[Significance and future prospects of the ISO15189 accreditation topics on systems of operation in preparation for accreditation].

ISO 15189 is a standard for systems of operation to provide medical laboratory services. It is essential that daily operations be performed in accordance with ISO 15189, but acquisition of accreditation under ISO 15189 should not be the goal. Furthermore, since ISO 15189 does not stipulate operational procedures, the optimal method for the individual laboratory should be used. After obtaining ISO 15189 accreditation, the laboratory only has to manage and perform daily operations in accordance with ISO 15189 on the basis of the quality management system that has been established, and the quality of service that the medical laboratory provides will improve accordingly.