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ISO/IEC 17025：2017《檢測(cè)和校準(zhǔn)實(shí)驗(yàn)室能力的通用要求》的管理體系要求
更新日期：2023-03-16 10:37:51 已瀏覽：7420次
中國合格評(píng)定國家認(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)購買和使用正版國際和國家標(biāo)準(zhǔn)。
8 管理體系要求Management system requirements
8.1 方式Options8.1.1 總則General
實(shí)驗(yàn)室應(yīng)建立、實(shí)施和保持形成文件的管理體系，該管理體系應(yīng)能夠支持和證明實(shí)驗(yàn)室持續(xù)滿足本標(biāo)準(zhǔn)的要求，并且保證實(shí)驗(yàn)室結(jié)果的質(zhì)量。除滿足第4章至第7章的要求外，實(shí)驗(yàn)室應(yīng)按方式A或方式B實(shí)施管理體系。
The laboratory shall establish, document, implement and maintain a management system that is capable of supporting and demonstrating the consistent achievement of the requirements of this document and assuring the quality of the laboratory results. In addition to meeting the requirements of Clauses 4 to 7, the laboratory shall implement a management system in accordance with Option A or Option B.
注：更多信息參見附錄B。
NOTE See Annex B for more information.
G001應(yīng)用說明：如果實(shí)驗(yàn)室是某個(gè)機(jī)構(gòu)的一部分，該機(jī)構(gòu)的管理體系已覆蓋了實(shí)驗(yàn)室的活動(dòng)，實(shí)驗(yàn)室應(yīng)將該組織管理體系中有關(guān)實(shí)驗(yàn)室的規(guī)定予以提煉和匯總，形成針對(duì)實(shí)驗(yàn)室活動(dòng)的文件，并明確相關(guān)的支持性文件；如果針對(duì)實(shí)驗(yàn)室建立單獨(dú)的管理體系，管理體系還應(yīng)覆蓋為支撐體系運(yùn)作的所有相關(guān)部門，管理體系中有關(guān)實(shí)驗(yàn)室和相關(guān)支持部門工作職責(zé)的文件應(yīng)由對(duì)實(shí)驗(yàn)室和相關(guān)部門承擔(dān)管理職責(zé)的該組織的負(fù)責(zé)人批準(zhǔn)。
8.1.2 方式Option A
實(shí)驗(yàn)室管理體系至少應(yīng)包括下列內(nèi)容：
As a minimum, the management system of the laboratory shall address the following:
——管理體系文件（見8.2）；
— management system documentation (see 8.2);
——管理體系文件的控制（見8.3）；
— control of management system documents (see 8.3);
——記錄控制（見8.4）；
— control of records (see 8.4);
——應(yīng)對(duì)風(fēng)險(xiǎn)和機(jī)遇的措施（見8.5）；
— actions to address risks and opportunities (see 8.5);
——改進(jìn)（見8.6）；
— improvement (see 8.6);
——糾正措施（見8.7）；
— corrective action (see 8.7);
——內(nèi)部審核（見8.8）；
— internal audits (see 8.8);
——管理評(píng)審（見8.9）。
— management reviews (see 8.9).
8.1.3 方式Option B
實(shí)驗(yàn)室按照GB/T 19001的要求建立并保持管理體系，能夠支持和證明持續(xù)符合第4章至第7章的要求，也至少滿足了8.2至8.9中規(guī)定的管理體系要求的目的。
A laboratory that has established and maintains a management system, in accordance with the requirements of ISO 9001, and that is capable of supporting and demonstrating the consistent fulfilment of the requirements of Clauses 4 to 7, also fulfils at least the intent of the management system requirements specified in 8.2 to 8.9.
G001應(yīng)用說明：如果實(shí)驗(yàn)室采用方式B建立和運(yùn)行管理體系，實(shí)驗(yàn)室也應(yīng)提供證據(jù)證明實(shí)驗(yàn)室活動(dòng)的管理和運(yùn)作滿足標(biāo)準(zhǔn)中第8.2條款至第8.9條款中規(guī)定的管理體系要求。
8.2 管理體系文件Management system documentation（方式Option A）
8.2.1 實(shí)驗(yàn)室管理層應(yīng)建立、編制和保持符合本標(biāo)準(zhǔn)目的的方針和目標(biāo)，并確保該方針和目標(biāo)在實(shí)驗(yàn)室組織的各級(jí)人員得到理解和執(zhí)行。
Laboratory management shall establish, document, and maintain policies and objectives for the fulfilment of the purposes of this document and shall ensure that the policies and objectives are acknowledged and implemented at all levels of the laboratory organization.
