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1、 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01 检测和校准实验室能力的通用要求检测和校准实验室能力的通用要求修订：ISO/IEC 170251 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01讲师介绍2 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01学员自我介绍学员自我介绍姓名姓名职务职务参加本次课程的目的参加本次课程的目的期望期望3 Copy Right Reserved by UL-
2、CCIC Company LimitedIEC4 ,Rev.01Day 1 Agenda第1天日程表 Introduction to ISO/IEC 17025:2005 标准介绍 质量管理八大原则介绍 Management requirement管理要求4 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Day 2 Agenda 第2天日程表Process approach -Laboratory Audit 过程方法实验室审核Technical requirement技术要求 5 Copy Right Reserved b
3、y UL-CCIC Company LimitedIEC4 ,Rev.01Day 3 Agenda 第3天日程表Technical requirement技术要求Introduction to Uncertainty of Measurement测量不确定度介绍Exam 考试6 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01 练习练习1 1 请列举你认为一个请列举你认为一个好的校好的校准准或或检测实验检测实验室室应应具具备备哪些哪些条件条件或或特色，以符合客戶的要求特色，以符合客戶的要求并使客户满意并使客户满意。(使用时间使
4、用时间：10分分钟钟)请请各各组讨论后组讨论后，派一名代表上台，派一名代表上台发发表。表。 (各各组组使用使用时间时间: : 3 分分钟钟以內以內)ISO/IEC 17025 标准介绍标准介绍7 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.018 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01ISO/IEC17025ISO/IEC17025的制定目标的制定目标证明其按管理体系运行、具有技术能力并能提供正确证明其按管理体系运行、具有技术能力并能提供正确的技术结
5、果所必须满足的所有要求的技术结果所必须满足的所有要求主要适用实验室，也必须可用作认可准则主要适用实验室，也必须可用作认可准则必须代替必须代替EN45001EN45001，达成国际上的统一达成国际上的统一必须明确与必须明确与ISO9000ISO9000的关系的关系作为国际标准出版作为国际标准出版扩大范围，纳入抽样、新方法制定和专业判断内容扩大范围，纳入抽样、新方法制定和专业判断内容将管理要求和技术要求分离，利于使用将管理要求和技术要求分离，利于使用更具灵活性更具灵活性更关注电子手段的应用更关注电子手段的应用避免制定过多应用或解释性文件避免制定过多应用或解释性文件 9 Copy Right Res
6、erved by UL-CCIC Company LimitedIEC4 ,Rev.01ISO/IEC17025ISO/IEC17025新旧版的显著区别新旧版的显著区别增加了适用性条款增加了适用性条款强调了管理强调了管理更关注顾客更关注顾客规定了质量方针声明的最基本内容规定了质量方针声明的最基本内容扩大了合同评审内容扩大了合同评审内容新增加了纠正措施章节新增加了纠正措施章节10 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01(接上页) 新增加了预防措施章节新增加了预防措施章节 新增加了持续改进章节（新增加了持续改进章节（20
7、052005版本）版本） 增加了管理评审过程中应包括的内容增加了管理评审过程中应包括的内容 增加了新方法制定要求，规定了有效性（确认）的准则增加了新方法制定要求，规定了有效性（确认）的准则 强化了对测量不确定度要求强化了对测量不确定度要求 区分开校准和检测实验室的量值溯源性区分开校准和检测实验室的量值溯源性 结果报告增加了很多内容结果报告增加了很多内容ISO/IEC17025ISO/IEC17025新旧版的显著区别新旧版的显著区别11 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Biological (生物生物)Mecha
8、nical (机械机械性性)Acoustical & Vibration (声学与振动声学与振动)Non-destructive (非非破坏破坏性性)Chemical (化化学学)Environmental (环环境境)Construction Materials (结构结构材料材料)Electrical (电学电学)Thermal (热热)Calibration (校正校正)12 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01ISO/IEC17025:2005ISO/IEC17025:2005包含了包含了ISO 9001中
9、与实验室管理中与实验室管理体系所覆盖的检测和校准服务有关的所有要求体系所覆盖的检测和校准服务有关的所有要求实验室质量管理体系符合实验室质量管理体系符合ISO 9001的要求，并不证明的要求，并不证明实验室具有出具技术上有效数据和结果的能力实验室具有出具技术上有效数据和结果的能力实验室质量管理体系符合本准则，也不意味其运作符实验室质量管理体系符合本准则，也不意味其运作符合合ISO 9001的所有要求。的所有要求。13 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.011.Scope范围2.Normative References参
10、考标准3.Terms and Definitions名词与定义4.Management Requirements 管理要求5.Technical Requirements 技术要求ISO/IEC 17025规范的架构14 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01范围制定执行测试与校正的一般能力要求， 包括取样涵盖了使用标准标准、非非标准实验标准实验室自行室自行开发开发之方法 所执行的测试与校正适用于所有的实验实验室，而与实验实验室的人数和所执行的测试与校正的范围无关本准则中的注是对正文的说明、举例和指导。它们既不包含要
11、求，也不构成本准则的主体部分本准则是CNAS对检测和校准实验室能力进行认可的依据，也可用于实验室建立管理体系，以及为实验室的客户、法定管理机构对实验室的能力进行确认或承认提供指南不涵盖实验实验室作业的相关法规与安全要求ISO/IEC 17025 标准介绍标准介绍15 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01质量质量管理八大原管理八大原则则 顾客导向 (Customer Focus) 领导作用 (Leadership) 全员参与 (Involvement of People) 系统性管理 (System Approach
12、 to Management) 流程导向 (Process Approach) 持续改善 (Continual Improvement) 基于事实的决策 ( Factual Approach to Decision Making) 互利(双赢)的供应链关系 ( Mutually Beneficial Supplier Relationship)16 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01安全与健康（安全与健康（1.51.5） 任何国家的认可活动，都是以符合该国的安全与健康相关法律任何国家的认可活动，都是以符合该国的安
