Introduction A modern approach to quality control and safety of medical activities is a risk-based approach in order to prevent, identify and prevent risks that threaten the life and health of citizens, and minimize the consequences of their occurrence. Internal audits are one of the tools for identifying the risks of undesirable events. At the same time, conducting audits within the framework of internal quality control and safety of medical activities is a mandatory requirement in the work of medical organizations. However, at the legislative level, the technology of internal audits and the methodology of risk identification are not defined. The article presents a methodology for conducting internal audits from the perspective of a risk-based approach. The aim of the study is to develop an audit methodology as a source of identification of the risks of undesirable events within the framework of internal quality control and safety of medical activities. Materials and methods The content analysis of the regulatory framework regulating the requirements for the implementation of medical activities, which was the basis for the formation of the audit program, was carried out. The design of the visual model of the audit process was carried out using the BPwin 7.2.5.1918 program. Results and discussions The methodology of internal audit, consisting of successive stages, has been developed. At the first stage, based on the results of the analysis of the regulatory framework, the following areas were identified for the audit: quality and safety of medical activities; safety when using medical devices; safety when using medicines; epidemiological safety; identification of patients and biological material; the procedure for dealing with citizens' appeals; patient satisfaction and a sociological survey; information security; compliance with human rights citizens; awareness of patients about the medical organization and the rights of the patient. The second and third stages are the preparation of the program and the definition of the audit plan. A checklist is formed for each unit, which includes questions in accordance with the specifics of the activities, goals and objectives of the unit and the persons being audited. At the next stages, auditors directly monitor the processes, interview patients, interview staff, fill out checklists, where they note inconsistencies, defects, and undesirable events identified during the audit. Next, an audit report is issued, where a list of identified undesirable events and inconsistencies is compiled and an action plan is drawn up to eliminate violations. Conclusion The introduction of a risk-based approach in the development of measures based on internal audits will allow medical organizations to carry out activities to prevent, identify and prevent risks that threaten the life and health of citizens.