Supplier Evaluation and Monitoring spreadsheet - ISO 13485

Effectively evaluate, monitor, and manage suppliers with our ISO 13485:2016 Clause 7.4 Supplier Evaluation & Monitoring Spreadsheet Template. Supplier quality management is critical in medical device manufacturing, ensuring that all materials, components, and services meet regulatory, quality, and performance requirements. This structured spreadsheet helps organizations assess supplier compliance, track performance, and ensure ongoing conformance with ISO 13485:2016, MDR, IVDR, and FDA requirements.

✔ Pre-Formatted Supplier Evaluation & Monitoring Spreadsheet – Covers key ISO 13485:2016 Clause 7.4 requirements.

✔ Supplier Assessment & Qualification Criteria – Rate suppliers based on quality, delivery, cost, and compliance.

✔ Ongoing Supplier Performance Tracking – Monitor non-conformities, corrective actions, and audit results.

✔ Risk-Based Supplier Categorization – Classify suppliers based on criticality and regulatory impact.

✔ Approval & Re-Evaluation Logs – Document supplier approvals, reviews, and contract renewals.

✔ Compliance with Regulatory Standards – Ensure alignment with ISO 14971 risk management and QMS requirements.

✔ Editable Digital Format – Fully customizable for various supplier types and business needs.

This ready-to-use supplier management tool is ideal for quality managers, procurement teams, and regulatory professionals, ensuring structured, audit-ready supplier evaluation and monitoring.

Download the ISO 13485:2016 Supplier Evaluation & Monitoring Spreadsheet Template today and improve supply chain quality and compliance!