It’s 1995, and I’m ready to lead the charge in implementing ISO 13485 and the new Quality System Regulation. I am new to the quality system game, as are we all – it has been good manufacturing practice until now.  In fact, we just got the hang of ISO 9001 just a few years ago. I’ve read more manuals than I have fingers, and I’m trying to wrap my head around what a “Quality Management System” even is. We already have an ISO 9001 certificate, so how hard can it be, right? Oh, how wrong I was.

First order of business – educating the troops. I wheel in the old VCR and TV cart like a boss and pop in the first of many thrilling videos titled “New Quality System Regulation: The Director’s Cut”. Let the fun begin! Fast forward through endless hours of regulations and confused faces. But hey, at least we’re all equally lost together. It’s like being on the front lines of the war – and I have to tell you I am still great friends with many of those people still almost 30 years later.

Recently, as I was working on a client’s SOP and stumbling through the maze of QMS jargon, it hits me – I am now a certified QMS implementation offender. Move over, world; there’s a new quality sheriff in town! I realize that, as I look back on my career, it has been a rollercoaster of QMS implementations and improvements. I’ve become a harmonizing, streamlining, risk-assessing machine. I’ve tackled IVDs, Medical Devices, Pharmaceuticals, Biologics, HCTP’s – you name it, I’ve QMS-ed it.

And don’t even get me started on those articles touting ‘one-size-fits-all’ electronic QMS systems. Sure, they sound great on paper, but every company is like a box of chocolates – you never know what you’re gonna get. From risk assessments to CEO personalities, every QMS journey is a wild ride.

Fast forward to 2024 and here I am, still knee-deep in the QMS game. It’s now time for the QMSR and I am excited to take it on again!  Every new project feels like a blast from the past gathering the troops for another round of quality bootcamp. It’s a never-ending cycle of regulations, risks, and random CEO (or worse yet, Director of Quality) demands – but hey, someone’s gotta keep the quality train chugging along!

So, as I don my QMS cape once again, I raise a toast to all the quality warriors out there. May your risk assessments be logical, your workflows be efficient, and your VCR tapes never wear out (I swear I still have them– hello grandkids!) Here’s to the crazy world of Quality Management Systems – may we never run out of chocolate or patience!