EN ISO 22367:2020
(Main)Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)
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 22367:2020)
Dieses Dokument legt einen Prozess fest, anhand dessen medizinische Laboratorien mit medizinischen Untersuchungen verbundene Risiken für Patienten, Labormitarbeiter und Dienstleister erkennen und handhaben können. Der Prozess umfasst die Erkennung, Einschätzung, Bewertung, Kontrolle und Überwachung der Risiken.
Die Anforderungen dieses Dokuments gelten für alle Aspekte der Untersuchungen und Dienstleistungen eines medizinischen Laboratoriums, einschließlich der präanalytischen und postanalystischen Phase, der Untersuchungen, der genauen Übertragung der Prüfergebnisse in eine elektronische medizinische Patienten¬akte sowie andere in ISO 15189 beschriebene technische und Verwaltungsprozesse.
In diesem Dokument wird kein annehmbarer Grad des Risikos spezifiziert.
Dieses Dokument gilt nicht für Risiken durch klinische Entscheidungen, die Anbieter medizinischer Versorgungsleistungen nach der Untersuchung treffen.
Dieses Dokument gilt nicht für das Management von medizinische Laborbetriebe betreffenden Risiken, die in ISO 31000 angesprochen werden, wie z. B. geschäftliche, wirtschaftliche, rechtliche und regulatorische Risiken.
Laboratoires de biologie médicale - Application de la gestion des risques aux laboratoires de biologie médicale (ISO 22367:2020)
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 22367:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2020
Nadomešča:
SIST-TS CEN ISO/TS 22367:2010
Medicinski laboratoriji - Uporaba obvladovanja tveganja v medicinskih
laboratorijih (ISO 22367:2020)
Medical laboratories - Application of risk management to medical laboratories (ISO
22367:2020)
Medizinische Laboratorien - Fehlerverringerung durch Risikomanagement und ständige
Verbesserung (ISO 22367:2020)
Laboratoires de biologie médicale - Application de la gestion des risques aux
laboratoires de biologie médicale (ISO 22367:2020)
Ta slovenski standard je istoveten z: EN ISO 22367:2020
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.
EN ISO 22367
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2020
EUROPÄISCHE NORM
ICS 11.100.01 Supersedes CEN ISO/TS 22367:2010
English Version
Medical laboratories - Application of risk management to
medical laboratories (ISO 22367:2020)
Laboratoires de biologie médicale - Application de la Medizinische Laboratorien - Fehlerverringerung durch
gestion des risques aux laboratoires de biologie Risikomanagement und ständige Verbesserung (ISO
médicale (ISO 22367:2020) 22367:2020)
This European Standard was approved by CEN on 7 February 2020.
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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22367:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 22367:2020) 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 September 2020, and conflicting national standards
shall be withdrawn at the latest by September 2020.
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 CEN ISO/TS 22367:2010.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 22367:2020 has been approved by CEN as EN ISO 22367:2020 without any modification.
INTERNATIONAL ISO
STANDARD 22367
First edition
2020-02
Medical laboratories — Application
of risk management to medical
laboratories
Laboratoires de biologie médicale — Application de la gestion des
risques aux laboratoires de biologie médicale
Reference number
ISO 22367:2020(E)
©
ISO 2020
ISO 22367:2020(E)
© ISO 2020
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO 22367:2020(E)
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 .10
4.4 Risk management plan .10
4.4.1 General.10
4.4.2 Scope of the plan .11
4.4.3 Contents of the plan .11
4.4.4 Revisions to the plan .11
4.4.5 Risk management documentation .12
5 Risk analysis .12
5.1 General .12
5.2 Risk analysis process and documentation .13
5.3 Intended medical laboratory use and reasonably foreseeable misuses .13
5.4 Identification of characteristics related to safety .13
5.5 Identification of hazards .13
5.6 Identification of potentially hazardous situations .14
5.7 Identification of foreseeable patient harms .14
5.8 Estimation of the risk(s) for each hazardous situation.14
6 Risk evaluation .15
6.1 Risk acceptability criteria .15
6.2 Risk evaluation process .16
7 Risk control .16
7.1 Risk control options.16
7.2 Risk control verification .17
7.3 Role of standards in risk control.17
7.4 Role of IVD medical devices in risk control .17
7.5 Risks arising from risk control measures .17
7.6 Residual risk evaluation .17
8 Benefit-risk analysis .18
9 Risk management review .18
9.1 Completeness of risk control .18
9.2 Evaluation of overall residual risk .18
9.3 Risk management report .19
10 Risk monitoring, analysis and control activities .19
10.1 Surveillance procedure .19
10.2 Internal sources of risk information .20
10.3 External sources of risk information .20
10.4 Immediate actions to reduce risk .20
Annex A (informative) Implementation of risk management within the quality
management system .22
Annex B (informative) Developing a risk management plan .32
Annex C (in
...
