TCVN TIEU CHuAN QUaC GIA TCVN ISO/IEC 17025:2017 ISO/IEC 17025:2017 Soat xet Ian 3 YEU cAu CHUNG VE NANG LU'C . cAc PHONG THO' NGHIEM . vA HIEU . CHuAN General requirements for the competence of testing and calibration laboratories HA NOI- 2017 TCVN ISOIlEe 17025:2017 MlJc Iuc Lai noi d~u 5 Lai gi&i thi~u 6 1 Pharn vi ap dl,lng 7 2 Tiii li~uvi~nd§n 7 3 Thu:\lt ngCPva dinh nghia Yeu cau chung 8 11 4.1 Tinh khachquan 11 4.2 Sao m~it Yeu cau v~ co c~u 12 Yeu cau v~ ngu6n life 6.1 Yeu cau chung 6.2 Nhan SI)' 15 15 15 6.3 CO'sO>v~t chat va oi~u ki~n moi truang 6.4 Thi~t bi 16 17 6.5 Lien k~t chuan do ILPang 6.6 San ph§m va djch Vl,I do ben ngoai cung clip Yeu cau v8 qua trlnh 7.1 Xem xet yeu c§u, d8 nghj th~u va hop <l6ng 7.2 Lila chon, ki~m tra xac nh~n va xac nh~n gia tri sti dt,mg cua phLPO'ngphap 20 22 23 23 25 4 5 6 7 13 L~y mc1u Xli' Iy aOi tLPQ'ngthl) nghi~m ho~c hi~u chuan H6 so ky thu~t. £>f:lnhgia d9 khong dam bao do Dam baa gia trj sti dl,lng clla k~t qua 7.8 Bao cao kElt qua 31 32 32 34 7.9 Khi~u n<ili 41 7.10 Cong vi~c khong phu hQ'p 42 7.11 Ki~m soat dii Ii~u - Quan Iy thOng tin Yeu c~u h~ thong quan 19' : 43 45 8.1 Cac It)'a·.chQn 8.2 Tai Ii~uh~ thong quan Iy (Lila chQn A) 45 7.3 7.4 7.5 7.6 7.7 8 8.3 Ki~m soat liJi Ii~u M thong quan 19(Lva 29 30 , 46 : chQn A) : 46 47 8.4 Ki~m soat h6 sO'( Lila chon A) : 8.5 Hfmh aC)nga~giai quy~t rui ro va cO'h9i (Lila chQn A) .48 8.6 Cai tj~n (Lila chon A) 49 8~7 Hanh 09ng khac phl,lc (Lila chon ~) 8.8 Danh gia nQi be:'> (Ll)'a chon A) 49 : 50 8.9 Xem xet cua lanh d~o (Ll)'a chon A) 51 Phl,l It,lcA (tham khao) Lien k~t chuan ao.ILPung 53 Pht,l It,lcB (tham kMo) Cae Ilia chon dOi vai hlf!thOng quan ThLPmJ,lclei Ii~u tham khao . Iy 56 . 59 3 TCVN ISOIIEC 17025:2017 Table of content Foreword Introduction 1 Scope, 2 Normativereferences 3 Terms and definitions 4 General requirements : " ",." , 4.1 Impartiality 5 6 7 ,.:." 6.4 Equipment 6.5 Metrological·traceability : 6.6 Externally provided products and services Process requirements 7.1 Review of requests, tenders and contracts 7.2 Selection, verification and validation of methods 7.3 Sampling Handling of test or calibration items Technical records Evaluation of measurement uncertainty Ensuring the validity of results Reporting of results 7.9 Complaints 7.10 Nonconforming work 7.11 Control of data -Information management Management system requirements 8.1 Options 8.2 Management system documentation {Option A) B.3 Control of management system documents (Option A) 8.4 Control of records (Option A) Improvement (Option A) Corrective action (Option A) Internal audits (Option A) Management reviews (Option A) 11•••••••••••••••• 11•••• 11••••••••••••••••• : 4.2 Confidentiality Structural requirements : Resource requirements : 6.1 General 6.2 Personnel 6.3 Facilities and environmental conditions 8.6 8.7 8.8 8.9 11•••• 7 8 11 7.4 7.5 7.6 7.7 7.8 8 5 6 7 11 12 13 15 : ~ , 15 .. 15 16 ~ 17 20 22 23 23 25 29 30 31 32 32 34 41 42 43 45 45 46 .46 47 49 . 49 50 51 Annex A (informative) Metrological traceability 53 Annex B (informative) Management System Options 56 Bibliography 59 4 TCVN ISOllEe 17025:2017 l(yj 061 dau TCVN ISOIIEC 17025:2017 thay th~ cho TCVN ISOIIEC 17025:2007. TCVN ISOIIEC 17025:2017 hoan toan tllO'ng dll'O'ng val ISO/IEC 17025:2017. TCVN ISOIIEC 11025:2017 do Ban Ou6c gia TCVN/CASCO f);!mh gill ky thu~t Treu chuan Sv phli htlP bien soan, T6ng eve Tieu chuan Do 11I'c7ngChat 11I'Q'ngd~ nghi. BO Khoa hQC va Cong ngh~ cong bO - I 5 TeVN ISO/lEe 17025:2017 Introduction Tleu chuan nay dlJ'OOc xay dllng nhjjm thuc d~ySl! This document has been developed with the tin c~y trong heat d<)ngcua cac ph6ng thi nghl~m. objectiveof promoting.confidencein the operation Tleu chu€mnay bao gOm cac yeu cau dOl vai phOngthl nghi~m,giup ph6ngthf nghi~m chung to of laboratories. This document contains requirements for laboratories to enable them to minh heat dQngc6 nang h,Ycva c6 kha nang cung demonstrate they operate competently, and are cap cac k~t qua co gia trj sUodl)ng. Noi chung, cac able to generate valid results. Laboratories that phOngthl nghl~m tuan theo tieu chuan nay cOng conform to this document will also operate se v~n hanh theo cac nguyen ~c cua TCVN ISO generally in accordancewith the principlesof ISO 9001. 9001. Tieu chuan nay yeu cau phOngthi nghi~m hoaeh This document requires the laboratory to plan and dinh va thl!C hi~n cac hanh dt}ng nh~m giili quy~t implement rui ro va CCl hQi.Vi~c giai quy~t ca rui ro va CeJ hOi actions opportuhities. to address Addressing both risks and risks and t<;30CCl so cho vi~c nang cao hi~u IIlC cua h~ opportunities.establishesa basis for increasingthe thong quan Iy, dC;ltaLPQ'c cac k~t qua tot hO'nva effectiveness of the ngan nglia nh£1nganh hU'o-ngtieu CI,PC. Phong thi achieving improved management system, results .and preventing nghi~m chju trj3ch nhi~m alli vai vi~c quy~t ojnh negative effects. The ·Iaboratoryis responsiblefor nhung rUiro va CCl hQInao c§n aU'Q'cgilli quy~t. deciding which risks and opportunities need to be addressed. Vi~c SLY dl,lngtieu chu~n nay sa Sl! t1;l0 thu~n lQ'icho The use of this documentwill facilitate cooperation hOOp tac giua .cac ph6ng thf nghi~m va cac CCl between laboratories and other bodies, and assist quan khac, h6 trQ'trong viec trao 06i thong tin va in the exchange of information and experience, kinh nghiem va trong vi~c Mi hoa cac th3Uchuan and in the harmonization of standards and va tM tl,lC.Vi~c chap nh~n k~t qua giua cac nU'cYc procedures. The acceptance of results between cOngsa thu~n lQ'ikhi cac phOngthl nghi~m d~u countries is facilitated if laboratories conform to tuan thea tieu chuan nay. this document. Trong tieu