注：實(shí)驗(yàn)室的目標(biāo)應(yīng)具體、可量化、可考核，并與其方針保持一致。
GL030認(rèn)可指南：實(shí)驗(yàn)室在制定質(zhì)量方針和目標(biāo)時(shí)，應(yīng)考慮所在母體組織的業(yè)務(wù)內(nèi)容、質(zhì)量方針和目標(biāo)，應(yīng)有利于控制和提高檢測(cè)結(jié)果準(zhǔn)確性，保障所在組織的產(chǎn)品質(zhì)量。
8.2.2 方針和目標(biāo)應(yīng)能體現(xiàn)實(shí)驗(yàn)室的能力、公正性和一致運(yùn)作。
The policies and objectives shall address the competence, impartiality and consistent operation of the laboratory.
8.2.3 實(shí)驗(yàn)室管理層應(yīng)提供建立和實(shí)施管理體系以及持續(xù)改進(jìn)其有效性承諾的證據(jù)。
Laboratory management shall provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness.
8.2.4 管理體系應(yīng)包含、引用或鏈接與滿足本標(biāo)準(zhǔn)的要求相關(guān)的所有文件、過程、系統(tǒng)和記錄等。
All documentation, processes, systems, records, related to the fulfilment of the requirements of this document shall be included in, referenced from, or linked to the management system.
注：管理體系文件可包括質(zhì)量手冊(cè)、程序文件、作業(yè)指導(dǎo)書（含記錄格式、表格）、記錄。
GL030認(rèn)可指南：實(shí)驗(yàn)室的管理體系應(yīng)覆蓋母體組織中的協(xié)助部門。注：如實(shí)驗(yàn)室服務(wù)與供應(yīng)品的采購、新進(jìn)人員的招聘與培訓(xùn)及廢棄物處理等工作，可能由母體中的相關(guān)部門協(xié)助完成。
8.2.5 參與實(shí)驗(yàn)室活動(dòng)的所有人員應(yīng)可獲得適用其職責(zé)的管理體系文件和相關(guān)信息。
All personnel involved in laboratory activities shall have access to the parts of the management system documentation and related information that are applicable to their responsibilities.
8.3 管理體系文件的控制Control of management system documents（方式Option A）
8.3.1 實(shí)驗(yàn)室應(yīng)控制與滿足本標(biāo)準(zhǔn)的要求有關(guān)的內(nèi)部和外部文件。
The laboratory shall control the documents (internal and external) that relate to the fulfilment of this document.
注：本標(biāo)準(zhǔn)中，“文件”可以是政策聲明、程序、規(guī)范、制造商的說明書、校準(zhǔn)表格、圖表、教科書、張貼品、通知、備忘錄、圖紙、計(jì)劃等。這些文件可承載于各種載體，例如硬拷貝或數(shù)字形式。
NOTE In this context, “document” can be policy statements, procedures, specifications, manufacturer’s instructions, calibration tables, charts, text books, posters, notices, memoranda, drawings, plans, etc. These can be on various media, such as hard copy or digital.
GL030認(rèn)可指南：
實(shí)驗(yàn)室質(zhì)量管理體系文件在引用母體組織的相關(guān)文件時(shí)，應(yīng)進(jìn)行有效銜接和控制。注：實(shí)驗(yàn)室的母體組織在運(yùn)行ISO 9001、ISO 14001等管理體系時(shí)，如果已經(jīng)包含了實(shí)驗(yàn)室的相關(guān)工作規(guī)范，實(shí)驗(yàn)室在建立自身管理體系時(shí)可將母體組織的相關(guān)規(guī)范名稱或章節(jié)直接引用至實(shí)驗(yàn)室管理規(guī)范中。
實(shí)驗(yàn)室接收到外來文件時(shí)，需對(duì)其適用性、有效性和分發(fā)范圍等進(jìn)行識(shí)別，并根據(jù)識(shí)別結(jié)果確定是否納入質(zhì)量管理體系，進(jìn)行有效控制。
8.3.2 實(shí)驗(yàn)室應(yīng)確保：
The laboratory shall ensure that:
a)文件發(fā)布前由授權(quán)人員審查其充分性并批準(zhǔn)；
a) documents are approved for adequacy prior to issue by authorized personnel;
b)定期審查文件，并在必要時(shí)更新；
b) documents are periodically reviewed, and updated as necessary;
c)識(shí)別文件更改和當(dāng)前修訂狀態(tài)；
c) changes and the current revision status of documents are identified;
d)在使用地點(diǎn)應(yīng)可獲得適用文件的相關(guān)版本，并在必要時(shí)控制其發(fā)放；
d) relevant versions of applicable documents are available at points of use and, where necessary, their distribution is controlled;
e)對(duì)文件進(jìn)行唯一性標(biāo)識(shí)；
e) documents are uniquely identified;
f)防止誤用作廢文件，并對(duì)出于某種目的而保留的作廢文件做出適當(dāng)標(biāo)識(shí)。
f) the unintended use of obsolete documents is prevented, and suitable identification is applied to them if they are retained for any purpose.
g）對(duì)需要保密的文件應(yīng)按有關(guān)保密規(guī)定確定適當(dāng)密級(jí)，并進(jìn)行管理。
8.4 記錄控制Control of records（方式Option A）
8.4.1 實(shí)驗(yàn)室應(yīng)建立和保存清晰的記錄以證明滿足本標(biāo)準(zhǔn)的要求。
The laboratory shall establish and retain legible records to demonstrate fulfilment of the requirements in this document.
