审核指南中英文对照版

2021年2月6日发(作者：lux)

International Organization for Standardization

International Accreditation Forum

Date:

21 September 2004

ISO 9001 Auditing Practices Group

The

ISO 9001 Auditing Practices Group

is an informal group of quality management

system (QMS) experts, auditors and practitioners drawn from the ISO Technical Committee

176

Quality Management and Quality Assurance

(ISO/TC 176) and the International

Accreditation Forum (IAF).

It has developed a number of guidance papers and presentations (see

below) that contain ideas, examples and explanations about the auditing of QMSs. These

reflect the process-based approach that is essential for auditing the requirements of ISO

9001:2000

Quality management systems - Requirements

.

The guidance is primarily aimed at QMS auditors, consultants and quality practitioners, but is

not definitive. The papers and presentations reflect a number of different views in QMS

auditing. As such, their content may not always be consistent. It is not intended that the

guidance will be used as specified requirements, an industry benchmark, or as criteria that

all QMS auditors, consultants or practitioners have to follow.

QMS auditing topics

?

The need for a 2-stage approach to auditing

2

阶段审核的必要性

?

Measuring QMS effectiveness and improvements

测量

QMS

的有效性及其改进

?

Identification of processes

过程的识别

?

Understanding the process approach

过程方法的理解

?

Determination of the ―where appropriate‖ processes

确定”适当的”过程

?

Auditing the ―where appropriate‖ requirements

审核”适当的”要求

?

Demonstrating conformity to the standard

证明符合标准

?

Linking an audit of a particular task, activity or process to the overall system

?

Auditing continual improvement

审核持续改进

?

Auditing a QMS which has minimum documentation

审核

QMS

文件化的最低要求

?

How to audit top management processes

如何审核最高管理层

?

The role and value of the audit checklist

审核检查表的角色和价值

?

Scope of ISO 9001:2000, Scope of Quality Management System and Defining Scope of

Certification

ISO9001

：

2000

的 范围，质量管理体系的范围和定义认证范围

?

How to Add Value during the audit process

审核过程如何增值

?

Auditing competence and the effectiveness of actions taken< /p>

审核能力要求和采取措施的有

效性

?

Auditing Statutory and Regulatory requirements

审核法规和指令要求

?

Auditing the Quality Policy andQuality Objectives

审核质量方针和质量目标

?

Auditing ISO 9001, Clause 7.6

Control of monitoring and measuring devices

审核

ISO9001, 7.6

条款监视和测量装置的要求

?

Making effective use of ISO 19011

ISO19011

< p>
的有效应用

?

Auditing Customer Feedback processes

审核顾客反馈过程

?

Documenting a Nonconformity

文件化不符合项

?

Guidance for reviewing and closing nonconformities

评审和关闭不符合项指南

?

Auditing Internal Communications

审核内部沟通

?

Auditing Preventive Action

审核预防措施

?

Auditing Service Organizations

审核服务组织

?

Auditing the Effectiveness of the Internal Audit

审核内部审核的有效性

?

Auditing Electronic Based Management Systems

审核电子管理体系

A

is also available.

< br>可获得以上文件的

ZIP

档。

Feedback from users will be used by the

ISO 9001 Auditing Practices Group

to determine

whether additional guidance documents should be developed, or if these current ones

should be revised. Comments on the papers or presentations can be sent to the following

email address: @.

The other papers and presentations may be downloaded from the web sites:

/iso- tc176-sc2

The need for a 2 stage approach to auditing

2

阶段审核的必要性

Auditing

ISO

9001:2000

requires

auditors

to

obtain

a

good

understanding

of

an

auditee‘s

quality management system (QMS) and the nature of its business. This is why it is beneficial

for an organization to be visited prior to its certification audit and for a1

st

stage audit to be

< p>
conducted.

审核

ISO9001

：

2000

要求审核员很好地理解受审核方的 质量管理体系和业务性

质。这就是在认证审核前访问组织，建立第一阶段审核的好处。< /p>

This

1

st

stage

audit

is

primarily

for

scoping

and

planning

a

certification

audit

(the

stage

2

audit) and to allow the auditor to obtain an understanding of the organisation. For example,

to gain knowledge of its QMS, policies, objectives, risks, processes, locations, etc. It is also

may

be

used

for

the

auditing

body

to

communicate

its

needs

and

expectations

to

the

auditee.

第一阶段审 核可初步确定认证审核

(

第二阶段审核

)

范围并进行策划，让审核员了解组

织。如了解质量管理体系， 方针，目标，风险，过程，现场等信息。也可用于审核机构与受

审核方沟通需求和期望。

Activities performed at a preliminary 1

stage audit include

第一阶段审核活动包括

:

?

Identification of the key risks of the business and related statutory, regulatory aspects

and compliance

识别业务的主要风险和相关的法令法规及其符合性

?

An assessment of whether the auditee's defined processes are adequate to meet its

objectives and customer requirements

评价受审核方确定的过程是否充分，并满足目标和顾客要求

?

Conducting aDocumentation Review

进行文件审核

?

This review should determine if the organisation's QMS documentation adequately

covers all the requirements of ISO 9001:2000. The review would normally be carried out

at the auditee's premises (unless otherwise requested and justified). As a result of this

activity, a report should be provided that notes any deficient areas. As part of the

documentation review, the auditor should assess the extent and availability of supporting

procedures and process descriptions. Collecting necessary information regarding the

scope of the organization's management system, processes and location(s)

确定组织的质量管理体系文件是否充分覆盖了

ISO9001

：

2000

的要求。此评审通常基于受

审核方的前提下进行

(

除非有另外的要求和证明

)

。结果应提供报告描述不 足之处。作为文

件评审的一部分，审核员应评价支持程序和过程描述的程度和可获得性。 收集关于组织管

理体系，过程和场所的必要信息。

?

Drafting the future certification documentation, including the Scope statement

起草下一步认证文件，包括范围的确定

?

Planning the certification (stage 2) audit, including the requirements for audit team

selection

策划认证

(

第二阶段

)

审核，包括审核组选择的要求

?

Obtaining evidence that internal audits and management reviews are being planned, or

performed, effectively

获得内部审核和管理评审有效策划或实施的证据

?

Checking that the QMS is implemented and ready for the stage 2 audit, including

appropriate level of documents and supporting records.

检查实施的 质量管理体系及为第二阶段审核的准备，包括必要的文件和支持记录的水平。

st

If the system is lacking in any way, the auditor should note this in the audit report, so

that the organisation has an opportunity to rectify deficiencies prior to its certification

nd

(2

stage) audit.

如果体系有缺失，审核员应记录在审核报告中，以便组织在认证

(

第二阶段

)

审核前 矫

正缺失。

?

Agreeing a date for the stage 2 audit

确定第二阶段审核日期

Identification of processes

过程的识别

1. Distinguishing between the concepts of a process and an activity

过程和活动概念的区别

If an auditee cannot distinguish between the concepts of a process and an activity, the

auditor can briefly explain the differences by using the guidance (clause 2.4) and definition

((3.4.1) in ISO 9000:2000 as background information. The auditor must be able to adapt to

the auditee‘s situation. It is the auditor‘s responsibility to understand the auditee‘s systems

and approach.

如果受审核方不能区别过程和活动的概念，审核员可以

ISO 9000:2000

的指南和定义作为背

景知识简要地解释其不 同之处。审核员应有能力适应受审核方的状况。理解受审核方体系和方

式是审核员的职责 。

During the audit, the auditor should determine whether there is a problem of difference

of terminology only, or whether there is a lack of real implementation of the process

approach by the auditee. There may be a need to issue an NCR if the auditee is not fully

implementing the requirements stated in ISO 9001:2000, Clause 4.1. If this is simply a

terminology problem, there should be no need to issue an NCR, if all the requirements of in

Clause 4.1 are satisfied.

在审核期间，审核员应确定仅是术语不同的原因，还是受审核方过程方法实施的缺失。如果受

< br>审核方不能满足

ISO 9001:2000

条款

4.1

规定的要求，则需要发出

NCR

。如果满足了条款

4.1

的要求，仅是简单的 术语问题，则不需要发出

NCR

，

The auditee has the right to use its own terminology, provided the requirements of the

standard are met. The auditor should mentally develop a cross-reference list to ensure

consistency and better understanding. < /p>

倘若满足标准要求，受审核方有权利使用他自己的术语。审核员应在心里建立一个对照表以 确

保一致性和更好地理解。

2. A process has defined objective(s), input(s), output(s), activities, and resources

定义的过程目标、输入、输出、活动和资源

If the auditee does not understand that a process must have defined (but not necessarily

measurable) objective(s), input(s), output(s), activities, and resources, the auditor should try

reformulating the questions to the auditee avoiding the use of QM jargon, e.g. Can you

explain to me your operations here? What are the basic jobs carried out in your department?

What information do you need to start your work? Where does it come from? Who receives

the result o

f your work? How do you know if you‘ve done your job correctly? etc..

如果受审核方不了解过程 需定义

(

不适当可测量的

)

< p>
目标、输入、输出、活动和资源，审核员应

试着换一种形式，以便受审核方 避免使用质量管理行话，如你能向我解释你的运作吗？你部门

的基本工作是什么？你开始 工作需要哪些信息？这些信息从何处获得？谁接受你工作的结果？

你如何理解正确的工作 ？等。

This should help the auditor to establish whether the processes (as per ISO 9001: 2000) are

already defined, have clear inputs, outputs, objectives and so on.

这些帮助审核员确定是否已定义过程，有清晰的输入，输出，目标等。

< br>

3. Processes should be analysed, monitored and/or measured, and improved

应分析，监视和

/

或测量

,

改进过程

If after applying the audit techniques outlined above, there is an absence of any records or

other proof to demonstrate that the processes are analysed, and/or monitored, and/or

measured, and/or improved, there would appear to be non-conformity with part of ISO

9001:2000 Clause 4.1.

如果用以上的 审核技术，发现记录的不足或不足以证明过程已分析、监视、测量、改进，这会

成为

ISO 9001:2000

条款

4.1

的不符合项。

4. The auditee/auditor considers that each clause or sub- clause of ISO 9001:2000

must be defined as a separate process

受审核方和审核员认为

ISO9001:2000

< br>的每个条款须定义为一个独立的过程

If the auditor considers this as the right approach, he should refer to relevant ISO

documents, (notably the ISO/TC 176/SC 2 document

N544 ISO 9000 Introduction and

Support Package: Guidance on the Concept and Use of the Process Approach

) which

clearly indicates the contrary. If the auditee considers this as the right approach, it is

recommended that the techniques outlined in section 2 (above) should be used.

如果审核员认为这是正确的方法，他应参考

ISO

文件

(ISO/TC 176/SC 2

文件

N544 ISO9000

介 绍和支持文件包：过程方法的使用和概念指南

)

，规定正好相反 。如果受审核方认为这是正

确的方法，建议其使用第

2

节的技术。

5. Is the process approach as described in the 'Introduction' to ISO 9001:2000 a

requirement of the standard?

过程方法是

ISO9001: 2000

标准前言的一项要求吗？

The description of the process approach in the 'Introduction' to ISO 9001:2000 is purely

informative and not a set of additional requirements.

