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本文件明確了CNAS對檢測報告和校準證書(shū)（以下簡(jiǎn)稱(chēng)“報告”）的結果信息、使用、管理、評審等方面的相關(guān)要求，是對CNAS-CL01（等同采納ISO/IEC 17025）相關(guān)條款的進(jìn)一步解釋和說(shuō)明，目的在于統一對標準的理解，確保認可評審和管理的一致性。1.2 本文件僅適用于CNAS依據CNAS-CL01對檢測和校準實(shí)驗室開(kāi)展的認可活動(dòng)。 </div> <div id="t1hztlg" class="artview_content" style="display:block;font-family:Microsoft YaHei;font-size:14px;color:#5A5A5A;font-weight:normal;text-decoration:none;"> <div id="t1hztlg" class="artview_detail" setsid="article82"> <span style="font-size:16px;">檢測報告和校準證書(shū)相關(guān)要求的認可說(shuō)明</span><br /> <span style="font-size:16px;">1. 目的和范圍1.1 本文件明確了CNAS對檢測報告和校準證書(shū)（以下簡(jiǎn)稱(chēng)“報告”）的結果信息、使用、管理、評審等方面的相關(guān)要求，是對CNAS-CL01（等同采納ISO/IEC 17025）相關(guān)條款的進(jìn)一步解釋和說(shuō)明，目的在于統一對標準的理解，確保認可評審和管理的一致性。1.2 本文件僅適用于CNAS依據CNAS-CL01對檢測和校準實(shí)驗室開(kāi)展的認可活動(dòng)。</span><br /> <span style="font-size:16px;">2. 實(shí)驗室出具報告的要求2.1 實(shí)驗室應準確、清晰、明確和客觀(guān)地出具結果。（CNAS-CL01:2018, 7.8.1.2）a) 樣品信息準確，并且必須是實(shí)測樣品。示例1：客戶(hù)送測樣品A、B和C，聲稱(chēng)是三種型號對應同一原型產(chǎn)品，實(shí)驗室實(shí)際測試的是B樣品。實(shí)驗室在報告的樣品信息描述中，只能聲明被測樣品是B，不應列入A和C的信息，因該信息是由客戶(hù)提供，實(shí)驗室未進(jìn)行驗證。如果實(shí)驗室通過(guò)驗證能夠證明A、B、C三種型號確實(shí)是對應同一原型產(chǎn)品，實(shí)驗室可以在報告中列出三種型號的信息，但應聲明被測樣品是B，同時(shí)報告型號驗證結果和相應的支持數據或信息。示例2：實(shí)驗室在對客戶(hù)產(chǎn)品的第一次測試中發(fā)現有些項目是不合格的，客戶(hù)對產(chǎn)品進(jìn)行了改進(jìn)，再次送檢。第二次測試如果只是測試了不合格項目，實(shí)驗室出具的報告應只包括此次測試的項目。如果客戶(hù)要求將第一次測試合格的項目也納入到報告中，出具完整的測試合格報告，實(shí)驗室應在報告中以清晰的方式標明第一次測試合格和第二次測試合格的數據，并說(shuō)明第二次測試數據為第一次測試不合格經(jīng)客戶(hù)對樣品進(jìn)行改進(jìn)后測試的數據，必要時(shí)給出原不合格數據以及客戶(hù)所做的改進(jìn)工作說(shuō)明。b) 如果測試地點(diǎn)不在實(shí)驗室的固定場(chǎng)所，如在客戶(hù)地點(diǎn)或樣品所在地，報告中應給出詳細的地址信息，僅給出“客戶(hù)地點(diǎn)”等模糊信息是不充分的。（參見(jiàn)CNAS-CL01:2018, 7.8.2.1 c）c) 如果實(shí)際測試過(guò)程是由客戶(hù)的技術(shù)人員操作，實(shí)驗室只是目擊了試驗的過(guò)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。注：有些客戶(hù)會(huì )接受目擊試驗報告，但目擊試驗不在CNAS的認可范圍內。d) 實(shí)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(huì )產(chǎn)生誤解（參見(jiàn)CNAS-CL01:2018, 7.8.2.1 p）。