prEN ISO 15189

Medical laboratories - Requirements for quality and competence (ISO/DIS 15189:2021)

Resolution BT C87/2011 (extension of DOW): DOW = DAV + 36 months

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)

Medicinski laboratoriji - Zahteve za kakovost in kompetentnost (ISO/DIS 15189:2021)

General Information

• Status: Not Published
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.100.01 - Laboratory medicine in general
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Due Date: 15-Jul-2022
• Completion Date: 15-Jul-2022
• Ref Project: oSIST prEN ISO 15189:2021 - Medical laboratories - Requirements for quality and competence (ISO/DIS 15189:2021)

RELATIONS

• Revised: EN ISO 15189:2012 - Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
• Effective Date: 26-Sep-2018

Standards Content (sample)

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
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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

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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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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

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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
...