TCVN TIEU CHUAN QUOC GIA TCVN ISO/IEC 17025:2017 ISOMEC 17025:2017 Xuat ban lan 3 YEU CAU CHUNG VE NANG LUC CUA CAC PHONG THU’ NGHIEM VA HIEU CHUAN General requirements for the competence of testing and calibration laboratories HA NOI - 2017TCVN ISO/EC 17025:2017 Muc luc Lai néi dau. Loi gidi thigu.... 1 2 3 4 Phu Ive A (tham khdo) Lién két chuan do lwéng Phy Iyc B (tham khdo) Cc la chon ddl voi hg théng quan I. Thu myc tai ligu tham khéo.. Pham vi ap dung Tai ligu vién dan.. ‘Thuét ng@ va dinh nghia ‘Yéu cau chung... 4.1. Tinh khéich quan 42 Bao mét... ‘Yeu cau vé co cdu.. Yéu cau vé nguén lye. 6.1 Yéu cdu chung 6.2 Nhén sy 6.3 Co sé vat chat va diéu kin mdi trerdng ... 6.4 Thiét bj 6.5 Lién két chuan do luong 6.6 San phdm va dich vy do bén ngoai cung cdp_ Yéu cau vé qué trinh.. 7.4 Xem xét yéu cau, d8 nghi thu va hop dng 7.2 Lua chon, kiém tra xéc nhan va xac nhn gid trj si’ dyng cla phueng phap 7.3 Ldy ma 7.4 Xie ly déi twgng thir nghiém hode higu chuas 7.5 HO so ky thuat. 7.6 Banh gia 66 khong dam bao do. 7.7 Bam bao gia tri sir dung cla két qua. 7.8 Bao cdo kat qua.. 7.9 Khiéu nai.. 7.40 Céng viée khéng phit hop ... 7.11. Kidm soat dtr ligu — Quan ty thong ti Yéu cau hé thong quan ly. 81 Cac lya chon... 8.2 Tailigu hé théng quan ly (Luva chon A).. 8.3 Kiém soat tai liu hé théng quan ly (Lya chon A) 8.4 Kiém sot hd so ( Lira chon A).. 8.5 Hanh dGng dé gidi quyét ri ro va co’ hgi (Lya chon A} 8.6 Caitién (La chon A) 8.7 Hanh dong khde phyc (Lyra chon A). 8.8 Banh gid ngi bd (Lya chon A) 8.9 Xem xét ctia Idinh dao (Lyra chon A)..TCVN ISONEC 17025:2017 Table of content Foreword Introduction 1 Scope. 2 Normative references. 3 Terms and definitions . 4 General requirements.. 4.1 Impartiality. 42 Confidentiality Structural requirements 6 Resource requirements. 6.1 General. 6.2 Personnel . 6.3 Facilities and environmental conditions 64 Equipment. 6.5 Metrological traceability... 6.6 Externally provided products and services... 7 Process requirements. 7.1. Review of requests, tenders and contracts 7.2 Selection, verification and validation of methods 7.3 Sampling... 7.4 Handing of test or calibration items. 7.5 Technical records 7.8 Evaluation of measurement uncertaint 7.7 Ensuring the validity of results... 7.8 Reporting of results 7.8 Complaints 7.10 Nonconforming work... 7.11 Control of data — Information management 8 Management system requirements. 8.1. Options... 8.2 Management system documentation (Option A) 8.3 Control of management system documents (Option A). 8.4 Control of records (Option A) 8.6 Improvement (Option A) 8.7 Corrective action (Option A).. 8.8 Internal audits (Option A) 8.9 Management reviews (Option A). Annex A (informative) Metrological traceabilty.. Annex B (informative) Management System Option Bibliography aTCVN ISONEC 17025:2017 Loi néi dau TCVN ISO/IEC 17026:2017 thay thé cho TCVN ISO/IECT 17025:2007. TCVN ISONEC 17025:2017 hoan toan tuong duong voi ISONEC 17025:2017. TCVN ISONEC 17025:2017 do Ban ky thuat Tiéu chudn Quéc gia TCVN/CASCO Dénh gid sy phd hop bién soan, Téng cye Tiéu chudn Bo long Chat Iueng dé nghi, BO Khoa hoe va Cong nghé céng boTCVN ISO/IEC 17025:2017 Loi gi6i thigu Tiéu chun nay duge xay dung nham thuc day sv tin cay trong hoat dgng cila cdc phéng thi nghiém. Tiéu chudn nay bao gdm cae yéu cau déi voi phong thi nghiém, gitp phéng thi nghiém ching to minh hoat dng ¢6 nang lve va ¢6 kha nang cung cap cac két qua cé gid tri si dung. Noi chung, cac phdng thi nghiém tuan theo tiéu chudin nay cing sé van hanh theo cdc nguyén tée cla TCVN ISO 9001. Tiéu chuan nay yeu cau phong thi nghigm hoach dinh va thyc hién cac hanh déng nham giai quyét Tdi ro va co hdi. Viée gidi quyét cd ri ro va co hoi ta0 co sé cho vig nang cao higu le cla he théng quan ly, dat duoc cac két qué tt hon va gan ngira nhing anh hudng tiéu