Good Documentation Practices Procedure | ISO 13485 | FDA QMSR

The Good Documentation Practices Procedure defines how personnel complete and correct approved engineering, manufacturing and quality records.

Areas covered

Legible entries, signatures and dates, traceable corrections and completion of record fields.

Editable Microsoft Word procedure supplied as a digital download. Adapt responsibilities and workflows to your organization before approval and implementation.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.