EN 15224:2016

Quality management systems - EN ISO 9001:2015 for healthcare

This European Standard specifies requirements for a quality management system when a healthcare organization:
a)   needs to demonstrate its ability to consistently provide healthcare product or service that meets customer and applicable statutory and regulatory requirements, and
b)   aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer requirements, applicable statutory and regulatory requirements and requirements related to the quality characteristics; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical, psychological and social integrity; patient involvement; patient safety and timelines/accessibility.
NOTE 1   Statutory and regulatory requirements can be expressed as legal requirements.
Requirements related to material outputs such as tissue, blood products, pharmaceuticals, cell culture products and medical devices have not been focused in the scope of this standard as they are regulated elsewhere.
This standard is focused on requirements for clinical processes. Organizations that also include research or education processes, or both in their quality management system could use the requirements in this standard where applicable.
This standard aims to adjust and specify the requirements, as well as the “product and service” concept and customer perspectives in EN ISO 9001:2015 to the specific conditions for healthcare providing mainly services and where customers are mainly patients.

Qualitätsmanagementsysteme - EN ISO 9001:2015 für die Gesundheitsversorgung

Systèmes de management de la qualité - Application de l’EN ISO 9001:2015 aux soins de santé

La présente Norme internationale spécifie les exigences relatives au système de management de la qualité lorsqu’une organisation de soins de santé :
a)   doit démontrer son aptitude à fournir en permanence des produits ou des prestations de soins de santé conformes aux exigences du client et aux exigences légales et réglementaires applicables ; et
b)   vise à accroître la satisfaction de ses clients par l’application efficace du système, y compris les processus pour l’amélioration du système et l’assurance de la conformité aux exigences des clients, aux exigences légales et réglementaires applicables et aux exigences liées aux aspects qualitatifs : juste soins, disponibilité, continuité des soins, efficacité, efficience, équité, fondement des soins sur des preuves/connaissances, centrage des soins sur le patient, y compris son intégrité physique, psychologique et sociale, implication du patient, sécurité du patient et rapidité/accessibilité.
Toutes les exigences de la présente Norme internationale sont génériques et prévues pour s’appliquer à toute organisation de soins de santé, quels que soient son type ou sa taille, ou les produits et services qu’elle fournit.
NOTE 1   Dans la présente Norme, les termes « produit » et « service »/« prestation » s’appliquent uniquement aux produits et services/prestations destinés à, ou exigés par, un client.
NOTE 2   L’expression « legal requirement » recouvre en anglais le concept d’exigence légale et réglementaire.
Les exigences liées aux éléments de sortie matériels tels que les tissus, produits sanguins, produits pharmaceutiques, produits de culture cellulaire et dispositifs médicaux, n’ont pas été intégrées au domaine d’application de la présente Norme car elles sont traitées par ailleurs.
La présente Norme s’attache aux exigences relatives à la gestion des processus cliniques. Les organismes dont le système de management de la qualité inclut également des processus de recherche ou d’éducation peuvent utiliser les exigences de la présente Norme le cas échéant.
La présente Norme vise à spécifier et à compléter les exigences de l’EN ISO 9001:2015 pour les adapter aux conditions particulières des soins de santé, où les produits sont principalement des services et les clients principalement des patients.
1.1   Application
La présente Norme
a)   formule des exigences relatives à des approches systématiques concernant l’aptitude d’un organisme à produire des prestations de soins de santé de qualité ;
b)   peut être employée à tous les niveaux de l’organisation de soins de santé pour mettre en œuvre et tenir à jour un système de management de la qualité ou être utilisée par des parties internes et externes, dont les organismes de certification, pour évaluer l’aptitude de l’organisme à répondre aux besoins et aux attentes des patients et autres clients ;
c)   est applicable aux organisations de soins de santé, quels que soient leur structure, leur organisation, leur propriétaire, leur taille ou les types de prestations de soins de santé qu’elles proposent ;
d)   s’attache aux exigences relatives aux processus cliniques. Les organismes dont le système de management de la qualité inclut également des processus de recherche ou d’éducation peuvent utiliser les exigences de la présente Norme le cas échéant.

Zdravstvene storitve - Sistemi vodenja kakovosti - Zahteve na osnovi EN ISO 9001:2015

Ta evropski standard določa zahteve za sistem vodenja kakovosti v zdravstveni organizaciji.

