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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.

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The equiatomic CoCrFeNiMn high entropy alloys (HEAs) has been successfully manufactured using direct laser deposition (DLD) technique. The size and number of porosities, the microstructures along the height of samples and the tensile properties of DLDed HEAs prepared under room (293 K) and cryogenic temperatures (77 K and 200 K) were investigated. The results show that DLDed HEAs exhibit directional solidification, forming dendritic columnar grains with long pores at the grain boundary in bottom regions and transiting to equiaxed grains close to top regions. And in the top regions, the pores are round and the numbers are greatly reduced. Compared with tensile properties of DLDed HEAs, the 77 K tensile samples cut from the top region have better performance, but the elongation of 293 K tensile samples in the middle region and 200 K tensile samples in the bottom region are similar, owing to the difference of porosity and microstructure in the two regions.