State Hygienic Laboratory ISO/IEC 17025:2005 Accreditation

项目摘要/摘要 目标说明：国家卫生实验室(SHL)建议制定和实施 实验室内的流程，以获得国际标准化组织/国际电工委员会17025：2005年对微生物和 在五年内或之前由一个公正和国际公认的机构进行食品检测的化学分析 2016年。 研究设计和使用方法：SHL目前是蕨类FDA的化学和蕨类 FSIS微生物学实验室。SHL将利用刚刚完成的质量管理评估 与国际标准化组织/国际电工委员会17025：2995标准的要求相关的体系，以识别和解决 准备提交认证申请。卫生与公众服务部将确定、开发、实施和验证 方法根据国际标准化组织/国际电工委员会17025版标准要求进行微生物和化学分析。 食物样本。SHL将使用FDA蕨类项目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 细菌分析手册(BAM)，用于特定分析物的测定。房屋及规划地政局局长将识别及 参与适用于所实施的所有技术的适当水平测试(PT)计划。 将制定、审查和批准标准操作程序，并将所有方法验证数据 对所有微生物和化学食品检测技术进行汇编、评估和批准 在SHL实施。卫生与公众服务部将使用选定认证的国际标准化组织17025认证核对表 提供商对实验室的管理和分析系统进行自我评估，以评估 在认证机构现场视察之前，实验室的准备情况与标准的对比情况。此内部 审计应由质量保证协调员对SHL的安克尼和科拉维尔设施进行。 广泛的长期目标和具体的目标：本项目的广泛的长期目标是 SHL将成为国际标准化组织/国际电工委员会17025：2005年认可的国家人造食品检测实验室 监管计划。成功的认证将使卫生与公众服务部能够开发和实施微生物和 化学食品检测方法，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，提高探测和响应能力 食品安全问题。通过国际标准化组织/国际电工委员会17025：2005年认证，卫生与公众服务部将提供食品检测数据 已知和一致的质量，以帮助实现FDA的使命，保护公众免受食品 自带疾病和伤害。

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.