检测和校准实验室能力认可准则（ISOIEC 170252017）

1、Accreditation Criteria for the Competency of Testing and Calibration Laboratories 检测和校准实验室能力认可准则（ISO/IEC 17025:2017）CNAS-CL011ISO/IEC 17025修订进展 012015年年6月月工作小组草案（Work Draft；WD）2015年年8月月委员会草案1（Committee Draft1；CD1）22016年年2月月委员会草案2（Committee Draft2；CD2）2016年年12月月国际标准草案（Draft International Standard；DIS

2、）2017-8-14（投票期至（投票期至2017-10-9）最终国际标准版草案( Final Draft International Standard；FDIS )ISO P 成员，99%， IEC P成员，100%2017年年11月月国际标准版( International Standard；IS )0203040506ISO/IEC 17025修订 01020304主要原则主要原则与ISO 9001: 2015在管理要求上相协调采用新版术语标准，如 VIMLIMS广泛使用，如电子采集 数据和电子报告引入风险管理要求053简化主体内容，删 除不必要的注和解 释ISO/IEC 17025:20

3、05ISO/IEC 17025：20171 Scope1 范围2 Normative references2 引用标准3 Terms and definitions3 术语和定义4 Management requirements4 管理要求5 Technical requirements5 技术要求Annex A (informative) Nominal cross-references to ISO 9001:2000附录 ISO/IEC 17025 与 ISO9001:2000 的条款对照Annex B (informative) Guidelines for establishing

4、applications for specific fieldsBibliography参考文献1 Scope1 范围2 Normative references2规范性引用文件3 Terms and definitions3 术语和定义4 General requirements4 通用要求5 Structural requirements5 结构要求6 Resource requirements6 资源要求7 Process requirements7 过程要求8 Management requirements8 管理体系要求Annex A ( informative) Metrologi

5、cal traceability附录A （资料性）计量溯源性Annex B (informative) Management system in a laboratory附录B（资料性）实验室管理体系Bibliography参考文献Mandatory requirements4IntroductionThis document has been developed with the objective of promoting confidence in the operation of laboratories. This document contains requirements for

6、 laboratories to enable them to demonstrate they operate competently, and are able to generate valid results. Laboratories that conform to this document will also operate generally in accordance with the principles of ISO 9001.制定本准则的目的是增强对实验室运作的信任。本准则包含了 实验室能够证明其运作能力，并且能够产生出有效结果的要求。符 合本准则的实验室通常也是基本依

7、据ISO9001的原则来运作的。5效应的基础。实验室有责任确定要应对哪些风险和机遇。风险管理8.5 应对风险和机遇的措施（方式A）8.5 Actions to address risks and opportunities (Option A)IntroductionThis document requires the laboratory to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis fo

8、r increasing the effectiveness of the management system, achieving improved results and preventing negative effects. The laboratory is responsible for deciding which risks and opportunities need to be addressed.本准则要求实验室计划并采取措施应对风险和机遇。同时应对 风险和机遇是提升管理体系有效性、取得改进效果、以及预防负面6前 言7本准则等同采用 ISO/IEC 17025:2017“

9、检测和校准实验室能力的通用要求”。 本准则包含了检测和校准实验室为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。同时，本准则已包含了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，因此，符合本准则的检测和校准实验室，也是基本依据ISO 9001 的原则运作的。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。前言前言Introduction附录B（资料性附录）管理体系方式与ISO9001:2015的关系B.

10、3方式B（见8.1.3）允许实验室按照ISO 9001的要求建立和维持管理体系，并能支持 和证明持续符合第4条款至第7条款的要求。因此实验室实施第8条款的方式B，也是按 照ISO 9001运作的。实验室管理体系符合ISO 9001的要求，并不证明实验室具有出具 技术上有效的数据和结果的能力。此时，实验室还应符合第4条款至第7条款。8前言前言Introduction中国合格评定国家认可委员会（英文缩写：CNAS）使用本准则作为对检测和校 准实验室能力进行认可的基础。为支持特定领域的认可活动，CNAS 还根据不同领域 的专业特点，制定一系列的特定领域应用说明，对本准则的通用要求进行必要的补 充说明

11、和解释，但并不增加或减少本准则的要求。申请 CNAS 认可的实验室应同时满足本准则以及相应领域的应用说明。 本准则的附录是信息性的，不是要求，旨在帮助理解和实施本准则。9本准则规定了实验室能力公正性以及持续运作的通用要求。This document specifies the general requirements for the competence, impartiality and consistent operation of laboratories1范 围S c o p e101 范围范围S c o p e 本准则适用于所有从事实验室活动的组织，不论其人员数量多少。 This d