chuan nay. t\}: In this document, the following verbal forms are used: "pMi" chi mQtyeu cau; "shall" indicatesa requirement; "c~n/nen"chi m<)tkhuy~nnghj: Hshould"indicates a recommendation; "aU'Q'c phep"chi Sll cho phep; "may" indicates a permission; "c6 th~·chi mot kha nang hoi;icnang Il;I'c. "-can"indicatesa possibilityor a-capability. Vai mvc aich nghh~ncLm, khuyen khich ngU'oi For the purposes of research, users are dung chia sa quan di~m cua minh v~ tieu chu;~n encouragedto share their views on this document nay va cae nQidung lJ'Utien thay dElitrong nhiYng and their priorities for changes to future editions. phienban ti~p thea. Bclmvao lien k~t sau d~ tham Click on the link below to take part in the online gia'khaosat tr\l'c·tuy~n:17025 ed3 usersurvey survey: 17025 ed3 usersurvey 6 ., .,., TIEU CHuAN Qu6c GIA * NATIONAL STANDARD TCVN ISO/IEC 17025:2017 Yeu efiu chung v~ nang Il}'c ella phong thiP nghi~m va hi~u chuan General requirements for the competence of testing and calibration laboratories 1 Pham vi ap dl,lng 1 Scope Tleu chuan nay quy dinh cac yeu cAu chung vI! This document specifies the general requirements nang hlC, tinh khach quan va tinh nM,t quan trong for the competence. impartiality and consistent heat dong cua cac phong thi nghi~m (xem 3.6). Tleu chu~n nay ap dl,lng cho Ult ca cac to ch(lc operation of laboratories(see 3.6). This document Is applicable to aU organizations thl,l'chi~n hoat dong thi nghi~m, khOng phan bi~t performing laboratory activities, regardless of the v~ 56 IUQ'ngnhan viano numberof personnel. KMch hang cua phong thi nghi~m, C(J quan quan Laboratory customers. regulatory authorities. Iy, cac to ohuc va cac chuang trlnh SLP dl,lngdanh organizations gia d6ng dang, cac t6 chuc and schemes using peer- cong nMn va cac to assessment, accreditation bodies, and others use chuc khac sU>dl,lngtieu chulm nay trong vi~c xac this document in confirming or recogniZing the nMn hoac thLPanhan nang lI,Pccua cac phong thl competenceof laboratories. nghi~m. 2 Tili Ii~uvi~n din 2 Normative references Cac tai Ii~u vien dan dll'Oriday r§.t c§n thi~t cho The following documents are referredto in the text vi~c ap dl,lngtieu chw3n nay. e6i vai cae. tai li~4 in such a way that some or all of their content - . . 'ghi nam cOllg bOthi ap dl,lng ban dll'Q'c nsu. eOi constitutes requirements of this document. For vOricac tili Ii~u khOngghi nam congobOthi ap dl,lng d~ted references, only the edition cited applies. ban mai nhat (baa g6m ca cac slia dOi). For undated references, the latest edition of the referenceddocument (including any amendments) applies. TCVN 6165, Tv vvng qut5ctt! v~ aD lU'r}ng hQC- CaekMi niem, thu~t ngii' chung va C(J ban (VIM)1J ISOIIEC Guide 99 Intemational metrology - vocabulary of basic and general concepts and associated terms (VIM) I) Talli~u nay cQngdU'Q'cbj~t den g16ngnhU'JCGM 200 7 TCVN ISOIIEC 17025:2017 3 va dinh nghia 3 Terms and definitions Thuat ngUo Tleu chuan nay ap dl,mg cac thuat ngCi'va djnh For the purposes of this document, the following nghia trong TCVN 6165, TCVN ISO/IEC 17000 va terms and definitions given In ISO/IEC Guide 99 cac thu~t ngCi'va dlnh nghTadt16'1day. and ISOIlEe 17000 and the following apply. sa dCi'IifiiU v6 thu~t ngli sli dl,lngtrong tieu chuan hoa a dia chl sau: ISO and IEC maintain terminological databases - ISO va IEC cOng duy tr1 00 for use In standardization at the following addresses: N€:n trlnh duy~t tlVc tuy~n cua ISO: http://www.iso.org/obp http://www.iso.org/obp - Bach khoa di~n ISO Online -browsing platform: available at tli cua IEC: IEC Electropedia: available at http://www.electr{)pedia.org http://www.electropedia.org Khi c6 nhi~u d!nh nghTacho cung mOtthu~ ngQr, Where there is more than one definition for the thi t1U tien Sll' dl,lng dinh nghia trong TCVN same term, the definitions in ISO/IEC 17000 and ISO/IEC17000 va TCVN 6165. ISO/IECGuide 99 take precedence. 3.1 Tinh khach quan 3.1 Impartiality SI,I' th~ hi~n cua tlnh vo flr. presenceof objectivity CHOTHlcH 1: VOtil c6 nghia If! khOngc6 xung dQtv~ Note 1 to entry: Objectivity means that conflicts of lQ'ifch ho~c xung dOt lQ'irch dl1Q'cgiai quytlt sao cho Interest do not exist, or are resolved so as not to khong anh hl10ng bAt Ioi d~n cac heat dQngsau d6 cua adversely Influence subsequent activities of phOng thi nghi~m (3.6). laboratory (3.6). CHO THIcH 2: Cac thu~t ngli khac c6 thf, dung d~ Note 2 .to entry: Other terms that are useful in truy~n lal d~c trl1ng cua tinh khach quan 11lI: "khOngc6 conveying the element of Impartiality include "freedom the xung dot lQ'i Icho, "khong thien I~ch·, "khong thcinh from conflict of interests·, ':freedom from bias", "lack of kian", "trung I~p·, ·cong b~ngn,·cCli'!lan, "khOngthlen prejudice", "neutrality", "fairness", ·op~~-r:nLnde~ness·, vi", "tach .b?chn,"can b~ngn. "even-handedness·,"detachment", "balance", -• [NguOn:TCVN ISOIIEC 17021-1:2015, 3.2 dt1Q'c [SOURCE: ISO/IEC 17021-1:2015, 3.2 sua cOi - Tt) "t6 chuc chung nMn" dlJQ'cthay modified - The words ·certification body" have b~ng ·phong thl nghi~m" trang CM thich 1 va tI) been replaced by "laboratory" in Note 1 -to entry, and the word "independence" has been deleted "doc I~p" trong CM thlch 2 dlJQ'Cbe] from the list in Note 2 to entry] 3.2 complaint 3.2 Khi~u n~i ca nhan ho~c expression of dissatisfaction by any person or t6 chCrcb~t ky d5i v6'i phOngthi nghj~m (3.6), lien organization to a laboratory (3.6), relating to the Vi~c th~ hi~n 51,1' khong hai long cua quan d~n hoc;ttdOngho~c k~t qua eua phong thl activities or -results of that laboratory, where a nghi~md6, v6'i mong muOndU'Q'cdap l;;tl. 8 responseis expected TCVN ISOIIEC 17025:2\. (Ngulln: TCVN ISOIIEC 17000:2007. 