ISO9001:2000

前 言描述的过程方法完全是正常的要求，不是附加要求。

Understanding the process approach

理解过程方法

Helping an auditor to interpret the process approach

帮助审核员解释过程方法

If an auditor does not understand or misunderstands the process approach, direct him or her

to recognized information sources, such as the standard ISO 9000:2000

Quality

management systems

–

Fundamentals and Vocabulary

and the

ISO 9000 Introduction and

Support Package:

Guidance on the Concept and Use of the Process Approach

for

management systems (document ISO/TC176/SC2/N544

, available from

/iso-tc176-sc2

).

如果审核员不了解或误解过程方法，他或她应了解相关的信息资源，如标准

ISO90 00:2000

质

量管理体系

-

原理和术语和

(ISO/TC 176/SC 2

文件

N544 ISO9000

介 绍和支持文件包：管理体

系的过程方法使用和概念指南，可从

/ iso-tc176-sc2

网站获得

)

。

A certification body/registrar should ensure that all its auditors have received sufficient

training regarding the new requirements in ISO 9001:2000, particularly those on the process

approach. Thus, an auditor should realise that several steps are needed, including the

following

认证机构或注册方应确保其所有审 核员都接受了足够的

ISO 9001:2000

新要求的培< /p>

训，尤其是过程方法。因此审核员应清楚以下的几个步骤

:

-

-

-

-

determining the processes and responsibilities necessary to attain the quality objectives

of the organisation< /p>

确定必要的过程和职责以达成组织的质量目标

;

determining and providing the resources and information necessary

确定并提供必要的资

< p>
源和信息

;

establishing and applying methods to monitor and/or measure and analyse each process

确定并应用监视和测量和分析每个过程的方法

;

establishing and applying a process for continual improvement of the effectiveness of the

QMS

确定并应用持续改进质量管理体系的有效性的过程

.

The process approach concept must be so well understood by auditors that they are not

limited by the terminology in the standard; however, auditees may use their own ―in

-

house‖

terminology. Auditors must be aware that the application of the process approach will be

different from organisation to organisation, depending on the size and complexity of the

organisation and its activities. Special consideration should be given to the situation in small

and medium en

terprises (SME‘s), so that auditors should not expect so many processes in

their QMSs.

审核员应清楚地理解过程方法的概念 ，不仅限于标准的术语；可是，受审核方可能用他们自己

的术语。审核员应认识到不同组 织的过程方法应用，基于组织及其活动的规模和复杂程度。尤

其要考虑到中小型企业的情 况，审核员不应期望在他们的质量管理体系有太多过程。

Helping an auditee to interpret the process approach

帮助受审核方说明过程方法

If an auditor is faced with a complete misunderstanding by an auditee, this situation should

normally be identified at the 1

st

stage audit

审核 员面对完全误解的受审核方的情况通常在第一

阶段审核中发现

.

The auditor should refer the auditee to recognized information sources, such as those

indicated in the section above. (In particular, the referenced ISO/TC 176/SC 2/N544

document sets out different steps in the process approach and provides useful guidance with

examples)

审核员应参考受审核方的信息资 源，如以上章节显示的信息

(

通常参见

ISO/TC

176/SC 2/N544

文件设定的过程方法的步骤和提供的指南

.

The auditee should also pay sufficient consideration to

受审核方应充分考虑

- the establishment of process objectives

过程目标的建立

,

- process planning

过程策划

,

- the availability of suitable records

可获得适当的记录

.

Auditees frequently identify too many processes; some or all of them are activities,

which do not fulfil the requirements of a process, in the sense that ISO 9001:2000

uses the concept. In this situation, an auditor should (in the 1

st

stage audit) propose

that the auditee performs a redefinition of its processes, based on e.g. the criticality

of the activities. This might be particularly relevant for SME‘s.

受审核方通常会识别许多的过程，其中一部分或 全部是活动，不符合

ISO 9001:2000

中使用的过程 要求。这种情况下，审核员应

(

在第

1

阶段审核中

)

建议受审核方基于活

动的危险程度重新定义过程。通常在中小型企业可能遇到。

Determination of the “where appropriate” processes

确定适

当的过程

Terminology

术语

Where the terminology used by the auditee is different to that used by the auditor, the

auditor should understand the concepts in ISO 9001:2000 using ISO 9000:2000 and make a

mental or written cross reference between the terminology of the auditee and his/her own for

the same concepts, avoiding the use of QM jargon

当受审核方用的术语和 审核员不同时，审

核员应运用

ISO 9000:2000

理解

ISO 9001:2000

的概念，并在心里或写出书面的对照表，确

定受审核方和他自己对同一个 概念所用的术语，避免使用质量管理行话

.

The definition of process

过程的定义

If the definition of process is not interpreted in the same way by the auditor and the auditee,

the auditor should seek to understand the auditee‘s point of view and not impose his own

view unless it is clear (supported with enough objective evidence) that the requirements of

the standard are not met. The same is true if the auditor believes that certain processes

have not been correctly identified or are missing

如果审核员和受审核方对过程的 定义不能一

致时，审核员应理解受审核方的观点，而不能强加他自己的观点，除非确定不 能满足标准要求

(

足够的客观证据

.< /p>

支持

)

。审核员确定过程识别不正确或遗 漏时也同样处理

.

Exclusions

删减

The auditor should refer to clause 1.2 of ISO 9001:2000, to the ISO/TC 176/SC 2/N524

document

ISO 9000 Introduction and Support Package: Guidance on ISO 9001:2000,

Clause 1.2 'Application'

for further guidance, and the

APG's guidance on Scopes.

审核员宜参

考

ISO 9001:2000

的

1.2

条款，< /p>

ISO/TC 176/SC 2/N524

文件

ISO9000

介绍和支持文件：

ISO

< p>
9001:2000

的

1.2

条款“应用”指南和

APG

的范围指南

.

The auditor should obtain objective evidence that the auditee cannot exclude a specific

requirement, before reaching a conclusion.

审核员应在做出审核结论之前获取受审核方不能删减要求的客 观证据。

It is good practice for an auditor to utilize the standard ISO 9000:2000

Quality management

systems - Fundamentals and vocabulary

and ISO/TC 176/SC 2/N524 as support documents,

to explain the arguments to the auditee.

审核员利用标准

ISO 9000:2000

< br>质量管理体系

-

基础和术语和

I SO/TC 176/SC 2/N524

作为支

持文件，解释 和受审核方的争议是一个很好的办法。

Auditing “where appropriate” requirements

审核适当的要求

The auditee should determine the application of the ISO 9001 ―where appropriate

requirements, as this will affect its ability to satisfy its customers' requirements. (It may be

useful to refer the auditee to

ISO 9001:2000 clause 1.1

ion a) needs

to demonstrate its ability to consistently provide product that meets customer and applicable

regulatory requirements‖.)

受审核方应确定

ISO9001

”适当 的”要求的应用，因为这些会影响到满足顾客要求的能力。

(

请 受审核方参考

ISO 9001:2000

条款

1.1

“

…

当组织

< p>
A

需要证明其持续提供满足顾客和适用法

规要求 产品的能力时”

)

。

An auditor sho

uld ensure that the

in relation to the proposed/actual

scope of the auditee's quality management system

.

Therefore the basis of audit should be against this criterion, which should form the

benchmark when deciding what is appropriate or not.

审核员应确保”适当的”要求对于提议或 实际的受审核方的质量管理体系范围确实是”适当

的”。因些确定是否适当时，审核基准 应基于标准。

Issues that should be considered include

应考虑的问题包括

:

-

Does this requirement add value to this element of confidence, without the ?where

appropriate‘ being addressed?

没有确定“适当”时，此条款的要求是否可增值？

-

Does it increase the risk that the organisation cannot meet its customer requirements?

(This may be more than a specific set of customer requirements, as it can include the

demands and expectations of end users, consumers, or the supply chain).

是否增加组织不能满足顾客要求的风险？

(

这可能超 过一组特定顾客的要求，因为也包括最

终使用者、消费者或供应链的要求和期望

)

。

Need for experience to make a judgement on a technical issue

技术问题判定的经验需

求。

An auditing body should be able to demonstrate that its auditor has the necessary sector

knowledge, competence and auditing skills. The auditor needs to be able to demonstrate

knowledge of a process that is being examined and to be able to apply their skill in

evaluating whether the ?where appropriate‘ requirements are appropriate or not.

审核机构应有能力证明其审核员具备必要的知识、能 力和审核技能。审核员需证明过程相关的

知识经过测试，有能力应有其技能评价”适当的 ”要求是否适当。

The auditor will need to understand how the ?where appropriate‘ requirements fit into the

context of how a process is established and its expected outcomes. When the requirements

are not considered to be

demonstrate that the system is effective and that customer requirements are being

consistently met.

审核员需要理解适当的要求如何适合建立的过程及其期望的输出。当这个要求认为“不适当”

时，审核应提供客观证据以证明体系是有效的，并可持续满足顾客要求。

An auditing body should have the necessary processes in place to ensure that an auditor

has the specific skills for the organisation that is to be audited.

审核机 构应有必要的过程以确保审核员对于受审核组织具备所需的特定技能。

Demonstrating conformity to the standard

证明符合标准

―Performing the audit to the standard's clauses‖ versus ―Performing the audit to the auditee‘s

processes‖

审核标准条款和审 核受审核方过程

When assessing conformity to the standard, audit checklists may not be sufficient

评

价标准符合性时，审核 检查表可能不充分

At the end of an audit, the auditor should be in a position to know whether all requirements

of the standard are satisfied or not.

审核结束时，审核员应确定标准所有要求是否都能满足。

Trying to show compliance to a standard often brings people back to using checklists, where

an auditor is able to check-off the requirements of the standard one-by-one, making sure

that all the requirements have been covered. This basic approach of filling out a checklist is

an easy way to ensure that all requirements of the standards have been checked. However,

considering the approach of the ISO 9001:2000, performing an audit from a generic

checklist

might prevent an auditor from collecting evidence of effective interfacing between processes.

当审核员能逐个检查标准要求时，确保已覆 盖了标准所有要求时，常使用检查表显示符合标准

要求。填写检查表是确保标准所有要求 都已检查的基本方法。但是，考虑到

ISO9001

：

2000

的方法，用普通的检查表可能会妨碍审核员收集过程接口有效性 的证据。

In some situations, completely moving away from the checklist (or audit question list) might

not be possible, particularly if the organization needs to provide evidence of compliance to

the standard to third parties (e.g. regulators, conformity assessment bodies).

有些情况下，显然组织需要向第三方

(

如调节方，符 合性评价机构

)

提供符合标准的证据时，完

全使用检查表

(

或审核问卷

)

可能是不行的。

It is important to use a checklist in an appropriate way and at an appropriate time, i.e. as a

tool to help keep track of the requirements of the standard to be covered.

< p>
用适当的方式、在适当的时间使用检查表是很重要的，如作为帮助跟进标准要求是否覆盖的工

具。

What is adequate sampling?

足够的抽样

There is no statistical or mathematical formula to establish the right number of samples to be

taken during an audit. Defining the number of samples (e.g. one, five, or even more samples

of records for a particular requirement) to be taken to confirm conformity to the requirements

is not efficient and does not ensure conformity. It is of course a fact that by increasing the

number of samples taken, an auditor will have greater confidence regarding the actual status

of the implementation of the QMS.

of sampling taken during on-site interviews and record reviews that give sufficient confidence

that the auditee's QMS is implemented as described.

