ISO 18091-2014 Quality management systems - Guidelines for the application of ISO 9001 2008 in local government《质量评估体系 当地政府的ISO 9001-2008应用指南》.pdf

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1、 ISO 2014 Quality management systems Guidelines for the application of ISO 9001:2008 in local government Systmes de management de la qualit Lignes directrices pour lapplication de lISO 9001:2008 la collectivit locale INTERNATIONAL STANDARD ISO 18091 First edition 2014-02-15 Reference number ISO 1809

2、1:2014(E) ISO 18091:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2014 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or post

3、ing on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyr

4、ightiso.org Web www.iso.org Published in Switzerland ISO 18091:2014(E) ISO 2014 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 1.1 General . 1 1.2 Application . 2 2 Normative references 2 3 T erms and definitions . 2 4 Quality management system 7 4.1 General requirement

5、s . 7 4.2 Documentation requirements 8 5 Management responsibility .11 5.1 Management commitment .11 5.2 Customer/citizen focus .12 5.3 Quality policy .12 5.4 Planning .13 5.5 Responsibility, authority and communication 14 5.6 Management review 15 6 Resource management 17 6.1 Provision of resources

6、.17 6.2 Human resources .18 6.3 Infrastructure 20 6.4 Work environment 20 7 Product/service realization .21 7.1 Planning of product/service realization 21 7.2 Customer/citizen-related processes .22 7.3 Design and development .24 7.4 Purchasing .29 7.5 Production and service provision 31 7.6 Control

7、of monitoring and measuring equipment 35 8 Measurement, analysis and improvement .36 8.1 General 36 8.2 Monitoring and measurement 36 8.3 Control of nonconforming product/service .39 8.4 Analysis of data 40 8.5 Improvement .41 Annex A (informative) Processes for the integral quality management of lo

8、cal government .44 Annex B (informative) Integral diagnostic, check-up, evaluation and follow-up system for development of reliable local governments 46 Bibliography .56 ISO 18091:2014(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standard

9、s 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 committee. International organiz

10、ations, 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 of electrotechnical standardization. The procedures used to develop this document and those intended for its fu

11、rther maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/direct

12、ives). 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 patent rights. Details of any patent rights identified during the development of the document will be in the

13、Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions relate

14、d to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is Technical Committee ISO/TC 176, Quality management and qua

15、lity assurance. This first edition of ISO 18901 cancels and replaces IWA 4:2009, which has been technically revised.iv ISO 2014 All rights reserved ISO 18091:2014(E) Introduction 0.1 General One of the great challenges that societies are facing today is the need to develop and maintain citizens conf

16、idence in their governments and their institutions. In this respect, local governments have a mission to make possible the development of sustainable local communities. Management of quality in local governments can result in sustainable economic prosperity and social development at local level, inc

17、luding deployment of, and interaction with, national and regional policies in a coherent and compatible way. Citizens expect to have a community providing all public products/services with quality, such as safety and security, roads in good conditions, availability of public transportation, ease and

18、 speed in processing of documents, transparency and public information, availability of health and education systems, infrastructure; they expect all their needs to be satisfied. Citizens expect to feel the local government represents them and that their community is well protected. It is possible t

19、o build stronger regional, national and even global government working from the local level, based on managing the quality of the public products/services and increasing the confidence of the citizens in their government at local, regional and national level. Achieving a high quality of local govern

20、ment enables the whole system of government to become stronger. Coherence of such approaches can help to create reliable and sustainable governments at local, regional and national level. This International Standard has been prepared to provide guidelines to local governments throughout the world fo

21、r understanding and implementing a quality management system that meets the requirements of ISO 9001:2008, in order to meet the needs and expectations of its citizens. Annex A provides information about typical local government processes. Annex B gives a description of a diagnostic model that can be

22、 used as a starting point for the implementation of an integral quality management system aimed at achieving reliable local government. The relative stages in the implementation of a quality management system and the role of this International Standard can be seen schematically in Figure 1. ISO 2014

23、 All rights reserved v ISO 18091:2014(E) Excellence models ISO 9004:2009 ISO 9001:2008 Reliability line Quality levels in Local Governments Not reliable Reliable Efficient Excellent ISO 18091:2013 Figure 1 Schematic diagram to show the positioning of this International Standardvi ISO 2014 All rights

