[Accreditation of Medical Laboratory under International Standards in Clinical Trial].

ABSTRACT

In Japan, a medical laboratory accreditation program has been implemented on the basis of the international standard ISO 15189 (Medical laboratories-requirements for quality and competence), under the cooperation of the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the Japan Accreditation Body (JAB). It is carried out in accordance with the specific guidance document 'Guide RM300 2014'. The subject in the accreditation program is currently limited to common laboratory tests, which are covered by medical insur- ance, with regulatory approval. The 2012 version of ISO 15189 (ISO 151892012) expanded its scope, cover- ing genetic testing. In order to achieve the purpose of a clinical research core hospital that has recently been established in Japan, there is a need for an accreditation program to cover the lack of insurance coverage, such as molecular-genetic testing based on emerging technologies. To this end, the development of guid- ance documents intended for genetic testing by which medical laboratories can implement a quality system to meet ISO 151892012 is to be considered. In addition, it is necessary to secure human resources who are familiar with oversight and inspection regarding genome-specific matters. [Review].