SOPs (Standard Operating Procedures) are only as good as the people following them. Your QMS should enable behavior, not just document it.
In working with SaMD teams, we uncover common traps when developing their quality management systems and processes. One of the most common traps we find is the assertion that their QMS exists to organize policies and prove compliance.
Documentation isn't the end goal — it's a means to operationalize quality.
When push comes to shove, auditors want to see that your team isn’t just checking boxes — they want evidence that your employees are actually implementing the quality system.
That means your QMS needs to work for the people using it — not just the quality team managing it.
5 Systems of Behavior to Build Into Your QMS
Your QMS isn’t a filing cabinet — it’s a system of behavior.
Here are 5 practical ways to shift from passive documentation to active enablement:
- Map processes to people
Every SOP or policy should clearly assign responsibilities. Use your QMS to assign ownership to individuals or roles. If it doesn’t track “who’s on the hook,” it’s not enforceable.
- Automate workflows for employee onboarding and training
New hires shouldn’t rely on emails or tribal knowledge to figure out what they need. Build workflows that automatically assign required policies, procedures, and training based on department or role.
- Enable real-time task tracking
When change requests or CAPAs are initiated, make sure tasks are visible — not buried in email or lost in spreadsheets. You should be able to open your QMS and view what’s in progress, what’s overdue, and who’s accountable.
- Use built-in alerts and reminders
Don’t rely on manual follow-ups. Build your system to prompt users when reviews, approvals, or actions are due. Your QMS should nudge the right behavior without requiring micromanagement.
- Track the full chain of events.
Auditors don't want you to answer the question “did we write a policy?” — they want you to prove who read it, trained on it, and followed it. Build traceability into every step, so your team is always ready for audit without the last-minute scramble.
Why Humans Matter for SaMD Audit-Readiness
Audits rarely fail because documentation is missing. They fail because what’s on paper doesn’t match what’s in practice.
Ask yourself:
- Can we show real-time status of training completions?
- Can we prove a change control request followed the correct steps, with timestamps?
- Can we demonstrate that only authorized individuals accessed or modified certain policies?
If the answer to these is “yes,” you’re audit-ready — not just in theory, but in reality.
Four Compliance Takeaways for SaMD Companies
Modern SaMD companies need more than a digital filing cabinet. You need a system that helps your team take the right actions at the right times, reinforces accountability, and captures real-world implementation — not just policy intent.
Here are 4 (four) action items your quality or compliance team can start doing immediately to move toward a more human-centered, audit-ready QMS:
- Start by reviewing one key SOP through a human lens
Pick a core process — like onboarding or change control — and walk through it from an end user’s perspective. Is it clear? Actionable? Assigned to the right people?
- Map roles to responsibilities
Create or update a RACI (Responsible, Accountable, Consulted, and Informed) chart for your most critical quality processes. If ownership is ambiguous or unknown, audit risk goes up.
- Set up recurring training accountability
Don’t just send PDFs. Use your system (or even a simple tracker) to assign, track, and remind users of their required training — and record when it's completed.
- Build a visible quality task board
Use your QMS or an external tool to centralize quality tasks (CAPAs, audits, document reviews). Make it clear who’s doing what — and by when.
Start small. Choose one area where documentation and real-world behavior are out of sync — and fix the gap. Then build on that.
Because when your QMS makes life easier for your team, compliance stops being a project — and starts becoming part of how you operate every day.
What do Auditors Really Want?
If you’re preparing for an audit—or just want to test your current quality processes, start with our 30-Point Audit Readiness Checklist for SaMD Companies that outlines the critical areas most quality teams miss when they rely on documentation alone.