檢測和校準(zhǔn)實驗室能力認(rèn)可準(zhǔn)則（ISOIEC 170252017）

1、Accreditation Criteria for the Competency of Testing and Calibration Laboratories 檢測和校準(zhǔn)實驗室能力認(rèn)可準(zhǔn)則（ISO/IEC 17025:2017）CNAS-CL011ISO/IEC 17025修訂進(jìn)展 012015年年6月月工作小組草案（Work Draft；WD）2015年年8月月委員會草案1（Committee Draft1；CD1）22016年年2月月委員會草案2（Committee Draft2；CD2）2016年年12月月國際標(biāo)準(zhǔn)草案（Draft International Standard；DIS

2、）2017-8-14（投票期至（投票期至2017-10-9）最終國際標(biāo)準(zhǔn)版草案( Final Draft International Standard；FDIS )ISO P 成員，99%， IEC P成員，100%2017年年11月月國際標(biāo)準(zhǔn)版( International Standard；IS )0203040506ISO/IEC 17025修訂 01020304主要原則主要原則與ISO 9001: 2015在管理要求上相協(xié)調(diào)采用新版術(shù)語標(biāo)準(zhǔn)，如 VIMLIMS廣泛使用，如電子采集 數(shù)據(jù)和電子報告引入風(fēng)險管理要求053簡化主體內(nèi)容，刪 除不必要的注和解 釋ISO/IEC 17025:20

3、05ISO/IEC 17025：20171 Scope1 范圍2 Normative references2 引用標(biāo)準(zhǔn)3 Terms and definitions3 術(shù)語和定義4 Management requirements4 管理要求5 Technical requirements5 技術(shù)要求Annex A (informative) Nominal cross-references to ISO 9001:2000附錄 ISO/IEC 17025 與 ISO9001:2000 的條款對照Annex B (informative) Guidelines for establishing

4、applications for specific fieldsBibliography參考文獻(xiàn)1 Scope1 范圍2 Normative references2規(guī)范性引用文件3 Terms and definitions3 術(shù)語和定義4 General requirements4 通用要求5 Structural requirements5 結(jié)構(gòu)要求6 Resource requirements6 資源要求7 Process requirements7 過程要求8 Management requirements8 管理體系要求Annex A ( informative) Metrologi

5、cal traceability附錄A （資料性）計量溯源性Annex B (informative) Management system in a laboratory附錄B（資料性）實驗室管理體系Bibliography參考文獻(xiàn)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.制定本準(zhǔn)則的目的是增強對實驗室運作的信任。本準(zhǔn)則包含了 實驗室能夠證明其運作能力，并且能夠產(chǎn)生出有效結(jié)果的要求。符 合本準(zhǔn)則的實驗室通常也是基本依

7、據(jù)ISO9001的原則來運作的。5效應(yīng)的基礎(chǔ)。實驗室有責(zé)任確定要應(yīng)對哪些風(fēng)險和機遇。風(fēng)險管理8.5 應(yīng)對風(fēng)險和機遇的措施（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.本準(zhǔn)則要求實驗室計劃并采取措施應(yīng)對風(fēng)險和機遇。同時應(yīng)對 風(fēng)險和機遇是提升管理體系有效性、取得改進(jìn)效果、以及預(yù)防負(fù)面6前 言7本準(zhǔn)則等同采用 ISO/IEC 17025:2017“

9、檢測和校準(zhǔn)實驗室能力的通用要求”。 本準(zhǔn)則包含了檢測和校準(zhǔn)實驗室為證明其按管理體系運行、具有技術(shù)能力并能 提供正確的技術(shù)結(jié)果所必須滿足的所有要求。同時，本準(zhǔn)則已包含了ISO 9001 中與 實驗室管理體系所覆蓋的檢測和校準(zhǔn)服務(wù)有關(guān)的所有要求，因此，符合本準(zhǔn)則的檢測和校準(zhǔn)實驗室，也是基本依據(jù)ISO 9001 的原則運作的。實驗室質(zhì)量管理體系符合ISO 9001 的要求，并不證明實驗室具有出具技術(shù)上有 效數(shù)據(jù)和結(jié)果的能力；實驗室質(zhì)量管理體系符合本準(zhǔn)則，也不意味其運作符合ISO 9001 的所有要求。前言前言Introduction附錄B（資料性附錄）管理體系方式與ISO9001:2015的關(guān)系B.

