De Blasio Pasquale, Biunno Ida
Integrated Systems Engineering Srl, c/o OpenZone, Via Meucci 3, 20091 Bresso, MI, Italy.
BioTech (Basel). 2021 Jul 2;10(3):13. doi: 10.3390/biotech10030013.
The emergence of "multi-omics" and "multi-parametric" types of analysis based on a high number of biospecimens enforces the use of a great number of high-quality (BMaD). To meet the demands of biomedical research, several Biological Resource Centers (BRCs) or Biobanks world-wide have implemented a specific Quality Management System (QMS) certified ISO 9001:2015 or accredited by CAP ISO 20387:2018. For the first time, ISO, with the support of several Biobanking experts, issued the ISO 20387:2018 which is the first ISO norm specific for Biobanks. The fundamental difference with present certification/accreditation standards is that the ISO 20387:2018 focuses not only on the operational aspects of the Biobank, but also on the "competence of the Biobank to carry our specific Biobanking tasks".
The accreditation process for ISO 20387:2018 required the definition of: (1) objectives, goals and organizational structure of the Biobank, including procedures for governance, confidentiality and impartiality policies; (2) standard operating procedures (SOPs) of all activities performed, including acquisition, analysis, collection, data management, distribution, preparation, preservation, testing facility and equipment maintenance, calibration, and monitoring; (3) procedures for control of documents and records, the identification of risks and opportunities, improvements, corrective actions, nonconforming records and evaluation of external providers (4) an internal audit and management reviews, verification of QMS performance, monitoring of quality objectives and personnel qualification and competency in carrying out specific Biobanking tasks.
The accreditation process is performed by an independent authorized organization which certifies that all processes are performed according to the QMS, and that the infrastructure is engineered and managed according to the GDP and/or GMP guidelines.
Accreditation is given by an accreditation body, which recognizes formally that the Biobank is "competent to carry out specific Biobanking tasks".
基于大量生物样本的“多组学”和“多参数”分析方法的出现，使得大量高质量生物样本（BMaD）的使用成为必然。为满足生物医学研究的需求，全球多个生物资源中心（BRC）或生物样本库已实施了经ISO 9001:2015认证或获得CAP ISO 20387:2018认可的特定质量管理体系（QMS）。ISO在多位生物样本库专家的支持下，首次发布了ISO 20387:2018，这是首个针对生物样本库的ISO标准。与现行认证/认可标准的根本区别在于，ISO 20387:2018不仅关注生物样本库的运营方面，还关注“生物样本库执行特定生物样本库任务的能力”。
ISO 20387:2018的认可过程需要定义：（1）生物样本库的目标、目的和组织结构，包括治理程序、保密和公正政策；（2）所有执行活动的标准操作程序（SOP），包括获取、分析、收集、数据管理、分发、制备、保存、检测设施及设备维护、校准和监测；（3）文件和记录控制程序、风险和机会识别、改进、纠正措施、不合格记录以及外部供应商评估；（4）内部审核和管理评审、QMS绩效验证、质量目标监测以及人员在执行特定生物样本库任务方面的资质和能力。
认可过程由一个独立的授权组织进行，该组织证明所有流程均按照QMS执行，且基础设施是根据GDP和/或GMP指南进行设计和管理的。
认可由认可机构授予，该机构正式认可生物样本库“有能力执行特定生物样本库任务”。
