SIST EN 15224:2012
(Main)Health care services - Quality management systems - Requirements based on EN ISO 9001:2008
Health care services - Quality management systems - Requirements based on EN ISO 9001:2008
This European standard specifies requirements for a quality management system where an organization:
a) needs to demonstrate its ability to consistently provide health care services that meet requirements from customers as well as applicable statutory and regulatory requirements, and professional standards
b) aims to enhance customer satisfaction through the effective application of the system, including continual improvement of the management system, the clinical processes and the assurance of conformity to 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. Material products such as tissue, blood products, pharmaceuticals, cell culture products and medical devices have not been focused in the scope of the standard as they are regulated elsewhere. This European 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 European Standard where applicable. This European Standard aims to adjust and specify the requirements, as well as the “product” concept and customer perspectives in EN ISO 9001:2008 to the specific conditions for health care where products are mainly services and customers are mainly patients. The focus of this European Standard is the clinical processes and their risk management in order to promote good quality health care.
Dienstleistungen in der Gesundheitsversorgung - Qualitätsmanagementsysteme - Anforderungen nach EN ISO 9001:2008
1.1 Allgemeines
Diese Europäische Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, in Rahmen dessen eine Organisation:
a) ihre Fähigkeit nachweisen muss, gleichbleibend Dienstleistungen der Gesundheitsversorgung zu erbringen, die sowohl die Anforderungen der Kunden als auch anwendbare, gesetzlich festgelegte und behördliche Anforderungen und berufliche Standards erfüllen.
b) beabsichtigt, die Kundenzufriedenheit durch die effektive Anwendung des Systems zu verbessern; eingeschlossen sind die kontinuierliche Verbesserung des Managementsystems, der klinischen Prozesse und die Zusicherung, die Anforderungen hinsichtlich der Qualitätsmerkmale einzuhalten; das sind angemessene, richtige Versorgung; Verfügbarkeit; Kontinuität der Versorgung; Wirksamkeit, Effizienz; Gleichheit; evidenzbasierte/wissensbasierte Versor¬gung; auf den Patienten, einschließlich der körperlichen, geistigen und sozialen Unversehrtheit ausgerichtete Versorgung; Einbeziehung des Patienten; Patientensicherheit und Rechtzeitigkeit und Zugänglichkeit.
Materielle Produkte, wie Gewebe, Blutprodukte, Arzneimittel, Zellkulturprodukte und Medizinprodukte standen nicht im Mittelpunkt des Anwendungsbereichs der Norm, da sie an anderer Stelle reguliert werden.
Diese Europäische Norm ist auf die Anforderungen an klinische Prozesse ausgerichtet. Organisationen, die außerdem noch Forschung oder Ausbildung oder beides in ihr Qualitätsmanagementsystem aufgenommen haben, können die Anforderungen dieser Norm nutzen, wenn zutreffend.
Diese Europäische Norm zielt auf die Anpassung und Spezifizierung der Anforderungen sowie des „Produkt“-Konzeptes und der Kundensichtweise in EN ISO 9001:2008 an die speziellen Bedingungen einer Gesund¬heits-versorgung, unter denen Produkte größtenteils Dienstleistungen und Kunden vorwiegend Patienten sind.
Zur Förderung einer qualitativ guten Gesundheitsversorgung liegt der Schwerpunkt dieser Europäischen Norm auf den klinischen Prozessen und deren Risikomanagement.
1.2 Anwendung
Diese Europäische Norm:
a) gibt Anforderungen für systematische Herangehensweisen an, um die Organisation zu befähigen, eine gute Qualität der Gesundheitsversorgung herzustellen.
b) kann durch die Leitung auf jeder Ebene der Organisation der Gesundheitsversorgung benutzt werden, um ein Qualitätsmanagementsystem einzuführen und aufrechtzuhalten oder interne oder externe Parteien, einschließlich der Zertifizierungsstellen können sie benutzen, um die Fähigkeit der Organisation zu bewerten, die Erfordernisse und Erwartungen der Patienten wie auch der anderer Kunden zu erfüllen.
c) ist ungeachtet der Struktur, Organisation, des Eigentümers, des Umfangs oder des Typs der erbrachten Dienstleistungen der Gesundheitsversorgung auf Organisationen der Gesundheitsversorgung anwend¬bar.
d) ist anwendbar auf z. B. medizinische Grundversorgung, vorklinische und klinische Versorgung, Behandlungspflege, Pflegeheime, Hospize, Gesundheitsvorsorge, psychiatrische Versorgungs-leistungen, Zahngesundheitsdienst, Physiotherapie, Arbeitsschutzdienstleistungen und Apotheken.
e) ist auf die Anforderungen klinische Prozesse ausgerichtet. Organisationen, die außerdem noch Forschung oder Ausbildung in den Anwendungsbereich ihres Qualitätsmanagementsystems aufgenommen haben, können die Anforderungen dieser Norm nutzen, wenn zutreffend.
