EN ISO 22367:2020

Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)

Publication date:   Jul 15, 2020

General information

60.60 Standard published   Mar 11, 2020


CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100.01   Laboratory medicine in general



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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


CEN ISO/TS 22367:2010


EN ISO 22367:2020
60.60 Standard published
Mar 11, 2020