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EN ISO 22367:2026

Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2026)

Edition date: 2026-04-15
In Force
Available languages: English, French
Summary: 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, examination, and post-examination aspects including accurate transmission of examination results into the electronic medical record, as well as 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 complements the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

Le présent document spécifie un processus permettant à un laboratoire médical 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 médical. 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 médical, y compris les aspects avant, pendant et après les examens, y compris la transmission rigoureuse des résultats d’examen dans un dossier médical électronique ainsi que d’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 complète la gestion des risques afférents aux entreprises de laboratoire médical qui sont couverts par l’ISO 31000, tels que les risques commerciaux, économiques, juridiques et réglementaires.

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 Phase, der Untersuchung und der postanalytischen Phase, einschließlich der genauen Übertragung der Untersuchungsergebnisse in eine elektronische medizinische Patientenakte sowie andere in ISO 15189 beschriebene technische und Verwaltungsprozesse. In diesem Dokument wird kein annehmbarer Grad des Risikos festgelegt. Dieses Dokument ist nicht anwendbar für Risiken durch klinische Entscheidungen, die Gesundheitsdienstleister nach der Untersuchung treffen. Dieses Dokument ergänzt das Management von medizinische Laborbetriebe betreffenden Risiken, die in ISO 31000 angesprochen werden, wie z. B. geschäftliche, wirtschaftliche, rechtliche und regulatorische Risiken.
ICS: 11.100.01-Laboratory medicine in general
CTN: CEN/TC 140 - 6122

Otras Relaciones

Acuerdo de Viena ISO 22367:2026

Reemplazo Normas

Reemplaza a EN ISO 22367:2020

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