13、全与健康相关法律/ /法规为前提的法规为前提的 实验室的活动，也应以遵守实验室的活动，也应以遵守17 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01Management Requirements 管理要求管理要求4.1 Organization组织组织组织4.2 Quality System质量体系质量体系4.3 Document Control文控文控4.4 Review of Requests, Tenders and Contracts合同评审合同评审4.5 Subcontracting of Tests and Ca
14、librations检测和校准的分包检测和校准的分包4.6 Purchasing Services and Supplies服服务和供应品的采购务和供应品的采购4.7 Service to the Client服务客户服务客户4.8 Complaints抱怨抱怨4.9 Control of Nonconforming Testing and/or Calibration Work不合格检测和校准的控制不合格检测和校准的控制4.10 Improvement 改进改进4.11 Corrective Action纠正措施纠正措施4.12 Preventive Action预防措施预防措施4.13 C
15、ontrol of Records纪录控制纪录控制4.14 Internal Audits内审内审4.15 Management Reviews管理评审管理评审18 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.1 Organization (I)组织组织ILegally responsible法律实体Meet Standard, Customer, Regulatory & Accreditation Bodies Requirements满足标准 客户 法规 和认可机构的要求Cover work carried ou
16、t in permanent, offsite,mobile or temporary facilities覆盖固定 外部 移动或临时场所Other activities/responsibilities influencing lab work shall be defined in order to identify potential conflicts of interest 明确责任以鉴别潜在的利益冲突 Other functions (e.g. Sales, Production or Finance etc.)其他职能 Independence of third party la
17、boratories三方实验室的独立性19 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.1 Organization (II)组织组织IIThe laboratory shall实验室应a) Have managerial and technical personnel with authority and resources to carry out their duties拥有所需权力和资源的管理人员和技术人员b) Ensure management and personnel are free from any
18、undue pressure (commercial or financial etc.)识别偏离c) Have policies and procedures for protection of clients confidential information and proprietary rights方针和程序确保机密信息和所有权的保护d) Have policies and procedures to protect competence, impartiality and judgment or operational integrity方针和程序避免有损能力 公正 判断能力 诚实性
19、20 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.1 Organization (III)组织组织IIIe) Define the organization structure, its place in parent organization and relationships between laboratory and support services确定组织机构和母体与支持服务的关系f) Specify the responsibilities, authorities and interrelationshi
20、ps of all personnel规定责任 权限和相互关系g) Provide adequate supervision of testing and calibration staff对测试和校准人员实施适当监督h) Have technical management responsible for the technical operations技术管理者i) Appoint a Quality Manager ( however named) who can direct access to the highest level of management质量经理j) Appoint
21、deputies for key managerial personnel代理人21 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01关键人员（关键人员（4.1.44.1.4）关键人员的范围一般至少含关键人员的范围一般至少含：首席执行官（首席执行官（CEOCEO）技术主管、授权签字人技术主管、授权签字人质量主管质量主管22 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.2 Quality System (I)质量体系IvEstablish, Implem
22、ent, and Maintain a quality system appropriate to the scope of its activities建立、实施和维持与其活动范围相适应的质量体系vDocument its policies, system, procedures and instructions文件化政策、制度、计划、程序和指导书等等v Policies and objectives shall be defined in the Quality Manual在质量手册中规定质量方针和目标vQuality Policy statement authorized by Chi
23、ef Executive, include at least the following:主要管理者发布批准质量方针: Commitment to good practice and client service承诺为客户服务的良好职业操守 Standard of service实验室服务标准的声明 Objectives of the quality system确定目标 Familiarity, Understanding and Implementation by all personnel为全员认知 Commitment to compliance with ISO 17025承诺符合I
24、SO 1702523 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01质量方针与质量质量方针与质量目目标举标举例例 (仅供参考) 实验实验室室质量方针质量方针以优良的测试品质提供客戶最佳的滿意服务 实验实验室室质量质量目目标标 每月客诉件数不超过2件 延误报告交期不超过 1天 报告出错率小于5% 客户满意度高于80分 2005年取得ISO/IEC 17025的证书24 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01订定目标的原则订定目标的原则- SMART
25、特定性特定性 (Specific) 可衡量可衡量 (Measurable) 可达成性可达成性v.s. 有挑战性有挑战性 (Attainable) 相关性相关性 (Relevant) 时限性时限性 (Timeframe)上司的支持与承诺，以及员工的认同是达上司的支持与承诺，以及员工的认同是达成目标的关键因素！成目标的关键因素！25 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01实验室的工作范围实验室的工作范围 专业领域和学科专业领域和学科 校准领域校准领域 检测领域检测领域 实验室的质量体系应覆盖其工作范围实验室的质量体系应覆