cc. Phong thi nghiém chiu trach nhiém déi véi viée quyét hing rili ro va cor hdi nao can duge gidi quyét. Vide sir dung tigu chudn nay sé tao thuan Igi cho sy hgp tac gitra céc phang thi nghigm va c&c oo quan khac, hé try trong viée trao adi théng tin va kinh nghiém va trong viée hai hoa cdc tiéu chuan va thi tuc. Vige ch4p nhan két qua gitra cdc nude fing sé thuan igi khi cde phong thi nghigm déu tuan theo tiéu chudn nay. Trong tiéu chudn nay, tt: — — “phai* chi mét yéu cau; = “can/nén” chi mot khuyén nghi; = "duge phép” chi sy cho phép; “c6 thé* chi mOt kha nang hodc nang lye. Voi mye dich nghién oiru, khuyén khich nguéi ding chia s@ quan diém cila minh vé tigu chudn nay va cdc néi dung wu tién thay ddi trong nhing phién ban tigp theo, Bam vao lién két sau dé tham, gla khdo sat tryc tuyén: 17025 _ed3_usersurvey Introduction This document has been developed with the objective of promoting confidence in the operation of laboratories. This requirements for laboratories to enable them to demonstrate they operate competently, and are able to generate valid results. Laboratories that document contains conform to this document will also operate generally in accordance with the principles of ISO 9001. This document requires the laboratory to plan and implement actions to address risks opportunities. Addressing both opportunities establishes a basis for increasing the effectiveness of system, achieving improved results and preventing negative effects, The laboratory is responsible for deciding which risks and opportunities need to be addressed. The use of this document will faciitate cooperation between laboratories and other bodies, and assist in the exchange of information and experience, and risks and the management and in the harmonization of standards and procedures. The acceptance of results between countries is facilitated if laboratories conform to this document. In this document, the following verbal forms are used: - “shall” indicates a requirement; - “should” indicates a recommendation; - *may’ indicates a permission; - “can” indicates a possibility or a capability. For the purposes of research, users are encouraged to share their views on this document and their priorities for changes to future editions, Click on the link below to take part in the online survey: 17025 ed3_usersurveyTIEU CHUAN QUOC GIA * NATIONAL STANDARD TCVN ISO/IEC 17025:2017 Yéu cau chung vé nang lye cia phong tht nghiém va hiéu chuan General requirements for the competence of testing and calibration laboratories 1 Pham vi 4p dung Tiéu chudn nay quy dinh céc yéu cdu chung vé ‘nang lye, tinh khach quan va tinh nhat quan trong hoat dong cla céc phéng thi nghiém (xem 3.6). Tiéu chuan nay 4p dyng cho tat cA cc t8 chive thye hign hoat dong thi nghiém, khong phan biét vé 86 lurgng nhan vién. Khach hang cla phong thi nghiém, co quan quan ly, cc t chire va cdc churong trinh st dung danh gia déng dang, cac t8 chirc céng nhan va cac t6 chize khde si dung tiéu chudn nay trong viée xc nhan hode thiva nhan nang lye cia cdc phong thi nghiém. 2 Tailigu vign din Cac tai ligu vién dan du6i day rt can thiét cho viée &p dyng tiéu chudn nay. Béi voi céc tai ligu ghi n&im e6ng bé thi 4p dung ban duge néu. Ddi véi cc tai figu khong ghi nam céng bé thi dp dung ban méi nhat (bao gdm ca céc siva Adi). TCVN 6165, Tir vung quéc té vé do luong hoc — Céc khai niém, thuét nga chung va co ban (VIM)” ‘Tai ligu nay eBing duge bidt @én gidng nh YOGM 200 1 Scope This document specifies the general requirements for the competence, impartiality and consistent operation of laboratories (see 3.6). This document is applicable to all organizations performing laboratory activities, regardless of the number of personnel, Laboratory customers, and assessment, accreditation bodies, and others use regulatory authorities, organizations schemes using _peer- this document in confirming or recognizing the competence of laboratories. 