12、ocument is applicable to all organizations performing laboratory activities, regardless of the number of personnel.111 范围范围S c o p e 实验室的客户、法定管理机构、采用同行评审的组织和制度、认可机 构及其他机构使用本准则来确认或承认实验室能力。Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodi

13、es, and others use this document in confirming or recognizing the competence of laboratories.121 范围范围S c o p e CNAS-CL01：2006 检测和校准实验室能力认可准则删除e1.3 本标准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1.5 本标准不包含实验室运作中应符合的法规和安全要求1.6 如果检测和校准实验室遵守本准则的要求，其针对检测和校准所运作的质量管理体系也就满足了ISO 9001 的原则。附录提供了ISO/IEC 17025:2005 和

14、ISO 9001 标准的对照。本准则包含了ISO 9001 中未包含的技术能力要求。注 1：为确保这些要求应用的一致性，或许有必要对本准则的某些要求进行说 明或解释。注 2：如果实验室希望其部分或全部检测和校准活动获得认可，应当选择一个 依据ISO/IEC 17011 运作的认可机构。132 规范性引用文件Normative references本准则引用了下列文件，这些文件的部分或全部内容构成了本准则的要 求。对注明日期的引用文件，只采用引用的版本；对没有注明日期的引 用文件，采用最新的版本（包括任何的修订）。ISO/IEC 指南99 国际计量学词汇基本和通用概念及相关术语1） ISO/IE

15、C 17000 合格评定词汇和通用原则The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any

16、 amendments) applies.ISO/IEC Guide 99, International vocabulary of metrology Basic and general concepts and associated terms (VIM)ISO/IEC 17000, Conformity assessment Vocabulary and general principles1）也称为JCGM 200 (Joint Committee for Guides in Metrology)14ISO/IEC指南99和ISO/IEC 17000中界定的以及下述术语和定义适用于本准

17、 则。For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99 and ISO/IEC 17000 and the following apply.ISO和IEC维护的用于标准化的术语数据库地址如下：ISO and IEC maintain terminological databases for use in standardization at the following addresses:- ISO 在线浏览平台: /obp- ISO O

18、nline browsing platform: available at https:/ www .iso .org/ obp- IEC 电子开放平台: /- IEC Electropedia: available at http:/ www .electropedia .org/3 术语和定义Terms and definitions153.1 impartialitypresence of objectivity公正性客观性的存在。Note 1 to entry: Objectivity means that conflicts of

19、interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory (3.6).注1：客观性意味着不存在或已解决利益冲突，不会对实验室（3.6）的活动产生不利影响。Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “independence”, “freedom from conflict of inte

20、rests”, “freedom from bias”, “lack of prejudice”,“neutrality”, “fairness”, “open-mindedness”, “even-handedness”, “detachment”, “balance”.注2：其他可用于表示公正性的要素的术语包括：无利益冲突、没有成见、没有偏见、中 立、公平、思想开明、不偏不倚、不受他人影响、平衡。SOURCE: ISO/IEC 17021-1:2015, 3.2, modified The words “the certification body” have been replaced

21、by “the laboratory” in Note 1 to entry.源自: ISO/IEC 17021-1:2015, 3.2，修改在注1中以“实验室”代替“认证机构”3 术语和定义术语和定义Terms and definitions163.2 Complaint投诉expression of dissatisfaction by any person or organization to a laboratory (3.6), relating to the activities or results of that laboratory, where a response is

22、expected 任何人员或组织向实验室（3.6）就其活动或结果表达不满意，并期望得到回 复的行为。SOURCE: ISO/IEC 17000:2004, 6.5, modified The words “other than appeal” have been deleted, and the words “a conformity assessment body or accreditation body, relating to the activities of that body” have been replaced by “a laboratory, relating to th

23、e activities or results of that laboratory”.源自: ISO 17000:2004, 6.5 修改删除了“除申诉外”，以“实验室就其活动或结 果”代替“合格评定机构或认可机构就其活动”3 术语和定义术语和定义Terms and definitions173 术语和定义术语和定义Terms and definitions3.3 interlaboratory comparison实验室间比对organization, performance and evaluation of measurements or tests on the same or si

