The first Accreditation Body for Organoid Biobanks
Setting standards for organoid biobanks worldwide with ISO/IEC 17011 compliance
ISO/IEC 17011 Aligned
Independent Governance Structure
Global Accreditation Scope
Organoid-Specific Standards
About Isoor-AB
ISoOR-AB is the world’s first accreditation body dedicated to organoid biobanks. Founded by the International Society of Organoid Research (ISoOR), it operates as a fully independent organization, ensuring impartiality, transparency, and integrity in all its activities.
In full compliance with ISO/IEC 17011, ISoOR-AB accredits Conformity Assessment Bodies (CABs) that evaluate organoid biobanks against the ISoOR International Standard for Organoid Biobanking (ISoOR-ISOB). Its work includes defining assessment criteria, conducting audits, and verifying ongoing compliance, supporting quality, reliability, and global recognition for accredited biobanks.
ISoOR-AB’s governance and operational procedures are carefully designed to maintain complete independence and operational transparency. Robust safeguards, clear procedures, and comprehensive documentation prevent conflicts of interest and ensure credibility in every accreditation decision.
Today, ISoOR-AB serves as a trusted authority in organoid biobanking, promoting excellence in research, fostering global standards, and building confidence in the practices of accredited biobanks worldwide.
Operating in accordance with ISO/IEC 17011, ISoOR-AB ensures impartial, transparent, and globally recognized accreditation of organoid biobanks.
Our Services
Accrediting organoid biobanks with trusted standards.
The ISoOR-AB Accreditation process ensures that Conformity Assessment Bodies (CABs) are fully competent to evaluate organoid biobanks against the ISoOR-ISOB standard. It involves a thorough review of each CAB’s policies, procedures, technical expertise, and resources, followed by on-site or remote assessments of their operational practices and staff qualifications.
Accreditation decisions are made by an impartial ISoOR-AB committee, ensuring transparency and objectivity. Accredited CABs are recognized for their ability to reliably certify organoid biobanks, with periodic reassessments maintaining ongoing compliance and high standards of quality, integrity, and scientific rigor.
ISoOR-AB conducts comprehensive and systematic evaluations of Conformity Assessment Bodies (CABs) to verify their competence, consistency, and impartiality in assessing organoid biobanks. These evaluations include detailed reviews of CAB procedures, documentation, technical expertise, and personnel qualifications, ensuring they can reliably apply the ISoOR-ISOB standard in practice.
Assessment activities may involve on-site or remote observations, interviews, and sampling of CAB assessment reports to confirm adherence to ISO/IEC 17011 principles and best practices. Findings are analyzed by an impartial evaluation team, and recommendations are made to ensure any gaps are addressed. Through this process, ISoOR-AB guarantees that CABs operate with the highest levels of objectivity, accuracy, and scientific rigor, maintaining confidence in the certification of organoid biobanks worldwide.
ISoOR-AB provides structured training and guidance to Conformity Assessment Bodies (CABs) and organoid biobanks to ensure a consistent and accurate interpretation and application of the ISoOR-ISOB standard. Training programs cover all aspects of the standard, including quality management, sample handling, data integrity, and ethical compliance, while emphasizing competence, impartiality, and scientific rigor.
These programs combine workshops, practical exercises, and expert-led guidance to help CABs and biobanks implement best practices in their operations. By reinforcing knowledge, skills, and understanding of ISO/IEC 17011 principles, ISoOR-AB ensures that assessments and operations are carried out with consistency, transparency, and high professional standards, fostering confidence in the accreditation process across the organoid research community.
For assistance with training, reach out to us at info@isoor-ab.org
Accreditation Process
1- Required Documents
Quality manual and operational procedures
Personnel qualifications and training records
Scope of activities and biosafety documentation
2- Complete the Application Forms
3- Attach Supporting Documentation
Fill out the relevant application documents listed in Step 1 with accurate information about your organoid biobank, including its scope of accreditation and quality management system
4- Submit your Application
Submit the completed application and supporting documents via the ISoOR-AB portal or email to info@isoor-ab.org. Pay the application fee as applicable
5- Assessment by Accredited CAB
An ISoOR-AB designated CAB will conduct the assessment of your organoid biobank according to ISoOR-ISOB standards. Optional preliminary assessments may be available
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.
6- Accreditation Decission
Organizational Structure
&
Governance Framework
The organizational structure of ISoOR-AB is designed to ensure clear allocation of responsibilities, transparency in decision-making, and effective operational control. A well-defined governance framework is essential to maintain consistency, accountability, and impartiality across all accreditation activities.
In alignment with ISO/IEC 17011, ISoOR-AB establishes independent committees, documented procedures, and defined roles that prevent conflicts of interest and safeguard objective evaluations. This structure supports the separation of authority between governance, operational, and decision-making functions, reinforcing credibility and trust in the accreditation process.
