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 anwendbar auf die patientennahe Sofortdiagnostik (POCT).
ANMERKUNG Internationale, nationale oder regionale Regelungen bzw. Anforderungen können ebenfalls für bestimmte Themen in diesem Dokument gelten.
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 anwendbar auf die patientennahe Sofortdiagnostik (POCT).
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
SIST EN ISO 15189:2023
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
SIST EN ISO 15189:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 15189:2023
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SIST EN ISO 15189:2023
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.
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SIST EN ISO 15189:2023
EN ISO 15189:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 15189:2023
EN ISO 15189:2022 (E)
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.
3
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SIST EN ISO 15189:2023
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SIST EN ISO 15189:2023
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 2022
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SIST EN ISO 15189:2023
ISO 15189:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© 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 2022 – All rights reserved
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SIST EN ISO 15189:2023
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 . 15
6.4.4 Equipment instructions for use . 15
6.4.5 Equipment maintenance and repair . 15
6.4.6 Equipment adverse incident reporting . 16
6.4.7 Equipment records . 16
6.5 Equipment calibration and metrological traceability . 17
6.5.1 General . 17
6.5.2 Equipment calibration . 17
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SIST EN ISO 15189:2023
ISO 15189:2022(E)
6.5.3 Metrological traceability of measurement results . 17
6.6 Reagents and consumables . 18
6.6.1 General . 18
6.6.2 Reagents and consumables — Receipt and storage . 18
6.6.3 Reagents and consumables — Acceptance testing . 18
6.6.4 Reagents and consumables — Inventory management . . 18
6.6.5 Reagents and consumables — Instructions for use . 19
6.6.6 Reagents and consumables — Adverse incident reporting . 19
6.6.7 Reagents and consumables — Records . 19
6.7 Service agreements . 19
6.7.1 Agreements with laboratory users . 19
6.7.2 Agreements with POCT operators . 19
6.8 Externally provided products and services . 20
6.8.1 General .20
6.8.2 Referral laboratories and consultants . 20
6.8.3 Review and approval of externally provided products and services .20
7 Process requirements .21
7.1 General . 21
7.2 Pre-examination processes . 21
7.2.1 General . 21
7.2.2 Laboratory information for patients and users . 21
7.2.3 Requests for providing laboratory examinations . 21
7.2.4 Primary sample collection and handling .22
7.2.5 Sample transportation .23
7.2.6 Sample receipt . 24
7.2.7 Pre-examination handling, preparation, and storage. 24
7.3 Examination processes .25
7.3.1 General . 25
7.3.2 Verification of examination methods . . 25
7.3.3 Validation of examination methods . 25
7.3.4 Evaluation of measurement uncertainty (MU) . 26
7.3.5 Biological reference intervals and clinical decision limits .26
7.3.6 Documentation of examination procedures . 27
7.3.7 Ensuring the validity of examination results . 27
7.4 Post-examination processes . 30
7.4.1 Reporting of results .30
7.4.2 Post-examination handling of samples . 32
7.5 Nonconforming work . 33
7.6 Control of data and information management . 33
7.6.1 General . 33
7.6.2 Authorities and responsibilities for information management.33
7.6.3 Information systems management .34
7.6.4 Downtime plans .34
7.6.5 Off site management .34
7.7 Complaints.34
7.7.1 Process .34
7.7.2 Receipt of complaint . 35
7.7.3 Resolution of complaint . . 35
7.8 Continuity and emergency preparedness planning . 35
8 Management system requirements .35
8.1 General requirements . 35
8.1.1 General . 35
8.1.2 Fulfilment of management system requirements .36
8.1.3 Management system awareness .36
8.2 Management system documentation . 36
8.2.1 General .36
8.2.2 Competence and quality . 36
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SIST EN ISO 15189:2023
ISO 15189:2022(E)
8.2.3 Evidence of commitment . 36
8.2.4 Documentation.36
8.2.5 Personnel access .36
8.3 Control of management system documents . 37
8.3.1 General . 37
8.3.2 Control of documents . 37
8.4 Control of records . 37
8.4.1 Creation of records . 37
8.4.2 Amendment of records . 37
8.4.3 Retention of records .38
8.5 Actions to address risks and opportunities for improvement .38
8.5.1 Identification of risks and opportunities for improvement .38
8.5.2 Acting on risks and opportunities for improvement .38
8.6 Improvement . 39
8.6.1 Continual improvement. 39
8.6.2 Laboratory patients, user, and personnel feedback .39
8.7 Nonconformities and corrective actions . 39
8.7.1 Actions when nonconformity occurs .39
8.7.2 Corrective action effectiveness .40
8.7.3 Records of nonconformities and corrective actions .40
8.8 Evaluations .40
8.8.1 General .40
8.8.2 Quality indicators .40
8.8.3 Internal audits .40
8.9 Management reviews .
...
