QM manual
The GBN manual for quality management forms the decisive basis for implementing a harmonised quality management system at the GBN sites.
The manual is based on the standard documents DIN EN ISO 9001, 17025, 17020 and 15189 as well as DIN ISO 20387 "Biotechnology - Biobanking - General requirements for biobanking". It also takes into account the DIN/CEN technical specifications for pre-analytical processes. It thus includes all currently existing certification and accreditation requirements for biobanks. It is updated and expanded several times a year. The manual has also been available in English since the end of May 2020.
Both the German manual and the English language version are available Open Access via the Zenodo platform.
Introduction of a quality management system
The following information provides an overview of the scope of the tasks and the workload:
At the beginning, the current status, including the existing equipment of the respective biobank, is documented with the employees. The processes and procedures to be certified/accredited are defined. In a project plan, the work to be performed is planned and estimated by assigning responsibilities. The employees are then trained in the procedure and implementation of the quality management system (QMS). The procedures, methods and processes to be certified/accredited must then be validated. Another essential component is the creation of a concept for data protection and data security. This is followed by the creation of documents, starting with the quality policy, the definition of responsibilities and the description of procedures and methods. Each procedure is checked and verified. The developed QMS is "put into effect"; the employees comply with the described processes in routine operations. Internal audits are carried out at regular intervals to check the processes for their requirements and improve them if necessary. Once the QMS has been implemented, certification/accreditation is applied for from the responsible body. External independent experts review the QMS on the basis of the documents and as part of an on-site inspection and then evaluate it. If they identify deviations from the requirements, these are reassessed after measures have been implemented. At the end of the process, a certificate of certification/accreditation is issued.
