ISO 22367:2020

Medical laboratories — Application of risk management to medical laboratories ISO 22367:2020

Publication date:   Feb 25, 2020

General information

90.92 Standard to be revised   Sep 12, 2023

ISO

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

International Standard

11.100.01   Laboratory medicine in general

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Published

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO/TS 22367:2008

WITHDRAWN
ISO/TS 22367:2008/Cor 1:2009

NOW

PUBLISHED
ISO 22367:2020
90.92 Standard to be revised
Sep 12, 2023

REVISED BY

IN_DEVELOPMENT
ISO/AWI 22367