SIST EN ISO 15189:2023
(Main)Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
Medical laboratories - Requirements for quality and competence (ISO 15189:2022)
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO 15189:2022)
Dieses Dokument legt Anforderungen an die Qualität und Kompetenz in medizinischen Laboratorien fest.
Dieses Dokument ist anwendbar auf medizinische Laboratorien bei der Entwicklung von deren Management¬systemen und der Beurteilung ihrer Kompetenz. Des Weiteren ist es anwendbar bei der Bestätigung oder Anerkennung der Kompetenz medizinischer Laboratorien durch Kunden des Laboratoriums, Aufsichts¬behörden und Akkreditierungsstellen.
Dieses Dokument ist auch auf die patientennahe Sofortdiagnostik (POCT) anwendbar.
ANMERKUNG Internationale, nationale oder regionale Regelungen bzw. Anforderungen können ebenfalls für bestimmte Themen in diesem Dokument gelten.
Laboratoires de biologie médicale - Exigences concernant la qualité et la compétence (ISO 15189:2022)
Le présent document spécifie les exigences concernant la qualité et la compétence des laboratoires médicaux (laboratoires de biologie médicale et autres laboratoires médicaux comme les structures d’anatomie et de cytologie pathologiques).
Le présent document est également applicable aux laboratoires médicaux dans le cadre de l’élaboration de leur système de management et de l’évaluation de leur compétence. Il est également applicable par les utilisateurs des laboratoires, les autorités réglementaires et les organismes d’accréditation pour confirmer ou reconnaître la compétence des laboratoires médicaux.
Le présent document est applicable aux examens de biologie médicale délocalisée (EBMD).
NOTE Des réglementations ou exigences internationales, nationales ou régionales peuvent également s’appliquer à des sujets spécifiques traités dans le présent document.
Medicinski laboratoriji - Zahteve za kakovost in kompetentnost (ISO 15189:2022)
Ta dokument določa zahteve za kakovost in kompetentnost medicinskih laboratorijev.
Ta dokument uporabljajo laboratoriji pri oblikovanju sistemov upravljanja kakovosti in vrednotenju lastne kompetentnosti. Uporablja se tudi za potrjevanje ali prepoznavanje kompetentnosti medicinskih laboratorijev s strani laboratorijskih uporabnikov ter upravnih in akreditacijskih organov.
Ta dokument se uporablja tudi za testiranje ob pacientu (POCT).
OPOMBA: Za določene teme, ki so zajete v tem dokumentu, se lahko uporabljajo tudi mednarodni, nacionalni ali regionalni predpisi ali zahteve.
General Information
Relations
Standards Content (Sample)
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
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 .
...
SL O V EN S K I
S T ANDAR D
marec 2023
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)
Referenčna oznaka
ICS 03.120.10; 11.100.01 SIST EN ISO 15189:2023 (sl)
Nadaljevanje na straneh II in III ter od 1 do 100
© 2025-09. Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO 15189 : 2023
NACIONALNI UVOD
Standard SIST EN ISO 15189 (sl), Medicinski laboratoriji – Zahteve za kakovost in kompetentnost, 2023,
ima status slovenskega standarda in je istoveten evropskemu standardu EN ISO 15189 (en), Medical
laboratories – Requirements for quality and competence, 2022.
NACIONALNI PREDGOVOR
Evropski standard EN ISO 15189:2022 je pripravil tehnični odbor CEN/TC 140 In vitro diagnostic
medical devices.
Slovenski standard SIST EN ISO 15189:2023 je prevod evropskega standarda EN ISO 15189:2022. V
primeru spora glede besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski
standard v angleškem jeziku. Slovensko izdajo standarda je pripravil in potrdil tehnični odbor SIST/TC
VAZ Varovanje zdravja.
Odločitev za privzem tega standarda je marca 2023 sprejel tehnični odbor SIST/TC VAZ Varovanje
zdravja.
ZVEZE S STANDARDI
SIST-V ISO/IEC Vodilo 99:2012 Mednarodni slovar za meroslovje – Osnovni in splošni
koncepti ter z njimi povezani izrazi (VIM)
SIST EN ISO/IEC 17000:2020 Ugotavljanje skladnosti – Slovar in splošna načela
SIST EN ISO/IEC 17025:2017 Splošne zahteve za usposobljenost preskuševalnih in kalibracijskih
laboratorijev
OSNOVA ZA IZDAJO STANDARDA
̶ privzem standarda EN ISO 15189:2022 (en)
OPOMBE
̶ Povsod, kjer se v besedilu standarda uporablja izraz "evropski standard", v SIST EN ISO
15189:2023 to pomeni "slovenski standard".
− Nacionalni uvod in nacionalni predgovor nista sestavna dela standarda.
