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Quality Management System (QMS) — Overview

The Quality Management System (QMS) is the management framework that holds every other compliance discipline together. It defines who is responsible for quality, how decisions are made, and how problems are caught and fixed before they reach customers.

Without a functioning QMS, the other sections (documentation, production, testing) are isolated activities rather than an integrated system.

What this section covers

  • What a QMS is and why regulators require it
  • Writing a Quality Policy and Quality Manual
  • Defining roles and responsibilities (organisation chart)
  • Management review — periodic health check of the system
  • Internal audit — self-inspection programme
  • Non-conformance, corrective action, and preventive action (CAPA)
  • Supplier qualification and approved supplier list
  • Change control — how to manage changes without breaking compliance