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Quality Management System

Meaning

A Quality Management System (QMS) is a formalized set of policies, processes, and procedures required for planning and execution in the core business area of an organization, ensuring consistent quality in its products or services. In the context of pharmaceutical manufacturing and clinical practice, a robust QMS is mandatory for compliance with regulatory standards like ISO and FDA guidelines. The implementation of a QMS is critical for minimizing errors, ensuring product safety, and maintaining the integrity of patient care protocols.