成都ISO9000認(rèn)證 ISO9001：2008標(biāo)準(zhǔn)文件化要求的貫徹指南

ISO9001：2008標(biāo)準(zhǔn)文件化要求的貫徹指南

Introduction and support package:

Guidance on the documentation requirements of ISO 9001:2008

document: ISO/TC 176/SC 2/N525R2

October 2008

1. Introduction 引言

Two of the most important objectives in the revision of the ISO 9000

series of standards have been

這次ISO 9000系列標(biāo)準(zhǔn)修訂的目的中有兩個(gè)最重要的目標(biāo)：

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) 使文件化形式簡(jiǎn)化，適用于小型，同時(shí)也適用于中、大型組織，以及

b) 要求文件化數(shù)量和詳盡程度更加和組織的各個(gè)過(guò)程活動(dòng)結(jié)果聯(lián)系起來(lái)。

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《質(zhì)量管理體系要求》已經(jīng)達(dá)到了這些目的，本附加指南專門從文件化方面說(shuō)明新版標(biāo)準(zhǔn)的意圖。

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

讓組織在選擇用什么文件描述質(zhì)量管理體系時(shí)可更加靈活了。這樣，可以讓每個(gè)組織能用最少數(shù)量的文件來(lái)展示有效的策劃、運(yùn)作和控制各種過(guò)

程并加以貫徹實(shí)施和持續(xù)改進(jìn)質(zhì)量管理體系的有效性。

It is stressed that ISO 9001 requires (and always has required) a

“documented quality management system”, and not a “system of

documents”.

必須強(qiáng)調(diào)指出，ISO 9001:2008 要求（過(guò)去一直如此要求）“ 文件化的質(zhì)量管理體系 ”而不是一個(gè)“文件的體系”。

2 What is a “document”? - Definitions and references

什么叫“文件” ? －術(shù)語(yǔ)和定義

The following are some of the main objectives of an organization’s

documentation, independent of whether or not it has implemented a

formal QMS;

以下是一個(gè)組織為什么要文件化的某些主要目的，不管這個(gè)組織是否已經(jīng)貫徹實(shí)施一個(gè)正式的質(zhì)量管理體系：

a) Communication of Information 溝 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.

a)文件作為信息傳遞和溝通的一種工具。文件化的型式和程度將取決于組織所生產(chǎn)產(chǎn)品和采用過(guò)程的性質(zhì)、組織內(nèi)部相互溝通系統(tǒng)的格式化程度、溝通技能的水平以

及組織的文化。

b) Evidence of conformity

提供符合性的證據(jù)

provision of evidence that what was planned, has actually been

done.——

提供證據(jù)證明已經(jīng)做過(guò)策劃，實(shí)際上已經(jīng)按照策劃做過(guò)了什么工作，結(jié)果如何。

c) Knowledge sharing 分享知識(shí)

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.

為了傳播并保留組織的經(jīng)驗(yàn)。典型的例子譬如技術(shù)規(guī)范可以用來(lái)作為設(shè)計(jì)和開發(fā)新

產(chǎn)品的基礎(chǔ)。

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:

附錄 A 列出了常用的與文件有關(guān)的各種術(shù)語(yǔ)（錄自ISO 9000:2005 ）。必須重點(diǎn)說(shuō)明，根據(jù)ISO 9001:2008 4. 2

條“文件化的要求”規(guī)定，文件可以用各種形式或各種媒介，根據(jù)ISO 9000:2000 第3.7.2條對(duì)文件所下定義中列出的例子有：

paper 紙的；

magnetic 磁的；

electronic or optical computer disc 計(jì)算機(jī)用的磁盤或者光盤；

photograph 照相；

sample標(biāo)準(zhǔn)樣件。

Users are also referred to ISO/TR 10013:2001, Guidelines for quality

management systems documentation for further guidance.

讀者可以進(jìn)一步參閱ISO/TR 10013《質(zhì)量管理體系文件化指南》。

3 ISO 9001:2008 documentation Requirements

ISO9001：2008對(duì)文件化的要求

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”

ISO9001：2008標(biāo)準(zhǔn)第4.1條總的要求中要求組織“按照本國(guó)際標(biāo)準(zhǔn)的各項(xiàng)要求建立、文件化、執(zhí)行和維持質(zhì)量管理體系和持續(xù)改進(jìn)體系的有效性?！?/P>

Clause 4.2.1 General explains that the quality management system

documentation shall include:

ISO9001：2008第4.2.1條總的解釋質(zhì)量管理體系文件化應(yīng)包括：

documented statements of a quality policy and quality objectives;

a quality manual

形成文件的質(zhì)量方針和目標(biāo)；

documented procedures required by this International Standard

documents needed by the organization to ensure the effective

planning, operation and control of its processes, and

records required by this International Standard;

