? ISO/IEC 17025:2017《檢測和校準實驗室能力的通用要求》的過程要求-深圳市九域企業管理顧問有限公司
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                      CNAS實驗室認可

                      ISO/IEC 17025:2017《檢測和校準實驗室能力的通用要求》的過程要求

                      更新日期:2023-03-16 10:34:36  已瀏覽:498次

                      中國合格評定國家認可委員會(英文縮寫:CNAS)等同采用ISO/IEC 17025:2017《檢測和校準實驗室能力的通用要求》 作為對檢測和校準實驗室能力進行認可的基本認可準則。為支持特定領域的認可活動, CNAS還根據不同領域的專業特點,制定一系列的特定領域應用說明,對本準則的要求進行必要的補充說明和解釋,但并不增加或減少本準則的要求。本準則內容及條款號與國際標準 ISO/IEC 17025:2017內容及條款號完全一致。CNAS鼓勵申請認可的機構購買和使用正版國際和國家標準。


                      7 過程要求Process requirements

                      7.1 要求、標書和合同的評審Review of requests, tenders and contracts
                      7.1.1 實驗室應有要求、標書和合同評審程序。該程序應確保:
                      The laboratory shall have a procedure for the review of requests, tenders and contracts. The procedure shall ensure that:
                      GL030認可指南:實驗室應結合自身特點建立可行和有效的要求、標書和合同評審的程序。
                      a)要求被予以充分規定,形成文件,并易于理解;
                      a)the requirements are adequately defined, documented and understood;
                      注1:要求可包括(但不限于):
                      ——客戶明示的要求;
                      ——隱含的要求;
                      ——必須執行的要求(如法律法規規定的要求)。
                      注2:必要時,實驗室承擔軍工產品檢測任務能力的評審應按軍工產品檢測的有關規定進行。
                      b)實驗室有能力和資源滿足這些要求;
                      b) the laboratory has the capability and resources to meet the requirements;
                      c)當使用外部供應商時,應滿足6.6的要求,實驗室應告知客戶由外部供應商實施的實驗室活動,并獲得客戶同意;
                      c) where external providers are used, the requirements of 6.6 are applied and the laboratory advises the customer of the specific laboratory activities to be performed by the external provider and gains the customer’s approval;
                      A011應用說明:實驗室委托外部制樣時,應告知客戶制樣活動由外部機構提供,并獲得客戶同意。
                      A002應用說明:需要時,實驗室應與客戶在合同中明確約定與后續檢測相關的抽樣(含取樣、采樣)的方案,包括抽樣位置、時間、方法、樣本量等信息。
                      注1:在下列情況下,可能使用外部提供的實驗室活動:
                      NOTE 1  It is recognized that externally provided laboratory activities can occur when:
                      ——實驗室有實施活動的資源和能力,但由于不可預見的原因不能承擔部分或全部活動;
                      — the laboratory has the resources and competence to perform the activities, however, for unforeseen reasons is unable to undertake these in part or full;
                      ——實驗室沒有實施活動的資源和能力。
                      — the laboratory does not have the resources or competence to perform the activities.
                      注4:使用外部提供的實驗室活動時,應優先選擇獲得DILAC認可的實驗室。
                      d)選擇適當的方法或程序,并能滿足客戶的要求。
                      d) the appropriate methods or procedures are selected and are capable of meeting the customers’ requirements.
                      注2:對于內部或例行客戶,要求、標書和合同評審可簡化進行。
                      NOTE 2  For internal or routine customers, reviews of requests, tenders and contracts can be performed in a simplified way.
                      GL030認可指南:根據實驗室實際情況可將母體組織(包括代加工廠)或原料供應商的要求分為的單次檢測要求或重復性檢測要求。無論何種形式的要求都應明確檢測項目、檢測依據。對于重復性檢測要求至少每年評審一次。
                      7.1.2 當客戶要求的方法不合適或是過期的,實驗室應通知客戶。
                      The laboratory shall inform the customer when the method requested by the customer is considered to be inappropriate or out of date.
                      7.1.3 當客戶要求針對檢測或校準作出與規范或標準符合性的聲明時(如通過/未通過,在允許限內/超出允許限),應明確規定規范或標準以及判定規則。應將選擇的判定規則通知客戶并得到同意,除非規范或標準本身已包含判定規則。
                      When the customer requests a statement of conformity to a specification or standard for the test or calibration (e.g. pass/fail, in-tolerance/out-of-tolerance) the specification or standard, and the decision rule shall be clearly defined. Unless inherent in the requested specification or standard, the decision rule selected shall be communicated to, and agreed with, the customer.
                      注:符合性聲明的詳細指南見ISO/IEC指南98-4。
                      NOTE  For further guidance on statements of conformity, see ISO/IEC Guide 98-4.
                      7.1.4 要求或標書與合同之間的任何差異均應在實施實驗室活動前解決。每項合同都應被實驗室和客戶雙方接受??蛻粢蟮钠x不應影響實驗室的誠信或結果的有效性。
                      Any differences between the request or tender and the contract shall be resolved before laboratory activities commence. Each contract shall be acceptable both to the laboratory and the customer. Deviations requested by the customer shall not impact the integrity of the laboratory or the validity of the results.
                      7.1.5 與合同的任何偏離都應通知客戶。
                      The customer shall be informed of any deviation from the contract.
                      7.1.6 如果工作開始后修改合同,應重新進行合同評審,并將修改的內容通知所有受影響的人員。
                      If a contract is amended after work has commenced, the contract review shall be repeated and any amendments shall be communicated to all affected personnel.
                      7.1.7 在澄清客戶要求和允許客戶監控其相關工作表現方面,實驗室應與客戶或其代表合作。
                      The laboratory shall cooperate with customers or their representatives in clarifying the customer’s request and in monitoring the laboratory’s performance in relation to the work performed.
                      注:這種合作可包括:
                      NOTE  Such cooperation can include:
                      a)允許客戶合理進入實驗室相關區域,以見證與該客戶相關的實驗室活動。
                      a) providing reasonable access to relevant areas of the laboratory to witness customer-specific laboratory activities;
                      b)客戶出于驗證目的所需物品的準備、包裝和發送。
                      b) preparation, packaging, and dispatch of items needed by the customer for verification purposes.
                      G001應用說明:必要時,實驗室應給客戶提供充分說明,以便客戶在申請檢測或校準項目時能更加適合自身的需求與用途。
                      GL030認可指南:當實驗室的客戶均為內部客戶時,可邀請客戶不定期到實驗室觀察檢測活動、宣傳檢測活動的相關知識。
                      7.1.8 實驗室應保存評審記錄,包括任何重大變化的評審記錄。針對客戶要求或實驗室活動結果與客戶所進行的討論,也應作為記錄予以保存。
                      Records of reviews, including any significant changes, shall be retained. Records shall also be retained of pertinent discussions with a customer relating to the customer’s requirements or the results of the laboratory activities.
                      7.2 方法的選擇、驗證和確認Selection, verification and validation of methods
                      7.2.1 方法的選擇和驗證Selection and verification of methods
                      7.2.1.1 實驗室應使用適當的方法和程序開展所有實驗室活動,適當時,包括測量不確定度的評定以及使用統計技術進行數據分析。
                      The laboratory shall use appropriate methods and procedures for all laboratory activities and, where appropriate, for evaluation of the measurement uncertainty as well as statistical techniques for analysis of data.
                      注:本標準所用“方法”可視為是ISO/IEC指南99定義的“測量程序”的同義詞。
                      NOTE “Method” as used in this document can be considered synonymous with the term “measurement procedure” as defined in ISO/IEC Guide 99.