GL030認(rèn)可指南：質(zhì)量記錄包括內(nèi)部審核報(bào)告和管理評(píng)審報(bào)告以及糾正措施和預(yù)防措施的記錄等。技術(shù)記錄包括檢驗(yàn)相關(guān)工作記錄，包括檢驗(yàn)原始記錄、環(huán)境監(jiān)測(cè)記錄、儀器設(shè)備使用及維護(hù)記錄、原始圖譜等。
8.4.2 實(shí)驗(yàn)室應(yīng)對(duì)記錄的標(biāo)識(shí)、存儲(chǔ)、保護(hù)、備份、歸檔、檢索、保存期和處置實(shí)施所需的控制。實(shí)驗(yàn)室記錄保存期限應(yīng)符合合同義務(wù)。記錄的調(diào)閱應(yīng)符合保密承諾，且記錄應(yīng)易于獲得。
The laboratory shall implement the controls needed for the identification, storage, protection, back-up, archive, retrieval, retention time, and disposal of its records. The laboratory shall retain records for a period consistent with its contractual obligations. Access to these records shall be consistent with the confidentiality commitments and records shall be readily available.
注：對(duì)技術(shù)記錄的其他要求見7.5。
NOTE Additional requirements regarding technical records are given in 7.5.
G001應(yīng)用說明：除特殊情況外，所有技術(shù)記錄，包括檢測(cè)或校準(zhǔn)的原始記錄，應(yīng)至少保存6年。如果法律法規(guī)、CNAS專業(yè)領(lǐng)域認(rèn)可要求文件或客戶規(guī)定了更長的保存期要求，則實(shí)驗(yàn)室應(yīng)滿足這些要求。人員或設(shè)備記錄應(yīng)隨同人員工作期間或設(shè)備使用時(shí)限全程保留，在人員調(diào)離或設(shè)備停止使用后，人員或設(shè)備技術(shù)記錄應(yīng)再保存6年。技術(shù)記錄，無論是電子記錄還是紙面記錄，應(yīng)包括從樣品的接收到出具檢測(cè)報(bào)告或校準(zhǔn)證書過程中觀察到的信息和原始數(shù)據(jù)，并全程確保樣品與報(bào)告/證書的對(duì)應(yīng)性。注：除非相關(guān)法規(guī)另有規(guī)定外，當(dāng)實(shí)驗(yàn)室承擔(dān)的檢測(cè)或校準(zhǔn)結(jié)果用于產(chǎn)品認(rèn)證、行政許可等用途時(shí)，相關(guān)技術(shù)記錄和報(bào)告副本的保存期應(yīng)當(dāng)考慮相關(guān)產(chǎn)品認(rèn)證、行政許可證書規(guī)定的有效期。
8.5 應(yīng)對(duì)風(fēng)險(xiǎn)和機(jī)遇的措施Actions to address risks and opportunities（方式Option A）
8.5.1 實(shí)驗(yàn)室應(yīng)考慮與實(shí)驗(yàn)室活動(dòng)相關(guān)的風(fēng)險(xiǎn)和機(jī)遇，以：
The laboratory shall consider the risks and opportunities associated with the laboratory activities in order to:
a)確保管理體系能夠?qū)崿F(xiàn)其預(yù)期結(jié)果；
a) give assurance that the management system achieves its intended results;
b)增強(qiáng)實(shí)現(xiàn)實(shí)驗(yàn)室目的和目標(biāo)的機(jī)遇；
b) enhance opportunities to achieve the purpose and objectives of the laboratory;
c)預(yù)防或減少實(shí)驗(yàn)室活動(dòng)中的不利影響和可能的失敗；
c) prevent, or reduce, undesired impacts and potential failures in the laboratory activities;
d)實(shí)現(xiàn)改進(jìn)。
d) achieve improvement.
8.5.2 實(shí)驗(yàn)室應(yīng)策劃：
The laboratory shall plan:
a)應(yīng)對(duì)這些風(fēng)險(xiǎn)和機(jī)遇的措施；
a) actions to address these risks and opportunities;
b)如何：
b) how to:
——在管理體系中整合并實(shí)施這些措施；
— integrate and implement these actions into its management system;
——評(píng)價(jià)這些措施的有效性。
— evaluate the effectiveness of these actions.
注：雖然本標(biāo)準(zhǔn)規(guī)定實(shí)驗(yàn)室應(yīng)策劃應(yīng)對(duì)風(fēng)險(xiǎn)的措施，但并未要求運(yùn)用正式的風(fēng)險(xiǎn)管理方法或形成文件的風(fēng)險(xiǎn)管理過程。實(shí)驗(yàn)室可決定是否采用超出本標(biāo)準(zhǔn)要求的更廣泛的風(fēng)險(xiǎn)管理方法，如：通過應(yīng)用其他指南或標(biāo)準(zhǔn)。
NOTE Although this document specifies that the laboratory plans actions to address risks, there is no requirement for formal methods for risk management or a documented risk management process. Laboratories can decide whether or not to develop a more extensive risk management methodology than is required by this document, e.g. through the application of other guidance or standards.
