When the FDA conducts a Quality System Inspection Technique (QSIT), they look at seven specific subsystems, shown in the diagram below. The seven subsystems represent the most important parts of the quality system regulations.

Diagram of the essential 7 subsystems of a quality management system as described by QSI

Learning Objectives:

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