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1 Overview of Laboratory Accreditation 实验室认可业务简介 Chen Yanqing 陈延青 Deputy Director Accreditation Department 3 认可制度 Accreditation Schemes 大门类制度项基本认可制度项专项认可制度项分项认可制度 1

2 检测领域 Testing area 01 生物 Biology 02 化学 Chemistry 机械 Machinery 04 电气 Electric 05 日用消费品 Consumption 06 植物检疫 Plant quarantine 07 卫生检疫 Health quarantine 08 医疗器械 Medical device 09 兽医 Veterinarian 10 建工与建材 Construction and building materials 11 无损检测 NDT 12 电磁兼容 EMC 13 特种设备 Special equipment 14 软件及信息安全检测 Software and information safety 司法鉴定领域法医 Forensic Units 电子物证 Digital Forensic 司法鉴定 Forensic Science 物证 Physical evidence 声像资料 Forensic Audio and Image 4 2

3 校准领域 Calibration area 60 几何量测量 Geometric sense 61 热学测量 Thermal 62 力学测量 Mechanics 声学测量 Acoustics 电磁学测量 Electromagnetism 65 无线电测量 Wireless 66 时间和频率 Time and frequency 测量 68 校准光学测量 Optics 68 化学测量 Chemical 电离辐射测量 Ionizing radiation 专用检测设备 Special testing equipment 5 医学参考测量领域 Medical Reference Measurement Area 01 血细胞计数 Blood cell counting 02 血气 Blood gases 03 血型 Blood groupings 04 凝血因子 Coagulation factors 05 药物 Drugs 06 电解质 Electrolytes 07 酶 Enzymes 08 代谢物和底物 Metabolites and substrates 09 微生物血清 Microbial serology 10 非电解质金属 Non electrolyte metals 11 非肽激素 Non peptide hormones 12 核酸 Nucleic acids 13 蛋白质 Proteins 14 维生素和微量营养元素 vitamins and micronutrients 6 3

认可数量 ( 截至 2017 年 6 月 30 日 ) Statistic figures of Accreditation (up to 2017-06-30) 项目 Category 校准实验室 Cal Labs 检测实验室 Testing Las 能力验证提供者 PTP 标准物质 / 标准样品生产者 RMP 医学实验室

4 认可数量 ( 截至 2017 年 6 月 30 日 ) Statistic figures of Accreditation (up to ) 项目 Category 校准实验室 Cal Labs 检测实验室 Testing Las 能力验证提供者 PTP 标准物质 / 标准样品生产者 RMP 医学实验室 Medical Labs 生物安全实验室 Bio safety Labs 合计 Sub 数量 Amount CNAS 认可的检测 / 校准实验室增长图 Growth chart of CNAS testing and calibration labs 8 4

CNAS 认可的检测 / 校准实验室地域分布图 Geographical distribution map of CNAS testing and calibration labs 地域 Region 广东 Guangdong 江苏 Jiangsu 上海 Shanghai 北京 Beijing 浙江 Zhejiang 认可数量 Amount 1232 (15.4%) 940 (11.

5 CNAS 认可的检测 / 校准实验室地域分布图 Geographical distribution map of CNAS testing and calibration labs 地域 Region 广东 Guangdong 江苏 Jiangsu 上海 Shanghai 北京 Beijing 浙江 Zhejiang 认可数量 Amount 1232 (15.4%) 940 (11.8%) 667 (8.4%) 661 (8.3%) 608 (7.6%) 9 CNAS 实验室专门委员会 Laboratory Committee 法庭科学专业委员会 Forensic Science 动植物检疫专业委员会 Animal and plant uarantine 食品专业委员会 Food 药品专业委员会 Drug 化学专业委员会 Chemistry 石油石化专业委员会 Petroleum 电气专业委员会 Electric 机械专业委员会 Machinery 电磁兼容专业委员会 Emc 校准专业委员会 Calibration 信息技术专业委员会 IT 纤纺专业委员会 Textile 纳米专业委员会 Nanometer 医学专业委员会 Medical 生物安全专业委员会 Bio-safety 能力验证专业委员会 PT 标物标样专业委员会 RMP 10 5

