prEN ISO 22367
(Main)Medical laboratories - Application of risk management to medical laboratories (ISO/DIS 22637:2025)
Medical laboratories - Application of risk management to medical laboratories (ISO/DIS 22637:2025)
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
Medizinische Laboratorien - Anwendung des Risikomanagements auf medizinische Laboratorien (ISO/DIS 22637:2025)
Laboratoires de biologie médicale - Application de la gestion des risques aux laboratoires de biologie médicale (ISO/DIS 22637:2025)
Le présent document spécifie un processus permettant à un laboratoire de biologie médicale d'identifier et de gérer les risques pour les patients, le personnel de laboratoire et les prestataires de service qui sont associés aux examens de laboratoire de biologie médicale. Le processus inclut l'identification, l'estimation, l'évaluation, la maîtrise et la gestion des risques.
Les exigences du présent document sont applicables à tous les aspects relatifs aux examens et aux services d'un laboratoire de biologie médicale, y compris les aspects préanalytiques et postanalytiques, les examens, la transmission rigoureuse des résultats d'examen dans un dossier médical électronique et les autres processus techniques et managériaux décrits dans l'ISO 15189.
Le présent document ne spécifie pas les niveaux de risque acceptables.
Le présent document ne s'applique pas aux risques liés aux décisions cliniques postanalytiques prises par des prestataires de soins de santé.
Le présent document ne s'applique pas à la gestion des risques afférents aux entreprises de laboratoire de biologie médicale qui sont couverts par l'ISO 31000, tels que les risques commerciaux, économiques, juridiques et réglementaires.
Medicinski laboratoriji - Uporaba obvladovanja tveganja v medicinskih laboratorijih (ISO/DIS 22367:2025)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2025
Medicinski laboratoriji - Uporaba obvladovanja tveganja v medicinskih
laboratorijih (ISO/DIS 22367:2025)
Medical laboratories - Application of risk management to medical laboratories (ISO/DIS
22367:2025)
Medizinische Laboratorien - Anwendung des Risikomanagements auf medizinische
Laboratorien (ISO/DIS 22367:2025)
Laboratoires de biologie médicale - Application de la gestion des risques aux
laboratoires de biologie médicale (ISO/DIS 22367:2025)
Ta slovenski standard je istoveten z: prEN ISO 22367
ICS:
03.100.01 Organizacija in vodenje Company organization and
podjetja na splošno management in general
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.
DRAFT
International
Standard
ISO/DIS 22367
ISO/TC 212
Medical laboratories — Application
Secretariat: ANSI
of risk management to medical
Voting begins on:
laboratories
2025-04-02
Laboratoires de biologie médicale — Application de la gestion
Voting terminates on:
des risques aux laboratoires de biologie médicale
2025-06-25
ICS: 11.100.01
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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NOTIFICATION OF ANY RELEVANT PATENT
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Reference number
ISO/DIS 22367:2025(en)
DRAFT
ISO/DIS 22367:2025(en)
International
Standard
ISO/DIS 22367
ISO/TC 212
Medical laboratories — Application
Secretariat: ANSI
of risk management to medical
Voting begins on:
laboratories
Laboratoires de biologie médicale — Application de la gestion
Voting terminates on:
des risques aux laboratoires de biologie médicale
ICS: 11.100.01
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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Published in Switzerland Reference number
ISO/DIS 22367:2025(en)
ii
ISO/DIS 22367:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Risk Management . 8
4.1 Risk management process .8
4.2 Management responsibilities .9
4.3 Qualification of personnel .9
4.4 Risk management activities .10
4.4.1 Foreseeable risk .11
4.4.2 Opportunity . 12
4.4.3 Information provided to users . 12
5 Management of proactive risks .12
5.1 Proactive risk management plan. 12
5.2 Scope of the plan . 13
5.3 Contents of the plan . 13
5.4 Revisions to the plan . 13
5.5 Documentation of the risk management plan.14
6 Proactive risk analysis . 14
6.1 General .14
6.2 Risk analysis process . 15
6.3 Documentation of the risk analysis process . 15
6.3.1 Intended medical laboratory use and reasonably foreseeable misuses . 15
6.3.2 Identification of characteristics related to safety . 15
6.3.3 Identification of hazards . 15
7 Risk evaluation .16
7.1 General .16
7.1.1 Evaluation of reactive risks .16
7.1.2 Evaluation of proactive risks.16
7.2 Benefit-Risk analysis .17
7.3 Proactive risk evaluation .17
7.3.1 Risk acceptability criteria .17
7.3.2 Risk reduction . . .18
8 Risk control .18
8.1 Risk control options .19
8.1.1 Role of standards in risk control .19
8.1.2 Role of IVD medical devices in risk control .19
8.2 Risks external to the laboratory . 20
8.3 Risks arising from risk control measures . 20
8.4 Residual risk evaluation . 20
8.5 Risk control verification .21
9 Risk management review .21
9.1 Completeness of risk control .21
9.2 Evaluation of overall residual risk .21
9.3 Risk management report . 22
10 Risk monitoring, analysis and control activities .22
10.1 Surveillance procedure . 22
10.2 Internal sources of risk information . 23
10.3 External sources of risk information. 23
iii
ISO/DIS 22367:2025(en)
11 Immediate actions to reduce risk .23
Annex A (informative) Implementation of risk management within the management system .24
Annex B (informative) Risk acceptability considerations .34
Annex C (informative) Risk acceptability considerations .
...
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