2 Normative references The following documents are referred to in the text jin such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISOMEC Guide 99 International vocabulary of metrology — basic and general concepts and associated terms (VIM)TCVN ISO/IEC 17025:2017 3 Thuat ngir va dinh nghia Tiéu chudn nay ap dung céc thuét ng va dinh nghia trong TCVN 6165, TCVN ISO/EC 17000 va cc thuat ng& va dinh nghia dudi day. ISO va IEC cing duy tri co sé dé liéu vé thuat ngi str dung trong tiéu chudn héa & dia chi sau: - Nén trinh duyét trvc tuyén cia ISO: httpvwww.iso.ora/obp + Bach khoa ign ty la—IEC: httpu/www.electropedia.org Khi ¢6 nhiéu dinh nghia cho clung mét thual ngi, thi vu {ign s& dung dinh nghfa trong TCVN ISO/IEC 17000 va TCVN 6165, 3.1 Tinh khach quan Sy thé hign cda tinh vo tu. CHU THICH 1: V6 tu 6 nghfa fa khéng od xung d6t vé Igi Ich hogc xung d6t Igi Ich duge gidi quyét sao cho khong anh hydng bat igi dén c4c hoat dong sau 66 cla hang thi nghiém (3.6). CHU THICH 2: Cac thuat ng khéc 06 thé dung 42 truyén tai dc trung cla tinh khéch quan la: “khong o6 xung Gt Igi ich’, “khong thién lech", "khéng thanh kién’, “trung lap", “cng bang’, “coi ma”, “khéng thién vi’, “tach bach’, “can bang’. [Ngudn: TCVN ISOMEC 17021-1:2019, 3.2 dugc siva déi — Tir “té chire chtng nhan’ dug thay bang “phong thi nghiém" trong Chi thich 1 va tu “doc lap" trong Cho thich 2 duge bd] 3.2 Khiéu nai Vigc thé hién sy khong hai long cua cé nhan hode (6 chire bat ky déi voi phong thi nghiém (3.8), lien quan dén hoat dong hod két qua cla phdng thi nghiém dé, voi mong muén duge dép lai. 3 Terms and definitions For the purposes of this document, the following terms and definitions given in ISO/IEC Guide 99 and ISO/IEC 17000 and the following apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at http://www.iso.ora/obp IEC Electropedia: httpu/www.electropedia.org available at Where there is more than one definition for the same term, the definitions in ISOMEC 17000 and ISO/IEC Guide 99 take precedence. 3.1 impartiality presence of objectivity Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory (3.6). Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “freedom from confict of interests", “freedom from bias”, “lack of prejudice’, *neutrality’, “faimess, “open-mindedness", “even-handedness’, “detachment, “balance”. (SOURCE: ISOMEC 17021-12015, 3.2 modified - The words “certification body” have been replaced by “laboratory” in Note 1 to entry, and the word “independence” has been deleted from the list in Note 2 to entry] 3.2 complaint expression of dissatisfaction by any person or organization to a faboratory (3.6), relating to the activities or results of that laboratory, where a response is expected[Ngudn: TCVN ISONEC 17000:2007, 6.5 duge siva déi - Tir "khéng phai fa yeu cdu xem xét lai” duge bd va tir 3 chi d4nh gia sy phil hop hode 18 chirc cong nhan, lién quan dén hoat d6ng ctla 16 chic 46" duge thay bing “phéng thi nghim, lign quan én hoat dng hoac két qua cia phong thi nghiém 6} 3.3 So sénh lign phong Vide t6 chive, thyc hién va danh gid cdc phép do hodc phép thir trén cling déi tveng hoae trén aéi tong tuong ty nhau béi hai hay nhiéu phdng thi nghiém theo nhtng diéu kign dinh treée. INGUON: TCVN ISONEC 17043:2011, 3.4] 3.4 So sanh ngi bé phong thi nghigm Viée 16 chite, thc hign va danh gia cdc phép do hoae phép thir trén cling mau thir hode tren mau thr tong tw nhau trong cling mot phéng thi nghiém (3.6) theo nhieng diéu kién x4c dinh truéc. 