6.5 dlJ'Q'c [SOURCE: ISOIIEC 17000:2004, 6.5, modified- slia d6i - Tll' "khOngphai Itl yau cau xem xet lal" The words "other than appeal" have been deleted, dlJ'Q'cbe)va tl) "t6 chirc dimh gia SI! phu hop hoac and the words "a conformity assessmentbody or to chli'c cong nMn, lien quan d~n hoat dQngcua accreditation body, relating to the activities of that to ch(rc d6" dlJ'Q'cthay b~ng "phOngthi nghi~m, body" have been replaced by "a laboratory, lien quan d~n hoat oQngho~c k~t qua cua phOng relating to the activities or results of that thl nghi~m d6] laboratory".] 3.3 So sanh lien phong 3.3 interlaboratory comparison Vi~c to chec, thl,l'chl~n va danh gill cac phep do organization, performance and evaluation of hoac phep thli tran cung d6i tlJ'Q'ngho~c tren d6i measurements'or tests on the same or similar tlJ'Q'ngtLFO'ng tl! nhau bai hai hay nhi~u ph6ng thi items by two or more laboratories in accordance nghi~mtheo .. nhii'ng..di~u . ki~n djnh tmac. with predeterminedconditions [NGUON: TCVN ISO/IEC 17043:2011, 3.4] [SOURCE: ISOIlEC 17043:2010, 3.4] -3.4 So sanh n9i b{) phong thf nghi~m 3.4 intralaboratory comparison Vi~c to chtrc, thl,l'c hi~n va danh gia cac phep do organization, performance and evaluation of hoac phep thli tren cung m§.uthlf ho~c tren mau measurements or tests on the same or similar thli tU'O'ngtt,J' nhau trong cung mot phOng thi items, within the same laboratory (3.6). in nghirtm (3.6) theo nhiing di€luki~n xac djnh trU'ac. accordancewith predeterminedconditions 3.5 ThCPnghi~m thanh th~o 3.5 proficiency testing Banh gia vi~c thl!c hj~n cua cac ben tham gia evaluation of participant performanceagainst pre~ theo tieu chi da dlJ'Q'cthi~t I~p thong qua so sanh established criteria by means of Interlaboratory lien phong (3.3). comparisons (3.3) [NGUON: TCVN ISOIIEC 17043:2011, 3,7 dLFQ'C[SOURCE: ISOIIEC 17043:2010,3.7, modifled- slia dOl- B6 chUthfch] Notes to entry have been deletedj 3.6 Phong thi nghi9m 3.6 laboratory TOchtic thllc hi~n mOthay nhi~uho~t c:JQng sau: body that performs one or more of the following activities: - thli nghi{lm _ testing - hi~u chu~n calibration - Jely mau, lien quan d~n vi~c thli nghi~m ho;1ic hi~u chu§n sau d6 sampling, associatedwith subsequenttesting or calibration CHO THlcH 1: Trang bOi ccinh cua tieu chu~n nay, tCP Note 1 to entry: in the context of this document, ·ho~f dQngthi nghi~mtl dll c~p d~n ba hOl;ltdQngnau "laboratory activities" refer to the three above- 9 TCVN ISO/IEC 17D25:2017 tren. mentionedaetlvltles 3.7 Quy tlic ra quy~t djnh 3.7 decision rule Quy t~c nau each th(rc dQ khOng dam bao do rule that describes how measurement uncertainty dU'Q'c tlnh d~n khi ·k~t [u~n SI)' phu hop vai mQt is accounted for' when stating conformity with a yeu chu X8C djnh. specifiedrequirement 3.8 Ki~m tra xae nh~n 3.8 verification Vi~c cung c§p b~ng chung khach quan r~ng d5i provision of objective evidence that a given item tU'Q'ngda cho dap ll'ng cac yeu chu quy djnh. fulfils specified requirements vi DI) 1: Xac n~n rang mau chu~n ca cho theo yeu EXAMPLE 1 Confirmation that a given reference c§u la d5ng nh~t d6i vai gia trj di;li lLrQ'ngva thu tuc do material as claimed is homogeneous for, the quantity lien quan, khl gh~mph§n chia do Iliang tal khc3i1lJ'Q'ngvalue and measurement procedure concerned, down to 10 mg. a measurementportion having a mass of 10 mg. vi DI,J2: Xac nh~n ding cac tinh nang ho;iic yeu cAu EXAMPLE 2 Confirmation that performance properties phap djnh cua m¢t h~ thOngdo la d~t dlJ'Q'c. or legal requirements of a measuring system are achieved. vi Dl) 3: Xac nhan rAng de)kheng cam bao do rnuc lieu 1ftco th~ phu hop, uncertaintycan be met. CHO THlcH 1: Khi c6 thll ap dl,lng,dQkhong dam baa Note 1 to entry: When applicable, measurement do C§ndU'Q'cdU'avao d~ x~m xet. uncertaintyshould be taken into consideration. CHO THlcH 2: 66i tlIQ'ng c6 th~ la, vi dl,l nhU' qua Note 2 to entry: The item may be, for example, a trlnh, thu tl,lCdo, v~t Ii~~,hQ'pch~t ho~c h~ th6ng do. process, measurement procedure, material, compound, EXAMPLE 3 Confirmation that a target measurement or measuringsystem. CHO THlcH 3: Cac yeu cau quy dinh c6 th6 la, vi dl,l, Note 3 to entry: The specified requirementsmay be, for cae yeu c~u ky thu~t C:,ua nha san xu§t dll'Q'Ccap (mg. example,that a manufacturer's specificationsare met. GHOTHIGH 4: Ki6m tra xac n~~n/ki~m djnh trong do Note 4 t? entry: Verification i~ leg~1 metrology, ~ (lPang phap dlnh, nhU'djnh nghTatrong VIML va trong de~ned in 'VIML, and in conf9rmity assessment in danh gia 511 phI) hQ'pnoi chung. lien .quan d~n vi~c general, pertains to the examination and mar1dng kiem tra va g~n dAu vaJho~c pM! hanh giciy'chung and/or issuing of a verification certificate for a nh~n kiem dinh cho M th6ng do. measuringsystem. GHO THICH 5: Khong dU'Q'cnhAm I~n, ki~m tra xc'!c Nole 5 to entry: Verification should not be confused nh~nvai hj~u chuan. Khengc6 bat-cu vi~c kjem tra xac nh~n nao la XBC nh?n gia tri sci' d(Jng (3.9). CHO THlcH 6: Trang hoa hQ<:,killm tra xac nh{in with calibration. Not every verification is a validation (3.9). Sl,l' Note 6 to entry: In chemistry, verification of the Identity d6ng nh~t cua thllc th~ lien quan, ho~c cua h01;lttinh of the entity Involved, or of activity, requires a ta v~ cau truc ho~c cae tlnh ch§! cua descriptionof the structure or propertiesQf that entity or can c6 SIl me thl,l'Cthe ho;iich01;lttinh do. 10 activity_ TCVN ISOllEe 17025:2l1. [NGUON TCVN 6165:2009, 2.44, dU'Q'cslia d~i [SOURCE: ISO/IEC Guide 99:2007, 2.44] thu~t ngCPnki~m djnh" dll'Q'cthay b~ng' "ki~m tra xac nh~n"J 3.9 Xac nh~ngia tr] SLP dlJng 3.9 validation K;~m tra XBC nh(m (3.8), trong d6 cac yeu cAuquy verification(3.8), where the specifiedrequirements djnh la thoa dang cho vi~c sLi dl)ng da djnh. are adequate for an intended use vi DV: Mi)t thu tuc do, thlJ'cmgdU'Q'cSlr dl,mgcho phep EXAMPLE A measurement procedure, ordinarily used. do nOngd¢ kh6i 1lJ'Q'ng nita trang nlJ'&c;cung co th~ for the measurement of mass concentrationof nitrogen dlJ'Q'cxac nhan gia tri sUodl,lngcho phep do trong huy~t in water, may be validated also for measurement of thanh nglJ'c)oi. mass concentration of nitrogen in human serum. 