没有统计或数学公式来确定在 审核期间抽样的正确数量。确定抽样数量来确认与标准的符合性

是效率低下的，且不能确 保其符合性。当然增加抽样数量，审核员对质量管理体系实施的真实

状态更具信心。抽样 的适量会涉及到现场面谈和记录评价的抽样水平，对受审核方质量管理体

系实施性充满信 心。

Multi-site sampling, or sampling of the organizational units of a company, are covered in

Annex II of the

IAF

's

Guidance on the Application of ISO/IEC Guide 62

, along with the

required on-site auditor days and sampling formula for multi-sites.

多现场抽样或公司的组织单位抽样，在

IAF

的

ISO/IEC

导则

62

< br>应用指南文件中规定，包括了

多现场审核人天要求和多现场的抽样公式。

The auditor needs to perform interviews and check records and evidence during the

interview. The number of samples to be taken depends on the complexity of the process

being audited, and on the quality of information received from the auditee during the

interview. It is also important that the auditor maintains the schedule outlined in the audit

plan. At the end of the day, the auditor needs to feel comfortable that the samples and the

objective evidence seen are representative, in order to draw appropriate conclusions

regarding the implementation of the QMS.

审核员在审核中应进行面 谈，并检查记录和证据。抽样的数量取决于受审核过程的复杂程度和

在面谈时从受审核方 处获得的信息质量。审核日结束时，审核员应觉得抽样是适当的，客观证

据具有代表性， 以便对质量管理体系实施状态作出结论。

Recording audit information

记录审核信息

ISO 19011 and the IAF Guidance on the Application of ISO/IEC Guide 62 explain what an

audit report should contain. However, it is important that the audit reports to the auditee only

contain important information for the auditee, e.g. information on possible improvements,

positive observations, and non-conformities to the standard. Merely reiterating and

explaining the requirements of the standard is unlikely to be what the auditee is looking for.

ISO19011

和

< p>
IAF

文件

ISO/IEC

导则

62

的应用说明了审核报告应包含的内容。但是，重要的

是给受审核方的审核报告仅包括一些重要信息，如可改进的信息，正面的观察和不符合项 。仅

重复和解释标准的要求不是受审核方所需要的。

There may also be a requirement for the auditor to demonstrate the sequence in which the

audit was performed, sometimes called the audit trail. Using audit notes is a very efficient

way for an auditor to record the audit. The main disadvantage of using audit notes is that

they tend to be a very personal way of recording information during an audit, and the levels

of recording detail and styles will vary greatly from one auditor to another.

这也是对审核员的要求，证明执行审核的 顺序，有时叫审核路线。对于审核员记录审核，使用

审核笔记是很有效的方法。使用审核 笔记主要不足是趋向于非常人个化的方法记录审核信息，

每个审核员的记录详细程度和类 型都有很大的不同。

A checklist can ensure some uniformity in the performance of the auditors. However,

auditors should never forget to spend their time auditing, not filling out checklists or taking

notes.

检查表可确保审核员的一致性。但是，审核员不应忘记时间的分配，而不是填写检查表或 审核

笔记。

Linking an audit of a particular task, activity or process to

the overall system

体系特定的任务、活动或过程的审核

The auditor should not lose sight of the overall direction of the audit, and get side- tracked by

superfluous details. It is important that the auditor keep a close eye on the information

provided by the auditee in the quality manual or documentation where the auditee has

defined the interaction of processes. Interviews should also be performed in such a way that

the auditors should determine the input and output of the process being audited. Keeping in

mind the auditee's process map should ensure that the auditor will be able to determine the

importance of the process he is auditing at any time, and will therefore be able to keep sight

of the overall direction of the audit. This will also help the auditor to understand the linkage

between the processes.

审核员不能忽视审核的全面趋势，获取 边缘资料。重要的是审核员应密切关注质量手册或定义

过程接口的文件中受审核方提供的 信息。审核员应确定受审核的过程输入和输出。关注受审核

方的过程图，以确保审核员任 何时候都有能力确定过程的重要性，因而能够看到审核的全面趋

势。这样也有助于审核员 理解过程间的联系。

During an audit, the auditor has an opportunity to check the auditee's description of the

interrelation of its processes. The auditor should take some samples to see if the

descriptions are a proper reflection of the actual interrelation of the processes, as this will

help determine if the process description is adequate.

在审核期间，审核员有机会检查 受审核方对过程相互关系的描述。审核员应抽样看描

述是否反映过程的相互关系，以便确 定过程描述是否充分。

Auditing continual improvement

审核持续改进

How much improvement is “enough”?

多少改进才“足够”

It should be emphasised that the requirement in ISO 9001:2000 is for continual improvement

of the

effectivenessof the QMS

.

ISO 9001:2000

强调持续改进质量管理体系的有效性。

Continual improvement emanates from the objectives set by top management, which should

(at least) address: the improvement of internal efficiency (for the organization to remain

economically competitive), individual customer needs, and the level of performance that the

market normally expects.

持续改进源于最高管理者设定的目标，

(

至少

)

说明：内部效率

(

组织保持经济竞争力

)

的改 进，

单个顾客需求和市场正常期望的业绩水平。

For example, in the aeronautical sector, the ―acceptable rate‖ of non

-conforming delivered

product is zero percent, so it would not be useful for the organization to set objectives for an

―improvement― in this rate. However, it would be useful for the or

ganization to have

objectives aimed in improving its internal efficiency and its competitiveness (e.g. through

innovation).

例如，对于航空 业，交付不合格品的接受率为零，所以组织不能用此作为目标改进。但是，组

织可以改进 其内部效率和竞争力作为目标

(

如通过创新

)

。

The auditor should seek to determine if the auditee has attempted to set objectives that

establish the correlation between the 3 factors of: corporate objectives, customer needs, and

market expectations. Thereafter, it is up to the organization to balance the need for

improving internal efficiency and the need to progress with external performance (although

the two are very often closely related). No one in isolation can ever be considered as being

―enough‖ or ―not enough‖.

审核员应确定受审核方设定目标建立以下< /p>

3

方面的关系：公司目标，顾客需求和市场期望。随

后组织平衡其内部效率改进需求和外部业绩

(

这两项 通常紧密相关

)

发展需求。不可孤立地考虑

是否足够。

One area which can be problematic for the auditor is to know what is a reasonable market

benchmark. Continuing the above aeronautical example, if the organization announced that

it had improved from a level of 50% non-conforming product delivered to 40%, this would

demonstrate continual improvement, but would hardly be acceptable, given the industry

sector's zero percent normal rate. However, if it announced that it had set an objective to

improve its performance from 0,50% to 0,40%, this would be much nearer the market norm.

对于审核员有一处问题是什么是合理的市场绩效。继续上 面航空的例子，如果组织告知从

50%

的交付不良品率改进到< /p>

40%

，这可证明持续改进，但是对于行业内零缺陷却是不能接受

的。但是，告知其绩效从

0,50%

改 进到

0,40%

，这样就比较接近行业正常水平。

The only real solution for the auditor is to verify how the organization has determined this

proposed rate of improvement, how it has evaluated the associated risks, and how this

relates to customer requirements and the monitoring of feedback on customer satisfaction.

It would be almost impossible to issue an NCR that stated ―There was not enough continual

improvement‖.

审核员 最真实的解决方法就是验证组织如何确定其改进比率，如何评价其关联风险，如何考虑

顾 客要求和顾客满意反馈的监视。几乎不可能开出

NCR

“持续改 进不够”。

What sort of information is relevant and where can we find it?

相关信息和何处可发现？

The auditor has to verify how the overall corporate objectives have been translated into

internal requirements throughout the appropriate processes, and how these requirements

are communicated and monitored. So, the auditor should look for evidence that the

organization is analysing data from process monitoring, and is then taking the results

forward for evaluating process efficiency and/or improving process output. One point that

should be specifically examined, is the consistency of the way in which the improvement of

any one process contributes to meeting the overall objectives, in order to ensure that this will

not cause conflict in the achievement of other objectives.

审核员须验证公司目标如何通过必适当的 过程转化为内部要求，以及这些要求如何沟通和监

视。因此，审核员应寻找组织分析过程 监视数据，并利用结果评价过程效率和

/

或改进过程输

出的证据。有一点要特别注意，任何一个过程对满足目标的贡献的改进，以确保不会引起达成

目标的抵制。

The type of information that an auditor needs to look for, is evidence of how the corporate

objectives are translated into specific QMS objectives. For example: an organization could

set an objective to reduce customer complains by 30%. The top management analysis

shows that 50% of the complaints concern overdue deliveries. The auditor should then look

for evidence that the organization is monitoring and analysing key aspects of its scheduling

and planning activities, throughout its processes, and the process interfaces, to reduce

delays. < /p>

审核员要寻找的信息类型是如何将组织目标转为具体的质量管理体系目标的证据。如：组织 可

设定目标降低顾客投诉

30%

。最高 管理者分析

50%

投诉和延迟交货有关。审核员应寻找的证

据有组织通过过程、过程的接口监视和分析其排程和策划活动的关键因素，以降低延迟交货< /p>

率。

Improvement of the process or improvement of the QMS?

过 程改进或

QMS

改进

An auditor should remember that it would be unrealistic to expect an organization to make

progress all potential improvements simultaneously. Each improvement will require the

commitment of resources, which may need prioritisation by top management, especially

where investments are needed. Instead, the auditor should seek to ensure that the

improvement objectives are consistent overall, and are coherent with the trilogy of factors

mentioned above. However, an organization that does not have a policy and objectives

relating to continual improvement is clearly not complying with the standard. Similarly, the

absence of any evidence of improvement on at least one of these aspects would have to be

considered as indicating that an organization's quality policy is not in line with ISO 9001:

2000.

审核员应记住期望组织同时 进行所有的改进机会是不切实际的。每项改进都要求承诺资源

，

尤其是需要投资时，最高管理者就需要优先选择。相反，审核员应寻求确保改进目标符 合整体

目标，和上面提到的三个方面相一致。但是，组织没有关于持续改进的方针和目标 是明显不符

合标准的。相同的，这些方面有一项的改进缺乏证据则显示组织的质量方针和

ISO 9001:

2000

不一致。

One word of warning: There is no requirement that the organization should set objectives for

improvement of all its processes at any one time. As in the above example on reducing

customer complaints, some processes may not be deemed by top management to contribute

significantly to the reduction of delays, and it is only normal therefore, that the organization

would not concentrate on these areas.

注意：没有要求 组织应在任何时间所有过程都设定改进目标。如以上降低顾客投诉率的例子

中，最高管理 者可能不认同一些过程对降低延迟的能力，认为这是正常的，所以组织也没有集

中关注到 这些区域。

If the top management has set a (realistic) objective for a process, and there is no evidence

of improvement, this information must be fed back into the management review so that top

management can decide what type of action is appropriate - for example, re-adjusting the

objective or providing other means to impact on the process.

