hi All,
sorry if this is not in the right place and that I explain it adequately!
I've recently started work for a manufacturer of IIa devices in QA/RA and I am trying to update the QMS to address the newer revision of 13485 and the MDR.
we also distribute items for another company.
However, somehow (even though we are the manufacturer of 2 x devices and have always been responsible for the revision of the products - albeit they have employed external consultants to draw up new schematics etc) this company have managed to get through audits on their QMS and tech files as 'exempt' from the Design & Development elements of the Standard...not even so much as a Design History File anywhere to show what changes have been made over the years to the product (and I am unable, so far, to contact the CAD consultant to gain this information)
the products are DEFINITELY ours (not an OBL or anything) and the tech files have been given the 'ok' by the N.B, but I can't understand HOW on earth we can possible by exempt from the D&D elements of the Standard, given that the devices are our responsibility and WE decide how and when changes are made!? Our tech file has a very old revision of a drawing, which I don't even believe is the one currently being used by our Critical Supplier.
Am I missing something? I really want to contact the N.B, but i'm holding off so that I don't kick up too much dust prior to our audit (nobody likes to draw unwanted attention to themselves!)
i'm struggling to comprehend how this has been passed so many times by both auditors from the N.B as well as other Consultants that have been here before me (to be honest, it's making me feel stupid!!)
if there is anybody that can shed any light, i'd be very grateful.
I don't have anybody here that really understands what it is i'm talking to them about when I raise it - they just seem to think that because it's been ok and passed before, that it can't be a problem NOW - not an attitude I can take, myself, to be honest.
thanks in advance my lovelies!!:
sorry if this is not in the right place and that I explain it adequately!
I've recently started work for a manufacturer of IIa devices in QA/RA and I am trying to update the QMS to address the newer revision of 13485 and the MDR.
we also distribute items for another company.
However, somehow (even though we are the manufacturer of 2 x devices and have always been responsible for the revision of the products - albeit they have employed external consultants to draw up new schematics etc) this company have managed to get through audits on their QMS and tech files as 'exempt' from the Design & Development elements of the Standard...not even so much as a Design History File anywhere to show what changes have been made over the years to the product (and I am unable, so far, to contact the CAD consultant to gain this information)
the products are DEFINITELY ours (not an OBL or anything) and the tech files have been given the 'ok' by the N.B, but I can't understand HOW on earth we can possible by exempt from the D&D elements of the Standard, given that the devices are our responsibility and WE decide how and when changes are made!? Our tech file has a very old revision of a drawing, which I don't even believe is the one currently being used by our Critical Supplier.
Am I missing something? I really want to contact the N.B, but i'm holding off so that I don't kick up too much dust prior to our audit (nobody likes to draw unwanted attention to themselves!)
i'm struggling to comprehend how this has been passed so many times by both auditors from the N.B as well as other Consultants that have been here before me (to be honest, it's making me feel stupid!!)
if there is anybody that can shed any light, i'd be very grateful.
I don't have anybody here that really understands what it is i'm talking to them about when I raise it - they just seem to think that because it's been ok and passed before, that it can't be a problem NOW - not an attitude I can take, myself, to be honest.
thanks in advance my lovelies!!: