Are examined the problems of the introduction of standard ISO 13485:2003 “Мedical articles. Systems of the management of quality. System of the requirements for purposes of regulation” at the Russian enterprise, which lets out medical instruments. The applied recommendations of the adaptation of Russian enterprises to the requirements of this international standard are proposed.
менеджмент риска, медицинские изделия, the management of risk, medical articles
1. Oficial'nyy sayt Rumex International [Elektronnyy resurs] / Rezhim dostupa: http://rumex.net/
2. S.V. Solonnikov, L.V. Goryunova Menedzhment kachestva v promyshlennosti medicinskih izdeliy// Kompetentnost'. - 2004. - № 4. - S. 25-31.
3. L.V. Petuhova, S.M. Goryunova. Vnedrenie samoocenki v deyatel'nost' ispytatel'noy laboratorii // Vestnik Kazan. tehnol un-ta. 2010. №5. S. 178-183.
4. C.M. Goryunova, A.F. Dresvyannikov, L.V. Petuhova, N.M. Ahtyamova, V.A. Fedotov. Problemy polucheniya mezhdunarodnogo sertifikata sistemy menedzhmenta kachestva predpriyatiya // Vestnik Kazan. tehnol un-ta. 2005. №1. S. 401-406.
5. EN ISO 15004-1:2009 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (Oftal'mologicheskie instrumenty - Osnovnye trebovaniya i metody ispytaniy - Chast' 1: Obschie trebovaniya ko vsem oftal'mologicheskim instrumentam)
6. EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (Sterilizaciya medicinskih izdeliy - Informaciya, predostavlyaemaya izgotovitelem dlya provedeniya povtornoy sterilizacii medicinskih izdeliy)
7. EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (Izdeliya medicinskie. Sistemy menedzhmenta kachestva. Reglamentiruyuschie trebovaniya.)
8. EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (Izdeliya medicinskie. Analiz riskov.)
9. EN 1041:2008 Information supplied by the manufacturer of medical devices (Informaciya, predostavlyaemaya proizvoditelem medicinskih izdeliy)
10. EN 980:2008 Symbols for use in the labeling of medical devices (Graficheskie simvoly, ispol'zuemye na etiketkah medicinskih izdeliy.)
11. NB-MED/2.5.1/Rec 5 Technical Documentation. (Tehnicheskaya dokumentaciya.)
12. NB-MED/2.5.2/Rec 2 Reporting of design changes and changes of the quality system. (Soobscheniya ob izmenenii proekta i izmenenii sistemy kachestva)
13. MEDDEV 2.12-1 rev 5 Guidelines on a medical devices vigilance system. (Rukovodyaschie ukazaniya po sisteme nadzora za medicinskimi izdeliyami.)
14. MED DEV 2.12.2 Market Follow-Up.-Guidelines on post market clinical follow-up. (Klinicheskoe postmarketingovoe nablyudenie.)
15. V.F. Sopin, N.G. Nikolaeva, E.V. Priymak, S.M. Goryunova. Strategiya upravleniya zatratami na kachestvo // Vestnik Kazan. tehnol un-ta. 2005. №2. ch. II. S. 201-206.
