Ohno Hiroie
CGIKK, Minato-ku, Tokyo 106-0041, Japan.
Rinsho Byori. 2010 Jan;58(1):69-72.
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.
ISO 15189是用于提供医学实验室服务的操作体系标准。日常操作必须按照ISO 15189执行，但获取ISO 15189认可不应成为目标。此外，由于ISO 15189未规定操作程序，应采用适合单个实验室的最佳方法。获得ISO 15189认可后，实验室只需在已建立的质量管理体系基础上，依据ISO 15189进行日常管理和操作，医学实验室提供的服务质量也会相应提高。
