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ISO/IEC 17025:2017《檢測和校準實(shí)驗室能力的通用要求》的管理體系要求

更新日期:2023-03-16 10:37:51  已瀏覽:3922次

中國合格評定國家認可委員會(huì )(英文縮寫(xiě):CNAS)等同采用ISO/IEC 17025:2017《檢測和校準實(shí)驗室能力的通用要求》 作為對檢測和校準實(shí)驗室能力進(jìn)行認可的基本認可準則。為支持特定領(lǐng)域的認可活動(dòng), CNAS還根據不同領(lǐng)域的專(zhuān)業(yè)特點(diǎn),制定一系列的特定領(lǐng)域應用說(shuō)明,對本準則的要求進(jìn)行必要的補充說(shuō)明和解釋?zhuān)⒉辉黾踊驕p少本準則的要求。本準則內容及條款號與國際標準 ISO/IEC 17025:2017內容及條款號完全一致。CNAS鼓勵申請認可的機構購買(mǎi)和使用正版國際和國家標準。

8 管理體系要求Management system requirements

8.1 方式Options
8.1.1 總則General
實(shí)驗室應建立、實(shí)施和保持形成文件的管理體系,該管理體系應能夠支持和證明實(shí)驗室持續滿(mǎn)足本標準的要求,并且保證實(shí)驗室結果的質(zhì)量。除滿(mǎn)足第4章至第7章的要求外,實(shí)驗室應按方式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(jiàn)附錄B。
NOTE  See Annex B for more information.
G001應用說(shuō)明:如果實(shí)驗室是某個(gè)機構的一部分,該機構的管理體系已覆蓋了實(shí)驗室的活動(dòng),實(shí)驗室應將該組織管理體系中有關(guān)實(shí)驗室的規定予以提煉和匯總,形成針對實(shí)驗室活動(dòng)的文件,并明確相關(guān)的支持性文件;如果針對實(shí)驗室建立單獨的管理體系,管理體系還應覆蓋為支撐體系運作的所有相關(guān)部門(mén),管理體系中有關(guān)實(shí)驗室和相關(guān)支持部門(mén)工作職責的文件應由對實(shí)驗室和相關(guān)部門(mén)承擔管理職責的該組織的負責人批準。
8.1.2 方式Option A
實(shí)驗室管理體系至少應包括下列內容:
As a minimum, the management system of the laboratory shall address the following:
——管理體系文件(見(jiàn)8.2);
— management system documentation (see 8.2);
——管理體系文件的控制(見(jiàn)8.3);
— control of management system documents (see 8.3);
——記錄控制(見(jiàn)8.4);
— control of records (see 8.4);
——應對風(fēng)險和機遇的措施(見(jiàn)8.5);
— actions to address risks and opportunities (see 8.5);
——改進(jìn)(見(jiàn)8.6);
— improvement (see 8.6);
——糾正措施(見(jiàn)8.7);
— corrective action (see 8.7);
——內部審核(見(jiàn)8.8);
— internal audits (see 8.8);
——管理評審(見(jiàn)8.9)。
— management reviews (see 8.9).
8.1.3 方式Option B
實(shí)驗室按照GB/T 19001的要求建立并保持管理體系,能夠支持和證明持續符合第4章至第7章的要求,也至少滿(mǎn)足了8.2至8.9中規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應用說(shuō)明:如果實(shí)驗室采用方式B建立和運行管理體系,實(shí)驗室也應提供證據證明實(shí)驗室活動(dòng)的管理和運作滿(mǎn)足標準中第8.2條款至第8.9條款中規定的管理體系要求。
8.2 管理體系文件Management system documentation(方式Option A)
8.2.1 實(shí)驗室管理層應建立、編制和保持符合本標準目的的方針和目標,并確保該方針和目標在實(shí)驗室組織的各級人員得到理解和執行。
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)驗室的目標應具體、可量化、可考核,并與其方針保持一致。
GL030認可指南:實(shí)驗室在制定質(zhì)量方針和目標時(shí),應考慮所在母體組織的業(yè)務(wù)內容、質(zhì)量方針和目標,應有利于控制和提高檢測結果準確性,保障所在組織的產(chǎn)品質(zhì)量。
8.2.2 方針和目標應能體現實(shí)驗室的能力、公正性和一致運作。
The policies and objectives shall address the competence, impartiality and consistent operation of the laboratory.
