[Accreditation of ISO 15189 in the Department of Laboratory Medicine, Kumamoto University Hospital: successful cases].

: Recently, attention has been focused on international standard organization (ISO) 15189 accreditation, ensuring the quality and competence of medical laboratories in Japan. The Department of Laboratory Medicine, Kumamoto University Hospital also received ISO 15189 accreditation on August 30, 2007. In this paper, we describe our successful experiences before and after ISO 15189 accreditation, and discuss how to apply the qualification more effectively from now on. The key points to use the ISO 15189 tool effectively were summarized as follows: 1. Making sense of the purpose: Successful leadership is one of the most important factors. Our director came up with our slogan, which was called the 4 S's (speed, service, science, and strictness) to apply ISO 15189. 2. Improvement of technical and scientific competence: the development of detailed standard operating procedures(SOPs) aids the improvement of technical and scientific competence. 3. Enrich the contents of the teaching system: after we received ISO 15189 accreditation, the teaching system, not only for medical students but also medical staff and foreign students, was markedly improved to take advantage of the global standard. As it is expensive to run ISO 15189, we must utilize the specified and/or standard health check ups from now on. A laboratory cafe, which we are preparing in our hospital now, may be a new unique trial of how to apply ISO 15189. In conclusion, ISO 15189 may become an effective tool to develop and advance medical laboratories.