EN 15224-2016 en Quality management systems - EN ISO 9001 2015 for healthcare《质量管理系统-EN ISO 9001 2015医疗保健》.pdf

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1、BS EN 15224:2016Quality management systems EN ISO 9001:2015 forhealthcareBSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN 15224:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 15224:2016. It supersedes BS EN 15224:2012

2、which is withdrawn.BSI, as a member of CEN, is obliged to publish EN 15224:2016 as a British Standard. However, attention is drawn to the fact that during the development of this European Standard, the UK committee voted against its approval as a European Standard.The UK committee submitted a negati

3、ve vote at the last stage of voting due to their concerns that the wording of the title and scope are confusing. It is not clearly defined what is classed as healthcare and this could raise potential confusion with standards that define quality management systems applicable to healthcare products. T

4、he UK committee prefers the previous title of EN 15224:2012, Health care servicesQuality management systemsRequirements based on EN ISO 9001:2008.This version implements CEN correction notice 25 January 2017, which implements corrections to cross-references in sub-clauses 0.1.1, 3.8.2, 3.15 and Anne

5、x E.The UK participation in its preparation was entrusted by Technical Committee CH/100, Healthcare and Medical Equipment, to Subcommittee CH/100/-/2, Healthcare services - Quality management systems.A list of organizations represented on this subcommittee can be obtained on request to its secretary

6、.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017. Published by BSI Standards Limited 2017ISBN 978 0 580 92703 4ICS 03.100.70; 03.120.10; 11.020.01Compliance with a Briti

7、sh Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 February 2017.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15

8、224 December 2016 ICS 03.100.70; 03.120.10; 11.020.01 Supersedes EN 15224:2012English Version Quality management systems - EN ISO 9001:2015 for healthcare Services de sant - Systmes de management de la qualit - Application de lEN ISO 9001:2015 aux soins de sant Qualittsmanagementsysteme - EN ISO 900

9、1:2015 fr die Gesundheitsversorgung This European Standard was approved by CEN on 20 December 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-

10、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 European Standard exists in three official versions (English, French, German). A version in any other language made by transl

11、ation 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 the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland

12、, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION C

13、OMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15224:2016 EEN 15224:2016 (E) 3 A.2 Products and ser

14、vices . 57 A.3 Understanding the needs and expectations of interested parties 57 A.4 Risk-based thinking and systematic clinical risk management 58 A.5 Applicability . 58 A.6 Documented information 59 A.7 Organizational knowledge 59 A.8 Control of externally provided healthcare products and services

15、 . 60 Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176 61 Annex C (informative) Correlation matrix EN 15224:2012 to EN ISO 9001:2015 to EN 15224:2016 . 65 Annex D (informative) Quality requirements and quality characteri

16、stics in healthcare 71 Annex E (informative) Guidance for process approach in healthcare . 74 E.1 Background . 74 E.2 Processes and workflow in general . 74 E.3 Clinical Processes 75 E.4 Analysis and management of clinical processes . 79 Bibliography . 82 EN 15224:2016 (E) 2 Contents European forewo

17、rd . 4 Introduction 5 1 Scope 15 2 Normative references 16 3 Terms and definitions . 16 4 Context of the organization . 27 4.1 Understanding the organization and its context . 27 4.2 Understanding the needs and expectations of interested parties 28 4.3 Determining the scope of the quality management

18、 system 28 4.4 Quality management system and its processes . 28 5 Leadership . 29 5.1 Leadership and commitment. 29 5.2 Policy. 31 5.3 Organizational roles, responsibilities and authorities 31 6 Planning . 32 6.1 Actions to address risks and opportunities . 32 6.2 Quality objectives and planning to

19、achieve them 33 6.3 Planning of changes . 34 7 Support . 34 7.1 Resources 34 7.2 Competence . 36 7.3 Awareness. 37 7.4 Communication 37 7.5 Documented information 38 8 Operation . 40 8.1 Operational planning and control 40 8.2 Requirements for products and services 41 8.3 Design and development of p

20、roducts and services 43 8.4 Control of externally provided healthcare processes, products and services . 45 8.5 Production and service provision 47 8.6 Release of products and services . 49 8.7 Control of nonconforming outputs . 50 9 Performance evaluation . 51 9.1 Monitoring, measurement, analysis

21、and evaluation 51 9.2 Internal audit 52 9.3 Management review 52 10 Improvement 54 10.1 General . 54 10.2 Nonconformity and corrective action . 54 10.3 Continual improvement . 55 Annex A (informative) Clarification of new structure, terminology and concepts . 56 A.1 Structure and terminology . 56 BS

22、 EN 15224:2016EN 15224:2016 (E)EN 15224:2016 (E) 3 A.2 Products and services . 57 A.3 Understanding the needs and expectations of interested parties 57 A.4 Risk-based thinking and systematic clinical risk management 58 A.5 Applicability . 58 A.6 Documented information 59 A.7 Organizational knowledge

