[Procedure for accurate evaluation of laboratory data and its international trends].
From the work at ISO/TC212 (Clinical laboratory testing and in vitro diagnostic test systems), the international standards on medical laboratories--particular requirements for quality and competence and reference materials were issued. The accreditation of clinical laboratory was started using ISO 15189. Furthermore, on setting and usage of reference materials were constituted with compatibility global harmonization by newly organizing JCTLM (Joint Committee on Traceability in Laboratory Medicine). As the results, the work of the standardization based on reliability such as validation of reagent's kits and the measured values and uncertainty evaluation would be internationally advanced.
Kuwa
Katsuhiko
K
Graduate School of Comprehensive Human Sciences/Institute of Clinical Medicine, University of Tsukuba, Tsukuba, 305-8575.
D000068:Accreditation; D019411:Clinical Laboratory Techniques / Q000592:standards*; D038622:Internationality; D007753:Laboratories / Q000592:standards*; D010338:Pathology, Clinical / Q000458:organization & administration; D011785:Quality Assurance, Health Care / Q000458:organization & administration / Q000592:standards*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results
D011933:Reagent Kits, Diagnostic