10、3方式B（見8.1.3）允許實驗室按照ISO 9001的要求建立和維持管理體系，并能支持 和證明持續(xù)符合第4條款至第7條款的要求。因此實驗室實施第8條款的方式B，也是按 照ISO 9001運作的。實驗室管理體系符合ISO 9001的要求，并不證明實驗室具有出具 技術(shù)上有效的數(shù)據(jù)和結(jié)果的能力。此時，實驗室還應(yīng)符合第4條款至第7條款。8前言前言Introduction中國合格評定國家認(rèn)可委員會（英文縮寫：CNAS）使用本準(zhǔn)則作為對檢測和校 準(zhǔn)實驗室能力進(jìn)行認(rèn)可的基礎(chǔ)。為支持特定領(lǐng)域的認(rèn)可活動，CNAS 還根據(jù)不同領(lǐng)域 的專業(yè)特點，制定一系列的特定領(lǐng)域應(yīng)用說明，對本準(zhǔn)則的通用要求進(jìn)行必要的補 充說明

11、和解釋，但并不增加或減少本準(zhǔn)則的要求。申請 CNAS 認(rèn)可的實驗室應(yīng)同時滿足本準(zhǔn)則以及相應(yīng)領(lǐng)域的應(yīng)用說明。 本準(zhǔn)則的附錄是信息性的，不是要求，旨在幫助理解和實施本準(zhǔn)則。9本準(zhǔn)則規(guī)定了實驗室能力公正性以及持續(xù)運作的通用要求。This document specifies the general requirements for the competence, impartiality and consistent operation of laboratories1范 圍S c o p e101 范圍范圍S c o p e 本準(zhǔn)則適用于所有從事實驗室活動的組織，不論其人員數(shù)量多少。 This d

12、ocument is applicable to all organizations performing laboratory activities, regardless of the number of personnel.111 范圍范圍S c o p e 實驗室的客戶、法定管理機構(gòu)、采用同行評審的組織和制度、認(rèn)可機 構(gòu)及其他機構(gòu)使用本準(zhǔn)則來確認(rèn)或承認(rèn)實驗室能力。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 范圍范圍S c o p e CNAS-CL01：2006 檢測和校準(zhǔn)實驗室能力認(rèn)可準(zhǔn)則刪除e1.3 本標(biāo)準(zhǔn)中的注是對正文的說明、舉例和指導(dǎo)。它們既不包含要求，也不構(gòu) 成本準(zhǔn)則的主體部分1.5 本標(biāo)準(zhǔn)不包含實驗室運作中應(yīng)符合的法規(guī)和安全要求1.6 如果檢測和校準(zhǔn)實驗室遵守本準(zhǔn)則的要求，其針對檢測和校準(zhǔn)所運作的質(zhì)量管理體系也就滿足了ISO 9001 的原則。附錄提供了ISO/IEC 17025:2005 和

14、ISO 9001 標(biāo)準(zhǔn)的對照。本準(zhǔn)則包含了ISO 9001 中未包含的技術(shù)能力要求。注 1：為確保這些要求應(yīng)用的一致性，或許有必要對本準(zhǔn)則的某些要求進(jìn)行說 明或解釋。注 2：如果實驗室希望其部分或全部檢測和校準(zhǔn)活動獲得認(rèn)可，應(yīng)當(dāng)選擇一個 依據(jù)ISO/IEC 17011 運作的認(rèn)可機構(gòu)。132 規(guī)范性引用文件Normative references本準(zhǔn)則引用了下列文件，這些文件的部分或全部內(nèi)容構(gòu)成了本準(zhǔn)則的要 求。對注明日期的引用文件，只采用引用的版本；對沒有注明日期的引 用文件，采用最新的版本（包括任何的修訂）。ISO/IEC 指南99 國際計量學(xué)詞匯基本和通用概念及相關(guān)術(shù)語1） ISO/IE

15、C 17000 合格評定詞匯和通用原則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）也稱為JCGM 200 (Joint Committee for Guides in Metrology)14ISO/IEC指南99和ISO/IEC 17000中界定的以及下述術(shù)語和定義適用于本準(zhǔn)

17、 則。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維護(hù)的用于標(biāo)準(zhǔn)化的術(shù)語數(shù)據(jù)庫地址如下：ISO and IEC maintain terminological databases for use in standardization at the following addresses:- ISO 在線瀏覽平臺: /obp- ISO O

