中國(guó)合格評(píng)定國(guó)家認(rèn)可委員會(huì)（英文縮寫：CNAS）等同采用ISO/IEC 17025：2017《檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力的通用要求》 作為對(duì)檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力進(jìn)行認(rèn)可的基本認(rèn)可準(zhǔn)則。為支持特定領(lǐng)域的認(rèn)可活動(dòng)， CNAS還根據(jù)不同領(lǐng)域的專業(yè)特點(diǎn)，制定一系列的特定領(lǐng)域應(yīng)用說明，對(duì)本準(zhǔn)則的要求進(jìn)行必要的補(bǔ)充說明和解釋，但并不增加或減少本準(zhǔn)則的要求。本準(zhǔn)則內(nèi)容及條款號(hào)與國(guó)際標(biāo)準(zhǔn) ISO/IEC 17025:2017內(nèi)容及條款號(hào)完全一致。CNAS鼓勵(lì)申請(qǐng)認(rèn)可的機(jī)構(gòu)購(gòu)買和使用正版國(guó)際和國(guó)家標(biāo)準(zhǔn)。
7 過程要求Process requirements 7.1 要求、標(biāo)書和合同的評(píng)審Review of requests, tenders and contracts
7.1.1 實(shí)驗(yàn)室應(yīng)有要求、標(biāo)書和合同評(píng)審程序。該程序應(yīng)確保：
The laboratory shall have a procedure for the review of requests, tenders and contracts. The procedure shall ensure that:
GL030認(rèn)可指南：實(shí)驗(yàn)室應(yīng)結(jié)合自身特點(diǎn)建立可行和有效的要求、標(biāo)書和合同評(píng)審的程序。
a)要求被予以充分規(guī)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(zhí)行的要求（如法律法規(guī)規(guī)定的要求）。
注2：必要時(shí)，實(shí)驗(yàn)室承擔(dān)軍工產(chǎn)品檢測(cè)任務(wù)能力的評(píng)審應(yīng)按軍工產(chǎn)品檢測(cè)的有關(guān)規(guī)定進(jìn)行。
b)實(shí)驗(yàn)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(dāng)使用外部供應(yīng)商時(shí)，應(yīng)滿足6.6的要求，實(shí)驗(yàn)室應(yīng)告知客戶由外部供應(yīng)商實(shí)施的實(shí)驗(yàn)室活動(dòng)，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(yīng)用說明：實(shí)驗(yàn)室委托外部制樣時(shí)，應(yīng)告知客戶制樣活動(dòng)由外部機(jī)構(gòu)提供，并獲得客戶同意。
A002應(yīng)用說明：需要時(shí)，實(shí)驗(yàn)室應(yīng)與客戶在合同中明確約定與后續(xù)檢測(cè)相關(guān)的抽樣(含取樣、采樣)的方案，包括抽樣位置、時(shí)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(shí)驗(yàn)室活動(dòng)：
NOTE 1 It is recognized that externally provided laboratory activities can occur when:
——實(shí)驗(yàn)室有實(shí)施活動(dòng)的資源和能力，但由于不可預(yù)見的原因不能承擔(dān)部分或全部活動(dòng)；
— 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(shí)驗(yàn)室沒有實(shí)施活動(dòng)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(shí)驗(yàn)室活動(dòng)時(shí)，應(yīng)優(yōu)先選擇獲得DILAC認(rèn)可的實(shí)驗(yàn)室。
d)選擇適當(dāng)?shù)姆椒ɑ虺绦颍⒛軡M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(duì)于內(nèi)部或例行客戶，要求、標(biāo)書和合同評(píng)審可簡(jiǎn)化進(jìn)行。
NOTE 2 For internal or routine customers, reviews of requests, tenders and contracts can be performed in a simplified way.
GL030認(rèn)可指南：根據(jù)實(shí)驗(yàn)室實(shí)際情況可將母體組織（包括代加工廠）或原料供應(yīng)商的要求分為的單次檢測(cè)要求或重復(fù)性檢測(cè)要求。無論何種形式的要求都應(yīng)明確檢測(cè)項(xiàng)目、檢測(cè)依據(jù)。對(duì)于重復(fù)性檢測(cè)要求至少每年評(píng)審一次。
7.1.2 當(dāng)客戶要求的方法不合適或是過期的，實(shí)驗(yàn)室應(yīng)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(dāng)客戶要求針對(duì)檢測(cè)或校準(zhǔn)作出與規(guī)范或標(biāo)準(zhǔn)符合性的聲明時(shí)（如通過/未通過，在允許限內(nèi)/超出允許限），應(yīng)明確規(guī)定規(guī)范或標(biāo)準(zhǔn)以及判定規(guī)則。應(yīng)將選擇的判定規(guī)則通知客戶并得到同意，除非規(guī)范或標(biāo)準(zhǔn)本身已包含判定規(guī)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(xì)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(biāo)書與合同之間的任何差異均應(yīng)在實(shí)施實(shí)驗(yàn)室活動(dòng)前解決。每項(xiàng)合同都應(yīng)被實(shí)驗(yàn)室和客戶雙方接受。客戶要求的偏離不應(yīng)影響實(shí)驗(yàn)室的誠(chéng)信或結(jié)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(yīng)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(yīng)重新進(jìn)行合同評(píng)審，并將修改的內(nèi)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(jiān)控其相關(guān)工作表現(xiàn)方面，實(shí)驗(yàn)室應(yīng)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(jìn)入實(shí)驗(yàn)室相關(guān)區(qū)域，以見證與該客戶相關(guān)的實(shí)驗(yàn)室活動(dòng)。
a) providing reasonable access to relevant areas of the laboratory to witness customer-specific laboratory activities;
b)客戶出于驗(yàn)證目的所需物品的準(zhǔn)備、包裝和發(fā)送。
b) preparation, packaging, and dispatch of items needed by the customer for verification purposes.
G001應(yīng)用說明：必要時(shí)，實(shí)驗(yàn)室應(yīng)給客戶提供充分說明，以便客戶在申請(qǐng)檢測(cè)或校準(zhǔn)項(xiàng)目時(shí)能更加適合自身的需求與用途。
GL030認(rèn)可指南：當(dāng)實(shí)驗(yàn)室的客戶均為內(nèi)部客戶時(shí)，可邀請(qǐng)客戶不定期到實(shí)驗(yàn)室觀察檢測(cè)活動(dòng)、宣傳檢測(cè)活動(dòng)的相關(guān)知識(shí)。
7.1.8 實(shí)驗(yàn)室應(yīng)保存評(píng)審記錄，包括任何重大變化的評(píng)審記錄。針對(duì)客戶要求或?qū)嶒?yàn)室活動(dòng)結(jié)果與客戶所進(jìn)行的討論，也應(yīng)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(yàn)證和確認(rèn)Selection, verification and validation of methods
7.2.1 方法的選擇和驗(yàn)證Selection and verification of methods
7.2.1.1 實(shí)驗(yàn)室應(yīng)使用適當(dāng)?shù)姆椒ê统绦蜷_展所有實(shí)驗(yàn)室活動(dòng)，適當(dāng)時(shí)，包括測(cè)量不確定度的評(píng)定以及使用統(tǒng)計(jì)技術(shù)進(jìn)行數(shù)據(jù)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(biāo)準(zhǔn)所用“方法”可視為是ISO/IEC指南99定義的“測(cè)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(yīng)用說明：實(shí)驗(yàn)室開展力學(xué)性能檢測(cè)時(shí)，應(yīng)防止不正確的試樣夾持或放置對(duì)檢測(cè)結(jié)果的影響。使用不同標(biāo)準(zhǔn)進(jìn)行力學(xué)性能檢測(cè)時(shí)，應(yīng)注意標(biāo)準(zhǔn)之間的差異部分，包括試樣尺寸和精度、對(duì)設(shè)備的要求、試驗(yàn)過程的要求、計(jì)算結(jié)果的修約等。用同一臺(tái)火花放電原子發(fā)射光譜儀對(duì)不同基體材料進(jìn)行化學(xué)分析時(shí)，應(yīng)有程序保證在基體切換時(shí)不會(huì)造成元素干擾。
A002應(yīng)用說明：實(shí)驗(yàn)室應(yīng)關(guān)注檢測(cè)方法中提供的限制說明、濃度范圍和樣品基體，選擇的檢測(cè)方法應(yīng)確保在限值附近給出可靠的結(jié)果。實(shí)驗(yàn)室應(yīng)建立和執(zhí)行與檢測(cè)方法要求相匹配的校準(zhǔn)曲線，并定期使用中間濃度水平的校準(zhǔn)標(biāo)樣檢查校準(zhǔn)曲線，建立檢查結(jié)果可否接受的判定標(biāo)準(zhǔn)。