Kann eine der Anforderungen dieser Europäischen Norm aufgrund der Beschaffenheit einer Organisation und ihres Produktes (einschließlich der Dienstleistungen) nicht angewendet werden, kann dies Gegenstand von Ausnahmebestimmungen sein.
Services de santé - Systèmes de management de la qualité - Exigences d'après l'EN ISO 9001:2008
1.1 Objet principal
La présente norme vise à adapter et préciser les exigences, ainsi que le concept de « produit » et les
perspectives client de l’ISO 9001, aux conditions particulières des soins de santé où les produits sont
principalement des services et les clients principalement des patients.
Elle traite des processus de santé et des processus cliniques et de la gestion de leurs risques afin de
promouvoir des soins de bonne qualité.
Elle met l’accent sur les exigences relatives aux processus de santé et processus cliniques. Les organisations
comportant également la recherche et/ou la formation comme processus de base peuvent s’appuyer sur les
exigences de la présente norme le cas échéant.
Elle indique les exigences pour un système de management de la qualité lorsqu'une organisation :
a) doit démontrer sa capacité à fournir régulièrement des services de santé satisfaisant aux exigences des
clients, de la réglementation et des normes professionnelles ;
b) cherche à améliorer la satisfaction du client grâce à l’application efficace du système, y compris une
amélioration continue du système de management, des processus de santé et cliniques et de l’assurance
de conformité aux exigences relatives aux caractéristiques de qualité (3.11) : soins adaptés, soins
corrects, disponibilité des soins, continuité des soins, efficacité des soins, efficience des soins, équité des
soins, centrage des soins sur le patient – y compris son intégrité physique et psychologique –, implication
du patient, sécurité du patient, rapidité/accessibilité.
Les produits matériels – tels que les tissus, produits sanguins, produits pharmaceutiques, produits de culture
cellulaire – n’ont pas été intégrés au domaine d'application de la norme car ils sont traités par ailleurs ; par
exemple dans l’ISO 13485 Dispositifs médicaux – Systèmes de management de la qualité – Exigences à des
fin réglementaires.
Zdravstvene storitve - Sistemi vodenja kakovosti - Zahteve na osnovi EN ISO 9001:2008
Ta evropski standard specificira zahteve za sistem vodenja kakovosti. Uporablja se, kadar organizacija:
a) dokazuje svojo sposobnost, da dosledno izvaja storitve zdravstvenega varstva, ki izpolnjujejo zahteve strank, zahteve ustrezne zakonodaje in regulative ter profesionalne standarde,
b) poskuša z učinkovito uporabo sistema povečati zadovoljstvo uporabnikov, vključno s stalnimi izboljšavami sistema upravljanja, kliničnih postopkov in zagotavljanja spoštovanja zahtev, povezanih z značilnostmi kakovosti; primerno, pravilno nego; dostopnost; stalnost nege; uspešnost; učinkovitost; pravičnost; nego, ki temelji na znanju/dokazih; nego, ki je osredotočena na bolnika in vključuje fizično, psihološko in socialno integriteto; vključenost bolnikov; varnost bolnikov in pravočasnost/dostopnost. Standard ne vsebuje izdelkov za tkiva in kri, farmacevtskih izdelkov, izdelkov celične kulture, medicinskih pripomočkov in drugih izdelkov, ker so regulirani drugje. Ta evropski standard se osredotoča na zahteve za klinične procese. Organizacije, ki v sistemu vodenja kakovosti vsebujejo raziskovalne in/ali izobraževalne postopke, lahko, kjer je mogoče, uporabijo zahteve iz tega evropskega standarda. Cilj tega evropskega standarda je, da določenim pogojem za zdravstveno varstvo prilagaja in določa zahteve, koncepte »izdelkov« in vidike strank iz standarda EN ISO 9001:2008, kjer so izdelki predvsem storitve in stranke bolniki. Standard se osredotoča na klinične postopke in upravljanje s tveganji pri njih, ker želi spodbujati dobro in kakovostno zdravstveno varstvo.
General Information
Relations
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 9001:2008Dienstleistungen in der Gesundheitsversorgung - Qualitätsmanagementsysteme - Anforderungen nach EN ISO 9001:2008Services de santé - Systèmes de management de la qualité - Exigences d'après l'EN ISO 9001:2008Health care services - Quality management systems - Requirements based on EN ISO 9001:200811.020]GUDYVWYHQRYDUVWYHQLMedical sciences and health care facilities in general03.120.10Vodenje in zagotavljanje kakovostiQuality management and quality assuranceICS:Ta slovenski standard je istoveten z:EN 15224:2012SIST EN 15224:2012en,fr,de01-december-2012SIST EN 15224:2012SLOVENSKI
STANDARDSIST-TS CEN/TS 15224:20061DGRPHãþD
SIST EN 15224:2012
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 15224
October 2012 ICS 03.120.10; 11.020 Supersedes CEN/TS 15224:2005English 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 2012.
