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[Achieving ISO 15189 Certification -Iwate Medical University Hospital's Approaches -]
Rinsho Byori. the Japanese Journal of Clinical Pathology
|February 15, 2019
Summary
Achieving ISO 15189 Certification for international clinical trials presents challenges like staff retirement. However, implementing certification approaches aids human resource development and quality assurance.
Area of Science:
- Clinical Laboratory Science
- Quality Management Systems
Background:
- International clinical trials require ISO 15189 Certification for quality and reliability.
- Several challenges impede the achievement of this certification.
Purpose of the Study:
- To explore the challenges in achieving ISO 15189 Certification for international clinical trials.
- To highlight the benefits of certification approaches for human resource development and quality assurance.
Main Methods:
- The study reviews the implications of staff retirement on knowledge transfer and technical expertise.
- It examines how quality assurance and reliability are affected by these factors.
Main Results:
- Staff retirement can lead to a deficit in essential knowledge and technical skills.
- Approaches to ISO 15189 Certification offer solutions for human resource development and enhancing quality assurance.
- Standardization and efficiency improvements are identified as key benefits.
Conclusions:
- Implementing ISO 15189 Certification strategies can mitigate challenges posed by staff attrition.
- These strategies contribute to continuous education, workforce development, and improved quality assurance in clinical trials.