THE EXPERIENCE OF TRANSITION TO RISK-ORIENTED MODEL OF SYSTEM OF QUALITY MANAGEMENT IN MEDICAL ORGANIZATION

Introduction. During implementation of medical activity an uncertainty and increased risk are present. to manage these two conditions a single system of management is needed capable preventing negative risks even during period of planning. The article presents experience of medical organization of transition to risk-oriented model of quality management system in concordance to ISO 9001:2015. Material and methods. The study was carried out in quarter IV 2016-quarter I 2017 in the research institute of complex problems of cardio-vascular diseases (hereinafter referred to as the organization). In the capacity of study techniques audit, SWOT analysis and logical analysis were applied. Results. According to step-by-step transition to risk-oriented model of quality management system training of administrators and owners of processes was organized. The genuine methodology of risk evaluation was developed. The implemented audit established 11 risks through 14 processes and directions of activity of medical organization. Among causes of risks internal causes were mentioned in 90%, including human factor (half of cases) i.e. the personnel of organization. With purpose of management, all established risks were separated to critical and non-critical ones in functioning of institution. The percentage of risks of critical character made up to 26%. The application of SWOT analysis permitted to establish 80 factors of internal and external environment of the organization. The results of implemented activities concerning transition to the new risk-oriented model of quality management system permitted to revise the strategic map of achievement of targets of the management system of the organization subject to evaluation of risks and factors of internal and external environment of the organization. The outcome of implemented activity became a positive assessment of quality management system of the institution during external certification audit according requirements of standard ISO 9001:2015. Conclusion. The application of methodology of step-by-step transition to risk-oriented model of quality management system of medical organization made it possible to implement an in-depth analysis of strong and weak aspects, to identify risks, threats and possibilities oriented to achievement of strategic targets of organization.

ISO 9001:2015, SWOT-анализ, quality management system, risk-oriented mentality, risk management, SWOT analysis, ISO 9001:2015