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ISO 22367:2026

ISO 22367:2026 Medical laboratories — Application of risk management to medical laboratories

CDN $422.00

This publication was last reviewed and confirmed in 2026.

Medical laboratories — Application of risk management to medical laboratories

Description

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.

Edition

2

Published Date

2026-06-18

Status

PUBLISHED

Pages

83

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

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.

Previous Editions

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