BSI 13485:2016

[Garry]

Hi All,

Is anybody in renal working under the ISO13485:2016  quality management system?  I am slowly working through updating policies and procedures with a view to eventually being incorporated within the MEBS department's registration.

Most certainly untrodden ground for myself, so a chat with anybody who has been through the pain would be welcome!

Thanks

Garry  

[Roger Moore]

Hi Garry

Not under 13485:2016 but Clinical Engineering here (of which Renal is one section) are curretly in process of working towards 9001:2015.

[Roger Moore]

Hi Garry

Forgot to say give me a call or drop me an email to chat further about this.