SLOVENSKI STANDARD
oSIST prEN ISO 15189:2021
01-december-2021
Medicinski laboratoriji - Zahteve za kakovost in kompetentnost (ISO/DIS
15189:2021)
Medical laboratories - Requirements for quality and competence (ISO/DIS 15189:2021)
Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO/DIS
15189:2021)
Laboratoires de biologie médicale - Exigences concernant la qualité et la compétence
(ISO/DIS 15189:2021)
Ta slovenski standard je istoveten z: prEN ISO 15189
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
oSIST prEN ISO 15189:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 15189:2021
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oSIST prEN ISO 15189:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15189
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-10-19 2022-01-11
Medical laboratories — Requirements for quality and
competence
Laboratoires de biologie médicale — Exigences concernant la qualité et la compétence
ICS: 11.100.01; 03.120.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15189:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
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oSIST prEN ISO 15189:2021
ISO/DIS 15189:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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 2021 – All rights reserved
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oSIST prEN ISO 15189:2021
ISO/DIS 15189:2021(E)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 7
4.1 Impartiality . 7
4.2 Confidentiality . 7
4.3 Requirements regarding patients . 8
5 Structural and governance requirements . 8
5.1 Legal entity . 8
5.2 Laboratory director. 8
5.2.1 Laboratory director competence . 8
5.2.2 Laboratory director responsibilities. 8
5.2.3 Delegation of duties. 9
5.3 Laboratory activities . 9
5.3.1 Scope of laboratory activities . 9
5.3.2 Conformance with requirements. 9
5.3.3 Advisory activities . 9
5.4 Structure and authority . 9
5.4.1 General. 9
5.4.2 Quality management .10
5.5 Objecti ves and policies .10
5.6 Risk management .10
6 Resource requirements .11
6.1 General .11
6.2 Personnel .11
6.2.1 General.11
6.2.2 Qualification, duties and responsibilities .11
6.2.3 Training and competence assessment .11
6.2.4 Continuing education and professional development .12
6.2.5 Authorization .12
6.3 Facilities and environmental conditions .12
6.3.1 General.12
6.3.2 Facility controls.12
6.3.3 Storage facilities .13
6.3.4 Personnel facilities .13
6.3.5 Specimen collection facilities .13
6.4 Equipment .13
6.4.1 General.13
6.4.2 Equipment requirements .13
6.4.3 Equipment acceptance testing .14
6.4.4 Equipment instructions for use .14
6.4.5 Equipment maintenance and repair .14
6.4.6 Equipment adverse incident reporting .14
6.4.7 Equipment records .15
6.5 Equipment calibration and metrological traceability .15
6.5.1 Metrological traceability of equipment and method .15
6.5.2 Metrological traceability of measurement results .16
6.6 Reagents and consumables .16
6.6.1 Reagents and consumables - General .16
6.6.2 Reagents and consumables - Receipt and storage .16
© ISO 2021 – All rights reserved iii
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oSIST prEN ISO 15189:2021
ISO/DIS 15189:2021(E)
6.6.3 Reagents and consumables - Acceptance testing .17
6.6.4 Reagents and consumables - Inventory management .17
6.6.5 Reagents and consumables - Instructions for use .17
6.6.6 Reagents and consumables - Adverse incident reporting .17
6.6.7 Reagents and consumables - Records.17
6.7 Service agreements .17
6.8 Externally provided products and services .18
6.8.1 General.18
6.8.2 Referral laboratories and consultants.18
6.8.3 Review and approval of externally provided products and services .18
7 Process requirements .19
7.1 Pre-examination processes .19
7.1.1 Laboratory information for patients and users .19
7.1.2 Requests for providing laboratory examinations .19
7.1.3 Primary sample collection and handling .20
7.1.4 Sample transportation .21
7.1.5 Sample receipt .22
7.1.6 Pre-examination handling, preparation, and storage .22
7.2 Examination processes .23
7.2.1 General.23
7.2.2 Verification of examination methods .23
7.2.3 Validation of examination methods .23
7.2.4 Measurement uncertainty of measured quantity values .24
7.2.5 Biological reference intervals and clinical decision limits .24
7.2.6 Documentation of examination procedures .25
7.2.7 Ensuring the validity of examination results.25
7.3 Post-examination processes .28
7.3.1 Result reporting .28
7.3.2 Post-examination handling of samples.30
7.4 Nonconforming work .30
7.5 Control of data and information management .31
7.5.1 General.31
7.5.2 Authorities and responsibilities for information management .31
