MDR internal audit

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Mike Towers

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#4
Hello,
I was going to open a new topic, but I need the same, especifically, for our MDR certificaton audit process our auditor, asked the following:
There is no evidence that an internal audit was carried out aimed at evaluating the main MDR requirements of Annex IX Chapter I applicable to the organization (there is no checklist that provides this evidence);
Someone has something, about this?
Thank you so much,
 

primavesvera

Involved In Discussions
#5
Hello,
I was going to open a new topic, but I need the same, especifically, for our MDR certificaton audit process our auditor, asked the following:
There is no evidence that an internal audit was carried out aimed at evaluating the main MDR requirements of Annex IX Chapter I applicable to the organization (there is no checklist that provides this evidence);
Someone has something, about this?
Thank you so much,
Hi, I believe we had a similar situation for the MDD certification audit.
During the audit, the auditor asked us if we had evidence of how we audited our QMS per Annex II and, of course, we didn’t have. It was marked down and we needed to buy EN 13485, where in Annex Z we found the additional information and included it in our internal audit checklist per ISO 13485.
So next surveillance audit, we had evidence on how we considered these specific clauses.
Do I agree, not really. At least not for all clauses, since our QMS was already ISO 13485 certified.

Hope this helps, good luck with the audit.
 
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