當使用認可標識時(shí)，按“外部提供的信息”（視同“分包”）要求控制。2.2 實(shí)驗室對報告中的所有信息負責，客戶(hù)提供的信息除外?？蛻?hù)提供的數據應予明確標識。此外，當客戶(hù)提供的信息可能影響結果的有效性時(shí)，報告中應有免責聲明。（CNAS-CL01:2018, 7.8.2.2）對于客戶(hù)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(diǎn)），實(shí)驗室應以顯著(zhù)方式在報告正文中說(shuō)明此為客戶(hù)提供信息，實(shí)驗室對此真實(shí)性不承擔責任。示例1：客戶(hù)聲稱(chēng)所送樣品是為某品牌供貨的原材料，并要求將品牌信息寫(xiě)入報告中。由于對原材料是無(wú)法辨別品牌信息的，實(shí)驗室不應將客戶(hù)提供的品牌信息寫(xiě)入報告中，除非有信息來(lái)源說(shuō)明和免責聲明。示例2：客戶(hù)聲稱(chēng)樣品來(lái)自某個(gè)地點(diǎn)，要求實(shí)驗室將樣品的地點(diǎn)信息寫(xiě)入報告中。由于此信息實(shí)驗室是客戶(hù)提供的，實(shí)驗室無(wú)法證明，因此不應將此信息寫(xiě)入報告，除非有信息來(lái)源說(shuō)明和免責聲明。2.3當實(shí)驗室在永久控制之外的地點(diǎn)或設施中實(shí)施實(shí)驗室活動(dòng)時(shí)，應確保滿(mǎn)足本準則中有關(guān)設施和環(huán)境條件的要求（CNAS-CL01:2018, 6.3.5）。實(shí)驗室使用永久控制以外的設備時(shí)，應確保滿(mǎn)足本準則對設備的要求。（CNAS-CL01:2018, 6.4.2）a) 在客戶(hù)或樣品所在地現場(chǎng)進(jìn)行的測試活動(dòng)，如果設備無(wú)法便攜、設備的運輸對設備的準確度有影響、或樣品的運輸會(huì )影響測試結果，實(shí)驗室可以使用客戶(hù)的設備，在原始記錄中應體現設備信息，包括設備型號信息、唯一性識別、校準證書(shū)信息等。測試方法對設施和環(huán)境條件有要求時(shí)，相應的環(huán)境條件也應予以記錄。b) 對設施和環(huán)境條件有嚴格要求的校準活動(dòng)，原則上不應進(jìn)行現場(chǎng)校準，除非實(shí)驗室可以提供充分的證據證明試驗現場(chǎng)符合方法要求。記錄應包括環(huán)境監測的設備信息和監測數據，必要時(shí)拍攝照片保存。 2.4實(shí)驗室應在認可范圍和認可有效期內按照CNAS-R01以及相關(guān)要求的規定使用 CNAS 認可標識或聲明認可狀態(tài)。a) 在認可的“校準和測量能力范圍”表中，包括“測量?jì)x器名稱(chēng)”、“被測量”、“校準規范名稱(chēng)及編號”、“測量范圍”和“擴展不確定度”5個(gè)欄目的信息。校準實(shí)驗室如果使用認可標識或做出認可聲明，應確保出具的校準證書(shū)中這5項信息均在認可范圍內。實(shí)驗室在簽發(fā)校準證書(shū)時(shí)應重點(diǎn)審查上述信息。對不在認可范圍內的項目，應以簡(jiǎn)潔、顯著(zhù)的方式做出標注或說(shuō)明。注：隨著(zhù)儀器產(chǎn)業(yè)的快速發(fā)展，儀器名稱(chēng)也出現多樣化。當被校的儀器名稱(chēng)與認可能力范圍內的儀器名稱(chēng)不一致時(shí)，校準實(shí)驗室應分析所選校準方法的適用性，除對方法的適用范圍中給出的信息進(jìn)行分析外，也需分析校準參數和校準方法是否適用于送校樣品。如果判斷校準方法適用于被校儀器及校準參數，則校準證書(shū)中可以使用認可標識或聲明認可狀態(tài)。b) 實(shí)驗室簽發(fā)的帶認可標識或聲明認可狀態(tài)的報告中不應包含認證標志及相關(guān)內容，以免產(chǎn)生誤導，如CE認證、3C認證等。c) 實(shí)驗室簽發(fā)的報告中僅包含意見(jiàn)或解釋時(shí)，不得在報告上使用認可標識或聲明認可狀態(tài)。</span><br /> <span style="font-size:16px;">3. 實(shí)驗室對認可能力的管理要求 3.1對初次申請認可的項目，包含擴項，實(shí)驗室每個(gè)項目均應出具過(guò)報告。如果實(shí)驗室沒(méi)有對外提供過(guò)正式報告，內部報告或測試結果也可以作為檢測/校準經(jīng)歷。實(shí)驗室應在申請書(shū)中如實(shí)填寫(xiě)檢測/校準經(jīng)歷次數。