NF EN ISO 22367

NF EN ISO 22367

March 2020
Standard Current

Medical laboratories - Application of risk management to medical laboratories

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.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2020

Number of pages

92 p.

Reference

NF EN ISO 22367

ICS Codes

11.100.01   Laboratory medicine in general

Classification index

S92-081

Print number

1

International kinship

ISO 22367:2020

European kinship

EN ISO 22367:2020
Sumary
Medical laboratories - Application of risk management to medical laboratories

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.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Gestion des risques
  • 5 Analyse du risque
  • 6 Évaluation du risque
  • 7 Maîtrise du risque
  • 8 Analyse du rapport bénéfice/risque
  • 9 Revue de la gestion des risques
  • 10 Surveillance du risque, analyse et contrôle des activités
  • Annexe A Mise en oeuvre de la gestion des risques au sein du système de management de la qualité
  • Annexe B Développement d'un plan de gestion des risques
  • Annexe C Considérations relatives à l'acceptabilité d'un risque
  • Annexe D Identification des caractéristiques liées à la sécurité
  • Annexe E Exemples de phénomènes dangereux, séquences d'événements prévisibles et situations dangereuses
  • Annexe F Non-conformités susceptibles d'entraîner des risques significatifs
  • Annexe G Outils et techniques d'analyse du risque
  • Annexe H Analyse du risque des actions prévisibles de l'utilisateur
  • Annexe I Méthodes d'appréciation du risque, y compris l'estimation de la probabilité et la gravité du dommage
  • Annexe J Évaluation du risque résiduel global et revue de la gestion des risques
  • Annexe K Mener une analyse du rapport bénéfice/risque
  • Annexe L Risque (s) résiduel (s)
  • Bibliographie
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