Document Control Procedure | ISO 13485 | FDA QMSR

The Document Control Procedure follows an engineering change notice from assignment and document approval through revision, issuance and status reporting. It also explains document requests, specification numbering and the handling of applicable external standards.

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Supplied as one editable Microsoft Word document in a digital download.

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.

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.

• ECN assignment and document approval cycles

• Revision, issuance and status reporting

• Specification numbering and document requests

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 the change request, affected-item review and approval form, see the Engineering Change Notice Procedure.

Use this document workflow with the Record Retention Procedure for archived quality records, the External Standards Procedure for revised external references, and the Specification Format Procedure for consistent identifiers and presentation. All four are included in the Document Control Procedure Bundle.

Explore complete A.P. Lyon QMS packages

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.

Part of a procedure bundle

This document is also included in ISO 13485 Document Control Procedure Bundle. Explore the bundle for the related documents.