4 4.1 Yeu cAu eh ung TfnhkM~h quan 4 General requirements 4.1 Impartiality 4.1.1 H09t dOngthl nghl~m pMi dll'Q'cthl,l'chi~n 4.1.1 Laboratory activities shall be undertaken mOt each khach quan va pMi dU'Q'Ct6 ch(rc va Impartially and structured and managed so as to quan lyo sao cho dam bao tfnh khach quan. safeguard impartiality. 4.1.2 Lanh d~o phong thl nghi~m phciicam k~t v~ 4.1.2 The laboratory management shall be tinh kMch quan. committedto impartiality. 4.1.3 Phong thf nghi~m phai chju trach nhi~m d6i 4.1.3 The laboratory shall be responsible for the voi tlnh kMch quan trong cac ho~t d¢ng cua minh impartiality of its laboratory activities and shall not va khang dlPQ'Ccho phep cac ap Illc thU'O'ngm~i, allow commercial, financial or other pressures to tai chfnh ho~c cac ap hlc khac lam anh hlPang compromiseimpartiality. d8n tinh khachquan. 4.1.4 Ph6ng thi nghi~m phsi nh~n di(3ncac nii ro 4.1.4 The laboratory shall identify risks to its doi v&i trnh khach quan cua minh m¢t cach lien impartiality on an on-going basis. This shall tl,lc.f)ieu nay phai baa gam cae·nii ro nay sinh tli include those risks that arise from its activities, or cae hotilt dOng ho~c tli cac mOl quan h(3 cUa frC?mits relationships, or from the relationshipsof pMng thi nghi(3mhay cac mOiquan h(3cua nhan its personnel. However, such relationshipsdo not Sl! cua pMng thi nghi~m. Tuy nhien, cac mOi necessarily present a laboratory with a risk to quan h~ nay kh6ng nhl1tthil!t thA hi~n phong thi impartiality. nghi~mco rui ro d6i voi tinh khach quan. . CHU THlcH: M6i Quan M de dQatfnh kMch quan cua NOTE A relationship that threatens the impartiality of ph6ng thl nghl~m c6 th~ do quy~n sa hCiu, 51,1' dillu the laboratory can be based on ownership.governance. himh, quan Iy, nhan 51,1', chia se nguOn lI,rc',tai chlnh, management, personnel, shared resources, finances, hQ'pdong, marketing (gbm ca xay dl,l'ngnhan hi{!u) va contracts, marketing (including branding),and payment chi tra hoa h6ng hay chi tra khac cho vl{!c giai thi~u of a sales commission or other inducement for the 11 TCVN ISOIIEe 17025:2017 referral of new customers, etc. khaeh hang mol, .•. 4.1.5 Khi mOtrui ro dOivai tlnh khach quan dllQ'c 4.1.5 If a risk to impartiality is identified, the nhan di~n, phong thf nghi~m phal co kha nang laboratory shall be able to demonstrate how it chung t6 each thuc leal bo hoac giam thi~u rai ro eliminates.or minimizessuch risk. do. 4.2 4.2 Confidentiality Bao m~t 4.2.1 B~ng cac cam k~t c6 gia tr] phap Iy, phong 4.1.1 The laboratory shall be responsible, thf nghi~mpMi chlu trach.nhi~mdOivai vl~c quan through legal,lyenforceable commitments,for the Iy t~t ca CaGthong tin dllQ'c'thu dU'Q'chO~Gt9-0ra managementof all informationobtained or created trong qua trinh thl,l'C Iii~n cac hoat dong thi during the performance of laboratory activities. nghi{lm. Phong thf nghi~m phsi thOng bao wac The laboratory shall inform 'the customer in cho khach hang, vfl cac thOng tin dl,l' dJnh cOng advance, of the information it intends to place in khai. Ngo~1trLYthong tin rna khach himg cOngkhai the public domain. Except for informationthat the hO~Gkhi d§ dU'Q'cphOng thi nghi~m va khach customer makes publicly available, or when hang thOng nh§t (vi dl,l vai rnuc dich dap ung agreed between the laboratory and the customer khl~u nai), t~t ca cac thong tin khac dflu dllQ'c coi (e.g.for the purpose of respondingto complaints), 18tai san,thOngtin cua khach hang va phai dllQ'c all other information is considered proprietary coi lil bi m~t. Informationand shall be regardedas confidential. 4.2.2 Khi phong thi nghi~m thea yeu cAu-cualu~t 4.2.2 When the laboratory is required by law or phap ho~c oUQ'cuy quy~n theo thoa thu~n hQ'p authorizedby contractual arrangementsto release dong o~ cungcc1pthong tin bi m~t, thi khach hang confidentialinformation,the customeror individual ho~c ca nhan co lien quan phai duQ'c thOng bao concerned shall, unless prohibited by law, be v~ thong tin oUQ'ccung c§p, trlt trU'ang hQ'plu~t notifiedof the informationprovided. philp ngiln c§m. 4.2.3 Thong tin v~ khach hang thu oUQ'ctlt:.cac 4.2.3 Information ~b,out the customer obtained ngu6n kh6ng phai lei kMch hang (vi dl,l: from sources other than .the customer (e.g. ben khi~u nfJi,cO'quan quan Iy) phai OlJ'Q'c giii -hi complainant, regulators) shall be confidential m~t giCrakhach hang va phongthi nghl(lm. Ngu6n between the customer and the laboratory. The cung c~p thOng tin nay phili dllQ'c phOng thi provider (source) of this information shall be nghi(lm giCYbi m~t va kh6ng OllQ'Cchia se val confidential to the 'laboratory and shall not be khach hang. tru khi dU'Q'cngllai cung c§p thong shared with the customer, unless agreed by the tin 06ng y. source. 