About SmartQMS

Democratising access to top-tier quality expertise.

SmartQMS was born to fill a gap in the market for skilled quality professionals, and the growing demand from startups and small organisations for that expertise. By introducing fractional quality management, we've made specialist quality systems accessible to organisations that previously found them out of reach.

Why we exist

Our mission

Supporting Australian scientific innovation through effective quality management systems.

Improving awareness and knowledge of quality systems within the scientific community.

Leading the quality revolution in the life science industry.

Driving a culture where quality is more than a compliance requirements but a way to make things better.

Our story

From the laboratory to the quality system.

SmartQMS emerged from the vision of Keren Natalia, whose background in biotechnology, medical microbiology, and immunology transitioned into a passion for enhancing quality within the scientific community — creating simple, effective systems that let organisations meet their compliance objectives with ease.

We bring over 20 years of quality management experience in MedTech and Biotech across a wide range of products and services, including orthopaedics, biologics, genomics, and nuclear science.

Today we extend our services across Australia to a diverse portfolio of scientific and medical technology companies. We have established enduring partnerships with top-tier institutions, developing and implementing quality systems for laboratories within the University of New South Wales, the Garvan Institute of Medical Research, and the Telethon Kids Institute.

Through our outreach we are also committed to nurturing the next wave of quality-informed leaders within the science community, providing mentorship and support to foster a future where quality and innovation go hand in hand.

What guides us

Our core values.

Simplicity

We create lean and efficient systems, simplifying compliance without compromising quality.

Innovation

We seek out and adopt innovative approaches and technologies to provide the best quality management solutions.

Expertise

Our deep industry knowledge, drawn from years of experience in various roles, forms the bedrock of our work.

Partnership

We believe in the power of collaboration, providing clients with the resources and guidance they need to grow and succeed.

Meet the team

Meet our friendly quality team.

Director & Principal Consultant

Keren Natalia

Quality Consultant

Shilpa Patil (Hunakunti)

Admin Officer & Document Controller

Yemima Gloria

Course Developer

Jamie Li

Quality Intern

Khoi Nguyen

Marketing Intern

Linh Huynh

Ready to talk about your situation?

30 minutes with our team. No obligation, no sales pitch. Just clarity on your next practical step.

Book a free consultation