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.

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

Completing and correcting quality records

The instructions cover permanent, legible entries on approved forms, attribution by signature and date, and correction of an error without obscuring the original entry. Pencil and unfilled blank spaces are addressed explicitly. The same practices apply when engineering, manufacturing and quality staff record work or inspection results, helping a later reviewer establish who performed a task, when it was done and what was originally recorded.

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.

For approved document revisions, see the separately sold Document Control Procedure; for how long completed quality records are kept, see the separately sold Record Retention Procedure. Those two are included in the Document Control Procedure Bundle. This Good Documentation Practices Procedure is not included in that bundle.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Document Control: From Approval to Record Retention for workflow guidance, a checklist and common mistakes.