{ "item_title" : "Quality Management System for Medical Laboratories (2nd Edition)/医", "item_author" : [" 周庭银 胡继 "], "item_description" : "Written by over a hundred domestic laboratory medicine experts in accordance with the latest ISO 15189:2022 guidelines, this book provides essential guidance for applying for medical laboratory accreditation. 依据ISO15189：2022最新指南，国内百余位检验专家编写，可为申请医学实验室认可提供重要指导 The Medical Laboratory ISO 15189 Accreditation Guidance Series is developed in accordance with CNAS-CL02:2023 Accreditation Criteria for the Quality and Competence of Medical Laboratories and CNAS-CL02-A001:2023 Application Requirements for the Accreditation Criteria for the Quality and Competence of Medical Laboratories. Written by experts across all specialties of laboratory medicine nationwide, this series provides important guidance and practical value for pursuing ISO 15189 medical laboratory accreditation. This volume comprises three sections and thirteen chapters. Section One presents an overview of quality management systems for medical laboratories, covering the emergence, development, and significance of medical laboratory accreditation in China; the basic requirements for establishing, operating, and maintaining a quality management system; the revision process and major changes in ISO 15189:2022; and the accreditation process. Section Two contains the original text of the CNAS-CL02:2023 clauses along with interpretive annotations, offering clause-by-clause explanations to facilitate readers' understanding of the underlying concepts. Section Three provides document templates, including a model quality manual and model procedure documents, which offer strong practical guidance and valuable reference for laboratories establishing a quality management system suited to their own circumstances. The appendices include documentation required for accreditation applications and on-site assessment documents for direct use, as well as typical nonconformity case studies with key corrective action points, providing useful reference and prominent guidance. This book is comprehensive, well-structured, concise, and highly practical. It is intended for management and technical personnel in laboratories preparing to apply for medical laboratory accreditation, as well as those already accredited who now need to transition their management systems to the updated standards. It can also serve as a training textbook for standardized management and standardized operating procedures in Chinese medical laboratories. 医学实验室ISO15189认可指导丛书以CNAS-CL02：2023《医学实验室质量和能力认可准则》、CNAS-CL02-A001：2023《医学实验室质量和能力认可准则的应用要求》为指导，由全国医学检验各专业领域专家共同编写，对开展ISO15189医学实验室认可有重要的指导意义和实用价值。 本书共3篇13章。第一篇为医学实验室质量管理体系概述，介绍我国医学实验室认可的产生、发展及意义，质量管理体系的建立、运行及维护的基本要求，ISO15189：2022修订历程及主要变化，以及医学实验室认可流程。第二篇为CNAS-CL02：2023条款原文及释义，针对CNAS-CL02：2023的主要条款逐一进行解读，有助于读者对条款内涵的深入理解。第三篇为文件样例，包括质量手册范例及程序文件范例，指导性强，对实验室结合自身情况建立质量管理体系有较大借鉴意义。附录部分不仅收录了实验室认可申请上报文件、现场评审文件，方便读者直接引用，而且列举了典型不符合案例及整改要点，有利于读者借鉴和参考，指导作用突出。 本书内容全面，编排格式规范，言简意赅，实用性强，适用于正在准备申请医学实验室认可的单位，或已通过认可现在需要完成管理体系换版的单位的管理和技术人员学习和借鉴，还可作为我国医学实验室规范化管理和标准化操作的培训教材。", "item_img_path" : "https://covers3.booksamillion.com/covers/bam/7/54/786/519/7547865194_b.jpg", "price_data" : { "retail_price" : "43.99", "online_price" : "43.99", "our_price" : "43.99", "club_price" : "43.99", "savings_pct" : "0", "savings_amt" : "0.00", "club_savings_pct" : "0", "club_savings_amt" : "0.00", "discount_pct" : "10", "store_price" : "" } }

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