3.5 Thi nghigm thanh thao Danh gid viée thy hign olia oc bén tham gia theo tiéu chi da dugc thiét lap thong qua so sanh lién phong (3.3). INGUON: TCVN ISO/IEC 17043:2011, 3,7 duge sia ddi- Bé chi thich} 3.6 Phong thi nghigm TS chic thyc hién mét hay nhiu hoat déng sau: = thir nghigm + higu chuan = lay mau, lién quan dén viée thir nghiém hoac higu chuan sau do CHU THICH 1: Trong b6i can ca tiéu chudn nay, ti “hoat dong thi nghigm* 48 cap dén ba hoat dong néu TCVN ISONEC 17025:2017 [SOURCE: ISONEC 17000:2004, 6.8, modified — ‘The words “other than appeal” have been deleted, and the words “a conformity assessment body or accreditation body, relating to the activities of that body’ have been replaced by “a laboratory, relating to the activities or results of that laboratory") 3.3 interlaboratory comparison organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions (SOURCE: ISONEC 17043:2010, 3.4] 3.4 intralaboratory comparison organization, performance and evaluation of measurements or tests on the same or similar items, within the same laboratory (3.6), in accordance with predetermined conditions 3.5 proficiency testing evaluation of participant performance against pre- established criteria by means of interlaboratory comparisons (3.3) {SOURCE: ISONEC 17043:2010, 3.7, modified — Notes to entry have been deleted) 3.6 laboratory body that performs one or more of the following activities: ~ testing = calibration — sampling, associated with subsequent testing or calibration Note 1 to entry: in the context of this document, “laboratory activities’ refer to the three above-TCVN ISONEC 17025:2017 tren, 3.7 Quy tac ra quyét dinh Quy te néu cach thive 46 khéng dam bao éo duge tinh dén khi két luan sy phU hop voi mét yéu cau xae dinh, 3.8 Kiém tra xac nhan Viéc cung cdp bang chieng khach quan rang déi twong 64 cho dap tng cdc yéu cau quy dinh, ‘VI DY 1: Xée mhan rang mau chudn 48 cho theo yéu edu la ddng nhat 664i v6i gid tr dai Iugng va thi tye do. lin quan, khi gim phan chia do luting toi khdi lung 10mg Vi DY 2: X4c nhan rang cac tinh nang hoae yeu cau phap dinh cia mgt h@ théng do 1 dat duc. VI DU 3: Xéc nhén ring 4} khdng dam bao do muc titu 18.06 thé phi hop, CHU THICH 1: Khi co thé ap dung, 46 khong dam bao do can duge dura vao dé xem xét, CHU THICH 2: Déi tugng 06 thé 1a, vi dy nhu qua trinh, thd tyc do, vat ligu, hyp chat hoge hé théng do. CHU THICH 3: Cac yéu cu quy inh c6 thé la, vi dy, cdc yéu cdu ky thuat cila nha san xudt duge dap ing. CHU THICH 4: Kiém tra xa¢ nhan/kiém dinh trong do. uéng phép dinh, nhur dinh nghfa trong VIML va trong Ganh gia sy phi hop néi chung, lién quan dén vite kiém tra va gan déu vashoge phat hanh gidy chang nbn kiém dinh cho hé théng do. CHU THICH 5: Khéng duge nham ln kiém tra xac nhan voi higu chun, Khéng o6 bat ctr vige kiém tra xdc. ihn ndo la xée nhin gid tr} sd dung (3.9). CHU THICH 6: Trong hoa hoe, kiém tra xa nhan sy dng nhét ciia thyc thé lién quan, hoc cila hoat tinh cn 66 sy md ta vé cu tric hodc cae tinh chat ola thyc thé ho&c hoat tinh 46. 10 mentioned activities 3.7 decision rule rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement 3.8 verification provision of objective evidence that a given item fulfils specified requirements EXAMPLE 1 Confirmation that a given reference material as claimed Is homogeneous for the quantity value and measurement procedure concerned, down to ‘a measurement portion having a mass of 10 mg. EXAMPLE 2 Confirmation that performance properties or legal requirements of a measuring system are achieved. EXAMPLE 3 Confirmation that target measurement uncertainty can be met. Note 1 to entry: When applicable, measurement uncertainty should be taken into consideration. Note 2 to entry: The item may be, for example, a process, measurement procedure, material, compound, ‘or measuring system. Note 3 to entry: The specified requirements may be, for example, that a manufacturer's specifications are met. Note 4 to entry: Verification in legal metrology, as defined in VIML, and in conformity assessment