8.5.3 應(yīng)對(duì)風(fēng)險(xiǎn)和機(jī)遇的措施應(yīng)與其對(duì)實(shí)驗(yàn)室結(jié)果有效性的潛在影響相適應(yīng)。
Actions taken to address risks and opportunities shall be proportional to the potential impact on the validity of laboratory results.
注1：應(yīng)對(duì)風(fēng)險(xiǎn)的方式包括識(shí)別和規(guī)避威脅，為尋求機(jī)遇承擔(dān)風(fēng)險(xiǎn)，消除風(fēng)險(xiǎn)源，改變風(fēng)險(xiǎn)的可能性或后果，分擔(dān)風(fēng)險(xiǎn)，或通過信息充分的決策而保留風(fēng)險(xiǎn)。
NOTE 1 Options to address risks can include identifying and avoiding threats, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.
注2：機(jī)遇可能促使實(shí)驗(yàn)室擴(kuò)展活動(dòng)范圍，贏得新客戶，使用新技術(shù)和其他方式應(yīng)對(duì)客戶需求。
NOTE 2 Opportunities can lead to expanding the scope of the laboratory activities, addressing new customers, using new technology and other possibilities to address customer needs.
GL030認(rèn)可指南：實(shí)驗(yàn)室應(yīng)根據(jù)檢測(cè)結(jié)果的趨勢(shì)為生產(chǎn)環(huán)節(jié)進(jìn)行風(fēng)險(xiǎn)提示。
8.6 改進(jìn)Improvement（方式Option A）
8.6.1 實(shí)驗(yàn)室應(yīng)識(shí)別和選擇改進(jìn)機(jī)遇，并采取必要措施。
The laboratory shall identify and select opportunities for improvement and implement any necessary actions.
注：實(shí)驗(yàn)室可通過評(píng)審操作程序、實(shí)施方針、總體目標(biāo)、審核結(jié)果、糾正措施、管理評(píng)審、人員建議、風(fēng)險(xiǎn)評(píng)估、數(shù)據(jù)分析和能力驗(yàn)證結(jié)果識(shí)別改進(jìn)機(jī)遇。
NOTE Opportunities for improvement can be identified through the review of the operational procedures, the use of the policies, overall objectives, audit results, corrective actions, management review, suggestions from personnel, risk assessment, analysis of data, and proficiency testing results.
8.6.2 實(shí)驗(yàn)室應(yīng)向客戶征求反饋，無論是正面的還是負(fù)面的。應(yīng)分析和利用這些反饋，以改進(jìn)管理體系、實(shí)驗(yàn)室活動(dòng)和客戶服務(wù)。實(shí)驗(yàn)室應(yīng)有為軍工產(chǎn)品提供現(xiàn)場(chǎng)服務(wù)的承諾和規(guī)定。
The laboratory shall seek feedback, both positive and negative, from its customers. The feedback shall be analysed and used to improve the management system, laboratory activities and customer service.
注：反饋的類型示例包括：客戶滿意度調(diào)查、與客戶的溝通記錄和共同評(píng)價(jià)報(bào)告。
NOTE Examples of the types of feedback include customer satisfaction surveys, communication records and review of reports with customers.
GL030認(rèn)可指南：實(shí)驗(yàn)室可結(jié)合母體組織的工作模式，通過溝通會(huì)、郵件、電話、短信息、意見本等多種形式征求客戶反饋意見并及時(shí)處理。
8.7 糾正措施Corrective actions（方式Option A）
8.7.1 當(dāng)發(fā)生不符合時(shí)，實(shí)驗(yàn)室應(yīng)：
When a nonconformity occurs, the laboratory shall:
a)對(duì)不符合作出應(yīng)對(duì)，并且在適用時(shí)：
a) react to the nonconformity and, as applicable:
——采取措施以控制和糾正不符合；
— take action to control and correct it;
——處置后果；
— address the consequences;
b)通過下列活動(dòng)評(píng)價(jià)是否需要采取措施，以消除產(chǎn)生不符合的原因，避免其再次發(fā)生或者在其他場(chǎng)合發(fā)生：
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
——評(píng)審和分析不符合；
— reviewing and analysing the nonconformity;
——確定不符合的原因；
— determining the causes of the nonconformity;
——確定是否存在或可能發(fā)生類似的不符合；
— determining if similar nonconformities exist, or could potentially occur;
c)實(shí)施所需的措施；
c) implement any action needed;
d)評(píng)審所采取的糾正措施的有效性；
d) review the effectiveness of any corrective action taken;
e)必要時(shí)，更新在策劃期間確定的風(fēng)險(xiǎn)和機(jī)遇；
e) update risks and opportunities determined during planning, if necessary;
f)必要時(shí)，變更管理體系。
f) make changes to the management system, if necessary.
