语和定义 本标准采用GB/T 19000-2000及以下给出的术语和定义。 本标准描述供应链所使用的以下术语经过了更改，以反映当前的使用情况： 供方——> 组织 ——>顾客 本标准中的术语“组织”取代GB/T 19001-1994所使用的术语“供方”，术语“供方”取代术语“分承包方”。 本标准中所出现的术语“产品”，也可指“服务”。
ISO 9000:—1) , 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”. 4 质量管理体系 4.1 总要求 组织应依照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。 组织应： a) 识别质量管理体系所需的过程及其在组织中的应用(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有效运作和控制所需的准则和方法，以； d) 确保可获得必要的资源和信息，以支持这些过程的运作和对这些过程的监视； e) 监视、测量和分析这些过程； f) 实施必要的措施，以实现这些过程所策划的结果和对这些过程的持续改进。 组织应按本标准的要求管理这些过程。 注：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、产品实现和测量有关的过程。 针对组织所外包的任何影响产品符合性的过程，组织应确保对其实施控制。对此类外包过程的控制应在质量管理体系中加以识别。 4.2 文件要求 4.2.1总则 质量管理体系文件应该包括： Quality management system 4.1 General requirements 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. 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 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 NOTE 1: Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. 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. 4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include: 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； d) 组织为确保其过程有效策划、运作和控制所要求的文件； e)本标准所要求的质量记录。 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。 (2)不同组织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) 过程和它们之间的相互作用的复杂程度； c) 人员的能力。 (3)文件可采用任何形式或类型的媒体。 4.2.2质量手册 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与合理性(见1.2)； b) 为质量管理体系编制的形成文件的程序或对其引用； c) 对质量管理体系所包括过程的相互作用的表述。 4.2.3文件控制 质量管理体系所要求的文件应予以控制。质量记录是一种特殊类型的文件，应依据条款4.2.4的要求进行控制。 a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this 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 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 organisation 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. 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. 应编制形成文件的程序，以规定以下方面所需的控制： a) 文件发布前得到批准，以确保文件是充分与适宜的； 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有关版本的适用文件； e) 确保文件保持清晰、易于识别； f) 确保外来文件得到识别，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，对这些文件加以适当的标识。 4.2.4质量记录的控制 应建立并保持质量记录，以提供符合要求和质量管理体系有效运行的证据。质量记录应保持清晰、易于识别和检索。应编制形成文件的程序，以规定质量记录的标识、贮存、保护、检索、保存期限和处置所需的控制。 5 管理职责 5.1 管理承诺 最高管理者应通过以下活动，对建立、实施质量管理体系并持续改进其有效性所做出的承诺提供证据： a) 向组织传达满足顾客要求及法律法规要求的重要性； 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. 4.2.4 Control of records Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality 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. 5 Management responsibility 5.1 Management commitment 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) 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。 5.2 以顾客为中心 最高管理者应以增强顾客满意为目标，确保顾客的要求得到确定并予以满足(见7.2.1和8.2.1)。 5.3 质量方针 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)在组织内得到沟通和理解； e)在持续适宜性方面得到评审。 5.4 策划 5.4.1质量目标 最高管理者应确保在组织的相应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7.1a)。质量目标应是可测量的，并与质量方针保持一致。 5.4.2质量管理体系策划 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条款4.1的要求。 b) 在对质量管理体系的更改进行策划和实施时，保持质量管理体系的完整性。