II
SIST EN ISO 15189 : 2023
– Ta nacionalni dokument je istoveten EN ISO 15189:2012 in je objavljen z dovoljenjem
CENManagement CentreAvenue Marnix 17
B-1000 Bruxelles
Belgija
This national document is identical with EN ISO 15189:2012 and is published with the permission of
CEN Management Centre
Avenue Marnix 17
B-1000 Bruxelles
Belgium
III
SIST EN ISO 15189 : 2023
(Prazna stran)
IV
EVROPSKI STANDARD EN ISO 15189
EUROPEAN STANDARD
NORME EUROPÉENNE
december 2022
EUROPÄISCHE NORM
ICS 03.120.01; 01.100.01
Slovenska izdaja
Medicinski laboratoriji – Zahteve za kakovost in kompetentnost
(ISO 15189:2022)
Medical laboratories - Laboratoires de biologie médicale - Medizinische Laboratorien -
Requirements for quality and Exigences concernant la qualité et Anforderungen an die Qualität und
competence (ISO 15189:2022) la compétence (ISO 15189:2022) Kompetenz (ISO 15189:2022)
Ta evropski standard je CEN sprejel 15. novembra 2022.
Člani CEN morajo izpolnjevati določila notranjih predpisov CEN/CENELEC, s katerimi je predpisano,
da mora biti ta evropski standard brez kakršnihkoli sprememb sprejet kot nacionalni standard.
Seznami najnovejših izdaj teh nacionalnih standardov in njihovi bibliografski podatki so 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, Nemčije, Nizozemske, Norveške, Poljske, Portugalske, Republike
Severna Makedonija, Romunije, Slovaške, Slovenije, Srbije, 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: Rue de la Science 23, B-1040 Bruselj
© 2022 CEN/CENELEC Lastnice avtorskih pravic so vse države članice CEN in člani Ref. št. EN ISO 15189:2022 E
CENELEC.
SIST EN ISO 15189 : 2023
VSEBINA CONTENTS
Evropski predgovor . 3 European foreword . 3
SIST EN ISO 15189 : 2023
Evropski predgovor European foreword
Ta dokument (EN ISO 15189:2022) je pripravil This document (EN ISO 15189:2022) has been
tehnični odbor ISO/TC 212 "Preskušanje prepared by Technical Committee ISO/TC 212
kliničnih laboratorijev ter diagnostični sistemi in "Clinical laboratory testing and in vitro diagnostic
vitro" v sodelovanju s tehničnim odborom test systems" in collaboration with Technical
CEN/TC 140 "Diagnostični medicinski Committee CEN/TC 140 "In vitro diagnostic
pripomočki in vitro", katerega sekretariat vodi medical devices" the secretariat of which is held
DIN. by DIN.
Ta evropski standard mora dobiti status This European Standard shall be given the
nacionalnega standarda bodisi z objavo status of a national standard, either by
istovetnega besedila bodisi z razglasitvijo publication of an identical text or by
najpozneje do junija 2023; nacionalne endorsement, at the latest by June 2023, and
standarde, ki so v nasprotju s tem standardom, conflicting national standards shall be withdrawn
pa je treba razveljaviti najpozneje do decembra at the latest by December 2025.
2025.
Opozoriti je treba na možnost, da so lahko Attention is drawn to the possibility that some of
nekateri elementi tega dokumenta predmet the elements of this document may be the
patentnih pravic. CEN ne prevzema subject of patent rights. CEN shall not be held
odgovornosti za identifikacijo nekaterih ali vseh responsible for identifying any or all such patent
takih patentnih pravic. rights.
Ta dokument nadomešča standarda EN ISO This document supersedes EN ISO 15189:2012
15189:2012 in EN ISO 22870:2016. and EN ISO 22870:2016
Ta dokument je bil pripravljen v okviru mandata, This document has been prepared under a
ki sta ga CEN podelila Evropska komisija in Standardization Request given to CEN by the
Evropsko združenje za prosto trgovino (EFTA). European Commission and the European Free
Trade Association.
Uporabnik naj vse povratne informacije ali Any feedback and questions on this document
vprašanja o tem dokumentu posreduje should be directed to the users’ national
nacionalnemu organu/komiteju za standarde v standards body/national committee. A complete
svoji državi. Celoten seznam teh organov je na listing of these bodies can be found on the CEN
voljo na spletnem mestu CEN. website.
