Quality system improvement

Abstract

This research project is focused on the improvement of the quality system in a healthcare/medical industry. Quality system is defined as the organizational structure, responsibilities, procedures, processes and resources for implementing quality management. Based on the FDA regulation, each manufacturer shall stablish and maintain a quality system that is appropriate for the specific for the medical device designed and/or manufactured. Basically, is important to ensure that the quality systems requirements are effectively stablished and maintained in accordance with the regulations. A set of activities belonging to different sub-systems are monitored consistently with the purpose to define the health of the quality system and understand what is needed to be improved. This project seeks the improvement of the quality system by looking the performance of the subsystems. This will provide a better standing of the company within the regulatory requirements and will simplify processes. The DMAIC methodology will be used to conduct the analysis and define opportunities to improve. DMAIC were selected as the appropriate method to use since is a data-driven quality strategy used to improve processes. Key Terms - Continuous Improvement, Quality System, Regulations, Subsystems, System Monitoring.