J
jzengj
Hi guys ,
I'm confused by what seems like a basic issue..and would like to clarify with all you knowledgeable people out there, hope you may pardon my noobness...
My organization has been re-certified to ISO 13485 last May, and our surveillance audit is coming up soon. We're certified for the production scope - we run production for a short while (over a span of 2months), and move on to the next one. I would like to know if there is a need for us to have at least one new production project between our last audit and upcoming one to have something for the auditors to see.
Reason why i'm asking this is because of this statement on the ISO 13485 wiki page, which states that " an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration."
Appreciate your kind help in advance!
I'm confused by what seems like a basic issue..and would like to clarify with all you knowledgeable people out there, hope you may pardon my noobness...
My organization has been re-certified to ISO 13485 last May, and our surveillance audit is coming up soon. We're certified for the production scope - we run production for a short while (over a span of 2months), and move on to the next one. I would like to know if there is a need for us to have at least one new production project between our last audit and upcoming one to have something for the auditors to see.
Reason why i'm asking this is because of this statement on the ISO 13485 wiki page, which states that " an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration."
Appreciate your kind help in advance!