DZ/T 0101.12-1994
Active
GB/T 43278-2023
Active
National standards
GB/T 43278-2023 Medical laboratories—Application of risk management to medical laboratories
GB/T 43278-2023 Medical laboratories—Application of risk management to medical laboratories
Basic Information
Standard Code:
GB/T 43278-2023
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
-
Publish Date:
2023-11-27
Implement Date:
2024-06-01
Pages:
72 pages
Scope
This document specifies the process for medical laboratories to identify and manage risks related to patients, laboratory staff, and service providers associated with their testing. This process includes risk identification, estimation, evaluation, control, and monitoring. The requirements of this document apply to all aspects of medical laboratory testing and services, including pre-test, test, and post-test phases, accurate transmission of test results to electronic medical records, and other technical and management processes included in ISO 15189. This document does not specify acceptable risk levels. This document does not apply to risks related to clinical decisions made by medical personnel after testing. This document does not apply to risk management affecting the operation of medical laboratories covered by ISO 31000, such as commercial, economic, legal, and regulatory risks.
Development Information
Adopt standards
ISO 22367:2020
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