[下载]9000：2005吐血奉献

yuank · 发表于 2006-1-7 15:42:05

ISO 9000:2005新版本标准 日前，国际标准化组织（ISO）发布ISO 9000:2005新版本标准,在国际标准9000族的基础上对质量管理体系定义术语词作了新的描述与编辑。　

　 ISO 9000:2005，质量管理体系-基础和术语，ISO 9000:2005，质量管理体系的基本原理如ISO 9000：2000版标准所述，未做任何改变，只是增加了一些定义，对解释的条款的内容已做了进一步扩充。例如:技术专家，要求，能力，合同，审核员，审核组，审核计划和审核范围等。

　　ISO技术委员会ISO/TC 176工作组负责ISO 9000标准的解释：这个新版本的主要内容是提供各种各样的管理体系标准所使用的关键术语和单个术语的明确解释，特别是国际标准组织9001:2000，质量管理系统-要求和ISO19011:2002质量及/或环境的管理系统审核的指南。

　　重编的ISO 2000：2005得到了IEC (国际电工委员会)的认可。

　　ISO 2000：2005版本出现了许多图表，所发生的这些变化证明标准已经被提高。

　　ISO9000族ISO 9000:2005的标准将对所有的用户是有用的，特别是下列方面:

　　-对供方、消费者和调整者提供质量管理的术语的解释；

　-评审质量管理体系（QMS）的人，或接受ISO9001:2000标准符合性审核的人，例如内审员，审核员，或调整者；

　　-咨询师或QMS培训人员。

[此贴子已经被作者于2006-1-7 15:56:33编辑过]

yuank · 发表于 2006-1-7 16:03:19

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INTERNATIONAL ISO

STANDARD 9000

Third edition

2005-09-15

Reference number

ISO 9000:2005(E)

Quality management systems —

Fundamentals and vocabulary

Systèmes de management de la qualité — Principes essentiels et

vocabulaire

ISO 9000:2005(E)

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ISO 9000:2005(E)

Contents Page

1 Scope .................... 1

2 Fundamentals of quality management systems ............................................................................... 1

2.1 Rationale for quality management systems ..................................................................................... 1

2.2 Requirements for quality management systems and requirements for products ........................ 1

2.3 Quality management systems approach ........................................................................................... 2

2.4 The process approach ........................................................................................................................ 2

2.5 Quality policy and quality objectives ................................................................................................ 2

2.6 Role of top management within the quality management system ................................................. 3

2.7 Documentation .... 4

2.8 Evaluating quality management systems ......................................................................................... 4

2.9 Continual improvement ...................................................................................................................... 5

2.10 Role of statistical techniques ........................................................................................................... 6

2.11 Quality management systems and other management system focuses ..................................... 6

2.12 Relationship between quality management systems and excellence models ............................ 6

3 Terms and definitions .......................................................................................................................... 6

3.1 Terms relating to quality ..................................................................................................................... 7

3.2 Terms relating to management .......................................................................................................... 8

3.3 Terms relating to organization ........................................................................................................... 9

3.4 Terms relating to process and product ........................................................................................... 11

3.5 Terms relating to characteristics ..................................................................................................... 12

3.6 Terms relating to conformity ............................................................................................................ 13

3.7 Terms relating to documentation ..................................................................................................... 14

3.8 Terms relating to examination ......................................................................................................... 15

3.9 Terms relating to audit ...................................................................................................................... 16

3.10 Terms relating to quality management or measurement processes .......................................... 18

Annex A (informative) Methodology used in the development of the vocabulary ................................ 20

Bibliography ............... 29

Alphabetical index ..... 30

ISO 9000:2005(E)

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

(ISO member bodies). The work of preparing International Standards is normally carried out through ISO

technical committees. Each member body interested in a subject for which a technical committee has been

established has the right to be represented on that committee. International organizations, governmental and

non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International

Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 9000 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance,

Subcommittee SC 1, Concepts and terminology.

This third edition cancels and replaces the second edition (ISO 9000:2000). It includes the changes accepted in

the Draft Amendment ISO/DAM 9000:2004.

Annex A includes concept diagrams that provide a graphical representation of the relationships between terms

in specific fields relative to quality management systems.

