Selection and Implementation of the ISO9001 Standard to Support Biobanking Research Infrastructure Development

The UK DNA Banking Network (UDBN) undertakes biobanking for genetic epidemiology research projects. A task assigned to it is the addition of scientific value to the resources under its management. This task is implemented by enabling appropriate access to the resources. We reasoned that access requires not only a fair access policy but also a quality policy implemented via a Quality Management System (QMS). UDBN decided to achieve consistency in sample management by identifying and implementing a suitable QMS with external certification. UDBN selected ISO9001 as a QMS. It was soon recognized that the QMS needed to encompass not only UDBN but also the academic department in which UDBN sits. An external certification body was selected and a post was dedicated to the role of QMS-Management Representative. Specialized software was acquired. A Quality Manual, individual training files and Standard Operating Procedures (SOPs) were prepared. QMS training was provided. These actions led to the approval of the ISO9001:2000 standard. This is the first report of an academic genetic epidemiology research laboratory receiving approval of the ISO9001 standard to validate the consistency of its operations. ISO9001 was selected because of its greater breadth of scope compared with other QMSs. We found that while laboratory protocols are transferable between labs, QMS SOPs are not transferable. This has consequences for efforts to ensure consistency across a biobank network: joint adoption of one multiparty QMS is probably required. We found that it was not possible to implement a QMS for biobanking in isolation: its host university department needed to be included. We have found that ISO9001 helps enable longitudinal accrual of data on the use of biobanking methods. Thus ISO9001 is not only a management tool to improve access to a biobanking research infrastructure but also a research tool for research infrastructure development.