质量管理体系 要求GB/T 19001-2016 8.3.2 设计和开发策划 中英文对照
质量管理体系 要求GB/T 19001-2016 8.3.2 设计和开发策划中英文对照
8.3 产品和服务的设计和开发
更新日期：2024-07-19
8.3.2 设计和开发策划
在确定设计和开发的各个阶段和控制时，组织应考虑：
- 设计和开发活动的性质、持续时间和复杂程度；
- 所需的过程阶段，包括适用的设计和开发评审；
- 所需的设计和开发验证和确认活动；
- 设计和开发过程涉及的职责和权限；
- 产品和服务的设计和开发所需的内部和外部资源：
- 设计和开发过程参与人员之间接口的控制需求；
- 顾客和使用者参与设计和开发过程的需求；
- 对后续产品和服务提供的要求；
- 顾客和其他有关相关方期望的设计和开发过程的控制水平；
- 证实已经满足设计和开发要求所需的形成文件的信息。
8.3.2 Design and development planning
In determining the stages and controls for design and development, the organization shall consider:
- the nature, duration and complexity of the design and development activities;
- the required process stages, including applicable design and development reviews;
- the required design and development verification and validation activities;
- the responsibilities and authorities involved in the design and development process;
- the internal and external resource needs for the design and development of products and services;
- the need to control interfaces between persons involved in the design and development process;
- the need for involvement of customers and users in the design and development process;
- the requirements for subsequent provision of products and services;
- the level of control expected for the design and development process by customers and other relevant interested parties;
- the documented information needed to demonstrate that design and development requirements have been met.