8.2.3 實(shí)驗室管理層應提供建立和實(shí)施管理體系以及持續改進(jìn)其有效性承諾的證據。
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 管理體系應包含、引用或鏈接與滿(mǎn)足本標準的要求相關(guān)的所有文件、過(guò)程、系統和記錄等。
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、程序文件、作業(yè)指導書(shū)(含記錄格式、表格)、記錄。
GL030認可指南:實(shí)驗室的管理體系應覆蓋母體組織中的協(xié)助部門(mén)。注:如實(shí)驗室服務(wù)與供應品的采購、新進(jìn)人員的招聘與培訓及廢棄物處理等工作,可能由母體中的相關(guān)部門(mén)協(xié)助完成。
8.2.5 參與實(shí)驗室活動(dòng)的所有人員應可獲得適用其職責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)驗室應控制與滿(mǎn)足本標準的要求有關(guān)的內部和外部文件。
The laboratory shall control the documents (internal and external) that relate to the fulfilment of this document.
注:本標準中,“文件”可以是政策聲明、程序、規范、制造商的說(shuō)明書(shū)、校準表格、圖表、教科書(shū)、張貼品、通知、備忘錄、圖紙、計劃等。這些文件可承載于各種載體,例如硬拷貝或數字形式。
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認可指南:
實(shí)驗室質(zhì)量管理體系文件在引用母體組織的相關(guān)文件時(shí),應進(jìn)行有效銜接和控制。注:實(shí)驗室的母體組織在運行ISO 9001、ISO 14001等管理體系時(shí),如果已經(jīng)包含了實(shí)驗室的相關(guān)工作規范,實(shí)驗室在建立自身管理體系時(shí)可將母體組織的相關(guān)規范名稱(chēng)或章節直接引用至實(shí)驗室管理規范中。
實(shí)驗室接收到外來(lái)文件時(shí),需對其適用性、有效性和分發(fā)范圍等進(jìn)行識別,并根據識別結果確定是否納入質(zhì)量管理體系,進(jìn)行有效控制。
8.3.2 實(shí)驗室應確保:
The laboratory shall ensure that:
a)文件發(fā)布前由授權人員審查其充分性并批準;
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)識別文件更改和當前修訂狀態(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)對文件進(jìn)行唯一性標識;
e) documents are uniquely identified;
f)防止誤用作廢文件,并對出于某種目的而保留的作廢文件做出適當標識。
f) the unintended use of obsolete documents is prevented, and suitable identification is applied to them if they are retained for any purpose.
g)對需要保密的文件應按有關(guān)保密規定確定適當密級,并進(jìn)行管理。
8.4 記錄控制Control of records(方式Option A)
8.4.1 實(shí)驗室應建立和保存清晰的記錄以證明滿(mǎn)足本標準的要求。
The laboratory shall establish and retain legible records to demonstrate fulfilment of the requirements in this document.
GL030認可指南:質(zhì)量記錄包括內部審核報告和管理評審報告以及糾正措施和預防措施的記錄等。技術(shù)記錄包括檢驗相關(guān)工作記錄,包括檢驗原始記錄、環(huán)境監測記錄、儀器設備使用及維護記錄、原始圖譜等。
8.4.2 實(shí)驗室應對記錄的標識、存儲、保護、備份、歸檔、檢索、保存期和處置實(shí)施所需的控制。實(shí)驗室記錄保存期限應符合合同義務(wù)。記錄的調閱應符合保密承諾,且記錄應易于獲得。
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:對技術(shù)記錄的其他要求見(jiàn)7.5。
NOTE  Additional requirements regarding technical records are given in 7.5.
G001應用說(shuō)明:除特殊情況外,所有技術(shù)記錄,包括檢測或校準的原始記錄,應至少保存6年。如果法律法規、CNAS專(zhuān)業(yè)領(lǐng)域認可要求文件或客戶(hù)規定了更長(cháng)的保存期要求,則實(shí)驗室應滿(mǎn)足這些要求。人員或設備記錄應隨同人員工作期間或設備使用時(shí)限全程保留,在人員調離或設備停止使用后,人員或設備技術(shù)記錄應再保存6年。技術(shù)記錄,無(wú)論是電子記錄還是紙面記錄,應包括從樣品的接收到出具檢測報告或校準證書(shū)過(guò)程中觀(guān)察到的信息和原始數據,并全程確保樣品與報告/證書(shū)的對應性。注:除非相關(guān)法規另有規定外,當實(shí)驗室承擔的檢測或校準結果用于產(chǎn)品認證、行政許可等用途時(shí),相關(guān)技術(shù)記錄和報告副本的保存期應當考慮相關(guān)產(chǎn)品認證、行政許可證書(shū)規定的有效期。
8.5 應對風(fēng)險和機遇的措施Actions to address risks and opportunities(方式Option A)
8.5.1 實(shí)驗室應考慮與實(shí)驗室活動(dòng)相關(guān)的風(fēng)險和機遇,以:
The laboratory shall consider the risks and opportunities associated with the laboratory activities in order to:
a)確保管理體系能夠實(shí)現其預期結果;
a) give assurance that the management system achieves its intended results;
b)增強實(shí)現實(shí)驗室目的和目標的機遇;
b) enhance opportunities to achieve the purpose and objectives of the laboratory;
c)預防或減少實(shí)驗室活動(dòng)中的不利影響和可能的失??;
c) prevent, or reduce, undesired impacts and potential failures in the laboratory activities;
d)實(shí)現改進(jìn)。
d) achieve improvement.