國(guó)際標(biāo)準(zhǔn)要求形成文件的程序以及組織為了確保他們的各個(gè)過(guò)程有效策劃、運(yùn)作和控制而必須形成文件化的程序；

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:

國(guó)際標(biāo)準(zhǔn)第4.2條后面有一個(gè)注，清楚說(shuō)明，凡是標(biāo)準(zhǔn)規(guī)定要“形成文件的程序”，那么，這個(gè)程序必須建立，形成文件，執(zhí)行和維持這個(gè)程序。它還強(qiáng)調(diào)，組織和組織之間的質(zhì)量管理體系文件化的程度可以根據(jù)以下情況是不同的。

the size of organization and type of activities; 組織的規(guī)模和活動(dòng)的類型；

the complexity of processes and their interactions, and

過(guò)程的復(fù)雜性以及過(guò)程和過(guò)程相互作用，和

the competence of personnel. 人員的勝任能力；

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.

所有形成質(zhì)量管理體系組成部分的各種文件都必須按照ISO9001：2008標(biāo)準(zhǔn)第4.2.3條要求加以控制，或者，各種特定的記錄，按照第4.2.4條要求加以控制。

4 Guidance on Clause 4.2 of ISO 9001:2008

ISO9001：2008標(biāo)準(zhǔn)第4.2條要求的輔導(dǎo)

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.

以下內(nèi)容是幫助標(biāo)準(zhǔn)使用者理解ISO9001：2008文件化要求總的意圖：

a) documented statements of a quality policy and objectives:

質(zhì)量方針和各種目標(biāo)要用文件來(lái)闡明

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.

質(zhì)量方針要符合ISO9001：2008標(biāo)準(zhǔn)第5.3條規(guī)定的要求。要形成文件，按照第4.2.3條要求加以控制。

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：凡是第一次對(duì)他們的質(zhì)量方針進(jìn)行評(píng)審的組織，或者看了ISO9001：2008的補(bǔ)充解釋而對(duì)他們的質(zhì)量方針進(jìn)行評(píng)審的組織，特別要注意滿足第4.2.3條c）d）和g）這幾條要求。

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.

對(duì)質(zhì)量目標(biāo)的要求在標(biāo)準(zhǔn)第5.4.1條中有規(guī)定。這些形成文件的質(zhì)量目標(biāo)也必須按照標(biāo)準(zhǔn)第4.2.3條要求加以控制。

b) Quality Manual: 質(zhì)量手冊(cè)

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

標(biāo)準(zhǔn)ISO9001：2008第4.2.2條規(guī)定了質(zhì)量手冊(cè)最少必須要有的內(nèi)容。質(zhì)量手冊(cè)的格式和結(jié)構(gòu)由各個(gè)組織自己來(lái)決定，取決于組織規(guī)模、文化和復(fù)雜性。某些組織除了把質(zhì)量手冊(cè)作為描述他們的質(zhì)量管理體系以外，還可以作為其他各種用途。

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.

小型組織可以采用一份簡(jiǎn)單的質(zhì)量手冊(cè)就能用來(lái)描述他們整個(gè)質(zhì)量管理體系，其中包括標(biāo)準(zhǔn)規(guī)定必須要有的形成文件的各個(gè)程序。

Large, multi-national organizations may need several manuals at the

global, national or regional level, and a more complex hierarchy of

documentation.

The quality manual is a document that has to be controlled in

accordance with the requirements of clause 4.2.3.

大型、跨國(guó)的組織也許需要幾份手冊(cè)，譬如，全球的、國(guó)家的或者地區(qū)的，更加復(fù)雜的不同層次的文件。質(zhì)量手冊(cè)是一份必須按照標(biāo)準(zhǔn)第4.2.3條要求加以控制的文件。

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:

ISO9001：2008規(guī)定組織必須要有以下六和活動(dòng)的“形成文件的程序”：

4.2.3 Control of documents文件控制的程序

4.2.4 Control of records記錄控制的程序

8.2.2 Internal audit內(nèi)審程序

8.3 Control of nonconforming product不合格品控制的程序

8.5.2 Corrective action糾正措施程序

8.5.3 Preventive action 程防措施程序

These documented procedures have to be controlled in accordance with

the requirements of clause 4.2.3

這些文件化程序必須按照標(biāo)準(zhǔn)第4.2.3條要求加以控制。

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.

有些組織也許發(fā)現(xiàn)把幾個(gè)活動(dòng)的程序組合起來(lái)，用一份文件（譬如，把糾正措施和預(yù)防措施和起來(lái)）。有的組織也許把某一要求文件化的程序的活動(dòng)用幾份文件化程序來(lái)描述（譬如，各種不同的內(nèi)審）。這兩種做法都是可以的。

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.

