ISO/IEC 17025:2017《檢測和校準(zhǔn)實(shí)驗(yàn)室能力的通用要求》通用要求
更新日期:2023-03-16 10:15:16 已瀏覽:3412次
中國合格評定國家認(rèn)可委員會(英文縮寫:CNAS)等同采用ISO/IEC 17025:2017《檢測和校準(zhǔn)實(shí)驗(yàn)室能力的通用要求》 作為對檢測和校準(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。
申請CNAS認(rèn)可的實(shí)驗(yàn)室應(yīng)同時(shí)滿足本準(zhǔn)則以及相應(yīng)領(lǐng)域的應(yīng)用說明。
本準(zhǔn)則內(nèi)容及條款號與國際標(biāo)準(zhǔn) ISO/IEC 17025:2017內(nèi)容及條款號完全一致。CNAS鼓勵(lì)申請認(rèn)可的機(jī)構(gòu)購買和使用正版國際和國家標(biāo)準(zhǔn)。
4 通用要求General requirements
4.1 公正性Impartiality4.1.1 實(shí)驗(yàn)室應(yīng)公正地實(shí)施實(shí)驗(yàn)室活動(dòng),并從組織結(jié)構(gòu)和管理上保證公正性。
Laboratory activities shall be undertaken impartially and structured and managed so as to safeguard impartiality.
4.1.2 實(shí)驗(yàn)室管理層應(yīng)作出公正性承諾。
The laboratory management shall be committed to impartiality.
4.1.3 實(shí)驗(yàn)室應(yīng)對實(shí)驗(yàn)室活動(dòng)的公正性負(fù)責(zé),不允許商業(yè)、財(cái)務(wù)或其他方面的壓力損害公正性。
The laboratory shall be responsible for the impartiality of its laboratory activities and shall not allow commercial, financial or other pressures to compromise impartiality.
4.1.4 實(shí)驗(yàn)室應(yīng)持續(xù)識別影響公正性的風(fēng)險(xiǎn)。這些風(fēng)險(xiǎn)應(yīng)包括實(shí)驗(yàn)室活動(dòng)、實(shí)驗(yàn)室的各種關(guān)系,或者實(shí)驗(yàn)室人員的關(guān)系而引發(fā)的風(fēng)險(xiǎn)。然而,這些關(guān)系并非一定會對實(shí)驗(yàn)室的公正性產(chǎn)生風(fēng)險(xiǎn)。
The laboratory shall identify risks to its impartiality on an on-going basis. This shall include those risks that arise from its activities, or from its relationships, or from the relationships of its personnel. However, such relationships do not necessarily present a laboratory with a risk to impartiality.
注:危及實(shí)驗(yàn)室公正性的關(guān)系可能基于所有權(quán)、控制權(quán)、管理、人員、共享資源、財(cái)務(wù)、合同、市場營銷(包括品牌推廣)、支付銷售傭金或其他引薦新客戶的傭金。
NOTE A relationship that threatens the impartiality of the laboratory can be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales commission or other inducement for the referral of new customers, etc.
4.1.5 如果識別出公正性風(fēng)險(xiǎn),實(shí)驗(yàn)室應(yīng)能夠證明如何消除或最大程度降低這種風(fēng)險(xiǎn)。
If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it eliminates or minimizes such risk.
4.2 保密性Confidentiality
4.2.1 實(shí)驗(yàn)室應(yīng)通過作出具有法律效力的承諾,對在實(shí)驗(yàn)室活動(dòng)中獲得或產(chǎn)生的所有信息承擔(dān)管理責(zé)任。實(shí)驗(yàn)室應(yīng)將其準(zhǔn)備公開的信息事先通知客戶。除了客戶公開的信息,或當(dāng)實(shí)驗(yàn)室與客戶有約定時(shí)(例如為回應(yīng)投訴的目的),其他所有信息都被視為專有信息,應(yīng)予以保密。
The laboratory shall be responsible, through legally enforceable commitments, for the management of all information obtained or created during the performance of laboratory activities. The laboratory shall inform the customer in advance, of the information it intends to place in the public domain. Except for information that the customer makes publicly available, or when agreed between the laboratory and the customer (e.g. for the purpose of responding to complaints), all other information is considered proprietary information and shall be regarded as confidential.
實(shí)驗(yàn)室應(yīng)有遵守軍工產(chǎn)品、國防科技工業(yè)保密的有關(guān)規(guī)定。
4.2.2 實(shí)驗(yàn)室依據(jù)法律要求或合同授權(quán)透露保密信息時(shí),應(yīng)將所提供的信息通知到相關(guān)客戶或個(gè)人,除非法律禁止。
When the laboratory is required by law or authorized by contractual arrangements to release confidential information, the customer or individual concerned shall, unless prohibited by law, be notified of the information provided.
4.2.3 實(shí)驗(yàn)室對于從客戶以外的渠道(如投訴人、監(jiān)管機(jī)構(gòu))所獲取的有關(guān)客戶的信息,應(yīng)在客戶和實(shí)驗(yàn)室間保密。除非信息的提供方同意,實(shí)驗(yàn)室應(yīng)為信息提供方(來源)保密,且不應(yīng)告知客戶。
Information about the customer obtained from sources other than the customer (e.g. complainant, regulators) shall be confidential between the customer and the laboratory. The provider (source) of this information shall be confidential to the laboratory and shall not be shared with the customer, unless agreed by the source.
4.2.4 人員,包括委員會委員、簽約人員、外部機(jī)構(gòu)人員或代表實(shí)驗(yàn)室的個(gè)人,應(yīng)對在實(shí)施實(shí)驗(yàn)室活動(dòng)過程中獲得或產(chǎn)生的所有信息保密,法律要求除外。
Personnel, including any committee members, contractors, personnel of external bodies, or individuals acting on the laboratory’s behalf, shall keep confidential all information obtained or created during the performance of laboratory activities, except as required by law.