What is the function of a Quality Management System (QMS)?

The function of a Quality Management System (QMS) is primarily focused on ensuring consistent product quality and compliance with regulations. A QMS establishes standardized processes and procedures designed to monitor and control the quality of products and services, ensuring they meet both customer expectations and regulatory requirements. By implementing a QMS, organizations can systematically identify areas for improvement, enhance operational efficiency, and reduce risks associated with product quality failures.

Regulatory compliance is particularly important in fields such as pharmaceuticals and medical devices, where adherence to established standards and regulations is crucial for ensuring safety and efficacy. This systematized approach to quality management helps organizations maintain high standards throughout the product lifecycle.

In contrast, while increasing production efficiency, conducting clinical trials, and managing research and development teams may involve quality principles, these functions do not encapsulate the core purpose of a QMS, which is centered on quality assurance and regulatory compliance.