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1、ForewordISO (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 te
2、chnical 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
3、of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document
4、 was drafted in accordance with the editorial rules of the ISO/IECDirectives, Part2 (seewww.iso.org/directives).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 pate
5、nt rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (seewww.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not co
6、nstitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:www.iso.org/iso/fo
7、reword.html.The committee responsible for this document is Technical Committee ISO/TC176,Quality management and quality assurance, Subcommittee SC1,Concepts and terminology.This fourth edition cancels and replaces the third edition (ISO9000:2005), which has been technically revised.IntroductionThis
8、International Standard provides the fundamental concepts, principles and vocabulary for quality management systems (QMS) and provides the foundation for other QMS standards. This International Standard is intended to help the user to understand the fundamental concepts, principles and vocabulary of
9、quality management, in order to be able to effectively and efficiently implement a QMS and realize value from other QMS standards.This International Standard proposes a well-defined QMS, based on a framework that integrates established fundamental concepts, principles, processes and resources relate
10、d to quality, in order to help organizations realize their objectives. It is applicable to all organizations, regardless of size, complexity or business model. Its aim is to increase an organizations awareness of its duties and commitment in fulfilling the needs and expectations of its customers and
11、 interested parties, and in achieving satisfaction with its products and services.This International Standard contains seven quality management principles supporting the fundamental concepts described in2.2. In2.3, for each quality management principle, there is a “statement” describing each princip
12、le, a “rationale” explaining why the organization would address the principle, “key benefits” that are attributed to the principles, and “possible actions” that an organization can take in applying the principle.This International Standard contains the terms and definitions that apply to all quality
13、 management and QMS standards developed by ISO/TC176, and other sector-specific QMS standards based on those standards, at the time of publication. The terms and definitions are arranged in conceptual order, with an alphabetical index provided at the end of the document.AnnexAincludes a set of diagr
14、ams of the concept systems that form the concept ordering.NOTEGuidance on some additional frequently-used words in the QMS standards developed by ISO/TC176, and which have an identified dictionary meaning, is provided in a glossary available at:http:/www.iso.org/iso/03_terminology_used_in_iso_9000_f
15、amily.pdf1ScopeThis International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: organizations seeking sustained success through the implementation of a quality management system; customers seeking confidence in an
16、organizations ability to consistently provide products and services conforming to their requirements; organizations seeking confidence in their supply chain that product and service requirements will be met; organizations and interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management; organizations performing conformity assessments against the requ