Implementation of IT Solutions for the Quality Management System Based on ISO 13485 (2016) Standard in a Biomedical Company in Poland.

This paper presents an application-oriented analyses of IT solutions implementation for quality management processes in accordance with ISO 13485 (2016) standards, based on the concepts of Juran and Deming. The proposed on-line solution is focused on accessibility, efficiency, and quality monitoring. The IT-based production management system presented was practically validated in a biomedical company in Poland. Efficiency of the proposed model was confirmed quantitatively by OEE indicators. As a result, the paper can be a practical guideline for further development of quality management systems in biomedical factories.