                      A011應用說明:實驗室開展力學性能檢測時,應防止不正確的試樣夾持或放置對檢測結果的影響。使用不同標準進行力學性能檢測時,應注意標準之間的差異部分,包括試樣尺寸和精度、對設備的要求、試驗過程的要求、計算結果的修約等。用同一臺火花放電原子發射光譜儀對不同基體材料進行化學分析時,應有程序保證在基體切換時不會造成元素干擾。
                      A002應用說明:實驗室應關注檢測方法中提供的限制說明、濃度范圍和樣品基體,選擇的檢測方法應確保在限值附近給出可靠的結果。實驗室應建立和執行與檢測方法要求相匹配的校準曲線,并定期使用中間濃度水平的校準標樣檢查校準曲線,建立檢查結果可否接受的判定標準。
                      G001應用說明:實驗室應對使用的檢測或校準方法實施有效的控制與管理,明確每種新方法投入使用的時間,并及時跟進檢測或校準技術的發展,定期評審方法能否滿足檢測或校準需求。
                      GL030認可指南:
                      實驗室使用方法進行檢測活動,應確保:
                      (1) 遵循樣品制備步驟;
                      (2) 遵循標準物質/試劑存儲和使用要求;
                      (3) 遵循儀器設備的運行和操作要求;
                      (4) 按檢測方法規定程序檢測空白樣品和質量控制樣品;
                      (5) 遵循檢測方法中定性/定量的方法和要求。
                      7.2.1.2 所有的方法、程序和支持文件,例如與實驗室活動相關的指導書、標準、手冊和參考數據,應保持現行有效并易于人員獲?。ㄒ?.3)。
                      All methods, procedures and supporting documentation, such as instructions, standards, manuals and reference data relevant to the laboratory activities, shall be kept up to date and shall be made readily available to personnel (see 8.3).
                      A011應用說明:采用與標準圖譜比較的方法進行金相評估檢驗時,應至少配有一套原版圖譜或標準圖譜圖集。為方便操作而進行的復制,應確保與原版圖譜或標準圖譜的一致性(大小、色彩、灰度、分辨率等)。
                      7.2.1.3 實驗室應確保使用最新有效版本的方法,除非不合適或不可能做到。必要時,應補充方法使用的細則以確保應用的一致性。
                      The laboratory shall ensure that it uses the latest valid version of a method unless it is not appropriate or possible to do so. When necessary, the application of the method shall be supplemented with additional details to ensure consistent application.
                      注:如果國際、區域或國家標準,或其他公認的規范文本包含了實施實驗室活動充分且簡明的信息,并便于實驗室操作人員使用時,則不需要再進行補充或改寫為內部程序??赡苡斜匾贫▽嵤┘殑t,或對方法中的可選擇步驟提供補充文件。
                      NOTE  International, regional or national standards or other recognized specifications that contain sufficient and concise information on how to perform laboratory activities do not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used by the operating personnel in a laboratory. It can be necessary to provide additional documentation for optional steps in the method or additional details.
                      A011應用說明:實驗室對抽樣和取樣活動在必要時應制訂作業指導書,取樣作業指導書應規定取樣部位、取樣方向、取樣量和取樣方法。對力學性能檢測、金相檢驗及微觀結構檢測、儀器法化學成分分析的試樣制備應制定作業指導書,明確加工及其他相關的技術要求,如關鍵參數的具體指標(尺寸、形位公差、表面粗糙度等)、避免加工硬化和過熱等要求。必要時,力學性能檢測的制樣作業指導書應有相應的圖紙,并對加工的試樣圖紙進行管理和控制。微觀結構分析如果采用通則方法,應針對檢測對象制定具體的作業指導書。
                      G001應用說明:對于標準方法,應定期跟蹤標準的制修訂情況,及時采用最新版本標準。
                      GL030認可指南:實驗室應建立在用檢測標準的清單,并規定方法查新的頻率、查新方式和查新結果的處置要求。 如檢測標準存在可選擇執行要求或易產生歧義理解時,實驗室應編制作業指導書,以保證在實驗室內部檢測操作的一致性。
                      7.2.1.4 當客戶未指定所用的方法時,實驗室應選擇適當的方法并通知客戶。推薦使用以國際標準、區域標準或國家標準發布的方法,或由知名技術組織或有關科技文獻或期刊中公布的方法,或設備制造商規定的方法。實驗室制定或修改的方法也可使用。
                      When the customer does not specify the method to be used, the laboratory shall select an appropriate method and inform the customer of the method chosen. Methods published either in international, regional or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment, are recommended. Laboratory-developed or modified methods can also be used.
                      注:實驗室開展軍工產品的檢測和校準工作時,應優先選擇國家軍用標準。
                      GL030認可指南:實驗室應優先使用以國際、區域、國家或行業標準發布的方法,也可選擇母體組織制定的方法。除使用國家強制執行的標準外,鼓勵實驗室根據應用需要開發適用性更強、技術更先進、效率更高的非標準檢測方法。
                      7.2.1.5 實驗室在引入方法前,應驗證能夠正確地運用該方法,以確保實現所需的方法性能。應保存驗證記錄。如果發布機構修訂了方法,應依據方法變化的內容重新進行驗證。
                      The laboratory shall verify that it can properly perform methods before introducing them by ensuring that it can achieve the required performance. Records of the verification shall be retained. If the method is revised by the issuing body, verification shall be repeated to the extent necessary.
                      A002應用說明:實驗室應對首次采用的標準方法進行技術能力的驗證,如適用的濃度范圍和樣品基體、正確度和精密度等,尤其對于痕量分析和超痕量分析,還應關注檢出限、定量限等。當標準方法發生變更涉及到技術能力發生變化,如檢測方法原理、儀器設備、環境設施、操作方法、方法適用范圍等,需要通過技術驗證重新證明正確運用新標準的能力。
                      G001應用說明:在引入檢測或校準方法之前,實驗室應對其能否正確運用這些標準方法的能力進行驗證,驗證不僅需要識別相應的人員、設施和環境、設備等,還應通過試驗證明結果的準確性和可靠性,如精密度、線性范圍、檢出限和定量限等方法特性指標,必要時應進行實驗室間比對。
                      7.2.1.6 當需要開發方法時,應予以策劃,并指定具備能力的人員,為其配備足夠的資源。在方法開發的過程中,應進行定期評審,以確定持續滿足客戶需求。開發計劃的任何變更應得到批準和授權。必要時,方法制定過程的相應階段應進行評審,以證實要求得到滿足。
                      When method development is required, this shall be a planned activity and shall be assigned to competent personnel equipped with adequate resources. As method development proceeds, periodic review shall be carried out to confirm that the needs of the customer are still being fulfilled. Any modifications to the development plan shall be approved and authorized.
                      7.2.1.7 對所有實驗室活動方法的偏離,應事先將該偏離形成文件,經技術判斷,獲得授權并被客戶接受。
                      Deviations from methods for all laboratory activities shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer.
                      注:客戶接受偏離可以事先在合同中約定。
                      NOTE Customer acceptance of deviations can be agreed in advance in the contract.
                      GL030認可指南:當使用標準方法不能滿足要求需要偏離檢測標準時,實驗室應將偏離形成作業指導書,并按非標準方法的控制要求執行。
                      7.2.2 方法確認Validation of methods
                      7.2.2.1 實驗室應對非標準方法(含軍工產品非通用的專用測試設備校準規范)、實驗室開發的方法、超出預定范圍使用的標準方法、或其他修改的標準方法進行確認。確認應盡可能全面,以滿足預期用途或應用領域的需要。
                      The laboratory shall validate non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or otherwise modified. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application.
                      A011應用說明:對儀器法成分分析,如果使用時超出了標準方法的預定范圍、或擴充和修改了標準方法,應進行方法確認,并制定作業指導書。
                      A002應用說明:任何對標準方法的修改, 包括超出適用的濃度范圍或基體范圍、采用分析性能更佳的替代技術等等都應進行確認。
                      GL030認可指南:非標準方法應進行確認,以滿足預期用途或應用領域的需要。
                      注1:確認可包括檢測或校準物品的抽樣、處置和運輸程序。
                      NOTE 1 Validation can include procedures for sampling, handling and transportation of test or calibration items.
                      注2:可用以下一種或多種技術進行方法確認:
                      NOTE 2  The techniques used for method validation can be one of, or a combination of, the following:
                      a)使用參考標準或標準物質進行校準或評估偏倚和精密度;
                      a)calibration or evaluation of bias and precision using reference standards or reference materials;
                      注3:實驗室的參考標準(實驗室最高標準)應溯源到國防最高測量標準或國家測量標準或國際測量標準 。
                      注4:可能時,標準物質(參考物質)應溯源到國防最高測量標準或國家測量標準或國際測量標準,包括溯源到國家有證軍用標準物質DILAC 認可準則 DILAC/AC01:2018(參考物質)或國家有證標準物質(參考物質)或國際有證標準物質(參考物質)。
                      b)對影響結果的因素進行系統性評審;
                      b) systematic assessment of the factors influencing the result;
                      c)通過改變受控參數(如培養箱溫度、加樣體積等)來檢驗方法的穩健度;
                      c) testing method robustness through variation of controlled parameters, such as incubator temperature, volume dispensed;
                      d)與其他已確認的方法進行結果比對;
                      d) comparison of results achieved with other validated methods;
                      e)實驗室間比對;
                      e) interlaboratory comparisons;
                      f) 根據對方法原理的理解以及抽樣或檢測方法的實踐經驗,評定結果的測量不確定度。
                      f) evaluation of measurement uncertainty of the results based on an understanding of the theoretical principles of the method and practical experience of the performance of the sampling or test method.