G001應(yīng)用說明：實(shí)驗(yàn)室應(yīng)對(duì)使用的檢測(cè)或校準(zhǔn)方法實(shí)施有效的控制與管理，明確每種新方法投入使用的時(shí)間，并及時(shí)跟進(jìn)檢測(cè)或校準(zhǔn)技術(shù)的發(fā)展，定期評(píng)審方法能否滿足檢測(cè)或校準(zhǔn)需求。
GL030認(rèn)可指南：
實(shí)驗(yàn)室使用方法進(jìn)行檢測(cè)活動(dòng)，應(yīng)確保：
(1) 遵循樣品制備步驟；
(2) 遵循標(biāo)準(zhǔn)物質(zhì)/試劑存儲(chǔ)和使用要求；
(3) 遵循儀器設(shè)備的運(yùn)行和操作要求；
(4) 按檢測(cè)方法規(guī)定程序檢測(cè)空白樣品和質(zhì)量控制樣品；
(5) 遵循檢測(cè)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(shí)驗(yàn)室活動(dòng)相關(guān)的指導(dǎo)書、標(biāo)準(zhǔn)、手冊(cè)和參考數(shù)據(jù)，應(yīng)保持現(xiàn)行有效并易于人員獲取（見8.3）。
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(yīng)用說明：采用與標(biāo)準(zhǔn)圖譜比較的方法進(jìn)行金相評(píng)估檢驗(yàn)時(shí)，應(yīng)至少配有一套原版圖譜或標(biāo)準(zhǔn)圖譜圖集。為方便操作而進(jìn)行的復(fù)制，應(yīng)確保與原版圖譜或標(biāo)準(zhǔn)圖譜的一致性（大小、色彩、灰度、分辨率等）。
7.2.1.3 實(shí)驗(yàn)室應(yīng)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(shí)，應(yīng)補(bǔ)充方法使用的細(xì)則以確保應(yīng)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(guó)際、區(qū)域或國(guó)家標(biāo)準(zhǔn)，或其他公認(rèn)的規(guī)范文本包含了實(shí)施實(shí)驗(yàn)室活動(dòng)充分且簡(jiǎn)明的信息，并便于實(shí)驗(yàn)室操作人員使用時(shí)，則不需要再進(jìn)行補(bǔ)充或改寫為內(nèi)部程序。可能有必要制定實(shí)施細(xì)則，或?qū)Ψ椒ㄖ械目蛇x擇步驟提供補(bǔ)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(yīng)用說明：實(shí)驗(yàn)室對(duì)抽樣和取樣活動(dòng)在必要時(shí)應(yīng)制訂作業(yè)指導(dǎo)書，取樣作業(yè)指導(dǎo)書應(yīng)規(guī)定取樣部位、取樣方向、取樣量和取樣方法。對(duì)力學(xué)性能檢測(cè)、金相檢驗(yàn)及微觀結(jié)構(gòu)檢測(cè)、儀器法化學(xué)成分分析的試樣制備應(yīng)制定作業(yè)指導(dǎo)書，明確加工及其他相關(guān)的技術(shù)要求，如關(guān)鍵參數(shù)的具體指標(biāo)（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(shí)，力學(xué)性能檢測(cè)的制樣作業(yè)指導(dǎo)書應(yīng)有相應(yīng)的圖紙，并對(duì)加工的試樣圖紙進(jìn)行管理和控制。微觀結(jié)構(gòu)分析如果采用通則方法，應(yīng)針對(duì)檢測(cè)對(duì)象制定具體的作業(yè)指導(dǎo)書。
G001應(yīng)用說明：對(duì)于標(biāo)準(zhǔn)方法，應(yīng)定期跟蹤標(biāo)準(zhǔn)的制修訂情況，及時(shí)采用最新版本標(biāo)準(zhǔn)。
GL030認(rèn)可指南：實(shí)驗(yàn)室應(yīng)建立在用檢測(cè)標(biāo)準(zhǔn)的清單,并規(guī)定方法查新的頻率、查新方式和查新結(jié)果的處置要求。 如檢測(cè)標(biāo)準(zhǔn)存在可選擇執(zhí)行要求或易產(chǎn)生歧義理解時(shí)，實(shí)驗(yàn)室應(yīng)編制作業(yè)指導(dǎo)書，以保證在實(shí)驗(yàn)室內(nèi)部檢測(cè)操作的一致性。
7.2.1.4 當(dāng)客戶未指定所用的方法時(shí)，實(shí)驗(yàn)室應(yīng)選擇適當(dāng)?shù)姆椒ú⑼ㄖ蛻簟Ｍ扑]使用以國(guó)際標(biāo)準(zhǔn)、區(qū)域標(biāo)準(zhǔn)或國(guó)家標(biāo)準(zhǔn)發(fā)布的方法，或由知名技術(shù)組織或有關(guān)科技文獻(xiàn)或期刊中公布的方法，或設(shè)備制造商規(guī)定的方法。實(shí)驗(yàn)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(shí)驗(yàn)室開展軍工產(chǎn)品的檢測(cè)和校準(zhǔn)工作時(shí)，應(yīng)優(yōu)先選擇國(guó)家軍用標(biāo)準(zhǔn)。
GL030認(rèn)可指南：實(shí)驗(yàn)室應(yīng)優(yōu)先使用以國(guó)際、區(qū)域、國(guó)家或行業(yè)標(biāo)準(zhǔn)發(fā)布的方法，也可選擇母體組織制定的方法。除使用國(guó)家強(qiáng)制執(zhí)行的標(biāo)準(zhǔn)外,鼓勵(lì)實(shí)驗(yàn)室根據(jù)應(yīng)用需要開發(fā)適用性更強(qiáng)、技術(shù)更先進(jìn)、效率更高的非標(biāo)準(zhǔn)檢測(cè)方法。
7.2.1.5 實(shí)驗(yàn)室在引入方法前，應(yīng)驗(yàn)證能夠正確地運(yùn)用該方法，以確保實(shí)現(xiàn)所需的方法性能。應(yīng)保存驗(yàn)證記錄。如果發(fā)布機(jī)構(gòu)修訂了方法，應(yīng)依據(jù)方法變化的內(nèi)容重新進(jìn)行驗(yàn)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(yīng)用說明：實(shí)驗(yàn)室應(yīng)對(duì)首次采用的標(biāo)準(zhǔn)方法進(jìn)行技術(shù)能力的驗(yàn)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(duì)于痕量分析和超痕量分析，還應(yīng)關(guān)注檢出限、定量限等。當(dāng)標(biāo)準(zhǔn)方法發(fā)生變更涉及到技術(shù)能力發(fā)生變化，如檢測(cè)方法原理、儀器設(shè)備、環(huán)境設(shè)施、操作方法、方法適用范圍等，需要通過技術(shù)驗(yàn)證重新證明正確運(yùn)用新標(biāo)準(zhǔn)的能力。
G001應(yīng)用說明：在引入檢測(cè)或校準(zhǔn)方法之前，實(shí)驗(yàn)室應(yīng)對(duì)其能否正確運(yùn)用這些標(biāo)準(zhǔn)方法的能力進(jìn)行驗(yàn)證，驗(yàn)證不僅需要識(shí)別相應(yīng)的人員、設(shè)施和環(huán)境、設(shè)備等，還應(yīng)通過試驗(yàn)證明結(jié)果的準(zhǔn)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(biāo)，必要時(shí)應(yīng)進(jìn)行實(shí)驗(yàn)室間比對(duì)。
7.2.1.6 當(dāng)需要開發(fā)方法時(shí)，應(yīng)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(fā)的過程中，應(yīng)進(jìn)行定期評(píng)審，以確定持續(xù)滿足客戶需求。開發(fā)計(jì)劃的任何變更應(yīng)得到批準(zhǔn)和授權(quán)。必要時(shí)，方法制定過程的相應(yīng)階段應(yīng)進(jìn)行評(píng)審，以證實(shí)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(duì)所有實(shí)驗(yàn)室活動(dòng)方法的偏離，應(yīng)事先將該偏離形成文件，經(jīng)技術(shù)判斷，獲得授權(quán)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(rèn)可指南：當(dāng)使用標(biāo)準(zhǔn)方法不能滿足要求需要偏離檢測(cè)標(biāo)準(zhǔn)時(shí)，實(shí)驗(yàn)室應(yīng)將偏離形成作業(yè)指導(dǎo)書，并按非標(biāo)準(zhǔn)方法的控制要求執(zhí)行。
7.2.2 方法確認(rèn)Validation of methods
7.2.2.1 實(shí)驗(yàn)室應(yīng)對(duì)非標(biāo)準(zhǔn)方法（含軍工產(chǎn)品非通用的專用測(cè)試設(shè)備校準(zhǔn)規(guī)范）、實(shí)驗(yàn)室開發(fā)的方法、超出預(yù)定范圍使用的標(biāo)準(zhǔn)方法、或其他修改的標(biāo)準(zhǔn)方法進(jìn)行確認(rèn)。確認(rèn)應(yīng)盡可能全面，以滿足預(yù)期用途或應(yīng)用領(lǐng)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(yīng)用說明：對(duì)儀器法成分分析，如果使用時(shí)超出了標(biāo)準(zhǔn)方法的預(yù)定范圍、或擴(kuò)充和修改了標(biāo)準(zhǔn)方法，應(yīng)進(jìn)行方法確認(rèn)，并制定作業(yè)指導(dǎo)書。
A002應(yīng)用說明：任何對(duì)標(biāo)準(zhǔn)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(shù)等等都應(yīng)進(jìn)行確認(rèn)。
GL030認(rèn)可指南：非標(biāo)準(zhǔn)方法應(yīng)進(jìn)行確認(rèn)，以滿足預(yù)期用途或應(yīng)用領(lǐng)域的需要。
注1：確認(rèn)可包括檢測(cè)或校準(zhǔn)物品的抽樣、處置和運(yùn)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(shù)進(jìn)行方法確認(rèn)：
