This lent term I’m once again mentoring an i-Teams group (and eating plenty of pizza doing so). We’re looking at potential market applications for a small hand-held gas chromatograph (GC) with a thermal conductivity sensor.
The technology is the result of the research done by Dr. R. Vasant Kumar and Dr. Sohab Sarfraz of the department of Material Science and Metallurgy. The novelty of their thermal conductivity sensor—in itself a very well established sensor type—is that their version is insensitive to gas flow rate variations.
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.
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.