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Quality management system – Requirement 质量管理体系– 要求 引言 0.1 General 总则 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) 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. 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 uniformity in the structure 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 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 organization's ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization's 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 process 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 desired 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 their 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 of a) understanding and meeting requirements, b) the need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness, and d) 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 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. 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 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