ISO 9000:2005(E)

Introduction

0.1 General

The ISO 9000 family of standards listed below has been developed to assist organizations, of all types and

sizes, to implement and operate effective quality management systems.

— ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality

management systems.

— ISO 9001 specifies requirements for a quality management system where an organization needs to

demonstrate its ability to provide products that fulfil customer and applicable regulatory requirements and

aims to enhance customer satisfaction.

— ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the quality management

system. The aim of this standard is improvement of the performance of the organization and satisfaction of

customers and other interested parties.

— ISO 19011 provides guidance on auditing quality and environmental management systems.

Together they form a coherent set of quality management system standards facilitating mutual understanding in

national and international trade.

0.2 Quality management principles

To lead and operate an organization successfully, it is necessary to direct and control it in a systematic and

transparent manner. Success can result from implementing and maintaining a management system that is

designed to continually improve performance while addressing the needs of all interested parties. Managing an

organization encompasses quality management amongst other management disciplines.

Eight quality management principles have been identified that can be used by top management in order to lead

the organization towards improved performance.

yuank · 发表于 2006-1-7 16:08:08

a) Customer focus

Organizations depend on their customers and therefore should understand current and future customer

needs, should meet customer requirements and strive to exceed customer expectations.

b) Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the

internal environment in which people can become fully involved in achieving the organization's objectives.

c) Involvement of people

People at all levels are the essence of an organization and their full involvement enables their abilities to be

used for the organization's benefit.

d) Process approach

A desired result is achieved more efficiently when activities and related resources are managed as a

process.

e) System approach to management

Identifying, understanding and managing interrelated processes as a system contributes to the

organization's effectiveness and efficiency in achieving its objectives.

ISO 9000:2005(E)

f) Continual improvement

Continual improvement of the organization's overall performance should be a permanent objective of the

organization.

g) Factual approach to decision making

Effective decisions are based on the analysis of data and information.

h) Mutually beneficial supplier relationships

An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the

ability of both to create value.

These eight quality management principles form the basis for the quality management system standards within

the ISO 9000 family.

INTERNATIONAL STANDARD ISO 9000:2005(E)

Quality management systems — Fundamentals and vocabulary

1 Scope

This International Standard describes fundamentals of quality management systems, which form the subject of

the ISO 9000 family, and defines related terms.

This International Standard is applicable to the following:

a) organizations seeking advantage through the implementation of a quality management system;

b) organizations seeking confidence from their suppliers that their product requirements will be satisfied;

c) users of the products;

d) those concerned with a mutual understanding of the terminology used in quality management (e.g.

suppliers, customers, regulators);

e) those internal or external to the organization who assess the quality management system or audit it for

conformity with the requirements of ISO 9001 (e.g. auditors, regulators, certification/registration bodies);

f) those internal or external to the organization who give advice or training on the quality management system

appropriate to that organization;

g) developers of related standards.

2 Fundamentals of quality management systems

2.1 Rationale for quality management systems

Quality management systems can assist organizations in enhancing customer satisfaction.

Customers require products with characteristics that satisfy their needs and expectations. These needs and

expectations are expressed in product specifications and collectively referred to as customer requirements.

Customer requirements may be specified contractually by the customer or may be determined by the

organization itself. In either case, the customer ultimately determines the acceptability of the product. Because

customer needs and expectations are changing, and because of competitive pressures and technical advances,

organizations are driven to improve continually their products and processes.

The quality management system approach encourages organizations to analyse customer requirements,

yuank · 发表于 2006-1-7 16:09:15

define the processes that contribute to the achievement of a product which is acceptable to the customer, and

keep these processes under control. A quality management system can provide the framework for continual

improvement to increase the probability of enhancing customer satisfaction and the satisfaction of other

interested parties. It provides confidence to the organization and its customers that it is able to provide products

that consistently fulfil requirements.

2.2 Requirements for quality management systems and requirements for products

The ISO 9000 family distinguishes between requirements for quality management systems and requirements

for products.

Requirements for quality management systems are specified in ISO 9001. Requirements for quality

management systems are generic and applicable to organizations in any industry or economic sector

regardless of the offered product category. ISO 9001 itself does not establish requirements for products.

ISO 9000:2005(E)

Requirements for products can be specified by customers or by the organization in anticipation of customer

requirements, or by regulation. The requirements for products and in some cases associated processes can be

contained in, for example, technical specifications, product standards, process standards, contractual

agreements and regulatory requirements.

