《TS16949中英文标准》.doc

TS16949中英文标准 4. Quality management system 4.质量管理系统4.1 General requirements 4.1一般要求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.组织须依照本国际标准之要求，建立、文件化、实施与维持一质量管理系统，及持续改进其有效性The organization shall:组织须：a)　identify the processes needed for the quality management system and their application throughout the organization (see 1.2),a)鉴别此质量管理系统与其应用于整个组织所需之过程(参照第1.2节)，b)　determine the sequence and interaction of these processes, b)决定此等过程之顺序与交互作用，c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, c)决定所需之准则与方法，以确保此等过程的运作与管制两者均有效，d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, d)确保必要资源与信息之可取用性，以支持过程的运作与监督，e) monitor, measure and analyse these processes, and e)监督、量测与分析此等过程，及f) implement actions necessary to achieve planned results and continual improvement of these processes. f)实施必要措施，以达成此等过程所规划的结果与持续改进。These processes shall be managed by the organization in accordance with the requirements of this International Standard.此等过程须由组织依照本国际标准之要求加以管理。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.当组织选择来自外部会影响产品要求符合性之任何过程时，组织须确保此等过程的管制。此等来自外部过程之管制，须在质量管理系统内加以鉴别。NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.备注：质量管理系统所需之过程参考上述，应包括管理阶层活动、资源之提供、产品实现及量测之过程。4.1.1 General requirements—SupplementalEnsuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all customer requiremen