NOTE 2 The techniques used for method validation can be one of, or a combination of, the following:
a)使用參考標(biāo)準(zhǔn)或標(biāo)準(zhǔn)物質(zhì)進(jìn)行校準(zhǔn)或評(píng)估偏倚和精密度；
a)calibration or evaluation of bias and precision using reference standards or reference materials;
注3：實(shí)驗(yàn)室的參考標(biāo)準(zhǔn)（實(shí)驗(yàn)室最高標(biāo)準(zhǔn)）應(yīng)溯源到國(guó)防最高測(cè)量標(biāo)準(zhǔn)或國(guó)家測(cè)量標(biāo)準(zhǔn)或國(guó)際測(cè)量標(biāo)準(zhǔn) 。
注4：可能時(shí)，標(biāo)準(zhǔn)物質(zhì)(參考物質(zhì))應(yīng)溯源到國(guó)防最高測(cè)量標(biāo)準(zhǔn)或國(guó)家測(cè)量標(biāo)準(zhǔn)或國(guó)際測(cè)量標(biāo)準(zhǔn)，包括溯源到國(guó)家有證軍用標(biāo)準(zhǔn)物質(zhì)DILAC 認(rèn)可準(zhǔn)則 DILAC/AC01：2018(參考物質(zhì))或國(guó)家有證標(biāo)準(zhǔn)物質(zhì)(參考物質(zhì))或國(guó)際有證標(biāo)準(zhǔn)物質(zhì)(參考物質(zhì))。
b）對(duì)影響結(jié)果的因素進(jìn)行系統(tǒng)性評(píng)審；
b) systematic assessment of the factors influencing the result;
c）通過改變受控參數(shù)（如培養(yǎng)箱溫度、加樣體積等）來檢驗(yàn)方法的穩(wěn)健度；
c) testing method robustness through variation of controlled parameters, such as incubator temperature, volume dispensed;
d）與其他已確認(rèn)的方法進(jìn)行結(jié)果比對(duì)；
d) comparison of results achieved with other validated methods;
e）實(shí)驗(yàn)室間比對(duì)；
e) interlaboratory comparisons;
f) 根據(jù)對(duì)方法原理的理解以及抽樣或檢測(cè)方法的實(shí)踐經(jīng)驗(yàn)，評(píng)定結(jié)果的測(cè)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(rèn)可指南：定量檢測(cè)的非標(biāo)方法確認(rèn)時(shí)還應(yīng)考慮測(cè)量結(jié)果不確定度的影響。
7.2.2.2 當(dāng)修改已確認(rèn)過的方法時(shí)，應(yīng)確定這些修改的影響。當(dāng)發(fā)現(xiàn)影響原有的確認(rèn)時(shí)，應(yīng)重新進(jìn)行方法確認(rèn)。
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(dāng)按預(yù)期用途評(píng)估被確認(rèn)方法的性能特性時(shí)，應(yīng)確保與客戶需求相關(guān)，并符合規(guī)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(cè)量范圍、準(zhǔn)確度、結(jié)果的測(cè)量不確定度、檢出限、定量限、方法的選擇性、線性、重復(fù)性或復(fù)現(xiàn)性、抵御外部影響的穩(wěn)健度或抵御來自樣品或測(cè)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(shí)驗(yàn)室應(yīng)保存以下方法確認(rèn)記錄：
The laboratory shall retain the following records of validation:
a)使用的確認(rèn)程序；
a) the validation procedure used;
b)要求的詳細(xì)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(jié)果；
d) results obtained;
e)方法有效性聲明，并詳述與預(yù)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(dāng)實(shí)驗(yàn)室為后續(xù)檢測(cè)或校準(zhǔn)對(duì)物質(zhì)、材料或產(chǎn)品實(shí)施抽樣時(shí)，應(yīng)有抽樣計(jì)劃和方法。抽樣方法應(yīng)明確需要控制的因素，以確保后續(xù)檢測(cè)或校準(zhǔn)結(jié)果的有效性。在抽樣地點(diǎn)應(yīng)能得到抽樣計(jì)劃和方法。只要合理，抽樣計(jì)劃應(yīng)基于適當(dāng)?shù)慕y(tǒng)計(jì)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(yīng)用說明：
a) 如果實(shí)驗(yàn)室僅進(jìn)行抽樣，而不從事后續(xù)的檢測(cè)或校準(zhǔn)活動(dòng)，CNAS將不認(rèn)可該抽樣項(xiàng)目。
b) 實(shí)驗(yàn)室如需從客戶提供的樣品中取出部分樣品進(jìn)行后續(xù)的檢測(cè)或校準(zhǔn)活動(dòng)時(shí)，應(yīng)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(gè)批次抽取樣品的活動(dòng)外，還包含檢測(cè)領(lǐng)域常用的概念“采樣”和“取樣”。
7.3.2 抽樣方法應(yīng)描述：
The sampling method shall describe:
a)樣品或地點(diǎn)的選擇；
a) the selection of samples or sites;
b)抽樣計(jì)劃；
b) the sampling plan;
c)從物質(zhì)、材料或產(chǎn)品中取得樣品的制備和處理，以作為后續(xù)檢測(cè)或校準(zhǔn)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(shí)驗(yàn)室接收樣品后，進(jìn)一步處置要求見7.4的規(guī)定。
NOTE When received into the laboratory, further handling can be required as specified in 7.4.
7.3.3 實(shí)驗(yàn)室應(yīng)將抽樣數(shù)據(jù)作為檢測(cè)或校準(zhǔn)工作記錄的一部分予以保存。相關(guān)時(shí)，這些記錄應(yīng)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(shí)間；
b) date and time of sampling;
c)識(shí)別和描述樣品的數(shù)據(jù)（如編號(hào)、數(shù)量和名稱）；
c) data to identify and describe the sample (e.g. number, amount, name);
d)抽樣人的識(shí)別；
d) identification of the personnel performing sampling;
e)所用設(shè)備的識(shí)別；
e) identification of the equipment used;
f)環(huán)境或運(yùn)輸條件；
f) environmental or transport conditions;
g)適當(dāng)時(shí)，標(biāo)識(shí)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(jì)劃的偏離或增減。
i)deviations, additions to or exclusions from the sampling method and sampling plan.
A011應(yīng)用說明：對(duì)大宗金屬材料的抽樣操作，應(yīng)記錄抽樣情況，如貨場(chǎng)堆垛情況、樣品批量數(shù)、抽樣數(shù)，抽樣樣品號(hào)、材料取樣部位等，需要時(shí)可用圖表、照片等方式標(biāo)記以證明樣品的代表性。
7.4 檢測(cè)或校準(zhǔn)物品的處置Handling of test or calibration items
7.4.1 實(shí)驗(yàn)室應(yīng)有運(yùn)輸、接收、處置、保護(hù)、存儲(chǔ)、保留、處理或歸還檢測(cè)或校準(zhǔn)物品的程序，包括為保護(hù)檢測(cè)或校準(zhǔn)物品的完整性以及實(shí)驗(yàn)室與客戶利益所需的所有規(guī)定。在物品的處置、運(yùn)輸、保存/等候和制備過程中，應(yīng)注意避免物品變質(zhì)、污染、丟失或損壞。應(yīng)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(cè)和校準(zhǔn)的物品涉及軍工產(chǎn)品保密要求時(shí)，物品處置的全過程應(yīng)遵守國(guó)防科技工業(yè)有關(guān)的保密規(guī)定。
A011應(yīng)用說明：實(shí)驗(yàn)室建立的樣品處置程序應(yīng)分別規(guī)定金屬材料大樣、加工后小樣和檢測(cè)后樣品的處置要求，包括保管條件和保留時(shí)間。對(duì)金相樣品應(yīng)適當(dāng)保存，避免損傷。對(duì)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(chǔ)存過程中，表面層及其內(nèi)部性能不被損壞。
G001應(yīng)用說明：通常情況下，樣品標(biāo)識(shí)不應(yīng)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(huì)導(dǎo)致樣品的混淆。
GL030認(rèn)可指南：
無論在實(shí)驗(yàn)室內(nèi)或母體組織指定的實(shí)驗(yàn)室外的其他部門進(jìn)行留樣時(shí)，都應(yīng)符合本條款要求。
母體組織可依據(jù)工作需求指定實(shí)驗(yàn)外的其他部門協(xié)助留樣，實(shí)驗(yàn)室應(yīng)建立留樣要求，并確保相關(guān)部門滿足這些要求。
