Effect of ISO15189 accreditation on Okayama University Hospital

The evaluation of medical laboratories by a third person has recently become popular in Japan. Establishing a quality management system, putting it into practice, and maintaining and improving it are considered to achieve the standardization, efficacy improvement, and safety management of laboratory activities. The Departments of Clinical Laboratory and Blood Transfusion, Okayama University Hospital was awarded ISO15189 accreditation on July 6, 2007. In this paper, we describe the process of ISO15189 accreditation in our institute. As an outcome of ISO accreditation, the frequency of laboratory incidents was reduced through seeking the causes of incidents and performing continual improvement according to ISO 15189: "Plan, Do, Check, Action". Additionally the motivation and competence of laboratory staff concerned have also improved, consequently leading to a favorable influence on other laboratory staff members. Therefore, we conclude that ISO15189 is an effective tool for medical laboratory management.