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Supplier Qualification Checklist

Use this Supplier Qualification Checklist template to systematically evaluate and document the suitability of potential or previously blocked suppliers before adding them to your Approved Supplier List. Completing this checklist is essential for ensuring compliance with medical device quality management requirements, as it helps you assess supplier performance, assign approval status, and identify any necessary surveillance measures. Fill out this document during initial supplier qualification or when reconsidering a blocked supplier to maintain a robust and compliant supply chain.
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Supplier Qualification Checklist

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1. Scope

The supplier qualification checklist is completed every time a supplier is evaluated for addition to the Approved Supplier List. The checklist will also be used if a blocked supplier is evaluated again for approval.

2. Supplier Information

Vestibulum Industries LLC

3. Purchase Description

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4. Supplier Evaluation

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Suppliers are evaluated along with these categories by assigning a score value to each category. Score values are as follows:

  • 0: Poor
  • 1: Fair
  • 2: Good
  • 3: Excellent

In order to complete the evaluation, an average score is calculated from all categories.

The overall score results in the following evaluation outcome:

  • Score 2+: Supplier can be approved.
  • Score 1 - 2: supplier can be approved, provided that surveillance measures are in place.
  • Score <1: supplier cannot be approved and is marked as blocked.

Average score:

2.3

Additional Criteria

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5. Final Evaluation Result

Supplier approved for addition to list.

The evaluation result is added to the Approved List of Suppliers.

Medical Device Certification Made Easy.