Engineering Change Notice Procedure | ISO 13485 | FDA QMSR

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The ISO 13485:2016 Engineering Change Notice (ECN) Procedure provides a system for creating, revising, and issuing company specifications and procedures.

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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.

Engineering Change Notice Procedure Overview

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 Sections 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 to Assess Affect Changes Will Have on CE Technical Files

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.