ISO 13485 certification

ISO 13485: My journey to certification – success

Last week I took scope of what I’d done: I solved all major non-conformances to the satisfaction of my assessor, and agreed to put my certification audit forward by one day

The last week has been hectic but not with ISO 13485 stuff: I was hard at work finishing another Horizon 2020 proposal I’m writing for a consortium of 16 parties—this one on using advanced simulation techniques in design and manufacturing. That was submitted yesterday just before 4pm.

Gloved hand with syringe

ISO 13485: My journey to certification – infrastructure

I work from home, where I have a comfortable office, small lab and well-equipped workshop

As far as the ISO 13485 standard is concerned, these rooms (two spare bedrooms and my garage) and the equipment, tools, machinery, IT systems and services I use in client projects are all part of the infrastructure used for product realisation, and I should therefore identify and maintain them.