ISO 20387 – Biotechnology – Biobanking – General requirements for biobanking
Scope of the Standard: ISO 20387 specifies general requirements for performing biobanking, which shall be characterized by competence, impartiality and consistent operations. Biobanking refers to the processes of acquisition, custody and management of biological material from multicellular organisms and microorganisms (such as human, animal, plants, fungi). This Standard is neither applicable to biological material intended for food/feed production and/or therapeutic use, nor to laboratories undertaking analyses for food/feed production.
Recipients of our consulting services: organizations (public and/or private) operating in the biobanking field.
Aim: biobanks accredited in accordance with ISO 20387 are structures with a very useful and relevant role in the fields of scientific research and testing; they are responsible for collecting, storing, analyzing, elaborating, processing, preserving and distributing biological material of high quality (both animal and plant) and managing the related information and technical data.
Competence, impartiality and consistent operation are the general requirements for biobanks to ensure biological material and data collection of appropriate quality. Therefore, we can support biotechnology R&D laboratories in the design and implementation of a Quality Management System aimed at a coherent functioning of biobank processes.
Some of our services (non-exhaustive list):
- Initial meeting with the customer: analysis of the existing operating processes
- Definition of the best path to take, defined in accordance with the customer’s needs and expectations, with the aim of integrating the whole Management System to the requirements of this Standard
- Training of the personnel involved
- Support during the control phase
- Planning of the periodic monitoring audit
Some of the advantages deriving from the accreditation according to ISO 20387 (with the help of ISO/TR 22758 guideline – Biotechnology – Biobanking – Implementation guide for ISO 20387):
- Accreditation according to ISO 20387 will be a clear and unmistakable proof of compliance with its requirements of competence, impartiality and consistency, and this will guarantee quality services
- Accredited biobanks can be clearly distinguished from non-accredited ones
- A higher level of compliance with this Standard will lead to greater recognition at national/international level, as well as increased business processes
- Better results will positively affect the degree of staff participation and involvement in the activities carried out, as well as the trust of customers and those benefiting from the offered services