V skladu z notranjimi predpisi CEN/CENELEC According to the CEN-CENELEC Internal
morajo ta evropski standard obvezno uvesti Regulations, the national standards
nacionalne organizacije za standardizacijo organizations of the following countries are
naslednjih držav: Avstrije, Belgije, Bolgarije, bound to implement this European Standard:
Cipra, Češke republike, Danske, Estonije, Austria, Belgium, Bulgaria, Croatia, Cyprus,
Finske, Francije, Grčije, Hrvaške, Irske, Czech Republic, Denmark, Estonia, Finland,
Islandije, Italije, Latvije, Litve, Luksemburga, France, Germany, Greece, Hungary, Iceland,
Madžarske, Malte, Nemčije, Nizozemske, Ireland, Italy, Latvia, Lithuania, Luxembourg,
Norveške, Poljske, Portugalske, Republike Malta, Netherlands, Norway, Poland, Portugal,
Severna Makedonija, Romunije, Slovaške, Republic of North Macedonia, Romania, Serbia,
Slovenije, Srbije, Španije, Švedske, Švice, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turčije in Združenega kraljestva. Türkiye and the United Kingdom.
Razglasitvena objava Endorsement notice
Besedilo standarda ISO 15189:2022 je CEN The text of ISO 15189:2022 has been approved
brez sprememb odobril kot standard EN ISO by CEN as EN ISO 15189:2022 without any
15189:2022. modification.
SIST EN ISO 15189 : 2023
VSEBINA CONTENTS
Predgovor . 8 Foreword. . 8
Uvod . 10 Introduction .10
1 Področje uporabe . 12 1 Scope .12
2 Zveze s standardi . 12 2 Normative references .12
3 Izrazi in definicije . 12 3 Terms and definitions .12
4 Splošne zahteve . 23 4 General requirements .23
4.1 Nepristranskost . 23 4.1 Impartiality .23
4.2 Zaupnost . 23 4.2 Confidentiality .23
4.2.1 Upravljanje informacij . 23 4.2.1 Management of information. .23
4.2.2 Objava informacij . 24 4.2.2 Release of information. .24
4.2.3 Odgovornost osebja . 24 4.2.3 Personnel responsibility .24
4.3 Zahteve glede pacientov . 24 4.3 Requirements regarding patients. . 24
5 Zahteve za strukturo in upravljanje . 25 5 Structural and governance requirements .25
5.1 Pravna oseba . 25 5.1 Legal entity .25
5.2 Vodja laboratorija . 25 5.2 Laboratory director. .25
5.2.1 Kompetentnost vodje laboratorija . 25 5.2.1 Laboratory director competence. .25
5.2.2 Odgovornosti vodje laboratorija . 25 5.2.2 Laboratory director responsibilities .25
5.2.3 Dodelitev dolžnosti . 25 5.2.3 Delegation of duties .25
5.3 Aktivnosti laboratorija . 25 5.3 Laboratory activities .25
5.3.1 Splošno . 25 5.3.1 General .25
5.3.2 Skladnost z zahtevami . 26 5.3.2 Conformance with requirements .28
5.3.3 Aktivnosti svetovanja . 26 5.3.3 Advisory activities .28
5.4 Struktura in pooblastila . 26 5.4 Structure and authority .29
5.4.1 Splošno . 26 5.4.1 General .26
5.4.2 Vodenje kakovosti . 27 5.4.2 Quality management .27
5.5 Cilji in politika . 27 5.5 Objectives and policies .27
5.6 Obvladovanje tveganja . 27 5.6 Risk management .28
6 Zahteve za vire . 28 6 Resource requirements .28
6.1 Splošno . 28 6.1 General .28
6.2 Osebje . 28 6.2 Personnel .28
6.2.1 Splošno . 28 6.2.1 General .28
6.2.2 Zahteve za kompetentnost . 28 6.2.2 Competence requirements .28
6.2.3 Pooblastitev . 29 6.2.3 Authorization .29
6.2.4 Stalno izobraževanje in strokovno 6.2.4 Continuing education and professional
izpopolnjevanje . 29 development .29
6.2.5 Zapisi o osebju . 29 6.2.5 Personnel records .29
6.3 Prostori in oprema ter okoljske razmere 30 6.3 Facilities and environmental conditions .30
6.3.1 Splošno . 30 6.3.1 General .30
6.3.2 Kontrole prostorov in opreme . 30 6.3.2 Facility controls .30
6.3.3 Prostori in oprema za shranjevanje . 31 6.3.3 Storage facilities .31
6.3.4 Prostori in oprema za osebje . 31 6.3.4 Personnel facilities .31
6.3.5 Prostori in oprema za odvzem vzorcev 31 6.3.5 Sample collection facilities .31
6.4 Oprema . 31 6.4 Equipment .32
6.4.1 Splošno . 32 6.4.1 General .32
6.4.2 Zahteve za opremo . 32 6.4.2 Equipment requirements .32
SIST EN ISO 15189 : 2023
6.4.3 Postopek za določitev sprejemljivosti 6.4.3 Equipment acceptance procedure .32
opreme .
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.