24、milar items by two or more laboratories in accordance with predetermined conditions 按照预先规定的条件，由两个或多个实验室对相同或类似的物品进行测 量或检测的组织、实施和评价。SOURCE: ISO/IEC 17043:2010, 3.4源自: ISO/IEC 17043:2010, 3.4183 术语和定义术语和定义Terms and definitions4. intralaboratory comparison实验室内比对organization, performance and evaluation o

25、f measurements or tests on the same or similar items, within the same laboratory (3.6), in accordance with predetermined conditions 按照预先规定的条件，在同一实验室（3.6）内部对相同或类似的物品进 行测量或检测的组织、实施和评价。5. proficiency testing能力验证evaluation of participant performance against pre-established criteria by means of interlabo

26、ratory comparisons (3.3) 利用实验室间比对，按照预先制定的准则评价参加者的能力。 SOURCE: ISO/IEC 17043:2010, 3.7, modified Notes to entry have been deleted. 源自: ISO/IEC 17043:2010, 3.7修改:删除了注193 术语和定义术语和定义Terms and definitions3.6 Laboratory实验室body that performs one or more of the following activities: testing calibration sampl

27、ing, associated with subsequent testing or calibration从事下列一个或多个活动的机构检测校准与后续检测或校准相关的抽样Note 1 to entry: In the context of this document, “laboratory activities” refer to the three above-mentioned activities.注1：在本准则中，“实验室活动”指上述三种活动。3.7 decision rule判定规则rule that describes how measurement uncertainty is

28、 accounted for when stating conformity with a specified requirement 当声明与规定要求的符合性时，描述如何考虑测量不确定度的规则。203 术语和定义术语和定义Terms and definitions3.8 Verification验证provision of objective evidence that a given item fulfils specified requirements提供客观证据，证明给定项目满足规定要求。EXAMPLE 1 Confirmation that a given reference mat

29、erial as claimed is homogeneous for the quantity value and measurement procedure concerned, down to a measurement portion having a mass of 10 mg. 例1：证实在测量取样量小至10mg时，对于相关量值和测量程序而言，给定 标准物质的均匀性与其声称的一致。EXAMPLE 2 Confirmation that performance properties or legal requirements of a measuring system are ach

30、ieved.例2：证实已达到测量系统的性能或法定要求。EXAMPLE 3 Confirmation that a target measurement uncertainty can be met.例3：证实可满足目标测量不确定度。21Note 1 to entry: When applicable, measurement uncertainty should be taken into consideration.注1：适用时，宜考虑测量不确定度。Note 2 to entry: The item may be, for example, a process, measurement pr

31、ocedure, material, compound, or measuring system.注2：项目可以是，例如一个过程、测量程序、物质、化合物或测量系统。Note 3 to entry: The specified requirements may be, for example, that a manufacturers specifications are met.注3：规定要求可以是如满足生产商的规定。Note 4 to entry: Verification in legal metrology, as defined in VIML, and in conformity a

32、ssessment in general, pertains to the examination and marking and/or issuing of a verification certificate for ameasuring system. 注4：在VIML中定义的法制计量中的验证，以及通常在合格评定中的验证，是指对测量系统的检 查并加标记和/或出具验证证书。（译者注：在我国的法制计量领域，“verification”翻译为 “检定”）3 术语和定义术语和定义Terms and definitions223 术语和定义术语和定义Terms and definitionsNot

33、e 5 to entry: Verification should not be confused with calibration. Not every verification is a validation (3.9).注5：验证不宜与校准混淆。不是每个验证都是确认。Note 6 to entry: In chemistry, verification of the identity of the entity involved, or of activity, requires a description of the structure or properties of that e

34、ntity or activity. 注6：在化学中，验证实体特性或活性时，需要描述该实体或活性的结构或特性。 SOURCE: ISO/IEC Guide 99:2007, 2.44源自: ISO/IEC 指南99:2007，2.44233 术语和定义术语和定义Terms and definitions3.9 Validation确认verification (3.8), where the specified requirements are adequate for an intended use对规定要求满足预期用途的验证（3.8）。EXAMPLE A measurement proce

35、dure, ordinarily used for the measurement of mass concentration of nitrogen in water, may be validated also for measurement of mass concentration of nitrogen in human serum. 示例：一个通常用于测量水中氮的质量浓度的测量程序，也可被确认为可用于测量 人体血清中氮的质量浓度。SOURCE: ISO/IEC Guide 99:2007, 2.45源自: ISO/IEC 指南99:2007，2.45244 通用要求General