26、盖其工作范围26 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.2 Quality System (II)质量体系IIq Quality Manual质量手册 Policies and objectives shall be defined定义方针目标 Outline the structure of the documentation used in the quality system概述质量体系文件结构 Include or make reference to the supporting & technical
27、procedures引用程序文件 Duties of Technical and Quality Managers shall be defined规定技术质量经理的职责27 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.3 Document Control (I)文件控制Iq General总则总则 Establish and maintain procedures to control internal/external documents建立程序控制外部文件,内部文件 External documents may
28、be regulations, standards, test/calibration methods, drawings, software, specifications and instruction manuals etc.外部文件可能包括法规 标准 测试校准方法 图纸 软件 规范和指导书等q Document Approval and Issue文件的批准和发布 All documents shall be reviewed and approved prior to issue发布前的审查和批准 Master list or equivalent control procedure
29、 shall be established to identify the current revision and distribution status建立清单 Authorized documents shall be available at point of use适当的授权版本 Documents shall be periodically reviewed and revised as necessary定期审查文件 Invalid/obsolete documents shall be removed from all points of use promptly, or as
30、sure against unintended use撤除作废文件28 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.01文件的价值文件可以沟通意图、统一行动，有助于：文件可以沟通意图、统一行动，有助于： 实现产品质量和质量改进；实现产品质量和质量改进； 提供适宜的培训；提供适宜的培训； 确保重复性和可追溯性；确保重复性和可追溯性； 提供客观的证据；提供客观的证据； 评价体系的有效性。评价体系的有效性。 文件的制定应是一项文件的制定应是一项增值增值的活动的活动29 Copy Right Reserved by UL-CCIC C
31、ompany LimitedIEC4 ,Rev.014.3 Document Control (II)文件控制II Retained obsolete documents (for legal or knowledge preservation purpose) shall be suitably marked标记保留作废文件 Documents shall be unique identified (date of issue/revision, page numbering, total number of pages and issuing authority)唯一标识q Documen
32、t Changes文件更改 Changes shall be reviewed and approved by authorized personnel审批 Changes (altered or new text) shall be identified标注更改 Procedures and authorities for hand written amendments shall be defined手改的程序和权限 Hand written amendments shall be clearly marked, initialed and dated 手改应清楚标记签名和注明日期 Pro
33、cedure for changes to electronic documents shall be established 电子版文件更改的程序30 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.4 Review of Requests, Tenders and Contracts要求、标书和合同的评审Iv Procedures for contract review shall ensure that:建立和维持评审客户要求，标书和合同的程序 Requirements are defined, documented
34、 and understood要求被适当地规定，形成文件，被理解 Capability and resources to meet the requirements能力和资源 Appropriate test and/or calibration method is selected and capable选择适当的检测和校准方法 Differences between tender and contract shall be resolved工作开始前，已解决差异 Subcontracted work shall be reviewed审查所有被分包的工作31 Copy Right Rese
35、rved by UL-CCIC Company LimitedIEC4 ,Rev.014.4 Review of Requests, Tenders and Contracts要求、标书和合同的评审IIv Records of review, including significant changes and discussions with client, shall be maintained保持评审记录包括重大变化的记录v Client shall be informed of any deviation from the contract对合同的任何偏离均应通知客户v Changes
36、to contract shall be reviewed and communicated to all affected personnel变更情况应评审并通知所有受影响的人员32 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.5 Subcontracting of Tests and Calibrations检测和校准的分包v Subcontracting of work:工作的分包Unforeseen reasons (e.g. workload, need for further expertise or te
37、mporary incapacity)不可预见原因Continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements)长期连续情况下shall be placed with a competent subcontractor应分包给合格的分包方v Advise the client in writing and gain approval when appropriate获得客户的批准v Laboratory is responsible to the client for th
