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[Effectiveness of incorporating a quality management system].
Akira Seki1, Raleigh W Hankins, Tetsumasa Miya
1Health Sciences Research Institute, Inc., Yokohama 240-0008, Japan. seki@hkk.co.jp
Rinsho Byori. the Japanese Journal of Clinical Pathology
|February 23, 2010
Summary
Implementing a quality management system (QMS) in clinical laboratories improves medical services. This study evaluates QMS effectiveness in the Health Sciences Research Institute Group, identifying challenges and successes through audits and feedback.
Area of Science:
- Medical Laboratory Science
- Quality Management Systems
Context:
- ISO 15189 international standardization for clinical laboratory quality and competence.
- 46 facilities globally have adopted Quality Management Systems (QMS) and accreditation.
- The Health Sciences Research Institute Group has 4 accredited facilities.
Purpose:
- To report on the effectiveness of adopting a Quality Management System (QMS) in clinical reference laboratories.
- To identify problems encountered during QMS implementation within the Health Sciences Research Institute Group.
Summary:
- The study evaluates QMS effectiveness using employee questionnaires, internal audits, customer complaint analysis, and external audits by the Japan Accreditation Board for Conformity Assessment (JAB).
- QMS encompasses managerial and technical factors influencing test results.
- Identified challenges and successes in QMS implementation are detailed.
Impact:
- Provides insights into the practical application and effectiveness of QMS in clinical laboratory settings.
- Offers valuable data for institutions seeking to implement or improve their QMS and achieve accreditation.
- Contributes to enhancing the overall quality and competence of medical laboratory services.
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