G001應(yīng)用說明：對(duì)于發(fā)現(xiàn)的不符合，實(shí)驗(yàn)室不應(yīng)僅僅糾正發(fā)生的問題，還應(yīng)進(jìn)行全面、細(xì)致的分析，確定不符合是否為獨(dú)立事件，是否還會(huì)再次發(fā)生，查找產(chǎn)生問題的根本原因，按本條款要求啟動(dòng)糾正措施。注：對(duì)于不符合，僅進(jìn)行糾正、無需采取糾正措施的情況很少發(fā)生。比如在認(rèn)可評(píng)審中，經(jīng)常發(fā)現(xiàn)實(shí)驗(yàn)室未按CNAS規(guī)定的要求參加能力驗(yàn)證，僅是提供事后參加能力驗(yàn)證的證據(jù)，這種措施是不充分的，實(shí)驗(yàn)室應(yīng)當(dāng)全面分析未參加能力驗(yàn)證的根本原因，如資金不足、能力驗(yàn)證計(jì)劃不全面、缺乏對(duì)計(jì)劃實(shí)施情況的有效監(jiān)督等，從而采取有效的糾正措施。
8.7.2 糾正措施應(yīng)與不符合產(chǎn)生的影響相適應(yīng)。
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
8.7.3 實(shí)驗(yàn)室應(yīng)保存記錄，作為下列事項(xiàng)的證據(jù)：
The laboratory shall retain records as evidence of:
a)不符合的性質(zhì)、產(chǎn)生原因和后續(xù)所采取的措施；
a) the nature of the nonconformities, cause(s) and any subsequent actions taken;
b)糾正措施的結(jié)果。
b) the results of any corrective action.
8.8 內(nèi)部審核Internal audits（方式Option A）
8.8.1 實(shí)驗(yàn)室應(yīng)按照策劃的時(shí)間間隔進(jìn)行內(nèi)部審核，以提供有關(guān)管理體系的下列信息：
The laboratory shall conduct internal audits at planned intervals to provide information on whether the management system:
a)是否符合：
a) conforms to:
——實(shí)驗(yàn)室自身的管理體系要求，包括實(shí)驗(yàn)室活動(dòng)；
— the laboratory’s own requirements for its management system, including the laboratory activities;
——本標(biāo)準(zhǔn)的要求；
— the requirements of this document;
b)是否得到有效的實(shí)施和保持。
b) is effectively implemented and maintained.
8.8.2 實(shí)驗(yàn)室應(yīng)：
The laboratory shall:
a)考慮實(shí)驗(yàn)室活動(dòng)的重要性、影響實(shí)驗(yàn)室的變化和以前審核的結(jié)果，策劃、制定、實(shí)施和保持審核方案，審核方案包括頻次、方法、職責(zé)、策劃要求和報(bào)告；
a) plan, establish, implement and maintain an audit programme including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the laboratory activities concerned, changes affecting the laboratory, and the results of previous audits;
b)規(guī)定每次審核的審核準(zhǔn)則和范圍；
b) define the audit criteria and scope for each audit;
G001應(yīng)用說明：實(shí)驗(yàn)室內(nèi)部審核依據(jù)應(yīng)包括CNAS發(fā)布的CNAS-CL01在相關(guān)領(lǐng)域的應(yīng)用說明。注：建議內(nèi)部審核每12個(gè)月進(jìn)行一次。內(nèi)部審核的周期和覆蓋范圍應(yīng)當(dāng)基于風(fēng)險(xiǎn)分析。CNAS-GL011《實(shí)驗(yàn)室和檢驗(yàn)機(jī)構(gòu)內(nèi)部審核指南》為內(nèi)部審核的實(shí)施提供了指南。
c)確保將審核結(jié)果報(bào)告給相關(guān)管理層；
c) ensure that the results of the audits are reported to relevant management;
d)及時(shí)采取適當(dāng)?shù)募m正和糾正措施；
d) implement appropriate correction and corrective actions without undue delay;
e)保存記錄，作為實(shí)施審核方案和審核結(jié)果的證據(jù)。
e) retain records as evidence of the implementation of the audit programme and the audit results.
注：內(nèi)部審核相關(guān)指南參見GB/T 19011。
NOTE ISO 19011 provides guidance for internal audits.
8.9 管理評(píng)審Management reviews（方式Option A）
8.9.1 實(shí)驗(yàn)室管理層應(yīng)按照策劃的時(shí)間間隔對(duì)實(shí)驗(yàn)室的管理體系進(jìn)行評(píng)審，以確保其持續(xù)的適宜性、充分性和有效性，包括執(zhí)行本標(biāo)準(zhǔn)的相關(guān)方針和目標(biāo)。
The laboratory management shall review its management system at planned intervals, in order to ensure its continuing suitability, adequacy and effectiveness, including the stated policies and objectives related to the fulfilment of this document.
