4.4.2、在必要的程度上，组织应：

a）保持成文信息以支持过程运行；

b）保留成文信息以确信其过程按策划进行。

组织应建立和维护包括下列内容的成文信息：

—— 相应相关方的通用描述（见 4.2a）；

—— 质量管理体系的范围，包括边界和适用性（见 4.3）；

—— 质量管理体系所需的过程和其在组织中应用的描述；

—— 这些过程的次序和关系；

—— 这些过程的职责分配和权限；

—— 为质量管理体系而建立或者引用的文件的信息。

注：上述对质量管理系统的描述可以整合进一个成文信息中，一般称为质量手册。

4.1.1、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.