[Overview of ISO15189 and accreditation with it]

Because of a growing need for good quality and safety in medical care, it is necessary for clinical laboratories to improve quality and competence, and for these improvements to be disclosed to clinicians and patients. To this end, each clinical laboratory should be evaluated and accredited by an international third-party organization. We, the Department of Clinical Laboratory, the University of Tokyo Hospital, achieved ISO15189 accreditation in January 2007. Thereafter, the Department of Blood Transfusion, the Department of Infection Control, and our system for specified health checkup also obtained ISO15189 accreditation in March 2008. Based on this ISO15189 accreditation, quality-certified laboratory test results are now reported and, therefore, clinicians can perform safe medical care for their patients. Furthermore, ISO15189 is useful for clinical trials and international collaboration in medical research. We hope our ISO15189 accreditation will be helpful in its dissemination in Japan, thereby playing a role in clinical laboratory standardization, benefiting both clinicians and patients.