3.2實(shí)驗室應對認可的能力進(jìn)行有效管理，以持續保持技術(shù)能力。對于已獲認可的項目，實(shí)驗室應有相應的測試經(jīng)歷，2年內應出具過(guò)相應的報告（可以是內部報告或測試結果）。對2年內沒(méi)有出具過(guò)報告或結果，也沒(méi)有內部驗證試驗或相關(guān)質(zhì)量控制記錄的項目，應主動(dòng)申請縮小認可范圍。3.3 實(shí)驗室在管理評審中應考慮實(shí)驗室活動(dòng)范圍和工作類(lèi)型的變化（參見(jiàn)CNAS-CL01:2018, 8.9.2h）。實(shí)驗室應在管理評審中對已認可的檢測和校準能力進(jìn)行定期評估，確保能力的維持。評估中應重點(diǎn)關(guān)注設施、設備和人員能力的變化、測試方法的更新、以及開(kāi)展業(yè)務(wù)的情況。對于無(wú)法持續滿(mǎn)足要求的檢測或校準能力，或2年以?xún)葲](méi)有測試經(jīng)歷的能力，應主動(dòng)申請縮小認可范圍。3.4 實(shí)驗室可利用設備的校準證書(shū)來(lái)管理其認可范圍。實(shí)驗室的設備應與其認可的能力范圍相匹配，在制定校準方案時(shí)，設備的校準參數、測量不確定度要求等應考慮依據認可范圍設定（參見(jiàn)CNAS-CL01:2018, 6.4.7）。實(shí)驗室應使用校準證書(shū)的實(shí)際校準結果評估設備是否滿(mǎn)足認可能力范圍的要求，如量程范圍和測量不確定度等，必要時(shí)，申請更新認可范圍。注1：通常情況下，校準方案包括設備名稱(chēng)、校準參數、測量范圍、測量不確定度要求和校準周期等內容。注2：更新認可范圍可以是變更、擴大或縮小認可范圍。注3：在認可評審中經(jīng)常發(fā)現實(shí)驗室提供的設備校準證書(shū)中測量范圍小于認可的范圍，或測量不確定度大于認可的測量不確定度，這些情況下實(shí)驗室應根據設備的實(shí)際校準結果縮小其認可范圍。</span><br /> <span style="font-size:16px;">4. CNAS對報告的認可評審要求4.1在現場(chǎng)評審中，評審組應注重抽查報告，由評審組現場(chǎng)隨機抽取，抽樣量應與出報告的數量相匹配。4.2 評審組應核查報告的以下內容：a) 與認可要求的符合性（以CNAS-CL01：2018的7.8條款為依據）；b) 信息的適宜性和充分性（以測試方法為依據）；c) 報告數據與原始記錄的可追溯性；d) 對客戶(hù)提供信息的控制，需要時(shí)應以醒目的方式標識并做出免責聲明；e) 發(fā)出報告或數據的控制管理；f) 報告的控制系統，應易于追溯報告編號，不得隨機編號；g) 認可標識使用及認可狀態(tài)聲明的管理；h) 客戶(hù)現場(chǎng)試驗出具報告的控制；i) 客戶(hù)現場(chǎng)試驗原始記錄的控制，是否含地點(diǎn)、設備、測試人員，以及必要時(shí)的環(huán)境信息；j) 對目擊試驗的控制，應在報告中以顯著(zhù)的方式如實(shí)說(shuō)明是目擊試驗。4.3 評審組應重點(diǎn)關(guān)注原始記錄與報告的符合性，可從報告追溯至原始記錄。實(shí)驗室應能夠提供實(shí)驗室活動(dòng)過(guò)程的充分信息，可以只有測試結果的原始記錄而不出具報告，但不應以試驗報告取代原始記錄。如果實(shí)驗室不能提供原始記錄及其它能證明實(shí)施過(guò)測試的相關(guān)記錄或證據（如設備使用記錄、自動(dòng)化儀器內后臺數據、相應樣品上的測試痕跡等）、且不能提供合理的解釋?zhuān)驅?shí)驗室的原始記錄不真實(shí)，均視為沒(méi)做試驗出報告，按不誠信行為處理。4.4 對初次申請認可的項目，包含擴項，要求每個(gè)申請認可的項目均應有相應的報告，（可以是內部報告或測試結果）?，F場(chǎng)評審時(shí)，評審組應檢查每個(gè)申請項目的報告，在時(shí)間允許的情況下，盡量擴大報告抽樣量。如果發(fā)現報告數量明顯少于申請書(shū)填寫(xiě)的經(jīng)歷，實(shí)驗室不能提供合理的解釋?zhuān)砂瓷暾埿畔⒉徽鎸?shí)做出處理。4.5 對于已獲認可的項目，在認可評審中，評審組將重點(diǎn)關(guān)注實(shí)驗室能力的有效保持以及對能力范圍的監控情況。在定期監督評審和復評審中，評審組應重點(diǎn)抽查自上次評審以來(lái)發(fā)出的報告或結果，每個(gè)認可的項目均在抽查范圍內。