The Document Control Handbook
How to Build and Run a Quality System Document Control Program That Passes Audit
The methodology behind a document-control program that holds together across audits, revisions, and team turnover. Covers the document hierarchy, the revision-control discipline, the change-control workflow, the training-and-acknowledgment chain, and the periodic-review cadence that keeps controlled documents current. Walks the failure modes that turn document-control programs into audit findings: uncontrolled copies in circulation, revisions that never reach the training record, periodic reviews that never happen, change-control requests that bypass the system. Framed for ISO 9001, ISO 13485, and FDA 21 CFR 820 environments. Written for quality managers, document-control program owners, and regulatory affairs leads. Pairs with the Document Control Log and Tracker by Wade Prescott.
View on AmazonThe methodology behind a document-control program that holds together across audits, revisions, and team turnover. Covers the document hierarchy, the revision-control discipline, the change-control workflow, the training-and-acknowledgment chain, and the periodic-review cadence that keeps controlled documents current.
Walks the failure modes that turn document-control programs into audit findings: uncontrolled copies in circulation, revisions that never reach the training record, periodic reviews that never happen, change-control requests that bypass the system.
Framed for ISO 9001, ISO 13485, and FDA 21 CFR 820 environments. Written for quality managers, document-control program owners, and regulatory affairs leads. Pairs with the Document Control Log and Tracker by Wade Prescott.
More in Quality Systems
