ISO9001：2008有关文件的术语6条。 　　
ISO9001: 2008 relevant documents terms 6.
7．1 信息：有意义的数据 　　
7.1: meaningful data information
★7．2 文件：信息及其承载媒体 　　
Of 7.2 files: information and its supporting medium
示例：记录、规范、程序文件、图样、报告、标准。 　　
Example: recording, norms, procedures, drawings, reports, standard.
注1：媒体可以是纸张，计算机磁盘、光盘或其他电子媒体，照片或标准样品，或它们的组合。 　　
Note 1: media can be paper, computer disk, CD or other electronic media, photos or standard sample, or a combination of them.
注2：一组文件，如若干个规范和记录，通常被称为“documentation”。 　　
Note 2: a group of documents, such as specifications and records, is often referred to as" documentation".
注3：某些要求（如易读的要求）与所有类型的文件有关；然而对规范（如修订受控的要求）和记录（如可检索的要求）可以有不同的要求。 　　
Note 3: certain requirements ( such as accessibility requirements) and all types of documents; however the norms ( such as the requirement to be revision controlled) and recorded ( such as retrieval requirements) can have different requirements.
7．3 规范：阐明要求的文件 　　
Specification 7.3: document stating requirements
注：规范可能与活动有关（如：程序文件、过程规范和试验规范）或与产品有关（如：产品规范、性能规范和图样）。 　　
Note: the norm may be associated with the activity ( such as: program files, process specification and test specification ) or associated with the products ( such as: product specification, performance specification and drawing ).
★7．4 质量手册：规定组织质量管理体系的文件 　　
In 7.4 the quality manual: regulation of the quality management system documentation
注：为了适应组织的规模和复杂程度，质量手册在其详略程度和编排格式方面可以不同。 　　
Note: in order to adapt to the organization's size and complexity, the quality manual in detail and format can be different.
7．5 质量计划：对特定的项目、产品、过程或合同，规定由谁及何时应使用哪些程序）和相关资源的文件 　　
7.5: quality plan for specific project, product, process or contract provisions, by whom and when should use what procedures ) and associated resource file
注1：这些程序通常包括所涉及的那些质量管理过程和产品实现过程。 　　
Note 1: these programs usually include those referring to quality management process and product realization process.
注2：通常，质量计划引用质量手册的部分内容或程序文件。 　　
Note 2: usually, quality plan reference to parts of the quality manual and procedure documents.
注3：质量计划通常是质量策划的结果之一。 　　
Note 3: quality plan is generally one of the results of quality planning.
★7．6 记录 :阐明所取得的结果或提供所完成活动的证据的文件 　　
On 7.6 records: stating results achieved or providing evidence of activities performed file
注1：记录可用于为可追溯性提供文件，并提供验证、预防措施和纠正措施的证据。 　　
Note 1: records can be used for traceability documentation, validation, and provide preventive measures and corrective action evidence.
注2：通常记录不需要控制版本。 　　
Note 2: usually records need not control version.