About Us

Our Mission

Supporting Australian scientific innovation through effective quality management systems, and
Improving awareness and knowledge of quality system within the scientific community

Our Vision:

Leading the quality revolution in Life Science industry.

SmartQMS emerged from the vision Keren Natalia, whose background in Biotechnology, Medical Microbiology, and Immunology seamlessly transitioned into a passion for enhancing quality within the scientific community. Keren is passionate about creating simple and effective systems that empowering businesses to excel and achieve their compliance objectives with ease.

We bring over 15 years of quality management experience in MedTech and Biotech across a wide range of products and services, including orthopedics, biologics, genomics, nuclear science.

Ultimately our goal is to cultivate a culture where quality is more than just a checkbox, and empowering organisations to achieve more while keeping things simple, offering tailored, practical solutions that translate into real-world impact.

SmartQMS was born to fill a gap in the market for skilled quality professionals and the growing demand from startups and small-sized organisations for such expertise. By introducing the concept of fractional quality management services, SmartQMS has democratised access to top-tier Quality System specialists for organisations that previously found such expertise out of reach.

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, Garvan Institute of Medical Research, and Telethon Kids Institute.

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

The fractional quality management service:

Provides organisations access to top-tier expertise without the need for a full-time commitment
Enhances both efficiency and adaptability for the company
Offers flexible opportunities for scientifically trained quality professionals who wish to apply their knowledge outside of the laboratory environment.

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What Clients Say

I can’t recommend Keren highly enough for her guidance in helping the UNSW RNA Institute become the first ISO 9001 certified RNA therapeutics manufacturer in Australia. Her knowledge of the QMS and certification landscape, excellent communication, and organized, pragmatic approach was invaluable. What could have been an overwhelming task was instead a manageable and rewarding effort in which we achieved our certification goals within an ambitious timeline. From the initial discussion as to which ISO certification best suited our needs, through to the final audit and follow up, her advice and direction were critical to our success.

Keren has consistently demonstrated outstanding leadership as our Quality Manager at The Ramaciotti Centre for Genomics over the course of several years. She played a crucial role in steering us through the ISO17025 accreditation process, overseeing the implementation of necessary procedures, and has continued to flawlessly manage our Quality Assurance system. Her impressive skill set and unwavering dedication make her a true standout leader. If anyone needs guidance and leadership going through NATA or other accreditation, I would recommend you contact Keren!

Keren has been our Quality Manager at the Recombinant Products Facility for the past four years, and we’re incredibly grateful for her strategic guidance. Thanks to her leadership, we smoothly achieved ISO 9001 certification in 2022, and we've just passed our fourth audit with no findings for the fourth consecutive time! What truly sets Keren apart is her people-centric approach. Rather than providing a one-size-fits-all template, she helped us develop a quality management system tailored to our unique needs. She went to great lengths to educate our team on the value of working within ISO standards, fostering a culture of quality awareness and continuous improvement. Keren instilled a strong sense of ownership by empowering us to build a system that’s both simple and flexible, allowing it to evolve over time. Her approach to making the quality system work for the people who use it is refreshing— With Keren, quality management is not a bureaucratic hurdle but a strategic asset. She has transformed our approach, making the quality system a tool that supports our goals rather than something we simply comply with.

Keren joined the Ramaciotti Centre for Genomics as a consultant when we started the process of working towards accreditation for key genomic applications. She provided expert guidance on how to approach the regulator and how to implement a QMS in what at the time was a core facility supporting a very broad range of research across the country. She prepared the lab team for the task ahead and prepared myself and the managers for the shift in thinking that is required as you move to towards accreditation. Keren's calm, considered and ordered approach, expertise and experience in all things quality and excellent communication skills make her a trusted colleague and advisor. Her unique skillset was invaluable and under her guidance the Centre successfully obtained and maintained its ISO17025 accreditation.