8.5.2 實(shí)驗室應策劃:
The laboratory shall plan:
a)應對這些風(fēng)險和機遇的措施;
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;
——評價(jià)這些措施的有效性。
— evaluate the effectiveness of these actions.
注:雖然本標準規定實(shí)驗室應策劃應對風(fēng)險的措施,但并未要求運用正式的風(fēng)險管理方法或形成文件的風(fēng)險管理過(guò)程。實(shí)驗室可決定是否采用超出本標準要求的更廣泛的風(fēng)險管理方法,如:通過(guò)應用其他指南或標準。
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 應對風(fēng)險和機遇的措施應與其對實(shí)驗室結果有效性的潛在影響相適應。
Actions taken to address risks and opportunities shall be proportional to the potential impact on the validity of laboratory results.
注1:應對風(fēng)險的方式包括識別和規避威脅,為尋求機遇承擔風(fēng)險,消除風(fēng)險源,改變風(fēng)險的可能性或后果,分擔風(fēng)險,或通過(guò)信息充分的決策而保留風(fēng)險。
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:機遇可能促使實(shí)驗室擴展活動(dòng)范圍,贏(yíng)得新客戶(hù),使用新技術(shù)和其他方式應對客戶(hù)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認可指南:實(shí)驗室應根據檢測結果的趨勢為生產(chǎn)環(huán)節進(jìn)行風(fēng)險提示。
8.6 改進(jìn)Improvement(方式Option A)
8.6.1 實(shí)驗室應識別和選擇改進(jìn)機遇,并采取必要措施。
The laboratory shall identify and select opportunities for improvement and implement any necessary actions.
注:實(shí)驗室可通過(guò)評審操作程序、實(shí)施方針、總體目標、審核結果、糾正措施、管理評審、人員建議、風(fēng)險評估、數據分析和能力驗證結果識別改進(jìn)機遇。
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)驗室應向客戶(hù)征求反饋,無(wú)論是正面的還是負面的。應分析和利用這些反饋,以改進(jìn)管理體系、實(shí)驗室活動(dòng)和客戶(hù)服務(wù)。實(shí)驗室應有為軍工產(chǎn)品提供現場(chǎng)服務(wù)的承諾和規定。
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(lèi)型示例包括:客戶(hù)滿(mǎn)意度調查、與客戶(hù)的溝通記錄和共同評價(jià)報告。
NOTE  Examples of the types of feedback include customer satisfaction surveys, communication records and review of reports with customers.
GL030認可指南:實(shí)驗室可結合母體組織的工作模式,通過(guò)溝通會(huì )、郵件、電話(huà)、短信息、意見(jiàn)本等多種形式征求客戶(hù)反饋意見(jiàn)并及時(shí)處理。
8.7 糾正措施Corrective actions(方式Option A)
8.7.1 當發(fā)生不符合時(shí),實(shí)驗室應:
When a nonconformity occurs, the laboratory shall:
a)對不符合作出應對,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(guò)下列活動(dòng)評價(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(lèi)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)險和機遇;
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應用說(shuō)明:對于發(fā)現的不符合,實(shí)驗室不應僅僅糾正發(fā)生的問(wèn)題,還應進(jìn)行全面、細致的分析,確定不符合是否為獨立事件,是否還會(huì )再次發(fā)生,查找產(chǎn)生問(wèn)題的根本原因,按本條款要求啟動(dòng)糾正措施。注:對于不符合,僅進(jìn)行糾正、無(wú)需采取糾正措施的情況很少發(fā)生。比如在認可評審中,經(jīng)常發(fā)現實(shí)驗室未按CNAS規定的要求參加能力驗證,僅是提供事后參加能力驗證的證據,這種措施是不充分的,實(shí)驗室應當全面分析未參加能力驗證的根本原因,如資金不足、能力驗證計劃不全面、缺乏對計劃實(shí)施情況的有效監督等,從而采取有效的糾正措施。
8.7.2 糾正措施應與不符合產(chǎn)生的影響相適應。
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
8.7.3 實(shí)驗室應保存記錄,作為下列事項的證據:
The laboratory shall retain records as evidence of:
a)不符合的性質(zhì)、產(chǎn)生原因和后續所采取的措施;
a) the nature of the nonconformities, cause(s) and any subsequent actions taken;
b)糾正措施的結果。
b) the results of any corrective action.
