This checklist is completed every time an initial supplier evaluation is carried out or if a blocked supplier is evaluated again for approval.
| Company Name | OpenReg GmbH |
|---|---|
| Address: | c/o Factory Works GmbH Rheinsberger Str. 76/77 10115 Berlin Germany |
| Point of Contact (job role, email, phone): |
(…) |
NOTE: enter here a description of the goods and services the organization intends to typically purchase from this supplier.
Quality Requirements:
NOTE: enter here requirements based on which you will assess the supplier as part of your continuous supplier surveillance. For example: server uptime (for cloud server providers), bugs resulting from development (for development providers).
| Criticality Criteria | Yes / No | Explanation / Commentary |
|---|---|---|
| (1.) Could the purchased goods or services have a direct impact on the safety of the organization’s medical devices? | ||
| (2.) Could the purchased goods or services have an indirect impact on the safety of the organization’s medical devices? | ||
| (3.) Could the purchased goods or services have a direct impact on the performance of the organization’s medical devices? | ||
| (4.) Could the purchased goods or services have an indirect impact on the performance of the organization’s medical devices? | ||
| (5.) Could the purchased goods or services have a direct impact on the regulatory compliance of the organization’s medical devices? | ||
| (6.) Could the purchased goods or services have an indirect impact on the regulatory compliance of the organization’s medical devices? | ||
| (7.) Is the organization not able to manufacture medical devices without the supplier’s goods or services? | ||
| (8.) Is this the only available supplier for these goods or services? |
Assessment of Criticality: <enter here>
(The assessment result is added to the List of Qualified Suppliers)
| Evaluation Criteria | Score | Explanation / Commentary |
|---|---|---|
| Quality of Products/Services | ||
| Timeliness / Punctuality | ||
| Cooperation | ||
| Payment Terms |
Average score:
Provisions for supplier evaluation and further information can be found in step 1.4 of the organization’s supplier process.
Additional evaluation criteria can be used to evaluate the suppliers:
| Further Criteria | Yes / No | Explanation / Commentary |
|---|---|---|
| Is there a non-disclosure agreement (NDA) in place between the supplier and our organization? | ||
| Does the supplier have a certified management system in place? | <e.g. ISO 9001, ISO 13485> | |
| Does the supplier conduct quality reviews before shipment? | ||
| Does the supplier have a system for traceability established? | ||
| Does the supplier have a procedure for the handling of nonconforming products in place? | ||
| Does the supplier have a procedure for the corrective and preventive actions in place? | ||
| Does the supplier have a procedure in place to notify customers of changes? | ||
| Does the supplier further subcontract the services/products concerned and does the supplier have its own supplier evaluation process in place? |
Additional supplier information / description:
<enter additional information>
| Final Evaluation Result | Yes / No | Explanation / Commentary |
|---|---|---|
| Does the supplier comply with the organization’s quality requirements? |
(The evaluation result is added to the List of Qualified Suppliers)
| Evaluation Completed By: | <enter name and job role> |
| Date Completed: | <enter date> |
| Surveillance Measures | Yes / No | Explanation / Commentary |
|---|---|---|
| Is the supplier required to provide proof of certification? | ||
| Is the supplier required to enter a quality assurance agreement (QAA)? | ||
| Is the supplier required to agree to a supplier audit program? | ||
| Are any other supplier surveillance measures required? |
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