AS NZS ISO 9000-2016 Quality management systems - Fundamentals and vocabulary.pdf

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1、AS/NZS ISO 9000:2016 (ISO 9000:2015, IDT) Australian/New Zealand Standard Quality management systems Fundamentals and vocabulary Superseding AS/NZS ISO 9000:2006 AS/NZS ISO 9000:2016AS/NZS ISO 9000:2016 This joint Australian/New Zealand standard was prepared by joint Technical Committee QR-008, Qual

2、ity Systems. It was approved on behalf of the Council of Standards Australia on 11 December 2015 and on behalf of the Council of Standards New Zealand on 11 December 2015. This standard was published on 26 February 2016. The following are represented on Committee QR-008: Association of Accredited Ce

3、rtification Bodies Australian Industry Group Australian Institute of Petroleum Australian Organisation for Quality Australian Prudential Regulation Authority Consumers Federation of Australia Engineers Australia Griffith University Housing NSW ISACA Joint Accreditation System of Australia and New Ze

4、aland Master Builders Australia Materials Australia New Zealand Organisation for Quality Royal Australian Chemical Institute University of Canterbury New Zealand University of Technology, Sydney University of Wollongong Keeping standards up to date Standards are living documents which reflect progre

5、ss in science, technology, and systems. To maintain their currency, all standards are periodically reviewed, and new editions are published. Between editions, amendments may be issued. Standards may also be withdrawn. It is important that readers assure themselves they are using a current standard,

6、which should include any amendments which may have been published since the standard was purchased. Detailed information about joint Australian/New Zealand standards can be found by visiting the standards webshop in Australia at .au or Standards New Zealands website at www.standards.co.nz. Alternati

7、vely, Standards Australia publishes an annual printed catalogue with full details of all current standards. For more frequent listings or notification of revisions, amendments, and withdrawals, Standards Australia and Standards New Zealand offer a number of update options. For information about thes

8、e services, users should contact their respective national standards organisation. We also welcome suggestions for improvement in our standards, and especially encourage readers to notify us immediately of any apparent inaccuracies or ambiguities. Please address your comments to the Chief Executive

9、of either Standards Australia or Standards New Zealand at the address shown on the title page. This standard was issued in draft form for comment as DR AS/NZS ISO 9000:2015.Australian/New Zealand Standard Quality management systems Fundamentals and vocabulary Originated in Australia as part of AS 10

10、571971. Originated in New Zealand as part of NZ 5604:1987. Reissued as part of AS/NZS 8402:1994. Previous edition AS/NZS ISO 9000:2006. Fifth edition 2016. COPYRIGHT Standards Australia Limited/Standards New Zealand All rights are reserved. No part of this work may be reproduced or copied in any for

11、m or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher, unless otherwise permitted under the Copyright Act 1968 (Australia) or the Copyright Act 1994 (New Zealand). Jointly published by SAI Global Limited under licence from Standards Aust

12、ralia Limited, GPO Box 476, Sydney, NSW 2001 and by Standards New Zealand, Private Bag 2439, Wellington 6140. ISBN (Print) 978-1-77664-404-9 ISBN (PDF) 978-1-77664-405-6 AS/NZS ISO 9000:2016 (ISO 9000:2015, IDT) PREFACE This Standard was prepared by the Standards Australia Committee QR-008. This Sta

13、ndard was prepared by the Joint Standards Australia/Standards New Zealand Committee QR-008, Quality Systems, to supersede AS/NZS ISO 9000:2006. The objective of this Standard is to describe the fundamental concepts and principles of quality management, and specify the terms and definitions that appl

14、y to all quality management and quality management system standards. This Standard is identical with, and has been reproduced from ISO 9000:2015, Quality management systemsFundamentals and vocabulary. As this Standard is reproduced from an International Standard, the following applies: (a) In the so

15、urce text this International Standard should read this Australian/New Zealand Standard. (b) A full point substitutes for a comma when referring to a decimal marker. None of the normative references in the source document have been adopted as Australian or Australian/New Zealand Standards. The term i

