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1、Page 1,检测和校准实验室能力的通用要求修订：,ISO/IEC 17025,Page 2,讲师介绍,Page 3,学员自我介绍,姓名职务参加本次课程的目的期望,Page 4,Day 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,Page 5,Day 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,Page 6,Day 3 Agenda
2、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,Page 7,练习1 请列举你认为一个好的校准或检测实验室应具备哪些条件或特色，以符合客戶的要求并使客户满意。(使用时间：10分钟)请各组讨论后，派一名代表上台发表。(各组使用时间:3 分钟以內),ISO/IEC 17025 标准介绍,Page 8,1.制定ISO/IEC17025目标 2.新版17025与17025:99版的区别3.ISO/IEC17025适用的专业领域4.ISO/IEC 标准与ISO9000的关系
3、,ISO/IEC/17025:2005标准介绍,Page 9,ISO/IEC17025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必须代替EN45001，达成国际上的统一必须明确与ISO9000的关系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将管理要求和技术要求分离，利于使用更具灵活性更关注电子手段的应用避免制定过多应用或解释性文件,Page 10,ISO/IEC17025新旧版的显著区别,增加了适用性条款强调了管理更关注顾客规定了质量方针声明的最基本内容扩大了合同评审内容新增加了纠正措施章节,P
4、age 11,(接上页),新增加了预防措施章节新增加了持续改进章节（2005版本）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结果报告增加了很多内容,ISO/IEC17025新旧版的显著区别,Page 12,ISO/IEC17025适用的专业领域,Biological(生物)Mechanical(机械性)Acoustical&Vibration(声学与振动)Non-destructive(非破坏性)Chemical(化学),Environmental(环境)Construction Materials
5、(结构材料)Electrical(电学)Thermal(热)Calibration(校正),Page 13,ISO/IEC 标准与ISO9000的关系,ISO/IEC17025:2005包含了ISO 9001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实验室质量管理体系符合ISO 9001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质量管理体系符合本准则，也不意味其运作符合ISO 9001的所有要求。,Page 14,Scope范围Normative References参考标准Terms and Definitions名词与定义Management Require
6、ments 管理要求Technical Requirements 技术要求,ISO/IEC 17025规范的架构,Page 15,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、非标准实验室自行开发之方法 所执行的测试与校正适用于所有的实验室，而与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室作业的相关法规与安全要求,ISO/IEC 1702
7、5 标准介绍,Page 16,质量管理八大原则,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 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),Page 17,安全与健康（1.5）,任何国家的认可活动
8、，都是以符合该国的安全与健康相关法律/法规为前提的实验室的活动，也应以遵守,Page 18,Management Requirements 管理要求,4.1 Organization组织组织4.2 Quality System质量体系4.3 Document Control文控4.4 Review of Requests,Tenders and Contracts合同评审4.5 Subcontracting of Tests and Calibrations检测和校准的分包4.6 Purchasing Services and Supplies服务和供应品的采购,4.7 Service to
9、the Client服务客户4.8 Complaints抱怨4.9 Control of Nonconforming Testing and/or Calibration Work不合格检测和校准的控制4.10 Improvement 改进4.11 Corrective Action纠正措施4.12 Preventive Action预防措施4.13 Control of Records纪录控制4.14 Internal Audits内审4.15 Management Reviews管理评审,Page 19,4.1 Organization(I)组织I,Legally responsible法
10、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 out 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 intere
11、st 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 laboratories三方实验室的独立性,Page 20,4.1 Organization(II)组织II,The 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)En
12、sure management and personnel are free from any 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
13、operational integrity方针和程序避免有损能力 公正 判断能力 诚实性,Page 21,4.1 Organization(III)组织III,e)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 interrelationships of all pers
14、onnel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 deputies for key mana
15、gerial personnel代理人,Page 22,关键人员（4.1.4）,关键人员的范围一般至少含：首席执行官（CEO）技术主管、授权签字人质量主管,Page 23,4.2 Quality System(I)质量体系I,Establish,Implement,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Document its policies,system,procedures and instructions文件化政策、制度、计划、程序和指导
16、书等等 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Quality Policy statement authorized by Chief 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 syst
17、em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ISO 17025,Page 24,质量方针与质量目标举例(仅供参考),实验室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室质量目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,Page 25,订定目标的原则-SMART,特定性(Specific)可衡量(Measurable)
