Accreditation Process

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The AATB Accreditation Process involves the following processes: Apply, Inspect, Evaluate, and Review.

Application

For New Applicants

In order to apply for accreditation, the following qualifications must be met for new applicants:

  • Must be registered with the FDA
  • Must be fully operational and compliant to AATB Standards at least six (6) months prior to the date of the application. 

Once the applicant meets the above qualifications, then the new applicant interest form can be completed online.

AATB's Accreditation Department will use the information provided in the application to determine if an applicant is eligible and ready to apply for accreditation.

For Renewing Applicants

In order to renew accreditation, the following qualifications must be met:

  • Must be registered with the FDA.

Application cycle opens 12 months prior to expiration of accrediation.

Accreditation Department notifies the accredited establishment about their upcoming expiration date.

Establishment confirms the intention to renew and fills out application. Applications are due 9 months prior to expiration of accreditation.

Inspection and Evaluation

On-site inspection is conducted by third party contract inspectors who provide a closing summary to the applicant upon exit.

Accreditation Committee receives and evaluates the blinded inspection report, and then assigns one of the levels listed below;

  • Level A: Pending corrective action, the applicant demonstrates adequate quality systems and compliance with AATB Standards.
  • Level B: Applicant's quality system and compliance with AATB Standards must be improved with corrective actions and a verification inspection.
  • Accredit: Applicant’s general operation and procedures were found to be in compliance with the Association's requirements for accreditation at the time of its review.
  • Suspension/Denial: Applicant has not adequately corrected any identified nonconformities, does not meet current AATB Standards, or does not have an adequate quality system. Suspension may last for up to 90 days. Applicant has the option to appeal the decision through a hearing panel.

Review Process

  1. Applicant receives report and Committee decision.
  2. Applicant provides responses to any nonconformities noted.
  3. Committee reviews the applicant's CA/PA (correction action/preventative action) responses.
  4. Committee will decide to accredit, request additional information, deny, or suspend accreditation.
  5. The review cycle continues until the committee reaches a decision to accredit, suspend, or deny accreditation.