Document Control Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Document Control Procedure provides a system for editing, issuing, and controlling documents.

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ISO 13485:2016 Document Control Procedure

The Document Control Procedure governs the process for editing, issuance, tracking, obsoleting, archiving and modification for all controlled documents within the organization.

Document Control Procedure Overview

The Document Control Procedure governs all aspects of documentation management needed to address GMP and ISO 13485:2016 requirements for controlled documents. The procedure defines departmental responsibilities and the process of creating and maintaining documents through the Engineering Change Notices (ECN) process. The Document Control Procedure addresses specification number assignment, provides instruction on issuance, storage of electronic and CAD files, obsoleting and archiving files, and much more.

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.