SLOVENSKI STANDARD
01-maj-2020
Nadomešča:
SIST-TS CEN ISO/TS 22367:2010
Medicinski laboratoriji - Uporaba obvladovanja tveganja v medicinskih
laboratorijih (ISO 22367:2020)
Medical laboratories - Application of risk management to medical laboratories (ISO
22367:2020)
Medizinische Laboratorien - Fehlerverringerung durch Risikomanagement und ständige
Verbesserung (ISO 22367:2020)
Laboratoires de biologie médicale - Application de la gestion des risques aux
laboratoires de biologie médicale (ISO 22367:2020)
Ta slovenski standard je istoveten z: EN ISO 22367:2020
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.
EN ISO 22367
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2020
EUROPÄISCHE NORM
ICS 11.100.01 Supersedes CEN ISO/TS 22367:2010
English Version
Medical laboratories - Application of risk management to
medical laboratories (ISO 22367:2020)
Laboratoires de biologie médicale - Application de la Medizinische Laboratorien - Fehlerverringerung durch
gestion des risques aux laboratoires de biologie Risikomanagement und ständige Verbesserung (ISO
médicale (ISO 22367:2020) 22367:2020)
This European Standard was approved by CEN on 7 February 2020.
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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22367:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 22367:2020) 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 September 2020, and conflicting national standards
shall be withdrawn at the latest by March 2023.
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 CEN ISO/TS 22367:2010.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 22367:2020 has been approved by CEN as EN ISO 22367:2020 without any modification.
INTERNATIONAL ISO
STANDARD 22367
First edition
2020-02
Medical laboratories — Application
of risk management to medical
laboratories
Laboratoires de biologie médicale — Application de la gestion des
risques aux laboratoires de biologie médicale
Reference number
ISO 22367:2020(E)
©
ISO 2020
ISO 22367:2020(E)
© ISO 2020
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO 22367:2020(E)
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 .10
4.4 Risk management plan .10
4.4.1 General.10
4.4.2 Scope of the plan .11
4.4.3 Contents of the plan .11
4.4.4 Revisions to the plan .11
4.4.5 Risk management documentation .12
5 Risk analysis .12
5.1 General .12
5.2 Risk analysis process and documentation .13
5.3 Intended medical laboratory use and reasonably foreseeable misuses .13
5.4 Identification of characteristics related to safety .13
5.5 Identification of hazards .13
5.6 Identification of potentially hazardous situations .14
5.7 Identification of foreseeable patient harms .14
5.8 Estimation of the risk(s) for each hazardous situation.14
6 Risk evaluation .15
6.1 Risk acceptability criteria .15
6.2 Risk evaluation process .16
7 Risk control .16
7.1 Risk control options.16
7.2 Risk control verification .17
7.3 Role of standards in risk control.17
7.4 Role of IVD medical devices in risk control .17
7.5 Risks arising from risk control measures .17
7.6 Residual risk evaluation .17
8 Benefit-risk analysis .18
9 Risk management review .18
9.1 Completeness of risk control .18
9.2 Evaluation of overall residual risk .18
9.3 Risk management report .19
10 Risk monitoring, analysis and control activities .19
10.1 Surveillance procedure .19
10.2 Internal sources of risk information .20
10.3 External sources of risk information .20
10.4 Immediate actions to reduce risk .20
Annex A (informative) Implementation of risk management within the quality
management system .22
Annex B (informative) Developing a risk management plan .32
Annex C (inform
...
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