36、requirements公正性Impartiality25保密性Confidentiality4.1 公正性Impartiality4.1.1 实验室应公正地实施实验室活动，并从组织结构和管理上保证 公正性。Laboratory activities shall be undertaken impartially and structured and managed so as to safeguard impartiality.4.1.2 实验室管理层应做出公正性承诺。The laboratory management shall be committed to impartiality.不

37、仅管理层做公正性承诺，全体员工都有公正性承诺，设计公正性承诺表格 规定一年一签，新进员工必签如果实验室为非独立实验室则双公正性声明4 通用要求264.1.3 实验室应对实验室活动的公正性负责，不允许商业、财务或其 他方面的压力损害公正性。The laboratory shall be responsible for the impartiality of its laboratory activities and shall not allow commercial, financial or other pressures to compromise impartiality4 通用要求通用

38、要求General requirements4.1 公正性I m p a r t i a l i t y 274.1.4 实验室应持续识别影响公正性的风险。这些风险应包括其活动、 实验室的各种关系，或者实验室人员的关系而引发的风险。然而，这 些关系并非一定会对实验室的公正性产生风险。The laboratory shall identify risks to its impartiality on an on-going basis. This shall include those risks that arise from its activities, or from its relat

39、ionships, or from the relationships of its personnel. However, such relationships do not necessarily present a laboratory with a risk to impartiality.注：危及实验室公正性的关系可能基于所有权、控制权、管理、人员、共享资源、财 务、合同、市场营销（包括品牌）、支付销售佣金或其它引荐新客户的奖酬等。NEWNOTE A relationship that threatens the impartiality of the laboratory can

40、be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales commission or other inducement for the referral of new customers, etc.4 通用要求通用要求General requirements284.1 公正性I m p a r t i a l i t y 4.1.5 如果识别出公正性风

41、险，实验室应能够证明如何消除或最大程 度减小这种风险If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it eliminates or minimizes such risk.4 通用要求通用要求General requirements294.1 公正性I m p a r t i a l i t y 4 通用要求通用要求General requirements4.1 公正性I m p a r t i a l i t y VSISO/IEC 17025:2017ISO/

42、IEC 17025:2005涉及公正性条款2个涉及公正性条款5个， 新增4个扩大了公正性范围，由第三 方实验室扩展到全部实验室4.1.4 注24.1.5 d30由政策和程序避免降低公正 性，转向从组织结构和管理 保证公正性CNAS-CL01：2006 检测和校准实验室能力认可准则 4.1.4 如果实验室所在的组织还从事检测和/或校准以外的活动，为识别 潜在利益冲突，应规定该组织中涉及检测和/或校准、或对检测和/或校 准有影响的关键人员的职责。注 1：如果实验室是某个较大组织的一部分，该组织应当使其有利益冲突的部分，如生产、 商业营销或财务部门，不对实验室满足本准则的要求产生不良影响。注 2：如

43、果实验室希望作为第三方实验室得到承认，实验室应能证明其公正性，并能证明实 验室及其员工不受任何可能影响其技术判断的、不正当的商业、财务或其他方面的压力。第三方 检测或校准实验室不应当参与任何可能损害其判断独立性和检测或校准诚信度的活动。4.1.5 实验室应：d) 有政策和程序以避免卷入任何会降低其在能力、公正性、判断力或运 作诚实性方面的可信度的活动；4 通用要求通用要求General requirements4.1 公正性I m p a r t i a l i t y 314.2 保密性Confidentiality4.2.1 实验室应通过做出具有法律效力的承诺，对在实验室活动中获 得或产生

44、的信息承担管理责任。实验室应将其准备公开的信息事先通 知客户。除客户公开的信息，或实验室与客户有约定（例如：为回应 投诉的目的），其他所有信息都被视为专属信息，应予保密。The laboratory shall be responsible, through legally enforceable commitments, for the management of all information obtained or created during the performance of laboratory activities. The laboratory shall inform th

45、e customer in advance, of the information it intends to place in the public domain. Except for information that the customer makes publicly available, or when agreed between the laboratory and the customer (e.g. for the purpose of responding to complaints), all other information is considered propri

46、etary information and shall be regarded as confidential.4 通用要求324.2.2 实验室依据法律要求或合同授权透露保密信息时，除法律禁止 外，所提供的信息应通知到相关客户或个人。When the laboratory is required by law or authorized by contractual arrangements to release confidential information, the customer or individual concerned shall, unless prohibited by

47、 law, be notified of the information provided.4.2.3 从客户以外渠道（如投诉人、监管机构）获取有关客户的信息， 应在客户和实验室间保密。除非信息的提供方同意，实验室应对信息 的提供方（来源）保密，且不应告知客户。Information about the customer obtained from sources other than the customer (e.g. complainant, regulators) shall be confidential between the customer and the laboratory

