Maintenance & Enhancement of ISO/IEC 17025 Accreditation for CA State Food Testing Laboratory

提案标题：维护和加强 ISO/IEC 17025 认证 加州国家食品检测实验室 项目概要/摘要 加州健康部食品和药物实验室分部 (FDLB) 是 国家食品检测实验室作为主要服务实验室 加利福尼亚州针对微生物的制造食品监管计划 (MFRP) 和化学分析。 FDLB 通过食品和药品部门在食品领域注册 与食品药品监督管理局 (FDA) 和 MFRP 签订安全检验合同。 该提案的目标是允许加州的制造食品监管计划 维持和加强 ISO/IEC 17025:2005 认证，以便实验室测试 可以符合 FDA 制造食品监管计划 标准。具体目标包括： A. 对质量管理体系评估进行年度管理评审 差距分析。 B. 制定行动计划以保持符合 ISO 17025 并提高质量 系统。 C. 实施行动计划以维持 ISO 17025:2005 认证并持续 认可机构的认证 D. 与国家协商扩大认证范围 制成品监管计划 E. 维护能力验证计划以支持 ISO 17025。 F. 制定样本收集和分析项目以增加国家数量 与国家制造食品一起收集的监测样本 监管计划 G. 实验室 ISO 17025:2017 认证准备工作 通过该合作协议增加的活动将增加分析 FDA 的能力并推进全国一体化的食品安全体系 加强食品安全并能够快速应对与食品相关的紧急情况。

Title of Proposal: Maintenance & Enhancement of ISO/IEC 17025 Accreditation for CA State Food Testing Laboratory Project Summary/Abstract The California Department of Health, Food and Drug Laboratory Branch (FDLB) is the State food testing laboratory which serves as the primary servicing laboratory for the State of California’s manufactured food regulatory program (MFRP) for microbiological and chemical analyses. FDLB is enrolled through the Food and Drug Branch in the food safety inspection contract with the Food and Drug Administration (FDA) and the MFRP. The goal of this proposal is to allow California’s manufactured food regulatory programs to maintain and enhance ISO/IEC 17025:2005 accreditation so that laboratory testing can achieve conformance with the FDA Manufactured Food Regulatory Program Standards. The specific aims include: A. Perform annual management review of quality management system assessment and gap analysis. B. Develop Action Plan to maintain compliance with ISO 17025 and improve quality system. C. Implement Action plan to maintain ISO 17025:2005 accreditation and continued certification by accreditation body D. Enhancement of the scope of accreditation in consultation with the State Manufactured Food Regulatory Program E. Maintain Proficiency Testing Plan to support ISO 17025. F. Develop a Sample Collection and Analysis Project to increase the number of State surveillance samples collected in conjunction with the State Manufactured Food Regulatory Program G. Preparation of the laboratory for ISO 17025:2017 accreditation Increased activity through this cooperative agreement would increase analytical capacity for the FDA and advance a nationally integrated food safety system which enhances food safety and allow rapid response to food-related emergencies.