General Information

• Status: Published
• Publication Date: 20-Dec-2016
• Withdrawal Date: 29-Jun-2017
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.020 - Medical sciences and health care facilities in general
• ICS: 11.020.01 - Quality and environmental management in health care
• ICS: 11.020.10 - Health care services in general
• Technical Committee: CEN/TC 362 - Project Committee - Healthcare services - Quality management systems
• Drafting Committee: CEN/TC 362 - Project Committee - Healthcare services - Quality management systems
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 16-Aug-2022
• Ref Project: SIST EN 15224:2017 - Health care services - Quality management systems - Requirements based on EN ISO 9001:2015

Relations

• Replaces: EN 15224:2012 - Health care services - Quality management systems - Requirements based on EN ISO 9001:2008
• Effective Date: 11-Nov-2015

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zdravstvene storitve - Sistemi vodenja kakovosti - Zahteve na osnovi EN ISO 9001:2015Dienstleistungen in der Gesundheitsversorgung - Qualitätsmanagementsysteme - Anforderungen nach EN ISO 9001:2015Services de santé - Systèmes de management de la qualité - Application de l'EN ISO 9001:2015 aux soins de santéHealth care services - Quality management systems - Requirements based on EN ISO 9001:201511.020.01Vodenje kakovosti in ravnanje z okoljem v zdravstvuQuality and environmental management in health care03.100.70Sistemi vodenjaManagement systemsICS:Ta slovenski standard je istoveten z:EN 15224:2016SIST EN 15224:2017en,fr,de01-februar-2017SIST EN 15224:2017SLOVENSKI
STANDARDSIST EN 15224:20121DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 15224
December
t r s x ICS
r uä s r rä y râ
r uä s t rä s râ
s sä r t rä r s Supersedes EN
s w t t vã t r s tEnglish Version
Quality management systems æ EN ISO
{ r r sã t r s w for healthcare Services de santé æ Systèmes de management de la qualité æ Application de l 5EN ISO
{ r r sã t r s w aux soins de santé
Qualitätsmanagementsysteme æ EN ISO
{ r r sã t r s w für die Gesundheitsversorgung This European Standard was approved by CEN on
t r December
t r s xä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey andUnited Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels
t r s x CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s w t t vã t r s x ESIST EN 15224:2017

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 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 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 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 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 . 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 structure, terminology and concepts . 56 A.1 Structure and terminology . 56 SIST EN 15224:2017

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 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 processes . 79 Bibliography . 82
...

S L O V E N S K I SIST EN 15224

S T A N D A R D februar 2017
Zdravstvene storitve – Sistemi vodenja kakovosti – Zahteve na osnovi
EN ISO 9001:2015
Healthcare services – Quality management systems – Requirements based on
EN ISO 9001:2015
Dienstleistungen in der Gesundheitsversorgung – Qualitätsmanagementsysteme
– Anforderungen nach EN ISO 9001:2015

Services de santé – Systèmes de management de la qualité – Application de
l'EN ISO 9001:2015 aux soins de santé

Referenčna oznaka
ICS 03.100.70; 11.020.01 SIST EN 15224:2017 (sl, en)

Nadaljevanje na straneh I in od 1 do 126

2022-11. Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno.

SIST EN 15224 : 2017
NACIONALNI UVOD
Standard SIST EN 15224 (sl, en), Zdravstvene storitve – Sistemi vodenja kakovosti – Zahteve na osnovi
EN ISO 9001:2015, 2017, ima status slovenskega standarda in je istoveten evropskemu standardu EN
15224 (en), Healthcare services – Quality management systems – Requirements based on EN ISO
9001:2015, 2016.
Ta standard nadomešča SIST EN 15224:2012.

NACIONALNI PREDGOVOR
Besedilo standarda EN 15224:2016 je pripravil tehnični odbor CEN/TC 362 Zdravstvene storitve –
Sistemi vodenja kakovosti, katerega sekretariat vodi SIS. Slovenski standard SIST EN 15224:2017 je
prevod angleškega besedila evropskega standarda EN 15224:2016. V primeru spora glede besedila
slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v angleškem jeziku.
Slovensko-angleško izdajo standarda je pripravil SIST/TC VZK Vodenje in zagotavljanje kakovosti.

Odločitev za privzem tega standarda je 4. januarja 2017 sprejel tehnični odbor SIST/TC VZK Vodenje
in zagotavljanje kakovosti.
ZVEZA S STANDARDI
S privzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen standarda, ki je že sprejet v nacionalno standardizacijo:

SIST EN ISO 9000:2015 (sl, en) Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2015)

OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN 15224:2016

PREDHODNA IZDAJA
– SIST EN 15224:2012, Zdravstvene storitve – Sistemi vodenja kakovosti – Zahteve na osnovi
EN ISO 9001:2008
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz "evropski standard", v SIST EN 15224:2017
to pomeni "slovenski standard".

– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.

– Ta nacionalni dokument je istoveten EN 15224:2016 in je objavljen z dovoljenjem

CEN-CENELEC
Upravni center
Avenue Marnix 17
1050 Bruselj
Belgija
This national document is identical with EN 15224:2016 and is published with the permission of

CEN-CENELEC
Management Centre
Avenue Marnix 17
1050 Bruxelles
Belgium
II
EVROPSKI STANDARD EN 15224
EUROPEAN STANDARD
NORME EUROPÉENNE
december 2016
EUROPÄISCHE NORM
ICS 03.100.70; 03.120.10; 11.020.01 Nadomešča EN 15224:2012

Slovenska izdaja
Zdravstvene storitve – Sistemi vodenja kakovosti – Zahteve na osnovi
EN ISO 9001:2015
Healthcare services – Quality Services de santé – Systèmes Dienstleistungen in der
management systems – de management de la qualité – Gesundheitsversorgung –
Requirements based on Application de l'EN ISO Qualitätsmanagementsysteme –
EN ISO 9001:2015 9001:2015 aux soins de santé Anforderungen nach EN ISO
9001:2015
Ta evropski standard je CEN sprejel 20. decembra 2016.

Člani CEN morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je predpisano, da
mora biti ta standard brez kakršnihkoli sprememb sprejet kot nacionalni standard. Seznami najnovejših
izdaj teh nacionalnih standardov in njihovi bibliografski podatki so na zahtevo na voljo pri Upravnem
centru CEN-CENELEC ali članih CEN.

Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih
jezikih, ki jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru CEN-
CENELEC, veljajo kot uradne izdaje.

Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike,
Danske, Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga,
Madžarske, Malte, Nekdanje jugoslovanske republike Makedonije, Nemčije, Nizozemske, Norveške,
Poljske, Portugalske, Romunije, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in Združenega
kraljestva.
CEN
Evropski komite za standardizacijo
European committee for standardization
Comité européen de normalisation
Europäisches komitee für normung

Upravni center CEN-CENELEC: Avenue Marnix 17, B-1040 Bruselj

© 2016 CEN Vse pravice do izkoriščanja v kakršnikoli obliki in na kakršenkoli Ref. oznaka EN 15224:2016 E
način imajo nacionalni člani CEN.