48、. The provider (source) of this information shall be confidential to the laboratory and shall not be shared with the customer, unless agreed by the source.334 通用要求通用要求General requirements4.2 保密性Confidentiality4.2.4 人员，包括委员会委员、合同方、外部机构人员或代表实验室 的个人，应对在实施实验室活动过程中所获得或产生的所有信息保密， 法律要求除外。Personnel, includi

49、ng any committee members, contractors, personnel of external bodies, or individuals acting on the laboratorys behalf, shall keep confidential all information obtained or created during the performance of laboratory activities, except as required by law.4 通用要求通用要求General requirements344.2 保密性Confiden

50、tiality4 通用要求通用要求General requirementsVSISO/IEC 17025:2005涉及保密性条款1个涉及保密性条款4个， 新增3个要求更高，由政策和程序要 求，转向做出具有法律效力 的承诺4.2 保密性Confidentiality4.1.5 c）保护保密ISO/IEC 17025:2017354 通用要求通用要求General requirements4.2 保密性ConfidentialityCNAS-CL01：2006 检测和校准实验室能力认可准则4.1.5 实验室应：c) 有保护客户的机密信息和所有权的政策和程序，包括保护 电子存储和传输结果的程序；36

51、5 结构要求Structural requirements5.1 实验室应为法律实体，或法律实体中被明确界定的一部分，该实 体对实验室活动承担法律责任。The laboratory shall be a legal entity, or a defined part of a legal entity, that is legally responsible for its laboratory activities.注：在本准则中，政府实验室基于其政府地位被视为法律实体。NOTE For the purposes of this document, a governmental labora

52、tory is deemed to be a legal entity on the basis of its governmental status.375 结构要求结构要求Structural requirements5.2 实验室应确定对实验室全权负责的管理层。The laboratory shall identify management that has overall responsibility for the laboratory.385 结构要求结构要求Structural requirements5.3 实验室应规定符合本准则的实验室活动范围并制定成文件。实验 室仅应声明符

53、合本准则的实验室活动范围，不应包括持续从外部获得 的实验室活动。The laboratory shall define and document the range of laboratory activities for which it conforms with this document. The laboratory shall only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory a

54、ctivities on an ongoing basis.分包subcontract395 结构要求结构要求Structural requirements5.4 实验室应以满足本准则、实验室客户、法定管理机构和提供承认 的组织要求的方式开展实验室活动，这包括实验室在固定设施、固定 设施以外的地点，在临时或移动设施、客户的设施中实施的实验室活 动。Laboratory activities shall be carried out in such a way as to meet the requirements of this document, the laboratorys custom

55、ers, regulatory authorities and organizations providing recognition. This shall include laboratory activities performed in all its permanent facilities, at sites away from its permanent facilities, in associated temporary or mobile facilities or at a customers facility.405 结构要求结构要求Structural require

56、ments5.5 实验室应：The laboratory shall:a) 确定实验室的组织和管理结构、其在母体组织中的位置，以及管 理、技术运作和支持服务间的关系；define the organization and management structure of the laboratory, its place in any parent organization, and the relationships between management, technical operations and support services;41b) 规定对实验室活动结果有影响的所有管理、操作或

57、验证人员的职责、 权力和相互关系;specify the responsibility, authority and interrelationship of all personnel who manage, perform or verify work affecting the results of laboratory activities;5 结构要求结构要求Structural requirementsc) 将程序形成文件的程度以确保实验室活动实施的一致性和结果有效性 为原则。document its procedures to the extent necessary to en

58、sure the consistent application of its laboratory activities and the validity of the results.425.6 实验室人员应具有履行职责所需的权利和资源（不论其他职责）， 这些职责包括：The laboratory shall have personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including:a)实施、保

59、持和改进管理体系；implementation, maintenance and improvement of the management system;b)识别与管理体系或实验室活动程序的偏离；identification of deviations from the management system or from the procedures for performing laboratory activities; c)采取措施以预防或最大程度减少这类偏离;initiation of actions to prevent or minimize such deviations;5

60、结构要求结构要求Structural requirements435 结构要求结构要求Structural requirementsd)向实验室管理层报告管理体系运行状况和改进需求；reporting to laboratory management on the performance of the management system and any need for improvement;e)确保实验室活动的有效性。ensuring the effectiveness of laboratory activities.445.7 实验室管理层应确保：Laboratory manageme