Implementation of quality management systems based on ISO standards within the framework of the single market for the circulation of medical products of the EAEU countries

Artamonova G.V., Karas D.V., Kryuchkov D.V., Danilchenko Ya.V. (2018). Originalnaya metodika otsenki riskov deyatelnosti meditsinskoy organizatsii. Rezultaty aprobatsii [The original method of activity risks assessment in a medical organization. Results of testing]. Bulletin of Roszdravnadzor. (6). 32-39. (in Russian).

Astapenko E.M., Sukhanova M.M. (2016). Pravila registratsii i ekspertizy bezopasnosti, kachestva i effektivnosti meditsinskikh izdeliĭ v ramkakh Evraziĭskogo ekonomicheskogo soyuza [Rules of registration and examination of safety, quality and effectiveness of medical products within the Eurasian Economic Union]. Bulletin of Roszdravnadzor. (5). 17-20. (in Russian).

Avanesov E. K. (2015). ISO 9001 novoy versii v sfere zdravookhraneniya. Ideologiya i praktika [ISO 9001 of the new version in the field of healthcare. Ideology and practice]. Meditsinskiy alfavit. (18). 18–26. (in Russian).

Belobragin V.Ya. (2019). Statistika po sertifikatam. Analiz otcheta The ISO Survey — 2018 [Statistics on certificates. The iso survey 2018 analysis]. Standards and Quality (Standarty i kachestvo). (12). 97-103. (in Russian).

Berezkina T.D., Bartsevich O.V., Gavrischuk Yu.G., Ivanova V.F. (2021). Pervichnyy opyt vnedreniya rekomendatsiy Roszdravnadzora po organizatsii vnutrennego kontrolya kachestva i bezopasnosti meditsinskoy deyatelnosti po razdelu «Bezopasnaya meditsinskaya sreda» v mnogoprofilnom statsionare [Initial experience in implementing the recommendations of roszdravnadzor (russian federation healthcare authority) on the organization of internal quality control and safety of medical activities under the section “safe medical environment” in a multidisciplinary hospital]. Menedzher zdravookhraneniya. (6). 27-34. (in Russian). doi: 10.21045/1811-0185-2021-6-27-34.

Danijela Anđelković, Milan Đurović (2020). Comparative analysis between the traditional and contemporary approach to efficiency measurement in companies Ekonomija: teorija i praksa. (13:1). 21-41.

Emanuel A.V., Ivanov G.A., Taut D.F., Averyanova E.V., Oksha T.A., Igumnova Yu.N. (2018). Sistemy menedzhmenta kachestva v sfere zdravookhraneniya: mify i realnost [Quality management systems in health care: myths and reality]. Bulletin of Roszdravnadzor. (6). 32-39. (in Russian).

Fet E.P. (2014). Prinyatie resheniy, osnovannoe na riskakh (izuchaya proekt MS ISO 9001:2015) [Risk-based decision-making (studying the MS ISO 9001:2015 project)]. Economy and society (Ekonomika i socium). (4-5 (13)). 56-61. (in Russian).

Gertsik Yu.G. (2020). K voprosu gosudarstvennogo regulirovaniya razvitiya meditsinskoy promyshlennosti v Rossiyskoy Federatsii [On the issue of state regulation of the medical industry development in the Russian Federation]. Controlling. (1). 12-19. (in Russian).

Gertsik Yu.G. (2021). Perspektivy razvitiya integrirovannyh proizvodstvennyh struktur meditsinskoy i farmatsevticheskoy promyshlennosti v ramkakh Evraziyskogo ekonomicheskogo soyuza [Prospects for the development of integrated production structures of the medical and pharmaceutical industry within the framework of the Eurasian Economic Union]. Ekonomika Tsentralnoy Azii. 5 (2). 135-152. (in Russian). doi: 10.18334/asia.5.2.111939.

Gertsik Yu.G., Kokueva Zh.M. (2019). Formirovanie i realizatsiya proektov integrirovannyh struktur v sfere meditsinskoy promyshlennosti i zdravookhraneniya [Formation and implementation of projects approach in integrated structures in the field of medical industry and health]. Rossiyskiy zhurnal upravleniya proektami. 8 (4). 16 – 26. (in Russian). doi: 10.12737/2587-6279-2020-16-26.

Gertsik Yu.G., Omelchenko I.N. (2020). Innovatsionnyy menedzhment v meditsinskoy promyshlennosti [Innovative management in the medical industry] (in Russian).

