K
kvrad
I am in need of a ISO 13485 documentation template package. We are developing a Class II device and need to build a system quickly and efficiently. Any suggestions would be greatly appreciated.
I am in need of a ISO 13485 documentation template package. We are developing a Class II device and need to build a system quickly and efficiently. Any suggestions would be greatly appreciated.
I am in need of a ISO 13485 documentation template package. We are developing a Class II device and need to build a system quickly and efficiently. Any suggestions would be greatly appreciated.
OK. We can help!We are not in a rush, but the company previously had consultants in that developed 'plans' and not procedures. There was a great deal of $$$ and time (18+ months) wasted. Parts of the system they implemented are salvagable, but not enough to encompass a whole system. Our device is software only so it is unique.
A good example is that the consultants had been training personnel and had DCO released a training form, but there is no training procedure (even a draft).
As an ISO 13485 lead auditor, I have seen many canned procedures which were adopted by companies and they basically had to go back to the drawing board since the procedures led to bureaucratic processes and were not able to be maintained.
I would recommend you obtain a copy of ISO 14969, which provides guidelines to all the requirements and start writing your procedures.
There is no requirement for a training procedure in ISO 13485, although it would be better to have one if your process is complex.
Danny