State Hygienic Laboratory ISO/IEC 17025:2005 Accreditation

项目总结/摘要 目标声明：国家卫生实验室（SHL）建议开发和实施 在实验室内的过程，以实现ISO/IEC 17025：2005认证的微生物和 在五年内，由公正和国际公认的机构进行食品检测的化学分析，或 2016. 研究设计和方法：SHL目前是FERN FDA化学和FERN FSIS微生物实验室。SHL将利用刚刚完成的质量管理评估 ISO/IEC 17025：2995标准的要求，以识别和解决 准备提交认证申请。SHL将确定、开发、实施和验证 方法符合ISO/IEC 17025：2005微生物和化学分析的标准要求 食品样品。SHL将使用FDA FERN计划提供的方法或可用的方法 通过国际官方分析化学家协会（AOAC International）和FDA 细菌学分析手册（BAM），用于测定特定分析物。SHL将识别和 参与适用于所有实施技术的适当能力验证（PT）计划。 将制定、审查和批准标准操作规程，所有方法验证数据将 为所有微生物和化学食品测试技术进行汇编、评估和批准 在SHL中执行。SHL将使用ISO 17025认证清单， 供应商对实验室的管理和分析系统进行自我评估， 在认证机构进行现场访问之前，实验室的准备工作与标准进行比较。这种内部 应由质量保证协调员对SHL的Ankeny和科拉尔维尔工厂进行稽查。 广泛、长期目标和具体目标：本项目的广泛、长期目标是： SHL将成为ISO/IEC 17025：2005认证的食品检测实验室，用于国家制造的食品 监管方案。成功的认证将使SHL能够开发和实施微生物和 化学食品测试方法，为国家和FDA提供更高的分析能力，以保护 食物供应SHL将作为国家实验室，提高检测和应对 食品安全问题。通过ISO/IEC 17025：2005认证，SHL将提供食品检测数据 以帮助满足FDA的使命，以保护公众免受食品 生病和受伤。

Project Summary/Abstract Statement of Objectives: The State Hygienic Laboratory (SHL) proposes to develop and implement processes within the laboratory to achieve ISO/IEC 17025:2005 accreditation for the microbiological and chemical analysis of food testing from an impartial and internationally recognized body within five years or by 2016. Research Design and Methods to be Employed: The SHL is currently a FERN FDA chemistry and FERN FSIS Microbiology laboratory. The SHL will utilize the just completed evaluation of the quality management system relative to the requirements of ISO/IEC 17025:2995 standard to identify and address gaps in preparation for submitting accreditation application. The SHL will identify, develop, implement and validate methods according to ISO/IEC 17025:2005 standard requirements for microbiological and chemical analyses of food samples. The SHL will utilize methods provided by the FDA FERN program or methods available through the Association of Official Analytical Chemists International (AOAC International) and FDA Bacteriological Analytical Manual (BAM) for the determination of specific analytes. The SHL will identify and participate in appropriate proficiency testing (PT) programs as available for all techniques implemented. Standard operating procedures will be developed, reviewed and approved and all method validation data will be compiled, evaluated and approved for all microbiological and chemistry food testing technologies implemented at the SHL. The SHL will use an ISO 17025 certification checklist from selected accreditation provider to conduct a self-evaluation of the laboratory's management and analytical systems to evaluate the preparedness of the lab versus the standard prior to the on-site visit from the certifying body. This Internal Audit shall be conducted by the QA Coordinator's for SHL's Ankeny and Coralville facilities. Broad, Long-term Objectives and Specific Aims: The broad, long-term objectives for this project are for the SHL to become an ISO/IEC 17025:2005 accredited food testing laboratory for the state's manufactured food regulatory program. Successful accreditation will allow the SHL to develop and implement microbiological and chemical food testing methods to provide increased analytical capacity for the state and FDA to protect the food supply. The SHL will serve as the state laboratory which will improve capacity to detect and respond to food safety problems. By achieving ISO/IEC 17025:2005 accreditation, the SHL will provide food testing data of known and consistent quality to the state to help meet the FDA's mission to protect the public from food borne illness and injury.