BoardQMS Services

Implementation and Maintenance of ISO 13485 Quality Management System (QMS)
Whether you’re establishing a new QMS from the ground up or optimizing existing workflows, BoardQMS provides comprehensive, end-to-end support to ensure not only ISO 13485 compliance but also operational efficiency improvement, redundancy reduction, and documentation optimization.

• Developing or boosting a QMS that meets your customer, team, regulatory and ISO 13485 requirements.
• Creating clear, user-friendly workflows and documentation, including manufacturing and testing forms, quality plans, procedures, manuals, etc.
• Leading internal or supplier audits, supporting external audit readiness, and conducting other compliance assessments.

By designing intuitive, scalable and tailored workflows, we empower teams to spend less time on administrative tasks and more time delivering results. The outcome is a system that works for the team — not the other way around.

Your Journey

To ensure your success, we’ll begin with a free discovery call, followed by a meeting to assess your current stage of development. Based on our discussion and your future market goals, I will recommend one of the following service options:

QMS Implementation
Whether you’re forming a new internal QMS or preparing for ISO 13485 certification, this service focuses on developing and implementing a set of sustainable, scalable workflows tailored to your organization’s needs, ensuring the system becomes a key driver in achieving your goals. At the end of the project, you should be able to continue to build quality into the process, iterate as your situation changes (new customers, new regulations, new markets…), and adopt quality, not as a department, but as a mindset.

QMS Boost
This service is designed for organizations looking to enhance the existing QMS and to check for and correct any wastage in the current system. It typically includes process reviews, audits, walk-troughs, and compliance checks, such as internal or supplier audits, preparation for external inspections, and gap assessments indicating where there is area for improvement in the current setup.

About BoardQMS

BoardQMS Solutions Inc., based in beautiful British Columbia, Canada, was founded out of passion for creating processes and systems that empower small and medium-sized biotech enterprises to successfully bring life-saving technologies to market.

The vision behind BoardQMS is to create systems that grow alongside the company and its products or services. These systems are designed to start flexibly, accommodating the natural ebbs and flows that startups often experience. Our values are Collaboration, Accountability, Purposefulness, and Authenticity, starting with Collaboration.

What do you know — CAPA!

We lead with Collaboration and the associated workflows because it lays the groundwork for everything else — accountability follows naturally, purpose becomes clearer, authenticity has room to thrive. Collaboration is more than a value — it’s the engine of progress. It’s how we move from ideas to action: by connecting people, breaking down big goals into achievable tasks, and celebrating successes as a team.

We also believe in saving the world from paper — and saving paper from the world. That’s why we advocate for electronic QMS workflows based on Microsoft SharePoint. Built on the secure Microsoft 365 platform, it offers enterprise-grade data protection, compliance controls, and robust permission management to safeguard your quality records. The soft-copy approach doesn’t just reduce waste — it improves traceability, efficiency, and real-time collaboration.

Lastly, our customizable, intuitive workflows take the guesswork out of compliance. From real-time document approvals to automated action reminders, your team can stay aligned, focused, and audit-ready — without the excess overhead. We design every solution to fit how your people actually work, so quality becomes second nature across departments.

About Me

With over 20 years of experience in regulated industries, medical device, IVD, and pharma, I have worked with numerous startups to establish effective QMSs that supported their growth and enabled market access. Every system I initiated and helped shape was made with a broader purpose: to drive meaningful impact, empower users, and create sustainable, scalable solutions that remain flexible enough to iterate, adapt, and evolve over time.

While I understand the compliance requirements and processes for designing and implementing a successful QMS, I also recognize the pain points faced by pre-revenue SMEs. This insight allows me to guide them through their quality operations development — from their early stages, to market entry, and beyond.

In July 2024, I founded BoardQMS Solutions and have since been working as a compliance consultant for some of Canada’s most successful biotech companies.