18、nline browsing platform: available at https:/ www .iso .org/ obp- IEC 電子開放平臺: /- IEC Electropedia: available at http:/ www .electropedia .org/3 術(shù)語和定義Terms and definitions153.1 impartialitypresence of objectivity公正性客觀性的存在。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：客觀性意味著不存在或已解決利益沖突，不會對實驗室（3.6）的活動產(chǎn)生不利影響。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”, “l(fā)ack 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術(shù)語包括：無利益沖突、沒有成見、沒有偏見、中 立、公平、思想開明、不偏不倚、不受他人影響、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“實驗室”代替“認(rèn)證機構(gòu)”3 術(shù)語和定義術(shù)語和定義Terms and definitions163.2 Complaint投訴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 任何人員或組織向?qū)嶒炇遥?.6）就其活動或結(jié)果表達(dá)不滿意，并期望得到回 復(fù)的行為。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 修改刪除了“除申訴外”，以“實驗室就其活動或結(jié) 果”代替“合格評定機構(gòu)或認(rèn)可機構(gòu)就其活動”3 術(shù)語和定義術(shù)語和定義Terms and definitions173 術(shù)語和定義術(shù)語和定義Terms and definitions3.3 interlaboratory comparison實驗室間比對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 按照預(yù)先規(guī)定的條件，由兩個或多個實驗室對相同或類似的物品進(jìn)行測 量或檢測的組織、實施和評價。SOURCE: ISO/IEC 17043:2010, 3.4源自: ISO/IEC 17043:2010, 3.4183 術(shù)語和定義術(shù)語和定義Terms and definitions4. intralaboratory comparison實驗室內(nèi)比對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 按照預(yù)先規(guī)定的條件，在同一實驗室（3.6）內(nèi)部對相同或類似的物品進(jìn) 行測量或檢測的組織、實施和評價。5. proficiency testing能力驗證evaluation of participant performance against pre-established criteria by means of interlabo

26、ratory comparisons (3.3) 利用實驗室間比對，按照預(yù)先制定的準(zhǔn)則評價參加者的能力。 SOURCE: ISO/IEC 17043:2010, 3.7, modified Notes to entry have been deleted. 源自: ISO/IEC 17043:2010, 3.7修改:刪除了注193 術(shù)語和定義術(shù)語和定義Terms and definitions3.6 Laboratory實驗室body that performs one or more of the following activities: testing calibration sampl

27、ing, associated with subsequent testing or calibration從事下列一個或多個活動的機構(gòu)檢測校準(zhǔn)與后續(xù)檢測或校準(zhǔn)相關(guān)的抽樣Note 1 to entry: In the context of this document, “l(fā)aboratory activities” refer to the three above-mentioned activities.注1：在本準(zhǔn)則中，“實驗室活動”指上述三種活動。3.7 decision rule判定規(guī)則rule that describes how measurement uncertainty is

28、 accounted for when stating conformity with a specified requirement 當(dāng)聲明與規(guī)定要求的符合性時，描述如何考慮測量不確定度的規(guī)則。203 術(shù)語和定義術(shù)語和定義Terms and definitions3.8 Verification驗證provision of objective evidence that a given item fulfils specified requirements提供客觀證據(jù)，證明給定項目滿足規(guī)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：證實在測量取樣量小至10mg時，對于相關(guān)量值和測量程序而言，給定 標(biāo)準(zhǔn)物質(zhì)的均勻性與其聲稱的一致。EXAMPLE 2 Confirmation that performance properties or legal requirements of a measuring system are ach

30、ieved.例2：證實已達(dá)到測量系統(tǒng)的性能或法定要求。EXAMPLE 3 Confirmation that a target measurement uncertainty can be met.例3：證實可滿足目標(biāo)測量不確定度。21Note 1 to entry: When applicable, measurement uncertainty should be taken into consideration.注1：適用時，宜考慮測量不確定度。Note 2 to entry: The item may be, for example, a process, measurement pr