7.4.2 實(shí)驗(yàn)室應(yīng)有清晰標(biāo)識(shí)檢測(cè)或校準(zhǔn)物品的系統(tǒng)。物品在實(shí)驗(yàn)室負(fù)責(zé)的期間內(nèi)應(yīng)保留該標(biāo)識(shí)。標(biāo)識(shí)系統(tǒng)應(yīng)確保物品在實(shí)物上、記錄或其他文件中不被混淆。適當(dāng)時(shí)，標(biāo)識(shí)系統(tǒng)應(yīng)包含一個(gè)物品或一組物品的細(xì)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(yīng)用說明：實(shí)驗(yàn)室的檢測(cè)樣品標(biāo)識(shí)應(yīng)存在于樣品抽樣、取樣、制樣、分組、檢測(cè)和留樣保存等各個(gè)環(huán)節(jié)。接收樣品時(shí)應(yīng)記錄客戶賦予樣品的標(biāo)識(shí)，并建立客戶賦予標(biāo)識(shí)與實(shí)驗(yàn)室賦予標(biāo)識(shí)的對(duì)應(yīng)關(guān)系。委托外部加工樣品的，必要時(shí)實(shí)驗(yàn)室應(yīng)進(jìn)行試樣標(biāo)識(shí)的轉(zhuǎn)移或監(jiān)督轉(zhuǎn)移。
7.4.3 接收檢測(cè)或校準(zhǔn)物品時(shí)，應(yīng)記錄與規(guī)定條件的偏離。當(dāng)對(duì)物品是否適于檢測(cè)或校準(zhǔn)有疑問，或當(dāng)物品不符合所提供的描述時(shí)，實(shí)驗(yàn)室應(yīng)在開始工作之前詢問客戶，以得到進(jìn)一步的說明，并記錄詢問的結(jié)果。當(dāng)客戶知道物品偏離了規(guī)定條件仍要求進(jìn)行檢測(cè)或校準(zhǔn)時(shí)，實(shí)驗(yàn)室應(yīng)在報(bào)告中作出免責(zé)聲明，并指出偏離可能影響的結(jié)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(yīng)用說明：實(shí)驗(yàn)室在接收樣品時(shí)，應(yīng)進(jìn)行符合性檢查（或按批抽查），應(yīng)根據(jù)方法的要求對(duì)試樣的關(guān)鍵參數(shù)指標(biāo)進(jìn)行檢查并提供相應(yīng)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(shí)，應(yīng)檢查試樣的取樣部位和方向。
7.4.4 如物品需要在規(guī)定環(huán)境條件下儲(chǔ)存或狀態(tài)調(diào)節(jié)時(shí)，應(yīng)保持、監(jiān)控和記錄這些環(huán)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(rèn)可指南：當(dāng)實(shí)驗(yàn)室母體組織其他部門協(xié)助留樣時(shí)，該部門應(yīng)具備保持樣品完整性和不改變其性狀的條件。
7.5 技術(shù)記錄Technical records
7.5.1 實(shí)驗(yàn)室應(yīng)確保每一項(xiàng)實(shí)驗(yàn)室活動(dòng)的技術(shù)記錄包含結(jié)果、報(bào)告和足夠的信息，以便在可能時(shí)識(shí)別影響測(cè)量結(jié)果及其測(cè)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(fù)該實(shí)驗(yàn)室活動(dòng)。技術(shù)記錄應(yīng)包括每項(xiàng)實(shí)驗(yàn)室活動(dòng)以及審查數(shù)據(jù)結(jié)果的日期和責(zé)任人。原始的觀察結(jié)果、數(shù)據(jù)和計(jì)算應(yīng)在觀察或獲得時(shí)予以記錄，并應(yīng)按特定任務(wù)予以識(shí)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(chǎn)品的檢測(cè)和校準(zhǔn)記錄的保存時(shí)間，應(yīng)按軍工產(chǎn)品、國(guó)防科技工業(yè)的有關(guān)要求在文件中作出規(guī)定。
A011應(yīng)用說明：檢測(cè)記錄應(yīng)有充分的信息。需要時(shí)，應(yīng)包含與試驗(yàn)過程有關(guān)的試樣和試驗(yàn)方法（條件）的詳細(xì)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(tài)信息、測(cè)量表面層厚度/深度時(shí)測(cè)量點(diǎn)的位置、浸蝕劑成分或代號(hào)、浸蝕的溫度和時(shí)間等。
A002應(yīng)用說明：當(dāng)實(shí)驗(yàn)室棄用檢測(cè)數(shù)據(jù)時(shí)，應(yīng)記錄原因（符合相關(guān)技術(shù)要求時(shí)除外）。
G001應(yīng)用說明：
a) 實(shí)驗(yàn)室應(yīng)確保能方便獲得所有的原始記錄和數(shù)據(jù)，記錄的詳細(xì)程度應(yīng)確保在盡可能接近條件的情況下能夠重復(fù)實(shí)驗(yàn)室活動(dòng)。只要適用，記錄內(nèi)容應(yīng)包括但不限于以下信息：
? 樣品描述；
? 樣品唯一性標(biāo)識(shí)；
? 所用的檢測(cè)、校準(zhǔn)和抽樣方法；
? 環(huán)境條件，特別是實(shí)驗(yàn)室以外的地點(diǎn)實(shí)施的實(shí)驗(yàn)室活動(dòng)；
? 所用設(shè)備和標(biāo)準(zhǔn)物質(zhì)的信息，包括使用客戶的設(shè)備；
? 檢測(cè)或校準(zhǔn)過程中的原始觀察記錄以及根據(jù)觀察結(jié)果所進(jìn)行的計(jì)算；
? 實(shí)施實(shí)驗(yàn)室活動(dòng)的人員；
? 實(shí)施實(shí)驗(yàn)室活動(dòng)的地點(diǎn)（如果未在實(shí)驗(yàn)室固定地點(diǎn)實(shí)施）；
? 檢測(cè)報(bào)告或校準(zhǔn)證書的副本；
? 其他重要信息。
注：檢測(cè)報(bào)告或校準(zhǔn)證書的副本是指實(shí)驗(yàn)室發(fā)給客戶的報(bào)告或證書版本的副本，可以是紙質(zhì)版本或不可更改的電子版本，其中應(yīng)包含報(bào)告或證書的簽發(fā)人、認(rèn)可標(biāo)識(shí)（如使用）等信息。
b) 實(shí)驗(yàn)室應(yīng)在記錄表格中或成冊(cè)的記錄本上保存檢測(cè)或校準(zhǔn)的原始數(shù)據(jù)和信息，也可直接錄入信息管理系統(tǒng)中，也可以是設(shè)備或信息系統(tǒng)自動(dòng)采集的數(shù)據(jù)。對(duì)自動(dòng)采集或直接錄入信息管理系統(tǒng)中的數(shù)據(jù)的任何更改，應(yīng)滿足7.5.2的要求。注1：原始記錄為試驗(yàn)人員在試驗(yàn)過程中記錄的原始觀察數(shù)據(jù)和信息，而不是試驗(yàn)后所謄抄的數(shù)據(jù)。當(dāng)需要另行整理或謄抄時(shí)，應(yīng)保留對(duì)應(yīng)的原始記錄。注2：實(shí)驗(yàn)室不能隨意用一頁(yè)白紙來保存原始記錄。
GL030認(rèn)可指南：對(duì)于技術(shù)記錄中的固定的、每日重復(fù)檢測(cè)的大批量樣品項(xiàng)目，可將相同信息固化到原始記錄中。
7.5.2 實(shí)驗(yàn)室應(yīng)確保技術(shù)記錄的修改可以追溯到前一個(gè)版本或原始觀察結(jié)果。應(yīng)保存原始的以及修改后的數(shù)據(jù)和文檔，包括修改的日期、標(biāo)識(shí)修改的內(nèi)容和負(fù)責(zé)修改的人員。電子形式存儲(chǔ)的記錄應(yīng)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(cè)量不確定度的評(píng)定Evaluation of measurement uncertainty
7.6.1 實(shí)驗(yàn)室應(yīng)識(shí)別測(cè)量不確定度的貢獻(xiàn)。評(píng)定測(cè)量不確定度時(shí)，應(yīng)采用適當(dāng)?shù)姆治龇椒紤]所有顯著貢獻(xiàn)，包括來自抽樣的貢獻(xiàn)。
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(cè)量不確定度的評(píng)定可參照國(guó)家軍用標(biāo)準(zhǔn)GJB 3756進(jìn)行。
A002應(yīng)用說明：實(shí)驗(yàn)室應(yīng)有文件規(guī)定，明確評(píng)定測(cè)量不確定度的要求。當(dāng)與客戶商定判定規(guī)則，需要時(shí)應(yīng)評(píng)估獲得測(cè)量不確定度的合理性，并制定報(bào)告規(guī)則。
7.6.2 開展校準(zhǔn)的實(shí)驗(yàn)室，包括校準(zhǔn)自有設(shè)備的實(shí)驗(yàn)室，應(yīng)評(píng)定所有校準(zhǔn)的測(cè)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(cè)的實(shí)驗(yàn)室應(yīng)評(píng)定測(cè)量不確定度。當(dāng)由于檢測(cè)方法的原因難以嚴(yán)格評(píng)定測(cè)量不確定度時(shí)，實(shí)驗(yàn)室應(yīng)基于對(duì)理論原理的理解或使用該方法的實(shí)踐經(jīng)驗(yàn)進(jìn)行評(píng)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(rèn)的檢測(cè)方法對(duì)測(cè)量不確定度主要來源規(guī)定了限值，并規(guī)定了計(jì)算結(jié)果的表示方式，實(shí)驗(yàn)室只要遵守檢測(cè)方法和報(bào)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(duì)某一特定方法，如果已確定并驗(yàn)證了結(jié)果的測(cè)量不確定度，實(shí)驗(yàn)室只要證明已識(shí)別的關(guān)鍵影響因素受控，則不需要對(duì)每個(gè)結(jié)果評(píng)定測(cè)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(biāo)準(zhǔn)。
NOTE 3 For further information, see ISO/IEC Guide 98-3, ISO 21748 and the ISO 5725 series.