6 CNAS 实验室专门委员会 Laboratory Committee 组成 Composition 有关的政府部门 Relevant government apartment 实验室及相关机构 Laboratories and related organizations 服务对象 Service object 实验结果的使用方 User of laboratory results 专业机构与技术专家 Professional organizations and experts 任期 4 年 four year term 职责 Responsibility 执行全体委员会有关决议 Implementing the resolutions of the board committee 审议或批准认可规范文件 Approval or review the specifications documents 对文件实施提供技术指导 Provide technical guidance for document implementation 提出相关工作建议 Put forward relevant suggestions 根据需要设立专业委员会 Establish Specialized Committee as needed 11 专业委员会 Specialized Committee 组成 Composition 本专业技术专家 Professional technical expert 可设立秘书处 Secretariat may be established 可成立项目工作组 Project team may be established 任期 4 年 four year term 职责 Responsibility 执行有关决议 Implementing relevant resolutions 参与文件制定修订审议或批准 Participate in the formulation, revision, review or approval of documents 跟踪国际活动, 参与技术交流 Follow up international activities and participate in technical exchanges 开展技术研究, 提供技术支持 Carry out technical research and provide technical support 有关的技术培训 Related technical training 12 6

7 CNAS Constitution CNAS 章程 Committee rules 委员会规则 Rules of the Board and committees 委员会工作规则 General rules 通用 Accreditation rules 认可规则 Specific rules 专用 CNAS Public Documents 公开文件 Accreditation normative documents 认可规范文件 Accreditation criteria 认可准则 General Criteria 通用 Specific Criteria 专用 Accreditation Note 认可说明 Accreditation Guidance 认可指南 Technical reports 技术报告 Accreditation Schemes 认可方案 13 认可条件 Accreditation conditions 在遵守国家的法律法规诚实守信的前提下, 自愿申请 By precondition of abiding by state laws and regulations and being honest and trustworthy, an applicant volunteers for accreditation 法律地位 legal status 管理体系 Manageme nt system 履行义务 obligation 明确的法律地位, 具备承担法律责任的能力 Having an unambiguous legal status and the ability of bearing legal liabilities. 符合 CNAS 颁布的认可准则和相关要求 Complying with the accreditation criteria and relevant requirements published by CNAS 遵守 CNAS 认可规范文件的有关规定, 履行相关义务 Observing the relevant provisions contained in the CNAS accreditation criteria documents and fulfilling the relevant obligations. 14 7

8 15 正式申请阶段 Formal application 申请步骤自我评估满足认可条件 Self evaluation 上网填写认可申请 Online application Steps 提交认可申请交纳申请费 Submit application and application fee 16 8

9 评审准备阶段 Assessment preparation 受理审查步骤Steps 申请资料的齐全性和完整性审查 Completeness and integrity review 满足受理要求的审查 Acceptance requirements review 需要时, 实验室澄清疑问或整改 Clarify or rectification, if necessary 必要时, 安排初访 Preliminary visit, if necessary 作出受理决定 Acceptance decision 17 申请受理要求法律地位 Legal status 管理体系 Management system 技术能力 Technical competence 资源 Resource 明确 explicit 运行 6 个月 operation for 6 months 内审 Internal audit 管理评审 Management review 技术经历 Technical experience 能力验证 PT 测量溯源性 Measurement traceability 人机料法环等 Personnel equipment material method environment 18 9

受理前的初访 Preliminary visit 初访不能确定是否满足受理条件 whether the

area 不能确定是否能在 3 个月内接受评审 whether the application can have

staff or assessor 由申请人承担 at the expenses of the applicant 19

the assessment team leader and assessors if necessary

system documents 需要时, 结果反馈, 实验室澄清或整改 Where necessary,

10 受理前的初访 Preliminary visit 初访不能确定是否满足受理条件 whether the application can be accepted 不能准确认定申请范围 determine application area 不能确定是否能在 3 个月内接受评审 whether the application can have on-site assessment within 3 months CNAS 秘书处人员或指定的评审员 CNAS staff or assessor 由申请人承担 at the expenses of the applicant 19 文件评审阶段 Document review 文件评审步骤Steps 选定评审组长, 必要时同时选定评审员 Arrange the assessment team leader and assessors if necessary 组长体系文件及审查申请资料 Lead assessor reviews the application and system documents 需要时, 结果反馈, 实验室澄清或整改 Where necessary, feedback and laboratory clarify or rectification 组长提交文件评审结论 Submit document review conclusion 20 10

文件评审建议 Document review conclusion 实施预评审 Preliminary visit 实施现场评审 On-site assessment 暂缓实施现场评审 Postpone

