“一带一路”认可发展研讨会 The Accreditation Development Workshop On the One Belt One Road CNAS医学实验室认可业务介绍 Brief introduction of CNAS medical laboratory accreditation 2017.9 Beijing

内 容 Contents CNAS医学实验室认可发展历程 内 容 Contents CNAS医学实验室认可发展历程 History of the CNAS medical accreditation program CNAS医学实验室认可制度 CNAS medical accreditation program CNAS医学实验室认可现状 Current status of CNAS medical accreditation CNAS医学实验室认可及标准化的国际事务 CNAS play role in international medical accreditation and standardization CNAS医学实验室认可展望 Future plan of CNAS medical accreditation

History of the CNAS medical accreditation program 开始跟踪ISO/DIS 15189 Began to follow up with ISO/DIS 15189 2001.11 开始接收ISO 15189认可申请 Began to accept ISO 15189 application 2004.7 CNAS代表开始参加ISO/TC212会议（第10届） CNAS representative began to attend the ISO/TC212 plenary meeting( the 10th ) 2004.10

History of the CNAS medical accreditation program 发出第1张ISO 15189认可证书 1st ISO 15189 certificate issued to China PLA General Hospital 2005.8 发布8份专业应用说明 Issued 8 application criteria for different discipline 2007.4 签署APLAC MRA Signed APLAC MRA 2007.12

History of the CNAS medical accreditation program CNAS代表被指定为ILAC/AIC/WG6召集人 CNAS representative was designated as the convenor of ILAC/AIC/WG6 2008.5 帮助马来西亚建立医学认可体系开展培训 Help Malaysia with the training on setting up medical accreditation scheme 2009.10 认可20家奥运定点医学实验室 20 med-labs accredited for medical service for 2008 Beijing Olympic Games 2008.7

History of the CNAS medical accreditation program 认可11家为世博会服务的医学实验室 11 med-labs accredited for Shanghai Expo Service 2010.4 启动西部地区医学实验室支持计划 Initiated the Plan for supporting the quality improvement of medical laboratories in western China 2011.8 帮助乌兹别克斯坦建立医学认可体系开展培训 Help Uzbekistan with the training on setting up medical accreditation scheme 2011.5

History of the CNAS medical accreditation program 开始受理血站实验室ISO 15189申请 Began to accept application from blood center against ISO 15189 2013.4 CNAS代表被ILAC指定为对口ISO/TC212官方联络人 CNAS representative was designated by ILAC as the official liaison with ISO/TC212 on Dec. 2014；and designated as the ISO/TC212 liaison with ILAC on Oct. 2015. 2014~ 2015 完成ISO 15189:2012版准则转换 ISO 15189:2012 identically translated to CNAS accreditation criteria 2013.10

History of the CNAS medical accreditation program 完成200余家医学实验室ISO 15189:2012换版 Issued the new certificate of ISO 15189:2012 to more than 200 accredited medical laboratories 2016.3 CNAS与西藏自治区卫计委签署医疗卫生技术支持合作备忘录 Signed MoU for technical cooperation between the CNAS and Tibet health authority 2016.5 CNAS代表加入ISO/TC276/WG2 生物样本库和生物资源 CNAS representative was approved as the member of ISO/TC276/WG2 Biobanks and bioresources 2017.1

CNAS medical accreditation program 认可规则（R，RL） Accreditation rules 认可准则、专门要求、应用说明（CL） Accreditation criteria, particular requirements and application guidance 认可指南（GL）、技术报告（TR） Guides and Technical Reports 程序文件（PD） Procedures 作业指导书及表格 Work Instructions and Work sheets 认可信息文件 Information documents 认可规范文件 Normative documents 认可体系文件 QMS documents

CNAS medical accreditation program ISO 15189 认可制度 规则 Rule 共用 Same as those used by ISO/IEC 17025 准则 （CL02） 应用说明 Application Criteria 10份:血液、体液、生化、免疫、微生物、输血、细胞病理、组织病理、基因扩增、LIS 10 discipline 指南 Guides 内审、管理评审、溯源、验证等 技术报告 TR 测量不确定度 TRL001：MU 评审程序（PD14） 评审SOP WI 评审报告 Assessment Report 申请书 （AL02） AL09领域分类 Field Code