G001應(yīng)用說明：對(duì)規(guī)模較大的實(shí)驗(yàn)室，管理評(píng)審可以分級(jí)、分部門、分次進(jìn)行。實(shí)驗(yàn)室應(yīng)根據(jù)具體情況進(jìn)行前期策劃，確保管理評(píng)審輸入和輸出的完整性。注1：建議管理評(píng)審每12個(gè)月進(jìn)行一次。CNAS-GL012《實(shí)驗(yàn)室和檢驗(yàn)機(jī)構(gòu)管理評(píng)審指南》為管理評(píng)審的實(shí)施提供了指南。注2：對(duì)于集團(tuán)式管理的實(shí)驗(yàn)室，通常每個(gè)地點(diǎn)均為單獨(dú)的法人機(jī)構(gòu)，對(duì)從屬于同一法人的實(shí)驗(yàn)室應(yīng)按本條款實(shí)施完整的管理評(píng)審。
8.9.2 實(shí)驗(yàn)室應(yīng)記錄管理評(píng)審的輸入，并包括以下相關(guān)信息：
The inputs to management review shall be recorded and shall include information related to the following:
a)與實(shí)驗(yàn)室相關(guān)的內(nèi)外部因素的變化；
a) changes in internal and external issues that are relevant to the laboratory;
b)目標(biāo)實(shí)現(xiàn)；
b) fulfilment of objectives;
c)政策和程序的適宜性；
c) suitability of policies and procedures;
d)以往管理評(píng)審所采取措施的情況；
d) status of actions from previous management reviews;
e)近期內(nèi)部審核的結(jié)果;
e) outcome of recent internal audits;
f)糾正措施；
f) corrective actions;
g)由外部機(jī)構(gòu)進(jìn)行的評(píng)審；
g) assessments by external bodies;
h)工作量和工作類型的變化或?qū)嶒?yàn)室活動(dòng)范圍的變化；
h) changes in the volume and type of the work or in the range of laboratory activities;
i)客戶和人員的反饋；
i) customer and personnel feedback;
j)投訴；
j) complaints;
k)實(shí)施改進(jìn)的有效性；
k) effectiveness of any implemented improvements;
l)資源的充分性；
l) adequacy of resources;
m)風(fēng)險(xiǎn)識(shí)別的結(jié)果；
m) results of risk identification;
n)保證結(jié)果有效性的輸出；
n) outcomes of the assurance of the validity of results; and
o)其他相關(guān)因素，如監(jiān)控活動(dòng)和培訓(xùn)。
o) other relevant factors, such as monitoring activities and training.
8.9.3 管理評(píng)審的輸出至少應(yīng)記錄與下列事項(xiàng)相關(guān)的決定和措施：
The outputs from the management review shall record all decisions and actions related to at least:
a)管理體系及其過程的有效性；
a) the effectiveness of the management system and its processes;
b)與滿足本標(biāo)準(zhǔn)要求相關(guān)的實(shí)驗(yàn)室活動(dòng)的改進(jìn)；
b) improvement of the laboratory activities related to the fulfilment of the requirements of this document;
c)提供所需的資源；
c) provision of required resources;
d) 所需的變更。
d) any need for change.
附錄Annex A：計(jì)量溯源性Metrological traceability
（資料性附錄informative）
計(jì)量溯源性Metrological traceability
A.1 總則General
計(jì)量溯源性是確保測(cè)量結(jié)果在國內(nèi)和國際上具有可比性的重要概念，本附錄給出了有關(guān)計(jì)量溯源性的更詳細(xì)的信息。
This annex provides additional information on metrological traceability, which is an important concept to ensure comparability of measurement results both nationally and internationally.
A.2 建立計(jì)量溯源性Establishing metrological traceability
A.2.1 建立計(jì)量溯源性需考慮并確保以下內(nèi)容：
Metrological traceability is established by considering, and then ensuring, the following:
a)規(guī)定被測(cè)量（被測(cè)量的量）；
a) the specification of the measurand (quantity to be measured);
b)一個(gè)形成文件的不間斷的校準(zhǔn)鏈，可以溯源到聲明的適當(dāng)參考對(duì)象（適當(dāng)參考對(duì)象包括國家標(biāo)準(zhǔn)或國際標(biāo)準(zhǔn)以及自然基準(zhǔn)）；
b) a documented unbroken chain of calibrations going back to stated and appropriate references (appropriate references include national or international standards, and intrinsic standards);
c)按照約定的方法評(píng)定溯源鏈中每次校準(zhǔn)的測(cè)量不確定度；
c) that measurement uncertainty for each step in the traceability chain is evaluated according to agreed methods;
d)溯源鏈中每次校準(zhǔn)均按照適當(dāng)?shù)姆椒ㄟM(jìn)行，并有測(cè)量結(jié)果及相關(guān)的、已記錄的測(cè)量不確定度；
d) that each step of the chain is performed in accordance with appropriate methods, with the measurement results and with associated, recorded measurement uncertainties;
e)在溯源鏈中實(shí)施一次或多次校準(zhǔn)的實(shí)驗(yàn)室應(yīng)提供其技術(shù)能力的證據(jù)。
e) that the laboratories performing one or more steps in the chain supply evidence for their technical competence.