2.3 Quality management systems approach

An approach to developing and implementing a quality management system consists of several steps including

the following:

a) determining the needs and expectations of customers and other interested parties;

b) establishing the quality policy and quality objectives of the organization;

c) determining the processes and responsibilities necessary to attain the quality objectives;

d) determining and providing the resources necessary to attain the quality objectives;

e) establishing methods to measure the effectiveness and efficiency of each process;

f) applying these measures to determine the effectiveness and efficiency of each process;

g) determining means of preventing nonconformities and eliminating their causes;

h) establishing and applying a process for continual improvement of the quality management system.

Such an approach is also applicable to maintaining and improving an existing quality management system.

An organization that adopts the above approach creates confidence in the capability of its processes and the

quality of its products, and provides a basis for continual improvement. This can lead to increased satisfaction

of customers and other interested parties and to the success of the organization.

2.4 The process approach

Any activity, or set of activities, that uses resources to transform inputs to outputs can be considered as a

process.

For organizations to function effectively, they have to identify and manage numerous interrelated and interacting

processes. Often, the output from one process will directly form the input into the next process. The systematic

identification and management of the processes employed within an organization and particularly the

interactions between such processes is referred to as the “process approach”.

The intent of this International Standard is to encourage the adoption of the process approach to manage an

organization.

Figure 1 illustrates the process-based quality management system described in the ISO 9000 family of

standards. This illustration shows that interested parties play a significant role in providing inputs to the

organization. Monitoring the satisfaction of interested parties requires the evaluation of information relating to

the perception of interested parties as to the extent to which their needs and expectations have been met. The

model shown in Figure 1 does not show processes at a detailed level.

2.5 Quality policy and quality objectives

Quality policy and quality objectives are established to provide a focus to direct the organization. Both

determine the desired results and assist the organization to apply its resources to achieve these results. The

quality policy provides a framework for establishing and reviewing quality objectives. The quality objectives

need to be consistent with the quality policy and the commitment to continual improvement, and their

achievement needs to be measurable. The achievement of quality objectives can have a positive impact on

product quality, operational effectiveness and financial performance and thus on the satisfaction and confidence

of interested parties.

ISO 9000:2005(E)

yuank · 发表于 2006-1-7 16:09:51

2.6 Role of top management within the quality management system

Through leadership and actions, top management can create an environment where people are fully involved

and in which a quality management system can operate effectively. The quality management principles (see

0.2) can be used by top management as the basis of its role, which is as follows:

a) to establish and maintain the quality policy and quality objectives of the organization;

b) to promote the quality policy and quality objectives throughout the organization to increase awareness,

motivation and involvement;

c) to ensure focus on customer requirements throughout the organization;

d) to ensure that appropriate processes are implemented to enable requirements of customers and other

interested parties to be fulfilled and quality objectives to be achieved;

e) to ensure that an effective and efficient quality management system is established, implemented and

maintained to achieve these quality objectives;

f) to ensure the availability of necessary resources;

g) to review the quality management system periodically;

h) to decide on actions regarding the quality policy and quality objectives;

i) to decide on actions for improvement of the quality management system.

NOTE Statements in parentheses do not apply to ISO 9001.

Figure 1 — Model of a process-based quality management system

ISO 9000:2005(E)

2.7 Documentation

2.7.1 Value of documentation

Documentation enables communication of intent and consistency of action. Its use contributes to

a) achievement of conformity to customer requirements and quality improvement,

b) provision of appropriate training,

c) repeatability and traceability,

d) provision of objective evidence, and

e) evaluation of the effectiveness and continuing suitability of the quality management system.

Generation of documentation should not be an end in itself but should be a value-adding activity.

2.7.2 Types of document used in quality management systems

The following types of document are used in quality management systems:

a) documents that provide consistent information, both internally and externally, about the organization's

quality management system; such documents are referred to as quality manuals;

b) documents that describe how the quality management system is applied to a specific product, project or

contract; such documents are referred to as quality plans;

c) documents stating requirements; such documents are referred to as specifications;

d) documents stating recommendations or suggestions; such documents are referred to as guidelines;

e) documents that provide information about how to perform activities and processes consistently; such

documents can include documented procedures, work instructions and drawings;

f) documents that provide objective evidence of activities performed or results achieved; such documents are

referred to as records.

