AABB Quality Management Systems Certification is an independent assessment of a facility's quality management system against AABB's Quality System Essentials, offered to organizations that handle cellular or biological materials but are not eligible for AABB accreditation. This service is for contract manufacturers, contract processing labs, cold-chain providers, biobanks and similar organizations that AABB has found eligible. Integral Healthcare Solutions (IHS) drafts the quality manual and controlled documents for the certification; your technical staff verify every activity.
Last reviewed: October 2026. AABB's Quality Management Systems Certification page checked on October 2, 2026.
What is AABB Quality Management Systems Certification?
AABB describes it this way: "The AABB Quality Management Systems Certification provides structured, independent assessment of a facility's quality management infrastructure." It offers "facilities and organizations who are not eligible for AABB accreditation an alternative pathway to demonstrate alignment with AABB's quality management system requirements" (AABB QMS Certification).
The assessment framework is AABB's Quality System Essentials, which AABB calls "a structured framework covering personnel, equipment, process control, documents and records, information management, occurrence management, assessments, and process improvement" (AABB). The AABB page links a white paper but does not name a separate requirements document or version; this page does not cite one.
The certification has a defined boundary. AABB states: "This certification is distinct from AABB accreditation and does not evaluate product safety, efficacy, regulatory compliance or clinical outcomes" (AABB).
AABB lists these steps: "Pre-application eligibility determination", "Completion of onboarding process with self-assessment", "On-site assessment", "Complete corrective actions based on assessment findings", "Final approval and issuance of Quality Management Systems Certification", and "Ongoing maintenance for recertification on a two-year cycle" (AABB).
Who needs it and what triggers it
Eligibility is AABB's decision, made in the pre-application step. AABB names two groups of eligible facilities: those that "Handle cellular materials but are not eligible for existing AABB accreditation programs," and "Facilities providing Platelet Rich Plasma (PRP) under the practice of medicine" (AABB).
- Vendors in the cell and tissue supply chain. AABB's examples "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" (AABB).
- PRP providers working under the practice of medicine (AABB). AABB says PRP facilities "may be eligible if the services are provided outside the perioperative setting"; AABB decides in its pre-application step.
Two groups are outside the program. Facilities eligible for an existing AABB accreditation: "Accreditation remains the required path for facilities eligible for AABB's existing accreditation programs." And clinical administering sites: "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)" (AABB).
How IHS helps
IHS starts after AABB has determined your eligibility. The process:
- Gap assessment. A comparison of your current quality system with each Quality System Essential: personnel, equipment, process control, documents and records, information management, occurrence management, assessments and process improvement.
- Document and evidence mapping. Each element tied to the procedure or record that shows it, set up as the evidence for the onboarding self-assessment.
- Drafting. IHS drafts the quality manual, controlled documents, occurrence management procedures and internal-assessment records for your technical and regulatory staff to review and approve.
- Mock assessment. A review against the Quality System Essentials before AABB's on-site assessment, listing what is missing.
- Readiness support. If the assessment produces findings, IHS drafts corrective actions for your staff to review and submit.
What you supply: AABB's eligibility determination, your current processes and records, and technical and regulatory staff who verify every activity and claim in the documents. Your organization applies and submits. For related programs, see the accreditation consulting practice.
The limit: the certification covers the quality system only. It makes no statement about product approval, safety or effectiveness, and IHS makes none.
What to have ready
The element names below are AABB's Quality System Essentials. The records listed under each are IHS's suggestion of the evidence to gather, not an AABB list.
- AABB's answer to the "Pre-application eligibility determination" (AABB).
- Personnel records: roles, qualifications and training, for the personnel element of the Quality System Essentials (AABB).
- Equipment records: inventory, qualification and maintenance, for the equipment element (AABB).
- Written procedures for each operation you perform, for process control (AABB).
- A document control system and record retention practice, for documents and records (AABB).
- A description of the systems that hold your data, for information management (AABB).
- Deviation and nonconformance logs, for occurrence management (AABB).
- Internal audit or assessment records, for assessments (AABB).
- Corrective action and improvement records, for process improvement (AABB).
- A named owner for the onboarding self-assessment and for "Complete corrective actions based on assessment findings" (AABB).
To go through the list with IHS, book the introductory call below.
How it compares
The table sets out the options the sources name. AABB decides which of its programs you are eligible for.
| Option | What the sources say |
|---|---|
| AABB QMS Certification | For facilities not eligible for AABB accreditation; assesses the quality management system; "does not evaluate product safety, efficacy, regulatory compliance or clinical outcomes" (AABB). |
| AABB accreditation | For facilities eligible for an existing AABB accreditation program, "Accreditation remains the required path" (AABB). |
| FACT accreditation | FACT says it "supports cellular therapy programs worldwide" (FACT). The sources reviewed do not say whether it fits non-clinical vendors. |
| ISO 9001 or ISO 20387 certification | Other quality certifications a vendor or biobank may consider. This page does not summarize their requirements. |
| Customer audits only | The sources reviewed do not address this option. |
What it costs
AABB does not publish a fee schedule for this certification on the pages we reviewed. The certification is not listed in the 2026 AABB Institutional Dues Fees document (read October 2, 2026). Verify current fees with AABB. IHS scopes each engagement after a free introductory call.
What this is not
- The certification is not AABB accreditation, and it is not a statement that a product is approved, safe, effective or compliant with FDA rules. IHS makes no such claim.
- IHS is not AABB, does not decide eligibility and does not grant or predict certification. IHS drafts; your organization applies and submits.
- This page is not legal or regulatory advice.
Frequently asked questions
What is AABB Quality Management Systems Certification?
It is AABB's structured, independent assessment of a facility's quality management infrastructure. It gives organizations that are not eligible for AABB accreditation another way to show alignment with AABB's quality management system requirements.
Is my organization eligible if we are a CDMO, contract processing lab, biobank or cold-chain provider?
AABB lists CDMOs, contract processing labs, logistics and cold-chain providers, and biobanks and repositories as examples of eligible facilities. AABB makes the eligibility determination before you apply.
How is QMS Certification different from AABB accreditation?
AABB says the certification is distinct from accreditation. Facilities eligible for an existing AABB accreditation program must take the accreditation path.
Can a platelet-rich plasma clinic get AABB QMS Certification?
AABB lists facilities providing platelet-rich plasma under the practice of medicine as potentially eligible. AABB says PRP facilities "may be eligible if the services are provided outside the perioperative setting"; AABB decides in its pre-application step.
What are AABB's Quality System Essentials and what evidence do they require?
AABB describes them as a framework covering personnel, equipment, process control, documents and records, information management, occurrence management, assessments and process improvement. The AABB page does not publish an element-by-element evidence list, so IHS maps your records to each element during the gap assessment.
What are the steps and timeline from eligibility determination to certification?
AABB lists eligibility determination, onboarding with self-assessment, on-site assessment, corrective actions, and final approval and issuance. The AABB page does not state a timeline.
How often must the certification be renewed?
AABB lists ongoing maintenance for recertification on a two-year cycle.
Does AABB QMS Certification mean our product is approved, safe or FDA compliant?
No. AABB states the certification does not evaluate product safety, efficacy, regulatory compliance or clinical outcomes.