[External quality assessment with reference to the certification/accreditation of medical laboratories].

Since ISO 15189 (Medical Laboratories-Particular requirements for quality and competence) was published in February 2003, interest in the accreditation of medical laboratories has increased in Japan. Under such conditions, the JCCLS (Japanese Committee for Clinical Laboratory Standards) and the JAB (Japan Accreditation Board for Conformity Assessment) are promoting a project on an accreditation program for medical laboratories in Japan. The JAB is planning to start their pilot inspections from October, 2004. In this paper, an external quality assessment scheme in Japan on proficiency testing for the accreditation of clinical laboratories is described.