Each organization determines the extent of documentation required and the media to be used. This depends on

factors such as the type and size of the organization, the complexity and interaction of processes, the

complexity of products, customer requirements, the applicable regulatory requirements, the demonstrated

ability of personnel, and the extent to which it is necessary to demonstrate fulfilment of quality management

system requirements.

2.8 Evaluating quality management systems

2.8.1 Evaluating processes within the quality management system

When evaluating quality management systems, there are four basic questions that should be asked in relation

to every process being evaluated.

a) Is the process identified and appropriately defined?

b) Are responsibilities assigned?

c) Are the procedures implemented and maintained?

d) Is the process effective in achieving the required results?

yuank · 发表于 2006-1-7 16:10:17

The collective answers to the above questions can determine the result of the evaluation. Evaluation of a quality

management system can vary in scope and encompass a range of activities, such as auditing and reviewing the

quality management system, and self-assessments.

ISO 9000:2005(E)

2.8.2 Auditing the quality management system

Audits are used to determine the extent to which the quality management system requirements are fulfilled.

Audit findings are used to assess the effectiveness of the quality management system and to identify

opportunities for improvement.

First-party audits are conducted by, or on behalf of, the organization itself for internal purposes and can form the

basis for an organization's self-declaration of conformity.

Second-party audits are conducted by customers of the organization or by other persons on behalf of the

customer.

Third-party audits are conducted by external independent organizations. Such organizations, usually

accredited, provide certification or registration of conformity with requirements such as those of ISO 9001.

ISO 19011 provides guidance on auditing.

2.8.3 Reviewing the quality management system

One role of top management is to carry out regular systematic evaluations of the suitability, adequacy,

effectiveness and efficiency of the quality management system with respect to the quality policy and quality

objectives. This review can include consideration of the need to adapt the quality policy and objectives in

response to changing needs and expectations of interested parties. The review includes determination of the

need for actions.

Amongst other sources of information, audit reports are used for review of the quality management system.

2.8.4 Self-assessment

An organization's self-assessment is a comprehensive and systematic review of the organization's activities

and results referenced against the quality management system or a model of excellence.

Self-assessment can provide an overall view of the performance of the organization and the degree of maturity

of the quality management system. It can also help to identify areas requiring improvement in the organization

and to determine priorities.

2.9 Continual improvement

The aim of continual improvement of a quality management system is to increase the probability of enhancing

the satisfaction of customers and other interested parties. Actions for improvement include the following:

a) analysing and evaluating the existing situation to identify areas for improvement;

b) establishing the objectives for improvement;

c) searching for possible solutions to achieve the objectives;

d) evaluating these solutions and making a selection;

e) implementing the selected solution;

f) measuring, verifying, analysing and evaluating results of the implementation to determine that the

objectives have been met;

g) formalizing changes.

Results are reviewed, as necessary, to determine further opportunities for improvement. In this way,

improvement is a continual activity. Feedback from customers and other interested parties, audits and review of

the quality management system can also be used to identify opportunities for improvement.

ISO 9000:2005(E)

2.10 Role of statistical techniques

The use of statistical techniques can help in understanding variability, and thereby can help organizations to

solve problems and improve effectiveness and efficiency. These techniques also facilitate better use of available

data to assist in decision making.

Variability can be observed in the behaviour and outcome of many activities, even under conditions of apparent

stability. Such variability can be observed in measurable characteristics of products and processes, and may be

seen to exist at various stages over the life cycle of products from market research to customer service and

final disposal.

Statistical techniques can help to measure, describe, analyse, interpret and model such variability, even with a

relatively limited amount of data. Statistical analysis of such data can help to provide a better understanding of

yuank · 发表于 2006-1-7 16:10:46

the nature, extent and causes of variability, thus helping to solve and even prevent problems that may result

from such variability, and to promote continual improvement.

Guidance on statistical techniques in a quality management system is given in ISO/TR 10017.

