Medical Device Supplier Quality Evaluation Form
Supplier Information
Company Name
Contact Person
Email
Phone Number
Address
Date of Evaluation
Quality System Assessment
Criteria
Yes / No
Comments
ISO 13485 Certification
Yes
No
Documented Quality Management System
Yes
No
Traceability Established
Yes
No
Complaint Handling Process
Yes
No
Change Control Procedure
Yes
No
Product & Service Performance
Products/Services Supplied
Criteria
Rating (1-5)
Comments
Product Quality
On-Time Delivery
Customer Service
Technical Support
Additional Notes
Observations / Recommendations
Evaluator Name
Signature