SVENSK STANDARD SS-EN 15224:2012

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1 SVENSK STANDARD SS-EN 15224:2012 Fastställd/Approved: Publicerad/Published: (Korrigerad version/corrected version, November 2012) Utgåva/Edition: 1 Språk/Language: engelska/english ICS: ; ; Ledningssystem för kvalitet i hälso- och sjukvården Krav baserade på EN ISO 9001:2008 Health care services Quality management systems Requirements based on EN ISO 9001:2008

2 Standarder får världen att fungera SIS (Swedish Standards Institute) är en fristående ideell förening med medlemmar från både privat och offentlig sektor. Vi är en del av det europeiska och globala nätverk som utarbetar internationella standarder. Standarder är dokumenterad kunskap utvecklad av framstående aktörer inom industri, näringsliv och samhälle och befrämjar handel över gränser, bidrar till att processer och produkter blir säkrare samt effektiviserar din verksamhet. Delta och påverka Som medlem i SIS har du möjlighet att påverka framtida standarder inom ditt område på nationell, europeisk och global nivå. Du får samtidigt tillgång till tidig information om utvecklingen inom din bransch. Ta del av det färdiga arbetet Vi erbjuder våra kunder allt som rör standarder och deras tillämpning. Hos oss kan du köpa alla publikationer du behöver allt från enskilda standarder, tekniska rapporter och standardpaket till handböcker och onlinetjänster. Genom vår webbtjänst e-nav får du tillgång till ett lättnavigerat bibliotek där alla standarder som är aktuella för ditt företag finns tillgängliga. Standarder och handböcker är källor till kunskap. Vi säljer dem. Utveckla din kompetens och lyckas bättre i ditt arbete Hos SIS kan du gå öppna eller företagsinterna utbildningar kring innehåll och tillämpning av standarder. Genom vår närhet till den internationella utvecklingen och ISO får du rätt kunskap i rätt tid, direkt från källan. Med vår kunskap om standarders möjligheter hjälper vi våra kunder att skapa verklig nytta och lönsamhet i sina verksamheter. Vill du veta mer om SIS eller hur standarder kan effektivisera din verksamhet är du välkommen in på eller ta kontakt med oss på tel Standards make the world go round SIS (Swedish Standards Institute) is an independent non-profit organisation with members from both the private and public sectors. We are part of the European and global network that draws up international standards. Standards consist of documented knowledge developed by prominent actors within the industry, business world and society. They promote cross-border trade, they help to make processes and products safer and they streamline your organisation. Take part and have influence As a member of SIS you will have the possibility to participate in standardization activities on national, European and global level. The membership in SIS will give you the opportunity to influence future standards and gain access to early stage information about developments within your field. Get to know the finished work We offer our customers everything in connection with standards and their application. You can purchase all the publications you need from us - everything from individual standards, technical reports and standard packages through to manuals and online services. Our web service e-nav gives you access to an easy-to-navigate library where all standards that are relevant to your company are available. Standards and manuals are sources of knowledge. We sell them. Increase understanding and improve perception With SIS you can undergo either shared or in-house training in the content and application of standards. Thanks to our proximity to international development and ISO you receive the right knowledge at the right time, direct from the source. With our knowledge about the potential of standards, we assist our customers in creating tangible benefit and profitability in their organisations. If you want to know more about SIS, or how standards can streamline your organisation, please visit or contact us on phone +46 (0)

3 Europastandarden EN 15224:2012 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN 15224:2012. Denna standard ersätter SIS-CEN/TS 15224:2005, utgåva 1. The European Standard EN 15224:2012 has the status of a Swedish Standard. This document contains the official version of EN 15224:2012. This standard supersedes the Swedish Standard SIS-CEN/TS 15224:2005, edition 1. Denna korrigerade version innehåller följande ändring / This corrected version contains the following correction: Den svenska titeln är ändrad från: Ledningssystem för kvalitet i hälso- och sjukvården Vägledning för användning av EN ISO 9001:2008 till: Ledningssystem för kvalitet i hälso- och sjukvården Krav baserade på EN ISO 9001:2008 The Swedish title is changed from: Ledningssystem för kvalitet i hälso- och sjukvården Vägledning för användning av EN ISO 9001:2008 to: Ledningssystem för kvalitet i hälso- och sjukvården Krav baserade på EN ISO 9001:2008 Copyright / Upphovsrätten till denna produkt tillhör SIS, Swedish Standards Institute, Stockholm, Sverige. Användningen av denna produkt regleras av slutanvändarlicensen som återfinns i denna produkt, se standardens sista sidor. Copyright SIS, Swedish Standards Institute, Stockholm, Sweden. All rights reserved. The use of this product is governed by the end-user licence for this product. You will find the licence in the end of this document. Upplysningar om sakinnehållet i standarden lämnas av SIS, Swedish Standards Institute, telefon Standarder kan beställas hos SIS Förlag AB som även lämnar allmänna upplysningar om svensk och utländsk standard. Information about the content of the standard is available from the Swedish Standards Institute (SIS), telephone Standards may be ordered from SIS Förlag AB, who can also provide general information about Swedish and foreign standards. Denna standard är framtagen av kommittén för Ledningssystem för kvalitet i hälso- och sjukvården, SIS / TK 457. Har du synpunkter på innehållet i den här standarden, vill du delta i ett kommande revideringsarbete eller vara med och ta fram andra standarder inom området? Gå in på - där hittar du mer information.

