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[ISO 15189 medical laboratory accreditation]
1The Japan Accreditation Board for Conformity Assessment, Shinagawa-ku, Tokyo 141-0032.
Rinsho Byori. the Japanese Journal of Clinical Pathology
|December 31, 2004
Summary
This International Standard, ISO 15189, outlines requirements for medical laboratory competence and quality. Accreditation under ISO 15189 enhances laboratory services and patient care through improved management and technical capabilities.
Area of Science:
- Medical Laboratory Science
- Quality Management Systems
- Clinical Diagnostics
Context:
- Based on ISO/IEC 17025 and ISO 9001, this standard addresses specific needs of medical laboratories.
- Intended for recognized medical laboratory disciplines, adaptable for other related services.
- Accreditation bodies can utilize this standard for evaluating medical laboratory competence.
Purpose:
- To provide specific requirements for medical laboratory competence and quality.
- To establish a framework for the accreditation of medical laboratories.
- To ensure impartiality and independence in conformity assessment bodies.
Summary:
- ISO 15189 comprises management and technical requirements, integrating ISO 9001 principles.
- Technical requirements cover personnel, facilities, instruments, examination methods, proficiency testing, measurement traceability, and uncertainty.
- Implementation aims to significantly improve medical laboratory management systems and technical competence.
Impact:
- Enhances medical laboratory services, benefiting patient care.
- Establishes a robust system for medical laboratory accreditation.
- Promotes higher standards in clinical laboratory diagnostics and operations.