7.5 形成文件的信息

7.5.1、总则

组织的质量管理体系应包括：

a. 本标准要求的形成文件的信息；

b. 组织确定的为确保质量管理体系有效性所需的形成文件的信息；

注：对于不同组织，质量管理体系形成文件的信息的多少与详略程度可以不同，取决于：

——组织的规模，以及活动、过程、产品和服务的类型；

——过程的复杂程度及其相互作用；

——人员的能力。

7.5.1、General

The organization’s quality management system shall include:

a. documented information required by this International Standard;

b. documented information determined by the organization as being necessary for the effectiveness of the quality management system.

NOTE The extent of documented information for a quality management system can differ from one organization to another due to:

—— the size of organization and its type of activities, processes, products and services;

—— the complexity of processes and their interactions;

—— the competence of persons.