7.7 確保結(jié)果有效性Ensuring the validity of results
7.7.1 實(shí)驗(yàn)室應(yīng)有監(jiān)控結(jié)果有效性的程序。記錄結(jié)果數(shù)據(jù)的方式應(yīng)便于發(fā)現(xiàn)其發(fā)展趨勢(shì)，如可行，應(yīng)采用統(tǒng)計(jì)技術(shù)審查結(jié)果。實(shí)驗(yàn)室應(yīng)對(duì)監(jiān)控進(jìn)行策劃和審查，適當(dāng)時(shí)，監(jiān)控應(yīng)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(biāo)準(zhǔn)物質(zhì)或質(zhì)量控制物質(zhì)；
a) use of reference materials or quality control materials;
b)使用其他已校準(zhǔn)能夠提供可溯源結(jié)果的儀器；
b) use of alternative instrumentation that has been calibrated to provide traceable results;
c)測(cè)量和檢測(cè)設(shè)備的功能核查；
c) functional check(s) of measuring and testing equipment;
d)適用時(shí)，使用核查或工作標(biāo)準(zhǔn)，并制作控制圖；
d) use of check or working standards with control charts, where applicable;
e)測(cè)量設(shè)備的期間核查；
e) intermediate checks on measuring equipment;
f)使用相同或不同方法重復(fù)檢測(cè)或校準(zhǔn)；
f) replicate tests or calibrations using the same or different methods;
g)留存樣品的重復(fù)檢測(cè)或重復(fù)校準(zhǔn)；
g) retesting or recalibration of retained items;
h)物品不同特性結(jié)果之間的相關(guān)性；
h) correlation of results for different characteristics of an item;
i)報(bào)告結(jié)果的審查；
i) review of reported results;
j)實(shí)驗(yàn)室內(nèi)比對(duì)；
j) intralaboratory comparisons;
k)盲樣測(cè)試。
l)testing of blind sample(s).
A011應(yīng)用說明：
實(shí)驗(yàn)室對(duì)金相檢驗(yàn)、微觀結(jié)構(gòu)分析等人為因素影響較大的檢測(cè)活動(dòng)，應(yīng)加強(qiáng)質(zhì)量監(jiān)控，可通過實(shí)施人員比對(duì)或者實(shí)驗(yàn)室間比對(duì)以保證相關(guān)檢測(cè)人員能力。
對(duì)于儀器法化學(xué)成分分析，應(yīng)按標(biāo)準(zhǔn)方法的要求建立校準(zhǔn)曲線，并使用與檢測(cè)樣品含量匹配的標(biāo)樣對(duì)建立的校準(zhǔn)曲線進(jìn)行驗(yàn)證。應(yīng)定期使用中間點(diǎn)的標(biāo)樣檢查校準(zhǔn)曲線，建立定期檢查結(jié)果可否接受的判定標(biāo)準(zhǔn)，且該判定標(biāo)準(zhǔn)應(yīng)與測(cè)量不確定度相當(dāng)。
G001應(yīng)用說明：
a) 實(shí)驗(yàn)室對(duì)結(jié)果的監(jiān)控應(yīng)覆蓋到認(rèn)可范圍內(nèi)的所有檢測(cè)或校準(zhǔn)（包括內(nèi)部校準(zhǔn)）項(xiàng)目，確保檢測(cè)或校準(zhǔn)結(jié)果的準(zhǔn)確性和穩(wěn)定性。當(dāng)檢測(cè)或校準(zhǔn)方法中規(guī)定了質(zhì)量監(jiān)控制要求時(shí)，實(shí)驗(yàn)室應(yīng)符合該要求。適用時(shí)，實(shí)驗(yàn)室應(yīng)在檢測(cè)方法中或其他文件中規(guī)定對(duì)應(yīng)檢測(cè)或校準(zhǔn)方法的質(zhì)量監(jiān)控方案。實(shí)驗(yàn)室制定內(nèi)部質(zhì)量監(jiān)控方案時(shí)應(yīng)考慮以下因素：
?檢測(cè)或校準(zhǔn)業(yè)務(wù)量；
?檢測(cè)或校準(zhǔn)結(jié)果的用途；
?檢測(cè)或校準(zhǔn)方法本身的穩(wěn)定性與復(fù)雜性；
?對(duì)技術(shù)人員經(jīng)驗(yàn)的依賴程度；
?參加外部比對(duì)（包含能力驗(yàn)證）的頻次與結(jié)果；
?人員的能力和經(jīng)驗(yàn)、人員數(shù)量及變動(dòng)情況；
?新采用的方法或變更的方法等。
注：實(shí)驗(yàn)室可以采取多種適用的質(zhì)量監(jiān)控手段，如：
?定期使用標(biāo)準(zhǔn)物質(zhì)、 核查標(biāo)準(zhǔn)或工作標(biāo)準(zhǔn)來監(jiān)控結(jié)果的準(zhǔn)確性；
?通過使用質(zhì)量控制物質(zhì)制作質(zhì)控圖持續(xù)監(jiān)控精密度；
?通過獲得足夠的標(biāo)準(zhǔn)物質(zhì)，評(píng)估在不同濃度下檢測(cè)結(jié)果的準(zhǔn)確性；
?定期留樣再測(cè)或重復(fù)測(cè)量以及實(shí)驗(yàn)室內(nèi)比對(duì)，監(jiān)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(cè)方法或設(shè)備測(cè)試同一樣品，監(jiān)控方法之間的一致性；
?通過分析一個(gè)物品不同特性結(jié)果的相關(guān)性，以識(shí)別錯(cuò)誤；
?進(jìn)行盲樣測(cè)試，監(jiān)控實(shí)驗(yàn)室日常檢測(cè)的準(zhǔn)確度或精密度水平。
b) 適用時(shí)，實(shí)驗(yàn)室應(yīng)使用質(zhì)量控制圖來監(jiān)控檢測(cè)或校準(zhǔn)結(jié)果的準(zhǔn)確性和精密度。
c) 一些特殊的檢測(cè)活動(dòng)，檢測(cè)結(jié)果無法復(fù)現(xiàn)，難以按照7.7.1a)進(jìn)行質(zhì)量控制，實(shí)驗(yàn)室應(yīng)關(guān)注人員的能力、培訓(xùn)、監(jiān)督以及與同行的技術(shù)交流。
7.7.2 可行和適當(dāng)時(shí)，實(shí)驗(yàn)室應(yīng)通過與其他實(shí)驗(yàn)室的結(jié)果比對(duì)監(jiān)控能力水平。監(jiān)控應(yīng)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(yàn)證；
a) participation in proficiency testing;
注：GB/T 27043包含能力驗(yàn)證和能力驗(yàn)證提供者的詳細(xì)信息。滿足GB/T 27043要求的能力驗(yàn)證提供者被認(rèn)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(yàn)證之外的實(shí)驗(yàn)室間比對(duì)。
c)participation in interlaboratory comparisons other than proficiency testing.
A011應(yīng)用說明：實(shí)驗(yàn)室按CNAS-RL02選擇參加能力驗(yàn)證計(jì)劃時(shí)，如果認(rèn)可的檢測(cè)項(xiàng)目在同一子領(lǐng)域內(nèi)有多項(xiàng)可獲得的能力驗(yàn)證活動(dòng)，應(yīng)避免連續(xù)只參加同一項(xiàng)目的能力驗(yàn)證，參加的人員、設(shè)備也應(yīng)考慮適當(dāng)更換。
G001應(yīng)用說明：外部質(zhì)量監(jiān)控方案不僅包括CNAS-RL02《能力驗(yàn)證規(guī)則》中要求參加的能力驗(yàn)證計(jì)劃，適當(dāng)時(shí)，還應(yīng)包含實(shí)驗(yàn)室間比對(duì)計(jì)劃。實(shí)驗(yàn)室制定外部質(zhì)量監(jiān)控計(jì)劃除應(yīng)考慮7.7.1a)中描述的因素外，還應(yīng)考慮以下因素：
?內(nèi)部質(zhì)量監(jiān)控結(jié)果；
?實(shí)驗(yàn)室間比對(duì)（包含能力驗(yàn)證）的可獲得性，對(duì)沒有能力驗(yàn)證的領(lǐng)域，實(shí)驗(yàn)室應(yīng)有其他措施來確保結(jié)果的準(zhǔn)確性和可靠性；
? CNAS、客戶和管理機(jī)構(gòu)對(duì)實(shí)驗(yàn)室間比對(duì)（包含能力驗(yàn)證）的要求。
注：CNAS-RL02《能力驗(yàn)證規(guī)則》要求參加的能力驗(yàn)證領(lǐng)域和頻次只是CNAS對(duì)能力驗(yàn)證的最低要求。實(shí)驗(yàn)室應(yīng)關(guān)注對(duì)于沒有能力驗(yàn)證的領(lǐng)域，可以采取有何措施確保結(jié)果的準(zhǔn)確性和可靠性。
RL02驗(yàn)證規(guī)則：
金屬與合金類材料與制品檢測(cè)領(lǐng)域的能力驗(yàn)證頻次：化學(xué)分析和機(jī)械性能每年至少1次，物理性能每2年至少1次。
7.7.3 實(shí)驗(yàn)室應(yīng)分析監(jiān)控活動(dòng)的數(shù)據(jù)用于控制實(shí)驗(yàn)室活動(dòng)，適用時(shí)實(shí)施改進(jìn)。如果發(fā)現(xiàn)監(jiān)控活動(dòng)數(shù)據(jù)分析結(jié)果超出預(yù)定的準(zhǔn)則時(shí)，應(yīng)采取適當(dāng)措施防止報(bào)告不正確的結(jié)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(yīng)用說明：適用時(shí)，實(shí)驗(yàn)室應(yīng)建立控制圖，觀察和分析控制圖顯示的趨勢(shì)，必要時(shí)采取處理措施。
7.8 報(bào)告結(jié)果Reporting of results
7.8.1 總則General
7.8.1.1 結(jié)果在發(fā)出前應(yīng)經(jīng)過審查和批準(zhǔn)。
The results shall be reviewed and authorized prior to release.