4.2.4 Nhan 51,l', baa g6m mQithfmh vien cua cac 4.2.4 Personnel, including any committee ban, cac nhfl th§u, nhan 51,1' eua cac t6 chuc ben members, contractors, personnel of external ngoai ho~ccac cil nhan ho~t ol?ngvai danh nghia bodies, or individuals acting on the laboratory's cua'phOngthi nghi~m phai giii bi moiitt§t ca cac behalf, shall keep confidential all Information 12 TCVN ISOIIEe 17025:a. obtained or created during the performance D. ,thong 'tin thu dU'Q'c hoac tao ra trong qua trlnh thl)'c hi(ln cac hoat dQng thl nghi~m, trLPkhi dU'Q'c laboratory activities, except as required by law. lu~t phap yeu c§u. 5 Yeu cau v~ cooc~u 5 Structural requirements 5.1 The laboratory shall be a legal entity, or a 5.1 PhOng thl nghi(lm phai If! mQt phap nhan, ho~c mQt b(> phan nhi~m pMp cua minh. xac djnh cua phap nhan, chiu traeh defined part of a legal entity, that is legally Iy d6i voi cac hoat d~ng thf nghi~m responsible for its laboratory activities. CHU THicH: Trangtieu chuan nay, phOngthl nghl~m NOTE For ella nha nlY6'c dlYQ'cco; la m(lt phap nhan tren CCI sa vi the purpose of this document, a governmental laboratory is deemed to be a legal entity trl cua ph6ng thl nghi~m !rang hI) tMng to chlic chinh quy~n. on the basis of Its governmentalstatus. 5.2 PMng thf nghi~m pha; xac djnh ngl1(Y; lanh 5.2 The laboratory shall identify management that d~o/nglPai quan Iy chju hosn toan trach nhi~m dOi has overall responsibility for the laboratory. vol pMng thf nghi~m. 5.3 Phc)ng thi nghiii!m philf xac djnh va I~p tMnh 5.3 The laboratory shall define and document the van ban ph~m vi cac ho~t d(>ng thi nghi~rn dap range of laboratory activities for Which It conforms ling tieu chu~n nfly. PMng thl nghi~m chJ dlPQ'c with this document. The laboratory shall only claim cong bO Sl,f pM hQ'p vOri tieu chuan nay d5i vai conformity with this document for this range of phlilm vi hOliltdQng thi nghl~m nay va phCilmvi hOlilt laboratory dQng kh6ng baa gOm cac hOliltc(>ng thf nghi~m do ben ngoai cung ~p mot each .thlPang xuyen. activities, which excludes externally provided laboratory activities on an ongoing basis. 5.4 Cae hOf)t dQng thi nghi~m phai dlJ'Q'cthllc hi~n 5.4 Laboratory activities shall be carried out in sao cho cap ling cac yeu du cua tieu chuan nfly, such a way as to meet the reqUirements of this cua kMch hang cua ph6ng thi nghi~m, cua cO' document, the laboratory's customers, regulatory quan quan Iy va cua cac t6 chCrc thllc hi~n vi~c thLPanh~n. Eli~u nay authorities and organizations provIding phci; bao gam cac hOCiitdOng recognition. This shall include laboratory activities, thr nghi~m dlPQ'cthl)'c hi~n, tlili t~t .ca eae cO' sa performed in all its, permanent facilities, at sites thU'ang xuyen cua ph6ng thl nghi~m, cac dja di~m away from its permanent facilities, In associated n~m ngoili CO' sa thlPang xuyen, cac CO' sa tlilm temporary or mobile facilities or di dong co lien quan ho~c tlili cO' sa cua facility. khach hang. at a customer's thai ho~c 5.5 PhOng thl nghl~m phai: a) xac dinh cO'~u t6 chlic va quan 5.5 The laboratory shall: Iy cua phOng thf nghf~m, vi trf cua n6 trong to Ghlic m~ va cac m6i quan h~ glCPa cac hOlilt dQng quan Iy, a) define the organization and management structure of the 'laboratory, its place in any parent organization, and the relationships 13 TCVN ISO/lEe 17025:2017 between management, technical operations ky thu~t va djch VI,I h6 trQ'; and supportservices: b) quy djnh trach nhi~m, quy€mhan va mOiquan b) specify the responsibility, authority and h~ tU'O'ngtac cua tat ca nhan 51! quan Iy, thl)'c interrelationshipof all personnelwho manage, hi~n hay ki~m tra xac nh~n cong vl~c c6 fmh perform or verify work affecting the results of huang d~n k~t qua heat d¢ng thi nghi~m; laboratoryactivities; c) I~p thBnh van ban cac thu tuc cna phong thi c) document its procedures to the extent a mue dQ cAn thi~t d~ dam bao ap necessaryto assure the consistent appllcatlon dvng nhat quan tat ca cac hoat dQng thl of its laboratory activities and the validity of the nghi~mva gh~tri Slf dl,mgcua kat qua. results. . nghi~m 5.6 Phong thi nghi~m phal co nhan Sl,l'.khOngk~ 5.6 The laboratory shall have personnel who, cac trach nhlern knac, cc quy~n han can thi~t d~ thl,l'c hi~n nhiem VI} va nguOnIl,I'c irrespective of other responsibilities, have the cua mlnh, baa authority and resources needed to carry out their gbm: duties,including: a) thl,l'chi~n,duy trl va·caiti~n h~ thOngquan IY; a) implementation, maintenance and improvementof the managemen~system; b) nh~n bi~t nhO'ngsai I~ch so val h~ thbng quan b) identification of deviations from the Iy ho~c cac thu t!,lcd~ thlfc hi~mcac hOliltdong management system or from the procedures thi nghi~m; for performinglaboratory activiti~s; c) khcYixU'6'ngcac hanh dQng d~ ngan ngua c) initiation of actions to prevent or minimize such deviations; ho~cgiam thi~u nhling sai I~ch nay; d) bao cao cho lanh d~o phong thi nghi~m v~ k~t d) reporting to laboratory management on the qua thl,l'Chi~n h~ thong quan Iy va mQi nhu performance of the management system and' any need·forimprovement; c~u cai ti~n; e) dam baa hi~u h,rc eua cae hOiilt dQng thi e) ensuring the nghi~m. effectiveness of laboratory· activities. 5.7 Quan ly phOngthi nghi~m pMi dam baa': 5.7 Laboratorymanagementshall ensurethat: a) vi~c trao dOi thOng tin dU'Q'cthl,l'c hi~n lien a) communication takes place regarding the quan d~n tinh hi~u h/C cua M thOng quan 19 effectiveneSSof the management system and va ·t~mquan trQng eua vi~ dap ung cac yeu the importance of meeting customers' and cau cua khach hang va cae yeu e~u khflc; otherrequirements M thong quim Iy khi b) the integrity of the management system is maintainedwhen changes to the management nhO'ngthay d6i dOiv6'; h~ th6ng quan 19 dU'Q'c b) duy tri tfnh toan v~n cua , hOi,lCh dinh va thl!c hil~n. 14 systemare planned and implemented. . J TCVN ISO/IEC 17025:2017 6 Yeu d.u v~ nguan Il)'c 6.1 vsu cftu 6 Resource requirements 6.1 General chung Ph6ng thl nghiE)mphal c6 san nhan ll,l'c, co sa V?t The laboratory shall have available the personnel, cheit, trang thi~t b!, cac h~ thOng va dlch VI,I h6 trQ' facilities, equipment, systems and support ccin thi8t de quan ly va thuc hiE)ncac hoat dQng thi services necessary to manage and perform its nghi~m cua rnlnh, laboratory activities. 