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CEN - EN ISO 22367

Medical laboratories - Application of risk management to medical laboratories

active, Most Current
Organization: CEN
Publication Date: 1 March 2020
Status: active
Page Count: 92
ICS Code (Laboratory medicine in general): 11.100.01
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.

Document History

EN ISO 22367
March 1, 2020
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...
January 1, 2010
Medical laboratories - Reduction of error through risk management and continual improvement
This Technical Specification 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...

References

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