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SLOVENSKI STANDARD
01-marec-2023
Nadomešča:
SIST EN ISO 15189:2013
SIST EN ISO 22870:2017
Medicinski laboratoriji - Zahteve za kakovost in kompetentnost (ISO 15189:2022)
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO
15189:2022)
Laboratoires de biologie médicale - Exigences concernant la qualité et la compétence
(ISO 15189:2022)
Ta slovenski standard je istoveten z: EN ISO 15189:2022
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 15189
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2022
EUROPÄISCHE NORM
ICS 03.120.10; 11.100.01 Supersedes EN ISO 15189:2012, EN ISO 22870:2016
English Version
Medical laboratories - Requirements for quality and
competence (ISO 15189:2022)
Laboratoires de biologie médicale - Exigences Medizinische Laboratorien - Anforderungen an die
concernant la qualité et la compétence (ISO Qualität und Kompetenz (ISO 15189:2022)
15189:2022)
This European Standard was approved by CEN on 15 November 2022.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15189:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 15189:2022) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee
CEN/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.
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 June 2023, and conflicting national standards shall be
withdrawn at the latest by December 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15189:2012 and EN ISO 22870:2016.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 15189:2022 has been approved by CEN as EN ISO 15189:2022 without any modification.
INTERNATIONAL ISO
STANDARD 15189
Fourth edition
2022-12
Medical laboratories — Requirements
for quality and competence
Laboratoires de biologie médicale — Exigences concernant la qualité
et la compétence
Reference number
ISO 15189:2022(E)
ISO 15189:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Email: [email protected]
Website: www.iso.org
Published in Switzerland
ii
ISO 15189:2022(E)
Contents Page
Foreword . vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 8
4.1 Impartiality . 8
4.2 Confidentiality . 8
4.2.1 Management of information . 8
4.2.2 Release of information . 9
4.2.3 Personnel responsibility . 9
4.3 Requirements regarding patients . 9
5 Structural and governance requirements . 9
5.1 Legal entity . 9
5.2 Laboratory director . 10
5.2.1 Laboratory director competence . 10
5.2.2 Laboratory director responsibilities . 10
5.2.3 Delegation of duties . 10
5.3 Laboratory activities . 10
5.3.1 General . 10
5.3.2 Conformance with requirements . 10
5.3.3 Advisory activities . 10
5.4 Structure and authority . 11
5.4.1 General . 11
5.4.2 Quality management . 11
5.5 Objectives and policies . 11
5.6 Risk management .12
6 Resource requirements .12
6.1 General .12
6.2 Personnel .12
6.2.1 General .12
6.2.2 Competence requirements .12
6.2.3 Authorization .13
6.2.4 Continuing education and professional development .13
6.2.5 Personnel records. 13
6.3 Facilities and environmental conditions . 13
6.3.1 General .13
6.3.2 Facility controls . 14
6.3.3 Storage facilities . 14
6.3.4 Personnel facilities . 14
6.3.5 Sample collection facilities . 14
6.4 Equipment . 15
6.4.1 General .15
6.4.2 Equipment requirements . 15
6.4.3 Equipment acceptance procedure .
...