[The practice of development and implementation of quality management systems in medical laboratories. The GOST R ISO 15189-2009 "medical laboratories. The detailed requirements to quality and competence". Particular difficulties of global nature].
The article discusses the methodological issues related to the implementation of international principles of standardization in the format of GOST R ISO 9001-2008 "Quality management systems. Requirements", GOST R ISO 15189-2009 "Medical laboratories. The detailed requirements to quality and competence" and GOST R ISO 18113.1-5 "Medical items for diagnostics in vitro. Information provided by manufacturer (marking)". This approach legibly assigns the responsibility concerning the support of metrological correctness of laboratory measurements. The lacking of both full-value public and sectorial normative documentation and coordinated positions of Rosstandard and Minzdrav of Russia on functioning of medical laboratories is noted.