DIN EN 15224-2017 Quality management systems - EN ISO 9001 2015 for healthcare German version EN 15224 2016《质量管理体系 EN ISO 9001-2015医疗保健 德文版本EN 15224-2016》.pdf

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1、May 2017 English price group 31No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 03.100.70; 03.120.10; 11.020.01!%d=“

2、2659426www.din.deDIN EN 15224Quality management systems EN ISO 9001:2015 for healthcare;English version EN 15224:2016,English translation of DIN EN 15224:2017-05Qualittsmanagementsysteme EN ISO 9001:2015 fr die Gesundheitsversorgung;Englische Fassung EN 15224:2016,Englische bersetzung von DIN EN 152

3、24:2017-05Services de sant Systmes de management de la qualit Application de lEN ISO 9001:2015 aux soins de sant;Version anglaise EN 15224:2016,Traduction anglaise de DIN EN 15224:2017-05SupersedesDIN EN 15224:201212www.beuth.deDocument comprises 87 pagesDTranslation by DIN-Sprachendienst.In case of

4、 doubt, the German-language original shall be considered authoritative.04.17 DIN EN 15224:2017-05 2 A comma is used as the decimal marker. National foreword This document (EN 15224:2016) has been prepared by Technical Committee CEN/TC 362 “Health services Quality management systems”, (Secretariat: S

5、IS, Sweden). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-01-10 AA “Quality management systems in health care facilities”. This standard contains DIN EN ISO 9001:2015, Quality management systems R

6、equirements and interprets the requirements of this International Standard for healthcare and supplements these by additional regulations specific to the sector. It is a stand-alone standard to be used as a basis for certification in healthcare. This standard contains sector-specific requirements fo

7、r uniform structures and processes for healthcare at a European, transnational level, thus achieving standardization at a European level. However, the healthcare industry is largely excluded from European harmonization, and in addition, it is characterized by national and regional differences in med

8、ical tradition, by different supply systems, healthcare and social policy and national legislation concerning healthcare professions or, where relevant, country-specific organizational structure prescribed by law and the focussed services of a service provider in healthcare. In the light of the diff

9、erent medical approaches, while laying down requirements for a uniform structural procedure and setting out the context for service providers in healthcare in the member countries of CEN, this standard leaves the ways and the medical methodology of examination and treatment open. The regionally diff

10、erent preferences are reflected in the nationally different guidelines. Also, different national legislation in healthcare plays an important role. This is also the reason why there are national footnotes in this standard for situations in which there are nationally different concepts for reference

11、values. Examples are the indications of blood sugar levels in 3.13.1. Significantly different provisions are also often to be observed with country-specific legislative and non-legislative provisions or legal circumstances concerning informed consent of patients or data protection, for example. The

12、heading of A.8 deviates from the English reference version of EN 15224:2016: in the German version, the correct heading of DIN EN ISO 9001:2015, A.8 Steuerung von extern bereitgestellten Prozessen, Produkten und Dienstleistungen has been used. In the English reference version, the word “processes” i

13、s missing. DIN EN 15224:2017-05 3 The DIN Standards corresponding to the International Standards and publications referred to in this document are as follows: ISO 9000:2015 DIN EN ISO 9000:2015-11 ISO 9001 DIN EN ISO 9001 ISO 10001 DIN ISO 10001 ISO 10002 DIN ISO 10002 ISO 10003 DIN ISO 10003 ISO 10

14、004 DIN ISO 10004 ISO 10005 DIN ISO 10005 ISO 10006 DIN-Fachbericht ISO 10006 ISO 10007 DIN ISO 10007 ISO 10008 DIN ISO 10008 ISO 10012:2003 DIN ISO 10012:2004-03 ISO/TR 10017 DIN-Fachbericht ISO/TR 10017 ISO/IEC 27000:2009 DIN ISO/IEC 27000:2010-05 ISO/IEC 27001:2005 DIN ISO/IEC 27 ISO 31000 DIN IS

15、O 31000 ISO 37500 DIN ISO 37500 Amendments This standard differs from DIN EN 15224:2012-12 as follows: a) the content of the standard has been revised and all clauses, including the previous Annex A and the Bibliography have been updated; b) in Clauses 4, 5, 6, 8, 9 and 10, risk-based thinking has b

16、een included; c) two new subclauses on the the organization and its context have been included (4.1, 4.2); d) the reference to ISO 9001:2008 has been changed to read ISO 9001:2015 throughout the document; e) the standard has been editorially revised. Previous editions DIN EN 15224: 2012-12 DIN CEN/T

