Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016

#1
Hello Everyone,

Our company is the legal manufacturer for some reagent kits and related instruments for IVD. We will be having the re certification for ISO 13485:2016, as we only had surveillance audit after the transition and we are not sure if we have sufficient updates on the documentation for outsourced OEM.

May we know for the sourcing, monitoring and controlling of the outsourced OEM, what needs to be updated/ prepared for ISO 13485:2016, especially from the transition of ISO 13485: 2003?

Thank you so much for your kind assistance.

Best Regards,
Clarence
 
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yodon

Staff member
Super Moderator
#2
The question is a bit vague. Do you have a copy of the standard and have you reviewed the changes to the relevant portions? The more specific question you can ask, the more likely you are to get a response.
 

somashekar

Staff member
Super Moderator
#3
Hello Everyone,

Our company is the legal manufacturer for some reagent kits and related instruments for IVD. We will be having the re certification for ISO 13485:2016, as we only had surveillance audit after the transition and we are not sure if we have sufficient updates on the documentation for outsourced OEM.

May we know for the sourcing, monitoring and controlling of the outsourced OEM, what needs to be updated/ prepared for ISO 13485:2016, especially from the transition of ISO 13485: 2003?

Thank you so much for your kind assistance.

Best Regards,
Clarence
Have a good look at the Table A.1 in the Annex A of the ISO 13485:2016
Do you have a written agreement with the outsourced entity to notify you prior to making any changes ?
See 7.4.2 completely in the ISO 13485:2016
 
#5
Have a good look at the Table A.1 in the Annex A of the ISO 13485:2016
Do you have a written agreement with the outsourced entity to notify you prior to making any changes ?
See 7.4.2 completely in the ISO 13485:2016
We have issued an agreement for the vendors supplying critical components/ materials, also we have the plan for supplier evaluation and re-evaluation.

But I am worrying if I miss anything....orz

Thank you for your replies indeed
 
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