16、nformative has been used in this Standard to define the application of the Annex to which it applies. An informative Annex is only for information and guidance. ii AS/NZS ISO 9000:2016 CONTENTS ISO 9000:2015(E)Foreword iv Introduction v 1 Scope . 1 2 Fundamental concepts and quality management princ

17、iples . 1 2.1 General . 1 2.2 Fundamental concepts . 2 2.2.1 Quality . 2 2.2.2 Quality management system . 2 2.2.3 Context of an organization 2 2.2.4 Interested parties 2 2.2.5 Support . 2 2.3 Quality management principles . 3 2.3.1 Customer focus 3 2.3.2 Leadership . 4 2.3.3 Engagement of people .

18、5 2.3.4 Process approach 6 2.3.5 Improvement. 6 2.3.6 Evidence-based decision making 7 2.3.7 Relationship management . 8 2.4 Developing the QMS using fundamental concepts and principles . 9 2.4.1 QMS model 9 2.4.2 Development of a QMS 9 2.4.3 QMS standards, other management systems and excellence mo

19、dels .10 3 T erms and definitions 10 3.1 Terms related to person or people .10 3.2 Terms related to organization.11 3.3 Terms related to activity 13 3.4 Terms related to process .15 3.5 Terms related to system .16 3.6 Terms related to requirement .18 3.7 Terms related to result 20 3.8 Terms related

20、to data, information and document .23 3.9 Terms related to customer .25 3.10 Terms related to characteristic 26 3.11 Terms related to determination 27 3.12 Terms related to action .29 3.13 Terms related to audit30 Annex A (informative) Concept relationships and their graphical representation 33 Bibl

21、iography .47 Alphabetical index of terms .49 ISO 2015 All rights reserved iii Contents Page iii AS/NZS ISO 9000:2016 INTRODUCTION ISO 9000:2015(E) Introduction This International Standard provides the fundamental concepts, principles and vocabulary for quality management systems (QMS) and provides t

22、he foundation for other QMS standards. This International Standard is intended to help the user to understand the fundamental concepts, principles and vocabulary of quality management, in order to be able to effectively and efficiently implement a QMS and realize value from other QMS standards. This

23、 International Standard proposes a well-defined QMS, based on a framework that integrates established fundamental concepts, principles, processes and resources related to quality, in order to help organizations realize their objectives. It is applicable to all organizations, regardless of size, comp

24、lexity 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 interested parties, and in achieving satisfaction with its products and services. This International Standard contains seven quality

25、management principles supporting the fundamental concepts described in 2.2. In 2.3, for each quality management principle, there is a “statement” describing each principle, a “rationale” explaining why the organization would address the principle, “key benefits” that are attributed to the principles

26、, 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 management and QMS standards developed by ISO/TC 176, and other sector-specific QMS standards based on those standards, at the ti

27、me of publication. The terms and definitions are arranged in conceptual order, with an alphabetical index provided at the end of the document. Annex A includes a set of diagrams of the concept systems that form the concept ordering. NOTE Guidance on some additional frequently-used words in the QMS s

28、tandards developed by ISO/TC 176, 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_family.pdf ISO 2015 All rights reserved v iv AS/NZS ISO 9000:2016 AUSTRALIAN/NEW ZEALAND STANDARD Quality management sys

29、temsFundamentals and vocabulary Quality management systems Fundamentals and vocabulary 1 Scope This International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: organizations seeking sustained success through the im

30、plementation of a quality management system; customers seeking confidence in an 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; organization

31、s and interested parties seeking to improve communication through a common understanding of the vocabulary used in quality management; organizations performing conformity assessments against the requirements of ISO 9001; providers of training, assessment or advice in quality management; developers o

32、f related standards. This International Standard specifies the terms and definitions that apply to all quality management and quality management system standards developed by ISO/TC 176. 2 Fundamental concepts and quality management principles 2.1 General The quality management concepts and principl

