What defines a quality management system according to ISO and CLSI?

A quality management system, according to ISO and CLSI, is fundamentally defined by the coordinated activities that direct and control an organization concerning quality. This definition emphasizes the structured approach required for effectively managing quality throughout an organization. It involves the integration of processes, responsibilities, and resources, ensuring that the products or services meet customer and regulatory needs.

A quality management system aims to enhance customer satisfaction and improve operational efficiency by systematically managing processes, reducing variation, and fostering continuous improvement. This aligns closely with the principles established by ISO standards, which prioritize a holistic and strategic approach to quality.

The other choices, while they may represent important aspects of organizational management, do not capture the comprehensive essence of what defines a quality management system. Strict adherence to regulations is essential but is part of the broader scope of quality management. Similarly, maximizing profits and continuous employee training are components that can contribute to an organization's success but do not encapsulate the structured and coordinated framework necessary for a quality management system.