2.11 Quality management systems and other management system focuses

The quality management system is that part of the organization's management system that focuses on the

achievement of results, in relation to the quality objectives, to satisfy the needs, expectations and requirements

of interested parties, as appropriate. The quality objectives complement other objectives of the organization

such as those related to growth, funding, profitability, the environment and occupational health and safety. The

various parts of an organization's management system might be integrated, together with the quality

management system, into a single management system using common elements. This can facilitate planning,

allocation of resources, definition of complementary objectives and evaluation of the overall effectiveness of the

organization. The organization's management system can be assessed against the organization's management

system requirements. The management system can also be audited against the requirements of International

Standards such as ISO 9001 and ISO 14001. These management system audits can be carried out separately

or in combination.

2.12 Relationship between quality management systems and excellence models

The approaches of quality management systems given in the ISO 9000 family of standards and in

organizational excellence models are based on common principles. Both approaches

a) enable an organization to identify its strengths and weaknesses,

b) contain provision for evaluation against generic models,

c) provide a basis for continual improvement, and

d) contain provision for external recognition.

The difference between the approaches of the quality management systems in the ISO 9000 family and the

excellence models lies in their scope of application. The ISO 9000 family of standards provides requirements for

quality management systems and guidance for performance improvement; evaluation of quality management

systems determines fulfilment of those requirements. The excellence models contain criteria that enable

comparative evaluation of organizational performance and this is applicable to all activities and all interested

parties of an organization. Assessment criteria in excellence models provide a basis for an organization to

compare its performance with the performance of other organizations.

3 Terms and definitions

A term in a definition or note which is defined elsewhere in this clause is indicated by boldface followed by its

entry number in parentheses. Such a boldface term may be replaced in the definition by its complete definition.

For example:

ISO 9000:2005(E)

product (3.4.2) is defined as “result of a process (3.4.1)”;

process is defined as “set of interrelated or interacting activities which transforms inputs into outputs”.

If the term “process” is replaced by its definition, as follows:

product then becomes “result of a set of interrelated or interacting activities which transforms inputs into

outputs”.

A concept limited to a special meaning in a particular context is indicated by designating the subject field in

angle brackets, . ., before the definition.

EXAMPLE In the context of an audit, the term entry for technical expert is:

3.9.11

technical expert

.audit. person who provides specific knowledge or expertise to the audit team (3.9.10)

3.1 Terms relating to quality

3.1.1

quality

degree to which a set of inherent characteristics (3.5.1) fulfils requirements (3.1.2)

NOTE 1 The term “quality” can be used with adjectives such as poor, good or excellent.

NOTE 2 “Inherent”, as opposed to “assigned”, means existing in something, especially as a permanent characteristic.

3.1.2

requirement

need or expectation that is stated, generally implied or obligatory

NOTE 1 “Generally implied” means that it is custom or common practice for the organization (3.3.1), its customers (3.3.5)

yuank · 发表于 2006-1-7 16:12:19

and other interested parties (3.3.7), that the need or expectation under consideration is implied.

NOTE 2 A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality management

requirement, customer requirement.

NOTE 3 A specified requirement is one that is stated, for example in a document (3.7.2).

NOTE 4 Requirements can be generated by different interested parties (3.3.7).

NOTE 5 This definition differs from that provided in 3.12.1 of ISO/IEC Directives, Part 2:2004.

3.12.1

requirement

expression in the content of a document conveying criteria to be fulfilled if compliance with the document is to be

claimed and from which no deviation is permitted

3.1.3

grade

category or rank given to different quality requirements for products (3.4.2), processes (3.4.1) or systems

(3.2.1) having the same functional use

EXAMPLE Class of airline ticket and category of hotel in a hotel guide.

NOTE When establishing a quality requirement, the grade is generally specified.

3.1.4

customer satisfaction

customer's perception of the degree to which the customer's requirements (3.1.2) have been fulfilled

NOTE 1 Customer complaints are a common indicator of low customer satisfaction but their absence does not necessarily

imply high customer satisfaction.

ISO 9000:2005(E)

NOTE 2 Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily

ensure high customer satisfaction.

3.1.5

capability

ability of an organization (3.3.1), system (3.2.1) or process (3.4.1) to realize a product (3.4.2) that will fulfil

the requirements (3.1.2) for that product

NOTE Process capability terms in the field of statistics are defined in ISO 3534-2.

3.1.6

competence

demonstrated ability to apply knowledge and skills

NOTE The concept of competence is defined in a generic sense in this International Standard. The word usage can be

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