Gloved hand with syringe

ISO 13485: My journey to certification – assessment visit

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.

After chatting about my business and going through the flowcharts and procedures I’d already written Allan outlined how the certification would work: He had assessed that there were 8 areas of major non-compliance that I needed to address, but that put me at a better than usual starting position. I had covered the most important operational areas, but e.g. had not kept training records for my personnel (that’s just me then). He felt it would be pretty easy to address those 8 areas, so that in 2 months time there would only be some minor non-compliances left—which is just as well as my certification audit is now booked for February 6th, 2015.

As mentioned the outcome of that audit might show there are still some minor non-compliances, but these could be sorted in the first year after certification. CQS has a fairly intensive programme of internal audits and improvement loops over that first year, such that at the year 2 renewal audit all minor non-compliances have been sorted and I’ll pass squeaky clean.

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