18、可达成性v.s.有挑战性(Attainable)相关性(Relevant)时限性(Timeframe),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！,Page 26,实验室的工作范围,专业领域和学科 校准领域 检测领域 实验室的质量体系应覆盖其工作范围,Page 27,4.2 Quality System(II)质量体系II,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 syst
19、em概述质量体系文件结构Include or make reference to the supporting&technical 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,Page 28,4.3 Document Control(I)文件控制I,General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 documen
20、ts may 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 s
21、hall 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 assure a
22、gainst unintended use撤除作废文件,Page 29,文件的价值,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；提供适宜的培训；确保重复性和可追溯性；提供客观的证据；评价体系的有效性。文件的制定应是一项增值的活动,Page 30,4.3 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 identifi
23、ed(date of issue/revision,page numbering,total number of pages and issuing authority)唯一标识Document 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
24、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Procedure for changes to electronic documents shall be established 电子版文件更改的程序,Page 31,4.4 Review of Requests,Tenders and Contracts要求、标书和合同的评审I,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Req
25、uirements are defined,documented 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
26、审查所有被分包的工作,Page 32,4.4 Review of Requests,Tenders and Contracts要求、标书和合同的评审II,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Client shall be informed of any deviation from the contract对合同的任何偏离均应通知客户Changes to contract shall be reviewed an
27、d communicated to all affected personnel变更情况应评审并通知所有受影响的人员,Page 33,4.5 Subcontracting of Tests and Calibrations检测和校准的分包,Subcontracting of work:工作的分包Unforeseen reasons(e.g.workload,need for further expertise or temporary incapacity)不可预见原因Continuing basis(e.g.through permanent subcontracting,agency or
28、 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Advise the client in writing and gain approval when appropriate获得客户的批准Laboratory is responsible to the client for the subcontractors work,except client or regulatory authority specifies实验室就其分包方的工作对客户负责Maintain a
29、 register of all subcontractors保存所有分包方的注册资料,Page 34,4.6 Purchasing Services and Supplies服务和供应品的采购I,Policy and procedures for拥有的政策和程序Selection of services 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Purchasing documents shall be reviewed and a
30、pproved 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Inspection or verification of purchased services or materials:检查验证购买的服务和供应品Prior to use使用前Compliance with specified requirements符合要求Records shall be maintained保持记录,Page 35,4.6 Purchasing Services and Supplies服务和供应品的采购II,Evaluation
31、of suppliers for critical consumables and services:评价重要供应品和服务的供应商Records of evaluation 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,Page 36,4.7 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 perf
32、ormance监视其工作有关的操作Ensure 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,Pa
33、ge 37,4.7 Service to the Client服务顾客,应理解并明确客户要求合理准许客户 到现场监督开展定期的客户调查是简便有效的方法,.OFFER A SMILE.,Page 38,4.8 Complaints报怨,Policy and procedure for compliant resolution有政策和程序处理来自客户的抱怨Records shall be maintained:保持记录Complaints抱怨Investigations调查Corrective actions taken纠正措施,Page 39,4.9 Control of Nonconformi
34、ng Testing and/or Calibration Work(I)不符合检测和校准工作的控制I,Policy and procedures for deviations shall ensure that有政策和程序确保: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
35、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 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,Page 40,4.9 Control of Nonconforming Testing and/or Calibration Work(II)不符合检测和校准工作的控制II,Examp
36、les:例如 Customer complaints,Internal/External audits,Management 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 wh
