Engineering Change Notice Procedure | ISO 13485 | FDA QMSR
Control changes to medical device specifications, procedures and affected materials with this editable ISO 13485 Engineering Change Notice (ECN) Procedure and forms. It guides change initiation, cross-functional approval, inventory and work-in-process disposition, implementation, technical-documentation impact review and closure.
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Supplied as two editable Microsoft Word documents (the procedure and one form) in a digital download.
ISO 13485:2016 Engineering Change Notice Procedure
The Engineering Change Notice (ECN) Procedure defines the process to create, modify, or obsolete controlled documents within the company in accordance with GMP and ISO 13485:2016 requirements.
The Engineering Change Notice Procedure governs the entire ECN process including responsibilities for originator and approvers, required approvals per document type.
The Engineering Change Notice Procedure includes detailed forms divided by Sections. The ECN form includes:
Coversheet and Summary Information
Documents and Locations Affected by Changes
Materials Affected and Disposition of Inventory, WIP, Open P.O.'s
Method of Implementation Options
ECN Content Checklist to Guide Originator
Checklist for assessing the effect of changes on technical documentation
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.
Use the ECN workflow with the Document Control Procedure for issuing, tracking and archiving approved revisions.
When an approved change affects the manufacturing file, see the Device Master Record and Technical Documentation Procedure. Both are included in the Document Control Procedure 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.
Part of a procedure bundle
This document is also included in ISO 13485 Document Control Procedure Bundle. Explore the bundle for the related documents.
