EN 15224-2012 1875 Health care services - Quality management systems - Requirements based on EN ISO 9001 2008《医疗服务质量管理体系 要求根据 EN ISO 9001 2008》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 15224:2012Health care services Quality management systems Requirements based on EN ISO 9001:2008Copyright European Committee for Standardization Provided by IHS under licen

2、se with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 15224:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 15224:2012. It supersedes DD CEN/TS 15224:2005, which is withdrawn.The UK participation in its preparat

3、ion was entrusted to Technical Committee CH/100, Healthcare and medical equipment (European and International).A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Us

4、ers are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012.ISBN 978 0 580 73262 1 ICS 03.120.10; 11.020 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the

5、 authority of the Standards Policy and Strategy Committee on 30 November 2012.Amendments issued since publicationDate T e x t a f f e c t e dCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license fr

6、om IHS-,-,-BS EN 15224:2012EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15224 October 2012 ICS 03.120.10; 11.020 Supersedes CEN/TS 15224:2005English Version Health care services - Quality management systems - Requirements based on EN ISO 9001:2008 Services de sant - Systmes de management de

7、la qualit - Exigences selon lEN ISO 9001:2008 Dienstleistungen in der Gesundheitsversorgung - Qualittsmanagementsysteme - Anforderungen nach EN ISO 9001:2008 This European Standard was approved by CEN on 13 July 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which st

8、ipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This Europea

9、n Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are t

10、he national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Roman

11、ia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means re

12、served worldwide for CEN national Members. Ref. No. EN 15224:2012: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 15224:2012EN 15224:2012 (E) 2 Contents Page Foreword 5 I

13、ntroduction .6 0.1 Quality in health care 6 0.1.1 General 6 0.1.2 The concept of “health“ 7 0.1.3 Health care 7 0.1.4 Quality in health care 7 0.1.5 The concept of “clinical“ .8 0.1.6 Clinical risk .8 0.1.7 Health care specific preconditions 8 0.2 Process approach . 10 0.2.1 General . 10 0.2.2 Proce

14、ss approach and improvements 11 0.3 Compatibility with other standards. 12 1 Scope . 13 1.1 General . 13 1.2 Application 13 2 Normative references . 14 3 Terms and definitions 14 4 Quality management systems . 18 4.1 General requirements . 18 4.2 Documentation requirements 19 4.2.1 General . 19 4.2.

15、2 Quality manual 20 4.2.3 Control of documents 20 4.2.4 Control of records. 21 5 Management responsibility . 21 5.1 Management commitment 21 5.2 Customer focus . 22 5.3 Quality policy 22 5.4 Planning . 22 5.4.1 Quality objectives . 22 5.4.2 Quality management system planning . 23 5.5 Responsibility,

16、 authority and communication . 23 5.5.1 Responsibility and authority . 23 5.5.2 Management representative 23 5.5.3 Internal communication . 24 5.6 Management review 24 5.6.1 General . 24 5.6.2 Review input 25 5.6.3 Review output . 25 6 Resource management 26 6.1 Provision of resources . 26 6.2 Human

17、 resources 26 6.2.1 General . 26 6.2.2 Competence, awareness and training 26 6.3 Infrastructure . 27 6.4 Work environment 27 7 Product realization 27 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without l

18、icense from IHS-,-,-BS EN 15224:2012EN 15224:2012 (E) 3 7.1 Planning of product realization 27 7.2 Customer-related processes 28 7.2.1 Determination of requirements related to the product (health care service) 28 7.2.2 Review of requirements related to the product (health care service) 29 7.2.3 Cust

19、omer communication 29 7.3 Design and development 30 7.3.1 Design and development planning 30 7.3.2 Design and development inputs 31 7.3.3 Design and development outputs 31 7.3.4 Design and development review 32 7.3.5 Design and development verification 32 7.3.6 Design and development validation 32 7

20、.3.7 Control of design and development changes 32 7.4 Purchasing . 32 7.4.1 Purchasing process 32 7.4.2 Purchasing information 33 7.4.3 Verification of purchased service/product . 33 7.5 Production and service provision . 33 7.5.1 Control of production and service provision . 33 7.5.2 Validation of

21、processes for production and service provision 34 7.5.3 Identification and traceability . 34 7.5.4 Customer property 35 7.5.5 Preservation of product 35 7.6 Control of monitoring and measuring equipment . 35 8 Measurement, analysis and improvement 36 8.1 General . 36 8.2 Monitoring and measurement 3

22、6 8.2.1 Customer satisfaction . 36 8.2.2 Internal audit 37 8.2.3 Monitoring and measurement of processes . 37 8.2.4 Monitoring and measurement of product (health care service) . 38 8.3 Control of non-conforming product (health care service) 38 8.4 Analysis of data . 38 8.5 Improvement 39 8.5.1 Conti

23、nual improvement 39 8.5.2 Corrective action . 39 8.5.3 Preventive action . 39 Annex A (informative) Correspondence between ISO 9001:2008 and EN 15224 . 41 Annex B (informative) Practical guide for the implementation of this standard in health care organizations . 45 B.1 General . 45 B.2 Preparation

