在巴西的法医遗传学实验室中实施ISO/IEC 17025
Laryssa Silva de Andrade Bezerra1, Advaldo Carlos de Souza-Neto2, Paulo B Chaves2
1Superintendência de Polícia Técnico-Científica de Goiás (SPTC-GO), Avenida Engenheiro Atílio Correia Lima 1223, Cidade Jardim, Goiânia, Goiás, Brazil; Universidade Federal de Goiás (UFG), Estrada Municipal, Quadra e Área Lote 04, Fazenda Santo Antônio, Aparecida de Goiânia, Goiás, Brazil.
Forensic science international
|May 3, 2025
概括
巴西的法医遗传实验室显示,他们更符合ISO/IEC 17025标准,但在校准和熟练测试等外部服务方面面临挑战. 需要认证支持.
科学领域:
- 法医科学 法医科学 法医科学
- 遗传学 遗传学 是一个
- 质量管理系统 质量管理系统
背景情况:
- 巴西的法律法规规定了基于ISO标准的法医学遗传实验室的技术要求.
- 对于这些实验室来说,认证ISO/IEC 17025还不是强制性的.
- 评估合规性和识别挑战对于改善质量管理至关重要.
研究的目的:
- 评估巴西法医遗传学实验室对ISO/IEC 17025标准的遵守情况.
- 确定这些实验室在满足ISO要求时遇到的具体挑战.
- 为提高实验室认证的政策制定提供信息.
主要方法:
- 在基因资料数据库综合网络 (RIBPG) 中,对28个实验室进行了调查.
- 合规性根据八个关键标准进行评估:人员,设备,校准,验证,能力测试,审计,风险管理和批判性审查.
- 数据分析的重点是确定高和低合规性的领域.
主要成果:
- 实验室对人员能力 (64%) 和设备管理 (57%) 等强制性条款的遵守率更高.
- 在满足外部服务的ISO要求方面发现了重大挑战,特别是校准 (29%) 和认可的熟练测试 (14%).
- 对于目前没有根据国家质量标准强制或审计的方面,合规性明显较低.
结论:
- 需要战略性公共政策举措来支持巴西的法医实验室认证.
- 能力建设,专业培训和实施监测至关重要.
- 需要外部动机和量身定制的策略来鼓励和促进实验室认证.
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