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: ESIST EN 15224:2012
EN 15224:2012 (E) 2 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. 21 5 Management responsibility . 21 5.1
Management commitment . 21 5.2 Customer focus . 22 5.3 Quality policy . 22 5.4 Planning . 22 5.4.1 Quality objectives . 22 5.4.2 Quality management system planning . 23 5.5 Responsibility, authority and communication . 23 5.5.1 Responsibility and authority . 23 5.5.2 Management representative . 23 5.5.3 Internal communication . 24 5.6 Management review . 24 5.6.1 General . 24 5.6.2 Review input . 25 5.6.3 Review output . 25 6 Resource management . 26 6.1 Provision of resources . 26 6.2 Human resources. 26 6.2.1 General . 26 6.2.2 Competence, awareness and training . 26 6.3 Infrastructure . 27 6.4 Work environment . 27 7 Product realization. 27 SIST EN 15224:2012
EN 15224:2012 (E) 3 7.1 Planning of product realization . 27 7.2 Customer-related processes . 28 7.2.1 Determination of requirements related to the product (health care service) . 28 7.2.2 Review of requirements related to the product (health care service) . 29 7.2.3 Customer communication . 29 7.3 Design and development . 30 7.3.1 Design and development planning . 30 7.3.2 Design and development inputs . 31 7.3.3 Design and development outputs . 31 7.3.4 Design and development review . 32 7.3.5 Design and development verification. 32 7.3.6 Design and development validation . 32 7.3.7 Control of design and development changes . 32 7.4 Purchasing . 32 7.4.1 Purchasing process . 32 7.4.2 Purchasing information . 33 7.4.3 Verification of purchased service/product . 33 7.5 Production and service provision . 33 7.5.1 Control of production and service provision . 33 7.5.2 Validation of processes for production and service provision . 34 7.5.3 Identification and traceability . 34 7.5.4 Customer property . 35 7.5.5 Preservation of product . 35 7.6 Control of monitoring and measuring equipment . 35 8 Measurement, analysis and improvement . 36 8.1 General . 36 8.2 Monitoring and measurement . 36 8.2.1 Customer satisfaction . 36 8.2.2 Internal audit . 37 8.2.3 Monitoring and measurement of processes . 37 8.2.4 Monitoring and measurement of product (health care service) . 38 8.3 Control of non-conforming product (health care service) . 38 8.4 Analysis of data . 38 8.5 Improvement . 39 8.5.1 Continual improvement . 39 8.5.2 Corrective action . 39 8.5.3 Preventive action . 39 Annex A
(informative)
Correspondence between ISO 9001:2008 and EN 15224 . 41 Annex B (informative)
Practical guide for the implementation of this standard in health care organizations . 45 B.1 General . 45 B.2 Preparation and planning . 45 B.2.1 General . 45 B.2.2 Leadership in quality. 46 B.2.3 Planning the quality management system set-up . 46 B.2.4 Education and training in quality management . 46 B.2.5 Customer focus . 47 B.2.6 Planning the documentation . 47 B.2.7 Provision of necessary resources . 48 B.3 Implementing the quality management system . 48 B.3.1 General . 48 B.3.2 Quality policy . 48 B.3.3 Quality characteristics and quality requirements in health care . 49 B.3.4 Quality objectives . 50 B.3.5 Personnel working for and on behalf of the organization . 50 B.3.6 Authority, responsibility and accountability . 51 B.3.7 Communication and information management . 51 B.3.8 Documenting the quality management system . 51 B.3.9 Process-oriented quality management . 53 SIST EN 15224:2012
EN 15224:2012 (E) 4 B.4 Establishing the monitoring and evaluation system . 55 B.4.1 General . 55 B.4.2 Risk management . 57 B.5 Continual improvement . 58 B.5.1 General . 58 B.5.2 Analysis of collected data . 59 B.5.3 Management reviews . 59 B.5.4 Corrective action. 59 Annex C (informative)
Correspondence between CEN/TS 15224:2005 and EN 15224 . 60 Bibliography . 64
SIST EN 15224:2012
EN 15224:2012 (E) 5 Foreword This document (EN 15224:2012) has been prepared by Technical Committee CEN/TC 362, "Health services - Quality management systems”f 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 2013. 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.
SIST EN 15224:2012
EN 15224:2012 (E) 6 Introduction 0.1 Quality in health care 0.1.1 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. SIST EN 15224:2012
EN 15224:2012 (E) 7 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. 0.1.2 The concept of "health"
qhe torld eealth lrganization (telc definition of health is “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.” qhe fnternational Classification of cunctioningf Disability and Health (ICF), by WHO, identifies five health components; body function, body structure, activity, participation and environmental factors.