5.2 Customer focus Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). 5.3 Quality policy 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 Planning 5.4.1 Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. 5.4.2 Quality management system planning 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 5.5.1职责和权限 最高管理者应确保在组织内职责、权限及其相互关系得到规定和沟通。 5.5.2管理者代表 最高管理者应指定一名管理人员， 无论该成员在其它方而职责如何，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)确保整个组织内提高对顾客要求的意识。 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。 5.5.3内部沟通 最高管理者应确保在在组织内建立适宜的沟通过程，并确保对质量管理体系的有效性进行沟通。 5.6 管理评审 5.6.1总则 最高管理者应按计划的时间间隔评审组织的质量管理体系，以确保其持续的适宜性、充分性和有效性。评审应包括评价组织的质量管理体系改进的机会和变更的需要，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)。 5.6.2评审输入 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Top management shall ensure that the responsibilities, authorities and their interrelation are defined and communicated within the organization. 5.5.2 Management representative Top management shall appoint a member of 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. 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). 管理评审的输入应包括以下有关信息； a)审核结果； b)顾客反馈； c)过程的业绩和产品的符合性； d)预防和纠正措施的状况； 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)改进的建议。 5.6.3评审输出 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)质量管理体系及其过程有效性的改进； b)与顾客要求有关的产品的改进； c)资源需求。 6 资源管理 6.1 资源的提供 组织应确定和提供所需的资源，以便： a)实施、保持质量管理体系并持续改进其有效性； b)通过满足顾客要求，增强顾客满意。 6.2 人力资源 6.2.1总则 基于适当的教育、培训、技能和经历，从事影响产品质量工作的人员应是能够胜任的。 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) planned changes that could affect the quality management system, and g) recommendations for improvement. 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. 6 Resource management 6.1 Provision of resources 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 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能力、培训和意识 组织应： a)确定从事影响产品质量工作的人员所必要的能力； b)提供培训或采取其他措施以满足这些需求； c)评价所采取措施的有效性； d)确保员工意识到他们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； e)保持教育、培训、技能和经历的适当记录(见4.2.4)。 6.3 基础设施 组织应确定、提供和维护为实现产品符合性所需的基础设施。基础设施包括，如： a) 建筑物、工作场所和相关的设施； b) 过程设备，包括硬件和软件； c)支持性服务，如运输或通讯。 6.4 工作环境 组织应确定和管理为实现产品符合性所需的工作环境。 7 产品实现 7.1 产品实现的策划 组织应策划和开发产品实现所需的过程。产品实现过程的策划应与质量管理体系其它要求相一致(见4.1)。
在对产品实现进行策划时，组织应确定以下方面的适当内容： a)产品的质量目标和要求； b)针对产品确定过程、文件和资源的需求； c)产品所要求的验证、确认、监视、检验和试验活动，以及产品接收准则； d)对实现过程及其产品满足要求提供证据所需的记录(见4.2.4)。 策划的输出形式应适于组织的运作方式。 注： (1)对应用于特定产品、项目或合同的质量管理体系的过程(包括产品实现过程)和资源作出规定的文件可称之为质量计划。 (2)组织也可将条款7.3的要求应用于产品实现过程的开发。 7.2 与顾客有关的过程 7.2.1与产品有关要求的确定 组织应确定： a)顾客规定的要求，包括对交付及交付后活动的要求； b)顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求； c)与产品有关的法律法规要求； d)组织确定的任何附加要求。 7.2.2与产品有关的要求的评审 组织应评审与产品有关的要求。评审应在向顾客做出提供产品的承诺之前进行(如：投标、接受合同或订单及接收合同或订单的更改)，并应确保： In planning product realization, the organization shall determine the following, as appropriate: 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 fulfil requirements(see 4.2.4). The output of this planning shall be in a form suitable for the organization's method of 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 given in 7.3 to the development of product realization processes. 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product The organization shall determine a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, b) requirements not stated by the customer but necessary for specified use or known and intended use, c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization. 7.2.2 Review of requirements related to the product The organization shall review the requirements related to the product.
