[Achieving ISO 15189 Certification -Iwate Medical University Hospital's Approaches -].

ABSTRACT

International clinical trials need to achieve ISO 15189 Certification. However, there are a large number of challenges to be addressed before the achievement. While the retirement of experienced staff may result in insufficient knowledge, technology, quality assurance, or reliability, approaches to achieve ISO 15189 Certifi- cation are useful for human resource development and quality assurance. Furthermore, work efficiency improvement and standardization as part of such approaches can be incorporatea into programs for continuous education.