33、es described in this International Standard give the organization the capacity to meet challenges presented by an environment that is profoundly different from recent decades. The context in which an organization works today is characterized by accelerated change, globalization of markets and the em

34、ergence of knowledge as a principal resource. The impact of quality extends beyond customer satisfaction: it can also have a direct impact on the organizations reputation. Society has become better educated and more demanding, making interested parties increasingly more influential. By providing fun

35、damental concepts and principles to be used in the development of a quality management system (QMS), this International Standard provides a way of thinking about the organization more broadly. All concepts, principles and their interrelationships should be seen as a whole and not in isolation of eac

36、h other. No individual concept or principle is more important than another. At any one time, finding the right balance in application is critical.ISO 9000:2015(E) ISO 2015 All rights reserved 1 1 COPYRIGHT AS/NZS ISO 9000:2016 ISO 9000:2015(E) 2.2 Fundamental concepts 2.2.1 Quality An organization f

37、ocused on quality promotes a culture that results in the behaviour, attitudes, activities and processes that deliver value through fulfilling the needs and expectations of customers and other relevant interested parties. The quality of an organizations products and services is determined by the abil

38、ity to satisfy customers and the intended and unintended impact on relevant interested parties. The quality of products and services includes not only their intended function and performance, but also their perceived value and benefit to the customer. 2.2.2 Quality management system A QMS comprises

39、activities by which the organization identifies its objectives and determines the processes and resources required to achieve desired results. The QMS manages the interacting processes and resources required to provide value and realize results for relevant interested parties. The QMS enables top ma

40、nagement to optimize the use of resources considering the long and short term consequences of their decision. A QMS provides the means to identify actions to address intended and unintended consequences in providing products and services. 2.2.3 Context of an organization Understanding the context of

41、 the organization is a process. This process determines factors which influence the organizations purpose, objectives and sustainability. It considers internal factors such as values, culture, knowledge and performance of the organization. It also considers external factors such as legal, technologi

42、cal, competitive, market, cultural, social and economic environments. Examples of the ways in which an organizations purpose can be expressed include its vision, mission, policies and objectives. 2.2.4 Interested parties The concept of interested parties extends beyond a focus solely on the customer

43、. It is important to consider all relevant interested parties. Part of the process for understanding the context of the organization is to identify its interested parties. The relevant interested parties are those that provide significant risk to organizational sustainability if their needs and expe

44、ctations are not met. Organizations define what results are necessary to deliver to those relevant interested parties to reduce that risk. Organizations attract, capture and retain the support of the relevant interested parties they depend upon for their success. 2.2.5 Support 2.2.5.1 General Top ma

45、nagement support of the QMS and engagement of people enables: provision of adequate human and other resources; monitoring processes and results;2 2 COPYRIGHT AS/NZS ISO 9000:2016 ISO 9000:2015(E) determining and evaluating of risks and opportunities; implementing appropriate actions. Responsible acq

46、uisition, deployment, maintenance, enhancement and disposal of resources support the organization in achieving its objectives. 2.2.5.2 People People are essential resources within the organization. The performance of the organization is dependent upon how people behave within the system in which the

47、y work. Within an organization, people become engaged and aligned through a common understanding of the quality policy and the organizations desired results. 2.2.5.3 Competence A QMS is most effective when all employees understand and apply the skills, training, education and experience needed to pe

48、rform their roles and responsibilities. It is the responsibility of top management to provide opportunities for people to develop these necessary competencies. 2.2.5.4 Awareness Awareness is attained when people understand their responsibilities and how their actions contribute to the achievement of

49、 the organizations objectives. 2.2.5.5 Communication Planned and effective internal (i.e. throughout the organization) and external (i.e. with relevant interested parties) communication enhances peoples engagement and increased understanding of: the context of the organization; the needs and expectations of customers and other relevant interested parties; the QMS. 2.3 Quality management principles 2.3.1 Customer focus 2.3.1.1 Statement The primary focus of quality management is to meet customer requirements and