2024年4月28日发(作者：)

品質管理系統----ISO9004:2000條文

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 ational organizations,

governmental and non-governmental, in liaison with

ISO, also take part in the 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 3.

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 International Standard may be the

subject of patent rights. ISO shall not be held

responsible for identifying any or all such patent rights.

International Standard ISO9004 was prepared by

Technical Committee ISO/TC 176,Quality management

and quality assurance, subcommittee SC2, Quality

systems.

This second edition of ISO9004 cancels and replaces

ISO 9004-1:1994,which has been technically revised.

The title has been modified to reflect the

comprehensiveness of the quality management system.

Many of the existing International Standards within the

ISO9000 family will be reviewed for withdrawal, or for

re-issue as Technical Reports, as many of their

provisions are incorporated into this International

Standard.

In comparison to previous editions,ISO9001 and

ISO9004 now form a consistent pair of standards on

quality 9001 aims to give quality

assurance of product and to enhance customer

satisfaction, while ISO9004 uses a broader perspective

of quality management to give guidance for

performance improvement.

Annexes A and B of this International Standard are for

information only.

Introduction

0.1 General

The adoption of a quality management system should

be a strategic decision by the top management of an

organization. The design and implementation of

organization’s quality management system is influenced

by varying needs,particular objectives, the products

provided, the processes employed and the size and

structure of the organization. This international

Standard is based on eight quality management

前言

ISO (國際標準化組織) 是各國標準組織 (ISO成員)的國

際聯盟.國際標準的擬案工作通常是由ISO技術委員會

完成的.每個成員負責一個項目, 並成立技術委員會, 技

術委員會成員享有表決權.與ISO聯繫的政府和非政府

國際組織也參與了這些工作.ISO在所有電子技術標準

方面與國際電子技術委員會進行了(IEC)緊密合作.

國際標準的起草符合ISO/IEC指導第三部份所列原則.

標準草案必須經過至少75%成員投票通過才能被技術

委員會採納,並作為國際標準在成員組織中使用.

值得注意的是本國際標準中部分內容可能是專利的主

題.ISO將不對任一或所有此類專利負有鑑別責任.

ISO9004國際標準由質量管理和質量保證技術委員會

ISO/TC 176,品質系統附屬委員會SC2擬案完成.

ISO9004第二版取消和取代了ISO9004-1: 1994, 在技術

方面做了修訂. 修改標題以反映對品質管理系統的理

解.許多ISO9000家族的國際標準將作為技術報告被重

新審查, 以決定是否撤銷或再修訂, 其中的許多規定組

成了本國際標準.

與舊版本相比,新版ISO9001和ISO9004形成了一對協調

的品質管理標準.ISO9001注重于產品的品質保證和提

高顧客滿意度, 而ISO9004在品質管理更廣泛範圍內為

績效改善提供指導.

本國際標準中的附件A和B中所列內容僅供參考.

說明

0.1概述

品質管理系統的採用必須是組織高階管理階層的戰略

決策.組織品質管理系統的規劃和實施受很多方面的影

響, 這些方面包括需求變化, 特定目標, 所提供的產品,

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品質管理系統----ISO9004:2000條文

principles. However, it is not the intent of this

International Standard to imply uniformity in the

structure of quality management systems or uniformity

of documentation.

The purpose of an organization is

--to identify and meet the needs and expectations of its

customers and other interested parties(people in the

organization suppliers, owners, society),to achieve

competitive advantage, and to do this in an effective

and efficient manner, and

--to achieve, maintain, and improve overall

organizational performance and capabilities.

The application of quality management of quality

management principles not only provides direct benefits

but also makes an important contribution to managing

costs and risks. Benefit, cost and risk management

considerations are important for the organization, its

customers and other interested parties. These

considerations on overall performance of the

organization may impact

--customer loyalty,

--repeat business and referral,

--operational results such as revenue and market share,

--flexible and fast responses to market opportunities,

--costs and cycle times through effectives and efficient

use of resources,

--alignment of processes which will best achieve

desired results,

--competitive advantage through improved

organizational capabilities,

--understanding and motivation of people towards the

organization’s goals and objectives, as well as

participation in continual improvement,

--confidence of interested parties in the effectiveness

and efficiency of the organization, as demonstrated

by the financial and social benefits from the

organization’s performance, product life cycle, and

reputation,

--ability to create value for both the organization and its

suppliers by optimization of costs and resources as

well as flexibility and speed of joint responses to

changing markets.

0.2 Process approach

This International Standard promotes the adoption of a

process approach when developing, implementing and

improving the effectiveness and efficiency of a quality

management system to enhance interested party

satisfaction by meeting interested party requirements.

For an organization to function effectively and

efficiently, it has to identify and manage numerous

linked activities. An activity using resource, and

managed in order to enable the transformation of inputs

into outputs, is considered as a process. Often the

output from one process directly forms the input to the

next.

The application of a system of processes within an

organization, together with the identification and

所使用製程及組織的大小和結構. 本國際標準建立在

八大質量管理原則基礎上.然而, 本國際標準的目標並

不是統一品質管理系統的結構或統一文件.

組織的目的是

--鑑別顧客及其他相關組織 (供應者, 組織及社會人員)

的需求和期望, 以取得有競爭力的優勢, 並通過有效的

和有效率的方式去執行.

--建立、維持和改善組織整體績效和能力.

品質管理系統原則的應用不僅提供了直接的效益,而且

對成本和風險的管理有重要貢獻.效益、成本和風險的

管理考量對組織、顧客及其他相關團體很重要.組織全

面績效的考量可能影響到

--顧客信任度

--重複交易和安排

--運作結果如收入和市場份額

--對市場機遇的靈活與快速反應度

--通過資源的有效和有效率使用達成的成本和週轉次數

--最適于達成預期結果的製程調整

--通過組織能力提昇達成有競爭力的優勢

--了解和激發員工向組織方針和目標努力, 並參與持續

改進.

--組織的相關團體在有效性和效率方面的信心, 及源于

組織的績效、產品生命週期和名氣的經濟和社會效

益.

--通過合理化成本和資源及對市場變更的反應的靈活度

與速度,達成的組織和供應商創造價值的能力

0.2 過程方法

本標準促進過程方法應用于建立、實施和改善品質管理

系統的有效性和效率,以符合相關組織要求增強相關組

織滿意度.

一個組織運行要具有有效性和效率,則必須鑑別和管理

大量相關聯的活動.通過資源利用和管理以實現從輸入

到輸出的轉變的活動就可當作一個過程. 通常一個過

程的直接輸出形成下一個過程的輸入.

在組織內,過程系統的應用及這些過程的鑑別、相互作

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