7.5.1、总则

组织的质量管理体系应包括：

a）本标准要求的成文信息；

b）组织所确定的、为确保质量管理体系有效性所需的成文信息。

注：对于不同组织，质量管理体系成文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；

—— 过程及其相互作用的复杂程度；

—— 人员的能力。

7.5.2 创建与更新

在创建和更新成文信息时，组织应确保适当的：

a）标识和说明（如标题、日期、作者、索引编号）；

b）形式（如语言、软件版本、图表）和载体（如纸质的、电子的）；

c）针对适宜性和充分性的评审和批准。

注：“批准”还隐含着组织已经定义了与各种不同类型的成文信息相对应的授权人员和批准方法。

7.2.1、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.

7.2.2、Creating and Updating

When creating and updating documented information, the organization shall ensure appropriate:

a. identification and description (e.g., a title, date, author, or reference number);

b. format (e.g., language, software version, graphics) and media (e.g., paper, electronic);

c. review and approval for suitability and adequacy.

NOTE: Approval implies authorized persons and approval methods are identified for the relevant types of documented information, as determined by the organization.