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1、1,ISO/TS 16949:2002 标准讲解 （中英文对照版） 因涉及ISO的版权问题，故仅限家园范围使用。请勿扩散。,2,Quality system documentation progression,3,Key Words 关键词语,Shall mandatory requirements 应 强制性要求 Should recommendation 应该 建议 Note guidance for understanding 注 指南以便明白 Such as for guidance 例如 指导性 Documented procedure must have documented sy
2、stem procedure 文件化程序 必须有文件化的体系程序,4,Process An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Process Approach The application of a system of processes within an organization, together with the identification and int
3、eractions of these processes, and their management, can be referred to as the “process approach”.,过程 通过使用资源和管理,将输入转化为输出的活动可视为过程。 过程方法 组织内诸过程的系统的应用，连同这些过程的识别和相互作用及其管理，可称之为“过程方法”。,5,6,质量管理体系8大原则,以客户为关注焦点 Customer Focus 领导作用 Leadership 全员参与 Involvement of People 过程方法 Process Approach 系统化管理 System Appro
4、ach to Management 持续改进 Continual Improvement 基于事实的决策方法 Factual approach to Decision Making 与供方互利的关系 Mutually Beneficial Supplier Relationships,7,4 Quality management system 质量管理体系,8,4.1 General requirements The organization shall establish, document, implement and maintain a quality management syste
5、m and continually improve its effectiveness in accordance with the requirements of this international Standards. 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 inter
6、action of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,4 Quality management system 4 质量管理体系,4.1 总要求 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. 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
7、这些过程的有效运行和控制所需的准则和方法,9,4 Quality management system 4 质量管理体系,4.1 General requirements 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 ac
8、hieve 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.,4.1 总要求 d) 确保可以获得必要的资源和信息,以支持这些过程的运行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,以实现对这些过程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
9、求管理这些过程.,10,4 Quality management system 4 质量管理体系,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
10、 system. Note: Process needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.,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.对此类外包过程的控制应在质量管理体系中加以识别. 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.,
11、11,4 Quality management system 4 质量管理体系,4.1.1 General requirements - Supplemental Ensuring control over outsourced processes shall not absolve the organization of the responsibility of conformity to all customers requirements. NOTE See also 7.4.1 and 7.4.1.3,4.1.1 总则 - 补充 确保控制外包过程不应 免除组织对符合所有客户要求的职责
12、。 注：见7.4.1 和7.4.1.3,12,4 Quality management system 4 质量管理体系,4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include: a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this inte
13、rnational 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),4.2 Documentation requirements 4.2.1 总则 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 d)
14、 组织为确保其过程的有效策划,运 行和控制所需的文件 e) 本标准所要求的记录(见4.2.4),13,4 Quality management system 4 质量管理体系,NOTE 1: Where the term 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 documen
15、tation 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.,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
16、,并加以实施和保持. 注 2: 不同组织的质量管理体系文件的多少于详略程度取决于: 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. 注 3: 文件可采用任何形式或类型的媒体.,14,4 Quality management system 4 质量管理体系,4.2.2 Quality manual The organization 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 th
