Outsourced storage Quality Agreement

#1
Good Day,
In our last CB audit for our company's Virtual Manufacturing company, we have received a finding that was new to us:
Orders are being shipped to an outsourced storage in a different country until the customer orders a pickup.
This outsourced storage company, is counted as a CRITICAL SUPPLIER and thus requires to comply accordingly as required by ISO13485.
Does anyone knows this requirement and maybe has an example of a suitable quality agreement?
Thank you
 
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Tagin

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#2
Can you provide the full text of the finding. including the clause the auditor cited?

Edit: It looks like the NC must be referring to 4.1.5:
4.1.5 When the organization chooses to outsource any process that affects product conformity to requirements, it shall....The controls shall include written quality agreements.
 
#3
The following was described:
Audit Topic: Supplier Control
Applicable standard/regulation and clause: EN ISO 13485:2016 Cl. 7.5.11, MDD Annex II
Statement of non-conformity:
The supplier is not control and identified as critical subcontractor (e.g. Warehouse subcontractor for finished goods products (e.g. Missing quality agreement, audits, ISO certification)
 

somashekar

Staff member
Admin
#4
The following was described:
Audit Topic: Supplier Control
Applicable standard/regulation and clause: EN ISO 13485:2016 Cl. 7.5.11, MDD Annex II
Statement of non-conformity:
The supplier is not control and identified as critical subcontractor (e.g. Warehouse subcontractor for finished goods products (e.g. Missing quality agreement, audits, ISO certification)
Agree on the missing quality agreement. You need to have one in place, within which you will detail the type and extent of controls. Audits, ISO certification and such other as determined by your risk management are the various types of controls you will detail within the quality agreement.
 
#5
Agree on the missing quality agreement. You need to have one in place, within which you will detail the type and extent of controls. Audits, ISO certification and such other as determined by your risk management are the various types of controls you will detail within the quality agreement.
Thank you !
I was wondering if someone has such agreement ready for example?
 
#8
Thanks, though all of the examples are for organizations that actually have a quality system.
The referred critical supplier is a warehouse , without a QMS and thus basic environmental controls, notifications of changes in the handling and storage , non-conformance notice, etc. are to be mainly described.
I might have covered most, but because this is new to me, I want to verify if indeed, all required is mentioned.
 
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