System-object modeling of quality management system of medical

Abstract

The article discusses the problems that commercial organizations face when undergoing external audits of the quality management system. The analysis of the domestic practice of certification of quality management systems is presented, which showed that the key problem in this context is the non-transparency of the certification procedure, which, in turn, creates more significant problems in the process of the organization’s economic activity. The authors propose the use of system-object simulation to improve the efficiency of the quality management system, as well as to simplify the first certification procedure. According to the authors, the system-object approach is an effective tool for systematizing and simplifying the procedures for certification of quality management systems. For this purpose, the work examines the interstate standard GOST ISO 13485-2017 in the form of a system-object simulation model, which in the future can be used as a tool for information-analytical support of the quality management system of medical devices.