title: [Outline of the revision of ISO 15189 and accreditation of medical laboratory for specified health checkup].
abstract: GOAL which accredited medical laboratory aims at is to continue "offering useful laboratory's service for patient medicine and treatment or the health of the nation". The medical laboratory, administers a quality management system, is competent technically and offers laboratory's service to satisfy the needs of all patients and clinicians taking responsibility for the medical testing and treatment. International standard ISO 15189 is a tool to embody thought of its basic quality and scientific grounds about the test result, and it was published in 2003. A revision for one part was considered to be it, and it was published afterwards for ISO 15189: 2,007 in this April. On the other hand, Ministry of Health, Labour and Welfare announced that all insurance members from 40 years old to 74 years old must have a checkup by the specified health checkup that paid its attention to visceral fat type obesity from April, 2008. And, in a standard health checkup program, it is shown that it strengthens the quality assurance management of laboratory carrying out medical testing. ISO 15189 which prescribed quality and competence of medical laboratory is an excellent standard, and it is hoped that it can offer high quality medical testing data with using quality management system. Here, I explain both outline of revised ISO 15189 and accreditation of the medical laboratory for specified health checkup using with this standard.
authors.affiliation: The Japan Accreditation Board for Conformity Assessment, Accreditation Center, Shinagawa, Tokyo.
authors.forename: Katsuo
authors.initials: K
authors.lastname: Kubono
mesh_terms: D000068:Accreditation / Q000592:standards*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D010808:Physical Examination / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000592:standards*; D011787:Quality of Health Care / Q000592:standards*; D017749:Total Quality Management