（一）总则设计是产品质量形成中的关键环节，供方通过设计把来自顾客和其他要求转化为对采购、制造、检验、服务等技术规范和文件，体现了产品质量的适用性。设计控制就是要从设计策划开始到设计确认的全过程实施控制和验证，通过制定并执行产品设计控制和验证的文件化程... (1) The general design is the key link in the product quality formation. The supplier transforms the request from the customers and other requirements into the technical specifications and documents of purchase, manufacture, inspection and service through design, demonstrating the applicability of the product quality. Design control is to control and verify the whole process from design planning to design confirmation through documenting and execution of product design control and verification ...