The following information provides an overview of the scope of the tasks and the workload:
At the beginning, the current status of the existing equipment of the respective biobank is documented with the employees. The processes and procedures to be certified/accredited have to be defined. The effort to be expended is planned and estimated in a project plan by assigning responsibilities. The employees are then trained in the procedure and implementation of the 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 preparation of documents, starting with the quality policy and the definition of responsibilities and the description of procedures and methods. Each procedure has to be checked and verified. The validity of the developed quality management system is "put into effect"; the employees adhere to the described processes in routine operations. At regular intervals, the processes are checked with internal audits and improved if necessary. Once the QMS has been implemented, certification/accreditation is applied for from the relevant body. External independent experts check the QMS on the basis of the documents and in the course of an on-site visit and subsequently evaluate it. If they find 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.