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Laboratory quality management system: road to accreditation and beyond
1Department of Microbiology, Yashoda Hospital, Kaushambi, Ghaziabad, U.P, India.
Indian Journal of Medical Microbiology
|June 6, 2012
Summary
This review clarifies Laboratory Quality Management Systems (Lab QMS) beyond basic quality control and assurance. It guides medical laboratories through the accreditation process, including practical preparation and avoiding common pitfalls.
Area of Science:
- Medical Laboratory Science
- Quality Management Systems
Background:
- Existing laboratory practices often focus narrowly on quality control and assurance.
- A holistic approach to Laboratory Quality Management Systems (Lab QMS) is needed for medical testing and diagnostic laboratories.
- Accreditation is a critical but complex process for laboratories.
Purpose of the Study:
- To provide a comprehensive understanding of Lab QMS beyond traditional quality control and assurance.
- To guide medical laboratories through the entire accreditation journey.
- To highlight previously underexplored aspects of laboratory accreditation.
Main Methods:
- Review of existing literature and accreditation standards.
- Inclusion of practical illustrations, tables, and detailed guidance on documentation.
- Explanation of staff training, privileging, and novel quality control exercises.
Main Results:
- Detailed insights into accreditation bodies and current laboratory practices.
- Specific guidance on consultant requirements, laboratory infrastructure, scope, application process, and document preparation.
- Clarification of staff training and privileging, with innovative quality control approaches.
Conclusions:
- This review prepares laboratories for accreditation by offering a holistic view of Lab QMS.
- Practical advice is provided for third-party assessments and preventing post-assessment issues.
- The document serves as a comprehensive resource for achieving and maintaining laboratory accreditation.
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