31、ocedure, material, compound, or measuring system.注2：項目可以是，例如一個過程、測量程序、物質(zhì)、化合物或測量系統(tǒng)。Note 3 to entry: The specified requirements may be, for example, that a manufacturers specifications are met.注3：規(guī)定要求可以是如滿足生產(chǎn)商的規(guī)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中定義的法制計量中的驗證，以及通常在合格評定中的驗證，是指對測量系統(tǒng)的檢 查并加標(biāo)記和/或出具驗證證書。（譯者注：在我國的法制計量領(lǐng)域，“verification”翻譯為 “檢定”）3 術(shù)語和定義術(shù)語和定義Terms and definitions223 術(shù)語和定義術(shù)語和定義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：驗證不宜與校準(zhǔn)混淆。不是每個驗證都是確認(rèn)。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：在化學(xué)中，驗證實體特性或活性時，需要描述該實體或活性的結(jié)構(gòu)或特性。 SOURCE: ISO/IEC Guide 99:2007, 2.44源自: ISO/IEC 指南99:2007，2.44233 術(shù)語和定義術(shù)語和定義Terms and definitions3.9 Validation確認(rèn)verification (3.8), where the specified requirements are adequate for an intended use對規(guī)定要求滿足預(yù)期用途的驗證（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：一個通常用于測量水中氮的質(zhì)量濃度的測量程序，也可被確認(rèn)為可用于測量 人體血清中氮的質(zhì)量濃度。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 實驗室應(yīng)公正地實施實驗室活動，并從組織結(jié)構(gòu)和管理上保證 公正性。Laboratory activities shall be undertaken impartially and structured and managed so as to safeguard impartiality.4.1.2 實驗室管理層應(yīng)做出公正性承諾。The laboratory management shall be committed to impartiality.不

37、僅管理層做公正性承諾，全體員工都有公正性承諾，設(shè)計公正性承諾表格 規(guī)定一年一簽，新進(jìn)員工必簽如果實驗室為非獨立實驗室則雙公正性聲明4 通用要求264.1.3 實驗室應(yīng)對實驗室活動的公正性負(fù)責(zé)，不允許商業(yè)、財務(wù)或其 他方面的壓力損害公正性。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 實驗室應(yīng)持續(xù)識別影響公正性的風(fēng)險。這些風(fēng)險應(yīng)包括其活動、 實驗室的各種關(guān)系，或者實驗室人員的關(guān)系而引發(fā)的風(fēng)險。然而，這 些關(guān)系并非一定會對實驗室的公正性產(chǎn)生風(fēng)險。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：危及實驗室公正性的關(guān)系可能基于所有權(quán)、控制權(quán)、管理、人員、共享資源、財 務(wù)、合同、市場營銷（包括品牌）、支付銷售傭金或其它引薦新客戶的獎酬等。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 如果識別出公正性風(fēng)

41、險，實驗室應(yīng)能夠證明如何消除或最大程 度減小這種風(fēng)險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涉及公正性條款2個涉及公正性條款5個， 新增4個擴大了公正性范圍，由第三 方實驗室擴展到全部實驗室4.1.4 注24.1.5 d30由政策和程序避免降低公正 性，轉(zhuǎn)向從組織結(jié)構(gòu)和管理 保證公正性CNAS-CL01：2006 檢測和校準(zhǔn)實驗室能力認(rèn)可準(zhǔn)則 4.1.4 如果實驗室所在的組織還從事檢測和/或校準(zhǔn)以外的活動，為識別 潛在利益沖突，應(yīng)規(guī)定該組織中涉及檢測和/或校準(zhǔn)、或?qū)z測和/或校 準(zhǔn)有影響的關(guān)鍵人員的職責(zé)。注 1：如果實驗室是某個較大組織的一部分，該組織應(yīng)當(dāng)使其有利益沖突的部分，如生產(chǎn)、 商業(yè)營銷或財務(wù)部門，不對實驗室滿足本準(zhǔn)則的要求產(chǎn)生不良影響。注 2：如

43、果實驗室希望作為第三方實驗室得到承認(rèn)，實驗室應(yīng)能證明其公正性，并能證明實 驗室及其員工不受任何可能影響其技術(shù)判斷的、不正當(dāng)?shù)纳虡I(yè)、財務(wù)或其他方面的壓力。第三方 檢測或校準(zhǔn)實驗室不應(yīng)當(dāng)參與任何可能損害其判斷獨立性和檢測或校準(zhǔn)誠信度的活動。4.1.5 實驗室應(yīng)：d) 有政策和程序以避免卷入任何會降低其在能力、公正性、判斷力或運 作誠實性方面的可信度的活動；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 實驗室應(yīng)通過做出具有法律效力的承諾，對在實驗室活動中獲 得或產(chǎn)生

