A Quality Management System (QMS) is a formal system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It is a set of activities that an organization performs to ensure that its products or services meet defined quality standards. A QMS typically includes processes for quality planning, quality control, quality assurance, and quality improvement. The purpose of a QMS is to provide a systematic approach to quality management that ensures consistency and continual improvement in the quality of products and services delivered to customers.
MDQMS is a specific type of quality management system designed for medical device manufacturers. It is focused on ensuring that medical devices are safe and effective for their intended use. The MDQMS framework includes the requirements set out in ISO 13485:2016, as well as any applicable regulatory requirements such as the FDA Quality System Regulation (QSR) in the US or the Medical Device Regulation (MDR) in the EU.