11 评审员 Assessor 评审组长 Team Leader 主任评审员 Chief Assessor 评审组员 Team Member 技术评审员 Technical Assessor 评审组员 Team Member 实习评审员 Intern Assessor 评审组员 Team Member 技术专家 Technical Expert 不能独立工作 Can not work independently 21 文件评审建议 Document review conclusion 实施预评审 Preliminary visit 实施现场评审 On-site assessment 暂缓实施现场评审 Postpone on-site assessment 不实施现场评审 Do not carry on on-site assessment 资料审查符合要求, 可对申请事项予以认可 Direct recognition 22 11

12 现场评审阶段 On-site assessment Steps 现场评审步骤组建评审组 Organize assessment team 现场评审策划, 确定评审日程 Assessment plan, assessment schedule 现场评审实施 Carry on on site assessment 23 公正性原则 imparti ality 申请能力范围 Applicatio n scope 组建评审组 Organize assessment team 场所标准 / 规范数量等 Sites, standards and quantity 征求意见 Obtain the consent of the applicant 必要时派观察员 Where necessary, CNAS secretariat may assign observer(s) to the assessment team

现场评审策划 Assessment plan 策划要求 :CNAS WI14 01 实验室评审工作指导书 Requirements: CNAS WI14 01 Laboratory assessment work instruction 任务分工 Assignment 能力确认

assessment process 覆盖申请范围所涉及的所有活动及相关场所 The onsite assessment shall cover all the activities and relevant sites relating to the application

13 现场评审策划 Assessment plan 策划要求 :CNAS WI14 01 实验室评审工作指导书 Requirements: CNAS WI14 01 Laboratory assessment work instruction 任务分工 Assignment 能力确认 Confirm competence 评审日程 Assessment schedule 申请范围 Application Scope 项目参数 Item parameter 实验室确认 consent of the applicant 25 现场评审过程 On-site assessment process 覆盖申请范围所涉及的所有活动及相关场所 The onsite assessment shall cover all the activities and relevant sites relating to the application scopes 首次会议 opening meeting; 现场参观 ( 需要时 ) site tour (where necessary); 现场取证 onsite evidence collection 沟通评审情况 communica tion 末次会议 Closing meeting

14 不符合项整改验收 verify the effectiveness of the corrective actions 整改验收方式 Verification Method 最长整改期限 2 个月 Maximum 2month 文审验收 Document review 现场验收 On-site verification 1) Influence the effectiveness of test results and laboratory integrity 2) Refers to environment, equipment, personnel which can be rectified in a short period 3) Can not be verified by document review 一般不符合项 General NC 1) 涉及影响检测结果的有效性和实验室诚信性的不符合项 2) 涉及环境设施设备人员能力等不符合, 且在短期内能够得到纠正 3) 仅进行书面审查不能确认其整改是否有效 27 验收合格,报CNAS 认可批准阶段 Accreditation approval Steps 认可批准步骤审查评审材料 Document review 认可评定 Accreditation appraisal 发证与公布 Issuing certificate and publication 28 14

认可评定 Accreditation appraisal 秘书处 CNAS secretariat Appraisal

根据评定结论作出认可决定 Accreditation decision 符合性审查 conduct compliance

the proposal is not consistent with the recommendation

laboratory and the assessment team of the inconsistency 29

Granting accreditation partially 不予认可 Refusing to grant

15 认可评定 Accreditation appraisal 秘书处 CNAS secretariat Appraisal Committee 评定委员会 Secretary General 秘书长评价并作出评定结论 Appraisal 根据评定结论作出认可决定 Accreditation decision 符合性审查 conduct compliance check of the assessment report, 与评审组意见不一致时通报实验室和评审组 Where the proposal is not consistent with the recommendation comments of the assessment team, notify the assessed laboratory and the assessment team of the inconsistency 29 评定结论 Appraisal conclusion 予以认可 Granting accreditation 部分认可 Granting accreditation partially 不予认可 Refusing to grant accreditation 补充证据或信息, 再行评定 Reappraisal after evidence or information is supplemented 30 15

后续工作内容2017-8-31 发证与公布 Issuing certificate and publication 证书有效期 :6 年 Certificate cycle: 6 years 列入获准认可实验室名录, 予以公布 Publishing the basic information 英文证书附件根据实验室自愿申请来提供 English appendix is voluntarily

16 后续工作内容发证与公布 Issuing certificate and publication 证书有效期 :6 年 Certificate cycle: 6 years 列入获准认可实验室名录, 予以公布 Publishing the basic information 英文证书附件根据实验室自愿申请来提供 English appendix is voluntarily applied 31 获得认可后续工作 Follow-up work 监督评审 Surveillance assessment 复评审 Reassessment 扩大缩小认可范围 Extending and reducing accreditation scopes 认可变更 Changes to accredited laboratories 暂停恢复撤销注销认可 Accreditation suspension, recovery, withdrawal and cancellation 32 16

定期监督及复评审 Periodic surveillance assessment and Reassessment 第 5.

