True Leadership Is Inviting Feedback on the QMS from the People Using It - Not Auditing Them

During a QMS transformation I led, I found myself asking a simple but often overlooked question: “When was the last time I asked how it feels to actually use this system?”

Not how well it is followed. Not whether it passes audits. But how it feels to the people relying on it every day to make safe, informed decisions.

That question led me down a deeper path. Because as I looked through the system with fresh eyes, I couldn’t shake the sense that something was missing. The procedures were complete. The documents were reviewed. The audits were clean.

But the experience? It was invisible.

We often assume that because a process exists, it works. That because it is documented, it is understood. That because people follow it, they believe in it.

But belief doesn’t come from compliance. It comes from feeling seen and supported by the system you are part of.

And in that moment, I realised: we weren’t auditing for that.

"But leadership isn’t about building a system people can follow. It is about building a system people can trust."

And trust doesn’t come from audits. It comes from inviting feedback and acting on it.

The Problem: A Culture of Compliance Without Conversation

We have all seen it:

• Internal audits that focus only on document accuracy, not usefulness
• CAPAs driven by missing fields, not missing logic
• Procedures that meet standards but contradict how work actually happens
• Quality reviews that prioritise pass/fail checkboxes over meaningful dialogue

What is missing in most QMS strategies? User experience.

The people actually engaging with the QMS every day, design engineers, tech writers, regulatory specialists, lab technicians often feel like passengers on a train they didn’t help build.

They get audited……. they get trained……. they get measured……..but they don’t get heard.

And that is a dangerous blind spot.

Because if your QMS isn’t shaped by the people who live in it, then it is likely disconnected from reality. And a disconnected system, no matter how compliant, is a risk.

Why This Matters Now More Than Ever

Today’s MedTech environment demands more than procedural conformity:

• EU MDR, FDA QMSR, and ISO 13485 are all aligning around risk-based, lifecycle-focused quality management
• Software-driven devices require integrated, agile documentation and rapid iteration
• Cross-functional collaboration is now a baseline expectation, not a bonus
• Remote work and digital platforms have exposed the friction in legacy systems

The common thread across all of this?

"Systems that don’t adapt to user needs will fail to scale and fail to protect."

We are no longer in an era where the QMS is just a backend archive for auditors. It is an active environment that should support daily decisions.

If the system isn’t supporting the people doing the work, then no audit will save you when complexity hits or when quality is tested in the real world.

The Reframe: Leadership = Listening, Not Just Leading

A shift in perspective changes everything:

"The best internal audit isn’t a checklist, it is a conversation."

True quality leadership means:

• Asking how your system feels to the user
• Exploring where it creates friction or fear
• Inviting feedback before findings
• Measuring effectiveness, not just adherence

That is not soft leadership. That is strategic empathy.

You learn:

• Which forms people avoid (and why)
• Where decisions get delayed because the process is unclear
• What real risks go unspoken because the documentation doesn’t match the dialogue
• Where your system enables excellence and where it obstructs it

And when you know that you don’t just prevent nonconformities. You enable performance.

Real Strategies to Build Feedback Into the QMS

I have helped organisations make the shift through approaches like these and why it made a measurable difference:

1. Turn Internal Audits into Empathy Walkthroughs

Instead of just checking whether records exist, auditors shadowed users through a full process:

• Filing a complaint
• Initiating a design change
• Completing a risk assessment

They observed, asked open-ended questions, noted where confusion or delays occurred. We turned those insights into system redesigns.

Result: streamlined forms, clearer procedures, fewer deviations and more engagement.

2. Add a “Voice of the User” Section to Your QMS Review

Every Management Review had a slide dedicated to user feedback:

• What is working in the QMS?
• What is confusing?
• What is missing?

I gathered this through surveys, anonymous forms, and in-person debriefs.

Not only did it reveal valuable insights, but it also signalled that leadership was listening.

3. Create a QMS Feedback Loop With Cross-Functional Champions

I trained champions from R&D, Operations, and RA to gather feedback quarterly from their teams on quality processes.

They weren’t there to enforce rules. They were there to connect the system to the people.

Those champions became the most trusted allies of the quality team.

4. Reward Feedback in the Same Way You Reward Findings

When someone identifies a systemic issue in a form, a workflow, or an SOP, treat it with the same seriousness as a nonconformance.

Celebrate it. Address it. Track it.

When feedback is valued, it flows more freely.

5. Measure System Usability, Not Just System Usage

Don’t just track how many forms were completed. Track:

• How long it took
• How many clarifications were needed
• Where users dropped off

Those are your true indicators of quality system performance.

A Personal Story That Changed My Thinking

Years ago, I conducted a root cause investigation for a delayed complaint closure. The data showed all the forms were completed, reviews done, CAPA in place.

But the problem had persisted for months.... Why?

The form was confusing. It asked for a risk rating that didn’t match any training. The team guessed. Reviewers reworked. Everyone was “compliant,” but no one was confident.

I asked the team, “What would make this easier?”

They had ten great ideas in ten minutes. I implemented a few: simplified scoring, embedded examples, dropdown guidance.

In the next quarter, complaint turnaround time improved by 43%.

"Not because we added controls… Because we added listening."

Reflection Prompt: Who is Auditing Your Quality System’s Impact?

Ask yourself and your team:

• When was the last time we asked users for feedback on our QMS?
• Which process do people avoid, delay, or work around?
• What feedback have we ignored because it didn’t come in the form of a finding?
• Are our internal audits surfacing truth, or just checking boxes?

And most importantly:

What would we hear if we asked, “How does our QMS help you do your best work?”

Final Thought: Leadership That Listens, Systems That Serve

I believe the strongest quality cultures aren’t built on surveillance.

They are built on shared ownership.

And ownership starts with voice.

We say we want engagement. We say we want accountability.

But if we are not designing systems with the people who use them, we are not leading. We are dictating.

True leadership is not auditing in isolation.

It is inviting dialogue, adjusting direction, and evolving together.

Because the most effective quality system is the one that helps people care not just comply.

Let us stop treating feedback like a threat.

Let us start treating it like fuel.

That is how quality becomes culture.

That is how systems become trusted.

That is how leadership becomes real.