Glossary of Terms

Quality Management System

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About the Author
Proxima CRO Team
Joel Reid
Regulatory Affairs Associate
Throughout his experience at Proxima, Joel has developed his skills to advise companies in the best path forward in the development of drugs and devices across a range of therapeutic and diagnostic areas.

A quality management system (QMS) is a structured system that is implemented to aid in the process of developing document processes, procedures, and responsibilities to achieve quality policies and objectives. A QMS coordinates an organization’s activities to meet customer and regulatory requirements and improve the company’s overall effectiveness and efficiency on a regular basis. The international standard specifying requirements for QMS (ISO 9001:2015) is the most common approach to quality management systems. The benefits to implementing a QMS include reducing waste, mistake prevention, lower costs, controlling processes, setting an organizational direction, and facilitating the training of employees.

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