ISO 13485: My journey to certification – success

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.

Today CQS’s Neil Urquhart showed up at my door at 10am to conduct a certification audit. This turned out to be a rather quick and painless process: As expected no major non-conformances came up. Neil ran me through the internal audit and review process they expect me to implement in the coming year, so that by this time next year my renewal audit will be straightforward too. He also left me with a hardcopy of my Quality Manual, which I’ll have to further tweak and finalise in the upcoming month.

So by 11am I was officially awarded the ISO 13485 certificate. Smiles, handshakes and a good photo-op. Spread the word…

ISO 13485 dual logo

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