in general, pertains to the examination and marking andlor issuing of a verification certificate for a measuring system. Note 5 to entry: Verification should not be confused with calibration. Not every verification is a validation (29). Note 6 to entry: In chemistry, verification of the identity of the entity involved, or of activity, requires a description of the structure or properties of that entity or activity.INGUON TCVN 6165:2009, 2.44, duge sira ddi thuat ng@ “kiém dinh” duge thay bang *kiém tra xée nhan’} 3.9 X4c nh4n gia tri si dung Kiém tra xée nhén (3.8), trong 46 céc yéu cdu quy inh Ja thoa dang cho vige si dung 44 dinh. ‘Vi DY: Mdt tha tye do, thuting duge six dyng cho phep do ning 46 khéi lrgng nite trong nuec, ofing 6 thé ‘duge xéc nhgn gid ti sir dung cho phép do trang huyat thanh ngudi. 4° Yéu cau chung 44 Tinh khach quan 4.4.1 Hoat dng thi nghiém phai duge thy hien mét cach khach quan va phai duge 18 chire va ‘quan ly sa0 cho dam bao tinh khach quan. 4.1.2 Lanh dao phong thi nghigm phai cam két vé tinh khach quan. 4.1.3 Phong thi nghigm phai chiu trach nhiém aéi \véi tinh khéch quan trong céc hoat déng cila minh va khéng duge cho phép cdc Ap lye thong mai, tai chinh hoge cae 4p Ive Khac lam anh hudng én tinh khach quan. 4.4.4 Phong thi nghiém phi nhan dién cae rbi ro 6i v6i tinh khach quan cia minh mét cach lién uc. Bidu nay phai bao gm cae nit ro nay sinh ti cdc hoat déng hode tir cc méi quan hé ola phong thi nghiém hay cae mdi quan hé cla nhdn sy oila phéng thi nghiém. Tuy nhién, cae méi quan hé nay khéng nhét thiét thé hién phdng thi nighiém c6 ri ro d6i véi tinh khdch quan, CHU THICH: Méi quan hé de doa tinh khach quan cla phong thi nghiém od thé do quyén sé hiru, sy diéu hanh, quan ly, nhan sy, chia sé ngudn luc, tai chinh, hp déng, marketing (gém cd xSy dung nhan hiéu) va chi tra hoa héng hay chi tré khac cho viéc gidi thiéu TCVN ISO/IEC 17025:2017 (SOURCE: ISONEC Guide 99:2007, 2.44) 3.9 validation verification (3.8), where the specified requirements are adequate for an intended use EXAMPLE A measurement procedure, ordinarily used for the measurement of mass concentration of nitrogen in water, may be validated also for measurement of ‘mags concentration of nitrogen in human serum. 4 General requirements 4.1 Impartiality 41.4 Laboratory activities shall be undertaken impartially and structured and managed so as to safeguard impartiality. 4.1.2. The laboratory management shall be committed to impartiality. 4.1.3 The laboratory shall be responsible for the impartiality of its faboratory activities and shall not allow commercial, financial or other pressures to ‘compromise impartiality. 4.1.4 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. 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 @ sales commission or other inducement for the "TCVN ISOMEC 17025:2017 khdch hang méi... 4.1.5 Khi mét rai ro déi voi tinh khdch quan duge han dién, phong thi nghigm phai co kha nang ching té cdch thire loai bd hodc giam thiéu rai ro 6. 42 Bao 4.2.1 Bang cdc cam két c6 gid tri phap ly, phong thi nghiém phai chiu tréch nhiém a6i véi viée quan ly tt c cdc théng tin duge thu duge hoae tao ra trong qua trinh thuc hign cae hoat dong thi nghiém. Phong thi nghiém phai théng béo true cho khach hang, vé cdc théng tin diy dinh cdng Khai, Ngogi tri thng fin ma khach hang cing khei ho&e khi 68 dugc phdng thi nghigm va khdch hang théng nhat (vi dy voi myc dich dap Gng khiéu nai), tt cd cae théng tin khac déu duge coi 1a ti sn théng tin cla khach hang va phai duge coi la bi mat. 4.2.2 Khi phong thi nghigm theo yéu cau cila luat phap ho&e duoc uy quyén theo théa thuan hop dng a8 cung cdp thong tin bi mat, thi khach hang hoe c@ nhén cé lién quan phai duge thong béo vé théng tin dugc cung cp, trir trudng hop luat phap ngan cdm. 4.2.3 Théng tin vé