AABB Launches New Quality Management Systems Certification

AABB is pleased to announce the launch of its new Quality Management Systems Certification, offering independent validation of quality systems in organizations handling cellular and tissue-based products or providing certain other services.  

As the diversity of organizations in the blood and biotherapies ecosystem continues to expand, experts have warned of a “quality gap,” noting that facilities in the non-accredited segment of the value chain often operate with varying degrees of quality system maturity or without access to the external validation benchmarks that accredited programs provide. 

AABB’s new Quality Management Systems Certification is designed to address the “quality gap” by offering a structured, independent assessment of a facility’s quality management infrastructure. Facilities that achieve certification must demonstrate commitment to operational accountability, transparency and effective systems supporting patient safety, while maintaining quality systems that align with AABB's Quality Systems Essentials. 

The Quality Management Systems Certification is available only to facilities and organizations that are not eligible for traditional AABB accreditation, offering a new option for such facilities to demonstrate operational excellence. The scope of this certification program does not extend to the administration of products and therapies. Examples of eligible facilities include contract development and manufacturing organizations (CDMOs), contract processing labs, logistics and cold-chain providers, facilities offering platelet-rich-plasma services outside of the perioperative setting, biobanks and repositories, therapeutic apheresis operations such as plasma exchange services, and other specialized facilities that manage biological products but fall outside traditional accreditation scopes.  

Those interested in learning more about AABB’s new Quality Management Systems Certification are invited to complete the inquiry form; an AABB staff member will follow up to all inquiries.