At Quanterix, quality is foundational to everything we do. Our mission to transform precision health through ultrasensitive biomarker detection depends on the rigor, reliability, and consistency of our processes, products, and services. We design our quality management system (QMS) to meet the highest global standards and to ensure confidence in every instrument, assay, and software solution.
A Culture Built on Quality
Quality is not a single department. Quality is a shared responsibility embraced across our organization. From research and development to manufacturing, product support, and customer experience, every team member is committed to operational excellence. We foster a culture where continuous improvement, scientific integrity, and regulatory compliance guide our daily decisions.
Certified to international standards
Quanterix maintains globally recognized quality certifications that demonstrate our dedication to robust, well‑controlled, and continuously improving processes.
ISO 9001 Certified
Our facility at 900 Middlesex Turnpike, Billerica, MA, is certified to ISO 9001 for the development, manufacturing, instrument and software engineering, and engineering of assay instruments.
This certification reflects our commitment to customer satisfaction, process integrity, and consistent quality throughout product development and production.
ISO 13485 Certified
Quanterix is also certified to ISO 13485 for the design and development, manufacture, installation, and servicing of reagents, test kits, instruments, and software for neurological immunoassays.
This standard demonstrates our adherence to stringent regulatory and quality requirements essential for the development of medical and diagnostic‑related products.
Our quality principles
Customer focus
We listen to and partner closely with our customers—researchers, clinicians, industry leaders—to ensure our products meet the evolving needs of precision biomarker analysis.
Scientific and data integrity
Every data point matters. Our quality practices ensure that the instruments and assays we deliver support the highest levels of accuracy, reproducibility, and analytical performance.
Operational excellence
We continuously evaluate and optimize our processes through risk‑based thinking, root‑cause analysis, and proactive quality planning.
Compliance and traceability
Our systems ensure full traceability, controlled documentation, and compliance with applicable global regulations and standards.
Continuous improvement
We leverage customer feedback, internal audits, quality metrics, and employee expertise to constantly refine our operations and elevate product quality.
Committed to advancing precision health
Quanterix is dedicated to enabling breakthroughs in research and healthcare through unmatched analytical sensitivity. Our commitment to quality ensures that our customers can trust the performance of our technology as they pursue discoveries in neurology, oncology, infectious disease, inflammation, and beyond.
By upholding rigorous quality standards, we empower the scientific community to generate insights that improve earlier detection, better patient monitoring, and transformative clinical outcomes.