24、and planning . 45 B.2.1 General . 45 B.2.2 Leadership in quality. 46 B.2.3 Planning the quality management system set-up 46 B.2.4 Education and training in quality management . 46 B.2.5 Customer focus . 47 B.2.6 Planning the documentation 47 B.2.7 Provision of necessary resources . 48 B.3 Implementi

25、ng the quality management system . 48 B.3.1 General . 48 B.3.2 Quality policy . 48 B.3.3 Quality characteristics and quality requirements in health care . 49 B.3.4 Quality objectives 50 B.3.5 Personnel working for and on behalf of the organization . 50 B.3.6 Authority, responsibility and accountabil

26、ity 51 B.3.7 Communication and information management 51 B.3.8 Documenting the quality management system 51 B.3.9 Process-oriented quality management . 53 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted with

27、out license from IHS-,-,-BS EN 15224:2012EN 15224:2012 (E) 4 B.4 Establishing the monitoring and evaluation system 55 B.4.1 General . 55 B.4.2 Risk management . 57 B.5 Continual improvement 58 B.5.1 General . 58 B.5.2 Analysis of collected data 59 B.5.3 Management reviews 59 B.5.4 Corrective action.

28、 59 Annex C (informative) Correspondence between CEN/TS 15224:2005 and EN 15224 60 Bibliography . 64 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 15224:2012EN 15224:2012

29、 (E) 5 Foreword This document (EN 15224:2012) has been prepared by Technical Committee CEN/TC 362, “Health services - Quality management systems”, the secretariat of which is held by SIS. This European Standard shall be given the status of a national standard, either by publication of an identical t

30、ext or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the latest by April 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsibl

31、e for identifying any or all such patent rights. This document supersedes CEN/TS 15224:2005. This document includes the text of ISO 9001 as published in 2008 by the International Organization for Standardization, ISO, and therefore may not be the last version published. According to the CEN/CENELEC

32、Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Icelan

33、d, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction

34、 or networking permitted without license from IHS-,-,-BS EN 15224:2012EN 15224:2012 (E) 6 Introduction 0.1 Quality in health care 0.1.1 General This is a sector specific quality management system standard for health care organizations. This standard incorporates EN ISO 9001:2008 and replaces CEN/TS

35、15224:2005 Health services Quality management systems Guide for the use of EN ISO 9001:2000. The text from EN ISO 9001:2008 in Clause 3 to Clause 8 is shown in black in this European Standard and additional text specific to health care services is in Clause 3 to Clause 8 shown in blue italics. This

36、is a stand alone standard and can be used for certification in health care. The requirements in this standard incorporate those from EN ISO 9001:2008 with additional interpretations and specifications for health care. Requirements have been added to and clarified according to the specific health car

37、e context. New requirements have been added when considered relevant. This standard also includes aspects related to clinical risk management throughout the planning, operation and control of processes. This quality management system does not include requirements specific to environmental management

38、. Therefore, it is recommended that organisations that apply a management system also apply an environmental management. The congruence and difference between this standard and EN ISO 9001:2008 is explained in this introduction and in cross reference table (Annex A). The congruence and difference be

39、tween CEN/TS 15224:2005 and this standard is explained in cross reference table (Annex C). A practical guide for the implementation of this standard in health care organizations is presented in Annex B. Further guidance for quality improvement approaches can be found in CEN/TR 15592:2007, Health ser

40、vices - Quality management systems - Guide for the use of EN ISO 9004:2000 in health services for performance Improvement. The following quality management principles from EN ISO 9000:2005 are applied in this standard: a) Customer focus Organizations depend on their customers and therefore should un

41、derstand current and future customer needs, should meet customer requirements and strive to exceed customer expectations. b) Leadership Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully invo

42、lved in achieving the organizations objectives. c) Involvement of personnel Staff at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit. Copyright European Committee for Standardization Provided by IHS under licen

43、se with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 15224:2012EN 15224:2012 (E) 7 d) Process approach A desired result is achieved more efficiently when activities and related resources are managed as a process. e) System approach to management Identif

44、ying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its objectives. f) Continual improvement Continual improvement of the organizations overall performance should be a permanent objective of the organization.

45、g) Factual approach to decision making Effective decisions are based on the analysis of data and information. h) Mutually beneficial supplier relationships An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. These

46、eight quality management principles form the basis for the quality management system standards within the ISO 9000 family. 0.1.2 The concept of “health“ The World Health Organization (WHO) definition of health is “a state of complete physical, mental and social well-being and not merely the absence

47、of disease or infirmity.” The International Classification of Functioning, Disability and Health (ICF), by WHO, identifies five health components; body function, body structure, activity, participation and environmental factors. 0.1.3 Health care In this standard health is not a stand alone concept

48、but is used in several terms as a prefix. When used as a prefix the concept of health is based on the health components in of ICF by WHO. The concept of health relates to both health care and social care. This standard is focused on requirements for health care. What is included in health care can d

49、iffer from country to country and this has to be considered in national applications. In this standard health care includes e.g. primary health care, pre-hospital and hospital care, tertiary care, nursing homes, hospices, preventive health care, mental health services, dental services, physiotherapy, occupational health services, rehabil