                      GL030認可指南:定量檢測的非標方法確認時還應考慮測量結果不確定度的影響。
                      7.2.2.2 當修改已確認過的方法時,應確定這些修改的影響。當發現影響原有的確認時,應重新進行方法確認。
                      When changes are made to a validated method, the influence of such changes shall be determined and where they are found to affect the original validation, a new method validation shall be performed.
                      7.2.2.3 當按預期用途評估被確認方法的性能特性時,應確保與客戶需求相關,并符合規定的要求。
                      The performance characteristics of validated methods, as assessed for the intended use, shall be relevant to the customers’ needs and consistent with specified requirements.
                      注:方法性能特性可包括但不限于:測量范圍、準確度、結果的測量不確定度、檢出限、定量限、方法的選擇性、線性、重復性或復現性、抵御外部影響的穩健度或抵御來自樣品或測試物基體干擾的交互靈敏度以及偏倚。
                      NOTE  Performance characteristics can include, but are not limited to, measurement range, accuracy, measurement uncertainty of the results, limit of detection, limit of quantification, selectivity of the method, linearity, repeatability or reproducibility, robustness against external influences or cross-sensitivity against interference from the matrix of the sample or test object, and bias.
                      7.2.2.4 實驗室應保存以下方法確認記錄:
                      The laboratory shall retain the following records of validation:
                      a)使用的確認程序;
                      a) the validation procedure used;
                      b)要求的詳細說明;
                      b) specification of the requirements;
                      c) 方法性能特性的確定;
                      c) determination of the performance characteristics of the method;
                      d) 獲得的結果;
                      d) results obtained;
                      e)方法有效性聲明,并詳述與預期用途的適宜性。
                      e) a statement on the validity of the method, detailing its fitness for the intended use.
                      7.3 抽樣Sampling
                      7.3.1 當實驗室為后續檢測或校準對物質、材料或產品實施抽樣時,應有抽樣計劃和方法。抽樣方法應明確需要控制的因素,以確保后續檢測或校準結果的有效性。在抽樣地點應能得到抽樣計劃和方法。只要合理,抽樣計劃應基于適當的統計方法。
                      The laboratory shall have a sampling plan and method when it carries out sampling of substances, materials or products for subsequent testing or calibration. The sampling method shall address the factors to be controlled to ensure the validity of subsequent testing or calibration results. The sampling plan and method shall be available at the site where sampling is undertaken. Sampling plans shall, whenever reasonable, be based on appropriate statistical methods.
                      G001應用說明:
                      a) 如果實驗室僅進行抽樣,而不從事后續的檢測或校準活動,CNAS將不認可該抽樣項目。
                      b) 實驗室如需從客戶提供的樣品中取出部分樣品進行后續的檢測或校準活動時,應有書面的取樣程序或記錄,并確保樣品的均勻性和代表性。注:抽樣除包含從一個批次抽取樣品的活動外,還包含檢測領域常用的概念“采樣”和“取樣”。
                      7.3.2 抽樣方法應描述:
                      The sampling method shall describe:
                      a)樣品或地點的選擇;
                      a) the selection of samples or sites;
                      b)抽樣計劃;
                      b) the sampling plan;
                      c)從物質、材料或產品中取得樣品的制備和處理,以作為后續檢測或校準的物品。
                      c) the preparation and treatment of sample(s) from a substance, material or product to yield the required item for subsequent testing or calibration.
                      注:實驗室接收樣品后,進一步處置要求見7.4的規定。
                      NOTE When received into the laboratory, further handling can be required as specified in 7.4.
                      7.3.3 實驗室應將抽樣數據作為檢測或校準工作記錄的一部分予以保存。相關時,這些記錄應包括以下信息:
                      The laboratory shall retain records of sampling data that forms part of the testing or calibration that is undertaken. These records shall include, where relevant:
                      a)所用的抽樣方法;
                      a) reference to the sampling method used;
                      b)抽樣日期和時間;
                      b) date and time of sampling;
                      c)識別和描述樣品的數據(如編號、數量和名稱);
                      c) data to identify and describe the sample (e.g. number, amount, name);
                      d)抽樣人的識別;
                      d) identification of the personnel performing sampling;
                      e)所用設備的識別;
                      e) identification of the equipment used;
                      f)環境或運輸條件;
                      f) environmental or transport conditions;
                      g)適當時,標識抽樣位置的圖示或其他等效方式;
                      g) diagrams or other equivalent means to identify the sampling location when appropriate;
                      h)與抽樣方法和抽樣計劃的偏離或增減。
                      i)deviations, additions to or exclusions from the sampling method and sampling plan.
                      A011應用說明:對大宗金屬材料的抽樣操作,應記錄抽樣情況,如貨場堆垛情況、樣品批量數、抽樣數,抽樣樣品號、材料取樣部位等,需要時可用圖表、照片等方式標記以證明樣品的代表性。
                      7.4 檢測或校準物品的處置Handling of test or calibration items
                      7.4.1 實驗室應有運輸、接收、處置、保護、存儲、保留、處理或歸還檢測或校準物品的程序,包括為保護檢測或校準物品的完整性以及實驗室與客戶利益所需的所有規定。在物品的處置、運輸、保存/等候和制備過程中,應注意避免物品變質、污染、丟失或損壞。應遵守隨物品提供的操作說明。
                      The laboratory shall have a procedure for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer. Precautions shall be taken to avoid deterioration, contamination, loss or damage to the item during handling, transporting, storing/waiting, and preparation for testing or calibration. Handling instructions provided with the item shall be followed.
                      檢測和校準的物品涉及軍工產品保密要求時,物品處置的全過程應遵守國防科技工業有關的保密規定。
                      A011應用說明:實驗室建立的樣品處置程序應分別規定金屬材料大樣、加工后小樣和檢測后樣品的處置要求,包括保管條件和保留時間。對金相樣品應適當保存,避免損傷。對有表面層及制樣有特殊要求的金屬材料要確保在抽樣、取樣、制樣及儲存過程中,表面層及其內部性能不被損壞。
                      G001應用說明:通常情況下,樣品標識不應粘貼在容易與盛裝樣品容器分離的部件上,如容器蓋,因其可能會導致樣品的混淆。
                      GL030認可指南:
                      無論在實驗室內或母體組織指定的實驗室外的其他部門進行留樣時,都應符合本條款要求。
                      母體組織可依據工作需求指定實驗外的其他部門協助留樣,實驗室應建立留樣要求,并確保相關部門滿足這些要求。
                      7.4.2 實驗室應有清晰標識檢測或校準物品的系統。物品在實驗室負責的期間內應保留該標識。標識系統應確保物品在實物上、記錄或其他文件中不被混淆。適當時,標識系統應包含一個物品或一組物品的細分和物品的傳遞。
                      The laboratory shall have a system for the unambiguous identification of test or calibration items. The identification shall be retained while the item is under the responsibility of the laboratory. The system shall ensure that items will not be confused physically or when referred to in records or other documents. The system shall, if appropriate, accommodate a sub-division of an item or groups of items and the transfer of items.
