质量管理体系 要求GB/T 19001-2016 8.1 运行的策划和控制 中英文对照

质量管理体系 要求GB/T 19001-2016 8.1 运行的策划和控制中英文对照

8 运行

更新日期:2024-07-19
8.1 运行的策划和控制

为满足产品和服务提供的要求,并实施第6章所确定的措施,组织应通过以下措施对所需的过程(见4.4)进行策划、实施和控制:

  • 确定产品和服务的要求;
  • 建立下列内容的准则:
    • 过程;
    • 产品和服务的接收。
  • 确定符合产品和服务要求所需的资源;
  • 按照准则实施过程控制;
  • 在必要的范围和程度上,确定并保持、保留形成文件的信息:
    • 确信过程已经按策划进行;
    • 证实产品和服务符合要求。

策划的输出应适合组织的运行需要。

组织应控制策划的变更,评审非预期变更的后果,必要时,采取措施减轻不利影响。

组织应确保外包过程受控(见8.4)。

8.1 Operational planning and control

The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by:

  • determining the requirements for the products and services;
  • establishing criteria for:
    • the processes;
    • the acceptance of products and services;
  • determining the resources needed to achieve conformity to the product and service requirements;
  • implementing control of the processes in accordance with the criteria;
  • determining, maintaining and retaining documented information to the extent necessary:
    • to have confidence that the processes have been carried out as planned;
    • to demonstrate the conformity of products and services to their requirements.

The output of this planning shall be suitable for the organization’s operations.

The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

The organization shall ensure that outsourced processes are controlled (see 8.4).

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