Gertsik Yu.G., Plutnitskiy A.N., Nizamova E.R. (2021). Vnedrenie sistemy menedzhmenta kachestva na predpriyatiyakh meditsinskoy promyshlennosti i otsenka ee sootvetstviya trebovaniyam EAES [Implementation of the quality management system in the medical industry and assessment of its compliance with the requirements of the EAEU]. Remedium. (1). 57-62. (in Russian). doi: 10.21518/1561-5936-2021-1-57-62.

Glukhov V. V. i dr. (2021). Strategicheskoe upravlenie promyshlennymi ekosistemami na osnove platformennoy kontseptsii [Strategic management of industrial ecosystems based on the platform concept]. Economics and management. 27 (10). 751-765. (in Russian). doi: 10.35854/1998-1627-2021-10-752-766.

Ivanov I.V., Astapenko E.M. (2016). Obespechenie bezopasnosti obrashcheniya meditsinskikh izdeliy v meditsinskoy organizatsii [Provision of medical products circulation safety in a medical organization]. Bulletin of Roszdravnadzor. (5). 28-31. (in Russian).

Jalnasow D. (2019). Implementation Of ISO 13485:2016 In Medical Products Handling Multinational Corporation Economics and Management. (16 (2)). 167-178.

Khalzanov D.P. (2022). Cistema menedzhmenta kachestva, razrabotka i vnedrenie [Development and implementation of a quality management system]. Biznes-obrazovanie v ekonomike znaniy. (2). 55-57. (in Russian).

Matytsin N.O., Baranov A.I. (2015). Ispolzovanie sovremennyh podkhodov k menedzhmentu kachestva dlya sozdaniya sistemy upravleniya kachestvom meditsinskoy pomoshchi [Using current approaches to quality management to create a healthcare quality management system]. Bulletin of Roszdravnadzor. (3). 44–48. (in Russian).

Neyaskin A.V., Zhilkina A.V. (2020). Razvitie sistemy menedzhmenta kachestva v organizatsiyakh zdravookhraneniya [Quality management system development in health organizations] Problems of certification, quality management and documentation management. 84-87. (in Russian).

Shmeleva A.N. (2009). Kontseptualnye osnovy otsenki operatsionnoy effektivnosti upravleniya predpriyatiem pri vnedrenii SMK po standartam ISO 9000 [Conceptual foundations for assessing the operational efficiency of enterprise management when implementing QMS according to ISO 9000 standards] (in Russian).

Shvabskiy O.R., Minulin I.B., Taut D.F., Scheblykina A.A. (2022). Prakticheskie rekomendatsii Roszdravnadzora. Vtoraya versiya. Novye podkhody k obespecheniyu kachestva i bezopasnosti meditsinskoy deyatelnosti [Practical recommendations of roszdravnadzor. the second version. new approaches to ensuring the quality and safety of medical activities]. Menedzhment kachestva v meditsine. (2). 2 – 7. (in Russian).

Sputnova D.V. (2022). O protsedure litsenzirovaniya pri tekhnicheskom obsluzhivanii meditsinskikh izdeliy [On the licensing procedure for the medical devices’ maintenance]. Kompetentnost. (8). 20-26. (in Russian). doi: 10.24412/1993-8780-2022-8-20-26.

Titenko E.A., Mekush G.E. (2020). Sravnitelnaya kharakteristika sistem menedzhmenta kachestva v sfere zdravookhraneniya [Comparative characteristics of quality management systems in the healthcare sector]. Vestnik of Samara State University of Economics. (12). 80-85. (in Russian). doi: 10.46554/1993-0453-2020-12-194-80-85.

Zimina E.A., Danilkina Yu.V. (2022). Vliyanie sertifikatsii sistemy menedzhmenta kachestva po GOST ISO 13485-2017 na konkurentosposobnost organizatsii, uchastvuyushchey v odnoy ili neskolkikh stadiyakh zhiznennogo tsikla meditsinskogo izdeliya [Impact of quality management system certificationin accordance with gost iso 13485-2017 on the compettiveness of an organization participated in one or more stages of the life cycle of a medical device]. Rostovskiy nauchnyy vestnik. (5). 107-111. (in Russian).

Zinoveva E.V., Sapunova A.V., Ivanov I.V. (2022). Bezopasnost obrashcheniya meditsinskikh izdeliy na vsekh etapakh ikh zhiznennogo tsikla [Safety of handling of medical devices at all stages of their life cycle]. Obschestvennoe zdorove. (3). 16-24. (in Russian). doi: 10.21045/2782-1676-2021-2-3-16-24.