Definition
An organised system of policies, processes, roles, responsibilities, resources and oversight used to establish and continually maintain required quality.
Human Explanation
It connects the activities needed to achieve required results consistently and demonstrate how they were achieved.
Why it Matters
Individual procedures, tests and controls cannot provide quality without a coherent system governing them.
Conceptual Boundary
A Quality System is not merely a set of documents or the responsibility of one department; it shapes how the organisation manages quality.
Practical Perspective
It commonly integrates Document Control, risk, change, Deviations, CAPA, training, audits and Validation.