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EBAA

EBAA

We restore sight worldwide

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        • EBAA is the nationally-recognized accrediting and standards setting body for eye banks.

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EyeQualify

Overview for Vendors

Our Vendor Quality Documentation Review Program is a centralized documentation review initiative created to make it easier for eye banks across the community to access standardized quality and regulatory information from key suppliers like you. Rather than responding to the same requests multiple times, vendors submit required documentation to EBAA, and we share it securely with participating eye banks.

This program is documentation-based only and should not be interpreted as a certification, endorsement, accreditation, or regulatory approval of your products or services.


Why Your Participation Matters

By participating in this program and completing the vendor submission form, you help eye banks:

  • Access key quality system documentation and regulatory information efficiently.
  • Reduce repetitive documentation requests to your team.
  • Spend less time on administrative follow?up so they can focus on internal quality processes.

Vendor Benefits

Participating in this program provides your organization with several tangible advantages:

  1. Time Savings โ€“ Submit your documentation and reduce repeated requests from multiple eye banks.
  2. Improved Efficiency โ€“ Streamline your communication and provide a single, centralized point of reference for participating EBAA member eye banks.
  3. Enhanced Visibility โ€“ Your companyโ€™s quality and regulatory information is shared securely with qualified eye bank professionals, increasing trust and transparency.
  4. Support for Compliance โ€“ By providing accurate documentation in a standardized format, you help eye banks meet their internal quality and regulatory review requirements.
  5. Relationship Building โ€“ Strengthen partnerships with eye banks by demonstrating a proactive commitment to quality and documentation excellence.

What We Ask from You

As a participating vendor, we ask that you provide:

  • Copies of your current quality system documentation.
  • Regulatory information pertinent to your products or services.
  • Any supporting materials that help eye banks understand your compliance and quality processes.

Once submitted, this documentation will be reviewed and stored in a secure portal for use by our member eye banks.


Next Step: Vendor Submission Form

Please complete the vendor form below to begin your submission.

Vendor Quality Documentation Review Program

Organization Information

This assessment is completed by:(Required)

Quality Assurance Program Details

Please complete the following questions providing explanation and/or supporting documentation, as applicable. Questions should be answered in relation to the services provided to eye banks. Therefore, not all questions will apply to your organization. If you answer “No” to any of the questions below, an explanation is required.
Is a Quality Assurance (QA) program in place?(Required)
Are audits performed for facilities, equipment, labeling, storage, and processes?(Required)
Max. file size: 256 MB.
Are audit findings documented and addressed through corrective/preventive actions, and are the actions confirmed to be effective?(Required)
Is there a staff orientation and training program?(Required)
Are staff competencies periodically assessed and documented?(Required)
Are SOPs controlled, current, and formally approved?(Required)
Is there a documented process for handling deviations, complaints, incidents, or issues?(Required)
Are deviations and incidents reviewed and corrective/preventive actions implemented and confirmed to be effective?(Required)
Is there a process for notifying regulatory agencies when required?(Required)
Are critical processes validated and documented?(Required)
Max. file size: 256 MB.
Is revalidation performed after changes to processes, equipment, or systems?(Required)
Are applicable systems (equipment, software, assays) validated and reviewed?(Required)
Is the facility suitable to prevent contamination and ensure safe operations?(Required)
Are environmental conditions monitored (temperature, cleanliness, microorganisms if relevant)?(Required)
Are records of environmental monitoring maintained?(Required)
Is equipment appropriate and qualified for its intended use?(Required)
Are procedures in place for operation, cleaning, maintenance, and calibration?(Required)
Are critical equipment maintenance and calibration performed on schedule?(Required)
Is critical equipment periodically tested for performance and out-of-spec results addressed?(Required)
Are QA checks performed on outputs (labeling, packaging, test results)?(Required)
If sterilization is performed, is there a validated monitoring process and are failures addressed?(Required)

Please provide copies of the following, as applicable:

Max. file size: 256 MB.
Max. file size: 256 MB.
Max. file size: 256 MB.
Max. file size: 256 MB.
Max. file size: 256 MB.
Max. file size: 256 MB.
Max. file size: 256 MB.
Max. file size: 256 MB.

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fax 202.429.6036

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