Zero Findings, Three Audits, One Year: How We Built a Living QMS Whilst Scaling Fast

Introduction

Zero findings. Three external audits. One year to transform templated procedures into a living Quality Management System. All whilst launching our product in a new region, onboarding US clinics, and scaling at considerable pace. 

When I joined Vertigenius as Head of QARA just over a year ago, this seemed an impossible brief. Yet it became our reality, demonstrating that the right approach to QMS implementation can accelerate rather than impede innovation. 

The company had done what many start-ups do: engaged a consultancy to provide an off-the-shelf set of QMS procedures and forms. We had a complete regulatory framework on paper, but it existed in parallel to, not integrated with, our daily operations. My mission was to bridge that gap, transforming these foundational documents into a functional system that could support a brilliant team moving at considerable pace. 

The Challenge: Building QMS at Start-up Speed 

The team I joined were experts in their fields, focused on breakthrough innovation rather than the intricacies of medical device regulations. We faced a particular challenge: we couldn’t afford to slow down to build quality systems. During that same year, we needed to register and soft-launch our software product in the US, complete design transfer for our proprietary head sensor, produce our first at-scale batch with a new contract manufacturer, and navigate the complex logistics of US clinic onboarding. All whilst our development team rolled out regular updates and our leadership provided thought leadership at international conferences. 

The QMS couldn’t be a roadblock. It had to be an enabler. 

Phase 1: Starting with People, Not Paper (Months 1-3) 

Rather than diving into procedure rewrites, I started with understanding. I conducted a comprehensive internal audit. Not to find faults, but as a diagnostic tool to map our current reality against formal requirements. 

My primary question to the team was straightforward: “Show me how you do X.” What I discovered was revealing and sometimes stark. Their talent and informal problem-solving were often outpacing the documentation, but equally telling were the moments when we discovered we weren’t actually doing X at all. Or even close to it. These weren’t failures; they were honest revelations that highlighted the genuine disconnect between templated procedures and startup reality. 

The Critical Success Factor: Total Team Engagement 

What proved absolutely essential was that every single team member engaged with this process. In small teams, you simply cannot afford to have anyone mentally check out or adopt a “that’s QA’s problem” mentality. The beauty of working with this team was their collective ownership – not one person disengaged or tried to delegate quality responsibilities elsewhere. This universal buy-in became the foundation of everything that followed. 

The Foundation: Collaborative Education 

Next came targeted training during one of our monthly in-person meetings. This wasn’t a generic regulatory overview, it was specifically tailored to Vertigenius. We explored how medical device regulations, ISO 13485, and the Medical Device Regulation (MDR) applied directly to our product, processes, and target markets. Most importantly, we established the “why” behind the “what.” 

This phase accomplished two critical objectives: 

• Created a transparent, objective baseline that became our collective roadmap – gaps and all. 
• Built genuine engagement by empowering the entire team with knowledge to help build the system themselves. 

Phase 2: Co-Creating a Practical, Scalable QMS (Months 4 – 8)

With an engaged team, we began tailoring the QMS to fit our culture and scale. We replaced lengthy, generic templates with lean, intuitive documents. Our guiding principle: “as simple as possible, but no simpler”.

A Pragmatic, Tool-First Approach to QMS

We maximised existing tools – SharePoint, Google Workspace – leveraging their native capabilities for automation. This practical, risk-based approach built efficient systems without unnecessary expense. 

 Finding Our Quality Champion 

I identified someone on the team who, despite lacking a formal quality background, had extensive experience delivering high-quality products and possessed the right mindset – attention to detail, methodical problem-solving approach. Developing this internal ally accelerated progress considerably. Whilst getting full team buy-in is gradual, having someone to bounce ideas off and share responsibilities with proved essential. 

Reality Check: Building QMS While Scaling Operations

All this QMS development happened whilst we maintained significant business momentum. We weren’t pausing operations to build quality systems. We were building systems that enabled operations. The QMS supported our pace rather than constraining it. 

Phase 3: Proving the System Through External Audits (Months 9-12) 

Three external audits loomed – not as threats, but as the ultimate validation of our approach. We treated them as comprehensive system tests, conducting rigorous internal audits and management reviews as genuine improvement opportunities. 

I brought in a trusted consultant for internal audits, someone whose work I’d evaluated during my notified body days. I asked her not to be kind. I wanted to know precisely where we stood. 

 The Moment of Truth 

By the time external auditors arrived, I knew our system was imperfect but ready. It was a work in progress we could stand behind, one that required no cramming or memorisation from the team. 

The results spoke for themselves: zero findings across all three audits. 

What Zero Findings Really Means 

In an industry where audit findings are commonplace – even expected, particularly for start-ups or initial assessments – achieving zero findings validates more than compliance. It demonstrates the system works in practice, not just on paper. It proves that quality systems can be built without sacrificing innovation pace or team productivity. 

More importantly, it meant no delays to product launches, no additional compliance costs, and no market access disruptions, critical for a scaling start-up operating across multiple jurisdictions. 

A Living System: Where We Stand Today 

Our QMS is no longer a collection of unused documents. It’s a dynamic, actively used tool that supports innovation rather than stifling it. We’re not perfect and never will be. The goal was never perfection, but achieving “good enough” whilst embracing continuous improvement. 

Our procedures now truly reflect the work we do, and the team understands the “why” behind every process. Most importantly, we’ve built something sustainable that can scale with our growth.

The Proven Methodology: What We Learned 

This approach didn’t just create a functioning QMS. It delivered zero findings whilst we launched products and scaled operations. For any QARA leader facing similar challenges: 

• Start with people, not paper.  

Understand current reality before imposing new processes. Build the system around how your organisation actually works. 

• Make the team part of the solution.  

Education and engagement create ownership. When people understand why processes matter, they become advocates rather than reluctant participants. 

• Embrace “good enough”.

Perfect procedures that sit on shelves help no one. Functional processes that evolve with your business create lasting value. 

• Leverage what you have.  

Pragmatic implementation using existing tools beats expensive solutions that create adoption barriers. 

• Find your champion.

Identify someone with the right mindset and develop their quality skills. Internal advocates accelerate progress. 

The results demonstrate it works: zero findings, successful product launches, and a quality culture that enables rather than constrains innovation. Build your QMS around your people and your reality, not the other way around.

References

www.vertigenius.com
www.donlonlsc.com

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.