体外诊断试剂自检实验室质量管理体系建设探讨

Discussion on Quality Management System for in vitro Diagnostic (IVD) Products Self-Testing Laboratories

目的:为注册申请人建立和运行与开展自检工作相适应的实验室质量管理体系提供参考,为注册质量管理体系现场核查注册申请人自检能力提供可操作的检查方法。方法:通过梳理新版《医疗器械监督管理条例》及欧美医疗器械的法规要求,结合检验检测实验室质量管理体系通用要求,分析实验室质量管理体系建立和运行关键要点。结果与结论:体外诊断试剂自检实验室质量管理体系建设的关注要点包括人员、设备和环境设施、样品、质量控制、记录、检验方法等,各关键要素的有效循环与改进,可持续提升实验室检验检测能力。而建立科学、规范的实验室质量管理体系是保证产品检验准确、结果可靠的基础,是深化“放管服”改革的有效探索,有助于激发注册申请人创新发展的活力。

Objective: The purpose of this discussion is to provide reference for registration applicants to establish and maintain a laboratory quality management system suitable for the self-testing work;to provide operational practical methods for inspectors to conduct onsite inspection on applicants’ self-inapection ability of the regiatered quality management system. Methods: Through sorting out the new Regulations on the Supervision and Administration of Medical Devices and relevant US/EU regulations on medical devices, by combining general requirements of quality system management for inspection and testing laboratory, and by analyzing key points of building and operating laboratory quality management system. Results and Conclusions: The key points for the construction of laboratory quality management system for self-testing IVD include personnel, equipment and environmental facilities, samples, quality control, record keeping, testing methods and others. The ef fective circulation and improvement of each key element are helpful to continuously improve the laboratory inspection and testing capacity. The establishment of a scientifi c and standardized laboratory quality management system is the basis to ensure the accuracy products testing and reliability of results, and is an ef fective exploration for deepening the reform of "streamlining administration and delegating power, improving regulation, and upgrading services", which stimulates the vitality of the innovation and development of the registration applicants.