质量管理体系 要求GB/T 19001-2016 8.5.1 生产和服务提供的控制 中英文对照
质量管理体系 要求GB/T 19001-2016 8.5.1 生产和服务提供的控制中英文对照
8.5 生产和服务提供
更新日期:2024-07-19
8.5.1 生产和服务提供的控制
组织应在受控条件下进行生产和服务提供。适用时,受控条件应包括:
- 可获得形成文件的信息,以规定以下内容:
- 所生产的产品、提供的服务或进行的活动的特性;
- 拟获得的结果。
- 可获得和使用适宜的监视和测量资源;
- 在适当阶段实施监视和测量活动,以验证是否符合过程或输出的控制准则以及产品和服务的接收准则;
- 为过程的运行提供适宜的基础设施和环境;
- 配备具备能力的人员,包括所要求的资格;
- 若输出结果不能由后续的监视或测量加以验证,应对生产和服务提供过程实现策划结果的能力进行确认,并定期再确认;
- 采取措施防范人为错误;
- 实施放行、交付和交付后活动。
8.5.1 Control of production and service provision
The organization shall implement production and service provision under controlled conditions.
Controlled conditions shall include, as applicable:
- the availability of documented information that defines:
- the characteristics of the products to be produced, the services to be provided, or the activities to be performed;
- the results to be achieved;
- the availability and use of suitable monitoring and measuring resources;
- the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;
- the use of suitable infrastructure and environment for the operation of processes;
- the appointment of competent persons, including any required qualification;
- the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
- the implementation of actions to prevent human error;
- the implementation of release, delivery and post-delivery activities.