                      A011應用說明:實驗室的檢測樣品標識應存在于樣品抽樣、取樣、制樣、分組、檢測和留樣保存等各個環節。接收樣品時應記錄客戶賦予樣品的標識,并建立客戶賦予標識與實驗室賦予標識的對應關系。委托外部加工樣品的,必要時實驗室應進行試樣標識的轉移或監督轉移。
                      7.4.3 接收檢測或校準物品時,應記錄與規定條件的偏離。當對物品是否適于檢測或校準有疑問,或當物品不符合所提供的描述時,實驗室應在開始工作之前詢問客戶,以得到進一步的說明,并記錄詢問的結果。當客戶知道物品偏離了規定條件仍要求進行檢測或校準時,實驗室應在報告中作出免責聲明,并指出偏離可能影響的結果。
                      Upon receipt of the test or calibration item, deviations from specified conditions shall be recorded. When there is doubt about the suitability of an item for test or calibration, or when an item does not conform to the description provided, the laboratory shall consult the customer for further instructions before proceeding and shall record the results of this consultation. When the customer requires the item to be tested or calibrated acknowledging a deviation from specified conditions, the laboratory shall include a disclaimer in the report indicating which results may be affected by the deviation.
                      A011應用說明:實驗室在接收樣品時,應進行符合性檢查(或按批抽查),應根據方法的要求對試樣的關鍵參數指標進行檢查并提供相應的檢查記錄,如沖擊試樣缺口、疲勞試樣表面粗糙度等。需要時,應檢查試樣的取樣部位和方向。
                      7.4.4 如物品需要在規定環境條件下儲存或狀態調節時,應保持、監控和記錄這些環境條件。
                      When items need to be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored and recorded.
                      GL030認可指南:當實驗室母體組織其他部門協助留樣時,該部門應具備保持樣品完整性和不改變其性狀的條件。
                      7.5 技術記錄Technical records
                      7.5.1 實驗室應確保每一項實驗室活動的技術記錄包含結果、報告和足夠的信息,以便在可能時識別影響測量結果及其測量不確定度的因素,并確保能在盡可能接近原條件的情況下重復該實驗室活動。技術記錄應包括每項實驗室活動以及審查數據結果的日期和責任人。原始的觀察結果、數據和計算應在觀察或獲得時予以記錄,并應按特定任務予以識別。
                      The laboratory shall ensure that technical records for each laboratory activity contain the results, report and sufficient information to facilitate, if possible, identification of factors affecting the measurement result and its associated measurement uncertainty and enable the repetition of the laboratory activity under conditions as close as possible to the original. The technical records shall include the date and the identity of personnel responsible for each laboratory activity and for checking data and results. Original observations, data and calculations shall be recorded at the time they are made and shall be identifiable with the specific task.
                      軍工產品的檢測和校準記錄的保存時間,應按軍工產品、國防科技工業的有關要求在文件中作出規定。
                      A011應用說明:檢測記錄應有充分的信息。需要時,應包含與試驗過程有關的試樣和試驗方法(條件)的詳細信息,如抽樣情況、試樣的取樣部位和方向(可采用文字、圖片的形式說明)、試樣尺寸和形狀、試樣狀態信息、測量表面層厚度/深度時測量點的位置、浸蝕劑成分或代號、浸蝕的溫度和時間等。
                      A002應用說明:當實驗室棄用檢測數據時,應記錄原因(符合相關技術要求時除外)。
                      G001應用說明:
                      a) 實驗室應確保能方便獲得所有的原始記錄和數據,記錄的詳細程度應確保在盡可能接近條件的情況下能夠重復實驗室活動。只要適用,記錄內容應包括但不限于以下信息:
                      ? 樣品描述;
                      ? 樣品唯一性標識;
                      ? 所用的檢測、校準和抽樣方法;
                      ? 環境條件,特別是實驗室以外的地點實施的實驗室活動;
                      ? 所用設備和標準物質的信息,包括使用客戶的設備;
                      ? 檢測或校準過程中的原始觀察記錄以及根據觀察結果所進行的計算;
                      ? 實施實驗室活動的人員;
                      ? 實施實驗室活動的地點(如果未在實驗室固定地點實施);
                      ? 檢測報告或校準證書的副本;
                      ? 其他重要信息。
                      注:檢測報告或校準證書的副本是指實驗室發給客戶的報告或證書版本的副本,可以是紙質版本或不可更改的電子版本,其中應包含報告或證書的簽發人、認可標識(如使用)等信息。
                      b) 實驗室應在記錄表格中或成冊的記錄本上保存檢測或校準的原始數據和信息,也可直接錄入信息管理系統中,也可以是設備或信息系統自動采集的數據。對自動采集或直接錄入信息管理系統中的數據的任何更改,應滿足7.5.2的要求。注1:原始記錄為試驗人員在試驗過程中記錄的原始觀察數據和信息,而不是試驗后所謄抄的數據。當需要另行整理或謄抄時,應保留對應的原始記錄。注2:實驗室不能隨意用一頁白紙來保存原始記錄。
                      GL030認可指南:對于技術記錄中的固定的、每日重復檢測的大批量樣品項目,可將相同信息固化到原始記錄中。
                      7.5.2 實驗室應確保技術記錄的修改可以追溯到前一個版本或原始觀察結果。應保存原始的以及修改后的數據和文檔,包括修改的日期、標識修改的內容和負責修改的人員。電子形式存儲的記錄應做只讀處理。
                      The laboratory shall ensure that amendments to technical records can be tracked to previous versions or to original observations. Both the original and amended data and files shall be retained, including the date of alteration, an indication of the altered aspects and the personnel responsible for the alterations.
                      7.6 測量不確定度的評定Evaluation of measurement uncertainty
                      7.6.1 實驗室應識別測量不確定度的貢獻。評定測量不確定度時,應采用適當的分析方法考慮所有顯著貢獻,包括來自抽樣的貢獻。
                      Laboratories shall identify the contributions to measurement uncertainty. When evaluating measurement uncertainty, all contributions which are of significance, including those arising from sampling, shall be taken into account using appropriate methods of analysis.
                      注:測量不確定度的評定可參照國家軍用標準GJB 3756進行。
                      A002應用說明:實驗室應有文件規定,明確評定測量不確定度的要求。當與客戶商定判定規則,需要時應評估獲得測量不確定度的合理性,并制定報告規則。
                      7.6.2 開展校準的實驗室,包括校準自有設備的實驗室,應評定所有校準的測量不確定度。
                      A laboratory performing calibrations, including of its own equipment, shall evaluate the measurement uncertainty for all calibrations.
                      7.6.3 開展檢測的實驗室應評定測量不確定度。當由于檢測方法的原因難以嚴格評定測量不確定度時,實驗室應基于對理論原理的理解或使用該方法的實踐經驗進行評估。
                      A laboratory performing testing shall evaluate measurement uncertainty. Where the test method precludes rigorous evaluation of measurement uncertainty, an estimation shall be made based on an understanding of the theoretical principles or practical experience of the performance of the method.
                      注1:某些情況下,公認的檢測方法對測量不確定度主要來源規定了限值,并規定了計算結果的表示方式,實驗室只要遵守檢測方法和報告要求,即滿足7.6.3的要求。
                      NOTE 1  In those cases where a well-recognized test method specifies limits to the values of the major sources of measurement uncertainty and specifies the form of presentation of the calculated results, the laboratory is considered to have satisfied 7.6.3 by following the test method and reporting instructions.
                      注2:對某一特定方法,如果已確定并驗證了結果的測量不確定度,實驗室只要證明已識別的關鍵影響因素受控,則不需要對每個結果評定測量不確定度。
                      NOTE 2  For a particular method where the measurement uncertainty of the results has been established and verified, there is no need to evaluate measurement uncertainty for each result if the laboratory can demonstrate that the identified critical influencing factors are under control.
                      注3:更多信息參見ISO/IEC指南98-3、ISO 21748和ISO 5725系列標準。
                      NOTE 3  For further information, see ISO/IEC Guide 98-3, ISO 21748 and the ISO 5725 series.
                      7.7 確保結果有效性Ensuring the validity of results
                      7.7.1 實驗室應有監控結果有效性的程序。記錄結果數據的方式應便于發現其發展趨勢,如可行,應采用統計技術審查結果。實驗室應對監控進行策劃和審查,適當時,監控應包括但不限于以下方式:
                      The laboratory shall have a procedure for monitoring the validity of results. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to review the results. This monitoring shall be planned and reviewed and shall include, where appropriate, but not be limited to:
                      a)使用標準物質或質量控制物質;
                      a) use of reference materials or quality control materials;
                      b)使用其他已校準能夠提供可溯源結果的儀器;
                      b) use of alternative instrumentation that has been calibrated to provide traceable results;
                      c)測量和檢測設備的功能核查;
                      c) functional check(s) of measuring and testing equipment;
                      d)適用時,使用核查或工作標準,并制作控制圖;
                      d) use of check or working standards with control charts, where applicable;
                      e)測量設備的期間核查;
                      e) intermediate checks on measuring equipment;
                      f)使用相同或不同方法重復檢測或校準;
                      f) replicate tests or calibrations using the same or different methods;
                      g)留存樣品的重復檢測或重復校準;
                      g) retesting or recalibration of retained items;
                      h)物品不同特性結果之間的相關性;
                      h) correlation of results for different characteristics of an item;
                      i)報告結果的審查;
                      i) review of reported results;
                      j)實驗室內比對;
                      j) intralaboratory comparisons;
                      k)盲樣測試。
                      l)testing of blind sample(s).
