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LifeNet Health Achieves ISO 9001:2015 Certification

LifeNet Health, a prominent force in regenerative medicine, has proudly announced that its Assay Services Laboratory located in Kalamazoo, Michigan, has successfully attained ISO 9001:2015 Quality Management System (QMS) certification. This significant milestone strengthens the company's role in supporting pharmaceutical and biotechnology partners in crafting safe and effective solutions aimed at improving health outcomes and expanding access to healthcare innovations.

The ISO 9001:2015 certification process was carried out by BSI, an esteemed global certifying body. The audit evaluated the laboratory's quality management processes against the stringent requirements of the ISO 9001:2015 standard, along with BSI's operational terms and LifeNet Health's established policies and practices. By adhering to a structured, risk-based quality management system, LifeNet Health enables its collaborators to produce reliable and reproducible data, which is crucial in supporting regulatory submissions. This approach minimizes development risks and accelerates the journey from initial discovery to tangible patient impacts.

The auditing process was conducted in two phases, focusing on the effectiveness of the laboratory's quality management system. It assessed how well these systems can maintain consistent operations, deliver dependable data, and drive continuous improvements across non-clinical research activities.

Rony Thomas, the President and CEO of LifeNet Health, emphasized the significance of this certification, stating, "This certification reflects our commitment to building quality systems that empower our clients to advance critical research with confidence." He added, "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 audit's scope included a review of LifeNet Health's documented quality management systems, particularly as they relate to non-clinical laboratory research and analytical services. This encompasses research and testing in the fields of materials science and pharmaceutical safety. Furthermore, the laboratory operates in alignment with the 21 CFR Part 58 Good Laboratory Practice (GLP) requirements for non-clinical studies, thereby ensuring data integrity, traceability, and readiness for audits.

ISO 9001:2015 is an internationally acknowledged standard that underscores the importance of quality management systems, prioritizing customer focus, risk-based thinking, and a commitment to continuous improvement. For LifeNet Health's partners in the pharmaceutical and biotechnology sectors, this certification not only solidifies trust in research quality but also fosters collaborations that push the boundaries of innovation—ultimately enhancing patient outcomes and widening access to healthcare globally.

About LifeNet Health

LifeNet Health continues to be a leader in the field of regenerative medicine, pushing the envelope to provide superior healing solutions. The organization delivers cutting-edge transplant and cellular solutions designed to support healthcare providers and energize scientific research. With a vision focused on improvement and innovation, LifeNet Health has positively impacted the lives of millions, all while respecting the legacies of donor heroes and their families. For more information, visit www.lifenethealth.org.