23、 59 A.8 Control of externally provided healthcare products and services . 60 Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC 176 61 Annex C (informative) Correlation matrix EN 15224:2012 to EN ISO 9001:2015 to EN 15224:2016

24、 . 65 Annex D (informative) Quality requirements and quality characteristics in healthcare 71 Annex E (informative) Guidance for process approach in healthcare . 74 E.1 Background . 74 E.2 Processes and workflow in general . 74 E.3 Clinical Processes 75 E.4 Analysis and management of clinical proces

25、ses . 79 Bibliography . 82 EN 15224:2016 (E) 2 Contents European foreword . 4 Introduction 5 1 Scope 15 2 Normative references 16 3 Terms and definitions . 16 4 Context of the organization . 27 4.1 Understanding the organization and its context . 27 4.2 Understanding the needs and expectations of in

26、terested parties 28 4.3 Determining the scope of the quality management system 28 4.4 Quality management system and its processes . 28 5 Leadership . 29 5.1 Leadership and commitment. 29 5.2 Policy. 31 5.3 Organizational roles, responsibilities and authorities 31 6 Planning . 32 6.1 Actions to addre

27、ss risks and opportunities . 32 6.2 Quality objectives and planning to achieve them 33 6.3 Planning of changes . 34 7 Support . 34 7.1 Resources 34 7.2 Competence . 36 7.3 Awareness. 37 7.4 Communication 37 7.5 Documented information 38 8 Operation . 40 8.1 Operational planning and control 40 8.2 Re

28、quirements for products and services 41 8.3 Design and development of products and services 43 8.4 Control of externally provided healthcare processes, products and services . 45 8.5 Production and service provision 47 8.6 Release of products and services . 49 8.7 Control of nonconforming outputs .

29、50 9 Performance evaluation . 51 9.1 Monitoring, measurement, analysis and evaluation 51 9.2 Internal audit 52 9.3 Management review 52 10 Improvement 54 10.1 General . 54 10.2 Nonconformity and corrective action . 54 10.3 Continual improvement . 55 Annex A (informative) Clarification of new structu

30、re, terminology and concepts . 56 A.1 Structure and terminology . 56 BS EN 15224:2016EN 15224:2016 (E)EN 15224:2016 (E) 4 European foreword This document (EN 15224:2016) has been prepared by Technical Committee CEN/TC 362, Health care services Quality management systems, the secretariat of which is

31、held by SIS. This document supersedes EN 15224:2012. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2017, and conflicting national standards shall be withdrawn at the latest by June 2017. At

32、tention 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 responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations

33、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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Ne

34、therlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. EN 15224:2016 (E) 5 Introduction 0.1 General The adoption of a quality management system is a strategic decision for a healthcare organization that can help to improve its ove

35、rall performance and provide a sound basis for sustainable development initiatives. The potential benefits to a healthcare organization of implementing a quality management system based on this standard are: a) the ability to consistently provide healthcare products and services that meet customer a

36、nd applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system requirements. This st

37、andard can be used by internal and external parties. It is not the intent of this standard to imply the need for: uniformity in the structure of different quality management systems; alignment of documentation to the clause structure of this standard; the use of the specific terminology of this stan

38、dard within the organization. This standard includes requirements for quality management but does not specify requirements for specific healthcare services. The quality management system requirements specified in this standard are supposed to be complemented by requirements for levels of healthcare

39、services . This standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. The process approach enables an organization to plan its clinical and other processes and their interactions. The PDCA cycle enables an organization to ensure that it

40、s processes are adequately resourced and managed and opportunities for improvement are identified and acted on. Risk-based thinking enables a healthcare organization to determine the factors that could cause its clinical and other processes and its quality management system to deviate from the plann

41、ed results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see A.4). Consistently meeting requirements and addressing future needs and expectations poses a challenge for healthcare organizations in an increasingly dynamic and

42、complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization. In this standard, the following verbal forms are used: “sha

43、ll” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability. BS EN 15224:2016EN 15224:2016 (E)EN 15224:2016 (E) 4 European foreword This document (EN 15224:2016) has been prepared by Technical Committee CEN/TC 362, Hea

44、lth care services Quality management systems, the secretariat of which is held by SIS. This document supersedes EN 15224:2012. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2017, and confli

45、cting national standards shall be withdrawn at the latest by June 2017. 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 responsible for identifying any or all such patent rights. According to t

46、he CEN/CENELEC Internal Regulations, the national standards organizations 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,

47、Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. EN 15224:2016 (E) 5 Introduction 0.1 General The adoption of a quality management system is a strateg

48、ic decision for a healthcare organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to a healthcare organization of implementing a quality management system based on this standard are: a) the ability to

49、consistently provide healthcare products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system requirements. This standard can be used by internal and external parties. It is not the intent of this standard to imply the need for: uniformity in the structure of different quality management syste