ISO-9000-COLLECTION-1-2002.pdf
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1、INTERNATIONAL STANDARD ISO 9000 Second edition 2000-12-15 Reference number ISO 9000:2000(E) ISO 2000 Quality management systems Fundamentals and vocabulary Systmes de management de la qualit Principes essentiels et vocabulaire Copyright International Organization for Standardization Provided by IHS
2、under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/03/2007 05:24:18 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 9000:2000(E) ii ISO 2000 All rights reserved PDF disclaimer This PDF file may contain embedded typefaces. In a
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7、H-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/03/2007 0
8、5:24:18 MDTNo reproduction or networking permitted without license from IHS -,-,- ContentsPage 1Scope .1 2Fundamentals of quality management systems .1 2.1Rationale for quality management systems .1 2.2Requirements for quality management systems and requirements for products .1 2.3Quality management
9、 systems approach .2 2.4The process approach .2 2.5Quality policy and quality objectives 2 2.6Role of top management within the quality management system .3 2.7Documentation 4 2.8Evaluating quality management systems 4 2.9Continual improvement 5 2.10Role of statistical techniques .6 2.11Quality mana
10、gement systems and other management system focuses .6 2.12Relationship between quality management systems and excellence models .6 3Terms and definitions 7 3.1Terms relating to quality .7 3.2Terms relating to management 8 3.3Terms relating to organization .9 3.4Terms relating to process and product
11、10 3.5Terms relating to characteristics 12 3.6Terms relating to conformity 12 3.7Terms relating to documentation .14 3.8Terms relating to examination 15 3.9Terms relating to audit .16 3.10Terms relating to quality assurance for measurement processes 17 Annex AMethodology used in the development of t
12、he vocabulary.19 Bibliography 28 Alphabetical index 29 ISO 9000:2000(E) ISO 2000 All rights reserved iii Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/03/2007 05:24:18 MDTNo repr
13、oduction or networking permitted without license from IHS -,-,- ISO 9000:2000(E) iv ISO 2000 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards
14、 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 p
15、art 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 3. Draft International Standards adopted by th
16、e 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
17、 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 9000 was prepared by Technical Committee ISO/TC 176,Quality management and quality assurance, Subcommittee SC 1,Concepts and terminology. This second edition cancels and replac
18、es ISO 8402:1994. Annex A of this International Standard is for information only. It includes concept diagrams that provide a graphical representation of the relationships between terms in specific concept fields relative to quality management systems. Copyright International Organization for Standa
19、rdization Provided by IHS under license with ISO Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/03/2007 05:24:18 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 9000:2000(E) ISO 2000 All rights reserved v Introduction 0.1General The ISO 9000 fam
20、ily 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 specif
21、ies 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 eff
22、iciency 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
23、 of quality management system standards facilitating mutual understanding in national and international trade. 0.2Quality 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 i
24、mplementing 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 identi
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