AMA on QMS Implementation

  • 2 September 2022
  • 4 replies

Userlevel 5

Some people just have more guts than I do. Steve Gompertz carried his tri-fold-sized Quality Manual into an FDA inspection, and you know what the inspector said? 

Check out the video - I’ll let Steve tell the story. 

Steve has a TON of experience in this field, and loves to help companies implement lean Quality Management Systems. 

P.S. If you want to skip Steve and my chitchat, skip ahead to the 10-minute mark - we were recording from the get-go!


4 replies

What questions do you usually ask during an audit to try and uncover if an auditee is perhaps trying to hide something?

@SteveGQRX. I heard you say that you were willing to provide the template for that amazing tri-fold QM. I’m very interested in getting my hands on that for inspiration to make QMS a simpler and more easily understood topic. Where will you be posting this wonderful tool?

Thank you in advance for sharing! 


Thank you to everyone for showing up and for the great questions.  As we discussed, a copy of the tri-fold brochure style Quality Manual is attached to this message.  If you’d like to connect with me on LinkedIn, my profile is at  You can also follow my company, QRx Partners, at



Userlevel 5

Thanks again, @SteveGQRX , always fun getting to hear your thoughts on anything MedTech-related!