6.2 NMn 6.2 Personnel SI,!' 6.2.1 T§t cci nhan 51! cua phong thl nghi~m, ca nQi 6.1.1 All personnel of bQ hoac ben ngoai, co the anh hLPcmgd~n hoat that could internal or external, d{lng thl nghi~m d€lu phal co nang IIlC, hanh dQng laboratory mQt each khach quan thea M thOng quan va thl,l'c hi~n cong vi~c dung Iy cua phong thl nghiE)m. activities competent yeu cau v~ nang h,PedOi vai tl)ng vi shall and work laboratory, act either influence the impartially, be in accordance with the -laboratory's management system. 6.2.2 Phong thi nghi~m phid I~p thanh van ban 6.1.2 The cac the laboratory trf cnoc competence shall requirements the results document for each function nang co anh hLPang d~n k~t qua heat dQ'ng thi influencing nghi~m, baa g6m cac yeu cau v~ giao dl,lC, trinh including requirements for education, qualification, de) chuyen mon, dao t~o, ki~n thuc ky thu~t, ky training, nang va kinh nghi~m. experience. technical knowledge, 6.2.3 PhOng thl nghi~m phai dam bao rang nhan 6.1.3 The laboratory 51,1' co nang Il,I'c thl,l'c hiijn nghi~m rna hQ chju cae ho~t dong thi trach nhiE)mva danh gia mue de?nghiem trQng cua nhCrng sai I~ch. personnel have of laboratory the shall the vai nhan Sl,l' v~ nhiE)mVl), ensure and that to quy~n hCilneua hQ. perform laboratory activities for which they are responsible communicate to of the laboratory shall personnel their duties, responsibilities and authorities. tl,lC va 6.1.5 The laboratory shall have procedure(s) and ILPUh6 sa v8 vi~c: retain records for: a) xac djnh cae yeu cilu v~ nang It,J'c; a) determining the competence requirements; b) Il,I'achQn nhan s\)': b) selection of personnel: c) dao t90 nhan s\)': c) training of personnel; d) giam sat nhan Sl,l'; d) supervision of personnel; e) trao quy~n cho nMn st,J' e) authorization of personnel; f) f) thea d6i nang Il,Ic nhan Sll. the and to evaluate the significance of deviations. tnkh nhi~m va 6.2.5 PhOng thl nghf~m phai c6 (cac) thu skills competence 6.2.4 Lanh d~o phOng thi nghi~m phai trao dOi 6.1.4 The management thong tin activities, monitoring of competence of personnel. 15 TCVN ISOIIEC 17025:2017 6.2.6 Phongthl nghi~m pMi trao quy~n cho nhan 6.1.6 The laboratoryshall authorize personnelto Sll thl,l'chi~n cac heat d(>ngthf nghl~m cu th~, bao performspecific laboratoryactivities, Includingbut g5m, nhlPngkhOngglal han a: not limitedto, the following: a) xay dl,l'ng.sua dOi,kiem tra xac nMn va xac a) development, modification, verification and nhangia t~ sti dl,mgcua phU'O'ngphap: b) phan tlch k~t qua, k~ cci validationof methods; cac tuyen b6 v6 Sl)' b) analysis of results, including statements of phu hop ho~c cac y ki~n va di~n gial; confonnlty or opinions and Interpretations; c) bao cao, xem xet va phe duy~t k6t qua. c) 6.3 6.3 Facilities and environmental conditions CO'sa v~t chAt va di~u kl~n mol trU'ang report, reviewand authorizationof results. 6.3.1 CO"sOov~t chat va 9i6u kiE)nmoi truC7ngphal 6.3.1 The . facilities and environmental,conditions thlch hop vai heat d¢ng thi ngh~m va khOnggay shall be suitable for the 'laboratory activities and anhhuang blit [lli d8n gia trl Slr dl,lngcua k~t ql:lcl. shall not adverselyaffect the validity of results. CHOTHlcH: cac anh hU'ang bat 19'idiln gia trj Slt NOTE Influences that can adversely affect the validity dr,mg eua kilt qua c6 thA bao gAm. nhllng khOnggi&i of results can include, but are not limited to, microbial h;;tn a, lay nhi~m vi sinh, b1,Il,nhl~u t1i~n·tCr,bric X;;t,(II) contamination, dust, electromagnetic disturbances, ~m. nguOn~p di~n, nhi~t dQ,am thanh va rung dQAg. radiation, humidity, electrical supply, temperature, sound and vibration. 6.3.2 Cac yeu cc1uv8 cO'sa v~t chat va di~u -ki~n 6.3.2 The requirements for facilities and moi trucmg can thiilt cho vi~c thl,l'chi~n hO'iltdQng environmental conditions necessary for the performance of .the laboratory activities shall be thi nghi~mpMi dU'Q'cI~ptMnh van ban. ·documented. 6.3.3 Ph6ng thf nghi~m phai thea dol, kh~msoat 6.3.3 The laboratory shall monitor, control and va ghi nh~ncac di~u ki~n moi twang theo cae quy record environmental conditions in accordance djnh' ky thu~t, phU'O'ngphap ho~c thu tl)C quan ho~c khi chung anh hU'ong alln gill co fien with tri relevant. specifications, methods or sQr procedures or where they.influence the validity of dl,mgcua k~t qua. the results. 6.3.4 Caebif)n philp ki~msoat CO' sa v~t chat phai 6.3.4 Measures to control facilities shall be dlfQ'Cthl,l'chi~n, theo doi, djnh ky xem xet va phili implemented,monitored and .periodicallyreviewed baa gbm, nhung khOnggiai h'iln a: and shall include,but not be limited to: a) vi~c ti~p c~n va SLY dl,lng cac khu Vt,J'csnh a) accessto and use of areas affecting laboratory hU'angd~n ho;;ttdQngthi flghi~m; activities; b) vi~c ngan ngua nhi~m ban, Sl)' can thi~p ho~c b) prevention of contamination, interference or nhfrng snh hU'ang bat Iooid~n ho~t dOng thl adverseinfluences on laboratoryactivities; nghj~m; 16 J TCVN ISO/IEC 17025:2017 c) vi1~ctach bi('!tc6 hi~u h,Pccac khu VIlC c6 hoat e) effective separation between areas with dOngthi nghi('!mkhang tU'O'ngthich. incompatiblelaboratoryactivities. 