0.1.3 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.
0.1.4 Quality in health care
nuality in general is defined as “degree to which a set of inherent characteristics fulfils requirements”. qo 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 3.11. SIST EN 15224:2012
EN 15224:2012 (E) 8 To be able to define and describe the quality in health care the quality characteristics need to be identified and described. A quality characteristic always relates to a quality requirement. Therefore eleven quality characteristics of health care services with interrelated quality requirements are identified as:
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;
timeliness/accessibility.
The health care organisation defines their quality vision/policy and it identifies the quality characteristics for their context / situation.
A quality management system is a system to direct and control an organization with regard to quality. The requirements for a quality management system in this standard are consequently focused on the quality characteristics.
0.1.5 The concept of "clinical"
The term "Clinical” can have different meanings in different countries. In this standard "clinical" refers to all types of interactions between patients and all kinds of health care professionals. fn this standard “clinical” is not restricted to the hospital context. 0.1.6 Clinical risk
Clinical risk denotes any risk that could have negative effects on the outcomes for any of the quality requirements. The risk factors could be non-clinical, but the risk is considered a clinical risk if it could have any negative impact on any of the quality requirements. Aspects of clinical risk management are integrated in this standard.
0.1.7 Health care specific preconditions Health care is characterised by numerous interactions between patients, health care personnel, suppliers, insurers, industry and governmental bodies which shall be identified and taken into consideration. Examples of such specific preconditions in health care are given below: a) Health care is delivered through clinical processes which are dependent on a number of management and supporting activities/processes. A clinical process is a continuum of care from the patient's SIST EN 15224:2012
EN 15224:2012 (E) 9 perspective. Depending on the scope of the organization the clinical processes consists of the whole or part of the continuum of care. The results of processes in health care are mainly services. b) Patient satisfaction based on needs and expectations is an overall objective for the organization. The patient cannot always evaluate all aspects of the results of the processes in health care. Some aspects of the services have to be evaluated by health care professionals. c) It is the responsibility of the organization to support and balance between the patient's expectations and the professionally assessed needs of care. There
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SLOVENSKI SIST EN 15224
STANDARD
december 2012
Zdravstvene storitve – Sistemi vodenja kakovosti – Zahteve na osnovi
EN ISO 9001:2008
Health care services – Quality management systems – Requirements based on
EN ISO 9001:2008
Services de santé – Systèmes de management de la qualité – Exigences d'après
l'EN ISO 9001:2008
Dienstleistungen in der Gesundheitsversorgung – Qualitätsmanagementsysteme –
Anforderungen nach EN ISO 9001:2008
Referenčna oznaka
ICS 03.120.10; 11.020 SIST EN 15224:2012 (sl, en)
Nadaljevanje na straneh II in od 1 do 95
© 2014-07. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 15224 : 2012
NACIONALNI UVOD
Standard SIST EN 15224 (sl, en), Zdravstvene storitve – Sistemi vodenja kakovosti – Zahteve na
osnovi EN ISO 9001:2008, 2012, ima status slovenskega standarda in je istoveten evropskemu
standardu EN 15224, Health care services – Quality management systems – Requirements based on
EN ISO 9001:2008, 2012.
Ta standard nadomešča SIST-TS CEN/TS 15224:2006.
NACIONALNI PREDGOVOR
Besedilo standarda EN 15224:2012 je pripravil tehnični odbor CEN/TC 362 Zdravstvene storitve –
Sistemi vodenja kakovosti, katerega sekretariat vodi SIS. Slovenski standard SIST EN 15224:2012 je
prevod angleškega besedila evropskega standarda EN 15224:2012. 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 5. novembra 2012 sprejel tehnični odbor SIST/TC VZK Vodenje
in zagotavljanje kakovosti.
ZVEZE S STANDARDI
S privzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen standarda, ki smo ga že sprejeli v nacionalno standardizacijo:
SIST EN ISO 9000:2005 (sl, en) Sistemi vodenja kakovosti – Osnove in slovar (ISO 9000:2005)
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN 15224:2012
PREDHODNA IZDAJA
– SIST-TS CEN/TS 15224:2006, Zdravstvene storitve – Sistemi vodenja kakovosti – Vodilo za
uporabo EN ISO 9001:2000
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v SIST EN 15224:2012
to pomeni “slovenski standard”.
– Nacionalni uvod in nacionalni predgovor nista sestavni del standarda.