視實(shí)驗室出具報告的情況，原則上對所抽查的測試項目，每個(gè)項目在可行時(shí)至少查3份報告，查閱的報告應為評審員的主動(dòng)抽樣。二年之內沒(méi)有測試經(jīng)歷的項目，原則上不推薦認可。注：對認可范圍內同一測試項目有多個(gè)方法，方法的測試步驟和原理基本相同但屬于不同系列標準的，例如GB以及對應的ISO、IEC等標準，如果實(shí)驗室只有一個(gè)方法有相應的測試經(jīng)歷，其他類(lèi)同方法視為有經(jīng)歷，但評審員需重點(diǎn)評審實(shí)驗室技術(shù)人員是否了解方法之間的差異。如果實(shí)驗室人員不能明確說(shuō)明方法之間的差異，沒(méi)有測試經(jīng)歷的方法不予認可。4.6 在安排評審組時(shí)，應考慮評審組抽查報告的工作量，需要時(shí)適當增加人日數。</span><br /> <div style="clear:both;"></div> </div> </div> <div id="t1hztlg" class="artview_prev_next"> <div style="margin-top:20px;width:100%;"> <div style="" class="prevlist"> <a class="prev_next_link" style="display:block;float:left;" href="http://www.zanmennaer.com/xwxq.html?article_id=92" title="市場(chǎng)監管總局召開(kāi)電視電話(huà)會(huì )議全面推進(jìn)進(jìn)口冷鏈食品追溯平臺建設進(jìn)一步強化新冠病毒輸入風(fēng)險“物防”措施"> <span id="t1hztlg" class="up_arrow"></span> <span id="t1hztlg" class="prev_next_text prev_txt" style="display:block;float:left;margin-right: 5px;">上一篇： </span> 市場(chǎng)監管總局召開(kāi)電視...... </a> <div style="clear:both;"></div> </div> <div style="" class="nextlist"> <a class="prev_next_link" style="display:block;float:left;" href="http://www.zanmennaer.com/xwxq.html?article_id=80" title="國家市場(chǎng)監督管理總局令"> <span id="t1hztlg" class="down_arrow"></span> <span id="t1hztlg" class="prev_next_text next_txt" style="display:block;float:left;margin-right: 5px;">下一篇：</span> 國家市場(chǎng)監督管理總局...... </a> <div style="clear:both;"></div> </div> </div> </div> </div> </div> </div> </div> <div class="t1hztlg" id="site_footer" style="width:1200px;position:absolute;height:444px;z-index:500;margin-top:0px"> <div id="t1hztlg" class="full_width " margintopheight=0 style="position:absolute;height:444px;background-repeat:no-repeat;background-position:center top;background-color:#000000;background:;background-image:url('http://hkw741eed.pic48.websiteonline.cn/upload/kebosy_12.jpg');"></div> <div class="t1hztlg" id="footer_content" class="full_content" style="width:1200px; 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