如果最高管理者已设定了过程 的

(

现实

)

目 标，但是没有改进的证据，这个信息应反馈到管理评

审以便最高管理者能决定适当的措施

-

如，再调整目标或提供其它方法影响此过程。

Auditing a QMS which has minimum d ocumentation

审核文

件化最少的

< br>QMS

There can be disagreement between an auditor and an auditee on the absence of certain

documented procedures, when the auditee presents only a quality manual and the six

documented procedures specifically required by ISO 9001:2000.

当受审核方呈出的仅有质量手册和

ISO 9001:2000

明确要求的

6

份程序文件时，审核员和 受

审核方之间对于必要的文件化程序可能存在争议。

The differences inview between the auditor and the auditee can arise from differences in the

interpretation of the ISO 9001 requirements contained in Clause 4.2.1, and the related Note,

which state:

观 点的不同在于审核员和受审核方对于

ISO9001

条款

4.2.1

要求及相关说明的解释不同，规

定 是：

总则

The quality management systemdocumentation shall include

质量管理体系文件应包括

:

….

d) documents needed by theorganization to ensure theeffective planning, operationand

control of its processes.

组织确保过程有效策划、运作和控制所需的文件

NOTE 2 The extent of the qualitymanagement systemdocumentation can differ fromone organization to

anotherdue to

注

2

组织的质量管理体系文件化程度不同，取决于

a) the size of organizationand type of activities

组织的规模和活动类型

,

b) the complexity of processesand their interactions, and

过程及其接口的复杂程度，和

c) the competence ofpersonnel.

人员的能力

The auditor should requests information on the auditee's operating processes and

subsequently ask questions, record answers and observe staff at all levels (including

administrative personnel, process owners and operators), to confirm that the actual working

status conforms to the descriptions given.

审核员应要求受审核方提供过程运作的信息 ，随后提问题，记录回答和在各阶层观察员工

(

包

括管理人员，过程拥有者和操作员

)

以确认实际工作 状态是否符合所给出的描述。

Thereafter, the necessity for any documentation should be evaluated in the light of the

observed need for consistency, and the role that any documentation could play in avoiding

any significant, identified risks.

此后，结合观察到的一致性的需要评价所必需的文件，文件化可以避免重大的识别的风险。

The reader is referred

to the advice given in document referenced ―ISO/TC 176/SC 2/N 525,

ISO 9000 Introduction and Support Package: Guidance on the Documentation Requirements

of ISO 9 001:2000

‖

可参见

―ISO/ TC 176/SC

2/N 525,

ISO 9000

介绍和支持文件包

: ISO

9001:2000

文件化要求指南

‖

How to audit top management processe s

如何审核最高管理

过程

Recognizing

that

the

auditing

of

top

management

is

a

sensitive

issue,

this

document

provides guidance for this category of auditing.

审核最高管理层是 一个很敏感的话题，本文件提供了此类审核的指南。

Auditors should involve top management in the audit, i.e. invite them to opening and closing

meetings, allow sufficient time in the audit plan for interviewing top managers, discuss audit

findings directly with them, seek evidence of their commitment, etc.. It is important to change

the

focus

of

attention

from

just

the

quality

manager

to

the

top

management

of

the

organization.

审核应包括最高管理者，如邀请他们参加首末次会议，审核计划中安排足够的时间与最高管理

者面谈

，与他们直接讨论审核发现，寻求他们承诺的 证据等。将关注焦点从质量经理改变到

组织的最高管理者是非常重要的。

The auditor should consider top management activities to be processes, and should auditing

them accordingly.

审核员应视管理活动为过程，对他们进行审核。

Planning stage

策划阶段

The auditor needs to identify top management processes, and

审核员需识别最高管理过程

a) understand the organization and its management structure, by reviewing information

such as organization charts, annual reports, business plans, company profiles, press

releases, websites,

通过评审信息如 组织结构图，年度报告，业务计划，公司档案，新闻发布，网站了解组

织及其管理结构< /p>

b) make provision on the audit plan for gathering relevant information regarding top

management commitment, directly from and by interviewing top management,

审核计划安排直接与最高管理者面谈收集有关最高管理 者承诺的信息

c) understand the culture of the organization and its top management, in order to

determine its impact on the audit plan

–

and make appropriate adjustments.

了解组织及其最高管理者文件，以确定对审核计划的影响

-

并做适当的调整

d) take a professional approach in the auditor's own appearance, by determining the

dress code of the organization.

审核员的专业能力确定组织的专业代码

e) plan the timing of the top management interview, to ensure convenience and

punctuality.

计划与最高管理者面谈的时间表，以确保方便准时。

An auditor with limited auditing experience should not be assigned to interview top

management,

不宜分配审核经验有限的审核员和最高管理者面谈。

Conducting the audit

审核实施

Common methods of evaluating top management commitment are:

评审最高管理者承诺的通用方法是：

1.

Interviews with top management

和最高管理者面谈

The auditor can, by utilising business terminology appropriate for the top management,

ask relevant questions that

审核员能用适当的业务术语向最高管理者询问问题

a)

seek to obtain evidence of top management‘s awareness of and commitment to quality

and its relevance to the organization's overall objectives and management system,

寻求最高管理者的质量意识和承诺，组织的整体目标和管理体系的证据 ，

b) establish evidence of conformity to the ISO 9001 requirements for management

responsibility.

建 立符合

ISO9001

管理职责要求的证据

2.

Collecting and corroborating evidence

收集并确认证据

The auditor/audit team should be constantly looking for opportunities to corroborate the

answers received from top management when interviewed.

审核员

/

审核组宜不断寻找机会确认与最高管理者面谈时获取的信息。

This includes

包括

a) the availability and relevance of policies and objectives

方针和目标的可获得和适宜性

b) the establishment of linkage between the policies and objectives

方针和目标的关联性

c)

obtaining the evidence that these policies and objectives are effective and understood

throughout the organization

收集方针和目标有效性并为组织全员理解的证据

d) determining if the policies and objectives are appropriate for continual improvement of

the quality management system and for the achievement of customer satisfaction.

确定方针和目标是否适合于质量管理体系的持续改进和实 现顾客满意

e) determining if top management are involved in management reviews.

确定最高管理者是否参与管理评审。

Additional interviewing and gathering of evidence may be needed to provide the necessary

corroboration.

或能需要附加的面谈和收集证据以进行必要的验证。

The audit team should ensure that any additional evidence of top management commitment

is also collected.

审核组宜确保最高管理者承诺的证据已收集。

The auditor/audit team should review the collected evidence, to ensure the completeness

and accuracy of the information, and to provide confidence in the conclusions drawn.

< p>
审核员

/

审核组应评价所收集的证据以确保信息的 完整正确性，为作出结论提供信心。

Audit reporting

审核报告

Auditors

should

prepare

their

audit

reports

in

order

to

make

them

appropriate

for

presentation to the top management of organizations. It

may

be

appropriate

to

present

an

executive summary of the audit report, suitable for presentation to the top management and

key interested parties of the organization. The executive summary should highlight the key

findings, both positive and negative, and identify opportunities for improvement.

审核员应编制审核报告便于向组织的最高管理者传 达。应适于向组织的最高管理者和关键相关

方传达执行状况。执行状况应突出主要审核发 现，包括正面和负面和改进机会的识别。

The role and value of the audit checklist

审核检查表的角 色和

价值

Introduction

简介

This document provides information on the role and use of audit checklists to actively

support the audit process

本文介 绍了用以支持审核过程的检查表角色和应用

.

Whilst the document is primarily directed to external auditing organizations (including

registration and certification bodies), the information can also equally be used by any

organization conducting internal audits

本文主要用于外部审核组织

(

包括注册 和认证机构

)

，同

时也可用于任何组织 实施内部审核

.

Need for checklists

检查表的需要

:

In looking at current auditi

ng standards, ISO 19011 makes reference to ―Preparing work

documents‖ in Clause 6.4.3. The following is an extract from this clause

依据目前的审核标准

ISO19011

条款

6.4.3

“准备工作文件”。以 下是摘录自此条款

:

“The audit team members should review information relevant to their audit

assignment and

prepare work documents as necessary for reference and for recording audit proceedings.

Such documents may include

审核 组成员宜评审其审核任务的相关信息，准备必要的工作文

件以参考和记录审核发现

?

Checklists and audit sampling plans, and

检查表和审核抽样计划，和

?

Forms for recording information, such as supporting evidence, audit findings and

records of meetings

记录信息表格，如支持证据，审核发现和会议记录

.

The use of checklists and forms should not restrict the extent of audit activities, which can

change as a result of information collected during the audit

检查表和表格的使用不能限制可

能改变审核过程收集信息的结果审核 活动的范围

‖

The use of audit checklists

审核检查表的使用

:

Whilst not always required in management system standards, audit checklists are just one

tool available from the ―auditors toolbox‖. Many organizations will use them to ensure that

the audit at a minimum will address the requirements as defined by the scope of the audit

审

核检 查表仅是审核员所用的工具，随时可获得，管理体系标准中无明确的要求。许多组织用以

确保审核范围的至少的审核要求

.

An example auditing approach is shown below

审核方法案例如下

:

ISO 9001:2000

Requirements

Use of checklist

C

C

to audit from

P

o

O

the

e

requirements to

m

r

M

Audit from the

the

organization's

p

f

P

organization's

management

l

o

L

management

system to the ISO

system

I

r

I

9001:2000

requirements.

a

m

A

n

a

N

Organization's Management System

c

n

C

It is beneficial to audit from the organization's quality management system up to the requirements.

A checklist may be used to ensure that all relevant ISO 9001 requirements addressed

对于按要求审核

e

c

E

组织 的质量管理体系是有益的。检查表可用于确保所有

ISO9001

的要求都可以覆盖。

&

e

Advantages

优点

:

Literature available in the marketplace notes the following with respect to the use of audit

checklists

以下关系到检查表使用的要 点

:

1.

Checklists if developed for a specific audit and used correct ly

为特定的审核制定检查

表并正确使用

:

a.

Promote planning for the audit

利于审核策划

.

b.

Ensure a consistent audit approach

确保审核过程的一致性

.

c.

Act as a sampling plan and time manager

用于抽样计划和时间管理

.

d.

Serve as a memory aid

想备忘录作用

.

e.

Provide a repository for notes collected during the audit process (audit field

notes)

审核过程中提供关注点收集的指引

2.

Audit checklists need to be developed to provide assistance to the audit process

制定

审核检查表为审核过程提供帮助

< p>
.

3.

Auditors need to be trained in the use of a particular checklist and be shown how to

use it to obtain maximum information by using good questioning tech niques

审核员需

接受常用检查表使用的培训，并展示如何 应用提问技巧获取最多的信息

.

4.

Checklists should assist an auditor to perform better during the audit process

检查表

应可帮助审核员更好地实施审核过程

.

5.

Checklists help to ensure that an audit is conducted in a systematic and

comprehensive manner and that adequate evidence is obtained

检查表帮助审核的系

统性和全面性，并获得足够的证据

.

6.

Checklists can provide structure and continuity to an audit and can ensure that the

audit scope is being followed

检查表能提供审核的结构及连续性，并能确保覆盖审核

范围

.

7.

Checklists can provide a means of communication and a place to record data for use

for future reference

检查表可提供沟通工具和记录为以后提供参考的数据区域

.

8.

A completed checklist provides objective evidence that the audit was per formed

完成

后的检查表可提供审核实施的客观证据

.

