ISO 13485 (Clause 7.4) - Supplier Audit

Ensure your suppliers consistently meet ISO 13485:2016 requirements with our Supplier Audit Template. Designed specifically to support compliance with Clause 7.4, this ready-to-use template provides a comprehensive framework for planning, conducting, and documenting supplier audits. Effective supplier auditing is essential for evaluating quality systems, regulatory adherence, and ongoing capability to deliver compliant materials, components, and services for medical device manufacturing.

✔ Pre-Formatted Supplier Audit Template – Fully aligned with ISO 13485:2016 Clause 7.4 for evaluating supplier performance and compliance.
✔ Audit Planning & Scope – Define the audit scope, objectives, and audit criteria based on risk level and supplier criticality.
✔ Detailed Audit Checklist – Assess supplier processes, quality management systems, regulatory certifications, and product controls.
✔ Non-Conformance & Observations Section – Document any gaps or deviations and assign appropriate corrective actions.
✔ Audit Summary & Evaluation – Capture overall audit findings, conclusions, and supplier approval status.
✔ Audit-Ready Records – Maintain structured, traceable documentation for internal audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various supplier types, industries, and audit types.

This Supplier Audit Template is ideal for quality managers, procurement teams, and regulatory affairs professionals, helping ensure a structured, consistent, and compliant supplier audit process.

Download the ISO 13485:2016 Supplier Audit Template today to strengthen your supplier oversight and QMS compliance!