It also ensures that ISoOR-AB operates independently from its founding body, International Society of Organoid Research, thereby upholding the principles of impartiality and integrity required by international standards.
Together, the organizational structure and governance framework provide the foundation for a robust, transparent, and internationally recognized accreditation system.er, the organizational structure and governance framework provide the foundation for a robust, transparent, and internationally recognized accreditation system.
Governance and Independence Framework Documentation (ISO/IEC 17011 Compliance)
ISoOR-AB Accreditation Policy
The ISoOR-AB organizational chart defines roles, reporting lines, and functional separation, ensuring impartiality and independence in alignment with ISO/IEC 17011 and clear distinction from International Society of Organoid Research.
ISoOR-AB Governance and Decision-Making
ISoOR-AB maintains a transparent governance framework ensuring impartial, consistent accreditation of CABs. Roles include the Board of Directors, Accreditation Committee, Technical Expert Panels, Independent Appeals Panel, and Secretariat. CAB applications are reviewed, assessed, and decided upon, with appeals handled independently, providing high-level oversight while protecting internal deliberations and individual identities.
ISoOR-AB Committee Governance Charter
ISoOR, the parent and founding organization of ISoOR-AB, advances organoid research and established ISoOR-ISOB, the first international standard for organoid biobanking (March 2025). Operating independently, ISoOR-AB accredits CABs against this standard, ensuring quality, impartiality, and global recognition through ISO/IEC 17011-aligned governance, robust procedures, and international stakeholder engagement.
ISoOR-AB Complaints and Appeals Procedure
ISoOR-AB provides impartial procedures for complaints and appeals from CABs or stakeholders. Concerns are submitted via email or online form, reviewed by designated panels, and decisions communicated transparently. Confidentiality is maintained, and corrective actions are implemented when required, ensuring fairness, accountability, and ISO/IEC 17011 compliance.
ISoOR-AB Impartiallity Policy
The ISoOR-AB Impartiality Policy explains how the ISoOR-AB maintains unbiased, independent, and transparent operations. It describes the rules for managing conflicts of interest, structuring committees to ensure balanced representation, conducting accreditation decisions based solely on objective evidence, and protecting confidentiality, all in alignment with ISO/IEC 17011 and industry best practices.
Legal Status & Ownership
ISoOR-AB is an independent, non-profit legal entity
Ownership: ISoOR-AB is a standalone organization, founded by the International Society of Organoid Research (ISoOR), but operates independently of ISoOR.
Legal authority: ISoOR-AB has the legal capacity to enter contracts, employ staff, and perform accreditation activities for Conformity Assessment Bodies (CABs).
Accountability: The organization’s Board of Directors oversees compliance with legal obligations and ensures its independence and non-profit status is maintained.
ISoOR-AB and ISoOR: Independence and Complementarity
The ISoOR-AB Accreditation Policy defines the framework for accrediting Conformity Assessment Bodies (CABs) assessing organoid biobanks. It ensures impartiality, transparency, confidentiality, and international alignment, follows ISO/IEC 17011, and establishes governance, accreditation processes, data protection, complaints handling, and recognition standards, reinforcing independence from ISoOR standard-setting activities.
FAQ
What is ISOOR-AB?
ISoOR-AB is the accreditation body of the International Society for Organoid Research (ISoOR). It operates according to ISO/IEC 17011 standards, which define requirements for accreditation bodies. ISoOR-AB ensures that organizations it accredits follow high-quality, transparent, and internationally recognized processes, providing credibility and trust in organoid research services.
Why align with ISO/IEC 17011?
Aligning with ISO/IEC 17011 ensures that ISoOR-AB follows consistent, transparent, and impartial accreditation practices. This international standard sets the requirements for accreditation bodies, helping ISoOR-AB operate with credibility and reliability. By adhering to ISO/IEC 17011, the accreditations it grants are recognized worldwide, fostering trust among laboratories, researchers, and stakeholders in the organoid research community.
Where can I find the documents?
All governance documents are available here as downloadable PDFs for easy reference.
Who uses these documents?
These documents are used by accreditation bodies and auditors to ensure compliance with international standards. They are also used by organoid biobank applicants to prepare their applications, demonstrate adherence to requirements, and align their practices with globally recognized standards.
Are updates frequent?
Updates occur as standards evolve to maintain alignment.
How do I stay informed about changes?
Subscribe to notifications or check back regularly for the latest documents.
Why align with ISoOR‑ISOB?
Alignment with ISoOR‑ISOB ensures that ISoOR-AB’s accreditation process is specifically tailored to organoid biobanking and research. It provides a clear framework of best practices, technical requirements, and evaluation criteria for applicants, promoting consistency, transparency, and high-quality standards in organoid biobanks worldwide.