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Selection and Implementation of the IS09001 Standard to Support Biobanking Research Infrastructure Development

机译：选择和实施支持生物银行研究基础设施发展的IS09001标准

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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 IS09001:2000 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 IS09001 is not only a management tool to improve access to a biobanking research infrastructure but also a research tool for research infrastructure development.
机译：英国DNA银行网络（UDBN）为遗传流行病学研究项目提供生物银行服务。分配给它的任务是为其管理的资源增加科学价值。通过启用对资源的适当访问来实现此任务。我们认为访问不仅需要公平的访问策略，还需要通过质量管理系统（QMS）实施的质量策略。 UDBN决定通过识别并实施具有外部认证的合适QMS来实现样品管理的一致性。 UDBN选择ISO9001作为QMS。很快人们意识到，质量管理体系不仅需要涵盖UDBN，还需要涵盖UDBN所在的学术部门。选择了一个外部认证机构，并专门设立了一个职位，担任QMS管理代表的角色。收购了专用软件。准备了质量手册，单独的培训文件和标准操作程序（SOP）。提供了QMS培训。这些措施导致IS09001：2000标准的批准。这是一个学术遗传流行病学研究实验室的第一份报告，该实验室获得了ISO9001标准的批准，以验证其操作的一致性。之所以选择ISO9001是因为与其他QMS相比，其范围更广。我们发现，虽然实验室协议可在实验室之间转移，但QMS SOP不可转移。这对确保整个生物库网络一致的努力产生了影响：可能需要联合采用一个多方QMS。我们发现不可能单独实施生物银行质量管理体系：需要包括其所在大学的部门。我们发现，ISO9001有助于纵向积累有关使用生物库方法的数据。因此，IS09001不仅是改善对生物银行研究基础设施的访问的管理工具，而且还是用于研究基础设施开发的研究工具。

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