ISO 13485 (Clause 7.4) - Approved Supplier List

Streamline your supplier management and ensure compliance with ISO 13485:2016 using our Approved Supplier List Template. Maintaining an approved supplier list is a critical aspect of the purchasing process for medical device manufacturers to ensure that raw materials, components, and services meet required quality standards. This ready-to-use template provides a structured framework for tracking, evaluating, and maintaining a list of approved suppliers, ensuring that your suppliers meet both regulatory requirements and your organization’s quality management system (QMS) expectations.

✔ Pre-Formatted Approved Supplier List – Fully aligned with ISO 13485:2016 Clause 7.4 for managing and tracking suppliers.
✔ Supplier Information – Capture essential details such as supplier name, contact information, approved products, and quality certifications.
✔ Supplier Evaluation & Assessment – Document performance reviews, audits, and quality assessments for each approved supplier.
✔ Risk Assessment – Evaluate risks associated with suppliers and the materials or services they provide.
✔ Compliance Tracking – Ensure ongoing supplier compliance with ISO 13485:2016 and regulatory standards.
✔ Editable Digital Format – Customizable for various supplier types, products, and business needs.

This Approved Supplier List Template is ideal for quality managers, procurement teams, and compliance officers, ensuring a systematic, compliant approach to supplier management.

Download the ISO 13485:2016 Approved Supplier List Template today and optimize your supplier evaluation and compliance processes!