WE DID IT! – IMed’s ISO 13485 QUALITY MANAGEMENT SYSTEM CERTIFICATE HAS LANDED!
Over the past 10 years, we have helped numerous clients gain their ISO 13485 quality management system certification, to support their CE Marking journey. Last year, we decided that it was high time, we certified ourselves to the industry standard too and so our journey began.
Having worked with manufacturers, design houses and virtual manufacturers to name just a few, implementing ISO 13485 in a regulatory consultancy, puts a slightly different spin on things. The team rose to the challenge though and got stuck in with great excitement (or so they told me 😉).
I accept that I can sound like a broken record sometimes, but a robust QMS, built to support your company, acts to improve staff understanding of processes and efficiency of working. A and, if you’re producing medical devices, it also gives you an all-important framework to ensure safety and efficacy in everything that you do. IAnd in going through this process ourselves, IMed wasis no exception and it has certainly improved our working processes too.
With our Stage 1 and 2 audit taking place in very close succession, we luckily passed with flying colours and are now the proud owners of our own shiny ISO 13485 certificate, with the following scope:
“Provision of quality assurance, regulatory affairs and United Kingdom Responsible Person (UKRP) services, to
medical device and in vitro diagnostic device manufacturers.”
Our own ISO 13485 development has strengthened our respect for this important Med Dev and IVD quality standard and given us another perspective in of understanding our clients’ experience. first–hand.– at first and this time. Our QMS Team (and some other unsuspecting IMed staff) have had to examine what we do and how we can promise and deliver the best possible guidance, advice and service to our clients. So, I would like to offer a personal, huge thank you to my team, who made this happen for IMed and rose to the challenge; especially everyone’s favourite Quality man, – Stephen Quinn, who is acting Management Representative, and now has the task of keeping us all on the ISO 13485 straight and narrow.
Well done Guys!
IMed Founder & Managing Director