Re: Does anyone have experience with how MDD unanounced audits of suppliers are going
Hi Jeffers,
We have had an interesting discussion on this over on this thread:
http://elsmar.com/Forums/showthread.php?t=68803
I think that my blanket statement of "if they aren't on the EC certificate they aren't critical" is not really valid.
My understanding is that there is no clear cut distinction of what makes a supplier critical. For any supplier you should be able to show your NB how you ensure that the materials/ services supplied are fit for purpose.
For components it could be that approval certification, from a recognised Certifying Body test house, would be appropriate.
For test services - accreditation to ISO 17025 for the relevant tests.
For a populated PCB - 100% comprehensive test.
For an OEM supplier (when you are acting as an OBL) - full 13485 certification for the devices in question.
Each of these provides the NB with clear proof of control of supply. In each case the control is likely more stringent than could be achieved by an unannounced audit.
My earlier statements, I think, were skewed by my previous experience when working for an Active Implant manufacturer where our sterilisation contractors were listed on our certification. The fact that you cannot verify sterility (other than by batch records etc) makes this process much more critical.
Hi Jeffers,
We have had an interesting discussion on this over on this thread:
http://elsmar.com/Forums/showthread.php?t=68803
I think that my blanket statement of "if they aren't on the EC certificate they aren't critical" is not really valid.
My understanding is that there is no clear cut distinction of what makes a supplier critical. For any supplier you should be able to show your NB how you ensure that the materials/ services supplied are fit for purpose.
For components it could be that approval certification, from a recognised Certifying Body test house, would be appropriate.
For test services - accreditation to ISO 17025 for the relevant tests.
For a populated PCB - 100% comprehensive test.
For an OEM supplier (when you are acting as an OBL) - full 13485 certification for the devices in question.
Each of these provides the NB with clear proof of control of supply. In each case the control is likely more stringent than could be achieved by an unannounced audit.
My earlier statements, I think, were skewed by my previous experience when working for an Active Implant manufacturer where our sterilisation contractors were listed on our certification. The fact that you cannot verify sterility (other than by batch records etc) makes this process much more critical.