The certification and accreditation of clinical diagnostic laboratory
Fedorova, M.M.; Abrashkina, N.N.; Dolgov, V.V.
Klinicheskaia Laboratornaia Diagnostika 6: 62-65
2014
ISSN/ISBN: 0869-2084 PMID: 25335405 Document Number: 672817
Two approaches are considered concerning evaluation of quality of functioning of clinical diagnostic laboratory--certification and accreditation. The comparison and juxtaposition of these two approaches is made. The practical importance and applicability of requirements of standards of GOSTK ISO 9001-2008 and GOSTR ISO 15189-2009 is demonstrated. The attention is paid to key issues of workability of system of quality management in laboratory and organization of its technical competence at required level. The standard basics of requirements of international and national quality standards are specified. The article can have crucial practical importance for laboratories which implement system of quality management and prepare for accreditation, pay proper attention to standardization of laboratory studies, strive for workability of system of quality management and determine future priorities in area of enhancement of laboratory services.