CNAS medical accreditation program 医学实验室认可相关文件共计34份，具体分类如下： Medical accreditation applied document lists（34）: 1、认可规则： Rules CNAS-R01《认可标识和认可状态声明管理规则》 Rules for the Use of Accreditation Symbols and Reference to Accreditation CNAS-R02《公正性和保密规则》 Rules for Impartiality and Confidentiality CNAS-R03《申诉、投诉和争议处理规则》 Rules for Dealing with Appeals, Complaints and Disputes

CNAS medical accreditation program 1、认可规则： Rules CNAS-RL01《实验室认可规则》 Rules for the Accreditation of Laboratories CNAS-RL02《能力验证规则》 Rules for Proficiency Testing CNAS-RL03《实验室和检验机构认可收费规则》 Rule for Accreditation Fees For Laboratories and Inspection Bodies CNAS-RL04《境外实验室和检验机构受理规则》 Rules on Accepting Accreditation Application from Cross-frontier Laboratories and Inspection Bodies

CNAS medical accreditation program 2、认可准则、专门要求及应用说明 Criteria, particular requirements and application guidance CNAS-CL02《医学实验室质量和能力认可准则》 Accreditation Criteria for the Quality and Competence of Medical Laboratories CNAS-CL06《溯源结果溯源性的要求》 Requirements on the Traceability of Measurement Results CNAS-CL07《测量不确定度的要求》 Requirements for Measurement Uncertainty CNAS-CL31《内部校准要求》 Requirements for In-house Calibration

CNAS medical accreditation program application guidance CNAS-CL35《医学实验室质量和能力认可准则在实验室信息系统的应用说明》LIS CNAS-CL36《医学实验室质量和能力认可准则在分子诊断检验领域的应用说明》Molecular Diagnostics CNAS-CL37《医学实验室质量和能力认可准则在组织病理学检查领域的应用说明》Histopathology CNAS-CL38《医学实验室质量和能力认可准则在临床化学检验领域的应用说明》Clinical Chemistry CNAS-CL39《医学实验室质量和能力认可准则在临床免疫学定性检验领域的应用说明》Clinical Immunology

CNAS medical accreditation program CNAS-CL40《医学实验室质量和能力认可准则在输血医学领域的应用说明》Transfusion Medicine CNAS-CL41《医学实验室质量和能力认可准则在体液学检验领域的应用说明》Body Fluid Examination CNAS-CL42《医学实验室质量和能力认可准则在临床微生物学检验领域的应用说明》Clinical Microbiology CNAS-CL43《医学实验室质量和能力认可准则在临床血液学检验领域的应用说明》Clinical Hematology CNAS-CL51《医学实验室质量和能力认可准则在细胞病理学检查领域的应用说明》Cytopathology

CNAS medical accreditation program 3、认可指南：Guidance CNAS-GL01《实验室认可指南》 Guidance on laboratory accreditation CNAS-GL09《实验室认可评审员不符合项分级指南》 Classification of Nonconformities CNAS-GL12《实验室和检验机构内部审核指南》 Guidance on internal audit CNAS-GL13《实验室和检验机构管理评审指南》 Guidance on management review CNAS-GL18《量值溯源在医学领域的实施指南》 Guidance on traceability in medical field CNAS-GL41《临床微生物检验程序验证指南》 Guidance on method verification in microbiology

CNAS medical accreditation program 4、技术报告：Technical Reports CNAS-TRL-001：2012《医学实验室―测量不确定度的评定与表达》 MU evaluation and expression

CNAS medical accreditation program 5、体系文件 QMS documents 程序文件：Procedure documents CNAS-PD14《实验室及相关机构和检验机构认可评审程序》 Assessment procedure for laboratory and inspection body 作业指导书：Work instructions CNAS-WI14-03《医学实验室质量和能力认可评审工作指导书》 Work instruction for medical laboratory assessment 信息文件:Information documents CNAS-AL09《医学实验室认可领域分类》 Field code for medical accreditation