38、e subcontractors work, except client or regulatory authority specifies实验室就其分包方的工作对客户负责v Maintain a register of all subcontractors保存所有分包方的注册资料33 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.6 Purchasing Services and Supplies服务和供应品的采购Iq Policy and procedures for拥有的政策和程序 Selection of ser
39、vices and supplies选择和购买的服务和供应品 Purchase, reception and storage of reagent and consumable materials采购接受储存试剂和易耗品q Purchasing documents shall be reviewed and approved for technical content prior to release采购文件在发出之前,其技术内容应经过审查和批准q Inspection or verification of purchased services or materials: 检查验证购买的服务和
40、供应品 Prior to use使用前使用前 Compliance with specified requirements符合要求符合要求 Records shall be maintained保持记录34 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.6 Purchasing Services and Supplies服务和供应品的采购IIq Evaluation of suppliers for critical consumables and services:评价重要供应品和服务的供应商 Records of e
41、valuation shall be maintained保存这些评价的记录 AVL (Approved Vendors List) shall be maintained获批准的供应商名单35 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.7 Service to the Client服务顾客Afford clients cooperation to与客户或其代表合作 Clarify clients request明确客户的要求 Monitor laboratorys performance监视其工作有关的操作 Ens
42、ure confidentiality to other clients保密Cooperation may include:合作可包括 Reasonable access to relevant areas for witness见证 Preparation, packaging, and dispatch of test and/or calibration items制备包装分发样品 Communication process沟通 Client surveys (positive and negative feedback from clients)客户调查36 Copy Right Re
43、served by UL-CCIC Company LimitedIEC4 ,Rev.014.7 Service to the Client服务顾客 应理解并明确客户要求应理解并明确客户要求 合理准许客户合理准许客户 到现场监督到现场监督开展定期的客户调查开展定期的客户调查是简便有效的方法是简便有效的方法. OFFER A SMILE. 37 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.8 Complaints报怨Policy and procedure for compliant resolution有政策和程序处理
44、来自客户的抱怨Records shall be maintained:保持记录 Complaints抱怨 Investigations调查 Corrective actions taken纠正措施38 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.9 Control of Nonconforming Testing and/or Calibration Work(I)不符合检测和校准工作的控制IPolicy and procedures for deviations shall ensure that有政策和程序确保:
45、Responsibilities and authorities for the management of nonconforming work are designated确定对不符合工作进行管理的责任和权力, 确定所采取的措施 Evaluation of the significance of the nonconforming work is made评价不符合工作的严重性 Remedial actions (containment) are taken immediately立即采取纠正措施 Client is notified and work is recalled where
46、necessary必要时,通知客户并取消工作 Responsibility for authorizing the resumption of work is defined确定批准恢复工作的职责39 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.9 Control of Nonconforming Testing and/or Calibration Work(II)不符合检测和校准工作的控制IIExamples: 例如 Customer complaints, Internal/External audits, Ma
47、nagement review顾客投诉 内/外审 管理评审 Test/Calibration/Maintenance results and Quality Control (e.g. IQC)测试/校准/维护结果和质量控制 Staff observations or supervision/Documentation checks人员监督管理/文件检查Corrective action procedures given in 4.11 shall be promptly followed where the nonconforming work could recur不合格工作重复发生应立即
48、运行4.11规定的纠正措施40 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.10 4.10 Improvement Improvement 改进改进The laboratory shall continually improve the effectiveness of its management system through the use of: quality policy Quality objectives Audit results Analysis of data Corrective and prev
49、entive actions Management review 實驗室應運用品質政策、品質目標、稽核結果、據分析、矯正及預防措施及管審查， 持續改進其管系統的有效性。 41 Copy Right Reserved by UL-CCIC Company LimitedIEC4 ,Rev.014.11 Corrective Action(I)纠正措施纠正措施IEstablish policy and procedure and designate appropriate authorities for implementing corrective action制定实施纠正措施的政策和程序Det
50、ermine the root causes of the problem确定问题的根本原因Selection and implementation of corrective actions纠正措施的选择和执行 Identify potential corrective actions识别潜在的纠正措施 Appropriate to the magnitude and the risk of the problem力度应与问题的严重性和危险性相适应 Document and implement any changes resulting from corrective actions文件化并