9.

A checklist can provide a record that the QMS was examined

< br>检查表可提供

QMS

检

查的记录

.

10. Checklists can be used as an information base for planning future audits< /p>

检查表可用

于以后审核的信息基础

.

11. Checklists can be provided to the auditee ahead of the on-site audit

检查表可在 现场

审核前提供给受审核方

.

Disadvantages

缺点

In contrast, when audit checklists are not available, or poorly prepared, the following

issues/concerns are noted

相比之 下，没有检查表或过于缺乏，应注意以下问题

:

1.

The checklist can be seen as intimidating to the auditee

检查表看起来对受审核方可 能

造成压力

.

2.

The focus of the checklist may be too narrow in scope to identify specific problem

< p>
areas

过份关注检查表可能缩小识别问题区域的范围

< br>.

3.

Check

lists are a tool to aid the auditor, but will be restrictive if used as the auditor‘s

only support mechanism

检查表是审核员的帮助工具，但如果当做审核员的支持设施

使用的话， 可能会限制审核活动

.

4.

Checklists should not be a substitute for audit planning

检查表不能代替审核策划

.

5.

An inexperienced auditor may not be able to clearly communicate what he/she is

looking for, if they depend too heavily on a checklist to guide their questions

一个没有

经验的审核员如果过份依赖检查表指导审核，可能不能清楚地 沟通他所需查找的内容

.

6.

Poorly prepared checklists can slow down an audit due to duplication and repetition

因简单复制检查表，过份缺乏可能导致审核缓慢

.

7.

Generic checklists, which do not reflect the specific organizational management

system, may not add any value and may interfere with the audit

没 有反映出组织管理

体系的检查表，不能增值，并对审核造成困扰

.

8.

Narrow focused checklists minimize unique assessment questions/ap proach

关注检

查表可能影响审核问题

/

方法。

Conclusion

结论

There are advantages and disadvantages in using audit checklists. It depends on many

factors, including customer needs, time and cost restraints, auditor experience and sector

scheme requirements. Auditors should assess the value of the checklist as an aid in audit

process and consider its use as a functional tool.

这些是使用检查表的优点和缺点。取决于很多方面 ，包括顾客需求，时间和成本控制，审核员

经验，部分要求。审核员应评价用作工具的检 查表在审核过程中的价值。

Scope of ISO 9001:2000, Scope of Quality Management

System (QMS) and Defining Scope of Certification ISO9001

范围，质量管理体系范围和定义证书范围

ISO 9001:2000 clause 1

Scope

defines the scope

of the standard itself

. This should not be

confused with the

scopeof the QMS

, which is a term commonly used within the context of

QMS certification/registration to describe the organization and products to which the QMS

applies

ISO 9001:200 0

条款

1

定义了标准的范围。不能和< /p>

QMS

范围混淆，后者指

QMS

认证

/

注

册所用的术语 以描述

QMS

所适用的组织和产品

.

ISO 9001:2000 is generic, and applicable to all organizations, regardless of type, size and

product category. It is recognised, however, that not all the requirements of this standard will

necessarily be relevant to all organizations. Under certain circumstances, an organization

may exclude some specific ISO 9001:2000 requirements from its QMS. ISO 9001:2000

makes allowance for such organizations, through clause 1.2

Application

ISO 9001:2000

是通

用的，适用于所有的组织，不论类型、规模和产品类别。但 是，应该认识到不是标准的所有要

求对于组织都是必要的。有些情况下，组织可以在其质 量管理体系内删减部分

ISO 9001

的要

求。

ISO 9001: 2000

通过条款

1.2

允许组织删减

.

The scope of the QMS should be based on the nature of the organization's products and

their realization processes, the result of risk assessment, commercial considerations, and

contractual, statutory and regulatory r equirements

质量管理体系应基于组织产品的性质及其

实现过程、风险评价结果、商业考虑、契约关系、法令和法规要求

.

< br>

If an organization chooses to implement a QMS and to be assessed to a limited scope, this

should be clearly defined in the organisation's Quality Manual and any publicly available

documents, to avoid confusing or misleading customers and end users (this includes, for

example, certification/registration documents and marketing material)

如果组织选择实施质量

管理体系并评价一个 限定的范围，应清晰地在组织的质量手册和公司文件中定义，以避免混淆

或误导顾客和最 终使用者（包括，例如认证

/

注册文件和市场材料）

< p>
.

ISO/TC 176/SC 2 has developed document N524 the

ISO 9000 Introduction and Support

Package: Guidance on ISO 9001:2000, Sub-clause 1.2 'Application'

to provide users with

information regarding the intent of ISO 9001:2000 clause 1.2 Application, including some

typical examples of its use in practical situations. (N524 is available for free download from

/iso-tc176-sc2

). Additionally, the IAF has published its

IAF Guidance on the

Application of ISO 9001:2000, Issue 2

, which should also be referenced.

How to add value during the audit process

审核过程如何增值

What do we mean by “adding value”?

如何理解增值

We

hear

so

much

about

the

importance

of

―adding

value‖

during

quality

management

systems (QMS) audits, but what does this really mean?

Is

it

possible

to

add

value

without

compromising

the

integrity

of

the

audit

or

providing

consultancy?

In

principle,

all

audits

should add value, but this is not always the case.

我们听说太多在质量 管理体系审核中

增值

的重要性，但是这意味着什么？

< p>

This

document

provides

guidance

on

how

an

audit

can

add

value

for

the

different

parties

involved, and the various situations that are likely to be encountered in the context of second

or third-party audits.

< p>
本文对第二方或第三方审核中，不同条件下的审核增值提供指南。

―

Value-

added” quality management systems

增值的质量管理体系

There are several dictionary definitions of ―value‖, but all focus on the concept of something

being

useful. “Adding value”

therefore means to make something

more useful.

< p>
对于价值有着不同的定义，但都集中一个概念，即有用的东西。因此，增值就是让他更有用。

Some

organizations

have

used

the

ISO

9000

series

of

standards

to

develop

quality

management systems that are integrated into the way they do business, and are

useful

in

helping them to achieve their strategic business objectives

–

in other words they

add value

for

the

organization.

Conversely,

other

organizations

may

have

simply

created

a

bureaucratic

set

of

procedures

and

records

that

do

not

reflect

the

reality

of

the

way

the

organization actually works, and simply add costs, without being useful. In other words, they

do not ―add value‖.

很多组织使用了

ISO9000

系列标准建立 质量管理体系，帮助达成组织的业务目标

-

换句话说，

为组织增值。相反，另外一些组织简单地建立一套官僚化的程序和记录，不能反映出组织的实

际工作方式，只是简单地增加无益的成本，他们不能增值。

It is a question of approach:

这是个问题导向：

A non- value-

added approach asks ―What procedures do we have to write to get the

ISO 9000 certification?‖

非增值导向问“我们应该写哪些程序可获得

ISO9000

< p>
认证？”

A ―value

-

added‖ approach asks the question ―

How can we use our ISO 9001:2000-

based quality management system to help us to improve our business

?‖

增值导向问题“我们如何用

ISO9000

质量管理体系帮助我们业务改进？”

How to add value during the audit process?

审核过程如何增值？

How can we ensure that an audit is

useful

to an organization in maintaining and improving

its QMS?(We should recognize, however, that there may be other perspectives that need to

be taken into consideration.)

我们如何确保审核对于组织维持和改进质量管理体 系是有用的？（我们应该认识到，或许还应

考虑到其他一些观点。）

In order to ―add value‖, a third

-party audit should be useful

为了增值，第三方审核应有益于

:

?

to the certified organization

被认证组织

o

by

providing

information

to

top

management

regarding

the

organization‘s

ability to meet strategic objectives

提供有关组织满足目标能力的信息给最高管理者。

o

by

identifying

problems

which,

if

resolved,

will

enhance

the

organization‘s

performance.

识别问题提高组织业绩。

o

by identifying improvement opportunities and possible areas of risk

识别改进机会和可能的风险区域

?

to

the

organization‘s

customers

by

enhancing

the

organization‘s

ability

to

provide

conforming product

提高组织的能力，提供合格产品给组织的顾客。

?

to

the

certification

body,

by

improving

the

credibility

of

the

third

party

certification

process.

提高认证机构的第三方认证过程的可信度。

The

approach

to

―adding

value‖

is

li

kely

to

be

a

function

of

the

level

of

maturity

of

the

organization‘s quality culture and the maturity of its QMS, with respect to the requirements of

ISO 9001:2000. < /p>

增值近似于组织质量文化的成熟水平和质量管理体系的成熟度，考虑

ISO 9001:2000

要求。

By referring to Figure 1, we can conceptually separate organizations into four different zones,

as follows:

参见图

1

，我们把组织大概分成

4< /p>

个不同的区域，如下图：

“

< p>
N

o

n

-

c

o

n

f

o

r

m

i

n

g

”

“

C< /p>

o

n

f

o

r

m

i

n

< p>
g

”

M

a

t

u

r

i

t

y

o

f

Q

M

S

Zone 3

Zone 4

Zone 1

Zone 2

Low

High

Maturity of “Quality culture”

Zone

1:

(Low

maturity

of

“quality

culture”;

immature

QMS,

not

conforming

to

ISO

9001:2000

质量文化成熟度低，不成熟的质量管理体系 ，不符合

ISO 9001:2000)

Zone 2:

(Mature “quality culture”; immature QMS, not conforming to ISO 9001:2000

成

熟的质量文化，不成熟的质量管理体系，不符合

ISO 9001:2000)

Zone 3: (Low maturity of “quality culture”; mature QMS, conforming to ISO 9 001:2000

质量文化成熟度低，成熟的质量管理体系，符合

ISO 9001:2000)

Zone 4: (Mature “quality culture”; mature QMS, conforming to ISO 9 001:2000

成熟的质

量文化，成熟的质量管理体系，符合

ISO 9001:2000)

It is important to note that in this context:

注意到这段文章很重要

―

Quality

culture

‖

refers

to

the

degree

of

awareness,

commitment,

collective

attitude

and

behaviour of the organization with regard to quality.

“

质量文化

”组织内对质量的意识，承诺，集体态度和行为。

―

Conformity to ISO 9001:2000

‖

relates to the maturity of the organization‘s QMS, and the

extent to which it meets the requirements of ISO 9001:2000. (It is recognized that specific

minor

nonconformities

might

be

detected

even

in

organizations

that

show

an

overall

high

degree of maturity and conformity to ISO 9001:2000.)

“符合

ISO

< p>
9001:2000

”

组织质量管理体系成熟，能 满足

ISO

9001:2000

的要 求。（应该认

识到尽管显示成熟度很高，符合

ISO 9001:2000

，依然可能在组织内发现轻微不符合。

）

Zone

1:

(Low

maturity

of

“quality

culture”;

immature

QMS,

not

conforming

to

ISO

9001:2000

质量文化成熟度低，不成熟的质量管理体系 ，不符合

ISO 9001:2000)

For an organization that has little or no ―quality culture‖ and a QMS that does not conform to

ISO

9001:2000,

the

expectation

of

how

an

audit

might

add

value

could

mean

that

the

organization

would

like

to

receive

advice

on

―

howto

‖

implement

the

quality

management

system and/or resolve any non- conformities raised.