A.2.2 當(dāng)使用被校準(zhǔn)的設(shè)備將計(jì)量溯源性傳遞至實(shí)驗(yàn)室的測(cè)量結(jié)果時(shí)，需考慮該設(shè)備的系統(tǒng)測(cè)量誤差（有時(shí)稱為偏倚）。有幾種方法來考慮測(cè)量計(jì)量溯源性傳遞中的系統(tǒng)測(cè)量誤差。
The systematic measurement error (sometimes called “bias”) of the calibrated equipment is taken into account to disseminate metrological traceability to measurement results in the laboratory. There are several mechanisms available to take into account the systematic measurement errors in the dissemination of measurement metrological traceability.
A.2.3 具備能力的實(shí)驗(yàn)室報(bào)告測(cè)量標(biāo)準(zhǔn)的信息中，如果只有與規(guī)范的符合性聲明（省略了測(cè)量結(jié)果和相關(guān)不確定度），該測(cè)量標(biāo)準(zhǔn)有時(shí)也可用于傳遞計(jì)量溯源性，其規(guī)范限是不確定度的來源，但此方法取決于：
Measurement standards that have reported information from a competent laboratory that includes only a statement of conformity to a specification (omitting the measurement results and associated uncertainties) are sometimes used to disseminate metrological traceability. This approach, in which the specification limits are imported as the source of uncertainty, is dependent upon:
——使用適當(dāng)?shù)呐卸ㄒ?guī)則確定符合性；
— the use of an appropriate decision rule to establish conformity;
——在后續(xù)的不確定度評(píng)估中，以技術(shù)上適當(dāng)?shù)姆绞絹硖幚硪?guī)范限。
— the specification limits subsequently being treated in a technically appropriate way in the uncertainty budget.
此方法的技術(shù)基礎(chǔ)在于與規(guī)范符合性聲明確定了測(cè)量值的范圍，并預(yù)計(jì)真值以規(guī)定的置信度處于該范圍內(nèi)，該范圍考慮了真值的偏倚以及測(cè)量不確定度。
The technical basis for this approach is that the declared conformance to a specification defines a range of measurement values, within which the true value is expected to lie, at a specified level of confidence, which considers both any bias from the true value, as well as the measurement uncertainty.
示例：使用國際法制計(jì)量組織（OIML）R111各種等級(jí)砝碼校準(zhǔn)天平。
EXAMPLE The use of OIML R 111 class weights to calibrate a balance.
A.3 證明計(jì)量溯源性Demonstrating metrological traceability
A.3.1 實(shí)驗(yàn)室負(fù)責(zé)按本準(zhǔn)則建立計(jì)量溯源性。符合本標(biāo)準(zhǔn)的實(shí)驗(yàn)室提供的校準(zhǔn)結(jié)果具有計(jì)量溯源性。符合 ISO 17034 的標(biāo)準(zhǔn)物質(zhì)生產(chǎn)者提供的有證標(biāo)準(zhǔn)物質(zhì)的標(biāo)準(zhǔn)值具有計(jì)量溯源性。有不同的方式來證明與本標(biāo)準(zhǔn)的符合性，即第三方承認(rèn)（如認(rèn)可機(jī)構(gòu)）、客戶進(jìn)行的外部評(píng)審或自我評(píng)審。國際上承認(rèn)的途徑包括但不限于：
Laboratories are responsible for establishing metrological traceability in accordance with this document. Calibration results from laboratories conforming to this document provide metrological traceability. Certified values of certified reference materials from reference material producers conforming to ISO 17034 provide metrological traceability. There are various ways to demonstrate conformity with this document, third party recognition (such as an accreditation body), external assessment by customers or self-assessment. Internationally accepted paths include, but are not limited to the following.
a)已通過適當(dāng)同行評(píng)審的國家計(jì)量院及其指定機(jī)構(gòu)提供的校準(zhǔn)和測(cè)量能力。該同行評(píng)審是在國際計(jì)量委員會(huì)相互承認(rèn)協(xié)議（CIPM MRA）下實(shí)施的。 CIPM MRA所覆蓋的服務(wù)可以在國際計(jì)量局的關(guān)鍵比對(duì)數(shù)據(jù)庫（BIPM KCDB）附錄C中查詢，其給出了每項(xiàng)服務(wù)的范圍和測(cè)量不確定度。
a) Calibration and measurement capabilities provided by national metrology institutes and designated institutes that have been subject to suitable peer-review processes. Such peer-review is conducted under the CIPM MRA (International Committee for Weights and Measures Mutual Recognition Arrangement). Services covered by the CIPM MRA can be viewed in Appendix C of the BIPM KCDB (International Bureau of Weights and Measures Key Comparison Database) which details the range and measurement uncertainty for each listed service.