8.8 內部審核Internal audits(方式Option A)
8.8.1 實(shí)驗室應按照策劃的時(shí)間間隔進(jìn)行內部審核,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)驗室自身的管理體系要求,包括實(shí)驗室活動(dòng);
— the laboratory’s own requirements for its management system, including the laboratory activities;
——本標準的要求;
— 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)驗室應:
The laboratory shall:
a)考慮實(shí)驗室活動(dòng)的重要性、影響實(shí)驗室的變化和以前審核的結果,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、策劃要求和報告;
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)規定每次審核的審核準則和范圍;
b) define the audit criteria and scope for each audit;
G001應用說(shuō)明:實(shí)驗室內部審核依據應包括CNAS發(fā)布的CNAS-CL01在相關(guān)領(lǐng)域的應用說(shuō)明。注:建議內部審核每12個(gè)月進(jìn)行一次。內部審核的周期和覆蓋范圍應當基于風(fēng)險分析。CNAS-GL011《實(shí)驗室和檢驗機構內部審核指南》為內部審核的實(shí)施提供了指南。
c)確保將審核結果報告給相關(guān)管理層;
c) ensure that the results of the audits are reported to relevant management;
d)及時(shí)采取適當的糾正和糾正措施;
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果的證據。
e) retain records as evidence of the implementation of the audit programme and the audit results.
注:內部審核相關(guān)指南參見(jiàn)GB/T 19011。
NOTE ISO 19011 provides guidance for internal audits.
8.9 管理評審Management reviews(方式Option A)
8.9.1 實(shí)驗室管理層應按照策劃的時(shí)間間隔對實(shí)驗室的管理體系進(jìn)行評審,以確保其持續的適宜性、充分性和有效性,包括執行本標準的相關(guān)方針和目標。
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應用說(shuō)明:對規模較大的實(shí)驗室,管理評審可以分級、分部門(mén)、分次進(jìn)行。實(shí)驗室應根據具體情況進(jìn)行前期策劃,確保管理評審輸入和輸出的完整性。注1:建議管理評審每12個(gè)月進(jìn)行一次。CNAS-GL012《實(shí)驗室和檢驗機構管理評審指南》為管理評審的實(shí)施提供了指南。注2:對于集團式管理的實(shí)驗室,通常每個(gè)地點(diǎn)均為單獨的法人機構,對從屬于同一法人的實(shí)驗室應按本條款實(shí)施完整的管理評審。
8.9.2 實(shí)驗室應記錄管理評審的輸入,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)驗室相關(guān)的內外部因素的變化;
a) changes in internal and external issues that are relevant to the laboratory;
b)目標實(shí)現;
b) fulfilment of objectives;
c)政策和程序的適宜性;
c) suitability of policies and procedures;
d)以往管理評審所采取措施的情況;
d) status of actions from previous management reviews;
e)近期內部審核的結果;
e) outcome of recent internal audits;
f)糾正措施;
f) corrective actions;
g)由外部機構進(jìn)行的評審;
g) assessments by external bodies;
h)工作量和工作類(lèi)型的變化或實(shí)驗室活動(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(hù)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)險識別的結果;
m) results of risk identification;
n)保證結果有效性的輸出;
n) outcomes of the assurance of the validity of results; and
o)其他相關(guān)因素,如監控活動(dòng)和培訓。
o) other relevant factors, such as monitoring activities and training.
8.9.3 管理評審的輸出至少應記錄與下列事項相關(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(guò)程的有效性;
a) the effectiveness of the management system and its processes;
b)與滿(mǎn)足本標準要求相關(guān)的實(shí)驗室活動(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:計量溯源性Metrological traceability
(資料性附錄informative)
計量溯源性Metrological traceability
A.1 總則General
計量溯源性是確保測量結果在國內和國際上具有可比性的重要概念,本附錄給出了有關(guān)計量溯源性的更詳細的信息。
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 建立計量溯源性Establishing metrological traceability
A.2.1 建立計量溯源性需考慮并確保以下內容:
Metrological traceability is established by considering, and then ensuring, the following:
a)規定被測量(被測量的量);
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鏈,可以溯源到聲明的適當參考對象(適當參考對象包括國家標準或國際標準以及自然基準);
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)按照約定的方法評定溯源鏈中每次校準的測量不確定度;
c) that measurement uncertainty for each step in the traceability chain is evaluated according to agreed methods;
d)溯源鏈中每次校準均按照適當的方法進(jìn)行,并有測量結果及相關(guān)的、已記錄的測量不確定度;
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)施一次或多次校準的實(shí)驗室應提供其技術(shù)能力的證據。
e) that the laboratories performing one or more steps in the chain supply evidence for their technical competence.
