ISoOR-AB Accreditation for Organoid Biobanks

What is ISoOR-AB Accreditation?

The International Society of Organoid Research Accreditation Body (ISoOR-AB) accredits Conformity Assessment Bodies (CABs) that demonstrate competence in assessing organoid biobanks according to the ISoOR International Standard for Organoid Biobanking (ISoOR-ISOB). CABs conduct assessments on organoid biobanks to ensure quality, reliability, and compliance with ISoOR-ISOB standards.

Organoid biobanks are the applicants seeking accreditation. Accredited CABs carry out the assessment process, and the accreditation certificate is awarded to the organoid biobank based on the CAB’s evaluation.

Accreditation applies to organoid biobanks handling biological materials from multicellular organisms (e.g., human or animal-derived organoids) and microorganisms.

Accreditation Steps

Application Instructions for Organoid Biobanks

Organoid biobanks seeking ISoOR-AB accreditation should follow these steps:

1. Download Required Documents

• ISoOR Accreditation Pathway for Organoid Biobanks (ISoOR-ISOB)
• ISoOR_ISOB_Accreditation_Checklist
• ISoOR-ISOB Pre-Assessment Questionnaire
• ISoOR-International Standards for Organoid Biobanking (ISoOR-ISOB) 1st Edition

2. Complete the Application Form

Fill out the ISoOR-AB Accreditation Application Form with details about your organoid biobank, scope of accreditation, and quality management system.

3. Attach Supporting Documentation

• Quality manual and operational procedures
• Personnel qualifications and training records
• Scope of activities and biosafety documentation

4. Submit Your Application

Submit the completed application and supporting documents via the ISoOR-AB portal or email to accreditation@isoor-ab.org. Pay the application fee as applicable.

5. Assessment by Accredited CAB

An ISoOR-AB accredited CAB will conduct the assessment of your biobank according to ISoOR-ISOB standards. Optional preliminary assessments may be available.

6. Accreditation Decision

After the CAB submits the assessment report to ISoOR-AB, corrective actions (if any) may be requested. Once requirements are met, the organoid biobank will receive its accreditation certificate.

Tips for a Successful Submission

• Review the ISoOR Accreditation Pathway to understand each step.
• Use the Pre-Assessment Questionnaire to self-check compliance.
• Ensure all documents are complete and up to date.

Featured Resources

• ISoOR Accreditation Procedures Manual – Full accreditation process for CABs assessing organoid biobanks.
• Implementation Guide for CABs – Guides CABs on implementing ISoOR-ISOB requirements.
• ISoOR-International Standards for Organoid Biobanking (ISoOR-ISOB) 1st Edition – Standard specifying competence and impartiality requirements.

Governance and Impartiality Documents

• ISoOR-AB Committee Governance Charter
• ISoOR-AB Impartiality Policy

These documents ensure transparency and impartiality in accreditation activities, aligned with ISO/IEC 17011.

Contact an Expert

Accreditation Manager, ISoOR-AB

Training Opportunities

Learn how to implement accreditation requirements for organoid biobanks per ISoOR-ISOB. Register for online or in-person courses led by experts.