– Ta nacionalni dokument je istoveten EN 15224:2012 in je objavljen z dovoljenjem
CEN
Management Centre
Avenue Marnix 17
B-1000 Bruselj
This national document is identical with EN 15224:2012 and is published with the permission of
CEN
Management Centre
Avenue Marnix 17
B-1000 Brussels
II
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EVROPSKI STANDARD EN 15224
EUROPEAN STANDARD
EUROPÄISCHE NORM
NORME EUROPÉENNE oktober 2012
ICS: 03.120.10; 11.020 Nadomešča CEN/TS 15224:2005
Slovenska izdaja
Zdravstvene storitve – Sistemi vodenja kakovosti – Zahteve na osnovi
EN ISO 9001:2008
Health care services – Services de santé – Systèmes de Dienstleistungen in der
Quality management systems – management de la qualité – Gesundheitsversorgung –
Requirements based on Exigences selon Qualitätsmanagementsysteme –
EN ISO 9001:2008 l'EN ISO 9001:2008 Anforderungen nach EN ISO 9001:2008
Ta evropski standard je CEN sprejel 13. julija 2012.
Člani CEN morajo izpolnjevati notranje predpise CEN/CENELEC, s katerim je predpisano, da mora biti
ta standard brez kakršnih koli sprememb sprejet kot nacionalni standard. Najnovejši seznami teh
nacionalnih standardov in njihovi bibliografski podatki se na zahtevo lahko dobijo pri Upravnem centru
CEN-CENELEC ali katerem koli članu 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: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN Lastnice avtorskih pravic so vse države članice CEN Ref. oznaka EN 15224:2012 E
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SIST EN 15224 : 2012
VSEBINA Stran Contents Page
Predgovor.6 Foreword. 6
Uvod.7 Introduction . 7
0.1 Kakovost v zdravstvenem varstvu .7 0.1 Quality in health care . 7
0.1.1 Splošno .7 0.1.1 General. 7
0.1.2 Pojem "zdravstven" .9 0.1.2 The concept of "health". 9
0.1.3 Zdravstveno varstvo .9 0.1.3 Health care . 9
0.1.4 Kakovost v zdravstvenem varstvu .9 0.1.4 Quality in health care . 9
0.1.5 Pojem "kliničen" .10 0.1.5 The concept of "clinical".10
0.1.6 Klinično tveganje .10 0.1.6 Clinical risk .10
0.1.7 Predpogoji, specifični za 0.1.7 Health care specific
zdravstveno varstvo.10 preconditions.10
0.2 Procesni pristop .12 0.2 Process approach .12
0.2.1 Splošno .12 0.2.1 General.12
0.2.2 Procesni pristop in 0.2.2 Process approach and
izboljšave.13 improvements .13
0.3 Združljivost z drugimi standardi.16 0.3 Compatibility with other standards.16
1 Področje uporabe .17 1 Scope.17
1.1 Splošno .17 1.1 General.17
1.2 Uporaba .17 1.2 Application .17
2 Zveza s standardi .19 2 Normative references.19
3 Izrazi in definicije .19 3 Terms and definitions .19
4 Sistemi vodenja kakovosti .24 4 Quality management systems .24
4.1 Splošne zahteve .24 4.1 General requirements .24
4.2 Zahteve glede dokumentacije .26 4.2 Documentation requirements.26
4.2.1 Splošno .26 4.2.1 General.26
4.2.2 Poslovnik kakovosti .27 4.2.2 Quality manual .27
4.2.3 Obvladovanje dokumentov .27 4.2.3 Control of documents.27
4.2.4 Obvladovanje zapisov .28 4.2.4 Control of records.28
5 Odgovornost vodstva.29 5 Management responsibility .29
5.1 Zavezanost vodstva .29 5.1 Management commitment .29
5.2 Osredotočenost na odjemalce .29 5.2 Customer focus .29
5.3 Politika kakovosti .30 5.3 Quality policy .30
5.4 Planiranje .30 5.4 Planning.30
5.4.1 Cilji kakovosti .30 5.4.1 Quality objectives .30
5.4.2 Planiranje sistema vodenja 5.4.2 Quality management system
kakovosti.31 planning.31
5.5 Odgovornosti, pooblastila in 5.5 Responsibility, authority and
komuniciranje .31 communication.31
5.5.1 Odgovornosti in pooblastila .31 5.5.1 Responsibility and authority.31
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5.5.2 Predstavnik vodstva .32 5.5.2 Management representative.32
5.5.3 Notranje komuniciranje .32 5.5.3 Internal communication.32
5.6 Vodstveni pregled .33 5.6 Management review.33
5.6.1 Splošno .33 5.6.1 General.33
5.6.2 Vhodni podatki za pregled .33 5.6.2 Review input.33
5.6.3 Rezultati pregleda .34 5.6.3 Review output.34
6 Vodenje virov .35 6 Resource management.35
6.1 Priskrba virov .35 6.1 Provision of resources.35
6.2 Človeški viri.35 6.2 Human resources.35
6.2.1 Splošno .35 6.2.1 General.35
6.2.2 Kompetentnost, zavedanje in 6.2.2 Competence, awareness
usposabljanje .35 and training .35
6.3 Infrastruktura .36 6.3 Infrastructure .36
