ISO 22367:2020

ISO 22367:2020

February 2020
International standard Current

Medical laboratories - Application of risk management to medical laboratories

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.

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Main informations

Collections

International ISO standards

Publication date

February 2020

Number of pages

82 p.

Reference

ISO 22367:2020

ICS Codes

11.100.01   Laboratory medicine in general

Print number

1
Sumary
Medical laboratories - Application of risk management to medical laboratories

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.

Replaced standards (2)
ISO/TS 22367:2008
May 2008
Technical specification Cancelled
Medical laboratories - Reduction of error through risk management and continual improvement

<p>ISO/TS 22367:2008 characterizes the application of ISO 15189 as a system for reducing laboratory error and improving patient safety by applying the principles of risk management, with reference to examination aspects, especially to pre- and post-examination aspects, of the cycle of laboratory medical care. ISO/TS 22367:2008 proposes a methodology for finding and characterizing medical laboratory error that would be avoided with the application of ISO 15189.</p>

ISO/TS 22367/AC1:2009
January 2009
Technical specification Cancelled
Technical corrigendum 1 to standard ISO/TS 22367:2008

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