有些組織（特別是大型組織，或者那些復(fù)雜的組織）也許要求附加的文件化程序（特別是有產(chǎn)品實(shí)現(xiàn)有關(guān)的那些過(guò)程）來(lái)執(zhí)行質(zhì)量管理體系。

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.

另外一些組織，也許要求增加各種程序，但是，由于組織的規(guī)模和/或文化程度容許他們不用文件化也能有效執(zhí)行的。不過(guò)，為了展示符合ISO9001：2008要求，組織還是不得不提供客觀證據(jù)（不一定形成文件）來(lái)證明質(zhì)量管理體系已經(jīng)有效得到執(zhí)行。

d) documents needed by the organization to ensure the effective

planning, operation and control of its processes:

組織為了確保對(duì)他們的過(guò)程進(jìn)行有效策劃、運(yùn)作和控制所必須的各種文件：

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:

組織為了展示有效執(zhí)行他們的質(zhì)量管理體系，除了標(biāo)準(zhǔn)規(guī)定必須要文件化程序之外，也許有必要開發(fā)和編寫某些文件。但是，ISO9001：2008標(biāo)準(zhǔn)中特別提到的那些文件是：

- Quality policy (clause 4.2.1.a) 質(zhì)量方針（見4.2.1.a）

- Quality objectives (clause 4.2.1.a)質(zhì)量目標(biāo)（見4.2.1.a）

- Quality manual (clause 4.2.1.b) 質(zhì)量手冊(cè)（見4.2.1.b）

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:

ISO9001：2008標(biāo)準(zhǔn)有一些要求，凡是組織能給他們質(zhì)量管理體系增值，而且通過(guò)編寫其他文件來(lái)展示符合性的地方，盡管標(biāo)準(zhǔn)沒(méi)有特別規(guī)定要求這些文件，組織還是需要編寫的。舉例說(shuō)可能包括下列文件：

- Process maps, process flow charts and/or process

descriptions各種過(guò)程途徑、流程圖和/或過(guò)程說(shuō)明文件；

- Organization charts 組織機(jī)構(gòu)圖；

- Specifications 各種規(guī)范（譯者：規(guī)定要求的文件叫規(guī)范）；

- Work and/or test instructions 工作和/或試驗(yàn)指導(dǎo)書；

- documents containing internal communications內(nèi)部溝通的各種文件；

- Production schedules生產(chǎn)進(jìn)度計(jì)劃；

- Approved supplier lists 合格供方目錄；

- Test and inspection plans 各種試驗(yàn)和檢驗(yàn)計(jì)劃；

- Quality plans 各種質(zhì)量計(jì)劃。

All such documents have to be controlled in accordance with the

requirements of clause 4.2.3 and/or 4.2.4, as applicable

所有上述各種文件都必須加以控制，相應(yīng)的要符合標(biāo)準(zhǔn)第4.2.3和4.2.4條要求。

e) Records:

各種記錄：

Examples of records specifically required by ISO 9001:2008 are

presented in Annex B.

舉例說(shuō)，ISO9001：2008規(guī)定的各種記錄見附錄B。

Organizations are free to develop other records that may be needed

to demonstrate conformity of their processes, products and quality

management system.

組織可以自由開發(fā)其他各種，用來(lái)展示他們各種過(guò)程、產(chǎn)品和質(zhì)量管理體系的符合性所必需的記錄。

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.

對(duì)各種記錄的控制要求和對(duì)文件控制要求是不同的，所有記錄都必須按照ISO9001：2008第4.2.4條要求加以控制。

5 Organizations preparing to implement a QMS

對(duì)正在貫徹執(zhí)行質(zhì)量管理體系的各個(gè)組織

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.

對(duì)于正在貫徹執(zhí)行質(zhì)量管理體系過(guò)程中的各個(gè)組織，以及希望滿足ISO9001：2008要求的組織來(lái)說(shuō)，下列建議也許有用的：

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:

對(duì)于正在貫徹執(zhí)行質(zhì)量管理體系過(guò)程中的各個(gè)組織，或者現(xiàn)在還在貫徹質(zhì)量管理體系的組織，ISO9001：2008強(qiáng)調(diào)采用過(guò)程模式，這包括：

- Identifying the processes necessary for the effective

implementation of the quality management system

識(shí)別（譯者：應(yīng)當(dāng)確定）為了有效執(zhí)行質(zhì)量管理體系所必需要的各種過(guò)程；

- understanding the interactions between these processes.

理解這些過(guò)程之間的相互作用（譯者：應(yīng)當(dāng)確定相互順序和理解相互作用）；

- 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.)

