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ISO 22367:2026

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

Medical laboratories - Application of risk management to medical laboratories

PUBLISH DATE 2026
ISO 22367:2026

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.

SDO ISO: International Organization for Standardization
Document Number ISO 22367
Publication Date April 1, 2026
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 212
Publish Date Document Id Type View
April 1, 2026 ISO 22367:2026 Revision
April 1, 2026 ISO 22367:2020 Revision
April 1, 2026 ISO 22367:2020[S] Revision