6.4 Delovno okolje .37 6.4 Work environment .37
7 Realizacija proizvoda.37 7 Product realization.37
7.1 Planiranje realizacije proizvoda .37 7.1 Planning of product realization .37
7.2 Procesi, povezani z odjemalci .38 7.2 Customer-related processes.38
7.2.1 Določitev zahtev v zvezi s proizvodom 7.2.1 Determination of requirements related
(zdravstveno storitvijo) .38 to the product (health care service).38
7.2.2 Pregled zahtev v zvezi s proizvodom 7.2.2 Review of requirements related to
(zdravstveno storitvijo) .39 the product (health care service).39
7.2.3 Komuniciranje z odjemalci .40 7.2.3 Customer communication .40
7.3 Snovanje in razvoj .40 7.3 Design and development .40
7.3.1 Planiranje snovanja in razvoja .40 7.3.1 Design and development planning .40
7.3.2 Vhodi za snovanje in razvoj .41 7.3.2 Design and development inputs .41
7.3.3 Rezultati snovanja in razvoja .42 7.3.3 Design and development outputs.42
7.3.4 Pregled snovanja in razvoja .43 7.3.4 Design and development review .43
7.3.5 Overjanje snovanja in razvoja.43 7.3.5 Design and development verification .43
7.3.6 Validacija snovanja in razvoja .43 7.3.6 Design and development validation .43
7.3.7 Obvladovanje sprememb snovanja 7.3.7 Control of design and development
in razvoja .44 changes.44
7.4 Nabava .44 7.4 Purchasing.44
7.4.1 Proces nabave .44 7.4.1 Purchasing process.44
7.4.2 Informacije za nabavo .45 7.4.2 Purchasing information .45
7.4.3 Overjanje nabavljenih storitev/ 7.4.3 Verification of purchased service/
proizvodov .45 product .45
7.5 Proizvodnja in izvedba storitev .46 7.5 Production and service provision.46
7.5.1 Obvladovanje proizvodnje in izvedbe 7.5.1 Control of production and service
storitev .46 provision.46
7.5.2 Validacija procesov za proizvodnjo 7.5.2 Validation of processes for
in izvedbo storitev .46 production and service provision.46
7.5.3 Identifikacija in sledljivost .47 7.5.3 Identification and traceability.47
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7.5.4 Lastnina odjemalcev .48 7.5.4 Customer property .48
7.5.5 Ohranitev proizvoda .48 7.5.5 Preservation of product.48
7.6 Obvladovanje nadzorne in merilne 7.6 Control of monitoring and measuring
opreme .49 equipment .49
8 Merjenje, analize in 8 Measurement, analysis and
izboljševanje .50 improvement .50
8.1 Splošno .50 8.1 General.50
8.2 Nadzorovanje in merjenje .50 8.2 Monitoring and measurement.50
8.2.1 Zadovoljstvo odjemalcev .50 8.2.1 Customer satisfaction.50
8.2.2 Notranja presoja .50 8.2.2 Internal audit.50
8.2.3 Nadzorovanje in merjenje 8.2.3 Monitoring and measurement of
procesov .51 processes.51
8.2.4 Nadzorovanje in merjenje proizvodov 8.2.4 Monitoring and measurement of
(zdravstvenih storitev) .52 product (health care service).52
8.3 Obvladovanje neskladnih proizvodov 8.3 Control of non-conforming product
(zdravstvenih storitev) .52 (health care service) .52
8.4 Analiza podatkov .53 8.4 Analysis of data .53
8.5 Izboljševanje .54 8.5 Improvement.54
8.5.1 Nenehno izboljševanje .54 8.5.1 Continual improvement.54
8.5.2 Korektivni ukrepi .54 8.5.2 Corrective action .54
8.5.3 Preventivni ukrepi .54 8.5.3 Preventive action.54
Dodatek A (informativni): Primerjava med Annex A (informative): Correspondence
ISO 9001:2008 in EN 15224 .56 between ISO 9001:2008 and EN 15224.57
Dodatek B (informativni): Praktična Annex B (informative): Practical guide for
navodila za izvajanje tega standarda the implementation of this standard
v zdravstvenih organizacijah .64 in health care organizations .64
B.1 Splošno .64 B.1 General.64
B.2 Priprava in planiranje .65 B.2 Preparation and planning .65
B.2.1 Splošno.65 B.2.1 General.65
B.2.2 Voditeljstvo na področju kakovosti .65 B.2.2 Leadership in quality.65
B.2.3 Planiranje vzpostavitve sistema B.2.3 Planning the quality management
vodenja kakovosti .66 system set-up.66
B.2.4 Izobraževanje in usposabljanje na B.2.4 Education and training in quality
področju kakovosti .66 management.66
B.2.5 Osredotočenost na odjemalce .67 B.2.5 Customer focus.67
B.2.6 Planiranje dokumentacije .68 B.2.6 Planning the documentation.68
B.2.7 Priskrba potrebnih virov .69 B.2.7 Provision of necessary resources .69
B.3 Izvajanje sistema vodenja B.3 Implementing the quality management
kakovosti .69 system.69
B.3.1 Splošno .69 B.3.1 General.69