组织很少有或没有质量文化，质量管理体系不符合

ISO 90 01:2000

，审核增值意味着组织接收

建议如何实施质量管 理体系和

/

或解决不符合。

Here

the

auditor

has

to

take

great

care,

because

in

a

third

party

audit

such

advice

would

certainly

generate

a

conflict

of

interest,

and

would

contravene

the

ISO/IEC

Guide

62

requirements for the accreditation of certification bodies. What the auditor

can

do, however,

is

ensure

that

whenever

non-conformities

are

encountered,

the

auditee

has

a

clear

understanding of

what

the standard requires, and

why

the non-conformity is being raised. If

the

organization

can

recognize

that

resolving

these

nonconformities,

will

lead

to

improved

performance, then it is more likely to believe in and commit to the certification process. It is

important, however, that all identified non-conformities

are

reported, so that the organization

clearly

understands

what

needs

to

be

done

in

order

to

meet

the

requirements

of

ISO

9001:2000.

这 种情况下审核员应特别注意，因为第三方审核的建议会产生违背公众利益的冲突，也违反了

ISO/IEC

导则

62

对认证机构认证要求。

但是审核员能做到的是让受审核方清楚地理解标准要

求，为什么会产生不符合。如果组织能认识到解决不符合，能改善业绩，他们就会更相信认证

过程，并对此负责。但有一点很重要：报告所有的不符合，这样组织才能理解需要做什么才能

满足

ISO 9001:2000

的要求。

While some organizations might not be totally satisfied with an audit outcome that does not

result in certification, the organization‘s customers (who receive

the organization‘s products)

will certainly consider this to have been a ―valuable‖ audit from their perspective. From the

perspective

of

the

certification

body,

failing

to

report

all

detected

nonconformities

and/or

providing guidance on

how to

implement the quality management system, adds no value to

the credibility of the auditing profession or the certification process.

有些组织可能对导致不能认证的审核 结果不满意，但组织的顾客（接受组织产品的人）当然会

认为是一个有价值的审核。站在 认证机构的立场，如果没有报告所有的不符合和

/

或提供如何< /p>

实施质量管理体系的指导，对于审核专业或认证过程的可信度没有增值。

< br>

We

must

recognize

that

the

above

discussion

relates

mainly

to

third

party

(certification)

audits.

There

is

no

reason

why

a

second

party

(supplier

evaluation)

audit

should

not

―add

value‖

by

providing

guidance

to

the

organization

on

how

to

implement

its

quality

management

system.

Indeed,

under

these

circumstances,

such

guidance

(if

it

is

well-

founded), would undoubtedly be useful for both the organization and its customer.

我们必须认识到以上的论点主要是针对第三方 （认证）审核的。没有理由第二方（供方评价）

审核不能提供增值的指导，告诉组织如何 实施质量管理体系。的确，在这种环境下，这些指导

无庸置疑地对组织及其顾客都是有用 的。

Zon

e 2: (Mature “quality culture”; immature QMS, not conforming to ISO 9001:2000

成

熟的质量文化，不成熟的质量管理体系，不符合

ISO 9001:2000)

For an organization that has a mature ―quality culture‖, but an immature QMS that does not

conform

to

the

ISO

9001:2000

requirements,

the

basic

expectation

of

how

an

audit

might

add value will probably be similar to that of Zone 1. In addition, however, the organization is

likely to have a much higher expectation of the auditor.

有

些

组

织

有

一

个

成

熟

的< /p>

质

量

文

化

，

但

是

却

< p>
又

有

一

个

不

成

熟

的

质

量

管

理

体

系

，

不

符< /p>

合

ISO9001:2000

的要求。< /p>

In

order

to

be

able

to

add

value,

the

auditor

has

to

understand

the

way

in

which

the

organization‘s

existing

practices

meet

the

requirements

of

ISO

9001:2000.

In

other

words,

understand

the

organization‘s

processes

in

the

context

of

ISO

9001:2000,

and

not,

for

example, insist that the organization redefine its processes and documentation to align to the

clause structure of the standard.

为了能够增值，审核员必须理解组织目前的运作满足

ISO < /p>

9001:2000

要求的方式。换句话

说，依

ISO

9001:2000

的 条文理解组织的过程，例如，如果没有，要求组织依据标准条款结

构重新定义和文件化。

The organization might, for example, base its management system on business excellence

models,

or

total

quality

management

tools

such

as

Hoshin

Kanri

(Management

by

Policy),

Quality

Function

Deployment,

Failure

Mode

and

Effect

Analysis,

―Six

-

sigma‖

methodology,

5S

programmes,

Systematic

Problem

Solving,

Quality

Circles

and

others.

In

order

to

add

value

during

the

audit

process,

the

auditor

should,

at

a

minimum,

be

aware

of

the

organization‘s methodologies, and be able to see to what extent they are effective in meeting

the requirements of ISO 9001:2000 for that particular organization.

< p>
组织的管理体系或许基于业务优化模式，或全面质量管理工具，如

Hosh in Kanri (

方针管理

)

，< /p>

质量职能展开，失效模式和影响分析，

6

sigma

方法，

5S

活动，系统问 题解决，质量圈

和其

他方法。为了审 核过程增值，审核员最少应意识到组织的方法，有能力认识到组织符合

ISO

9001:2000

要求的程度。

It is also important that the auditor not be ―intimidated‖ by the organization‘s apparent high

degree

of

sophistication.

While

the

organization

may

be

using

these

tools

as

part

of

an

overall

total

quality

philosophy,

there

might

still

be

gaps

in

the

way

the

tools

are

being

employed. Therefore, the auditor must be able to identify any systematic problems and raise

the appropriate non-conformities. In these situations, the auditor might be accused of being

pedantic or even bureaucratic, so it is important to be able to demonstrate the relevance of

the non-conformities that are being raised.

有一点也很重要，审核员不能为阻止明显的诡 辩胁迫。当组织可能用这些工具作为全面质量系

统的一部分时，这些工具的应用依然可能 有些差距。因此，审核员应有能力识别系统问题和提

出适当的不符合。在这种状态下，审 核员可能被视为书生气或有些官僚，所以有能力证明提出

的不符合的适当性是很重要的。

Zone 3: (Low maturity of “quality culture”; mature QMS, conforming to ISO 9 001:2000

质量文化成熟度低，成熟的质量管理体系，符合

ISO 9001:2000)

An

organization

that

has

been

certified

to

one

of

the

ISO

9000

series

of

standards

for

a

significant

period

of

time

might

be

able

to

demonstrate

a

high

level

of

conformity

to

ISO

9001:2000, but at the same time not have

truly implemented a ―quality culture‖ throughout

the

organization.

Typically,

the

QMS

might

have

been

implemented

under

pressure

from

customers,

and

built

around

the

requirements

of

the

standard,

rather

than

on

the

organization‘s

own

needs

and

expectations

.

As

a

result,

the

QMS,

may

be

operating

in

parallel

with

the

way

the

organization

carries

out

its

routine

operations,

generating

redundancy and inefficiency.

一个组织已认证了某个

ISO

900 0

系列标准，或许可以证实其高水平地满足了

ISO

9001:2000

的要求，但是同时却没有在劝阻之内实施“质量文化 ”。典型的情况就是在顾客的压力下实施

质量管理体系，围绕标准要求建立质量管理体系 胜于组织自己的需求和期望。质量管理体系的

运行与组织的日常操作相比较，显得繁琐和 低效率。

In order to add value in these circumstances, the primary objective of the auditor should be

to act as a catalyst for the organization to build on its ISO 9000-based quality management

system,

and

to

integrate

the

system

into

its

day-to-day

operations.

While

the

third

party

certification

auditor

cannot

provide

recommendations

on

how

to

meet

the

requirements

of

ISO 9001:2000, it is acceptable and indeed good practice to

encourage

and

stimulate

(but

not

require!

)

the

organization

to

go

beyond

the

requirements

of

the

standard.

The

questions

the

auditor

asks

(and

the

way

he

or

she

asks

those

questions)

can

provide

valuable

insights

for

the

organization

into

how

the

QMS

could

become

more

efficient

and

useful

. Identification of ―Opportunities for Improvement‖ by the auditor should include ways

in

which

the

effectiveness

of

the

QMS

might

be

enhanced,

but

could

also

address

opportunities for improved

efficiency

.

在这种情况下为了增值，审核员应成为组织建立

ISO

9000

质量管理体系的催化剂，将系统整

合 入日常运作中。虽然第三方审核员不能提供如何满足

ISO

9 001:2000

要求的建议，但是可

以鼓励和激励（但不是要 求）组织超越标准的要求。审核员提出的问题（和问题的方式）可以

提供有价值的观点， 使组织清楚如何让质量管理体系变得更有效和适宜。审核员识别改进机会

包括提高质量管 理体系的有效性，也可以指出改进效率的机会。

Zone 4: (Mature “quality culture”; mature QMS, conforming to ISO 9001:2000

成熟的质

< br>量文化，成熟的质量管理体系，符合

ISO 9001:2000)

For an organization that has a mature ―quality culture‖, and has been certified to one of the

ISO 9000 series of standards for a significant period of time, the expectation of how an audit

might add value will be the most challenging for an auditor. A common complaint among this

kind of organization is that the ―routine surveillance visits‖ by the auditor may be superfluous,

and do little to add value in the organization‘s eyes.

对于一个有成 熟的质量文化，已经通过

ISO9000

某个标准认证的组织， 期望审核如何增值是

审核员很大的挑战。这种组织通常抱怨正常的监督审核是多余的，在 组织眼里几乎没有增值。

In these cases, top management becomes an important customer of the certification process.

It is therefore important for the auditor to have a

clear

understanding

of

the

organization‘s

strategic

objectives,

and

to

be

able

to

put

the

QMS

audit

within

that

context.

The

auditor

needs

to

dedicate

time

for

detailed

discussions

with

top

management,

to

define

their

expectations for the QMS, and to incorporate these expectations into the audit criteria.

这种情况下，最高管理者成为认证过程 重要的顾客。因此审核员清楚地理解组织的战略目标，

并有能力融入到质量管理体系审核 中是很重要的。审核员需要和最高管理层详细地讨论，确定

他们对质量管理体系的期望， 并将这些期望融入进审核标准中。

Some tips for the auditor on how to add value

审核增值的一些方法

1)

Audit planning

审核策划

:

a.

Understand the auditee‘s expectations/corporate culture

理解受审核方的期望

/

企业文化

b.

Any specific concerns to be addressed (output from previous audits)

特定关心

的内容（以前审核的输出）

?

c.

Risk analysis of industry sector / specific to organization

组织的风险分 析

/

组织

特性

.

d.

Pre-evaluation of statutory/regulatory requirements

法令规则要求的在评价

e.

Appropriate audit team selection to achieve audit objectives

适当 的审核组选择

以达成审核目标

f.

Adequate time allocation

充足的时间分配

2)

Audit technique

审核技术

:

a.

Focus more on the process, and less on procedures.

Some

documented

procedures, work instructions, check- lists etc. may be necessary in order for

the organization to plan and control its processes, but the driving force should

be process performance.

更多关注 过程，少些关注程序。可能需要的文件化程序，作业指导书，检查表

等是组织策划和控制 过程，但是动力应该是过程业绩。

b.