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 feedback, including customer complaints. 7.3 Design and development 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,
7.3.2 Design and development inputs Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These shall include a) functional and performance requirements, b) applicable statutory and regulatory 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. 7.3.3 Design and development outputs The outputs of design and development shall be provided in a form that enables verification against the design and 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. 7.3.4 Design and development review
At suitable stages, systematic reviews of design and development shall be conducted a) to evaluate the ability of the results of design and development to fulfil requirements, and b) to identify any problems and propose necessary actions. Participants in such reviews shall include 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). 7.3.5 Design and development verification Verification shall be performed to ensure that the design and development outputs have satisfied the design and development input requirements. 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 arrangements (see 7.3.1) to ensure that the resulting product is capable of fulfilling the requirements for the specified or known intended use or application. 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). 7.3.7 Control of design and development changes Design and development changes shall be 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 delivered product. Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4). 7.4 采购 7.4.1采购过程 组织应确保采购的产品符合规定的采购要求。对供方及采购的产品控制的类型和程度应取决于采购的产品对随后的产品实现或最终产品的影响。 组织应根据供方按组织的要求提供产品的能力评价和选择供方。应制定选择、评价和重新评价的准则。评价结果及评价所引发的任何必要措施的记录应予以保持(见4.2.4)。 7.4.2采购信息 采购信息应表述拟采购的产品，适当时应包括： a)产品、程序、过程和设备批准的要求； b)人员资格的要求； c)质量管理体系的要求。 在与供方沟通前，组织应确保规定的采购要求是充分与适宜的。 7.4.3采购产品的验证 组织应建立和实施检验或其他必要的活动，以确保采购的产品符合规定的采购要求。 当组织或顾客拟在供方的现场实施验证时，组织应在采购信息中对拟验证的安排和产品放行的方法作出规定。 7.5 生产和服务提供 7.5.1生产和服务提供的控制 7.4 Purchasing 7.4.1 Purchasing process The organization shall ensure that purchased product conforms to specified purchase 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 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). 7.4.2 Purchasing information Purchasing information shall describe the product to be purchased, including where appropriate a) requirements for approval of product, procedures, processes and equipment, b) requirements for qualification of personnel, and c) quality management system requirements. The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 7.4.3 Verification of purchased product The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where 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. 7.5 Production and service provision 7.5.1 Control of production and service provision 组织应策划并在受控条件下进行生产和服务提供。适用时，受控条件应包括： a)获得表述产品特性的信息； b)获得作业指导书； c)使用适宜的设备； d)获得和使用监视和测量装置； e)实施监视与测量； f)放行、交付和交付后活动的实施。 7.5.2生产和服务提供过程的确认 当生产和服务提供过程的输出不能由后续的监视或测量加以验证时，组织应对任何这样的过程实施确认。这包括仅在产品使用或服务已交付之后问题才显现的过程。 确认应证实这些过程实现所策划的结果的能力。 组织应对这些过程作出安排，适用时包括： a)为过程的评审和批准所确定的准则； b)设备的认可和人员资格的鉴定； c)使用特定的方法和程序； d)记录的要求(见4.2.4)； e)再确认。 7.5.3标识和可追溯性 适当时，组织应在产品实现的全过程中使用适宜的方法标识产品。 组织应根据监视和测量要求标识产品的状态。 在有可追溯性要求的场合，组织应控制并记录产品的唯一性标识(见4.2.4)。 注：在某些行业，技术状态管理是保持标识和可追溯性的一种方法。 