27/01/2020
We passed our ISO 9001:2015 audit today :) but I am posting about what I heard as an example of why I am in favour of BREXIT. A new EU Directive states that from from Ist January 2020 any new piece of medical equipment, that is any piece of equipment from MRI scanners to sutures and plasters, to be added to the NHS inventory must comply with the medical equipment ISO. All but two certification agencies are so disgusted they are not offering certificates. One of these two is charging GP10,000 (not a mistype) per day for their consultants to help manufacturers prepare for audit and then GBP20,000 for the certificate. Most manufacturers are saying no and selling to the US and other non-EU countries where this is not required. Who will pay on the UK? the NHS through increased equipment costs, ultimately you and me for an inevitably reduced service. Either way the NHS and its patients are suffering. From 01.01.2021 our government can say no to the Directive and rightly so. Why does a new style of bandage or other dressing need this expensive certification. So roll on Friday when we can start working on making our own decisions as to what is best for the people of the UK