G001應(yīng)用說明：
a) 除檢測(cè)方法、法律法規(guī)另有要求外，實(shí)驗(yàn)室應(yīng)在同一份報(bào)告上出具特定樣品不同檢測(cè)項(xiàng)目的結(jié)果，如果檢測(cè)項(xiàng)目覆蓋了不同的專業(yè)技術(shù)領(lǐng)域，也可分專業(yè)領(lǐng)域出具檢測(cè)報(bào)告。
注：即使客戶有要求，實(shí)驗(yàn)室也不得隨意拆分檢測(cè)報(bào)告，如將“滿足規(guī)定限值”的結(jié)果與“不滿足規(guī)定限值”的結(jié)果分別出具報(bào)告，或只報(bào)告“滿足規(guī)定限量”的檢測(cè)結(jié)果。
c)一般情況下，實(shí)驗(yàn)室應(yīng)按GB/T 8170《數(shù)值修約規(guī)則與極限數(shù)值的表示和判定》進(jìn)行數(shù)值修約。
GL030認(rèn)可指南：結(jié)果的電子傳送，當(dāng)實(shí)驗(yàn)室利用網(wǎng)絡(luò)或信息化系統(tǒng)傳送檢測(cè)結(jié)果時(shí)，應(yīng)滿足7.11的要求，同時(shí)應(yīng)符合報(bào)告審核和發(fā)送報(bào)告的流程。
7.8.1.2 實(shí)驗(yàn)室應(yīng)準(zhǔn)確、清晰、明確和客觀地出具結(jié)果，并且應(yīng)包括客戶同意的、解釋結(jié)果所必需的以及所用方法要求的全部信息。實(shí)驗(yàn)室通常以報(bào)告的形式提供結(jié)果（例如檢測(cè)報(bào)告、校準(zhǔn)證書或抽樣報(bào)告）。所有發(fā)出的報(bào)告應(yīng)作為技術(shù)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(cè)報(bào)告和校準(zhǔn)證書有時(shí)稱為檢測(cè)證書和校準(zhǔn)報(bào)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(biāo)準(zhǔn)的要求，報(bào)告可以硬拷貝或電子方式發(fā)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(bào)告可不包括客戶有保密要求的信息。
A011應(yīng)用說明：應(yīng)按標(biāo)準(zhǔn)中規(guī)定的修約要求報(bào)告檢測(cè)結(jié)果。如果標(biāo)準(zhǔn)中有規(guī)定，在報(bào)告檢測(cè)結(jié)果時(shí)還應(yīng)報(bào)告試驗(yàn)條件。
A002應(yīng)用說明：檢測(cè)結(jié)果的報(bào)告應(yīng)符合如下要求：
a）當(dāng)檢出結(jié)果低于方法檢出限或定量限，應(yīng)在檢測(cè)報(bào)告中提供方法檢出限或定量限的數(shù)值。
b）如果報(bào)告的結(jié)果是用數(shù)字表示的數(shù)值，應(yīng)按照所用檢測(cè)方法的規(guī)定進(jìn)行表述。當(dāng)方法沒有相關(guān)規(guī)定時(shí)，應(yīng)依照有效數(shù)值修約的規(guī)定表述。
c）當(dāng)需要解釋檢測(cè)結(jié)果時(shí)，或客戶有要求時(shí)，或檢測(cè)方法要求時(shí)，實(shí)驗(yàn)室應(yīng)報(bào)告質(zhì)量控制結(jié)果。當(dāng)質(zhì)量控制結(jié)果不完全滿足檢測(cè)方法要求且無法重新測(cè)試時(shí)，應(yīng)在報(bào)告中以適當(dāng)方式進(jìn)行標(biāo)注和說明。
d）必要時(shí)，報(bào)告中應(yīng)注明與后續(xù)檢測(cè)相關(guān)的抽樣(含取樣、采樣)信息。
GL030認(rèn)可指南：實(shí)驗(yàn)室在為內(nèi)部客戶出具報(bào)告時(shí)，可以簡(jiǎn)化，但報(bào)告中簡(jiǎn)化的信息應(yīng)能方便地從實(shí)驗(yàn)室中獲得并可追溯。
EL-13認(rèn)可說明：樣品信息準(zhǔn)確，并且必須是實(shí)測(cè)樣品。
7.8.1.3 如客戶同意，可用簡(jiǎn)化方式報(bào)告結(jié)果。如果未向客戶報(bào)告7.8.2至7.8.7條款中所列的信息，客戶應(yīng)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(cè)、校準(zhǔn)或抽樣)報(bào)告的通用要求Common requirements for reports (test, calibration or sampling)
7.8.2.1 除非實(shí)驗(yàn)室有有效的理由，每份報(bào)告應(yīng)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(biāo)題（例如“檢測(cè)報(bào)告”、“校準(zhǔn)證書”或“抽樣報(bào)告”）；
a) a title (e.g. “Test Report”, “Calibration Certificate” or “Report of Sampling”);
b)實(shí)驗(yàn)室的名稱和地址；
b) the name and address of the laboratory;
c)實(shí)施實(shí)驗(yàn)室活動(dòng)的地點(diǎn)，包括客戶設(shè)施、實(shí)驗(yàn)室固定設(shè)施以外的場(chǎng)所、相關(guān)的臨時(shí)或移動(dòng)設(shè)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(rèn)可說明：如果測(cè)試地點(diǎn)不在實(shí)驗(yàn)室的固定場(chǎng)所，如在客戶地點(diǎn)或樣品所在地， 報(bào)告中應(yīng)給出詳細(xì)的地址信息，僅給出“客戶地點(diǎn)”等模糊信息是不充分的。
d)將報(bào)告中所有部分標(biāo)記為完整報(bào)告的一部分的唯一性標(biāo)識(shí)，以及表明報(bào)告結(jié)束的清晰標(biāo)識(shí)；
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(lián)絡(luò)信息；
e) the name and contact information of the customer;
f)所用方法的識(shí)別；
f) identification of the method used;
g)物品的描述、明確的標(biāo)識(shí)，以及必要時(shí)，物品的狀態(tài)；
g) a description, unambiguous identification, and, when necessary, the condition of the item;
A011應(yīng)用說明：必要時(shí)，檢測(cè)報(bào)告應(yīng)提供來樣實(shí)物照片，并標(biāo)記出取樣部位。
h)檢測(cè)或校準(zhǔn)物品的接收日期，以及對(duì)結(jié)果的有效性和應(yīng)用至關(guān)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(shí)施實(shí)驗(yàn)室活動(dòng)的日期；
i) the date(s) of performance of the laboratory activity;
j) 報(bào)告的發(fā)布日期；
j) the date of issue of the report;
k) 如與結(jié)果的有效性或應(yīng)用相關(guān)時(shí)，實(shí)驗(yàn)室或其他機(jī)構(gòu)所用的抽樣計(jì)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(jié)果僅與被檢測(cè)、被校準(zhǔn)或被抽樣物品有關(guān)的聲明；
l) a statement to the effect that the results relate only to the items tested, calibrated or sampled;
m) 結(jié)果，適當(dāng)時(shí)，帶有測(cè)量單位；
m) the results with, where appropriate, the units of measurement;
A011應(yīng)用說明：需要時(shí)，金相檢測(cè)報(bào)告應(yīng)提供試樣中有代表性的金相照片。
n) 對(duì)方法的補(bǔ)充、偏離或刪減；
n) additions to, deviations, or exclusions from the method;
o) 報(bào)告批準(zhǔn)人的識(shí)別；
o) identification of the person(s) authorizing the report;
p) 當(dāng)結(jié)果來自于外部供應(yīng)商時(shí)所做的清晰標(biāo)識(shí)。
p) clear identification when results are from external providers.
