Quality management system: A tool for the development of the organization or an additional burden?
A quality management system constitutes one of the organization’s management systems that provides for the selection of a set of processes in the organization’s activities designed to ensure the stable quality of products and services provided. The growth of global industrial production has under...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Eco-Vector
2023-09-01
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| Series: | Digital Diagnostics |
| Subjects: | |
| Online Access: | https://jdigitaldiagnostics.com/DD/article/viewFile/514629/pdf |
| _version_ | 1797300555197972480 |
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| author | Sergey Yu. Zayunchkovskiy Sergey A. Konovalov Viktoria V. Zinchenko Daria E. Sharova Ekaterina S. Ahkmad Anton V. Vladzymyrskyy |
| author_facet | Sergey Yu. Zayunchkovskiy Sergey A. Konovalov Viktoria V. Zinchenko Daria E. Sharova Ekaterina S. Ahkmad Anton V. Vladzymyrskyy |
| author_sort | Sergey Yu. Zayunchkovskiy |
| collection | DOAJ |
| description | A quality management system constitutes one of the organization’s management systems that provides for the selection of a set of processes in the organization’s activities designed to ensure the stable quality of products and services provided.
The growth of global industrial production has underscored the need for the creation of such production and management systems. These systems are designed to ensure that enterprises remains prepared to meet the constantly changing consumer value of manufactured products in accordance with consumer requirements, as well as the satisfaction of consumers themselves. As a result, attention began to focus on the production processes implemented within the organization when creating products. Regarding the production of medical devices, a quality management system can be defined as an organizational structure encompassing its functions, procedures, processes, and resources necessary for the coordinated direction and management of a manufacturing organization with respect to the quality of medical products.
The article reflects the principles of the quality management system and management processes. Noteworthy emphasis is placed on the features of quality management systems for medical devices, including the features of the quality management system for software that is a medical device. Furthermore, the conditions under which the quality management system becomes a tool for ensuring the sustainable development of the organization are noted. |
| first_indexed | 2024-03-07T23:09:47Z |
| format | Article |
| id | doaj.art-2a7b8ec9483449acad5a87ac8fdd36b4 |
| institution | Directory Open Access Journal |
| issn | 2712-8490 2712-8962 |
| language | English |
| last_indexed | 2024-03-07T23:09:47Z |
| publishDate | 2023-09-01 |
| publisher | Eco-Vector |
| record_format | Article |
| series | Digital Diagnostics |
| spelling | doaj.art-2a7b8ec9483449acad5a87ac8fdd36b42024-02-21T15:00:46ZengEco-VectorDigital Diagnostics2712-84902712-89622023-09-014343944710.17816/DD51462976543Quality management system: A tool for the development of the organization or an additional burden?Sergey Yu. Zayunchkovskiy0https://orcid.org/0009-0002-7463-7699Sergey A. Konovalov1https://orcid.org/0009-0003-0011-3371Viktoria V. Zinchenko2https://orcid.org/0000-0002-2307-725XDaria E. Sharova3https://orcid.org/0000-0001-5792-3912Ekaterina S. Ahkmad4https://orcid.org/0000-0002-8235-9361Anton V. Vladzymyrskyy5https://orcid.org/0000-0002-2990-7736Moscow Center for Diagnostics and TelemedicineMoscow Center for Diagnostics and TelemedicineMoscow Center for Diagnostics and TelemedicineMoscow Center for Diagnostics and TelemedicineMoscow Center for Diagnostics and TelemedicineMoscow Center for Diagnostics and TelemedicineA quality management system constitutes one of the organization’s management systems that provides for the selection of a set of processes in the organization’s activities designed to ensure the stable quality of products and services provided. The growth of global industrial production has underscored the need for the creation of such production and management systems. These systems are designed to ensure that enterprises remains prepared to meet the constantly changing consumer value of manufactured products in accordance with consumer requirements, as well as the satisfaction of consumers themselves. As a result, attention began to focus on the production processes implemented within the organization when creating products. Regarding the production of medical devices, a quality management system can be defined as an organizational structure encompassing its functions, procedures, processes, and resources necessary for the coordinated direction and management of a manufacturing organization with respect to the quality of medical products. The article reflects the principles of the quality management system and management processes. Noteworthy emphasis is placed on the features of quality management systems for medical devices, including the features of the quality management system for software that is a medical device. Furthermore, the conditions under which the quality management system becomes a tool for ensuring the sustainable development of the organization are noted.https://jdigitaldiagnostics.com/DD/article/viewFile/514629/pdfquality management systemmedical devicesoftwareartificial intelligence |
| spellingShingle | Sergey Yu. Zayunchkovskiy Sergey A. Konovalov Viktoria V. Zinchenko Daria E. Sharova Ekaterina S. Ahkmad Anton V. Vladzymyrskyy Quality management system: A tool for the development of the organization or an additional burden? Digital Diagnostics quality management system medical device software artificial intelligence |
| title | Quality management system: A tool for the development of the organization or an additional burden? |
| title_full | Quality management system: A tool for the development of the organization or an additional burden? |
| title_fullStr | Quality management system: A tool for the development of the organization or an additional burden? |
| title_full_unstemmed | Quality management system: A tool for the development of the organization or an additional burden? |
| title_short | Quality management system: A tool for the development of the organization or an additional burden? |
| title_sort | quality management system a tool for the development of the organization or an additional burden |
| topic | quality management system medical device software artificial intelligence |
| url | https://jdigitaldiagnostics.com/DD/article/viewFile/514629/pdf |
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