B.3.2 Politika kakovosti.70 B.3.2 Quality policy.70
B.3.3 Karakteristike in zahteve kakovosti v B.3.3 Quality characteristics and quality
zdravstvenem varstvu .70 requirements in health care.70
B.3.4 Cilji kakovosti .72 B.3.4 Quality objectives.72
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SIST EN 15224 : 2012
B.3.5 Osebje, ki dela za organizacijo B.3.5 Personnel working for and on
in v njenem imenu .72 behalf of the organization .72
B.3.6 Pooblastila in B.3.6 Authority, responsibility and
odgovornosti .73 accountability.73
B.3.7 Vodenje komuniciranja B.3.7 Communication and information
in informiranja .74 management.74
B.3.8 Dokumentiranje sistema vodenja B.3.8 Documenting the quality management
kakovosti .74 system.74
B.3.9 Procesno usmerjeno vodenje B.3.9 Process-oriented quality
kakovosti .76 management.76
B.4 Vzpostavljanje sistema nadzorovanja B.4 Establishing the monitoring and
in vrednotenja .80 evaluation system .80
B.4.1 Splošno .80 B.4.1 General.80
B.4.2 Obvladovanje tveganja .84 B.4.2 Risk management.84
B.5 Nenehno izboljševanje .86 B.5 Continual improvement.86
B.5.1 Splošno .86 B.5.1 General.86
B.5.2 Analiza zbranih podatkov.86 B.5.2 Analysis of collected data .86
B.5.3 Vodstveni pregledi .87 B.5.3 Management reviews .87
B.5.4 Korektivni ukrepi.87 B.5.4 Corrective action.87
Dodatek C (informativni): Primerjava med Annex C (informative): Correspondence
CEN/TS 15224:2005 between CEN/TS 15224:2005 and
in EN 15224 .88 EN 15224 .89
Literatura .94 Bibliography.94
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SIST EN 15224 : 2012
Predgovor Foreword
Ta dokument (EN 15224:2012) je pripravil This document (EN 15224:2012) has been
tehnični odbor CEN/TC 362 Zdravstvene storitve prepared by Technical Committee CEN/TC 362,
– Sistemi vodenja kakovosti, katerega sekretariat "Health services - Quality management
vodi SIS. systems”, the secretariat of which is held by SIS.
Ta evropski standard mora z objavo istovetnega This European Standard shall be given the
besedila ali z razglasitvijo dobiti status status of a national standard, either by
nacionalnega standarda najpozneje do aprila publication of an identical text or by
2013, nacionalne standarde, ki so v nasprotju s endorsement, at the latest by April 2013, and
tem standardom, pa je treba umakniti najpozneje conflicting national standards shall be
do aprila 2013. withdrawn at the latest by April 2013.
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of
elementov tega dokumenta predmet patentnih the elements of this document may be the
pravic. CEN [in/ali CENELEC] ne prevzema subject of patent rights. CEN [and/or
odgovornosti za identifikacijo katerihkoli ali vseh CENELEC] shall not be held responsible for
takih patentnih pravic. identifying any or all such patent rights.
Ta dokument nadomešča CEN/TS 15224:2005. This document supersedes CEN/TS 15224:2005.
V ta dokument je vključeno besedilo standarda This document includes the text of ISO 9001 as
ISO 9001, ki ga je leta 2008 izdala Mednarodna published in 2008 by the International
organizacija za standardizacijo ISO, zato ni Organization for Standardization, ISO, and
nujno, da je to zadnja objavljena izdaja. therefore may not be the last version published.
V skladu z notranjimi predpisi CEN/CENELEC According to the CEN/CENELEC Internal
morajo ta evropski standard obvezno uvesti Regulations, the national standards organisations
nacionalne organizacije za standardizacijo of the following countries are bound to
naslednjih držav: Avstrije, Belgije, Bolgarije, implement this European Standard: Austria,
Cipra, Češke republike, Danske, Estonije, Belgium, Bulgaria, Croatia, Cyprus, Czech
Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Republic, Denmark, Estonia, Finland, Former
Italije, Latvije, Litve, Luksemburga, Madžarske, Yugoslav Republic of Macedonia, France,
Malte, Nekdanje jugoslovanske republike Germany, Greece, Hungary, Iceland, Ireland,
Makedonije, Nemčije, Nizozemske, Norveške, Italy, Latvia, Lithuania, Luxembourg, Malta,
Poljske, Portugalske, Romunije, Slovaške, Netherlands, Norway, Poland, Portugal,
Slovenije, Španije, Švedske, Švice, Turčije in Romania, Slovakia, Slovenia, Spain, Sweden,
Združenega kraljestva. Switzerland, Turkey and the United Kingdom.
