Seven Subsystems

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 highlighting the essential 7 subsystems of a quality management system. This image has management at the center with branches from management to each of the other essential elements like spokes on a wheel. Corrective and preventive actions are at the top directly above management; moving clockwise, we have production and process controls; equipment and facility controls; records, documents and change controls; material controls; and design controls — 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.