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Updated July 27, 2021

Template: Supplier Checklist

Sven Piechottka
ISO 13485

This is a free template, provided by OpenRegulatory.

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Beginning of template

Supplier Checklist

Scope / Purpose

This checklist is completed every time an initial supplier evaluation is carried out or if a blocked supplier is evaluated again for approval.

1. General Supplier Information

Company Name OpenReg GmbH
Address: c/o Factory Works GmbH
Rheinsberger Str. 76/77
10115 Berlin
Germany
Point of Contact
(job role, email, phone):
(…)

2. Purchase Description

NOTE: enter here a description of the goods and services the organization intends to typically purchase from this supplier.

3. Supplier Criticality

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 there no alternative and equivalent supplier for these goods or services?    

Assessment of Criticality: <enter here>

(The assessment result is added to the List of Qualified Suppliers)

4. Supplier Evaluation

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 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>

5. Surveillance Measures

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?    

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

End of template

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