1、american national standardSEPTEMBER 2015ASQ/ANSI/ISO 9000:2015Quality management systems Fundamentals and vocabularyThis standard is an identical adoption of ISO 9000:2015AMERICAN NATIONAL STANDARD Quality management systems Fundamentals and vocabulary Approved as an American National Standard onSep
2、tember 9, 2015 American National Standards: An American National Standard implies a consensus of those substantially concerned with its scope and provisions. An American National Standard is intended as a guide to aid the manufacturer, the consumer, and the general public. The existence of an Americ
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11、ile is suitable for use by our customers. In the unlikely event that a problem relating to it is found, please inform ASQ at the address below.ASQ/ANSI/ISO 9000:2015ii rrrtrsw Foreword ivIntroduction v1 Scope .12 Fundamental concepts and quality management principles .12.1 General .12.2 Fundamental
12、concepts .2tts .2ttt .22.2.3 Context of an organization 22.2.4 Interested parties 22.2.5 Support .2tu .32.3.1 Customer focus 32.3.2 Leadership .42.3.3 Engagement of people .52.3.4 Process approach 62.3.5 Improvement.62.3.6 Evidence-based decision making 72.3.7 Relationship management .82.4 Developin
13、g the QMS using fundamental concepts and principles .92.4.1 QMS model 92.4.2 Development of a QMS 9tvu .10u 103.1 Terms related to person or people .103.2 Terms related to organization.11uu 133.4 Terms related to process .15uw .163.6 Terms related to requirement .183.7 Terms related to result 203.8
14、Terms related to data, information and document .233.9 Terms related to customer .253.10 Terms related to characteristic 263.11 Terms related to determination 273.12 Terms related to action .293.13 Terms related to audit30Annex A (informative) Concept relationships and their graphical representation
15、 33Bibliography .47Alphabetical index of terms .49iiiContents PageForewordISO (the International Organization for Standardization) is a worldwide federation of national standards committee has been established has the right to be represented on that committee. International organizations, government
16、al and non-governmental, in liaison with ISO, also take part in the work. electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed
17、 for the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). on the ISO list of patent declarations received (see www.iso.org/patents). constitute an endorsement. assessment, as well as information about ISOs adherence to World Trade Organization (WTO) principles in the T
18、echnical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 1, Concepts and terminology.This fourth edition cancels and replaces the thir
19、d edition (ISO 9000:2005), which has been rrrtrswiv Introduction Standard is intended to help the user to understand the fundamental concepts, principles and and realize value from other QMS standards. achieving satisfaction with its products and services. concepts described in 2.2. In 2.3 syx an al
20、phabetical index provided at the end of the document. Annex A includes a set of diagrams of the syx http:/www.iso.org/isoru44444rrr4 rrrtrswv(This page intentionally left blank.)Quality management systems Fundamentals and vocabulary1 Scope organizations and interested parties seeking to improve communication through a common r rs developers of related standards. s yx2 Fundamental concepts and quality management principles2.1 General accelerated change, globalization of markets and the emergence of knowledge as a principal resource. organizations reputation.