Focus more on results and less on records. In a similar fashion,

some

records may be necessary in order for the organization to provide objective

evidence that its processes are effective (generating the planned results) but

in order to add value, the auditor should be aware of and give credit for other

forms of evidence.

更多关 注结果，少些关注记录。相类似的，需要的纪录是组织为了提供过程有

效（达到策划的结 果）的客观证据，但是为了增值，审核员应明白其他形式证

据的认可。

< br>

c.

Remember the 8

Quality Management Principles

谨记

8

项管理原则

d.

Use the ―Plan

-Do-Check-

Act‖ approach to evaluate the organization‘s process

effectiveness.

运用

PDCA

方法评价组织过程的有效性。

i.

Has the process been planned

过程是否策划

?

ii.

Is it being carried out according to plan

是否根据计划实施

?

iii.

Are the planned results being achieved

是否达成策划的结果

?

iv.

Are opportunities for improvement being identified and implemented

是

否识别了改进机会并执行

?

—

By correcting non-conformities

纠正不符合

—

By

identifying

root

causes

of

problems

and

implementing

corrective action

识别问题的根本原因和采取纠正措施

—

By identifying trends, and the need for preventive action

< br>识别趋

势和预防措施的需求

—

By innovation

创新

e.

Adopt

a

―holistic‖

approach

to

evidence

gathering

throughout

the

audit,

instead of focusing on individual clauses of ISO 9001:2000.

采取整体方式通过

< p>
审核收集证据，取代关注

ISO 9001:2000

的单个条款。

3)

Analysis and decision

分析和决定

a.

Put

the

findings

into

perspective

(Risk

assessment

/

―common

sense‖).

将审核发现融入 看法（风险评价

/

常识判断）

b.

Relate findings to the effect on the organization‘s ability to provide conforming

product (see ISO 9001:2000 clause 1.1).

影响组织提供合格产品能力的审核发现

4)

Report and follow- up

报告和跟进

a.

Sensible reporting of audit findings

审核发现的判断报告

i.

Different

approaches

may

be

required

depending

on

基于以下要 求不

同的方式

:

?

the organization‘s maturity (Zones 1, 2, 3 and 4)

组织成熟度

?

the level of confidence in the organization‘s QMS

对组织

QMS

的信任水平

?

the risks involved

有关的风险

?

the auditee‘s attitude and commitment to the audit

pr ocess

受

审核方对审核过程的态度和承诺

< br>

o

Proactive

o

Reactive

ii.

Ensure that any cultural aspects are taken into consideration

考虑文 化

的影响

iii.

Emphasize positive findings as appropriate

必要时强调正面发现

iv.

Will the solution proposed by the organization in response to negative

findings be

useful< /p>

组织是否针对负面发现提出有用的解决方案

?

b.

Reports

should

be

objective

and

focused

on

the

right

―audience‖.

(Top

management will probably have expectations that are different from those of

the management representative)

报告应该客观，关注适当的听众（最高管理者

和管理者代表可能 有着不同的期望）。

.

Auditing 'competence' and the 'effectiveness of actions

taken'

审核“能力”和“采取措施的有效性”

< br>

The following information is provided to guide auditors performing certification audits in

understanding the ISO 9001:2000 clause 6.2.2 requirements for 'competence' and

'effectiveness of actions taken', e.g. training.

以下信息为审核员提供指南，在认证审核中理解

ISO 9001:2000

条款

6.2.2

对“能力”和“所

采取措施的有效性”的要求，如培训。

These requirements are usually audited as part of a product realization process audit and

not in isolation. However, it is recognised that some organizations will have separate human

resource processes, where most of the evidence needed can be found.

这些要求通常作为产品实现过程审核的一部分进行审核，而不是孤立的。但是，很多组织有独

立的人力资源过程，多数证据都能在此找到。

This document identifies typical activities performed by organizations to ensure the

competence of their personnel and to evaluate the effectiveness of actions taken to satisfy

those competence needs, and gives guidance to auditors regarding the types of evidence

they should aim to find, and provide examples where appropriate.

本文 识别了组织实施的典型活动以确保人员能力和评价所采取措施有效性，以满足能力需求，

并提供指导审核员需要关注的相关证据及提供适当的案例。

To satisfy the competence/effectiveness requirements of ISO 9001:2000, an organization

will typically need to do several things:

为了满足

ISO 9001:2000

能力和有效性的要求，组织

通常需要做以下事情：

?

Identify

what

competencies

are

required

by

personnel

performing

work

which

affects

quality

识别 执行影响质量工作人员的能力

?

Identify which personnel already performing the work have the required competencies

识

别已执行这些工作人员的能力

?

Decide what additional competencies are required

确定所要求的附加能力

?

Decide

how

these

additional

competencies

are

to

be

obtained

–

training

of

personnel

(external or internal), theoretical or practical training, hiring of new competent personnel,

assignment of existing competent personnel to different work

确定如何获得这些附加的能

力

-

人员培训

(

外部或内部

)

，理论或实践培训，具 备能力的新员工的招聘，现有具备能力人

员不同工作的分配

?

Train, hire or reassign personnel

人员培训，招聘或调职

?

Review the effectiveness of actions taken to satisfy competence needs

评价所采取措施

有效性，以 满足能力需求

?

Periodically review competence of personnel

定期评审人员的能力

Throughout

the

process,

the

organisation

is

required

to

maintain

appropriate

records

of

education, training, skills

and

experience.

However,

ISO

9001:2000

does

not

specify

how

the process will be established or the exact nature of the records to be maintained.

要求组织通过这些过程保持适当的教育、培训、技能和经验的记录。但是，

ISO

9001:2000

没

有规 定如何建立过程或如何正确地保持记录。

In

auditing

an

organisation‘s

compliance

with

the

competence

and

training

evaluation

requirements, an Auditor

would

typically

be

seeking

evidence

that

the

following

issues

are

addressed

审核组织 能力和培训评价的符合性，审核员应寻求以下问题的证据

:

1

-

Anorganisation

needs

to

identify

what

competencies

are

required

by

personnel

performing work that affects quality

组织需识别执行影响质量工作的人员的能力 要求

.

Guidance

- The objective of the auditor should be to determine whether there is a

systematic approach in place to identify these competencies and to verify that the

approach is effective. The outcome of the process may be a list, register, database,

human resources plan, competencies development plan, contract, project or product

plan, etc.

指南

-

审核员应确定是否有系统的方法 以识别能力并验证这种方法的有效性。过程的结

果可能是清单，登记表，数据库，人力资 源计划，能力开发计划，合同，项目或产品

计划等。

Discussions could initially be held with top management to ensure they understand

the importance of identifying the competencies required. These may also be a

potential source of information regarding new or changed activities or processes,

which may lead to different competency requirements in the organization.

可由最高管理者组织讨论以确保理解识 别能力要求的重要性。这也可能是新的或变更

的活动或过程导致组织内不同的能力要求的 信息来源。

A

review

of

competencies

might

also

be

needed

when

a

new

tender

or

contract

is

being

considered.

Evidence

of

this

could

be

found

in

related

records.

Competence

requirements

may

be

included

in

contract

documents

where

the

activities

of

subcontractors

can

have

an

impact

on

processes

and/or

product

quality

characteristics. < /p>

当有新的投标或合同时应考虑能力评审的需求。证据可从相关记录上发现。对于分承

包活动可能影响过程和

/

或产品质量特性的合 同，可能包括能力要求。

Auditors need to determine whether the organisation has identified new or changed

competence needs during surveillance audits.

在监督审核中，审核员需确定组织是否识别新的或变更的能力要求。

2

–

Are competent people assigned to those work place activities necessary to control the

quality characteristics of its processes and products?

是否是分配具备能力的人员以控制过程

和产品的质量特性？

Guidance -

Verify that some form of evaluation process is in place to ensure that the

competencies are appropriate to the organization's activities, and that the personnel

selected

as

competent

are

demonstrating

these

competencies.

Also,

the

process

should

ensure

that

any

deficiencies

are

being

acted

upon

and

the

effectiveness

of

personnel

is

being

measured.

Verify

that

the

activities

that

affect

quality

are

performed by persons selected as ce may be obtained throughout

the audit with an emphasis on those processes, activities, task and products where

human

intervention

may

have

the

greatest

impact.

The

auditor

may

review

job

descriptions,

testing

or

inspection

activities,

monitoring

activities,

records

of

management

reviews,

definition

of

responsibilities

and

authorities,

nonconformity

records, audit reports, customer complaints, processes validation records etc.

指南

-

验证这些评价过程的形式以确保其能力适于组织的活动，并且所选 择人员的能力

满足要求。同样，此过程 应确保能力不足已采取措施，人员的有效性已经过测量。验

证影响质量的活动由经过选择 有能力的人员执行。通过审核那些人员干涉有重大影响

的过程、活动、任务和产品来获得 证据。审核员可评价职位描述，测试或检验活动，

监视活动，管理评审记录，职责和权限 定义，不合格记录，审核报告，顾客投诉，过

程确认记录等。

3

- The organization needs to evaluate the effectiveness of

the

actions

taken

to

satisfy

the

competence needs

组织需评价所采取措施的有效性以满足能力需求

Guidance

-

The

organization

may

use

a

number

of

techniques

including

role-play,

peer

review,

observation,

reviews

of

training

and

employment

records

and/or

interviews (see ISO 19011, Table 2, for further examples). The appropriateness of a

particular

evaluation

method

will

depend

on

many

factors.

For

example,

training

records

could

be

viewed

to

verify

that

a

training

course

had

been

successfully

completed

(but

note,

this

alone

would

not

provide

evidence

that

the

trainee

is

competent).

However,

this

same

method

would

not

be

acceptable

to

evaluate

whether an auditor performed satisfactorily during an audit. Instead, this may require

observation,

peer

review,

interviews,

etc..

The

organization

may

need

to

demonstrate the attainment of competence of its personnel through a combination of

education, training and/or work experience.

指南－组织 可运用一定的技术包括角色扮演、同等评价、观察、培训评价和雇佣记录

和

/

或面试（见

ISO19011

）。评价方法应考虑很多方面。如可以看培训记录验证培训

课程是否已完成（但要注 意，这不能作为受训人员胜任的证据）。但是，同样的方法

用于评价审核员在审核期间是 否执行满足要求的审核是不可接受的。相反，这可能要

求观察、同等评价，面谈等。组织 需要通过结合教育、培训和

/

工作经验证明人员满足

< p>
能力要求。

4

–

Maintenance of competence

能力保持

.

Guidance

–

The

auditor

needs

to

verify

that

some

form

of

effective

monitoring

process is in place and being acted upon. Ways of doing this include a continuing

professional development process (such as the one described in ISO 19011), regular

appraisals

of

personnel

and

their

performance,

or

the

regular

inspection,

testing

or

auditing of product for which individuals or groups are responsible. Ongoing changes

in

competence

requirements

may

indicate

that

an

organization

is

proactive

in

maintaining personnel performance levels.