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SIST EN 15224 : 2012
Uvod Introduction
0.1 Kakovost v zdravstvenem varstvu 0.1 Quality in health care
0.1.1 Splošno 0.1.1 General
Ta standard za sisteme vodenja kakovosti je This is a sector specific quality management
namenjen posebej za zdravstvene organizacije. system standard for health care organizations.
Vključuje EN ISO 9001:2008 in nadomešča This standard incorporates EN ISO 9001:2008
CEN/TS 15224:2005, Zdravstvene storitve – and replaces CEN/TS 15224:2005 Health
Sistemi vodenja kakovosti – Vodilo za uporabo services – Quality management systems –
EN ISO 9001:2000. Besedilo iz standarda EN Guide for the use of EN ISO 9001:2000. The text
ISO 9001:2008 je v točkah 3 do 8 tega from EN ISO 9001:2008 in Clause 3 to Clause 8
evropskega standarda prikazano v črnem is shown in black in this European Standard and
pokončnem tisku, dodatno besedilo, posebej additional text specific to health care services is
namenjeno zdravstvenim storitvam, pa je v toč- in Clause 3 to Clause 8 shown in blue italics.
kah 3 do 8 prikazano v modrem poševnem tisku.
To je samostojen standard in se lahko uporablja This is a stand alone standard and can be used
za certificiranje v zdravstvenem varstvu. for certification in health care.
Zahteve v tem standardu vključujejo zahteve iz The requirements in this standard incorporate
standarda EN ISO 9001:2008 z dodatnimi those from EN ISO 9001:2008 with additional
razlagami in specifikacijami za zdravstveno interpretations and specifications for health
varstvo. Dodane in razjasnjene so zahteve v care. Requirements have been added to and
skladu s posebnostmi v zdravstvenem varstvu. clarified according to the specific health care
Po potrebi so dodane nove zahteve. Ta standard context. New requirements have been added
vključuje tudi vidike, povezane z obvladovanjem when considered relevant. This standard also
kliničnega tveganja med planiranjem, includes aspects related to clinical risk
delovanjem in obvladovanjem procesov. management throughout the planning,
operation and control of processes.
Ta sistem vodenja kakovosti ne vključuje This quality management system does not include
posebnih zahtev za ravnanje z okoljem. requirements specific to environmental
Organizacijam, ki uporabljajo sistem vodenja, se management. Therefore, it is recommended that
zato priporoča, da ga uporabljajo tudi za organisations that apply a management system
ravnanje z okoljem. also apply an environmental management.
V tem uvodu in v primerjalni preglednici (dodatek The congruence and difference between this
A) sta razložena ujemanje in razlika med tem standard and EN ISO 9001:2008 is explained in
standardom in EN ISO 9001:2008. this introduction and in cross reference table
(Annex A).
V primerjalni preglednici (dodatek C) sta The congruence and difference between
razložena ujemanje in razlika med CEN/TS CEN/TS 15224:2005 and this standard is
15224:2005 in tem standardom. explained in cross reference table (Annex C).
V dodatku B so podana praktična navodila za A practical guide for the implementation of this
izvajanje tega standarda v zdravstvenih standard in health care organizations is
organizacijah. presented in Annex B.
V tehničnem poročilu CEN/TR 15592:2007, Further guidance for quality improvement
Zdravstvene storitve – Sistemi vodenja kakovosti approaches can be found in CEN/TR
– Vodilo za uporabo EN ISO 9004:2000 za 15592:2007, Health services - Quality
izboljšanje izvajanja zdravstvenih storitev, so management systems - Guide for the use of EN
podani nadaljnji napotki za pristope k izboljšanju ISO 9004:2000 in health services for
kakovosti. performance Improvement.
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SIST EN 15224 : 2012
V tem standardu so uporabljena naslednja The following quality management principles
načela vodenja kakovosti iz EN ISO 9000:2005: from EN ISO 9000:2005 are applied in this
standard:
a) Osredotočenost na odjemalce a) Customer focus
Organizacije so odvisne od svojih Organizations depend on their customers
odjemalcev, zato naj razumejo njihove and therefore should understand current
trenutne in prihodnje potrebe, izpolnjujejo and future customer needs, should meet
njihove zahteve in si prizadevajo preseči customer requirements and strive to exceed
njihova pričakovanja. customer expectations.
b) Voditeljstvo b) Leadership
Voditelji poenotijo namen in usmeritev Leaders establish unity of purpose and
organizacije. Ustvarijo in vzdržujejo naj tako direction o
...
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