24、 reserved ISO 18091:2014(E) In this International Standard, the text reproduced from ISO 9001:2008 is placed in boxes, in order to distinguish it from the specific guidance for local government given for each clause. ISO 9001:2008, Quality management systems Requirements Introduction 0.1 General The

25、 adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced by a) its organizational environment, changes in that environment, and the risks associated with that environ- ment, b

26、) its varying needs, c) its particular objectives, d) the products it provides, e) the processes it employs, f) its size and organizational structure. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation

27、. The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement. This International Standard can be used by internal and external

28、parties, including certification bodies, to assess the organizations ability to meet customer, statutory and regulatory requirements applicable to the product, and the organizations own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration

29、 during the development of this International Standard. The guidelines in this International Standard are intended to help local government organizations relate the concepts of quality management, as described in ISO 9000, ISO 9001, ISO 9004 and associated standards, with the practice and terminolog

30、y commonly deployed in the context of local government. NOTE 1 The use of the terms and definitions presented in these guidelines can vary according to the culture, practices and customs of each location and region in which the local government is located. See also the guidance on terminology found

31、in Reference 18. It is expected that a development plan or work programme in the short or medium term is received, understood and applied by the employees, officers and representatives of local government. However, the plan or programme itself does not ensure that the needs and expectations of the l

32、ocal community will be covered, if the processes needed for the effective implementation of such plans or programmes are deficient or non-existent. The need to avoid these deficiencies has motivated the elaboration of this International Standard to help local governments in the implementation of an

33、effective quality management system. This International Standard does not assume that local governments will seek certification of their quality management system, although they might choose to seek certification to ISO 9001:2008 if they wish. Internal quality audits can provide the verification of

34、compliance with the requirements, in conjunction with the control of complaints or claims from customers, users, citizens and the local community in general. Any quality management system will be influenced by the different policies, objectives, diverse work methods, resource availability and admini

35、strative practices that are specific for each local government. Therefore, it can be expected that the details of each quality management system will vary in each local government. It is not the detailed method of implementation of the quality management system that is important; what matters is tha

36、t the quality management system yields effective, consistent and reliable results. It is important that the quality management system is as simple as possible in order to function ISO 2014 All rights reserved vii ISO 18091:2014(E) properly, and it needs to be sufficiently understandable to meet the

37、policies and quality objectives of local government. In order to achieve the objective of a reliable, responsive and transparent local government, it is not necessary to seek certification to ISO 9001:2008, although this might be encouraged by regional or national government initiatives. Nor is it i

38、ntended that conformity to ISO 9001:2008 be regarded as a final objective in itself: once a local government has achieved a level that allows it to provide consistent, conforming products/services to the local community, it is important that it looks beyond conformance to requirements, and that it c

39、onsiders using ISO 9004 and/or other excellence models to improve its overall efficiency. NOTE 2 For a better understanding of excellence models, see ISO 9004:2009, Annex A (Self-assessment tool), and the models of quality prizes. According to ISO 9000:2005, in order for an organization to be succes

40、sful, it needs to be guided and controlled in a systematic and transparent way. This is particularly true for local government, where transparency and accountability to its customers/citizens are vital in order to gain their trust and confidence. Sustained success will only result from the implement

41、ation of an integral quality management system that addresses the needs and expectations of all interested parties. It is therefore important that the quality management system of a reliable and successful local government covers all activities and processes that can affect its ability to satisfy th

42、e needs and expectations of its customers/citizens, the statutory and regulatory requirements applicable to the product, and the local governments own requirements, as well as those of other interested parties, such as regional or national governments.viii ISO 2014 All rights reserved ISO 18091:2014

43、(E) 0.2 Process approach ISO 9001:2008, Quality management systems Requirements Introduction 0.2 Process approach This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer

44、satisfaction by meeting customer requirements. For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a pr

45、ocess. 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 inter- actions of these processes, and their management to produce the desired outcome, can be referred to as the “proc

46、ess approach“. An advantage of the process approach is the ongoing control that it provides over the linkage between the indi- vidual processes within the system of processes, as well as over their combination and interaction. When used within a quality management system, such an approach emphasizes

47、 the importance of a) understanding and meeting requirements, b) the need to consider processes in terms of added value, c) obtaining results of process performance and effectiveness, and d) continual improvement of processes based on objective measurement. The model of a process-based quality manag

48、ement system shown in Figure 1 illustrates the process link- ages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception

49、 as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level. NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows. Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizations policies. Do: implement the processes. Check: monitor a