khdch hang thu duge tir cae nguén khéng phai la khach hang (vi du: bén khiéu nai, co quan quan ly) phai duce git bi mét gitva khdch hang va phéng thi nghiém. Ngudn cung cap théng tin nay phai due phdng thi nghiém git bi mat va khéng duge chia sé voi khach hang, trv khi dug ngudi cung c4p thong tin dong y. 4.2.4 Nhan su, bao gém moi thanh vién cla cac ban, c4¢ nha thdu, nhan sy cita céc (6 choc bén ngoai hogc céc c& nhan hoat ééng véi danh nghia ‘ta phéng thi nghiém phai gif bi mat tat ca cdc 12 referral of new customers, ete. 44.5 If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it eliminates or minimizes such risk, 4.2 Confidentiality 44.1 The laboratory shall through legally enforceable commitments, for the be responsible, 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. 4.2.2 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 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. 42.4 Personnel, any committee members, contractors, personnel of external bodies, or individuals acting on the laboratory's behalf, shall keep confidential all information includingthéng tin thu duege hode tao ra trong qué trinh thyc hign c&c hoat dong thi nghigm, trix khi dye luat phdp yéu cau. 5 Yéu cau vé co cdu 5.4 Phang thi nghiém phai la mét phap nhn, ho&e mét bd phan xée inh cia phap nh&n, chiu trach nhiém phap ly déi voi cac hoat déng thi nghiém cia minh, CHU THICH: Trong tiéu chuan nay, phong thi nghiém cha nha nuée durge coi la mot php nhan trén cor sé vi tri ca phong thi nghiém trong hé théng t8 chire chinh quyén. 5.2 Phang thi nghiém phai xéc dinh nguéi lanh dgoingudi quan ly chiu hoan toan trach nhigm déi vei phong thi nghigm. 5.3 Phong thi nghiém phai xac dinh va lap thanh van ban pham vi cdc hoat déng thi nghiém dap ing tiéu chuan nay. Phong thi nghiém chi duge c6ng bd sy ph hop vai tisu chudn nay déi voi pham vi hoat déng thi nghiém nay va pham vi hoat Gong khéng bao gém cdc hoat dng thi nghiém do bén ngoai cung cdp mét cach thudng xuyén. 5.4 Cac hoat dong thi nghiém phai dugc thyc hin sao cho dap trng cac yéu cau olla tiéu chudn nay, cia khach hang cila phong thi nghiém, cla co quan quan ly va cla ede td chive thye hién viée thira nh4n. Diu nay phai bao gdm céc hoat déng thi nghiém duge thyc hign tai t&t c c&c co sé thuéng xuyén cla phong thi nghiém, cdc dia diém nam ngoai co sé thudng xuyén, c&c oo sé’ tam thoi hoac di dong cé lién quan hoa tai co’ sé clia khach hang. 5.5 Phong thi nghigm phi: a) x4 dinh co cdu td chire va quan ly cia phong thi nghiém, vi tri cilia n6 trong té chire me va céc méi quan hé gidta céc hoat déng quan Ij, TCVN ISONEC 17025:2017 obtained or created during the performance of laboratory activities, except as required by law. 5 Structural requirements 5.1 The laboratory shall be a legal entity, or a defined part of a legal entity, that is legally responsible for its laboratory activities. NOTE For the purpose of this document, a governmental laboratory is deemed to be a legal entity con the basis of its governmental status. 5.2 The laboratory shall identify management that has overall responsibilty for the laboratory. 5.3 The laboratory shall define and document the with this document. The laboratory shall only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis. 5.4 Laboratory activities shall be carried out in such a way as to meet the requirements of this document, the laboratory's customers, regulatory and organizations providing recognition. This shall include taboratory activities performed in all its permanent facilities, at sites authorities away from its permanent facilities, in associated temporary or mobile faciities or at @ customer's facility. 5.5 The laboratory shall a) define the organization and management structure of the laboratory, its place in any parent organization, and the relationships 13