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[ISO 15189, Up-To-Date Information and Prospective View]
Medical laboratory accreditation in Japan is expanding to include physiological testing, driven by new requirements for clinical trial core hospitals. This enhances the quality of healthcare and public health through rigorous external evaluations.
Area of Science:
- Medical Laboratory Science
- Quality Management Systems
- Healthcare Accreditation
Context:
- Japan's Medical Service Act revision mandates external evaluations for clinical trial core hospitals.
- Growing emphasis on third-party accreditation for medical laboratory testing services.
- World Accreditation Day 2015 highlights accreditation's role in health and social care.
Purpose:
- To report on the progress of medical laboratory accreditation activities in Japan.
- To detail the expansion of accreditation scope to include physiological testing.
- To underscore the importance of accreditation in improving healthcare quality.
Summary:
- Audits for transitioning to ISO 15189:2012 are ongoing, with increasing accreditations for medical laboratory and pathological examinations.
- Preparations for incorporating physiological testing into the accreditation scope are complete.
- External evaluation is now a requirement for approving clinical trial core hospitals.
Impact:
- Increased attention on third-party accreditation in medical laboratory testing.
- Contribution to improving the quality of healthcare in Japan.
- Enhancement of the overall health of Japanese citizens through reliable laboratory services.
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