[ISO 15189 So Far and in the Future -Effects of Quality Assurance and Management System Using ISO 15189-]

Clinical examinations are also influenced by medical globalization. Samples from patients for some special tests, including genetic analyses, are transported across the world. International standardization should be applied to clinical examinations as a part of medical care. The quality of techniques and management in clini- cal laboratories are evaluated by organizations for ISO 15189 authorization. This process helps detect issues overlooked on a daily basis and establish a system to maintain the high quality of laboratory examinations. In Ehime University Hospital Clinical Laboratory, we went through examinations from ISO 15189 authorization acquisition to the 3rd periodical surveillance. When the incongruent rate was assessed in each in- spection process under the quality management system (QMS), that of the process before the inspection ac- counted for 47% of the total. Therefore, the management of early processes including sample extraction, inspection, reception, and processing appears to be particularly important. [Review].