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5 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN October 2012 ICS ; Supersedes 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 European Standard was approved by CEN on 13 July 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 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 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, 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 United Kingdom. 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. EN 15224:2012: E

6 SS-EN 15224: :2012 (E) (E) Provläsningsexemplar / Preview Contents Page Foreword...5 Introduction Quality in health care General The concept of "health" Health care Quality in health care The concept of "clinical" Clinical risk Health care specific preconditions Process approach General Process approach and improvements Compatibility with other standards Scope General Application Normative references Terms and definitions Quality management systems General requirements Documentation requirements General Quality manual Control of documents Control of records Management responsibility Management commitment Customer focus Quality policy Planning Quality objectives Quality management system planning Responsibility, authority and communication Responsibility and authority Management representative Internal communication Management review General Review input Review output Resource management Provision of resources Human resources General Competence, awareness and training Infrastructure Work environment Product realization

7 SS-EN 15224:2012 (E) (E) 7.1 Planning of product realization Customer-related processes Determination of requirements related to the product (health care service) Review of requirements related to the product (health care service) Customer communication Design and development Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Control of design and development changes Purchasing Purchasing process Purchasing information Verification of purchased service/product Production and service provision Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring equipment Measurement, analysis and improvement General Monitoring and measurement Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product (health care service) Control of non-conforming product (health care service) Analysis of data Improvement Continual improvement Corrective action Preventive action Annex A (informative) Correspondence between ISO 9001:2008 and EN Annex B (informative) Practical guide for the implementation of this standard in health care organizations B.1 General B.2 Preparation and planning B.2.1 General B.2.2 Leadership in quality B.2.3 Planning the quality management system set-up B.2.4 Education and training in quality management B.2.5 Customer focus B.2.6 Planning the documentation B.2.7 Provision of necessary resources B.3 Implementing the quality management system B.3.1 General B.3.2 Quality policy B.3.3 Quality characteristics and quality requirements in health care B.3.4 Quality objectives B.3.5 Personnel working for and on behalf of the organization B.3.6 Authority, responsibility and accountability B.3.7 Communication and information management B.3.8 Documenting the quality management system B.3.9 Process-oriented quality management

8 SS-EN 15224: :2012 (E) (E) Provläsningsexemplar / Preview B.4 Establishing the monitoring and evaluation system B.4.1 General B.4.2 Risk management B.5 Continual improvement B.5.1 General B.5.2 Analysis of collected data B.5.3 Management reviews B.5.4 Corrective action Annex C (informative) Correspondence between CEN/TS 15224:2005 and EN Bibliography

9 SS-EN 15224:2012 (E) (E) 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 text or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the latest by April 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. 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 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. 5

10 SS-EN 15224: :2012 (E) (E) Provläsningsexemplar / Preview Introduction 0.1 Quality in health care 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 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 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 care 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. 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 between 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 services - 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 understand 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 involved in achieving the organization's 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 organization s benefit. 6

11 SS-EN 15224:2012 (E) (E) 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 Identifying, understanding and managing interrelated processes as a system contributes to the organization s effectiveness and efficiency in achieving its objectives. f) Continual improvement Continual improvement of the organization s overall performance should be a permanent objective of the organization. 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 eight quality management principles form the basis for the quality management system standards within the ISO 9000 family 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 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 Health care In this standard health is not a stand alone concept 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 differ 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, rehabilitation and pharmacies Quality in health care Quality in general is defined as degree to which a set of inherent characteristics fulfils requirements. To make quality in health care measurable and testable the quality characteristics of clinical processes must be identified and described. In this standard the requirements of the patients or customers for health care services must be specified according to effectiveness, safety, availability, timeliness/accessibility, continuity of care, respect of patient values and preferences and appropriateness, Aspects of efficiency; fair distribution and evidence must be considered (3.14, Note 2). Where any of the above mentioned requirements can not be applied due to the nature of an organisation and its product this can be considered for exclusion. The requirements can be specified in quality objectives according to