Non-conformance Report Template - ISO 13485
Non-conformance Report Template - ISO 13485
Template Overview
Template Overview
Effectively identify, document, and resolve non-conformities with our ISO 13485:2016 Clause 8.3 Non-Conformance Report (NCR) Form Template. A structured NCR process is essential for maintaining product quality, regulatory compliance, and continuous improvement in medical device manufacturing. This ready-to-use form helps organizations track, investigate, and correct non-conformances in compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR.
Key Features
Key Features
✔ Pre-Formatted Non-Conformance Report (NCR) Form – Covers key ISO 13485:2016 Clause 8.3 requirements.
✔ Issue Identification & Description Section – Log details of non-conforming materials, components, or processes.
✔ Root Cause Analysis & Risk Assessment – Document investigations and potential impact.
✔ Corrective & Preventive Actions (CAPA) Link – Ensure proper issue resolution and preventive measures.
✔ Material Disposition & Rework Tracking – Monitor repair, rework, quarantine, or disposal decisions.
✔ Approval & Sign-Off Workflow – Assign responsibility and track resolution progress.
✔ Audit-Ready Documentation – Maintain full traceability for regulatory inspections.
✔ Editable Digital Format – Fully customizable for various non-conformance scenarios.
Why choose a QMS Template?
Why choose a QMS Template?
This user-friendly NCR form is ideal for quality managers, regulatory teams, and production personnel, ensuring a structured, effective, and compliant non-conformance management process.
Download the ISO 13485:2016 Non-Conformance Report (NCR) Form Template today and enhance your quality control and compliance tracking!
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