Non-Conformance Log Template - ISO 13485
Non-Conformance Log Template - ISO 13485
Template Overview
Template Overview
Ensure full traceability and compliance in your Non-Conformance (NCR) process with our ISO 13485:2016 Clause 8.3 NCR Log Template. Proper non-conformance tracking is essential for maintaining product quality, regulatory compliance, and continuous improvement in medical device manufacturing. This structured, easy-to-use spreadsheet helps organizations log, track, and monitor non-conformances, ensuring compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, and IVDR.
Key Features
Key Features
✔ Pre-Formatted Non-Conformance Report Log – Covers key ISO 13485:2016 Clause 8.3 requirements.
✔ Issue Identification & Description Section – Track non-conforming materials, components, or processes.
✔ Root Cause Analysis & Corrective Action Tracking – Document investigations and link to CAPA actions.
✔ Material Disposition & Status Updates – Monitor rework, quarantine, disposal, or return decisions.
✔ Automated Tracking & Sorting Features – Easily filter and categorize non-conformances.
✔ Audit-Ready Documentation – Ensure complete records for regulatory inspections and compliance audits.
✔ Approval & Sign-Off Workflow – Assign accountability and verify resolution.
✔ Editable Digital Format – Fully customizable for various manufacturing processes and quality systems.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use NCR log is ideal for quality managers, compliance teams, and production staff, ensuring structured, effective, and transparent non-conformance management.
Download the ISO 13485:2016 NCR Log Template today and streamline your quality control process!
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Additional information
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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