13,485 Ways to Leave Your Lover

Our favorite standard, ISO 13485 (with whatever additional letters you want to add to it) has been around for most of the time that many of us have been in industry.  Only the real curmudgeons remember a time when it didn’t exist.

What about it works and what about it doesn’t?  Have you ever seen a finding related to “top management.” (I’ve always found that title weird, like I feel like you get them all spun up and they will stand up for what is right for a while, but then will eventually just fall down.)  Have you ever seen a finding related to preventative actions?  I have heard of them rarely, and because of the dreaded potential nonconformance on the preventing potential problems process, sites will create a “token” preventative CAPA.  What are we doing when we are making work just to keep auditors happy?  The last time I checked we don’t work for the auditors, at least I’m pretty sure…

So, what am I trying to say?  A good QMS is ideal to make sure that products are safe and effective, but just because you have a good QMS, does not mean that you have good products.  A QMS is not a business system, and it is going to be part of a business at the end of the day.  So just drop off the key, and get yourself free.