Supplier Evaluation and Monitoring Procedure - ISO 13485

Ensure consistent supplier quality and regulatory compliance with our ISO 13485:2016 Clause 7.4 Supplier Evaluation & Monitoring Procedure Template. Effective supplier evaluation and monitoring are critical for maintaining product safety, quality, and traceability in medical device manufacturing. This structured procedure template provides a clear, standardized approach for assessing, approving, and continuously monitoring suppliers in accordance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820 requirements.

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

✔ Supplier Qualification & Approval Process – Establish criteria for selecting and approving suppliers.

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

✔ Ongoing Supplier Performance Monitoring – Define KPIs for delivery, quality, and compliance.

✔ Supplier Audits & Re-Evaluation Process – Track periodic reviews and compliance assessments.

✔ Non-Conformance & Corrective Actions Handling – Manage supplier issues and CAPA requirements.

✔ Audit-Ready Record-Keeping – Ensure full traceability of supplier approvals and performance.

✔ Editable Digital Format – Fully customizable for various business models and supply chain processes.

This ready-to-use supplier management procedure is ideal for quality managers, procurement teams, and regulatory professionals, ensuring a structured, compliant, and effective supplier evaluation process.

Download the ISO 13485:2016 Supplier Evaluation & Monitoring Procedure Template today and strengthen your supply chain quality and compliance!