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ISO 15190:2003 Medical Laboratories - Requirements for Safety
1Associate Professor Department of Pathology and Laboratory Medicine, University of British Columbia, Canada and Chair, Canadian Advisory Committee to Standards Council of Canada for ISO Technical Committee 212 and Chair, Canadian Standards Association's National Committee for Medical Laboratory Quality Systems and Member, ISO Technical Committee 212, Working Group 1.
EJIFCC
|July 7, 2018
Summary
The International Organization for Standardization developed ISO 15190:2003, a standard for medical laboratory safety. This standard complements ISO 15189:2003 by providing a quality management framework for laboratory safety programs.
Area of Science:
- Medical Laboratory Science
- Occupational Health and Safety
Background:
- ISO 15189:2003 establishes quality and competence standards for medical laboratories.
- There was a need for a specific standard addressing safety within medical laboratory environments.
Purpose of the Study:
- To introduce and explain the framework provided by ISO 15190:2003.
- To highlight the linkage between quality management and laboratory safety.
Main Methods:
- Development of a new international standard (ISO 15190:2003).
- Integration of quality management principles into safety protocols.
- Emphasis on defined responsibilities, regular audits, and continuous improvement.
Main Results:
- Establishment of ISO 15190:2003, a dedicated standard for medical laboratory safety.
- A structured approach to laboratory safety is provided, aligned with quality management.
Conclusions:
- ISO 15190:2003 offers a comprehensive framework for enhancing safety in medical laboratories.
- Adherence to this standard promotes a culture of safety and continuous improvement, complementing existing quality standards.
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