b)簽署國際實(shí)驗(yàn)室認(rèn)可合作組織（ILAC）協(xié)議或ILAC承認(rèn)的區(qū)域協(xié)議的認(rèn)可機(jī)構(gòu)認(rèn)可的校準(zhǔn)和測(cè)量能力能夠證明具有計(jì)量溯源性。獲認(rèn)可的實(shí)驗(yàn)室的能力范圍可從相關(guān)認(rèn)可機(jī)構(gòu)公開獲得。
b) Calibration and measurement capabilities that have been accredited by an accreditation body subject to the ILAC (International Laboratory Accreditation Cooperation) Arrangement or to Regional Arrangements recognized by ILAC have demonstrated metrological traceability. Scopes of accredited laboratories are publicly available from their respective accreditation bodies.
A.3.2 當(dāng)需要證明計(jì)量溯源鏈在國際上被承認(rèn)的情況時(shí)，BIPM、OIML（國際法制計(jì)量組織International Organization of Legal Metrology）、ILAC和ISO關(guān)于計(jì)量溯源性的聯(lián)合聲明提供了專門指南。
The Joint BIPM, OIML (International Organization of Legal Metrology), ILAC and ISO Declaration on Metrological Traceability provides specific guidance when there is a need to demonstrate international acceptability of the metrological traceability chain.
附錄Annex B：管理體系方式Management system options
（資料性附錄informative）
管理體系方式Management system options
B.1 隨著管理體系的廣泛應(yīng)用，日益需要實(shí)驗(yàn)室運(yùn)行的管理體系既符GB/T 19001，又符合本標(biāo)準(zhǔn)。因此，本標(biāo)準(zhǔn)提供了實(shí)施管理體系相關(guān)要求的兩種方式。
Growth in the use of management systems generally has increased the need to ensure that laboratories can operate a management system that is seen as conforming to ISO 9001, as well as to this document. As a result, this document provides two options for the requirements related to the implementation of a management system.
B.2 方式A（見8.1.2）給出了實(shí)施實(shí)驗(yàn)室管理體系的最低要求，其已納入GB/T 19001中與實(shí)驗(yàn)室活動(dòng)范圍相關(guān)的管理體系所有要求。因此，符合本準(zhǔn)則第4條款至第7條款，并實(shí)施第8條款方式A的實(shí)驗(yàn)室，其運(yùn)作也基本符合GB/T 19001的原則。
Option A (see 8.1.2) lists the minimum requirements for implementation of a management system in a laboratory. Care has been taken to incorporate all those requirements of ISO 9001 that are relevant to the scope of laboratory activities that are covered by the management system. Laboratories that comply with Clauses 4 to 7 and implement Option A of Clause 8 will therefore also operate generally in accordance with the principles of ISO 9001.
B.3 方式B（見8.1.3）允許實(shí)驗(yàn)室按照GB/T 19001的要求建立和保持管理體系，并能支持和證明持續(xù)符合第4條款至第7條款的要求。因此實(shí)驗(yàn)室實(shí)施第8條款的方式B，也是按照GB/T 19001運(yùn)作的。實(shí)驗(yàn)室管理體系符合GB/T 19001的要求，并不證明實(shí)驗(yàn)室在技術(shù)上具備出具有效的數(shù)據(jù)和結(jié)果的能力。實(shí)驗(yàn)室還應(yīng)符合第4條款至第7條款。
Option B (see 8.1.3) allows laboratories to establish and maintain a management system in accordance with the requirements of ISO 9001, in a manner that supports and demonstrates the consistent fulfilment of Clauses 4 to 7. Laboratories that implement Option B of Clause 8 will therefore also operate in accordance with ISO 9001. Conformity of the management system within which the laboratory operates to the requirements of ISO 9001 does not, in itself, demonstrate the competence of the laboratory to produce technically valid data and results. This is accomplished through compliance with Clauses 4 to 7.
B.4 兩種方式的目的都是為了在管理體系的運(yùn)行，以及符合第4條款至第7條款的要求方面達(dá)到同樣的結(jié)果。
Both options are intended to achieve the same result in the performance of the management system and compliance with Clauses 4 to 7.
注：如同GB/T 19001和其他管理體系標(biāo)準(zhǔn)，文件、數(shù)據(jù)和記錄是成文信息的組成部分。8.3條款規(guī)定文件控制。8.4條款和7.5條款規(guī)定了記錄控制。7.11條款規(guī)定了有關(guān)實(shí)驗(yàn)室活動(dòng)的數(shù)據(jù)控制。
NOTE Documents, data and records are components of documented information as used in ISO 9001 and other management system standards. Control of documents is covered in 8.3. The control of records is covered in 8.4 and 7.5. The control of data related to the laboratory activities is covered in 7.11.
B.5 圖B.1給出了一種可能展示第7條款所描述的實(shí)驗(yàn)室運(yùn)作過程的示意圖。
Figure B.1 illustrates an example of a possible schematic representation of the operational processes of a laboratory, as described in Clause 7.
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