ISO/TC 176/SC 2/N 525R2关于“文件”的解释（中文版对照）

Document: ISO/TC 176/SC 2/N 525R2

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Secretariat of ISO/TC 176/SC 2 Date: 15 October 2008




ISO 9000 Introduction and Support Package: （略）
Guidance on the Documentation Requirements of ISO 9001:2008

In conjunction with the publication of the International Standard ISO 9001:2008, ISO/TC 176/SC 2 has published a number of guidance modules:

§ Guidance on ISO 9001:2008 Sub-clause 1.2 'Application'
§ Guidance on the Documentation requirements of ISO 9001:2008
§ Guidance on the Terminology used in ISO 9001 and ISO 9004
§ Guidance on the Concept and Use of the Process Approach for management systems
§ Guidance on 'Outsourced Processes'


Together these are being made available as the ISO/TC 176/SC 2 “ISO 9000 Introduction and Support Package”.

Feedback from users of the standards will be used to determine whether additional modules should be developed, or if these published modules should be revised.

The modules, and further information on the ISO 9001:2008 standard, may be downloaded from the following web sites:

www.iso.org
www.iso.org/tc176/sc2


C Corrie
For the BSI Secretariat of
ISO/TC 176/SC 2



1 Introduction 简介

Two of the most important objectives in the revision of the ISO 9000 series of standards have been
标准ISO 9000族修订本的两个最重要的目标：
a) to develop a simplified set of standards that will be equally applicable to small as well as medium and large organizations, and 制定简化标准适用于大中型组织
b) for the amount and detail of documentation required to be more relevant to the desired results of the organization’s process activities. 文件的数量和细节更贴近组织过程活动的策划结果

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.
ISO 9001:2008质量管理体系——要求已经实现这些目标，本指导的目的是解释新标准文件方面的明确的意图。
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允许组织在选择记录质量管理体系（QMS）的方法更具灵活性。这使每个组织制定最少量的证明有效策划、运行和控制过程和实施以及持续改进QMS有效性所需的文件数量。
It is stressed that ISO 9001 requires (and always has required) a “Documented quality management system”, and not a “system of documents”.
强调ISO 9001需要“文件化的质量管理体系，而不是文件体系。

2 What is a “document”? - Definitions and references 什么是文件？定义和参考书目

The following are some of the main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS;
以下是些组织文件化的主要目的，与是否实施正式的QMS无关。
a) Communication of Information 信息沟通

• 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.
• 作为信息传递和沟通的方法。文件类型和范围取决于组织产品和过程，沟通体系的正式性程度和组织内沟通技巧水平，以及组织文化。

b) Evidence of conformity 符合性证据

• provision of evidence that what was planned, has actually been done.
• 提供策划好了并已经完成的证据

c) Knowledge sharing 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.
• 传播和保护组织经验。典型的例子是技术规范，可以作为新产品设计开发的基础。

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:
附则A是与文件有关的常用术语表（摘自ISO 9000:2005）。必须强调的是，根据ISO 9001:2008的4.2条款文件要求规定，文件可以是媒介的任何形式或类型，ISO 9000:2005的3.7.2条款里文件的定义给出了以下例子：

• paper 纸张
• magnetic 磁带
• electronic or optical computer disc 电子的或光学的计算机盘
• photograph 照片
• master sample 标准样件

Users are also referred to ISO/TR 10013 Guidelines for quality management systems documentation for further guidance.
读者也可参阅ISO/TR 10013质量管理体系文件指南。

3 ISO 9001:2008 Documentation Requirements 文件要求

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”
ISO 9001:2008 4.1条款“总要求”要求组织“应按本标准的要求建立质量管理体系，形成文件，加以实施和保持，并持续改进其有效性。”
Clause 4.2.1 General explains that the quality management system documentation shall include:
4.2.1总则解释到质量管理体系应包括：
a) documented statements of a quality policy and quality objectives; 形成文件的质量方针和质量目标；
b) a quality manual质量手册；
c) documented procedures required by this International Standard本标准所要求的形成文件的程序
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and组织确定的为确保其过程有效策划、运作和控制所需的文件
e) records required by this International Standard; 本标准要求的记录

The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:
4.2条款后面的注释清晰说明了标准特别要求的“形成文件的程序”，即建立该程序，形成文件，并加以实施和保持。同时强调QMS文件的内容因以下因素而不同:

• the size of organization and type of activities; 组织的规模和活动的类型；
• the complexity of processes and their interactions, and过程及其相互作用的复杂程度；
• the competence of personnel. 人员的能力。

All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.
所有构成QMS一部分的文件都必须按照4.2.3条款之规定受控，对于一些特定记录按照4.2.4条款之规定受控。