SIST EN 15224 : 2017
VSEBINA Stran CONTENTS Page
Evropski predgovor . 4 European foreword . 4
Uvod  . 5 Introduction . 5
1 Področje uporabe . 23 1 Scope .23
2 Zveze s standardi . 23 2 Normative references .23
3 Izrazi in definicije . 23 3 Terms and definitions .23
4 Kontekst organizacije . 38 4 Context of the organization .38
4.1 Razumevanje organizacije in 4.1 Understanding the organization and its
njenega konteksta . 38 context .38
4.2 Razumevanje potreb in pričakovanj 4.2 Understanding the needs and
zainteresiranih strani . 39 expectations of interested parties .39
4.3 Opredeljevanje področja uporabe 4.3 Determining the scope of the quality
sistema vodenja kakovosti . 39 management system .39
4.4 Sistem vodenja kakovosti in njegovi 4.4 Quality management system and its
procesi . 40 processes .40
5 Voditeljstvo . 42 5 Leadership .42
5.1 Voditeljstvo in zavezanost . 42 5.1 Leadership and commitment .42
5.2 Politika . 43 5.2 Policy .43
5.3 Vloge, odgovornosti in pooblastila 5.3 Organizational roles, responsibilities and
organizacije . 44 authorities .44
6 Planiranje . 45 6 Planning .45
6.1 Ukrepi za obravnavanje tveganj in 6.1 Actions to address risks and
priložnosti . 45 opportunities .45
6.2 Cilji kakovosti in planiranje za 6.2 Quality objectives and planning to achieve
njihovo doseganje . 46 them .46
6.3 Planiranje sprememb . 47 6.3 Planning of changes .47
7 Podpora . 47 7 Support .47
7.1 Viri . 47 7.1 Resources .47
7.2 Kompetentnost . 51 7.2 Competence .51
7.3 Ozaveščenost . 52 7.3 Awareness .52
7.4 Komuniciranje . 52 7.4 Communication .52
7.5 Dokumentirane informacije . 53 7.5 Documented information .53
8 Delovanje . 56 8 Operation .56
8.1 Planiranje in obvladovanje delovanja . 56 8.1 Operational planning and control .56
8.2 Zahteve za izdelke in storitve . 57 8.2 Requirements for products and services .57
8.3 Snovanje in razvoj izdelkov in 8.3 Design and development of products and
storitev . 59 services .59
8.4 Obvladovanje procesov, izdelkov in 8.4 Control of externally provided
storitev zunanjih ponudnikov v healthcare processes, products and
zdravstvenem varstvu . 64 services .64
8.5 Proizvodnja in izvedba storitev . 66 8.5 Production and service provision .66
8.6 Sprostitev izdelkov in storitev . 70 8.6 Release of products and services .70
8.7 Obvladovanje neskladnih izhodov . 71 8.7 Control of nonconforming outputs .71
9 Vrednotenje izvedbe . 72 9 Performance evaluation .72
9.1 Nadzorovanje, merjenje, analiziranje 9.1 Monitoring, measurement, analysis and
in vrednotenje . 72 evaluation .72
9.2 Notranja presoja . 74 9.2 Internal audit .74
9.3 Vodstveni pregled . 74 9.3 Management review .74
SIST EN 15224 : 2017
10 Izboljševanje . 76 10 Improvement .76
10.1 Splošno . 76 10.1 General .76
10.2 Neskladnost in korektivni ukrepi . 76 10.2 Nonconformity and corrective action .76
10.3 Nenehno izboljševanje . 77 10.3 Continual improvement .77
Dodatek A (informativni): Pojasnilo o Annex A (informative) Clarification of new
novi strukturi, terminologiji in pojmih . 78 structure, terminology and concepts .78
A.1 Struktura in terminologija . 78 A.1 Structure and terminology .78
A.2 Izdelki in storitve . 80 A.2 Products and services .90
A.3 Razumevanje potreb in pričakovanj A.3 Understanding the needs and
zainteresiranih strani . 80 expectations of interested parties .80
A.4 Razmišljanje na podlagi tveganja in A.4 Risk-based thinking and systematic
sistematično obvladovanje kliničnega clinical risk management .81
tvveganja . 81

A.5 Primernost . 82 A.5 Applicability .82
A.6 Dokumentirane informacije . 83 A.6 Documented information .83
A.7 Znanje organizacije . 84 A.7 Organizational knowledge .84
A.8 Obvladovanje zdravstvenih storitev A.8 Control of externally provided healthcare
in izdelkov zunanjih ponudnikov . 85 products and services .85
Dodatek B (informativni): Drugi Annex B (informative) Other International
mednarodni standardi o vodenju Standards on quality management and
kakovosti in sistemih vodenja quality management systems developed
kakovosti, ki jih je razvil ISO/TC 176 . 86 by ISO/TC 176  .86
Dodatek C (informativni): Korelacijska Annex C (informative) Correlation matrix EN
matrika EN 15224:2012 proti EN ISO 15224:2012 to EN ISO 9001:2015 to EN
9001:2015 in proti EN 15224:2016 . 93 15224:2016 .93
Dodatek D (informativni): Zahteve in Annex D (informative) Quality requirements
karakteristike kakovosti v and quality characteristics
zdravstvenem varstvu . 105 in healthcare .105
Dodatek E (informativni): Smernice za Annex E (informative) Guidance for
procesni pristop v zdravstvenem process approach in healthcare .109
varstvu . 109

E.1 Ozadje . 109 E.1 Background .109
E.2 Procesi in potek dela na splošno . 109 E.2 Processes and workflow in general .109
E.3 Klinični procesi . 112 E.3 Clinical Processes .112
E.4 Analiziranje in u kliničnih procesov . 121 E.4 Analysis and management of clinical
processes .121
Literatura . 124 Bibliography .124

SIST EN 15224 : 2017
Evropski predgovor European foreword
Ta dokument (EN 15224:2016) je pripravil This document (EN 15224:2016) has been

tehnični odbor CEN/TC 362 Zdravstvene storitve prepared by Technical Committee CEN/TC 362,
– Sistemi vodenja kakovosti, katerega Healthcare services – Quality management
sekretariat vodi SIS. systems, the secretariat of which is held by SIS.
Ta dokument nadomešča EN 15224:2012.  This document supersedes EN 15224:2012.
Ta evropski standard mora dobiti status This European Standard shall be given the status
nacionalnega standarda bodisi z objav
...