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 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.