                      A011應用說明:
                      實驗室對金相檢驗、微觀結構分析等人為因素影響較大的檢測活動,應加強質量監控,可通過實施人員比對或者實驗室間比對以保證相關檢測人員能力。
                      對于儀器法化學成分分析,應按標準方法的要求建立校準曲線,并使用與檢測樣品含量匹配的標樣對建立的校準曲線進行驗證。應定期使用中間點的標樣檢查校準曲線,建立定期檢查結果可否接受的判定標準,且該判定標準應與測量不確定度相當。
                      G001應用說明:
                      a) 實驗室對結果的監控應覆蓋到認可范圍內的所有檢測或校準(包括內部校準)項目,確保檢測或校準結果的準確性和穩定性。當檢測或校準方法中規定了質量監控制要求時,實驗室應符合該要求。適用時,實驗室應在檢測方法中或其他文件中規定對應檢測或校準方法的質量監控方案。實驗室制定內部質量監控方案時應考慮以下因素:
                      ?檢測或校準業務量;
                      ?檢測或校準結果的用途;
                      ?檢測或校準方法本身的穩定性與復雜性;
                      ?對技術人員經驗的依賴程度;
                      ?參加外部比對(包含能力驗證)的頻次與結果;
                      ?人員的能力和經驗、人員數量及變動情況;
                      ?新采用的方法或變更的方法等。
                      注:實驗室可以采取多種適用的質量監控手段,如:
                      ?定期使用標準物質、 核查標準或工作標準來監控結果的準確性;
                      ?通過使用質量控制物質制作質控圖持續監控精密度;
                      ?通過獲得足夠的標準物質,評估在不同濃度下檢測結果的準確性;
                      ?定期留樣再測或重復測量以及實驗室內比對,監控同一操作人員的精密度或不同操作人員間的精密度;
                      ?采用不同的檢測方法或設備測試同一樣品,監控方法之間的一致性;
                      ?通過分析一個物品不同特性結果的相關性,以識別錯誤;
                      ?進行盲樣測試,監控實驗室日常檢測的準確度或精密度水平。
                      b) 適用時,實驗室應使用質量控制圖來監控檢測或校準結果的準確性和精密度。
                      c) 一些特殊的檢測活動,檢測結果無法復現,難以按照7.7.1a)進行質量控制,實驗室應關注人員的能力、培訓、監督以及與同行的技術交流。
                      7.7.2 可行和適當時,實驗室應通過與其他實驗室的結果比對監控能力水平。監控應予以策劃和審查,包括但不限于以下一種或兩種措施:
                      The laboratory shall monitor its performance by comparison with results of other laboratories, where available and appropriate. This monitoring shall be planned and reviewed and shall include, but not be limited to, either or both of the following:
                      a)參加能力驗證;
                      a) participation in proficiency testing;
                      注:GB/T 27043包含能力驗證和能力驗證提供者的詳細信息。滿足GB/T 27043要求的能力驗證提供者被認為是有能力的。
                      NOTE  ISO/IEC 17043 contains additional information on proficiency tests and proficiency testing providers. Proficiency testing providers that meet the requirements of ISO/IEC 17043 are considered to be competent.
                      b)參加除能力驗證之外的實驗室間比對。
                      c)participation in interlaboratory comparisons other than proficiency testing.
                      A011應用說明:實驗室按CNAS-RL02選擇參加能力驗證計劃時,如果認可的檢測項目在同一子領域內有多項可獲得的能力驗證活動,應避免連續只參加同一項目的能力驗證,參加的人員、設備也應考慮適當更換。
                      G001應用說明:外部質量監控方案不僅包括CNAS-RL02《能力驗證規則》中要求參加的能力驗證計劃,適當時,還應包含實驗室間比對計劃。實驗室制定外部質量監控計劃除應考慮7.7.1a)中描述的因素外,還應考慮以下因素:
                      ?內部質量監控結果;
                      ?實驗室間比對(包含能力驗證)的可獲得性,對沒有能力驗證的領域,實驗室應有其他措施來確保結果的準確性和可靠性;
                      ? CNAS、客戶和管理機構對實驗室間比對(包含能力驗證)的要求。
                      注:CNAS-RL02《能力驗證規則》要求參加的能力驗證領域和頻次只是CNAS對能力驗證的最低要求。實驗室應關注對于沒有能力驗證的領域,可以采取有何措施確保結果的準確性和可靠性。
                      RL02驗證規則:
                      金屬與合金類材料與制品檢測領域的能力驗證頻次:化學分析和機械性能每年至少1次,物理性能每2年至少1次。
                      7.7.3 實驗室應分析監控活動的數據用于控制實驗室活動,適用時實施改進。如果發現監控活動數據分析結果超出預定的準則時,應采取適當措施防止報告不正確的結果。
                      Data from monitoring activities shall be analysed, used to control and, if applicable, improve the laboratory’s activities. If the results of the analysis of data from monitoring activities are found to be outside pre-defined criteria, appropriate action shall be taken to prevent incorrect results from being reported.
                      A011應用說明:適用時,實驗室應建立控制圖,觀察和分析控制圖顯示的趨勢,必要時采取處理措施。
                      7.8 報告結果Reporting of results
                      7.8.1 總則General
                      7.8.1.1 結果在發出前應經過審查和批準。
                      The results shall be reviewed and authorized prior to release.
                      G001應用說明:
                      a) 除檢測方法、法律法規另有要求外,實驗室應在同一份報告上出具特定樣品不同檢測項目的結果,如果檢測項目覆蓋了不同的專業技術領域,也可分專業領域出具檢測報告。
                      注:即使客戶有要求,實驗室也不得隨意拆分檢測報告,如將“滿足規定限值”的結果與“不滿足規定限值”的結果分別出具報告,或只報告“滿足規定限量”的檢測結果。
                      c)一般情況下,實驗室應按GB/T 8170《數值修約規則與極限數值的表示和判定》進行數值修約。
                      GL030認可指南:結果的電子傳送,當實驗室利用網絡或信息化系統傳送檢測結果時,應滿足7.11的要求,同時應符合報告審核和發送報告的流程。
                      7.8.1.2 實驗室應準確、清晰、明確和客觀地出具結果,并且應包括客戶同意的、解釋結果所必需的以及所用方法要求的全部信息。實驗室通常以報告的形式提供結果(例如檢測報告、校準證書或抽樣報告)。所有發出的報告應作為技術記錄予以保存。
                      The results shall be provided accurately, clearly, unambiguously and objectively, usually in a report (e.g. a test report or a calibration certificate or report of sampling) and shall include all the information agreed with the customer and necessary for the interpretation of the results and all information required by the method used. All issued reports shall be retained as technical records.
                      注1:檢測報告和校準證書有時稱為檢測證書和校準報告。
                      NOTE 1  For the purposes of this document, test reports and calibration certificates are sometimes referred to as test certificates and calibration reports, respectively.
                      注2:只要滿足本標準的要求,報告可以硬拷貝或電子方式發布。
                      NOTE 2  Reports can be issued as hard copies or by electronic means, provided that the requirements of this document are met.
