State Hygienic Laboratory ISO/IEC 17025:2017 Accreditation and Sample Surveillance

国家卫生实验室ISO/IEC 17025:2017认可和样品监测

• 批准号: 9933416
• 负责人: MICHAEL David SCHUELLER
• 金额: $ 14.5万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-05 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9933416
• 关键词: State; Hygienic; Laboratory; ISO; IEC

Project Summary/Abstract: The State Hygienic Laboratory (SHL) at the University of Iowa proposes three objectives for the ISO/IEC 17025:2017 Accreditation and Sample Surveillance project: First, the laboratory will maintain the current scope of ISO/IEC 17025:2005 accreditation for the microbiological and chemical analysis of food testing; Second, SHL will maintain and improve upon the current Quality Management Systems (QMS), specifically by applying an approach based on the iterative four-step PDCA (Plan-Do-Check-Act; also known as the “Shewhart cycle”) management method. SHL will improve traceability practices emphasized in the ISO 17025- 2017 standards and continue to develop risk assessment tools and implement risk management practices to address high-risk areas in the laboratory quality system. The laboratory will continue to conduct internal audits and management reviews, actively engage and evaluate customer feedback, utilize best practices to improve upon service quality, and identify and participate in appropriate proficiency testing (PT) programs as available for all techniques implemented; Third, the laboratory will continue to collaborate with the Iowa Department of Inspection and Appeals (IDIA) to perform surveillance sampling and testing for FDA's Manufactured Food Regulatory Program. We will continue to develop strategic, targeted, comprehensive surveillance sampling and inspection on products with a history of challenges, broadly distributed products, and products that are of significance to the local food commerce. Sampling will follow the methods outlined in Chapter 4 of the FDA Investigations Operations Manual (IOM), and any supplementary FDA guidance on sample collection. The successful completion of this project will help the FDA advance the National Integrated Food Safety System (IFSS) and enhance efforts to protect the food supply.

项目概要/摘要： 爱荷华州大学的国家卫生实验室（SHL）为ISO/IEC提出了三个目标 17025：2017认证和样品监督项目： 首先，实验室将维持ISO/IEC 17025：2005认证的微生物 和化学分析食品检测; 第二，SHL将维护和改进当前的质量管理体系（QMS），特别是通过 应用基于迭代四步PDCA（计划-执行-检查-行动;也称为 “休哈特循环”）管理方法。SHL将改进ISO 17025中强调的可追溯性实践， 2017年标准，并继续开发风险评估工具和实施风险管理实践， 解决实验室质量体系中的高风险领域。化验所会继续进行内部审核 和管理层审查，积极参与和评估客户反馈，利用最佳实践来改进 根据服务质量，并确定和参与适当的能力验证（PT）计划 所有已实施的技术; 第三，实验室将继续与爱荷华州检查和上诉部（IDIA）合作， 为FDA的制成品监管计划进行监督取样和检测。我们将继续 对有历史的产品开展战略性、有针对性、全面的监督抽检 挑战的挑战，广泛分布的产品，以及对当地食品贸易具有重要意义的产品。 采样将遵循FDA调查操作手册（IOM）第4章中概述的方法， 以及FDA关于样本采集的任何补充指南。 该项目的成功完成将有助于FDA推进国家综合食品安全 粮食安全综合系统（IFSS），并加强努力保护粮食供应。