M E M O R A N D U M
To:
From:
cc: N/A
Date:
RE: Justification for Supplier Approval Outside standard SOPs (or something like this)
Purpose:
The purpose of this memo is to document the benefits of using this supplier despite not adhering to established predicate standards defined for other suppliers....
Background:
<A background on how you got here and what the history is>
References:
· Risk Management SOP-RISK-001
FDA QSR Reference
· Traceability Matrix, list your documents here
· Design and Development Plan for devices # # #
· ISO 14971:2019 Medical devices – Application of risk management to medical devices.
Methods:
· Test Reports, literature review, etc.
The official opinion of an expert in this subject matter.
That persons resume cv
Justification:
During the design process of your product name, one of the product requirements was that <Explain why this supplier is unique to provide the parts/service to meet customer requirements.>
Explain the risk of not using your normal SOP
Explain how you will mitigate that risk
Explain the duration of time this memo will serve
Conclusion:
Why this is acceptable.
To:
From:
cc: N/A
Date:
RE: Justification for Supplier Approval Outside standard SOPs (or something like this)
Purpose:
The purpose of this memo is to document the benefits of using this supplier despite not adhering to established predicate standards defined for other suppliers....
Background:
<A background on how you got here and what the history is>
References:
· Risk Management SOP-RISK-001
FDA QSR Reference
· Traceability Matrix, list your documents here
· Design and Development Plan for devices # # #
· ISO 14971:2019 Medical devices – Application of risk management to medical devices.
Methods:
· Test Reports, literature review, etc.
The official opinion of an expert in this subject matter.
That persons resume cv
Justification:
During the design process of your product name, one of the product requirements was that <Explain why this supplier is unique to provide the parts/service to meet customer requirements.>
Explain the risk of not using your normal SOP
Explain how you will mitigate that risk
Explain the duration of time this memo will serve
Conclusion:
Why this is acceptable.