Comparison of AAVLD Laboratory Accreditation Requirements V 2021.01 with ISO17025:2017

AAVLD 实验室认可要求 V 2021.01 与 ISO17025:2017 的比较

• 批准号: 10215868
• 负责人: Timothy Baszler
• 金额: $ 1.02万
• 依托单位: WASHINGTON STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-20 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10215868
• 关键词: Comparison; AAVLD; Laboratory; Accreditation; Requirements

Project Summary: The Food Safety Modernization Act (FSMA), signed into law on January 11, 2011, was designed to enable the Food and Drug Administration to better protect public health by helping ensure safety and security of the food and animal feed supplies. One of the goals of FSMA is to ensure there is sufficient capacity of high quality laboratories in the United States to provide food safety and animal feed testing as well as effective response to outbreaks. The following key goals were identified. To establish a foundation for high quality laboratory results from animal health testing laboratories and assist in implementation of the FSMA, the FDA formally partnered with veterinary medical diagnostic laboratories in 2012 through the formation of the Veterinary Laboratory Investigation and Response Network (Vet‐LIRN). Most laboratories in the Vet-LIRN are accredited by the American Association of Veterinary Laboratory Diagnostician Accreditation Program, which accredited laboratories using a laboratory accreditation standard that is congruent with the international laboratory accreditation standard ISO/IEC 17025, “General requirements for the competence of testing and calibration laboratories”. In 2016, a joint FDA-AAVLD White paper was published detailing the alignment of the AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory with ISO/IEC 17025:2005. The purpose of this project is to update the previous 2016 document by comparing the current version of “AAVLD Requirements for an Accredited Veterinary Medical Diagnostic Laboratory” with ISO/IEC 17025:2017, the updated version of “General requirements for the competence of testing and calibration”.

项目摘要：《食品安全现代化法案》（FSMA），于2010年12月15日签署成为法律。 2011年1月11日，旨在使食品和药物管理局更好地 通过帮助确保食品和动物饲料的安全和保障来保护公众健康 用品. FSMA的目标之一是确保有足够的高容量 在美国的质量实验室提供食品安全和动物饲料测试， 有效应对疫情。确定了以下关键目标。到 为动物健康检测的高质量实验室结果奠定基础 实验室，并协助实施FSMA，FDA正式合作， 2012年通过组建兽医医学诊断实验室， 兽医实验室调查和反应网络（Vet‐LIRN）。最 Vet-LIRN中的实验室获得美国兽医协会的认证 实验室诊断师认证计划，该计划使用 与国际实验所一致的实验所认可标准 认证标准ISO/IEC 17025，“通用要求的能力， 测试和校准实验室”。2016年，FDA-AAVLD白色联合文件 发布了详细说明AAVLD认证要求的一致性 符合ISO/IEC 17025：2005的兽医医学诊断实验室。的目的 该项目是通过比较当前版本的 《AAVLD对经认可的兽医诊断实验室的要求》 与ISO/IEC 17025：2017，更新版本的“通用要求， 测试和校准能力”。