quality management | Central BioHub GmbH: Order Human Biospecimens Online

Quality Management


Central BioHub GmbH was established in 2017 to provide high-quality human biospecimens to biomedical researchers in a fast, easy and compliant way. Our customers are primarily the diagnostic industry and research institutes; therefore, our operations are subject to legal guidelines as well as uncompromising ethical standards. From the day Central BioHub was founded, defined procedures manage all business workflows, interaction with our partners, and confidential processing of customer data. Central BioHub strictly follows international data protection regulations, in particular the EU General Data Protection Regulation (GDPR).

Our Quality Management System

Cornerstones of our company are high-quality human biological samples and customer satisfaction without compromises. We strive to provide our customers with products and services which meet and even exceed their expectations. For this purpose, Central BioHub has implemented a detailed and transparent quality management system. It sets out a framework defining the entire workflow and allows us to measure our performance. Central BioHub continuously improves and expands their quality standards through regular internal and external audits.

All partners are contractually committed to complying with our standards. Our biospecimen suppliers are validated according to a strict and defined protocol. Here, both the ethical compliance of the specimen collection and the quality management system are inspected regularly to meet our strict criteria. On-site audits at our partner’s biorepository facilities guarantee superior cryopreservation conditions for all specimens to maintain biomarkers for a long time. Continuous digital audits maintain our world-class standards and any deviations are immediately communicated with the biosample supplier.

ISO 9001 Certification

DIN EN ISO 9001:2015 defines the criteria for a coherent and seamlessly working quality management system. It includes a strong customer focus, the motivation and implication of top management, the process approach, and continual improvement. Central BioHub is certified according to ISO 9001. All business units operate in accordance with ISO 9001, which guarantees the highest level of safety and quality to match your products and regulated business areas. The quality manual and the official certification document are available in English and German upon request.


We are committed to international ethical standards for all biospecimens offered on centralbiohub.com, independently of which partner is providing the samples. Central BioHub observes the principles of the Declaration of Helsinki and the Declaration of Taipei as defined by the World Medical Association. Suppliers of Central BioHub are fully committed to strict compliance with the IRB and Ethics Committee (IEC) and all applicable regulations, guidelines, and best practices that meet international policies.

Our ethical requirements to procure human biospecimens:

  • Specimens for scientific research offered on centralbiohub.de that originate from dedicated specimens collections or clinical remnants have been collected and approved by an IRB/IEC or comparable ethics committee.
  • For all products obtained from specimen collections for scientific research, informed consent from the donor is available. The submission of the informed consent form is regularly checked by the Central BioHub compliance department.
  • Clinical remnant samples do not require informed consent from the subject regulating the further use of the specimens (see 45 CFR 46, §46.104 Exempt research, exemption d, 4). Sample-related data is available anonymized or highly pseudonymized so that the possibility of inference from specimen data to an identifiable donor is minimized.

Central BioHub will provide specimen compliance documentation upon request for every biospecimen procurement. Reach out to us for more information on quality management and international regulations by contacting our Compliance department.

All departments of Central BioHub are working according to a detailed and transparent Quality Management System (QMS) which is in compliance with DIN EN ISO 9001:2015. It includes regular internal audits and on-site inspections at the supplier’s facilities.
Central BioHub is certified according to ISO 9001 since July 2022.
Central BioHub observes principles of the Declaration of Helsinki, setting ethical principles regarding human experimentation defined by the World Medical Association. Furthermore, it acts in compliance with the Declaration of Taipei which defines applications of health data and biobanks.
  • Specimens derived from dedicated collections and clinical residuals are approved by IRB/IEC or equivalent ethics committee.
  • Specimens derived from dedicated collections were collected with the informed consent of the donor.
  • Documentation will be provided upon request.
  • All suppliers are subject to a multi-stage validation process, whereby all required documents are provided. Regular on-site audits at our supplier’s facilities and frequent reviews of legal documents ensure compliance with international regulations.
  • Customers are activated after completing a form with self-disclosure and additional research by our Customer Service.
Central BioHub operates with the utmost degree of transparency. The quality manual is made available on request.