                      注3:如有特殊需要,證書或報告可不包括客戶有保密要求的信息。
                      A011應用說明:應按標準中規定的修約要求報告檢測結果。如果標準中有規定,在報告檢測結果時還應報告試驗條件。
                      A002應用說明:檢測結果的報告應符合如下要求:
                      a)當檢出結果低于方法檢出限或定量限,應在檢測報告中提供方法檢出限或定量限的數值。
                      b)如果報告的結果是用數字表示的數值,應按照所用檢測方法的規定進行表述。當方法沒有相關規定時,應依照有效數值修約的規定表述。
                      c)當需要解釋檢測結果時,或客戶有要求時,或檢測方法要求時,實驗室應報告質量控制結果。當質量控制結果不完全滿足檢測方法要求且無法重新測試時,應在報告中以適當方式進行標注和說明。
                      d)必要時,報告中應注明與后續檢測相關的抽樣(含取樣、采樣)信息。
                      GL030認可指南:實驗室在為內部客戶出具報告時,可以簡化,但報告中簡化的信息應能方便地從實驗室中獲得并可追溯。
                      EL-13認可說明:樣品信息準確,并且必須是實測樣品。
                      7.8.1.3 如客戶同意,可用簡化方式報告結果。如果未向客戶報告7.8.2至7.8.7條款中所列的信息,客戶應能方便地獲得。
                      When agreed with the customer, the results may be reported in a simplified way. Any information listed in 7.8.2 to 7.8.7 that is not reported to the customer shall be readily available.
                      7.8.2 (檢測、校準或抽樣)報告的通用要求Common requirements for reports (test, calibration or sampling)
                      7.8.2.1 除非實驗室有有效的理由,每份報告應至少包括下列信息,以最大限度地減少誤解或誤用的可能性:
                      Each report shall include at least the following information, unless the laboratory has valid reasons for not doing so, thereby minimizing any possibility of misunderstanding or misuse:
                      a)標題(例如“檢測報告”、“校準證書”或“抽樣報告”);
                      a) a title (e.g. “Test Report”, “Calibration Certificate” or “Report of Sampling”);
                      b)實驗室的名稱和地址;
                      b) the name and address of the laboratory;
                      c)實施實驗室活動的地點,包括客戶設施、實驗室固定設施以外的場所、相關的臨時或移動設施;
                      c) the location of performance of the laboratory activities, including when performed at a customer facility or at sites away from the laboratory’s permanent facilities, or in associated temporary or mobile facilities;
                      EL-13認可說明:如果測試地點不在實驗室的固定場所,如在客戶地點或樣品所在地, 報告中應給出詳細的地址信息,僅給出“客戶地點”等模糊信息是不充分的。
                      d)將報告中所有部分標記為完整報告的一部分的唯一性標識,以及表明報告結束的清晰標識;
                      d) unique identification that all its components are recognized as a portion of a complete report and a clear identification of the end;
                      e)客戶的名稱和聯絡信息;
                      e) the name and contact information of the customer;
                      f)所用方法的識別;
                      f) identification of the method used;
                      g)物品的描述、明確的標識,以及必要時,物品的狀態;
                      g) a description, unambiguous identification, and, when necessary, the condition of the item;
                      A011應用說明:必要時,檢測報告應提供來樣實物照片,并標記出取樣部位。
                      h)檢測或校準物品的接收日期,以及對結果的有效性和應用至關重要的抽樣日期;
                      h) the date of receipt of the test or calibration item(s), and the date of sampling, where this is critical to the validity and application of the results;
                      i) 實施實驗室活動的日期;
                      i) the date(s) of performance of the laboratory activity;
                      j) 報告的發布日期;
                      j) the date of issue of the report;
                      k) 如與結果的有效性或應用相關時,實驗室或其他機構所用的抽樣計劃和抽樣方法;
                      k) reference to the sampling plan and sampling method used by the laboratory or other bodies where these are relevant to the validity or application of the results;
                      l) 結果僅與被檢測、被校準或被抽樣物品有關的聲明;
                      l) a statement to the effect that the results relate only to the items tested, calibrated or sampled;
                      m) 結果,適當時,帶有測量單位;
                      m) the results with, where appropriate, the units of measurement;
                      A011應用說明:需要時,金相檢測報告應提供試樣中有代表性的金相照片。
                      n) 對方法的補充、偏離或刪減;
                      n) additions to, deviations, or exclusions from the method;
                      o) 報告批準人的識別;
                      o) identification of the person(s) authorizing the report;
                      p) 當結果來自于外部供應商時所做的清晰標識。
                      p) clear identification when results are from external providers.
                      EL-13認可說明:實驗室出具的報告中如有摘用其他機構報告信息的內容,則應在報告中給出清晰的標注,標注的方式應確保報告的使用人不會產生誤解。當使用認可標識時,按“外部提供的信息”(視同“分包”)要求控制。
                      注:報告中聲明除全文復制外,未經實驗室批準不得部分復制報告,可以確保報告不被部分摘用。
                      NOTE Including a statement specifying that the report shall not be reproduced except in full without approval of the laboratory can laboratory can provide assurance that parts of a report are not taken out of context.
                      EL-13認可說明:如果實際測試過程是由客戶的技術人員操作,實驗室只是目擊了試驗的過程并記錄下測試數據和信息,報告應以清晰的方式在正文中注明是目擊試驗,并且不得使用認可標識或聲明認可。
                      7.8.2.2 除客戶提供的信息除外,實驗室應對報告中的所有信息負責??蛻籼峁┑臄祿杳鞔_標識。此外,當客戶提供的信息可能影響結果的有效性時,報告中應有免責聲明。當實驗室不負責抽樣(如樣品由客戶提供),應在報告中聲明結果適用于收到的樣品。
                      The laboratory shall be responsible for all the information provided in the report, except when information is provided by the customer. Data provided by a customer shall be clearly identified. In addition, a disclaimer shall be put on the report when the information is supplied by the customer and can affect the validity of results. Where the laboratory has not been responsible for the sampling stage (e.g. the sample has been provided by the customer), it shall state in the report that the results apply to the sample as received.
                      EL-13認可說明:對于客戶送樣,除非抽樣信息影響到測試結果,報告中不應包含抽樣信息。如果報告中包含樣品抽樣信息(如地點),實驗室應以顯著方式在報告正文中說明此為客戶提供信息,實驗室對此真實性不承擔責任。
                      7.8.3 檢測報告的特定要求Specific requirements for test reports
                      7.8.3.1 除7.8.2所列要求之外,當解釋檢測結果需要時,檢測報告還應包含以下信息:
                      In addition to the requirements listed in 7.8.2, test reports shall, where necessary for the interpretation of the test results, include the following:
                      a)特定的檢測條件信息,如環境條件;
                      a) information on specific test conditions, such as environmental conditions;
                      b)相關時,與要求或規范的符合性聲明(見7.8.6);
                      b) where relevant, a statement of conformity with requirements or specifications (see 7.8.6);
                      c)適用時,在下列情況下,帶有與被測量相同單位的測量不確定度或被測量相對形式的測量不確定度(如百分比):
                      c) where applicable, the measurement uncertainty presented in the same unit as that of the measurand or in a term relative to the measurand (e.g. percent) when:
                      ——測量不確定度與檢測結果的有效性或應用相關時;
                      — it is relevant to the validity or application of the test results;
                      ——客戶有要求時;
                      — a customer’s instruction so requires, or
                      ——測量不確定度影響與規范限的符合性時。
                      — the measurement uncertainty affects conformity to a specification limit;
                      d)適當時,意見和解釋(見7.8.7);
                      d) where appropriate, opinions and interpretations (see 7.8.7);
                      e)特定方法、法定管理機構或客戶要求的其他信息。
                      e) additional information which may be required by specific methods, authorities, customers or groups of customers.
                      7.8.3.2 如果實驗室負責抽樣活動,當解釋檢測結果需要時,檢測報告還應滿足7.8.5的要求。
                      Where the laboratory is responsible for the sampling activity, test reports shall meet the requirements listed in 7.8.5 where necessary for the interpretation of test results.
                      7.8.4 校準證書的特定要求Specific requirements for calibration certificates
                      7.8.4.1 除7.8.2的要求外,校準證書應包含以下信息:
                      In addition to the requirements listed in 7.8.2, calibration certificates shall include the following:
                      a)與被測量相同單位的測量不確定度或被測量相對形式的測量不確定度(如百分比);
                      a) the measurement uncertainty of the measurement result presented in the same unit as that of the measurand or in a term relative to the measurand (e.g. percent);
                      注:根據ISO/IEC指南99,測量結果通常表示為一個被測量值,包括測量單位和測量不確定度。
                      NOTE  According to ISO/IEC Guide 99, a measurement result is generally expressed as a single measured quantity value including unit of measurement and a measurement uncertainty.
                      b)校準過程中對測量結果有影響的條件(如環境條件);
                      b) the conditions (e.g. environmental) under which the calibrations were made that have an influence on the measurement results;
                      c)測量結果如何實現計量溯源性的聲明(參見附錄A);
                      c) a statement identifying how the measurements are metrologically traceable (see Annex A);
                      d)如可獲得,設備被調整或修理前后的結果;
                      d) the results before and after any adjustment or repair, if available;
                      e)相關時,與要求或規范的符合性聲明(見7.8.6);
                      e) where relevant, a statement of conformity with requirements or specifications (see 7.8.6);
                      f)適當時,意見和解釋(見7.8.7)。
                      f) where appropriate, opinions and interpretations (see 7.8.7).