37、ere the nonconforming work could recur不合格工作重复发生应立即运行4.11规定的纠正措施,Page 41,4.10 Improvement 改进,The laboratory shall continually improve the effectiveness of its management system through the use of:quality policyQuality objectivesAudit resultsAnalysis of dataCorrective and preventive actionsManagement
38、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。,Page 42,4.11 Corrective Action(I)纠正措施I,Establish 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Determine the root causes of the problem确定问题的根本原因Selection and implementation of corre
39、ctive 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文件化并执行任何需要的变更,Page 43,4.11 Corrective Action纠正措施II,Monitor the results to ensure that the
40、corrective actions taken have been effective监控结果确保措施有效Additional audits shall be done ASAP at appropriate areas in accordance with 4.13 where nonconformances not comply with laboratorys policies and procedures,or ISO 17025如果发现导致与实验室方针和程序不符合,应尽快实施附加审核 Note：问题严重或对业务有风险时采用，否则不强制要求进行。,Page 44,4.12 Preve
41、ntive Action预防措施,Develop,implement and monitor action plans when preventive action is required需要时制定监控措施计划To prevent from recurrence防止再发生To take advantage of the opportunities for improvement有利于持续改进Pro-active vs.Reactive(preventive vs.corrective action)事先对事后Procedure to ensure that the preventive act
42、ions are effective确保预防措施有效Preventive action might involve analysis of data,including trend and risk analysis and proficiency-testing results涉及数据分析,包括趋势（SPC）和风险水平和水平测试结果的分析,Page 45,纠正(Corrective)V.S.预防(Preventive),纠正解決已存在的问题被动的(Reactive)避免问题再发生通常为单一事件通常属于局部性的通常需要纠正对策消除问题的真因(治本),预防解決潜在的问题主动的(Proactive
43、)让问题不会发生资料分析/趋势分析通常为全面性的仅趋势不好时才需要采取对策消除潜在问题的真因,Page 46,趋势图与預防措施,月份,1 2 3 4 5 6 7 8 9 10 11 12,每月客诉件数,5,10,目标值：客诉件数每月小于10件,采取预防措施,趋势变差,趋势变好预防措施有效,Page 47,纠正与预防措施的步骤(8D),D1:成立问题处理小组D2:问题描述D3:采取临时的围堵措施D4:真因分析D5:采取永久的纠正措施D6:执行并确认纠正措施D7:防止再发生(预防措施)D8:肯定团队和个人表现,Page 48,4.13 Control of Records(I)记录的控制I,Pro
44、cedures for identification,collection,indexing,access,filing,storage,maintenance and disposal of quality and technical records应建立并维持识别、收集、索引、存取、存档、存放、维护和清理质量记录和技术记录的程序Quality records include internal audit&management review reports and records of corrective&preventive actions质量记录包括内审管理评审和纠正措施All rec
45、ords shall be legible,stored,retained and readily retrievable in a suitable environment所有记录应清晰明了，便于存放和保存Retention times shall be established规定保存时间All records shall be held secure and in confidence所有记录应保证安全保密Documented procedures to protect and back-up records stored electronically and to prevent una
46、uthorized access有程序来保护和备份以电子形式存储的记录，防止未经授权的侵入,Page 49,4.13 Control of Records(II)记录控制II,Retain records of original observations and derived data for a defined period对原始数据导出数据保持一定时间Sufficient for repetition充分可接受Identity of responsible personnel标识责任人Observations,data and calculations shall be recorded
47、观察值,数据和计算值应记录Mistakes in records shall be crossed out,not erased,and the correct value entered alongside and signed by the person making the correction出错记录不应擦掉应划去错值在旁标上正确值并签上姓名Equivalent measures shall be taken for electronic data to avoid loss or change of original data同样的措施对待电子数据,Page 50,4.14 Inte
48、rnal Audit内审,质量审核确定质量活动及其相关结果是否符合计划安排，以及这些安排是否有效贯彻并适合于达到目标的有系统的、独立的审查。（ISO8402）,Page 51,4.14 Internal Audit内审,Conduct internal audits periodically with a planned schedule 根据预定的日程表和程序定期进行Address all elements of the quality system 应涉及质量体系的全部要素Controlled by Quality Manager质量主管控制By trained and qualified
49、 personnel 由经过培训和有资格的人员来执行Take timely corrective action for any deviations应及时采取纠正措施Notify client in writing if doubt raised通知客户Area audited,audit findings and corrective actions taken shall be recorded审核活动的领域、审核发现和纠正措施应予以记录Implementation and effectiveness of the corrective action shall be verified a
50、nd recorded验证纠正措施有效性The cycle for IQA should normally be completed in one year 内审通常在一年内完成,Page 52,Lab Audit Process Approach实验室审过程方法审核,What is a Process and Process approach?什么是过程 和过程方法?,Page 53,Identification of Business Processes识别业务流程,COP(Customer oriented Processes)Product Realization Processes顾
