As the number and diversity of organizations handling cellular and tissue-based products expands, consistent external assessment of quality systems has not kept pace, creating a gap that AABB’s new Quality Management Systems Certification is designed to address.
The AABB Quality Management Systems Certification provides structured, independent assessment of a facility's quality management infrastructure. This certification reflects disciplined quality systems aligned with AABB's Quality Systems Essentials and reinforces an organization's commitment to operational accountability, transparency and patient safety.
This program is one of several offerings within AABB's quality portfolio, providing independent, third-party assessment of quality management systems for facilities seeking structured oversight as part of their operational development. It works in tandem with AABB's internationally recognized accreditation program, offering facilities and organizations who are not eligible for AABB accreditation an alternative pathway to demonstrate alignment with AABB's quality management system requirements.
In a field where process failures can directly affect patient outcomes, quality management systems are foundational to every aspect of handling biological materials - including the collection, processing, storage, testing, preparation and dispensing of such materials.
Disciplined systems help organizations:
This certification program focuses on how quality systems are implemented - not specific products, therapeutic claims or regulatory compliance status.
The AABB Quality Management Systems Certification is designed for facilities and organizations that:
Examples of eligible facilities include contract development and manufacturing organizations (CDMOs), contract processing labs, logistics and cold-chain providers, biobanks and repositories, and other specialized facilities that manage biological products but fall outside traditional accreditation scopes. In addition, facilities offering platelet-rich plasma services may be eligible if the services are provided outside the perioperative setting.
This program is not intended for clinical sites that directly administer cellular therapies to patients, including products regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps).
To inquire about your facility's eligibility, please submit your interest via the inquiry form below.
AABB advances quality and safety in transfusion medicine and biotherapies, with more than 1,300 accredited facilities throughout the world. Since 1947, AABB has developed standards-based frameworks to bring consistency and oversight to complex biologic systems.
As cellular therapies expand into new settings and organizations, AABB's experience provides a foundation for evaluating quality systems in environments where traditional oversight models do not apply. Central to this work is AABB's Quality System Essentials, a structured framework covering personnel, equipment, process control, documents and records, information management, occurrence management, assessments, and process improvement. The QMS Certification applies these established standards to facilities seeking independent quality system assessment outside the scope of full accreditation.
The AABB Quality Management Systems Certification:
This certification is distinct from AABB accreditation and does not evaluate product safety, efficacy, regulatory compliance or clinical outcomes.
Organizations that achieve AABB's Quality Management Systems Certification gain:
Independent Assessment
An objective assessment by trained AABB assessors of your quality management system's structure, documentation and ongoing performance.
Reinforced Quality Culture
External recognition supports continuous improvement and operational discipline in daily practices.
Credibility and Transparency
Signal to stakeholders - including customers, partners and regulators - that your organization maintains disciplined quality systems.
Recognition of Leadership
Facilities that voluntarily pursue structured oversight demonstrate a leadership mindset and commitment to quality infrastructure across the cellular therapy ecosystem.
The AABB Quality Management Systems Certification is built on core principles to ensure credibility and protect public trust:
These principles help ensure the certification supports operational rigor without overextending into clinical or regulatory interpretation.
Facilities seeking AABB's Quality Management Systems Certification will go through a multi-step process:
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