7.5.3 Information systems management .31
7.5.4 Contingency plans.32
7.5.5 Off site management .32
7.7 Continuity and emergency preparedness planning .32
8 Management s ystem requirements .33
8.1 General requirements and options .33
8.2 Management s ystem documentation .34
8.2.1 General.34
8.2.2 Competence, impartiality, and consistency .34
8.2.3 Evidence of commitment .34
8.2.4 Documentation .34
8.2.5 Personnel access .34
8.3 Control of management system documents .34
8.3.1 Control of Documents .34
8.3.2 Management of documents .34
8.4 Control of records .35
8.4.1 Creation of records . .35
8.4.2 Amendment of records .35
8.4.3 Retention of records .35
8.5 Actions to address risks and opportunities .35
8.5.1 Identification of risks and opportunities .35
8.5.2 Acting on risks.36
8.6 Improvement .36
8.6.1 Continual improvement .36
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oSIST prEN ISO 15189:2021
ISO/DIS 15189:2021(E)
8.6.2 Laboratory patients, user, and personnel feedback.36
8.7 Corrective Action .37
8.7.1 Actions when nonconformity occurs .37
8.7.2 Corrective action effectiveness .37
8.7.3 Records of nonconformities .37
8.8 Evaluations .37
8.8.1 General.37
8.8.2 Quality indicators .37
8.8.3 Internal audits .38
8.9 Management reviews .38
8.9.1 General.38
8.9.2 Review input .38
8.9.3 Review output .39
Annex A (informative) .40
Annex B (informative) Comparison of ISO 15189:2012 to ISO 15189:2022 .50
Bibliography .56
© ISO 2021 – All rights reserved v
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oSIST prEN ISO 15189:2021
ISO/DIS 15189:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO TC 212, Clinical laboratory testing and in vitro
diagnostic test systems.
This fourth edition cancels and replaces the third edition ISO 15189:2012, which has been technically
revised.
The fourth edition provides alignment with ISO/IEC 17025:2017
Correlations between this document, ISO 9001:2015 and ISO/IEC 17025:2017 are in Annex A. The
comparison of ISO 15189:2012 to ISO 15189:2022 is in Annex B.
Any feedback or questions on this document should be directed through the user’s national standards
body. A complete listing of these bodies can be found at www .iso .org/ members .html.
vi © ISO 2021 – All rights reserved
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oSIST prEN ISO 15189:2021
ISO/DIS 15189:2021(E)
Introduction
This document is based upon ISO/IEC 17025:2017 General requirements for the competence of testing and
calibration laboratories. It has been developed with the objective of promoting the welfare of patients
through confidence in the quality and competence of medical laboratories.
Because the primary consideration is the welfare of patients and the satisfaction of users, this document
contains requirements for the medical laboratory to plan and implement actions to address risks and
opportunities. This is the basis for increasing the effectiveness of the management system, achieving
improved results, and preventing negative effects which could result in harm to patients, laboratory
personnel, the public and the environment.
The requirements for risk management are aligned with the principles of ISO 22367:2020 Medical
laboratories – Application of risk management to medical laboratories.
The requirements for laboratory safety are aligned with the principles of ISO 15190:2020 Medical
laboratories – Requirements for Safety.
The requirements for sample collection and transport are aligned with ISO/TS 20658:2017 Medical
laboratories - Requirements for collection and transport of samples.
This document contains the requirements for point-of-care testing (POCT) and supersedes
ISO 22870:2016 Point-of-care testing (POCT) – Requirements for quality and competence, which is to be
withdrawn.
The medical laboratory is essential to patient care; activities are provided within an ethical and
governance framework, that recognizes the obligations of healthcare providers to the patient. These
activities are undertaken in a timely manner to meet the needs of all patients and the personnel
responsible for the care of those patients. Activities include arrangements for examination requests,
patient preparation, patient identification, collection of samples, transportation, processing of clinical
samples, selection of examinations that are fit for intended use, examination of samples, sample
storage, together with subsequent interpretation, reporting and advice to users. This may also include
the provision of results to the patient, arrangements for urgent testing and the notification of critical
results. It is recommended that the medical labo
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