LifeNet Health Achieves ISO 9001:2015 Certification, Advancing High-Quality Research That Expands Access to Healthcare Innovation
February 4, 2026 (Virginia Beach, VA) – LifeNet Health announces that its Assay Services Laboratory in Kalamazoo, Michigan, has successfully completed an ISO 9001:2015 Quality Management System (QMS) certification, strengthening its ability to support pharmaceutical and biotechnology partners in developing safe, effective solutions that improve lives and expand access to healthcare.
The ISO 9001:2015 certification audit was conducted by BSI, a globally recognized certification body, and evaluated the laboratory’s quality management system against the requirements of the ISO 9001:2015 standard, BSI’s Terms of Service, and LifeNet Health’s established policies and procedures.
By operating under a structured, risk-based quality management system, LifeNet Health enables its research partners to generate reliable, reproducible data that supports regulatory submissions, reduces development risk, and helps accelerate the path from discovery to patient impact.
The audit was performed in two phases and assessed the effectiveness of the laboratory’s quality management system in supporting consistent processes, reliable data generation, and continual improvement across non-clinical research activities.
“This certification reflects our commitment to building quality systems that empower our clients to advance critical research with confidence,” said Rony Thomas, President and CEO of LifeNet Health. “When pharmaceutical and biotech organizations can rely on disciplined, transparent, and repeatable research processes, they are better positioned to bring innovative therapies to the people who need them most.”
The scope of the audit included LifeNet Health’s documented QMS as it applies to non-clinical laboratory research and analytical services, including research and development testing in materials science and pharmaceutical safety. The laboratory’s operations are also aligned with 21 CFR Part 58 Good Laboratory Practice (GLP) requirements for non-clinical studies, supporting data integrity, traceability, and audit readiness.
ISO 9001:2015 is an internationally recognized standard for quality management systems, emphasizing customer focus, risk-based thinking, and continuous improvement. For LifeNet Health’s pharmaceutical and biotechnology partners, this certification reinforces confidence in research quality and collaboration, helping advance innovations that improve patient outcomes and broaden access to healthcare worldwide.
About LifeNet Health
As a global leader in regenerative medicine, LifeNet Health continues to push the boundaries to give healing every advantage. The organization offers groundbreaking transplantation and cellular solutions that support healthcare providers and powers scientific research. This forward-focused approach has improved life for millions of patients, all while honoring donor heroes and their families. For more information, visit: www.lifenethealth.org.