6.3.5 Khi phong thl nghi~m thuc hi';m cac hoat 6.3.5 When the laboratory performs laboratory dOngthi ngh[~mtal cac Cijadi~m hoac 'CO' sa nam activities at sites or facilities outside its permanent ngold 51l ki~m scat thU'Crngxuyen cua minh, control, it shall ensure that the requirements phOngthl nghi~m phal dam bao r~ng cac yeu cclu ' relatedto facilities and environmentalconditionsof lien quan d~n CrY sa v~t ch§t va. di~u ki~n moi this documentare met. trllCrngtheo tieu chuan na.yo~udU'Q'cdap (mg. 6.4 Thl~t bl 6.4 Equipment 6.4.1 Phongthi nghi~m phai tillp c~n OllQ'Cthi~t b] 6.4.1 The laboratory shall have access to baa g6m. nhllng kh6ng giai han ?:I. cac phllO'ng equipment (Including,but not limited to. measuring ti~n do. pha'nm~m. chuan do IU'Crng.rn~u chuan, instruments. software. measurement standards. dCi'Ii~u quy chi~u. thu6c thli. v~t tU'tieu hao hoil)c reference materials, reference data, reagents. thi~t bj phu trQ'can thi~t cho vi~c thV'c hien chinh consumables or auxiliary apparatus) that is xac heat dC>ng thl nghiem va nhCi'nggi c6 th~ anh required for the correct performance of laboratory hU'angd~n k~t qua. activities and that can influencethe result. CHO THlcH 1: Hi~n c6 nhi~u ten gQi dOi vai mau NOTE 1 A multitude of names exist for reference chuan va mAu chuan dll'Q'e chung nh~n. bao gam materials and certified reference materials. InCluding chuAn chinh, chuAn hi~u chuAn, mau chuan dOichung reference standards. calibration standards, standard va v~t Ii~u ki~m soat ch~t 1ll'Q'ng.TCVN ISO 17034 baa reference materials and quality control materials. ISO g6m thong tin b6 sung v~ nM san xu§t mau chuAn 17034 contains additional infonnation on reference (RMP). Cae RMP cap ling yeu cAu cua TCVN ISO material producers (RMPs). RMPs that meet the 17034 dllQ'c coi la c6 nang h,l'c. Mau chuAn cua cac requirements of ISO 17034 are considered to be RMP cap ung cac yeu cAu cua TCVN ISO 17034 dllQ'C competent. Reference materials from RMPs meeting cung dp kern theo ta thong tin/giay chung nh~n san pham. quy djnh nhung d~c trllng, trong 56 nhi~u d~c trung khac. v~ tfnh aOng nhat va dQ 6n cjnh cua cac the requirements of ISO 17034 are provied with a product infonnation sheeUcertificate that specifies. amongst other characteristics, homogene,ity and tinh chat xac djnh va val mau chuAndlJ'Q'cch(l'ng nh~n stability for specified properties and. for certified la cac tfnh ch~t xac ainh val cae gii!' tri dllQ'c chung reference materials, specified properties'with certified nh~n. dQ khang dam baa do kem thea va lien k~t chuan values, their associated measurement uncertainty and do Illang cua cac 9is t~ do. metrologicaltraceability. CHO THlcH 2: TCVN 8056 cJU'a ra hllp-ng dan v~ vi~c NOTE 2 ISO Guide II/a chQnva SLYdl,lngmau chuAn. ISO Guide 80 (fila ra selection and use of reference materials. ISO Guide 80 hll'ang dan san xuat v~t Ii~u dung d~ killm soat chat provides guidance to produce in house quality control ilJ'Q'ngnQibO. materials. 33 provides guidance on the 6.4.2 Nilu phong thl nghi~m sli dl,mgthi~t bj n~m 6.4.2 When the laboratoryuses equipmentoutside ngoai ki8m soat thU'Crngxuyen cua minh. thI its permanent control, it shall ensure that the 17 TCVN ISOIIEC 17025:2017 phonq thi nghi~m phal dam bao r~ng cac yeu cau requirementsfor equipment of this document are dOivai thiet bi theo tieu chuan nay dll'Q'cdap ling. met. 6.4~3 PhOngthl nghi~m pMI c6 thu tuc d6i val vi~c 6.4.3 The laboratory shall have a procedure for xep d6', v~n chuy~n,baa quan, sl) dl.mgva baa trl handling,. transport, storage, use and planned theo k~ hoach cac thlet bl d! dam bao heat dQng maintenance of equipment in order to ensure tOt va dll ngan ngLYavl~c nhl~m b~n hay hU'hong. proper functioning and in order to prevent contaminationor deterioration. 6.4.4 PhOngthi nghi~m phai killm tra xac nh~n 6.4.4 The laboratory shall verify that equipment riing thiet bi phClhop val cac yeu cau xac dinh conforms to specified requirements before being truac khi dU'Q'cdua vao Sll dl,lng ho~c trU'ac khl placedor returned into service. dU'atreYl<;IiSlt dl.lng. 6.4.5 Thiet bi do phai c6 kha nang dt,lt dl1Q'cde} 6.4.5 The equipment used for measurementshall chfnh xac do llJ'cl'ngho~c dO khOng dam bao do be capable of achieving the measurement efin thi~t dll cho ra ket qua c6 gia tri Slr dl,mg. accuracy or measurement uncertainty required to providea valid result. 6.4.6 Thiet bi do phai dl1Q'c·hl~uchuan khi: 6.4.6 Measuring equipment shall be calibrated when: - dQ chinh xac do ho~c de}khong dam bao do - the measurement accuracy or measurement anh hU'eYng den gia tri Slr d!,lng cua ket qua unoertainty affects the validity of the reported dU'Q'cbao cao, ho~c results,or vi~c hi~u ehuanthiet bi 18 c§n thiet de thiet I~p - calibration of the equipment is required to lien k~t chu~ndo 11I'cmg eua ket qua dU'Q'cbao establish the metrological traceability of the .cao. reportedresult. CHO THlcH: Cac 10~ithl~t bl c6 anh hllcmg d~n gia t~ NOTE Types of equipment having an effect on the sUrdl)ng cua k~t qua dW1Cbao cao cO thAbao gbm: thi~t bi dlYQ'cSLY dvng cho phep do tn,Pctj~p d~i validity of the reported results can include: - those used for the direct measurement of the ILYQ'I19 do, vi dl,l,sUrdl,mgcan d~ frulc hien p~epdo measurand, for example, use of a balance to kh6i ILYgng; perform a mass measurement; thiat bl dLYgcSLY dl,lngdA th'lc hi~n vi~ hi~u chinh - those used to make corrections to the measured gia tr! do dLYQ'c, vI dl), cae phep'do nhi~t dO; value, for example, temperaturemeasurements; thi~t bi dllQ'csli dl,mgd~ thu dllQ'ck~t qua do dllQ'c - those used to obtain a measurement r~sult tfnh toan b) nhi~u d<;liIlYgng. calculatedfrom multiple quantities. 6.4.7 Phongthi nghi~m phai thi~t I~p chU'O'ngtrlnh 6.4.7 The laboratory shall establish a calibration hi~u chucln,ehU'O'ng trlnh nay phai dU'Q'cxem xet, programme,which shall be reviewed and adjusted dj~u chlnh khi c§n de duy trl Sl! tin c~y v~ tlnh as necessary in order to maintain confidence in 18 TCVN ISO/IEC 17025:201i tr/ilng hi~u chuan, the status of calibration. 