                      7.8.4.2 如果實驗室負責抽樣活動,當解釋校準結果需要時,校準證書還應滿足7.8.5的要求。
                      Where the laboratory is responsible for the sampling activity, calibration certificates shall meet the requirements listed in 7.8.5 where necessary for the interpretation of test results.
                      7.8.4.3 校準證書或校準標簽不應包含校準周期的建議,除非已與客戶達成協議。
                      A calibration certificate or calibration label shall not contain any recommendation on the calibration interval, except where this has been agreed with the customer.
                      7.8.5 報告抽樣Reporting sampling——特定要求specific requirements
                      如果實驗室負責抽樣活動,除7.8.2中的要求外,當解釋結果需要時,報告還應包含以下信息:
                      Where the laboratory is responsible for the sampling activity, in addition to the requirements listed in 7.8.2, reports shall include the following, where necessary for the interpretation of results:
                      a)抽樣日期;
                      a) the date of sampling;
                      b)抽取的物品或物質的唯一性標識(適當時,包括制造商的名稱、標示的型號或類型以及序列號);
                      b) unique identification of the item or material sampled (including the name of the manufacturer, the model or type of designation and serial numbers, as appropriate);
                      c)抽樣位置,包括圖示、草圖或照片;
                      c) the location of sampling, including any diagrams, sketches or photographs;
                      d)抽樣計劃和抽樣方法;
                      d) a reference to the sampling plan and sampling method;
                      e)抽樣過程中影響結果解釋的環境條件的詳細信息;
                      e) details of any environmental conditions during sampling that affect the interpretation of the test results;
                      f)評定后續檢測或校準測量不確定度所需的信息。
                      f) information required to evaluate measurement uncertainty for subsequent testing or calibration.
                      7.8.6 報告符合性聲明Reporting statements of conformity
                      7.8.6.1 當做出與規范或標準的符合性聲明時,實驗室應考慮與所用判定規則相關的風險水平(如錯誤接受、錯誤拒絕以及統計假設),將所使用的判定規則形成文件,并應用判定規則。
                      When a statement of conformity to a specification or standard is provided, the laboratory shall document the decision rule employed, taking into account the level of risk (such as false accept and false reject and statistical assumptions) associated with the decision rule employed, and apply the decision rule.
                      注:如果客戶、法規或規范性文件規定了判定規則,無需進一步考慮風險水平。
                      NOTE  Where the decision rule is prescribed by the customer, regulations or normative documents, a further consideration of the level of risk is not necessary.
                      7.8.6.2 實驗室在報告符合性聲明時應清晰標識:
                      The laboratory shall report on the statement of conformity, such that the statement clearly identifies:
                      a)符合性聲明適用的結果;
                      a) to which results the statement of conformity applies;
                      b)滿足或不滿足的規范、標準或其中的條款;
                      b) which specifications, standards or parts thereof are met or not met;
                      c)應用的判定規則(除非規范或標準中已包含)。
                      c) the decision rule applied (unless it is inherent in the requested specification or standard).
                      注:詳細信息見ISO/IEC指南98-4。
                      NOTE  For further information, see ISO/IEC Guide 98-4.
                      7.8.7 報告意見和解釋Reporting opinions and interpretations
                      7.8.7.1 當表述意見和解釋時,實驗室應確保只有授權人員才能發布相關意見和解釋。實驗室應將意見和解釋的依據形成文件。
                      When opinions and interpretations are expressed, the laboratory shall ensure that only personnel authorized for the expression of opinions and interpretations releases the respective statement. The laboratory shall document the basis upon which the opinions and interpretations have been made.
                      注:注意區分意見和解釋與GB/T 27020中的檢驗聲明、GB/T 27065中的產品認證聲明以及7.8.6中符合性聲明的差異。
                      NOTE  It is important to distinguish opinions and interpretations from statements of inspections and product certifications as intended in ISO/IEC 17020 and ISO/IEC 17065, and from statements of conformity as referred to in 7.8.6.
                      G001應用說明:
                      實驗室可以選擇是否做出意見和解釋,并在管理體系中予以明確,并對其進行有效控制,包括合同評審。
                      注 1:根據檢測或校準結果,與規范或客戶的規定限量做出的符合性判斷,不屬于本準則所規定的“意見和解釋”?!耙庖姾徒忉尅钡氖纠?/span>
                      ? 對被測結果或其分布范圍的原因分析,比如在環境中毒素的檢測報告中對毒素來源的分析;
                      ? 根據檢測結果對被測樣品特性的分析;
                      ? 根據檢測結果對被測樣品設計、生產工藝、材料或結構等的改進建議。
                      注 2:在校準報告中,一般不需要做出意見和解釋。CNAS 暫不開展對校準結果的意見和解釋能力的認可。必要時, CNAS 將根據客戶需求和相關技術專家的意見,修訂此政策。
                      注 3:對于檢測活動,實驗室如果申請對某些特定檢測項目的“意見和解釋”能力的認可,應在申請書中予以明確,并說明針對哪些檢測項目做出哪類的意見和解釋,并提供以往做出“意見和解釋”時所依據的文件、記錄及報告。相關人員能力信息應隨同申請一同提交。實驗室人員如果僅從事過相關的檢測活動,而不熟悉檢測對象的設計、制造和使用,則不予認可其“意見和解釋”能力。
                      7.8.7.2 報告中的意見和解釋應基于被檢測或校準物品的結果,并清晰地予以標注。
                      The opinions and interpretations expressed in reports shall be based on the results obtained from the tested or calibrated item and shall be clearly identified as such.
                      7.8.7.3 當以對話方式直接與客戶溝通意見和解釋時,應保存對話記錄。
                      When opinions and interpretations are directly communicated by dialogue with the customer, a record of the dialogue shall be retained.
                      7.8.8 報告修改Amendments to reports
                      7.8.8.1 當更改、修訂或重新發布已發出的報告時,應在報告中清晰標識修改的信息,適當時標注修改的原因。
                      When an issued report needs to be changed, amended or re-issued, any change of information shall be clearly identified and, where appropriate, the reason for the change included in the report.
                      7.8.8.2 修改已發出的報告時,應僅以追加文件或數據傳送的形式,并包含以下聲明:
                      “對序列號為……(或其他標識)報告的修改”,或其他等效文字。
                      Amendments to a report after issue shall be made only in the form of a further document, or data transfer, which includes the statement “Amendment to Report, serial number... [or as otherwise identified]”, or an equivalent form of wording.
                      這類修改應滿足本標準的所有要求。
                      Such amendments shall meet all the requirements of this document.
                      7.8.8.3 當有必要發布全新的報告時,應予以唯一性標識,并注明所替代的原報告。
                      When it is necessary to issue a complete new report, this shall be uniquely identified and shall contain a reference to the original that it replaces.
                      7.9 投訴Complaints
                      7.9.1 實驗室應有形成文件的過程來接收和評價投訴,并對投訴作出決定。如果檢測和校準結果引起的投訴直接涉及軍工產品質量時,實驗室應立即進行調查,必要時應采取糾正措施,并保存記錄。
                      The laboratory shall have a documented process to receive, evaluate and make decisions on complaints.
                      G001應用說明:實驗室應及時處理收到的投訴。如果實驗室收到CNAS轉交的投訴,應在2個月內向CNAS反饋投訴處理結果。注:CNAS在收到對實驗室的投訴時,通常情況下將轉交給實驗室進行處理。如果投訴內容是針對實驗室能力和誠信時,CNAS將直接處理。處理方式包括安排不定期監督評審等,不定期監督評審可不預先通知實驗室。
                      7.9.2 利益相關方有要求時,應可獲得對投訴處理過程的說明。在接到投訴后,實驗室應證實投訴是否與其負責的實驗室活動相關,如相關,則應處理。實驗室應對投訴處理過程中的所有決定負責。
                      A description of the handling process for complaints shall be available to any interested party on request. Upon receipt of a complaint, the laboratory shall confirm whether the complaint relates to laboratory activities that it is responsible for and, if so, shall deal with it. The laboratory shall be responsible for all decisions at all levels of the handling process for complaints.