17、S 15224: 2006-02 DIN EN 15224:2017-05 4 National Annex NA (informative) Bibliography DIN EN ISO 9000:2015-11, Quality management systems Fundamentals and vocabulary (ISO 9000:2015) DIN EN ISO 9001, Quality management systems Requirements DIN ISO 10001, Quality management Customer satisfaction Guidel

18、ines for codes of conduct for organizations DIN ISO 10002, Quality management Customer satisfaction Guidelines for complaints handling in organizations DIN ISO 10003, Quality management Customer satisfaction Guidelines for dispute resolution external to organizations DIN ISO 10004, Quality managemen

19、t Customer satisfaction Guidelines for monitoring and measuring DIN ISO 10005, Quality management systems Guidelines for quality plans DIN-Fachbericht ISO 10006, Quality management systems Guidelines for quality management in projects DIN ISO 10007, Quality management systems Guidelines for configur

20、ation management DIN ISO 10008, Quality management Customer satisfaction Guidelines for business-to-consumer electronic commerce transactions DIN ISO 10012:2004-03, Measurement management systems Requirements for measurement processes and measuring equipment (ISO 10012:2003) DIN-Fachbericht ISO 1001

21、7, Guidance on statistical techniques for ISO 9001:2000 DIN ISO/IEC 27000:2010-05, Information technology Security techniques Information security management systems Overview and vocabulary (ISO/IEC 27000:2009) DIN ISO/IEC 27001:2007-02, Information technology Security techniques Information securit

22、y management systems Requirements (ISO/IEC 27001:2005) DIN ISO 31000, Risk management Principles and guidelines DIN ISO 37500, Guidance on Outsourcing EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15224 December 2016 ICS 03.100.70; 03.120.10; 11.020.01 Supersedes EN 15224:2012English Version

23、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 9001:2015 fr die Gesundheitsversorgung This European Standard was approved by CEN on 20 December

24、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-to-date lists and bibliographical references concerning such national standards may be obtaine

25、d 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 translation under the responsibility of a CEN member into its own language and notified to the CEN-C

26、ENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, I

27、taly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Av

28、enue 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) 2 Contents European foreword . 4 Introduction 5 1 Scope 15 2 Normative references 16 3 Terms and definitions . 16 4

29、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 system 28 4.4 Quality management system and its processes . 28 5 Leadership . 29 5.1 Lead

30、ership 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 achieve them 33 6.3 Planning of changes . 34 7 Support . 34 7.1 Resources 34 7.2 Competenc

31、e . 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 products and services 43 8.4 Control of externally provided healthcare processes, products

32、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 and evaluation 51 9.2 Internal audit 52 9.3 Management review 52 10 Improvement 54 10.1 Ge

33、neral . 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 DIN EN 15224:2017-05 EN 15224:2016 (E) 3 A.2 Products and services . 57 A.3 Understanding th

34、e 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 . 60 Annex B (informative) Oth

35、er 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 characteristics in healthcare 71 Annex E

36、(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 DIN EN 15224:2017-05 EN 15224:2016 (E) 4 European foreword This document (E

37、N 15224:2016) has been prepared by Technical Committee CEN/TC 362, Health 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 id

38、entical text or by endorsement, at the latest by June 2017, and conflicting 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 res

39、ponsible for identifying any or all such patent rights. According to the 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, Fin

40、land, 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 and the United Kingdom. DIN EN 15224:2017-05 EN 15224:2

41、016 (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 overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to a healthcare organization

42、 of implementing a quality management system based on this standard are: a) the ability to consistently provide healthcare products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risk

43、s 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 str

44、ucture of different quality management systems; alignment of documentation to the clause structure of this standard; the use of the specific terminology of this standard within the organization. This standard includes requirements for quality management but does not specify requirements for specific

45、 healthcare services. The quality management system requirements specified in this standard are supposed to be complemented by requirements for levels of healthcare services . This standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. T

46、he process approach enables an organization to plan its clinical and other processes and their interactions. The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed and opportunities for improvement are identified and acted on. Risk-based thinking ena

47、bles a healthcare organization to determine the factors that could cause its clinical and other processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (se

48、e A.4). Consistently meeting requirements and addressing future needs and expectations poses a challenge for healthcare organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addit

49、ion to correction and continual improvement, such as breakthrough change, innovation and re-organization. In this standard, the following verbal forms are used: “shall” indicates a requirement; “should” indicates a recommendation; “may” indicates a permission; “can” indicates a possibility or a capability. DIN EN 15224:2017-05 EN 15224:2016 (E) 6 Information marked as “NOTE” is for guidance in understanding or clarify