Система менеджмента качества в медицинской лаборатории: проблемные вопросы внедрения ГОСТ р ИСО 9001-2008, ГОСТ р ИСО 15189-2009 и ГОСТ р ИСО 53079-2008

The article presents the approaches to development and implementation of system of quality management in laboratory as an integral part of the given system in whole medical institution. The costs of works execution concerning quality support are to be weighted with economic profitability and timeliness of medical care provision to ill people considering pre-analytic stage (out-laboratory and in-laboratory) laboratory analysis. Factually it is a matter of development of system of balanced indicators concerning quality management of institution and laboratory functioning. The problematic issues are presented concerning maintenance of particular requirements of GOST R ISO 15189 about quality of production. The emphasis is made on the necessity of training of administrations of laboratories in the field of quality management and economics of laboratory business.