EL-13認(rèn)可說明：實(shí)驗(yàn)室出具的報(bào)告中如有摘用其他機(jī)構(gòu)報(bào)告信息的內(nèi)容，則應(yīng)在報(bào)告中給出清晰的標(biāo)注，標(biāo)注的方式應(yīng)確保報(bào)告的使用人不會(huì)產(chǎn)生誤解。當(dāng)使用認(rèn)可標(biāo)識(shí)時(shí)，按“外部提供的信息”（視同“分包”）要求控制。
注：報(bào)告中聲明除全文復(fù)制外，未經(jīng)實(shí)驗(yàn)室批準(zhǔn)不得部分復(fù)制報(bào)告，可以確保報(bào)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(rèn)可說明：如果實(shí)際測(cè)試過程是由客戶的技術(shù)人員操作，實(shí)驗(yàn)室只是目擊了試驗(yàn)的過程并記錄下測(cè)試數(shù)據(jù)和信息，報(bào)告應(yīng)以清晰的方式在正文中注明是目擊試驗(yàn)，并且不得使用認(rèn)可標(biāo)識(shí)或聲明認(rèn)可。
7.8.2.2 除客戶提供的信息除外，實(shí)驗(yàn)室應(yīng)對(duì)報(bào)告中的所有信息負(fù)責(zé)。客戶提供的數(shù)據(jù)應(yīng)予明確標(biāo)識(shí)。此外，當(dāng)客戶提供的信息可能影響結(jié)果的有效性時(shí)，報(bào)告中應(yīng)有免責(zé)聲明。當(dāng)實(shí)驗(yàn)室不負(fù)責(zé)抽樣（如樣品由客戶提供），應(yīng)在報(bào)告中聲明結(jié)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(rèn)可說明：對(duì)于客戶送樣，除非抽樣信息影響到測(cè)試結(jié)果，報(bào)告中不應(yīng)包含抽樣信息。如果報(bào)告中包含樣品抽樣信息（如地點(diǎn)），實(shí)驗(yàn)室應(yīng)以顯著方式在報(bào)告正文中說明此為客戶提供信息，實(shí)驗(yàn)室對(duì)此真實(shí)性不承擔(dān)責(zé)任。
7.8.3 檢測(cè)報(bào)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(dāng)解釋檢測(cè)結(jié)果需要時(shí)，檢測(cè)報(bào)告還應(yīng)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(cè)條件信息，如環(huán)境條件；
a) information on specific test conditions, such as environmental conditions;
b)相關(guān)時(shí)，與要求或規(guī)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(shí)，在下列情況下，帶有與被測(cè)量相同單位的測(cè)量不確定度或被測(cè)量相對(duì)形式的測(cè)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(cè)量不確定度與檢測(cè)結(jié)果的有效性或應(yīng)用相關(guān)時(shí)；
— it is relevant to the validity or application of the test results;
——客戶有要求時(shí)；
— a customer’s instruction so requires, or
——測(cè)量不確定度影響與規(guī)范限的符合性時(shí)。
— the measurement uncertainty affects conformity to a specification limit;
d)適當(dāng)時(shí)，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(jī)構(gòu)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(shí)驗(yàn)室負(fù)責(zé)抽樣活動(dòng)，當(dāng)解釋檢測(cè)結(jié)果需要時(shí)，檢測(cè)報(bào)告還應(yīng)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(zhǔn)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(zhǔn)證書應(yīng)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(cè)量相同單位的測(cè)量不確定度或被測(cè)量相對(duì)形式的測(cè)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(jù)ISO/IEC指南99，測(cè)量結(jié)果通常表示為一個(gè)被測(cè)量值，包括測(cè)量單位和測(cè)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(zhǔn)過程中對(duì)測(cè)量結(jié)果有影響的條件（如環(huán)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(cè)量結(jié)果如何實(shí)現(xiàn)計(jì)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(shè)備被調(diào)整或修理前后的結(jié)果；
d) the results before and after any adjustment or repair, if available;
e)相關(guān)時(shí)，與要求或規(guī)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(dāng)時(shí)，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(shí)驗(yàn)室負(fù)責(zé)抽樣活動(dòng)，當(dāng)解釋校準(zhǔn)結(jié)果需要時(shí)，校準(zhǔn)證書還應(yīng)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(zhǔn)證書或校準(zhǔn)標(biāo)簽不應(yīng)包含校準(zhǔn)周期的建議，除非已與客戶達(dá)成協(xié)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(bào)告抽樣Reporting sampling——特定要求specific requirements
如果實(shí)驗(yàn)室負(fù)責(zé)抽樣活動(dòng)，除7.8.2中的要求外，當(dāng)解釋結(jié)果需要時(shí)，報(bào)告還應(yīng)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(zhì)的唯一性標(biāo)識(shí)（適當(dāng)時(shí)，包括制造商的名稱、標(biāo)示的型號(hào)或類型以及序列號(hào)）；
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(jì)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(jié)果解釋的環(huán)境條件的詳細(xì)信息；
e) details of any environmental conditions during sampling that affect the interpretation of the test results;
f)評(píng)定后續(xù)檢測(cè)或校準(zhǔn)測(cè)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(bào)告符合性聲明Reporting statements of conformity
7.8.6.1 當(dāng)做出與規(guī)范或標(biāo)準(zhǔn)的符合性聲明時(shí)，實(shí)驗(yàn)室應(yīng)考慮與所用判定規(guī)則相關(guān)的風(fēng)險(xiǎn)水平（如錯(cuò)誤接受、錯(cuò)誤拒絕以及統(tǒng)計(jì)假設(shè)），將所使用的判定規(guī)則形成文件，并應(yīng)用判定規(guī)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(guī)或規(guī)范性文件規(guī)定了判定規(guī)則，無需進(jìn)一步考慮風(fēng)險(xiǎn)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(shí)驗(yàn)室在報(bào)告符合性聲明時(shí)應(yīng)清晰標(biāo)識(shí)：
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(jié)果；
a) to which results the statement of conformity applies;
b)滿足或不滿足的規(guī)范、標(biāo)準(zhǔn)或其中的條款；
b) which specifications, standards or parts thereof are met or not met;
c)應(yīng)用的判定規(guī)則（除非規(guī)范或標(biāo)準(zhǔn)中已包含）。
c) the decision rule applied (unless it is inherent in the requested specification or standard).
注：詳細(xì)信息見ISO/IEC指南98-4。
NOTE For further information, see ISO/IEC Guide 98-4.
7.8.7 報(bào)告意見和解釋Reporting opinions and interpretations
7.8.7.1 當(dāng)表述意見和解釋時(shí)，實(shí)驗(yàn)室應(yīng)確保只有授權(quán)人員才能發(fā)布相關(guān)意見和解釋。實(shí)驗(yàn)室應(yīng)將意見和解釋的依據(jù)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(qū)分意見和解釋與GB/T 27020中的檢驗(yàn)聲明、GB/T 27065中的產(chǎn)品認(rèn)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(yīng)用說明：
實(shí)驗(yàn)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(duì)其進(jìn)行有效控制，包括合同評(píng)審。
注 1：根據(jù)檢測(cè)或校準(zhǔn)結(jié)果，與規(guī)范或客戶的規(guī)定限量做出的符合性判斷，不屬于本準(zhǔn)則所規(guī)定的“意見和解釋”。“意見和解釋”的示例：
? 對(duì)被測(cè)結(jié)果或其分布范圍的原因分析，比如在環(huán)境中毒素的檢測(cè)報(bào)告中對(duì)毒素來源的分析；
? 根據(jù)檢測(cè)結(jié)果對(duì)被測(cè)樣品特性的分析；
? 根據(jù)檢測(cè)結(jié)果對(duì)被測(cè)樣品設(shè)計(jì)、生產(chǎn)工藝、材料或結(jié)構(gòu)等的改進(jìn)建議。
注 2：在校準(zhǔn)報(bào)告中，一般不需要做出意見和解釋。CNAS 暫不開展對(duì)校準(zhǔn)結(jié)果的意見和解釋能力的認(rèn)可。必要時(shí)， CNAS 將根據(jù)客戶需求和相關(guān)技術(shù)專家的意見，修訂此政策。
注 3：對(duì)于檢測(cè)活動(dòng)，實(shí)驗(yàn)室如果申請(qǐng)對(duì)某些特定檢測(cè)項(xiàng)目的“意見和解釋”能力的認(rèn)可，應(yīng)在申請(qǐng)書中予以明確，并說明針對(duì)哪些檢測(cè)項(xiàng)目做出哪類的意見和解釋，并提供以往做出“意見和解釋”時(shí)所依據(jù)的文件、記錄及報(bào)告。相關(guān)人員能力信息應(yīng)隨同申請(qǐng)一同提交。實(shí)驗(yàn)室人員如果僅從事過相關(guān)的檢測(cè)活動(dòng)，而不熟悉檢測(cè)對(duì)象的設(shè)計(jì)、制造和使用，則不予認(rèn)可其“意見和解釋”能力。
7.8.7.2 報(bào)告中的意見和解釋應(yīng)基于被檢測(cè)或校準(zhǔn)物品的結(jié)果，并清晰地予以標(biāo)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(dāng)以對(duì)話方式直接與客戶溝通意見和解釋時(shí)，應(yīng)保存對(duì)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(bào)告修改Amendments to reports
7.8.8.1 當(dāng)更改、修訂或重新發(fā)布已發(fā)出的報(bào)告時(shí)，應(yīng)在報(bào)告中清晰標(biāo)識(shí)修改的信息，適當(dāng)時(shí)標(biāo)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(fā)出的報(bào)告時(shí)，應(yīng)僅以追加文件或數(shù)據(jù)傳送的形式，并包含以下聲明：
“對(duì)序列號(hào)為……（或其他標(biāo)識(shí)）報(bào)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(yīng)滿足本標(biāo)準(zhǔn)的所有要求。
Such amendments shall meet all the requirements of this document.
