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BSI BS EN ISO 22367:2020

Medical laboratories. Application of risk management to medical laboratories
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BSI BS EN ISO 22367:2020

Medical laboratories. Application of risk management to medical laboratories

PUBLISH DATE 2020
PAGES 92
BSI BS EN ISO 22367:2020

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.

SDO BSI: British Standards Institution
Document Number ISO 22367
Publication Date May 6, 2020
Language en - English
Page Count 92
Revision Level
Supercedes
Committee CH/212
Publish Date Document Id Type View
April 15, 2026 BS EN ISO 22367:2026 Revision
March 16, 2020 BS EN ISO 22367:2020 Revision
May 6, 2020 BS EN ISO 22367:2020 Consolidated