The organization shall plan and carry out 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, c) the use of suitable equipment, d) the availability and use of monitoring and measuring devices, e) the implementation of monitoring and measurement, and f) the implementation of release, delivery and post-delivery activities. 7.5.2 Validation of processes for production and service provision The organization shall validate any processes for production and service provision where the 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, 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. 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 organization shall control and record the unique identification of the product (see 4.2.4). NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained. 7.5.4顾客财产 组织应爱护在组织控制下或组织使用的顾客的财产。组织应识别、验证、保护供其使用或构成其产品一部分的顾客的财产。当顾客财产发生丢失、损坏或发现不适用的情况时，应报告顾客，并保持记录。 注：顾客财产可包括知识产权。 7.5.5产品防护 在内部处理和交付到预定的地点期间，组织应针对产品的符合性提供防护，这种防护应包括标识、搬运、包装、贮存和保护。防护也适用于产品的组成部分。 7.6 监视和测量装置的控制 组织应确定需实施的监视和测量以及所需的监视和测量装置，产品符合确定的要求(见7.2.1)提供证据。 组织应建立过程，以确保监视和测量活动可行并以与监视和测量的要求相一致的方式实施。 在有必要确保有效结果的场合，测量设备应： a)对照能溯源到的国际或国家标准的测量标准，按照规定的时间间隔或在使用前,进行校准或验证，当不存在上述标准时，应记录校准或验证的依据； b) 必要时进行调整或再调整； c) 得到识别，以确保其校准状态； d)防止可能使测量结果失效的调整； e)在搬运、维护和贮存期间防止损坏和失效。 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 customer property provided for use or incorporation 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. 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. 7.6 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). 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, measuring equipment shall: a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such 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; 此外，当发现设备不符合要求时，组织应对以往测量结果的有效性进行评价和记录。组织应对该设备和任何受影响的产品采取适当的措施。校准和验证结果的记录应予以保持(见4.2.4)。 当计算机软件用于规定要求的监视和测量时，应确认其满足预期用途的能力。确认应在初次使用前进行，并在必要时予以重新确认。 注：作为指南，参见GB/T19022.1和GB/T19022.2。 8 测量、分析和改进 8.1 总则 组织应策划并实施所需的监视、测量、分析和改进过程，以便： a)证实产品的符合性； b)确保质量管理体系的符合性； c)持续改进质量管理体系的有效性。 这应包括统计技术在内的适宜方法及应用程度的确定。 8.2 监视和测量 8.2.1顾客满意 作为对质量管理体系业绩的一种测量，组织应监视顾客对组织是否满足其要求(见7.2.1)的感受的有关信息。并确定获取和利用这种信息的方法。 8.2.2内部审核 组织应按计划的时间间隔进行内部审核，以确定质量管理体系是否： 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 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. 8 Measurement, analysis and improvement 8.1 General The organization shall plan and implement the monitoring, measurement, analysis and 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. 8.2 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 fulfilled customer requirements. The methods for obtaining and using this information shall be determined. a)符合计划的安排(见7.1)、本标准的要求以及组织所确定的质量管理体系的要求； b)得到有效实施和保持。 考虑拟审核的过程和区域的状况和重要性以及以往审核的结果，组织应对审核方案进行策划。应规定审核的准则、范围、频次和方法。审核员的选择和审核的实施应确保审核过程的客观性和公正性。审核员不应审核自己的工作。 策划和实施审核以及报告结果和保持记录(见4.2.4)的职责和要求，应在形成文件的程序中作出规定。 负责受审区域的管理者应确保及时采取措施，已消除已发现的不合格及其产生的原因。跟踪活动应包括所采取措施的验证和验证结果的报告(见8.5.2)。 注：作为指南，参见GB/T19021.1、GB/T19021.2及GB/T19021.3。 8.2.3过程的监视和测量 组织应采用适宜的方法对质量管理体系过程进行监视，并在适用时进行测量。这些方法应证实过程实现所策划的结果的能力。当未能达到所策划的结果时，在适当时，应采取纠正和纠正措施，以确保产品的符合性。 8.2.4产品的监视和测量 组织应对产品的特性进行监视和测量，以验证产品的要求得到满足。这种监视和测量应依据策划的安排(见7.1)，在产品实现过程的适当阶段进行。 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 Standard and to the quality management system requirements established by the organization, and b) is effectively implemented and maintained. 