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ISO9001： 2008 文件 要求 指南
Guidance on the documentation requirements of ISO 9001:2008
Document: ISO/TC 176/SC 2/N525R2 October 2008
1. Introduction
1. 引言
Two of the most important objectives in the revision of the ISO 9000 series of
standards have been.
已 修订 的 ISO 9000 系列标准有两个最重要的目标：
to develop a simplified set of standards that will be equally applicable to small as well
as medium and large organizations, and
for the amount and detail of documentation required to be more relevant to the desired
results of the organization’s process activities.
a) 建立一套 简 明 的标准 ， 以 同时 适用于小型 、 中 型和 大型组织，以及
b) 文件化数量和详 略 程度 必需 更加 同 组织 的 过程活动 所期望的 结果 相关 。
ISO 9001:2008, Quality management systems – Requirements has achieved these
objectives, and the purpose of this additional guidance is to explain the intent of the
new standard with specific regard to documentation.
2008 版 ISO 9001《质量管理体系 要求》已经达到了这些目的，本附加指南专门从文
件化方面 解释 新版标准的意图。
ISO 9001:2008 allows an organization flexibility in the way it chooses to document its
quality management system (QMS This enables each individual organization to
develop the minimum amount of documentation needed in order to demonstrate the
effective planning, operation and control of its processes and the implementation and
continual improvement of the effectiveness of its QMS.
ISO 9001:2008 让组织在选择用什么文件描述质量管理体系时可更加灵活了。这样，可
以让每个组织能用最少数量的文件来展示有效的策划、运作和控制各种过程并加以贯彻
实施和持续改进质量管理体系的有效性。
It is stressed that ISO 9001 requires (and always has required) a “Documented quality
management system”, and not a “system of documents”.
必须强调 ISO 9001:2008 要求（ 并且 一直如此要求） “ 文件化的质量管理体系 ”而不是
一个 “文件 体系 ”。
2． What is a “document”? - Definitions and references
2． 什么叫 “文件 ” ? －术语和 参考 资料
The following are some of the main objectives of an organization’s documentation,
independent of whether or not it has implemented a formal QMS；
以下是 一个 组织文件化的 一 些主要目的，不管这个组织是否已经贯彻实施一个正式的质
量管理体系：
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a) Communication of Information
a) 沟通信息
as a tool for information transmission and communication. The type and extent of the
documentation will depend on the nature of the organization’s products and processes,
the degree of formality of communication systems and the level of communication
skills within the organization, and the organizational culture.
文 件作为信息传递和沟通的一种工具。文件化的型式和程度将取决于组织 产品和过程的
类型 、沟通系统的 正规化 程度、沟通技能的水平以及组织的文化。
b) Evidence of conformity
b)符合性的证据
provision of evidence that what was planned, has actually been done.
提供证据证明已经策划 且 实际上已 完成 了什么 。
c) Knowledge sharing
c)知识 共 享
to disseminate and preserve the organization’s experiences. A typical example would
be a technical specification, which can be used as a base for design and development
of a new product.
为了传播并保留组织的经验。典型的例子 比 如技术规范可以用来作为设计和开发新产品
的基础。
A list of commonly used terms relating to documentation is presented in Annex A
(taken from ISO 9000:2005 It must be stressed that, according to ISO 9001:2008
clause 4.2 Documentation requirements documents may be in any form or type of
medium, and the definition of “document” in ISO 9000:2005 clause 3.7.2 gives the
following examples:
附录 A 列出了常用的与文件有关的各种术语（录自 ISO 9000:2005 ）。必须重点说明，
根据 ISO 9001:2008 4. 2 条 “ 文件化的要求 ” 规定，文 件可以用 任何 形式或 类型的 媒
体 ，根据 ISO 9000:2005 第 3.7.2 条对 “ 文件 ” 所下定义中列出的例子有：
paper 纸；
magnetic 磁 性 的；
electronic or optical computer disc 电子媒体或 计算机光盘；
photograph 照 片 ；
master sample 标准样 品 。
Users are also referred to ISO/TR 10013:2001, Guidelines for quality management
systems documentation for further guidance.
使用 者可以进一步参阅 ISO/TR 10013《质量管理体系 文件指南》。
3． ISO 9001:2008 Documentation Requirements
3． ISO9001： 2008 文件化要求
ISO 9001:2008 clause 4.1 General requirements requires an organization to
“establish, document, implement, and maintain a quality management system and
continually improve its effectiveness in accordance with the requirements of this
International Standard”
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