ISO 13485 (Clause 7.4) - Supplier Evaluation Questionnaire

Ensure that your supplier evaluation process is thorough and compliant with ISO 13485:2016 using our Supplier Evaluation Questionnaire Template. Supplier performance is crucial in the medical device manufacturing process, and this questionnaire ensures that your suppliers meet the highest standards for quality, safety, and regulatory compliance. This ready-to-use template offers a comprehensive set of questions to assess a supplier’s capabilities, qualifications, and adherence to the regulatory requirements for medical devices, making it an essential tool for your supplier qualification process.

✔ Pre-Formatted Supplier Evaluation Questionnaire – Fully aligned with ISO 13485:2016 Clause 7.4 for evaluating suppliers.
✔ Supplier Qualification Criteria – Questions covering key aspects of quality systems, regulatory compliance, and product performance.
✔ Audit & Certification Validation – Ensure suppliers meet certification requirements (e.g., ISO 9001, ISO 13485) and relevant industry standards.
✔ Risk Management & Monitoring – Assess supplier risk management processes and how they monitor ongoing compliance.
✔ Performance Evaluation – Evaluate supplier delivery performance, product quality, and customer service.
✔ Audit-Ready Records – Maintain traceable records for internal audits and regulatory inspections.
✔ Editable Digital Format – Customizable to suit specific supplier types, products, and business needs.

This Supplier Evaluation Questionnaire Template is ideal for quality managers, procurement teams, and compliance officers, ensuring a systematic, compliant approach to supplier evaluation.

Download the ISO 13485:2016 Supplier Evaluation Questionnaire Template today to enhance your supplier management and compliance efforts!