We're just starting the process of using a quality management system (bit behind the times I know!)
Looking at other trusts the standard does appear to be ISO9001 but there are a small number using ISO13485.
Can anyone offer any advice on which one would be best to go for.
We are a Clinical Engineering department that offers a maintenance service to our trust, we don't design any kind of medical devices.
A quick look on line appears that 13485 is more suited to medical devices but leans towards the manufacturer rather than a service dept.
Timewise to achieve - what would be realistic? We're not starting from scratch, we have SOP's and procedures in place just not in the required format.
I have seen the articles by John Sandham on here, they look excellent and a great starting point.
Any advice greatly appreciated.