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). NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance. 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. 8.2.4 Monitoring and measurement of product 应保持符合验收准则的证据。记录应指明有权放行产品的人员(见4.2.4)。 除非得到有关授权人员的批准，适用时得到顾客的批准，否则，在所策划的安排均已圆满完成之前，不得放行产品和交付服务。 8.3 不合格品控制 组织应确保不符合产品要求的产品得到识别和控制，以防止其非预期的使用和交付。不合格品控制以及不合格处置的有关职责和权限应在形成文件的程序中做出规定。 组织应采取下列一种或几种方法，处置不合格品： a)采取措施，消除发现的不合格； b)经有关授权人员批准，适用时经顾客批准，让步使用、放行或接收不合格品； c)采取措施，防止其原预期的使用或应用。 应保持不合格的性质以及随后所采取的任何措施的记录，包括所批准的让步的记录(见4.2.4)。 应对纠正后的产品再次进行验证，以证实其符合要求。 当在交付或开始使用后发现产品不合格时，组织应采取与不合格的影响或潜在影响的程度相适应的措施。 8.4 数据分析 组织应确定、收集和分析适当的数据，以证实质量管理体系的适宜性和有效 The organization shall monitor and measure the characteristics of the product to verify that product requirements are fulfilled. This shall be carried out at appropriate stages of the product realization process in accordance with the planned 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 all the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer. 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 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 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. 性，并评价何处在可以进行质量管理体系的持续改进。这应包括来自监视和测量的结果以及其它有关来源的数据。 数据分析应提供以下有关方面的信息： a)顾客满意(见8.2.1)； b)与产品要求的符合性(见7.2.1)； c)过程和产品的特性及趋势，包括采取预防措施的机会； d)供方。 8.5 改进 8.5.1持续改进 组织应利用质量方针、质量目标、审核结果、数据分析、纠正和预防措施以及管理评审，持续改进质量管理体系的有效性。 8.5.2纠正措施 组织应采取措施，以消除不合格的原因，防止不合格的再发生。纠正措施应与所遇到的不合格的影响程度相适应。 应编制形成文件的程序，以规定以下方面的要求： a)评审不合格(包括顾客投诉)； b)定不合格的原因； c)评价确保不合格不再发生的措施的需求； d)确定和实施所需的纠正措施； e)记录所采取的纠正措施结果(见4.2.4)； f)评审所采取的纠正措施。 8.4 Analysis of data The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to a) customer satisfaction (see 8.2.1), b) conformance to product requirements (see 7.2.1), c) characteristics and trends of processes and products including opportunities for preventive action, and d) suppliers. 8.5 Improvement 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. 8.5.2 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. 8.5.3预防措施 组织应确定措施，以消除潜在不合格的原因，防止不合格的发生。预防措施应与潜在问题的影响程度相适应。 应编制形成文件的程序，以规定以下方面的要求： a)确定潜在不合格及其原因； b)评价防止不合格发生的措施的需求； c)确定并实施所需的措施； d)记录所采取措施的结果(见4.2.4)； e)评审所采取的预防措施。 8.5.3 Preventive action The organization shall determine action to 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. [编辑] 子章节 2[编辑] 章节 2[编辑] 子章节 1[编辑] 子章节 2[编辑] 参看
任何标准都是为了适应科学、技术、社会、经济等客观因素发展变化的需要而产生，ISO9000亦是如此。 科学技术的进步和社会的发展，使顾客需要把自己的安全、健康、日常生活置于“质量大堤的保护之下”；企业为了避免因产品质量问题而巨额赔款，要建立质量保证体系来提高信誉和市场竞争力；世界贸易的发展迅速，不同国家、企业之间在技术合作、经验交流和贸易往来上要求有共同的语言、统一的认识和共同遵守的规范。现代企业内部协作的规模日益庞大，使程序化管理成为生产力发展本身的要求。这些原因共同使ISO9000标准的产生成为必然。 1979年ISO组织成立质量管理和质量保证技术委员会TC176，专门负责制定质量管理和质量保证标准。 1979年英国标准协会BSI向ISO组织提交了一份建议，倡议研究质量保证技术和管理经验的国际标准化问题。同年ISO批准成立质量管理和质量保证技术委员会TC176，专门负责制定质量管理和质量保证标准。TC176主要参照了英国BS5750标准和加拿大CASZ299标准，从一开始就注意使其制定的标准与许多国家的标准相衔接。 ISO9000的诞生 人们并未等太长时间，在各国专家努力的基础上，国际标准化组织在1987年正式颁布了ISO9000系列标准(9000~9004)的第一版。ISO9000标准很快在工业界得到广泛的承认，被各国标准化机构所采用并成为ISO标准中在国际上销路最好的一个。截止1994年底已被70多个国家一字不漏地采用，其中包括所有的欧洲联盟和欧洲自由贸易联盟国家、日本和美国。有50多个国家建立了国家质量体系认证/注册机构，开展了第三方认证和注册工作。有些国家，等待注册的公司队伍如此之长，要等上几个月甚至1年才能得到认证。ISO9000标准被欧洲测试与认证组织EOTC作为开展本组织工作的基本模式。欧洲联盟在某些领域如医疗器械的立法中引用ISO9000标准，供应商在某些领域必须取得ISO9000注册。许多公司得出的结论是，要想与统一起来的欧洲市场做生意，取得ISO9000注册是绝对有好处的。许多国家级和国际级产品认证体系如英国BSI的风筝标志、日本JIS标志都把ISO9000作为取得产品认证的首要要求，把ISO9000结合到产品认证计划中去。 [编辑] 参考文献
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