Objective: To determine the strengths and weaknesses, opportunities and threats for the successful functioning of the Perinatal Center of the Republic of Mari El in the context of the development, implementation and maintenance of the quality management system Methods: An anonymous survey was conducted among the staff of a medical organization in the amount of 59 people (the sample size was determined by the method of K.A. Otdelnova, p<0.05). The questionnaire included questions to assess the opinion of employees on possible strengths and weaknesses, as well as opportunities and threats for the institution. In addition to the suggested answers, the respondents could offer their own solutions to the problems. The results were processed using descriptive statistics. Results: A SWOT analysis matrix was compiled, including strengths (orders of care, clinical recommendations (64.4%; CI 64.0-64.8), development and use of standard operating procedures, algorithms (59.3%; CI 58.9-59.8), work in medical and laboratory systems (50.8%; CI 50.4-51.3), quality control system, medical commission (42.4%; CI 41.7-43.1)) and weaknesses (weak material base (49.2%; CI 48.5-49.8), weak medical and laboratory systems (59.3%; CI 58.6-60.0 and 45.8%; CI 44.8-46.7, respectively)), opportunities (digital technologies (49.2%; CI 48.3-50.0), management commitment (62.7%; CI 62.5-62.9), employee training in quality control (50.8%; CI 50.5-51.2), request for quality and safety from patients (50.8%; CI 50.3-51.4), adherence to clinical guidelines (52.5%; CI 52.0-53.1)) and threats (medical system not functioning properly (67.8%; CI 67.1-68.5), regulatory framework for quality control (47.5%; CI 46.7-48.3) and races consumables (42.4%; CI 41.7-43.1)). Conclusion: Threats (3 of medium significance) and opportunities (1 of medium significance, 4 of high significance), as well as weaknesses (3 of medium significance) and strengths (2 of high significance) for the successful functioning of a medical organization, which were taken into account in the standard "Guidelines for quality” and activity planning. Keywords: Quality management system, medical organization, process management model, medical activity safety, SWOT-analysis.