                      7.9.3 投訴處理過程應至少包括以下要素和方法:
                      The process for handling complaints shall include at least the following elements and methods:
                      a)對投訴的接收、確認、調查以及決定采取處理措施過程的說明;
                      a) description of the process for receiving, validating, investigating the complaint, and deciding what actions are to be taken in response to it;
                      b)跟蹤并記錄投訴,包括為解決投訴所采取的措施;
                      b) tracking and recording complaints, including actions undertaken to resolve them;
                      c)確保采取適當的措施。
                      c) ensuring that any appropriate action is taken.
                      7.9.4 接到投訴的實驗室應負責收集并驗證所有必要的信息,以便確認投訴是否有效。
                      The laboratory receiving the complaint shall be responsible for gathering and verifying all necessary information to validate the complaint.
                      7.9.5 只要可能,實驗室應告知投訴人已收到投訴,并向投訴人提供處理進程的報告和結果。
                      Whenever possible, the laboratory shall acknowledge receipt of the complaint, and provide the complainant with progress reports and the outcome.
                      7.9.6 通知投訴人的處理結果應由與所涉及的實驗室活動無關的人員作出,或審查和批準。
                      The outcomes to be communicated to the complainant shall be made by, or reviewed and approved by, individual(s) not involved in the original laboratory activities in question.
                      注:可由外部人員實施。
                      NOTE  This can be performed by external personnel.
                      7.9.7 只要可能,實驗室應正式通知投訴人投訴處理完畢。
                      Whenever possible, the laboratory shall give formal notice of the end of the complaint handling to the complainant.
                      7.10 不符合工作Nonconforming work
                      7.10.1 當實驗室活動或結果不符合自身的程序或與客戶協商一致的要求時(例如設備或環境條件超出規定限值、監控結果不能滿足規定的準則),實驗室應有程序予以實施。該程序應確保:
                      The laboratory shall have a procedure that shall be implemented when any aspect of its laboratory activities or results of this work do not conform to its own procedures or the agreed requirements of the customer (e.g. equipment or environmental conditions are out of specified limits, results of monitoring fail to meet specified criteria). The procedure shall ensure that:
                      a)確定不符合工作管理的職責和權力;
                      a) the responsibilities and authorities for the management of nonconforming work are defined;
                      b)基于實驗室建立的風險水平采取措施(包括必要時暫?;蛑貜凸ぷ饕约翱郯l報告);
                      b) actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established by the laboratory;
                      c)評價不符合工作的嚴重性,包括分析對先前結果的影響;
                      c) an evaluation is made of the significance of the nonconforming work, including an impact analysis on previous results;
                      d)對不符合工作的可接受性作出決定;
                      d) a decision is taken on the acceptability of the nonconforming work;
                      e)必要時,通知客戶并召回;
                      e) where necessary, the customer is notified and work is recalled;
                      f)規定批準恢復工作的職責。
                      f) the responsibility for authorizing the resumption of work is defined.
                      G001應用說明:
                      實驗室常見的不符合工作包括(但不限于)實驗室環境條件不滿足要求、試驗樣品的處置時間不滿足要求、試樣未在規定的時間內檢測、質量監控結果超過規定的限制、能力驗證或實驗室間比對結果不滿意等。實驗室所有人員均應熟悉不符合工作控制程序,尤其是直接從事檢測、校準和抽樣活動的人員。實驗室在內部審核中應特別關注不符合工作控制程序的執行情況。
                      7.10.2 實驗室應保存不符合工作和執行7.10.1中b)至f)規定的措施的記錄。
                      The laboratory shall retain records of nonconforming work and actions as specified in 7.10.1, bullets b) to f).
                      7.10.3 當評價表明不符合工作可能再次發生時,或對實驗室的運行與其管理體系的符合性產生懷疑時,實驗室應采取糾正措施。
                      Where the evaluation indicates that the nonconforming work could recur, or that there is doubt about the conformity of the laboratory’s operations with its own management system, the laboratory shall implement corrective action.
                      G001應用說明:實驗室應對發生的不符合工作的原因進行分析,對于不是偶發的、個案的問題,不應僅僅糾正發生的問題,還應按本條款要求啟動糾正措施。
                      7.11 數據控制和信息管理Control of data and information management
                      7.11.1 實驗室應獲得開展實驗室活動所需的數據和信息。
                      The laboratory shall have access to the data and information needed to perform laboratory activities.
                      GL030認可指南:實驗室大型儀器如液相色譜儀、氣相色譜儀等原始譜圖,如果不保存紙版記錄,應按照電子記錄進行管理,明確保存路徑并可進行追溯。
                      7.11.2 用于收集、處理、記錄、報告、存儲或檢索數據的實驗室信息管理系統,在投入使用前應進行功能確認,包括實驗室信息管理系統中接口的正常運行。對管理系統的任何變更,包括修改實驗室軟件配置或現成的商業化軟件,在實施前應被批準、形成文件并確認。
                      The laboratory information management system(s) used for the collection, processing, recording, reporting, storage or retrieval of data shall be validated for functionality, including the proper functioning of interfaces within the laboratory information management system(s) by the laboratory before introduction. Whenever there are any changes, including laboratory software configuration or modifications to commercial off-the-shelf software, they shall be authorized, documented and validated before implementation.
                      注1:本標準中“實驗室信息管理系統”包括計算機化和非計算機化系統中的數據和信息管理。相比非計算機化的系統,有些要求更適用于計算機化的系統。
                      NOTE 1  In this document “laboratory information management system(s)” includes the management of data and information contained in both computerized and non-computerized systems. Some of the requirements can be more applicable to computerized systems than to non-computerized systems.
                      注2:常用的現成商業化軟件在其設計應用范圍內的使用可被視為已經過充分的確認。
                      NOTE 2  Commercial off-the-shelf software in general use within its designed application range can be considered to be sufficiently validated.
                      注3:處理與軍工產品有關的檢測和/或校準數據時,應實施保密措施(如,與因特網物理斷開)。
                      G001應用說明:實驗室使用信息管理系統(LIMS)時,應確保該系統滿足所有相關要求,包括審核路徑、數據安全和完整性等。實驗室應對 LIMS 與相關認可要求的符合性和適宜性進行完整的確認,并保留確認記錄;對 LIMS 的改進和維護應確??梢垣@得先前產生的記錄。
                      7.11.3 實驗室信息管理系統應:
                      The laboratory information management system(s) shall:
                      a)防止未經授權的訪問;
                      a) be protected from unauthorized access;
                      b)被安全保護以防止篡改和丟失;
                      b) be safeguarded against tampering and loss;
                      c)在符合系統供應商或實驗室規定的環境中運行,或對于非計算機化的系統,提供保護人工記錄和轉錄準確性的條件;
                      c) be operated in an environment that complies with supplier or laboratory specifications or, in the case of non-computerized systems, provides conditions which safeguard the accuracy of manual recording and transcription;
                      d)以確保數據和信息完整性的方式進行維護;
                      d) be maintained in a manner that ensures the integrity of the data and information;
                      e)包括記錄系統失效、適當的緊急措施及糾正措施的記錄。
                      e) include recording system failures and the appropriate immediate and corrective actions.
                      7.11.4 當實驗室信息管理系統在異地或由外部供應商進行管理和維護時,實驗室應確保系統的供應商或運營商符合本標準的所有適用要求。
                      When a laboratory information management system is managed and maintained off-site or through an external provider, the laboratory shall ensure that the provider or operator of the system complies with all applicable requirements of this document.
                      7.11.5 實驗室應確保員工易于獲取與實驗室信息管理系統相關的說明書、手冊和參考數據。
                      The laboratory shall ensure that instructions, manuals and reference data relevant to the laboratory information management system(s) are made readily available to personnel.
                      7.11.6 應對計算和數據傳送進行適當和系統地檢查。
                      Calculations and data transfers shall be checked in an appropriate and systematic manner.

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