CNAS medical accreditation program 5、体系文件 QMS documents 表格：Work sheets CNAS-AL02《医学实验室质量和能力认可申请书》 Application form CNAS-AL15《医学实验室质量和能力认可申请书填写指南》Guide for filling the application form CNAS-PD14/16《医学实验室质量和能力认可评审报告》 Assessment report for medical laboratory accreditation

Current status of CNAS medical accreditation 认可的实验室数量及分类： Accredited laboratory numbers and classification: 医学参考测量实验室：10家 Medical reference measurement laboratory: 10 包括：医院检验科、IVD制造商实验室、临床检验中心 Classified as hospital laboratory, IVD manufacture laboratory and center for laboratory medicine CNAS医学实验室认可现状 Current status of CNAS medical accreditation

Current status of CNAS medical accreditation 认可的医学实验室：281家 No. of accredited medical laboratory: 281 CNAS医学实验室认可现状 Current status of CNAS medical accreditation 分类如下： Classified as:

Current status of CNAS medical accreditation 认可的领域： Accredited disciplines: CNAS医学实验室认可现状 Current status of CNAS medical accreditation 血液学clinical hemotology 体液学body fluid examination 临床化学clinical biochemistry 临床免疫学 clinical immunology 流式细胞学 Flow Cytomytry 临床微生物学clinical microbiology 分子诊断学 Molecular Diagnostics 输血医学Transfusion medicine 病理学Cyto- and Histo-pathology 细胞遗传学cell genetics

Current status of CNAS medical accreditation 医学认可领域开展的研究工作： Research projects carried out in medical accreditation: 各专业应用要求 Application of the ISO 15189 requirements in different disciplines 病理认可要求 Requirements for accreditation in Pathology 血站认可要求 Requirements for accreditation in Blood bank 影像认可要求 Requirements for accreditation in Medical Imaging 方法验证要求 Requirements for method verification 生物样本库认可制度适宜性 Applicability of the accreditation scheme for biobank

Current status of CNAS medical accreditation 医学认可领域开展的相关业务工作： Relative works carried out in medical accreditation: 医学评审员培训教材更新 Revision of the training manual for medical assessors 定期进行医学评审员初始及持续培训 Arrange initial and continuous training class for the medical assessors 对已认可医学实验室实施督查 Supervision of the accredited medical laboratories

Current status of CNAS medical accreditation 医学实验室认可为行业提供的服务 Accreditation service for medical societies: 国家卫计委 National health authority 规范血站实验室的管理 Collaborate with the national health authority to administer Blood Centers 国家中医药管理局 State Administration of Traditional Chinese Medicine 中医药理基地准入条件 Entry criteria for clinical pharmacological research

Current status of CNAS medical accreditation 医学实验室认可为行业提供的服务: Accreditation service for medical societies: 北京市卫计委 Beijing Health Authority 要求奥运定点医院医学实验室认可 Requirements for designated hospital medical laboratories for 2008 Beijing Olympic Games 上海市卫计委 Shanghai Health Authority 对世博会提供服务的医学实验室的要求 Requirements for supplying hospital medical laboratories service for 2010 Shanghai Expo

Current status of CNAS medical accreditation 医学实验室认可为行业提供的服务： Accreditation service for medical societies: 医院等级评审 Hospital classification 部分地区医院等级评审中采信认可结果 Accreditation results adopted by hospital classification audit in some provincial areas 宣传认可 Accreditation promotion 利用行业教育平台宣传认可 Actively promote accreditation education at various medical seminars

CNAS医学实验室认可及标准化国际事务 CNAS play role in international medical accreditation and standardization CNAS参与医学相关国际事务主要有两方面: CNAS involved mainly in two areas of the international medical related issues: 参与ILAC与医学实验室认可相关事务 The medical accreditation issues covered by ILAC 参与ISO/TC212医学实验室认可相关标准制修订工作 The ISO standardization on medical laboratory management covered by ISO/TC212

CNAS play role in international medical accreditation and standardization ILAC 事务 ILAC issues ILAC/AIC/WG6 医学认可工作组 ILAC/AIC/WG6 medical Responsible for the development of policies and accreditation documents for medical laboratory accreditation. CNAS代表翟培军是WG6召集人、ILAC与ISO/TC212的官方联络人 CNAS representative Mr. Zhai Peijun is the convenor of the WG6，and the official liasion for ILAC and ISO/TC212.

