The Bottom Line: Your QMS Doesn't Need More Forms
Bottom line: I see this constantly. Startups building a QMS think “more documents = more compliant.” So they end up with 60 SOPs, half of which nobody on the team has actually read, let alone followed.
Here’s the thing. A quality system is like a toolbox. You don’t need every tool ever made. You need the handful you’ll actually reach for, built well enough to trust when you grab them.
A sprawling document library doesn’t protect you in an audit. It creates more places for actual practice to drift from what’s written down. And that gap, what the SOP says versus what your team actually does, is exactly where an inspector starts pulling threads.
So before you write one more procedure, ask:
- Does someone on my team actually use this document right now?
- Could a new hire follow it without me explaining it out loud first?
- If I deleted this SOP tomorrow, would anything in the building actually change?
Fewer documents, built right, beat a library nobody opens.
Want your QMS tightened down to what actually holds up? Book a free 30-minute call and we’ll look at it together.
Trey Thorsen, O’Connell & Myers, LLC. 20 years in medical device regulatory affairs. This post is part of The Bottom Line, a series I also share on LinkedIn.