Engineering Change Notice Procedure | ISO 13485 | FDA QSR Compliant

$149.00
$149.00
Unavailable
per item
The ISO 13485 Engineering Change Notice (ECN) Procedure provides a system for creating, revising, and issuing company specifications and procedure's. The Engineering Change Notice (ECN) procedure is ISO 13485:2016 and FDA QSR compliant. 
  • ISO 13485:2016 Compliant
  • FDA QSR Compliant
  • Includes Related Forms
  • MS Word Format 
  • Digital Content - Instant Download
SKU: SOP 4-001

ISO 13485 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

Engineering Change Notice Procedure Compliance

The Engineering Change Notice Procedure is ISO 13485:2016 and FDA 21 CFR Part 820 compliant.
​To learn more about our Engineering Change Notice Procedure please contact us at [email protected]

RELATED LINKS

​Document Control Procedure
​ISO 13485 Document Control Procedure Bundle
Medical Device Quality Management System BASE PLUS
Medical Device Quality Management System DESIGN PLUS
​Medical Device Quality Management System MANUFACTURING
​Medical Device Quality Management System MANUFACTURING PLUS
Engineering Change Notice Procedure
Engineering Change Notice Procedure

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