4 Guidance on Clause 4.2 of ISO 9001:2008 4.2 条款指南

The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.
以下内容是帮助ISO 9001的用户理解标准文件的一般性要求
a) Documented statements of a quality policy and objectives: 质量方针和目标的文件化陈述

• Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3. 对质量方针要求的规定在5.3条款里。文件化的质量方针必须按照4.2.3的要求进行控制。Note Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g). 注：第一次或者为了满足ISO 9001:2008修订要求而正在修订质量方针的组织应特别注意4.2.3条款的（c），（d）和（g）项。
• Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3. 质量目标要求的规定在5.4.1条款里。这些文件化的质量目标也受4.2.3要求的文件控制的约束。

b) Quality Manual: 质量手册

• Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS 4.2.2条款规定了质量手册最少的内容。质量手册的格式和结构由每个组织依据组织规模，文化和复杂程度自己来决定。某些组织可以选择使用质量手册用于QMS简化目的以外的其他目的。
• A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard. 小型组织发现囊括用单一的手册整个QMS的描述，包括标准要求的全部文件化的程序是适宜的。
• Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation. 大型跨国组织可能需要若干个手册用于全球，国家或地区级别，而且拥有复杂的文件结构。
• The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3. 质量手册必须按照4.2.3的要求受控

c) Documented procedures: 文件化的程序

• ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities: ISO 9001:2008特别要求组织制定文件化的程序用于以下六项活动：

§ 4.2.3 Control of documents 文件控制
§ 4.2.4 Control of records 记录控制
§ 8.2.2 Internal audit 内审
§ 8.3 Control of nonconforming product 不合格品控制
§ 8.5.2 Corrective action 纠正措施
§ 8.5.3 Preventive action 预防措施

• These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3 这些文件化的程序必须按照4.2.3的要求受控
• Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable. 许多组织发现把若干个活动组合成一个文件化的程序（例如纠正措施和预防措施）很方便。其他组织可以用多个文件化的程序记录活动（例如内审）。这两种方法都是可以接受的。
• Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS. 某些组织（特别是大型组织，或其他具有较复杂过程的组织）可能需要额外的文件化程序（特别是那些与产品实现过程有关的程序）来实施有效的QMS。
• Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented. 其它组织可能需要额外的程序，但是组织的规模和/或文化可以有效地实施这些程序，没有必要建立文件。但是为了证明符合ISO 9001：2008，组织须提供客观证据（没必要是文件）证明已经有效的实施了QMS。

d) Documents needed by the organization to ensure the effective planning, operation and control of its processes: 组织用于保证有效的策划、运行和控制过程所需的文件：

• In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are: 组织为了证明QMS的有效实施，有必要制定文件而非文件化的程序。但是，ISO 9001:2008特别提到的文件有：

§ Quality policy (clause 4.2.1.a) 质量方针
§ Quality objectives (clause 4.2.1.a) 质量目标
§ Quality manual (clause 4.2.1.b) 质量手册

• There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include: 还有许多ISO9001:2008要求，其中组织可以通过准备其他文件来为其QMS增值，并证明其符合性，尽管标准没有特别要求。例子包括：

§ Process maps, process flow charts and/or process descriptions 过程图，流程图和/或过程描述
§ Organization charts 组织结构图
§ Specifications 规范
§ Work and/or test instructions 作业指导书和/或测试指导书
§ Documents containing internal communications 包含内部沟通的文件
§ Production schedules 生产计划
§ Approved supplier lists 合格供应商名单
§ Test and inspection plans 试验检查计划
§ Quality plans 质量计划

• All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable 这样的文件必须按照4.2.3和/或4.2.4的要求受控

e) Records: 记录

• Examples of records specifically required by ISO 9001:2008 are presented in Annex B. 附则B是ISO9001:2008特别要求的记录的例子
• Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system. 组织不必制定证明过程、产品和质量管理体系符合性方面的其它记录
• Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008. 记录控制要求依文件的不同而不同，所有记录必须按照4.2.4的要求受控

5 Organizations preparing to implement a QMS 准备实施QMS的组织

For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008, the following comments may be useful.
对于那些处于QMS实施阶段并且希望满足ISO9001:2008要求的组织，以下建议或许有帮助：

• For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes: 对于处在实施过程或打算实施QMS的组织，ISO9001:2008确定过程方法。包括：

§ Identifying the processes necessary for the effective implementation of the quality management system 识别为有效实施质量管理体系所必要的过程
§ understanding the interactions between these processes. 理解这些间的相互作用
§ documenting the processes to the extent necessary to assure their effective operation and control. (It may be appropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)就这些过程形成必要的文件，以保证有效的运行和控制。（使用过程图法记录过程是适宜的。但这种方法强调文件化过程图不是ISO9001:2008要求的）

