2分析仪的符合性评估 维护性:对菲律宾国家标准的合规性实用性 PNS ISO 15189:2013 认证 认证
Geraldine B Dayrit1, Dennis Mok2, Rana Nabulsi3
1Department of Medical Microbiology, College of Public Health, University of the Philippines Manila, Manila, Philippines.
Acta medica Philippina
|November 1, 2024
概括
这项研究开发了一种工具,用于评估菲律宾国家标准ISO 15189:2013认证的Afinion 2分析仪的维护能力. 这种实用工具帮助医疗实验室进行设备合规性的内部审计.
科学领域:
- 医学实验室科学 医学实验室科学
- 质量管理系统 质量管理系统
- 认证标准 认证标准 认证标准
背景情况:
- 实施菲律宾国家标准 (PNS) ISO 15189:2013对医疗实验室提出了挑战,旨在获得合格的结果.
- 确保设备的可用性和可维护性对于认证至关重要,但通常需要优化.
- 没有先前的研究专门解决了在PNS ISO 15189:2013认证实验室内Afinion 2分析仪维护能力的合规性评估.
研究的目的:
- 为医疗实验室开发一个实用的工具,以支持内部审计流程.
- 根据PNS ISO 15189:2013要求确定Afinion 2分析仪可维护性的合规状态.
- 加强对实验室设备认证合规性的管理.
主要方法:
- 从PNS ISO 15189:2013 (第4和第5条),制造商规格和认证机构要求中确定了相关的符合性要求.
- 2 分析器合规性评估检查清单的选择审计标准,重点是维护和参考设备.
- 根据确定的要求制定了三个合规性评估检查清单和解释检查清单.
主要成果:
- 总共有44/1515 (2.9%) 的符合性要求被确定,其中33/1515 (2.2%) 与Afinion 2 Analyzer硬件和软件相关.
- 确定了五个关于预防性维护的制造商要求.
- 在13/75 (17%) 的认证机构中,选择了对参考设备维护的特定认证要求,以告知检查清单的制定.
结论:
- 该研究为医疗实验室提供了一种实际的工具,以评估Afinion 2分析仪的维护能力.
- 该工具有助于根据PNS ISO 15189:2013,制造商和认证要求确定符合性状态.
- 这有助于改善实验室设备的认证合规管理.
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