质量管理体系 要求GB/T 19001-2016 8.3.3 设计和开发输入 中英文对照
质量管理体系 要求GB/T 19001-2016 8.3.3 设计和开发输入中英文对照
8.3 产品和服务的设计和开发
更新日期:2024-07-19
8.3.3 设计和开发输入
组织应针对所设计和开发的具体类型的产品和服务,确定基本的要求。组织应考虑:
- 功能和性能要求;
- 来源于以前类似设计和开发活动的信息;
- 法律法规要求;
- 组织承诺实施的标准或行业规范;
- 由产品和服务性质所决定的、失效的潜在后果。
设计和开发输入应满足设计和开发的目的,且应完整、清楚。
应解决相互冲突的设计和开发输入。
组织应保留有关设计和开发输入的形成文件的信息。
8.3.3 Design and development inputs
The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider:
- functional and performance requirements;
- information derived from previous similar design and development activities;
- statutory and regulatory requirements;
- standards or codes of practice that the organization has committed to implement;
- potential consequences of failure due to the nature of the products and services.
Inputs shall be adequate for design and development purposes, complete and unambiguous.
Conflicting design and development inputs shall be resolved.
The organization shall retain documented information on design and development inputs.