A.2.2 當使用被校準的設備將計量溯源性傳遞至實(shí)驗室的測量結果時(shí),需考慮該設備的系統測量誤差(有時(shí)稱(chēng)為偏倚)。有幾種方法來(lái)考慮測量計量溯源性傳遞中的系統測量誤差。
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)驗室報告測量標準的信息中,如果只有與規范的符合性聲明(省略了測量結果和相關(guān)不確定度),該測量標準有時(shí)也可用于傳遞計量溯源性,其規范限是不確定度的來(lái)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:
——使用適當的判定規則確定符合性;
— the use of an appropriate decision rule to establish conformity;
——在后續的不確定度評估中,以技術(shù)上適當的方式來(lái)處理規范限。
— the specification limits subsequently being treated in a technically appropriate way in the uncertainty budget.
此方法的技術(shù)基礎在于與規范符合性聲明確定了測量值的范圍,并預計真值以規定的置信度處于該范圍內,該范圍考慮了真值的偏倚以及測量不確定度。
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:使用國際法制計量組織(OIML)R111各種等級砝碼校準天平。
EXAMPLE  The use of OIML R 111 class weights to calibrate a balance.
A.3 證明計量溯源性Demonstrating metrological traceability
A.3.1 實(shí)驗室負責按本準則建立計量溯源性。符合本標準的實(shí)驗室提供的校準結果具有計量溯源性。符合 ISO 17034 的標準物質(zhì)生產(chǎn)者提供的有證標準物質(zhì)的標準值具有計量溯源性。有不同的方式來(lái)證明與本標準的符合性,即第三方承認(如認可機構)、客戶(hù)進(jìn)行的外部評審或自我評審。國際上承認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(guò)適當同行評審的國家計量院及其指定機構提供的校準和測量能力。該同行評審是在國際計量委員會(huì )相互承認協(xié)議(CIPM MRA)下實(shí)施的。 CIPM MRA所覆蓋的服務(wù)可以在國際計量局的關(guān)鍵比對數據庫(BIPM KCDB)附錄C中查詢(xún),其給出了每項服務(wù)的范圍和測量不確定度。
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)驗室認可合作組織(ILAC)協(xié)議或ILAC承認的區域協(xié)議的認可機構認可的校準和測量能力能夠證明具有計量溯源性。獲認可的實(shí)驗室的能力范圍可從相關(guān)認可機構公開(kāi)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 當需要證明計量溯源鏈在國際上被承認的情況時(shí),BIPM、OIML(國際法制計量組織International Organization of Legal Metrology)、ILAC和ISO關(guān)于計量溯源性的聯(lián)合聲明提供了專(zhuān)門(mén)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(zhù)管理體系的廣泛應用,日益需要實(shí)驗室運行的管理體系既符GB/T 19001,又符合本標準。因此,本標準提供了實(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(jiàn)8.1.2)給出了實(shí)施實(shí)驗室管理體系的最低要求,其已納入GB/T 19001中與實(shí)驗室活動(dòng)范圍相關(guān)的管理體系所有要求。因此,符合本準則第4條款至第7條款,并實(shí)施第8條款方式A的實(shí)驗室,其運作也基本符合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(jiàn)8.1.3)允許實(shí)驗室按照GB/T 19001的要求建立和保持管理體系,并能支持和證明持續符合第4條款至第7條款的要求。因此實(shí)驗室實(shí)施第8條款的方式B,也是按照GB/T 19001運作的。實(shí)驗室管理體系符合GB/T 19001的要求,并不證明實(shí)驗室在技術(shù)上具備出具有效的數據和結果的能力。實(shí)驗室還應符合第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行,以及符合第4條款至第7條款的要求方面達到同樣的結果。
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和其他管理體系標準,文件、數據和記錄是成文信息的組成部分。8.3條款規定文件控制。8.4條款和7.5條款規定了記錄控制。7.11條款規定了有關(guān)實(shí)驗室活動(dòng)的數據控制。
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)驗室運作過(guò)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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