指南－审核员需验证监视过程和采取措施的有效性。包括持续 的专业提升过程（如

ISO19011

描述的一例），常规的人 员及其能力的评价，或负责常规检验，试验或

产品审核的个人或团体的能力评价。人员能 力要求的改变可显示组织在保持人员业

绩水平方面是正面积极的。

Auditing statutory and regulatory

requ irements

审核法令法规要求

ISO 9001:2000 requires an organization to identify and control the statutory and regulatory

requirements

applicable to its products (including services).

It is up to the organization

how to do this within its QMS.

ISO

9001:200 0

要求组织识别和控制与产品（包括服务）相关的法令和法规要求。依组织如何

在其质量管理体系中实施而定。

The organization should demonstrate that the statutory and regulatory requirements

applicable to its products / services have been properly identified, are available and

easily retrievable.

组织应证明适用于其产品

/

服务的法令法规要求已充分识别，可用并易于获取。

Auditors need to be aware of the general and specific statutory and regulatory requirements

applicableto the products/ services included within the scope of the QMS.

During the audit

preparation

phase,

the

audit

team

should

obtain

relevant

information

from

internal

or

external sources with respect to these statutory and regulatory requirements. This will allow

them to make a judgment on the suitability of the QMS to address such requirements. These

requirements need to be identified and integrated in the resource management and product

realization activities of the organization.

审核员需清楚质 量管理体系范围内产品

/

服务适用的一般和特殊的法令法规要求 。在审核准备

阶段，审核组应从内部或外部获取有关法令法规要求的信息。这些有助于判 定质量管理体系关

于法规要求的适宜性。这些要求需要被识别和整合进组织的资源管理和 产品实现活动中。

During the audit phase, the audit team should

在审核期间，审核组应

:

?

ensure that the organization has a methodology in place for identifying, maintaining and

updating all applicable statutory and regulatory requirements

确保组织的方法识别、保持

和更新 所有适用的法令和法规要求

?

ensure that these statutory and regulatory requirements are utilized as ?process inputs‘

while mo

nitoring ?process outputs‘ for compliance with requirements

确保这些法令法规要

求作为监视“过程输出“符合要求时的过程 输入

?

ensure that any claimed compliance to standards, statutory and regulatory requirements

etc. are properly

demonstrated

by

the

organization

确保宣称符合标准、法令和法规要求

等的组织已被充分证明

?

if evidence is found

, during the audit, that specific information regarding statutory and

regulatory

requirements

has

not

been

taken

into

account,

the

auditors

should

issue

a

nonconfor mity

如果在审核期间发现关于法令法规要求没有纳入的证据时，审核员应发出

不符合项

?

the

auditors

should

also

issue

a

nonconformity

if

a

non

compliance

with

such

requirements is directly identified

如果不符合识别的要求，审核员也应发出不符 合

.

Auditors

should

avoid

making

statements

about

what

statutory

or

regulatory

requirements

are applicable to the products/ services of the organization, or about methods of compliance,

because

of

possible

liability

审核员应避免陈述有关法令法规适用于组织的产品

/

服务，或 关

于符合的方法，因为

可能存在责任

.

Nonconformities should be issued only in situations where identification has been

made of system deficiencies or of direct violations in respect of statutory and

regulatory requirements applying to the products/ services of the organization.

只有系

统缺乏识别或违背与组织产品

/

服务适用的法令法规要求时才可发出不符合。

However, if a non-compliance with other kinds of statutory requirements (e.g. health and

safety, environment, etc.) is, co- incidentally, detected during the audit, this fact cannot be

ignored by the audit team. It should bereported without delay to the auditee and, if required,

to the audit client.

但是，如果审核期间发现不符合其它的法规要求（如健康和安全，环境

< br>等），审核组不能忽视。应即刻向受审核方报告，有要求时，向审核委托方报告。

Auditing Quality Policy and Quality Obj ectives

审核质量方针

和质量目标

The

quality

policy

and

its

effective

deployment

can

only

be

truly

assessed

based

on

the

overall results of the audit.

基于审核的整体结果可评价质量方针及其有效展开。

Audit methods should include

审核方法包括

:

-

Interviewing

Top

Management

to

understand

their

approach

and

commitment

to

quality

(click here to link to the guidance paper on the auditing of Top Management

processes)

与最高管理层面谈了解他们的质量意图和承诺。

-

Evaluating,

through

the

records

of

the

management

review,

the

commitment

and

involvement

of

Top

Management

in

the

establishment,

implementation,

monitoring

and

updating

of

the

quality

policy

通过管理评审的记录，评价最高管理层的承诺和 参

与质量方针的建立，实施，监视和更新。

-

A

ssessing

if

the

Management

has

effectively

―translated‖

the

quality

policy

into

understandable

words

and

guidelines

at

all

levels

of

the

organization,

with

corresponding objectives at each applicable function / level.

评价管理者是否有效地用

易理解的语言在组织内解释和指引质量方针，并在每个适当的职能、阶层建立相应的

目标。

Conducting

interviews

with

personnel

to

verify

if

they

have

appropriate

awareness,

understanding and knowledge of the way the organization‘s quality policy

relates to

their

own

activity,

regardless

of

the

terms

used

by

such

people

to

express

their

understanding.

< br>与员工谈话以验证他们是否适当地意识，了解和认识组织的质量方针与

其活动的关 系，不管他们用何术语来表达他们的理解。

-

Seeking

evidence

of

effective

dissemination

of

the

quality

policy

by

appropriate

communication.

用适当的沟通方式寻找质量方针有效发布的证据。

Auditing quality objectives

审核质量目标

The audit team needs

to

verify

that

the

organization‘s

overall

quality

objectives

have

been

defined;

that

they

reflect

the

quality

policy,

are

coherent,

aligned

and

compatible

with

the

overall

business

objectives,

including

customer

expectations.

The

audit

team

should

verify

that there is substantial alignment and compatibility between the quality objectives and the

overall

business

objectives.

If

this

is

not

the

case,

the

auditors

should

analyse

further

the

Top

Management

commitment

to

quality.

审核组需要 验证组织确定的整体质量目标，反映质

量方针的意图，与总体业务目标相关连一致，包括 顾客期望。审核组应验证质量目标和总体业

务目标间的关联一致性。如果不是这种状况， 审核员应进一步分析最高管理层对质量的承诺。

The quality objectives need to be measurable and documented.

质量目标应是可测量的，并

形成文件 化。

There is no specified way of documenting the quality objectives, these may appear through

business

plans,

manage

ment

review

outputs,

annual

budgets,

etc….

It

is

up

to

the

audit

team to satisfy itself that the objectives are adequately documented.

质量目标文件化没有特

定的方法，可以透过计划，管理评审输出，年度预 算等显示。审核组要使自己确信目标已充分

文件化。

The

auditors

should

obtain

evidence

of

the

way

the

quality

objectives

are

appropriately

cascaded throughout the organization structure and processes, linking the general strategic

objectives to management objectives and down to specific operational activities.

审核员应获

得证据确认质量目标已适当地分解到组织的结构和过程，结合管理战略目标 及具体的操作活

动。

It

is

recommended

that

the

documented

quality

objectives

should

be

examined

at

the

documentation review stage of the audit.

建议审核的文件评审阶段，应评价文件化质量 目标。

Before the end of the audit, the audit team has to satisfy itself that the quality objectives are

realistic

and

that

the

organization

has

assigned

to

responsible

personnel

appropriate

resources

to

meet

their

objectives.

It

is

appropriate

to

sample

this

at

all

levels

of

the

organization.

审核结束前，审核组应使自己确信质量目标是可实现的，组织已指派负责人员，

配备必 要的资源以满足目标。在组织的各阶层抽样检查是必要的。

Quality objectives are not static and need to be updated in the light of the current business

climate and the quest for continual improvement. The audit team should verify if the overall

organization

performance

reflects

the

aims

of

the

quality

policy

and

reasonably

meets

the

quality

objec tives.

考虑到当前的业务氛围和持续改进的要求，质量目标不是静态的，需要更< /p>

新。审核组应验证整个组织反映质量方针的意图和满足质量目标的业绩表现。

The auditors should keep in mind that the objectives can be measured in a quantitative or

qualitative

manner.

They

should

also

remember

that

there

is

a

clear

link

between

the

dynamic aspect of revising the quality policy and the quality objectives and the commitment

of the organization to continual improvement.

审核员应注 意质量目标是可测量的定量或定性的方式。应记住修订质量方针和质量目标的动态

因素和 组织持续改进承诺是相关联的

。

Auditing the control of monitoring

-

and measuring devices

审核监视和测量装置的控制

The following information is provided as guidance for auditingthe processes

associated with control of monitoring and measuring devices, and on the potential

exclusion of clause 7.6 from the scope of an organization‘s quality management

system

.

以下信息提供了审核相关监视和测量装置控制过程和组织的质量管理体系可能删减条

款

7.6

的指南。

In auditing these processes, it is important for the auditor to understand the

difference between

审核这些过程，审核员 理解以下的区别是很重要的

:

?

―

monitoring

‖ and ―

measurement

‖, and

监视和测量

?

―

equipment

‖ and ―

device

s‖

设备和装置

.

a) monitoring and measurement

监视和测量

?

monitoring

implies observing, supervising, keeping under review (using

monitoring devices); it can involve measuring or testing at intervals, especially

for the purpose of regulation or control

监视是指观察，监督，评审状态下的维 持

(

使用监视装置

)

< br>，可包括定期的测量或试验，尤其是调整或控制目的。

?

measurement

considers the determination of a physical quantity, magnitude or

dimension (using measuring equipment).

测量考虑物理量，量级或尺寸的规定

(

使用测量设备

)

b) devices and equipment

装置和设备

?

devices

: A device may deliver either qualitative (attribute based) or quantitative

results. Examples of devices include

装置可显示或定性

(

特性装置

)

，或定 量的结

果，例如装置包括

-

physical devices, e.g. a ship's flotation/load line, an overflow

物理装置，如船的浮线、载重线，溢水管

-

non-physical devices, e.g. records of the rate of customer returns, survey

questionnaires

非物理装置，如客户退货率的记录， 调查问卷

-

equipment or ―measuring equipment‖, see below;

设备或测量设备，见以下

?

equipment

: For the purposes of ISO 9001 equipment is regarded as a subset of

devices. Equipment may be separated into two categories:

设备：

ISO9001

中的设备被视为装置的 一部分。设备可分成两种

-

indicative equipment, for example an emergency flashing lamp, an electrical

power on/off indicator, a

显示设备，如应急灯，电源开关指示，止通规，水平显示表

-

―measuring equipment‖, defined in ISO 9000, clause 3.10.4 as follows:

测量 设备，

ISO9000

条款

3.10. 4

定义如下：

―

measuring instrument, software, measurement standard, reference material or

auxiliary apparatus or combination thereof necessary to realize a measurement

process”

测量工具，软件，测量标准，相关材料或辅助设备，或为实现 测量过程

以上几种的结合。

Various parts of clause 7.6 address the topics of monitoring and measurement,

devices and equipment. The first two paragraphs address all of these items. The

third paragraph, including bullets a) to e), and the first two sentences of the fourth

paragraph, are only directed at ―measuring equipment‖. The last sentence of the

fourth paragraph and the final paragraph once again address all of them. The

standard is clear in this respect, but its correct interpretation requires the auditor to

make a close analysis of its precise wo rding.

条款

7.6

各部分描述了 监视和测量，装置