Relevance. The article presents its own experience in the development and implementation of a quality management system (QMS), developed on the basis of the requirements of DSTU ISO 9001:2015. Modern management principles using international standards ISO 9001:2015 determine the basis for increasing the effectiveness of a medical research institution. The implementation of the QMS is a large-scale and rather complex project, it covers the entire contingent of employees.
Purpose of the study. To consider the experience of the medical research institute in the development and implementation of a quality management system in accordance with the requirements of DSTU ISO 9001:2015.
Materials and methods of investigation. The study used general scientific methods of empirical and theoretical knowledge, logical methods and techniques, as well as methods of system analysis, comparison, analogy and generalization.
Results of the study. The criteria and methods of monitoring and analysis have been applied to evaluate the effectiveness and level of effectiveness of the main processes of research and medical care, and plans for their improvement have been developed. Compliance with the DSTU ISO 9001:2015 standard confirms that the achieved management level meets the standard requirements that reflect internationally recognized management methods for the production of a scientific product and medical services of guaranteed quality.
Conclusions. Our own experience in implementing the QMS at the Institute has shown the feasibility of the decision. The creation of an organization management system focused on the introduction of modern technologies and quality management methods is the key to the stable functioning of a medical research institution in modern conditions.