44、的信息承擔(dān)管理責(zé)任。實驗室應(yīng)將其準(zhǔn)備公開的信息事先通 知客戶。除客戶公開的信息，或?qū)嶒炇遗c客戶有約定（例如：為回應(yīng) 投訴的目的），其他所有信息都被視為專屬信息，應(yīng)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 實驗室依據(jù)法律要求或合同授權(quán)透露保密信息時，除法律禁止 外，所提供的信息應(yīng)通知到相關(guān)客戶或個人。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 從客戶以外渠道（如投訴人、監(jiān)管機構(gòu)）獲取有關(guān)客戶的信息， 應(yīng)在客戶和實驗室間保密。除非信息的提供方同意，實驗室應(yīng)對信息 的提供方（來源）保密，且不應(yīng)告知客戶。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 人員，包括委員會委員、合同方、外部機構(gòu)人員或代表實驗室 的個人，應(yīng)對在實施實驗室活動過程中所獲得或產(chǎn)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涉及保密性條款1個涉及保密性條款4個， 新增3個要求更高，由政策和程序要 求，轉(zhuǎn)向做出具有法律效力 的承諾4.2 保密性Confidentiality4.1.5 c）保護(hù)保密ISO/IEC 17025:2017354 通用要求通用要求General requirements4.2 保密性ConfidentialityCNAS-CL01：2006 檢測和校準(zhǔn)實驗室能力認(rèn)可準(zhǔn)則4.1.5 實驗室應(yīng)：c) 有保護(hù)客戶的機密信息和所有權(quán)的政策和程序，包括保護(hù) 電子存儲和傳輸結(jié)果的程序；36

51、5 結(jié)構(gòu)要求Structural requirements5.1 實驗室應(yīng)為法律實體，或法律實體中被明確界定的一部分，該實 體對實驗室活動承擔(dān)法律責(zé)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：在本準(zhǔn)則中，政府實驗室基于其政府地位被視為法律實體。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 結(jié)構(gòu)要求結(jié)構(gòu)要求Structural requirements5.2 實驗室應(yīng)確定對實驗室全權(quán)負(fù)責(zé)的管理層。The laboratory shall identify management that has overall responsibility for the laboratory.385 結(jié)構(gòu)要求結(jié)構(gòu)要求Structural requirements5.3 實驗室應(yīng)規(guī)定符合本準(zhǔn)則的實驗室活動范圍并制定成文件。實驗 室僅應(yīng)聲明符

53、合本準(zhǔn)則的實驗室活動范圍，不應(yīng)包括持續(xù)從外部獲得 的實驗室活動。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 結(jié)構(gòu)要求結(jié)構(gòu)要求Structural requirements5.4 實驗室應(yīng)以滿足本準(zhǔn)則、實驗室客戶、法定管理機構(gòu)和提供承認(rèn) 的組織要求的方式開展實驗室活動，這包括實驗室在固定設(shè)施、固定 設(shè)施以外的地點，在臨時或移動設(shè)施、客戶的設(shè)施中實施的實驗室活 動。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 結(jié)構(gòu)要求結(jié)構(gòu)要求Structural require

56、ments5.5 實驗室應(yīng)：The laboratory shall:a) 確定實驗室的組織和管理結(jié)構(gòu)、其在母體組織中的位置，以及管 理、技術(shù)運作和支持服務(wù)間的關(guān)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) 規(guī)定對實驗室活動結(jié)果有影響的所有管理、操作或

57、驗證人員的職責(zé)、 權(quán)力和相互關(guān)系;specify the responsibility, authority and interrelationship of all personnel who manage, perform or verify work affecting the results of laboratory activities;5 結(jié)構(gòu)要求結(jié)構(gòu)要求Structural requirementsc) 將程序形成文件的程度以確保實驗室活動實施的一致性和結(jié)果有效性 為原則。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 實驗室人員應(yīng)具有履行職責(zé)所需的權(quán)利和資源（不論其他職責(zé)）， 這些職責(zé)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)實施、保

59、持和改進(jìn)管理體系；implementation, maintenance and improvement of the management system;b)識別與管理體系或?qū)嶒炇一顒映绦虻钠x；identification of deviations from the management system or from the procedures for performing laboratory activities; c)采取措施以預(yù)防或最大程度減少這類偏離;initiation of actions to prevent or minimize such deviations;5

60、結(jié)構(gòu)要求結(jié)構(gòu)要求Structural requirements435 結(jié)構(gòu)要求結(jié)構(gòu)要求Structural requirementsd)向?qū)嶒炇夜芾韺訄蟾婀芾眢w系運行狀況和改進(jìn)需求；reporting to laboratory management on the performance of the management system and any need for improvement;e)確保實驗室活動的有效性。ensuring the effectiveness of laboratory activities.445.7 實驗室管理層應(yīng)確保：Laboratory manageme