Practice of elaborating and introducing quality management systems in medical laboratories. GOST R ISO 15189-2009 "Medical laboratories. Particular requirements for quality and competence"

Émanuél' A.V.

FGUP "VNIIM im. D.I. Mendeleeva"

Ivanov G.A.

FGBU "Konsul'tativno-diagnosticheskiĭ tsentr s poliklinikoĭ" Upravleniia delami Prezidenta Rossiĭskoĭ Federatsii, Moskva

Emanuel’ V.L.

Federal State Budgetary Educational Institution of Higher Education «Academician I.P. Pavlov First Saint Petersburg State Medical University» of the Ministry of Healthcare of the Russia, Saint Petersburg, Russia

SPIN RSCI: 1177-4802
Scopus AuthorID: 6603693075

Practice of elaborating and introducing quality management systems in medical laboratories. GOST R ISO 15189-2009 "Medical laboratories. Particular requirements for quality and competence"

Authors:

Émanuél' A.V., Ivanov G.A., Emanuel’ V.L.

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Journal: Laboratory Service. 2012;(2): 9‑19

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To cite this article:

Émanuél' AV, Ivanov GA, Emanuel’ VL. Practice of elaborating and introducing quality management systems in medical laboratories. GOST R ISO 15189-2009 "Medical laboratories. Particular requirements for quality and competence". Laboratory Service. 2012;(2):9‑19. (In Russ.)

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The paper discusses methodological problems in introducing the international principles of standardization in the format of GOST R ISO 9001-2008 "Quality Management Systems. Requirements", GOST R ISO 15189-2009 "Medical Laboratories. Particular Requirements for Quality and Competence", and GOST R ISO 18113.1-5 "In Vitro Diagnostic Medical Products". Information Submitted by the Manufacturer (Labeling)". An attempt to describe the methodology of allocation of responsibility for providing the metrological correctness of laboratory measurements.

Keywords:

quality management system

laboratory medicine

GOST R ISO 15189