把這些過(guò)程加以文件化，其必要的程度是為了確保這些過(guò)程有效運(yùn)作和得到有效控制。（這也許用過(guò)程圖來(lái)文件話描述是比較恰當(dāng)?shù)?，但是，要?qiáng)調(diào)指出，標(biāo)準(zhǔn)ISO9001：2008沒(méi)有規(guī)定一定要有文件化的過(guò)程圖）。

These processes include the management, resource, product

realization and measurement processes that are relevant to the

effective operation of the QMS.

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.

上面講的各種過(guò)程包括與質(zhì)量管理體系有效運(yùn)有關(guān)的管理者管理過(guò)程、資源提供和管理過(guò)程、產(chǎn)品實(shí)現(xiàn)過(guò)程和測(cè)量過(guò)程。對(duì)這些過(guò)程加以分析，根據(jù)ISO9001：2008的要求，應(yīng)當(dāng)能有力地定義哪些必須形成文件的數(shù)量。不應(yīng)當(dāng)用文件化反過(guò)來(lái)確定各種過(guò)程。

6 Organizations wishing to adapt an existing QMS

正打算利用現(xiàn)有質(zhì)量管理體系的組織

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

對(duì)那些現(xiàn)在已經(jīng)有質(zhì)量管理體系的組織，以下建議對(duì)幫助理解現(xiàn)在有的文件如何方便地滿足ISO9001：2008標(biāo)準(zhǔn)要求也許有幫助的：

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.

對(duì)那些現(xiàn)在已經(jīng)有質(zhì)量管理體系的組織，不應(yīng)當(dāng)為了滿足ISO9001：2008的要求而把所有文件從頭再改寫一遍。特別是一個(gè)組織已經(jīng)按照過(guò)程模式，有他們自己的結(jié)構(gòu)，正在有效地在運(yùn)作的組織。在這樣情況下，現(xiàn)在有的文件也許是充分滿足要求的，可以利用這些修改質(zhì)量手冊(cè)的機(jī)會(huì)，只要把這些文件在手冊(cè)中簡(jiǎn)單加以引用就可以了。

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.

如果一個(gè)組織，過(guò)去并沒(méi)有采用過(guò)程模式的話，需要特別注意確定他們的各個(gè)過(guò)程，這些過(guò)程的順序和相互作用了。

An organization may be able to carry out some simplification and/or

consolidation of existing documents, in order to simplify its QMS.

組織可以通過(guò)這次機(jī)會(huì)對(duì)現(xiàn)有的文件考慮能否加以簡(jiǎn)單化，以便簡(jiǎn)化他們的質(zhì)量管理體系。

7 Demonstrating conformity with ISO 9001:2008

關(guān)于展示對(duì)ISO9001：2008的符合性

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.

對(duì)于想展示符合ISO9001：2008標(biāo)準(zhǔn)各項(xiàng)要求的各個(gè)組織，譬如，為了通過(guò)認(rèn)證/注冊(cè)，合同或者其他理由，記住，必須提供有效執(zhí)行質(zhì)量管理體系的客觀證據(jù)。

Organizations may be able to demonstrate conformity without the need

for extensive documentation.

組織也許沒(méi)有必要用過(guò)分的文件化來(lái)展示執(zhí)行質(zhì)量管理體系的符合性。

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.”

為了聲明符合ISO9001：2008，組織不得不提供客觀證據(jù)來(lái)證明有效執(zhí)行各種過(guò)程和質(zhì)量管理體系。ISO9000：2005第3.8.1條對(duì)客觀證據(jù)的定義是，“支持客觀存在的，或者驗(yàn)證某些存在的各種數(shù)據(jù)?！倍矣幸粋€(gè)注：“客觀證據(jù)可以同觀察、測(cè)量、試驗(yàn)或者其他手段來(lái)獲得的”。

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.

客觀證據(jù)沒(méi)有必要一定要用形成文件的程序、記錄或者其他文件來(lái)做證的，當(dāng)然，ISO9001：2008標(biāo)準(zhǔn)特別規(guī)定的應(yīng)當(dāng)有。在某些情況下（譬如，第7.1.d《產(chǎn)品實(shí)現(xiàn)的策劃》和第8.2.4條《產(chǎn)品的監(jiān)視和測(cè)量》），完全由組織來(lái)確定，為了提供客觀證據(jù)，哪些記錄是必需要有的。

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.

凡是組織針對(duì)某一特定的活動(dòng)，沒(méi)有規(guī)定內(nèi)部用的程序，而且，標(biāo)準(zhǔn)也沒(méi)有要求一定要有文件的，（譬如，第5.6條《管理評(píng)審》），直接利用ISO9001：2008規(guī)定作為基礎(chǔ)來(lái)執(zhí)行這樣的活動(dòng)，也是可以的。在這些情況下，內(nèi)審或者外審可以直接利用標(biāo)準(zhǔn)ISO9001：2008的條文來(lái)評(píng)估符合性。

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