Management with executive responsibility are ultimately responsible for the quality management system. This concept of ultimate responsibility is represented by the placement of management in the center of the diagram. The FDA holds management responsible for the quality management system and any failures of that system.

Management is also responsible for ensuring quality system compliance throughout the organization. According to the FDA "It is without question management’s responsibility to undertake appropriate actions to ensure that employees understand management’s policies and objectives.”

Learning Objectives:

- 1.3 - Explain how a quality management system helps a company meet the guidelines from regulatory bodies.