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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

Practical aspects of using the ISO standards in the sphere of laboratory medicine

Authors:

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

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Journal: Laboratory Service. 2012;(3): 3‑10

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PRACTICAL ASPECTS OF USING THE ISO STANDARDS IN THE SPHERE OF LABORATORY MEDICINE
PRACTICAL ASPECTS OF USING THE ISO STANDARDS IN THE SPHERE OF LABORATORY MEDICINE

To cite this article:

Émanuél' AV, Ivanov GA, Emanuel’ VL. Practical aspects of using the ISO standards in the sphere of laboratory medicine. Laboratory Service. 2012;(3):3‑10. (In Russ.)

Подписка 2025-2 (Laboratory Service)
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The paper describes the examples of using the GOST R ISO 15189 standards to solve practical tasks in the interaction of the laboratory and clinical subdivisions of healthcare facilities. It also considers the documentation of a quality management system in the medical laboratory in terms of the standardization of processes and operations and the design of tools for the continuous improvement of the laboratory's activities.

Keywords:

standardization
circulation of documents
GOST R ISO 15189
preanalytics
postanalytics
laboratory medicine

Authors:

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

List of references:

  1. GOST R ISO 9001-2008 "Sistemy menedzhmenta kachestva. Trebovaniya".
  2. GOST R ISO 9000-2008 "Sistemy me­nedzhmenta kachestva. Osnovnye polozheniya i slo­var'".
  3. GOST R ISO 9004-2010 "Menedzhment dlya dostizheniya ustoichivogo uspekha organizatsii. Podkhod na osnove menedzhmenta kachestva".
  4. Masaaki Imai. Gemba kaidzen. Put' k snizheniyu zatrat i povysheniyu kachestva. Al'pina Pablisherz. M 2009; 345.
  5. GOST R ISO 15189-2009 "Laboratorii meditsinskie. Chastnye trebovaniya k kachestvu i kompetentnosti".
  6. Burnett D. Understanding accreditation in laboratory medicine. ACB 1996; 312.

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