• These processes include the management, resource, product realization and measurement processes that are relevant to the effective operation of the QMS. 这些过程包括与有效运行QMS有关的管理，资源，产品实现和测量过程
• Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that drives the processes. 过程分析应该侧重于在考虑了ISO9001:2008的要求后所确定质量管理体系所需文件的数量。过程分析不是制定过程的记录

6 Organizations wishing to adapt an existing QMS 希望采用现有的QMS的组织

For organizations that currently have a QMS the following comments are intended to assist in understanding the changes to documentation that may be required or facilitated by the transition to ISO 9001:2008. 对于目前已有QMS的组织，以下建议试图帮助理解改变文件适应ISO 9001:2008.

• An organization with an existing QMS should not need to rewrite all of its documentation in order to meet the requirements of ISO 9001:2008. This is particularly true if an organization has structured its QMS based on the way it effectively operates, using a process approach. In this case, the existing documentation may be adequate and can be simply referenced in the revised quality manual. 已有QMS的组织没必要重写全部文件，以满足ISO 9001:2008的要求。这是非常正确的，如果组织已经用过程方法有效的运行其QMS。
• An organization that has not used a process approach in the past will need to pay particular attention to the definition of its processes, their sequence and interaction. 过去没有使用过程方法的组织需要特别注意其过程的定义，次序和相互作用。
• An organization may be able to carry out some simplification and/or consolidation of existing documents, in order to simplify its QMS. 组织可以简化和/或合并现有的文件，以便简化其QMS.

7 Demonstrating conformity with ISO 9001:2008 证明符合ISO 9001:2008

For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.
对于那些希望证明符合ISO 9001:2008要求的组织，认证/登记，合同或其它原因，记住提供有效实施QMS的证据是十分重要的。

• Organizations may be able to demonstrate conformity without the need for extensive documentation. 组织可以证明其符合性，而不需要增加其文件。
• To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.” 声称符合ISO 9001:2008，组织须提供过程和质量管理体系有效性方面的证据。ISO 9000:2005 3.8.1规定“客观证据”是“支持事物存在或其真实性的证据”，并说明“客观证据可以通过观察，测量，试验或其它方法获得”。
• Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d) Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence. 客观证据没必要依据文件化的程序、记录或其他文件（ISO 9001:2008要求的除外）而独立存在，在某些情况下，（例如7.1（d）产品实现策划，和8.2.4产品的监控与测量），由组织决定什么样的记录是必须的，以提供客观证据。
• Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes. 当组织对于特定的活动没有特定内部程序，并且不是本标准要求的时候，（例如5.6管理评审），将这种活动作为ISO9001:2008相关条款的根据，是可以接受的。在那些情况下，内外审可以使用ISO 9001:2008的内容进行符合性评价之目的。

Annex A

Terms and Definitions relating to Documents
文件相关的术语和定义

The following terms and definitions are taken from ISO 9000:2005:





Term

ISO 9000:2005 Clause

Definition


Document
文件

3.7.2

information and its supporting medium



Procedure
程序

3.4.5

specified way to carry out an activity or a process (Note: Procedures can be documented or not)


Quality Manual
质量手册

3.7.4

document specifying the quality management system of an organization


Quality Plan
质量计划

3.7.5

document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract


Record
记录

3.7.6

document stating results achieved or providing evidence of activities performed


Specification
规范

3.7.3

document stating requirements



Annex B

Records required by ISO 9001:2008






Clause

Record required 所需的记录


5.6.1

Management reviews


6.2.2 e)

Education, training, skills and experience


7.1 d)

Evidence that the realization processes and resulting product fulfil requirements


7.2.2

Results of the review of requirements related to the product and actions arising from the review


7.3.2

Design and development inputs relating to product requirements


7.3.4

Results of design and development reviews and any necessary actions


7.3.5

Results of design and development verification and any necessary actions


7.3.6

Results of design and development validation and any necessary actions


7.3.7

Results of the review of design and development changes and any necessary actions


7.4.1

Results of supplier evaluations and any necessary actions arising from the evaluations


7.5.2 d)

As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement


7.5.3

The unique identification of the product, where traceability is a requirement


7.5.4

Customer property that is lost, damaged or otherwise found to be unsuitable for use


7.6 a)

Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist


7.6

Validity of the previous measuring results when the measuring equipment is found not to conform to requirements


7.6

Results of calibration and verification of measuring equipment


8.2.2

Internal audit results and follow-up actions


8.2.4

Indication of the person(s) authorizing release of product.


8.3

Nature of the product nonconformities and any subsequent actions taken, including concessions obtained


8.5.2 e)

Results of corrective action


8.5.3 d)

Results of preventive action