5 年 : 复评审 surveillance 第 4 年 : 全面监督 Full surveillance 第 2 年 : 全面监督 Full surveillance 第 1 年 : 监督评审 surveillance 获得认可证书 Accreditation 获得认可证书

个认可周期 Oneaccreditation 所有认可周期 All 所有认可周期 ALL 定期监督 Periodic surveillance 不需申请 No application 全面监督 Full surveillance 不需申请 No application 复评审

17 定期监督及复评审 Periodic surveillance assessment and Reassessment 第 5.5 年 : 复评审 Reassessment 第 4 年 : 全面监督 Full surveillance 第 2 年 : 全面监督 Full surveillance 第 5.5 年 : 复评审 surveillance 第 4 年 : 全面监督 Full surveillance 第 2 年 : 全面监督 Full surveillance 第 1 年 : 监督评审 surveillance 获得认可证书 Accreditation 获得认可证书 Accreditation 初次认可 Initial accreditation 一个认可周期后 After one accreditation cycle 33 定期监督及复评审 Periodic surveillance assessment and Reassessment 仅第 1 个认可周期 Oneaccreditation 所有认可周期 All 所有认可周期 ALL 定期监督 Periodic surveillance 不需申请 No application 全面监督 Full surveillance 不需申请 No application 复评审 Reassessment 需要申请 application 侧重变化 Focus on change 部分要素 partial elements 技术能力 ( 需要时 ) Technical competence(wher e necessary) 全面评审 Full assessment 全部要素 Full elements 全部技术能力 Full technical competence 全面评审 Full assessment 全部要素 Full elements 全部技术能力 Full technical competence 换发认可证书 Certificate 34 17

变更Handling 处理changes 36 2017-8-31 认可变更 Changes to accredited laboratories Notify CNAS in writing within 20 working days 获认可实验室其他 Others 35 进行监督评审或提前进行复评审 conducting surveillance assessment or

18 变更Handling 处理changes 认可变更 Changes to accredited laboratories Notify CNAS in writing within 20 working days 获认可实验室其他 Others 35 进行监督评审或提前进行复评审 conducting surveillance assessment or carrying out the reassessment ahead of schedule; 评审考核 examining 登记备案 registering and recording the changes 维持扩大缩小暂停或撤销认可 maintaining, extending, reducing, suspending or withdrawing accreditation 18

accreditation certificate respectively according to the different sites 当同一技术活动需要在多个场所共同完成时, 可在认可证书 ( 附件 ) 内对地址进行说明 Where the same testing/calibration activity needs to be carried out jointly at

19 对多场所实验室认可的特殊要求 Special requirements for accreditation of multi site testing/calibration laboratories CNAS-RL01 实验室认可规则第 8 条 Article 8. CNAS-RL01 Laboratory Rule 内容涉及 : 管理体系申请及受理认可评审认可证书 Refers to: Management system, application, acceptance, assessment, accreditation certificate 认可证书 Accreditation certificate 不同场所, 分别出具认可证书附件 accreditation certificate respectively according to the different sites 当同一技术活动需要在多个场所共同完成时, 可在认可证书 ( 附件 ) 内对地址进行说明 Where the same testing/calibration activity needs to be carried out jointly at several sites, the addresses may be explained in the attachments to the accreditation certificate. 37 暂停撤销注销认可 (2002 年 7 月至 2017 年 6 月 30 日 ) Accreditation suspension, recovery, withdrawal and cancellation (From July, 2002 to 30 June, 2017) 类型 Category 暂停 suspension 撤销 withdrawal 注销 cancellation 数量 Amount

20 谢谢! Thank you 20

職業安全衛生績效量測技術手冊

職業安全衛生績效量測技術手冊 performance measurement Pro-active Reactive II . 1. 2 2.1.....2 2.2..2 2.2.1. 2 2.2.2. 3 2.2.3. 4 2.2.4.....5 2.2.5. 5 2.2.6 OHSAS 18001... 6 2.2.7 OHSAS 18002....7...12 3.1....12 3.2....14 3.3....16 3.3.1...16