Yantai, Shandong, China — 31 July 2026 — ISoOR-AB, the independent accreditation initiative established by the International Society of Organoid Research (ISoOR), conducted its first on-site assessment under the ISoOR-AB pilot accreditation programme at Shandong Qilu Organoid Biobank, a wholly owned subsidiary of AimingMed.
The assessment marks the first use of the ISoOR International Standard for Organoid Biobanking (ISoOR-ISOB) in an accreditation assessment. ISoOR-ISOB is the first international standard developed specifically for organoid biobanks.
Organoid technologies are advancing from basic research into drug discovery and development, precision medicine, disease modelling, regenerative medicine, and the evaluation of New Approach Methodologies (NAMs). As these applications expand, increasing demands are being placed on the biological materials, models, processes, and data that support them.
Quality frameworks for organoid biobanking are also evolving; however, practices remain highly variable across institutions. In addition, many research institutes and healthcare organizations are interested in establishing organoid biobanks but lack the necessary expertise, standardized protocols, and operational experience to develop and maintain high-quality biobanking systems.
Differences between institutional practices can affect the reproducibility and comparability of results and may create challenges for multicentre research, cross-institutional data sharing, and international scientific collaboration.
As regulatory authorities increasingly consider how organoid-based evidence may contribute to drug development and regulatory decision-making, attention is extending beyond the scientific potential of the technology to the reliability of the materials, methods, processes, and data through which evidence is generated.
ISoOR-ISOB was developed to support greater quality, consistency, and scientific rigour in organoid biobanking. The standard establishes a technical and managerial framework covering the full operation of an organoid biobank, including sample collection and processing, organoid resource preservation, quality control, data management, ethical requirements, and traceability.
Its purpose is to support the transition from locally developed procedures towards more harmonised and internationally understood practices，and provide guildlines and framwors for newly established organoid biobanks.
Standards deliver their full value when conformity with their requirements can be independently evaluated. Accreditation provides a structured mechanism for assessing whether a biobank’s quality management system and technical capabilities meet the requirements of the standard, and whether those requirements can be maintained through sustained operation and continual improvement.
ISoOR-AB was established by ISoOR, to conduct independent accreditation activities against ISoOR standards. Its assessment and accreditation decision-making processes are designed with reference to the relevant principles of ISO/IEC 17011, including impartiality, transparency, consistency, and functional independence in accreditation decisions.
The pilot accreditation programme represents the first phase of this work. It applies ISoOR-ISOB in an operational setting, examines whether its requirements can be consistently implemented and assessed, and provides practical experience for the continued refinement of the accreditation process.
The on-site assessment at Shandong Qilu Organoid Biobank was conducted by a multinational panel of experts representing diverse scientific, technical, and translational areas within the organoid field.
Through document review, facility inspection, personnel interviews, observation of operations, and sampling of records, the panel evaluated the biobank’s:
• quality management system;
• end-to-end sample management;
• personnel competence;
• facilities and equipment;
• technical operations;
• data integrity;
• ethical compliance; and
• lifecycle traceability.
The assessment considered both the implementation of individual procedures and the biobank’s capacity to operate consistently, reliably, and in conformity with ISoOR-ISOB over time.
Under the rules of the pilot accreditation programme, should Shandong Qilu Organoid Biobank be found to meet all applicable requirements, ISoOR-AB will issue the world’s first pilot accreditation certificate to an organoid biobank assessed under ISoOR-ISOB of the conclusion of the on-site assessment.
Unlike traditional accreditation bodies that primarily serve as evaluators, ISoOR Accreditation Body (ISoOR-AB) adopts a collaborative and developmental approach to accreditation. Our role is not to act as a judge, but as a partner in quality improvement. Through open communication, technical consultation, gap analysis, and continuous guidance, ISoOR-AB works closely with institutions to establish and continuously improve organoid biobanking quality management systems that comply with the ISoOR International Standards for Organoid Biobanking (ISoOR-ISOB).
The accreditation process is designed to help organizations understand the intent of the standards, identify opportunities for improvement, and implement best practices in governance, quality management, biosafety, ethics, sample processing, data management, and operational procedures. Rather than simply determining whether an institution passes or fails, ISoOR-AB aims to foster long-term quality culture and sustainable development, enabling organoid biobanks to achieve internationally recognized levels of quality, consistency, and reliability.
ISoOR-AB believes that accreditation is not the end point, but the beginning of continuous quality improvement. We work alongside institutions throughout the accreditation journey, providing constructive feedback, technical expertise, and practical recommendations to help them build robust, sustainable, and internationally aligned organoid biobanking quality systems. Our objective is to empower institutions to achieve compliance through collaboration, rather than evaluation alone, thereby promoting harmonization and excellence across the global organoid biobanking community.
The International Society of Organoid Research (ISoOR) is an international academic organisation dedicated to advancing organoid research, Standardization, and translation.
ISoOR-AB is an independent accreditation initiative established by ISoOR to assess organoid biobanks against ISoOR standards. Its activities include the development of assessment criteria, structured evaluation processes, accreditation decision-making procedures, and mechanisms for verifying ongoing conformity.
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