ÍST EN 15224:2016 Gildistaka 15.3.2017 ICS: 3.12 Health care services - Quality management systems - Requirements based on EN ISO 9001:2015 Staðfestur af Staðlaráði Íslands Staðlaráð Íslands - Eftirprentun háð leyfi útgefanda
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM FINAL DRAFT FprEN 15224 April 2012 ICS 03.120.10; 11.020 Will supersede CEN/TS 15224:2005 English Version Health care services - Quality management systems - Requirements based on EN ISO 9001:2008 Services de santé - Systèmes de management de la qualité - Exigences selon l'en ISO 9001:2008 Dienstleistungen in der Gesundheitsversorgung - Qualitätsmanagementsysteme - Anforderungen nach EN ISO 9001:2008 This draft European Standard is submitted to CEN members for formal vote. It has been drawn up by the Technical Committee CEN/TC 362. If this draft becomes a European Standard, 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. This draft European Standard was established by CEN 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 the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation. Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN 15224:2012: E
Contents Page Foreword...5 Introduction...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 Process 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 4.2.2 Quality manual... 20 4.2.3 Control of documents... 20 4.2.4 Control of records... 20 5 Management responsibility... 21 5.1 Management commitment... 21 5.2 Customer focus... 21 5.3 Quality policy... 21 5.4 Planning... 22 5.4.1 Quality objectives... 22 5.4.2 Quality management system planning... 22 5.5 Responsibility, authority and communication... 22 5.5.1 Responsibility and authority... 22 5.5.2 Management representative... 23 5.5.3 Internal communication... 23 5.6 Management review... 24 5.6.1 General... 24 5.6.2 Review input... 24 5.6.3 Review output... 24 6 Resource management... 25 6.1 Provision of resources... 25 6.2 Human resources... 25 6.2.1 General... 25 6.2.2 Competence, awareness and training... 25 6.3 Infrastructure... 26 6.4 Work environment... 26 7 Product (health care service) realization... 26 2
7.1 Planning of product (health care service) realization... 26 7.2 Customer-related processes... 27 7.2.1 Determination of requirements related to the product (health care service)... 27 7.2.2 Review of requirements related to the product (health care service)... 28 7.2.3 Customer communication... 28 7.3 Design and development... 29 7.3.1 Design and development planning... 29 7.3.2 Design and development inputs... 29 7.3.3 Design and development outputs... 30 7.3.4 Design and development review... 30 7.3.5 Design and development verification... 31 7.3.6 Design and development validation... 31 7.3.7 Control of design and development changes... 31 7.4 Purchasing... 31 7.4.1 Purchasing process... 31 7.4.2 Purchasing information... 32 7.4.3 Verification of purchased service/product... 32 7.5 Production and service provision... 32 7.5.1 Control of production and service provision... 32 7.5.2 Validation of processes for production and service provision... 33 7.5.3 Identification and traceability... 33 7.5.4 Customer property... 34 7.5.5 Preservation of product... 34 7.6 Control of monitoring and measuring equipment... 34 8 Measurement, analysis and improvement... 35 8.1 General... 35 8.2 Monitoring and measurement... 35 8.2.1 Customer satisfaction... 35 8.2.2 Internal audit... 35 8.2.3 Monitoring and measurement of processes... 36 8.2.4 Monitoring and measurement of product (health care service)... 36 8.3 Control of non-conforming product (health care service)... 36 8.4 Analysis of data... 37 8.5 Improvement... 37 8.5.1 Continual improvement... 37 8.5.2 Corrective action... 37 8.5.3 Preventive action... 38 Annex A (informative) Correspondence between ISO 9001:2008 and EN 15224... 39 Annex B (informative) Practical guide for the implementation of this standard in health care organizations... 43 B.1 General... 43 B.2 Preparation and planning... 43 B.2.1 General... 43 B.2.2 Leadership of quality... 44 B.2.3 Planning the quality management system set-up... 44 B.2.4 Education and training for quality... 44 B.2.5 Customer focus... 45 B.2.6 Planning the documentation... 45 B.2.7 Provision of necessary resources... 46 B.3 Implementing the quality management system... 46 B.3.1 General... 46 B.3.2 Quality policy... 46 B.3.3 Quality characteristics and quality requirements in health care... 46 B.3.4 Quality objectives... 48 B.3.5 Personnel working for and on behalf of the organization... 48 B.3.6 Authority, responsibility and accountability... 48 B.3.7 Communication and information management... 49 B.3.8 Documenting the quality management system... 49 B.3.9 Process-oriented quality management... 50 3
B.4 Establishing the monitoring and evaluation system... 53 B.4.1 General... 53 B.4.2 Risk management... 55 B.5 Continual improvement... 56 B.5.1 General... 56 B.5.2 Analysis of collected data... 56 B.5.3 Management reviews... 56 B.5.4 Corrective action... 57 Annex C (informative) Correspondence between CEN/TS 15224:2005 and EN 15224... 58 Bibliography... 61 4
Foreword This document (FprEN 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 document is currently submitted to the Formal Vote. This document will supersede CEN/TS 15224:2005. 5