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.
I’ve just had a first assessment visit by CQS (Certified Quality Systems), the certifying organisation I’m working with. That left me with a pretty positive feeling that I’ll be able to achieve certification within two months.
CQS’s Allan Baskerville is a big fan of using flowcharts. I also found that making them is very illustrative, as it forces you to think about the key activities and decision points in your processes. Allan’s most used phrase in our conversation was “is there appropriate evidence to support that …”. In a fair number of cases I could say “yes” to that.
The first thing I needed to do was to define the scope of the certification. In my case “product realisation” includes design and development but excludes series manufacturing.
If I make prototypes or models they are not stand-alone products, but secondary to the engineering documentation I’m delivering. This means that those clauses in the standard dealing with production issues—and for medical devices there are quite a few—are not applicable.
I like to think I deliver a quality service. My deliverables do the job, I have little overheads, and my clients are happy.
I never felt the need to get a quality certification and deal with the associated paperwork. But I’m now discussing another medical device development project from concept through to CE-marking and production, and my client is new to the medical device arena. They do not (yet) have their own medical device quality certification, so I see this as a good opportunity to pursue ISO 13485 certification of the Panchromos Quality Management System (QMS). To get external validation that Panchromos can compete with the big consultancies in this field.