CNAS play role in international medical accreditation and standardization ILAC 事务 ILAC issues ILAC/AIC/WG6 开展的系列工作 Work lists 在AIC范围内开展调查 AIC Survey 血站实验室认可 blood bank accreditation 医学影像实验室认可 medical imaging accreditation 样本采集中心认可Accreditation on collection center 生物样本库认可 biobank accreditation 制定发布ILAC-G26《医学实验室认可制度实施指南》 Issued ILAC-G26, Guidance for the Implementation of a Medical Laboratory Accreditation System

CNAS医学实验室认可及标准化国际事务 CNAS play role in international medical accreditation and standardization ISO 事务 ISO standardization ISO/TC212 临床实验室检验和体外诊断试验系统技术委员会 ISO/TC212 Clinical laboratory testing and in vitro diagnostic test systems 负责医学实验室、医学参考测量实验室、体外诊断系统相关国际标准的制修订工作 Responsible for the international standards development for medical laboratories, medical reference laboratories and IVD products

CNAS play role in international medical accreditation and standardization ISO/TC212下设5个工作组: ISO/TC212 is composed of 5 Working Groups： WG1：医学实验室的质量管理 WG1: Quality and competence in the medical laboratory ISO 15189 Medical laboratories — Requirements for quality and competence ISO 15190 Medical laboratories – Requirements for safety ISO/TS 22367 Medical laboratories—Reduction of error through risk management and continual improvement ISO 22870 Point of Care Testing (POCT) - Requirements for quality and competence ISO /TS 20658 Medical laboratories – Requirements for collection, transport, receipt and handling of samples

CNAS play role in international medical accreditation and standardization WG2：参考系统 WG2: Reference systems ISO 15193 In vitro diagnostic medical devices —Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures ISO 15194 In vitro diagnostic medical devices —Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation ISO 15195 Requirements for Reference Measurement Laboratories ISO 17511 Traceability of Assigned Values - Calibrators, Controls, Patient Samples ISO/DTS 20914 Medical laboratories – Practical guide for the estimation of measurement uncertainty ISO/NP 21151 Requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples

CNAS play role in international medical accreditation and standardization WG3：体外诊断产品 WG3: In vitro diagnostic products ISO 15197、ISO 15198、ISO 17593、ISO 19001 WG4：微生物学和分子诊断 WG4: Microbiology and molecular diagnostics ISO 20776-1、ISO 20776-2、分子诊断检验程序（molecular diagnostic procedures）等

CNAS play role in international medical accreditation and standardization WG5：实验室生物风险管理 ISO/WD 35001 Biorisk management for laboratories and other related organizations CNAS代表是ISO/TC212/WG1、WG2、WG5委员,参与多项国际标准的制修订工作。 CNAS representatives are members of WG1,WG2 and WG5 of ISO/TC212 and involved in several of their project teams.

Future plan of CNAS medical accreditation 例如医学影像学、生物样本库等 medical imaging, biobank etc. 拓展认可领域 Extend accreditation discipline 如性能验证、性能确认、风险分析等 Method verification, validation, risk management etc. 深化认可要求 Develop specific accreditation requirements ：

Future plan of CNAS medical accreditation 定期开展医学实验室认可培训 Implement training program annually for the western laboratories 支持西藏地区医学实验室获得认可 Support the 1st medical laboratory accreditation in Tibet 服务西部发展 Support the development of medical laboratory in western China ：

联系方式 Contact Information CNAS认可四处 翟培军 处长 zhaipj@cnas.org.cn 胡冬梅 高管 hudm@cnas.org.cn 周亚莉 高管 zhouyl@cnas.org.cn 李军燕 主管 lijy@cnas.org.cn Accreditation Department Four Zhai Peijun, Division Director zhaipj@cnas.org.cn Hu Dongmei, Senior Manager hudm@cnas.org.cn Zhou Yali, Senior Manager zhouyl@cnas.org.cn Li Junyan, Manager lijy@cnas.org.cn

Thank you for your attention! 谢谢！ Thank you for your attention!