Purpose / Scope
This checklist must be completed for any initial evaluation of a supplier or when re-evaluating a blocked supplier for potential approval.
1. General Supplier Details
| Company Name | FdaToday GmbH |
|---|---|
| Address: | c/o Factory Works GmbH Sample Str. 21 20113 SampleState Poland |
| Contact Information (role, email, phone): |
(…) |
2. Description of Purchases
Note: Provide a description of the typical goods and services that the organization plans to procure from the supplier.
Quality Standards:
- \
Note: Specify requirements to be used for assessing the supplier as part of ongoing supplier monitoring. Examples include server uptime for cloud service providers or bug frequency for software development vendors.
3. Criticality Assessment of Supplier
| Criticality Factor | Yes / No | Explanation / Notes |
|---|---|---|
| (1.) Could the purchased items or services directly impact the safety of the organization’s medical devices? | ||
| (2.) Could the purchased items or services indirectly affect the safety of the organization’s medical devices? | ||
| (3.) Could the purchased items or services directly impact the performance of the organization’s medical devices? | ||
| (4.) Could the purchased items or services indirectly impact the performance of the organization’s medical devices? | ||
| (5.) Could the purchased items or services directly impact the regulatory compliance of the organization’s medical devices? | ||
| (6.) Could the purchased items or services indirectly impact the regulatory compliance of the organization’s medical devices? | ||
| (7.) Are the supplier’s goods or services essential for the organization’s ability to manufacture medical devices? | ||
| (8.) Is this supplier the only source for these specific goods or services? |
- A supplier is considered critical if it directly impacts safety, performance, or regulatory compliance, or if questions (7) and (8) are answered affirmatively.
- A supplier is deemed non-critical if questions (1), (3), and (5) are all answered “No.”
- The QMO determines criticality on a case-by-case basis if questions (1), (3), and (5) are answered “No,” but one or more indirect impact questions (2, 4, 6) are marked “Yes.”
Criticality Assessment Result: \
(The criticality assessment should be added to the Qualified Suppliers List.)
4. Supplier Evaluation Criteria
| Evaluation Factor | Score | Explanation / Notes |
|---|---|---|
| Quality of Products/Services | ||
| Timeliness and Punctuality | ||
| Level of Cooperation | ||
| Payment Terms |
Average score:
Refer to section 1.4 of the organization’s supplier management process for further evaluation guidelines.
Additional evaluation criteria may include:
| Additional Criteria | Yes / No | Explanation / Notes |
|---|---|---|
| Is there an NDA (Non-Disclosure Agreement) between the supplier and the organization? | ||
| Does the supplier have an established certified management system (e.g., ISO 9001, ISO 13485)? | ||
| Does the supplier conduct quality inspections before shipment? | ||
| Is there a traceability system in place at the supplier? | ||
| Does the supplier have a process for managing non-conforming products? | ||
| Does the supplier have corrective and preventive action procedures? | ||
| Does the supplier have a procedure for notifying customers of changes? | ||
| Does the supplier subcontract any part of the provided services/products, and do they have their own evaluation process for sub-suppliers? |
Further Details / Description of Supplier Evaluation:
\
| Final Evaluation Result | Yes / No | Explanation / Notes |
|---|---|---|
| Does the supplier meet the organization’s quality requirements? |
(The final evaluation result is added to the Qualified Suppliers List.)
| Evaluator’s Name and Role | \
| Date of Evaluation | \
5. Ongoing Monitoring Measures
| Monitoring Measures | Yes / No | Explanation / Notes |
|---|---|---|
| Is proof of certification required from the supplier? | ||
| Does the supplier need to sign a quality assurance agreement (QAA)? | ||
| Is participation in a supplier audit program required? | ||
| Are any additional surveillance measures necessary? |