State Hygienic Laboratory ISO/IEC 17025:2005 Accreditation

国家卫生实验室ISO/IEC 17025:2005认证

• 批准号: 8730500
• 负责人: Michael Anthony Pentella
• 金额: $ 30万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-05 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8730500
• 关键词: State; Hygienic; Laboratory; ISO; IEC

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.

项目摘要/摘要 目标声明：国家卫生实验室（SHL）提议开发和实施 实验室内的过程以实现ISO/IEC 17025：2005微生物学和 五年内或通过 2016。 研究设计和要使用的方法：SHL目前是FERN FDA化学和蕨类植物 FSIS微生物学实验室。 SHL将利用刚刚完成的质量管理评估 系统相对于ISO/IEC 17025：2995标准的系统，以识别和解决差距 准备提交认证申请的准备。 SHL将识别，开发，实施和验证 根据ISO/IEC 17025：2005微生物和化学分析的标准要求 食品样品。 SHL将利用FDA FERN程序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国际）和FDA 细菌分析手册（BAM）用于确定特定分析物。 SHL将识别并 参与适用于实施的所有技术的适当能力测试（PT）程序。 将制定，审查和批准标准操作程序，所有方法验证数据将 对所有微生物和化学食品测试技术进行编译，评估和批准 在SHL上实施。 SHL将从选定的认证中使用ISO 17025认证清单 提供者对实验室管理和分析系统进行自我评估，以评估 在认证机构进行现场访问之前，实验室的准备与标准相比。这个内部 审计应由质量检查协调员对SHL的Ankeny和Coralville设施进行。 广泛的，长期的目标和具体目标：该项目的广泛，长期目标是为了 SHL成为ISO/IEC 17025：2005认可的食品测试实验室 监管计划。成功的认证将使SHL能够开发和实施微生物学和 化学食品测试方法可为国家和FDA提供提高分析能力以保护 食物供应。 SHL将作为国家实验室，将提高检测和回应的能力 食品安全问题。通过实现ISO/IEC 17025：2005认证，SHL将提供食物测试数据 已知且一致的国家质量，以帮助实现FDA保护公众免受食物的使命 疾病和伤害。