ISO TS 22163 标准培训课件.ppt

8.3.5 Design and development outputs设计开发输出 The organization shall ensure that design and development outputs: 组织应确保设计开发输出： a) meet the input requirements; 满足输入的要求； b) are adequate for the subsequent processes for the provision of products and services; 对随后的产品和服务提供过程是充分的； c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria; 包含或引用监视和测量要求，适用时，包含或引用接收准则； d) specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision. 规定对产品和服务的预期目的、安全和正常使用所必需的特性。 The organization shall retain documented information on design and development outputs. 组织应保留设计开发输出的文件化信息。 。 Design and development outputs – Supplemental 设计开发-补充 The organization shall ensure that design and development outputs: 组织应确保设计开发输出： a) are verified and approved prior to release; 在放行前得到验证和批准 b) are verified against production process input requirement; 针对生产过程输入要求进行验证 c) include the documentation (e.g. operations, maintenance manuals) and training related to the application. 包括与应用相关的文件（例如操作、维护手册）和培训。 The organization should 组织应该 a) ensure the traceability of outputs to the input requirements; 确保输出对于输入要求的可追溯性 b) define authorities and acceptance criteria for design approval; 确定设计批准的授权和接收准则 c) define escalation rules in case acceptance criteria for approval are not met; 如果批准的接收准则没有得到满足，确定降级规则 。 d) ensure that information for production and service provision include requirements for the preservation of product. 确保生产和服务提供的信息，包括产品防护的要求。 NOTE The design and development outputs can include e.g. specifications and drawings (also from external providers), information on materials, production process flow chart and (or) layout, inspection and test plan, work instructions for production, process and product approval acceptance criteria, results of error prevention activities (e.g. FMEA), as appropriate, methods of rapid detection and feedback of product and (or) production process nonconformities. 注：设