质量管理体系及其过程

4.4.2 在必要的范围和程度上，组织应：

a.保持形成文件的信息以支持过程运行；

b.保留确信其过程按策划进行的形成文件的信息

组织应建立和保持形成文件的信息以包含：

——相关方（见4.2 a）的概述；

——质量管理体系的范围，包括边界和适用性（见4.3）；

——质量管理体系所需过程的描述及其在整个组织中的应用；

——过程之间的相互关系；过程职责和权限的分配。

注：上述质量管理体系的描述可以编制为一份单一的形成文件的信息，参考质量手册。

4.4.2 To the extent necessary, the organization shall:

a. maintain documented information to support the operation of its processes;

b. retain documented information to have confidence that the processes are being carried out as planned.

The organization shall establish and maintain documented information that includes:

—— a general description of relevant interested parties (see 4.2 a);

—— the scope of the quality management system, including boundaries and applicability (see 4.3);

—— a description of the processes needed for the quality management system and their application throughout the

organization;

——the sequence and interaction of these processes; assignment of the responsibilities and authorities for these processes.

NOTE: The above description of the quality management system can be compiled into a single source of documented information and referred to as a quality manual.