7.8.8.3 當(dāng)有必要發(fā)布全新的報(bào)告時(shí)，應(yīng)予以唯一性標(biāo)識(shí)，并注明所替代的原報(bào)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(shí)驗(yàn)室應(yīng)有形成文件的過程來接收和評(píng)價(jià)投訴，并對(duì)投訴作出決定。如果檢測(cè)和校準(zhǔn)結(jié)果引起的投訴直接涉及軍工產(chǎn)品質(zhì)量時(shí)，實(shí)驗(yàn)室應(yīng)立即進(jìn)行調(diào)查，必要時(shí)應(yīng)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(yīng)用說明：實(shí)驗(yàn)室應(yīng)及時(shí)處理收到的投訴。如果實(shí)驗(yàn)室收到CNAS轉(zhuǎn)交的投訴，應(yīng)在2個(gè)月內(nèi)向CNAS反饋投訴處理結(jié)果。注：CNAS在收到對(duì)實(shí)驗(yàn)室的投訴時(shí)，通常情況下將轉(zhuǎn)交給實(shí)驗(yàn)室進(jìn)行處理。如果投訴內(nèi)容是針對(duì)實(shí)驗(yàn)室能力和誠(chéng)信時(shí)，CNAS將直接處理。處理方式包括安排不定期監(jiān)督評(píng)審等，不定期監(jiān)督評(píng)審可不預(yù)先通知實(shí)驗(yàn)室。
7.9.2 利益相關(guān)方有要求時(shí)，應(yīng)可獲得對(duì)投訴處理過程的說明。在接到投訴后，實(shí)驗(yàn)室應(yīng)證實(shí)投訴是否與其負(fù)責(zé)的實(shí)驗(yàn)室活動(dòng)相關(guān)，如相關(guān)，則應(yīng)處理。實(shí)驗(yàn)室應(yīng)對(duì)投訴處理過程中的所有決定負(fù)責(zé)。
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(yīng)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(duì)投訴的接收、確認(rèn)、調(diào)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(dāng)?shù)拇胧?/span>
c) ensuring that any appropriate action is taken.
7.9.4 接到投訴的實(shí)驗(yàn)室應(yīng)負(fù)責(zé)收集并驗(yàn)證所有必要的信息，以便確認(rèn)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(shí)驗(yàn)室應(yīng)告知投訴人已收到投訴，并向投訴人提供處理進(jìn)程的報(bào)告和結(jié)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(jié)果應(yīng)由與所涉及的實(shí)驗(yàn)室活動(dòng)無關(guān)的人員作出，或?qū)彶楹团鷾?zhǔn)。
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(shí)施。
NOTE This can be performed by external personnel.
7.9.7 只要可能，實(shí)驗(yàn)室應(yīng)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(dāng)實(shí)驗(yàn)室活動(dòng)或結(jié)果不符合自身的程序或與客戶協(xié)商一致的要求時(shí)（例如設(shè)備或環(huán)境條件超出規(guī)定限值、監(jiān)控結(jié)果不能滿足規(guī)定的準(zhǔn)則），實(shí)驗(yàn)室應(yīng)有程序予以實(shí)施。該程序應(yīng)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(zé)和權(quán)力；
a) the responsibilities and authorities for the management of nonconforming work are defined;
b)基于實(shí)驗(yàn)室建立的風(fēng)險(xiǎn)水平采取措施（包括必要時(shí)暫停或重復(fù)工作以及扣發(fā)報(bào)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(píng)價(jià)不符合工作的嚴(yán)重性，包括分析對(duì)先前結(jié)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(duì)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(shí)，通知客戶并召回；
e) where necessary, the customer is notified and work is recalled;
f)規(guī)定批準(zhǔn)恢復(fù)工作的職責(zé)。
f) the responsibility for authorizing the resumption of work is defined.
G001應(yīng)用說明：
實(shí)驗(yàn)室常見的不符合工作包括（但不限于）實(shí)驗(yàn)室環(huán)境條件不滿足要求、試驗(yàn)樣品的處置時(shí)間不滿足要求、試樣未在規(guī)定的時(shí)間內(nèi)檢測(cè)、質(zhì)量監(jiān)控結(jié)果超過規(guī)定的限制、能力驗(yàn)證或?qū)嶒?yàn)室間比對(duì)結(jié)果不滿意等。實(shí)驗(yàn)室所有人員均應(yīng)熟悉不符合工作控制程序，尤其是直接從事檢測(cè)、校準(zhǔn)和抽樣活動(dòng)的人員。實(shí)驗(yàn)室在內(nèi)部審核中應(yīng)特別關(guān)注不符合工作控制程序的執(zhí)行情況。
7.10.2 實(shí)驗(yàn)室應(yīng)保存不符合工作和執(zhí)行7.10.1中b)至f)規(guī)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(dāng)評(píng)價(jià)表明不符合工作可能再次發(fā)生時(shí)，或?qū)?shí)驗(yàn)室的運(yùn)行與其管理體系的符合性產(chǎn)生懷疑時(shí)，實(shí)驗(yàn)室應(yīng)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(yīng)用說明：實(shí)驗(yàn)室應(yīng)對(duì)發(fā)生的不符合工作的原因進(jìn)行分析，對(duì)于不是偶發(fā)的、個(gè)案的問題，不應(yīng)僅僅糾正發(fā)生的問題，還應(yīng)按本條款要求啟動(dòng)糾正措施。
7.11 數(shù)據(jù)控制和信息管理Control of data and information management
7.11.1 實(shí)驗(yàn)室應(yīng)獲得開展實(shí)驗(yàn)室活動(dòng)所需的數(shù)據(jù)和信息。
The laboratory shall have access to the data and information needed to perform laboratory activities.
GL030認(rèn)可指南：實(shí)驗(yàn)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(yīng)按照電子記錄進(jìn)行管理，明確保存路徑并可進(jìn)行追溯。
7.11.2 用于收集、處理、記錄、報(bào)告、存儲(chǔ)或檢索數(shù)據(jù)的實(shí)驗(yàn)室信息管理系統(tǒng)，在投入使用前應(yīng)進(jìn)行功能確認(rèn)，包括實(shí)驗(yàn)室信息管理系統(tǒng)中接口的正常運(yùn)行。對(duì)管理系統(tǒng)的任何變更，包括修改實(shí)驗(yàn)室軟件配置或現(xiàn)成的商業(yè)化軟件，在實(shí)施前應(yīng)被批準(zhǔn)、形成文件并確認(rèn)。
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(biāo)準(zhǔn)中“實(shí)驗(yàn)室信息管理系統(tǒng)”包括計(jì)算機(jī)化和非計(jì)算機(jī)化系統(tǒng)中的數(shù)據(jù)和信息管理。相比非計(jì)算機(jī)化的系統(tǒng)，有些要求更適用于計(jì)算機(jī)化的系統(tǒng)。
NOTE 1 In this document “l(fā)aboratory 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(xiàn)成商業(yè)化軟件在其設(shè)計(jì)應(yīng)用范圍內(nèi)的使用可被視為已經(jīng)過充分的確認(rèn)。
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(chǎn)品有關(guān)的檢測(cè)和/或校準(zhǔn)數(shù)據(jù)時(shí)，應(yīng)實(shí)施保密措施（如，與因特網(wǎng)物理斷開）。
G001應(yīng)用說明：實(shí)驗(yàn)室使用信息管理系統(tǒng)（LIMS）時(shí)，應(yīng)確保該系統(tǒng)滿足所有相關(guān)要求，包括審核路徑、數(shù)據(jù)安全和完整性等。實(shí)驗(yàn)室應(yīng)對(duì) LIMS 與相關(guān)認(rèn)可要求的符合性和適宜性進(jìn)行完整的確認(rèn)，并保留確認(rèn)記錄；對(duì) LIMS 的改進(jìn)和維護(hù)應(yīng)確保可以獲得先前產(chǎn)生的記錄。
7.11.3 實(shí)驗(yàn)室信息管理系統(tǒng)應(yīng)：
The laboratory information management system(s) shall:
a)防止未經(jīng)授權(quán)的訪問；
a) be protected from unauthorized access;
b)被安全保護(hù)以防止篡改和丟失；
b) be safeguarded against tampering and loss;
c)在符合系統(tǒng)供應(yīng)商或?qū)嶒?yàn)室規(guī)定的環(huán)境中運(yùn)行，或?qū)τ诜怯?jì)算機(jī)化的系統(tǒng)，提供保護(hù)人工記錄和轉(zhuǎn)錄準(zhǔn)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(shù)據(jù)和信息完整性的方式進(jìn)行維護(hù)；
d) be maintained in a manner that ensures the integrity of the data and information;
e)包括記錄系統(tǒng)失效、適當(dāng)?shù)木o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(dāng)實(shí)驗(yàn)室信息管理系統(tǒng)在異地或由外部供應(yīng)商進(jìn)行管理和維護(hù)時(shí)，實(shí)驗(yàn)室應(yīng)確保系統(tǒng)的供應(yīng)商或運(yùn)營(yíng)商符合本標(biāo)準(zhǔn)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(shí)驗(yàn)室應(yīng)確保員工易于獲取與實(shí)驗(yàn)室信息管理系統(tǒng)相關(guān)的說明書、手冊(cè)和參考數(shù)據(jù)。
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(yīng)對(duì)計(jì)算和數(shù)據(jù)傳送進(jìn)行適當(dāng)和系統(tǒng)地檢查。
Calculations and data transfers shall be checked in an appropriate and systematic manner.
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