6.4.8 Tefitca cac thi~t bi cclnhi~u chuan ho~c c6 6.4.8 All equipment'requiring calibration or which thai han hi~u h!c xac dinh phai dU'Q'cdan nhan, has a defined period of validity shall be labelled, rna hoa hoac ~6 each nhan bi~t khao cho phep coded or otherwise identified to allow the user of SLY dl,lOgthi~t bi d~ dllng nh~n bi~t dU'Q'c the equipment to readily identify the status of tinh tr~mghi~u chuan hay thai han hi~u lI,I'c. calibration or period of validity. ngU'(yj 6.4.9 Thi~t bi qua tai ho~c sli dvng sal, dlla ra cac 6.4.9 Equipment that has been subjected to k~t qua nghi nga, hoac thi~t bi dllgc pMt hi(rmbi overloading or mishandling, gives questionable " 10iho~c vi pham cac YElUcau xac O'jnh,phai dllQ'c 'results, or has been shown to be defective or leal khOi vi~c sl} dl,lng. NhCingthi~t bi 0'6 phcii outside speCifiedrequirements, shall be taken out dU'Q'cd~ tach bl~t d~ ngan chan vi~c sll dvng of service. It shall be Isolated to prevent its use or ho~c phai dllgc ghi nhan hay asnh dau ro rang lei clearly labelled or marked as being out of service khong SLY dl,mg dU'Q'ccho den khi n6 O'llQ'Ckiilm until it has been verified to perform correctly.The tra xac nh~n III hO',1t aQngbinh thuang. PMng thr laboratoryshall examine the effect of the defect or nghi~m pMi ki~m,tra anh hU'cyngcua thi~u s6t deViation from specified requirements and shall ho~c sai I~chso vai yeu cau aa djnh va phai quan initiate the management of nonconforming work Iy thea tM tvc v~ c6ng vi~c khOngpM hQ'p(xem procedure (see7.10). 7.10). .6,4.10 Khi cac ki~m tra gi(1aky Iii can thl~t d~ duy 6.4.10 When intermediate checks are necessary tr; Slf tin c~y v~ kijt qua thlfe hi~n cua thiet bi, thl to maintain confidence in the performance of the vi~c ki~m tra nay phSi dllQ'c thlfc hi~n thea mOt equipment, these checks shall be carried out quy trinh. accordingto a procedure. 6.4.11 Khi dCiJj~uhi~u chuan va d(1li~u v~ mau 6.4.11 When calibration and reference material M data Include reference values or correction so hi~uchinh, pMng thi nghl~m phai bao (Jamcac factors, the laboratory shall ensure the reference chuan baa gam cac gia trj quy chi~u hay cae gia tri quy chi~u va h~ so hi~u chfnh (JU'Q'c ~p values and correction factors are updated and nMt va O'Ll'Q'C sl) dt,mgm~t cach thlch hQ'p,a~ dap implemented, as appropriate, to meet specified lmg cac yeu xac djnh. requirements. cau 6.4.12 Ph6ng thi nghi~m phai th,!c hi~n cae bi~n 6.4.12 The laboratory shall take practicable pnap kha thi d~ ngan ngua vi~c hi~u chinhthi~t bi measures to prevent unintended adjustments of vo tlnh lam mat gla trj 51} dl.lngcua k~t qua. equipmentfrom invalidatingresults. 6.4.13 Phai 111U giCPcae hO sO'thi~t bi c6 thil snh 6.4.13 Records shall be retained for equipment hLl'iYnga~n ho~t dQngthl nghi~m. Khi thlch hQ'p, which can influence laboratory activities. The h6 sO' phB; baa g6m: records shall include the following, Where applicable: a) vi~c nh~n biet thlet bi, baa g6m phan m~mva a) the identity of eqUipment, Including software 19 TCVN ISO/IEC 17025:2017 and firmwareversion; phien ban phan m~m; b) ten cua nha san xuat, nh(in billt kl6u 109i,s6 b} the manufacturer's name, type identification, se-rl ho~c nh~n d~ng duy nhat khac; and serial number or other unique IdentifICation; c) bang chCPng cua vi~c kiAm tra xac nMn fang c) evidence of verification that equipment conformswith specified requirements; thi~t bi phu hop vai yeu cAu xac dinh: d) vi trl hi~nt~l: d) the current location; e) ngay hi~u chuan, cac k~t qua hi~u chuan,hi~u e) calibration dates, results of calibrations, cnlnh, tieu chi chap nh(in va ngay hi(lu chuan adjustments,acceptance criteria, and the due k~ tl';p ho~c chu ky hi~uchu~n; date of the next calibration or the calibration interval; f) cac tal Ii~uv~ mc1iu chuan, cac kilt qua, ti~u chi f) documentationof reference materials, results, chap nh~, ngay tMng c6 lien quan va thai acceptance criteria, relevant dates and the han hi~u hIe; period of validity; g) kll hoach bac trl va vi~c bao tr1da dU'Q'cthuc g) the maintenance plan and maintenance hi~n, khi vi~c nay lien quan d~n k~t qua thuc carried out to date, where relevant to the hi~ncua thi~t bi; performanceof the equipment; h) chi ti~t v~ mol hu hong, true tr~c, sua d6i ho~c h) details slia chria thi~t bl. of any damage, malfunction, modificationto, or repair of, the equipmenl 6.5 Lien k~t chuAn do ILPOtng 6.5 Metrological traceability 6.5.1 PhOngthi nghi~m phs] thi~t I~p va duy trl 6.5.1 The laboratory shall establish and maintain lien k~t ehu~n do luang cho cac k~t qua do cua metrologicaltraceabilityof Its measurementresults mlnh bang mOt chu6i khOngdl1t do~mcac phep by means of a documented unbroken chain of hi~u chuan duQ'c l~p thElnhvan ban, mOi pMp calibrations,each contributingto the measurement hieu chuan dong gop wo de)khong dam baa do, uncertainty, linking them to an lifm k~t_cac k~t qua.do tai m6c quy chi!u thich appropriate reference. hQ'p. CHO THlcH 1: Trong TCVN 6165, nen k~t ·chuAndo NOTE 1 In ISOIIEC Guide 99, metrological traceability 11100l1g dl1gc dinh nghTala "tlnh chat eua k~t qua do nha Is defined as the Uproperty of a measurement result do ket qua c6 thli lien h~ tai m6e quy chleu thong qua whereby the result can be related to a reference mOtchuOIkhOngdU1:do~n cac phep hl~u chuAn dl1Q'c through a documented unbroken chain of calibrations. l~p thanh van ban, mOlphep hi~u chuan d6ng g6p vilo each contributingto the measurement uncertainty". dQ khOngdam baa do· CHU THlcH 2: Xem Phl.l l!,IcA v~ Hen ket chu§n ao II100n9. 20 de biet tMm thOng tin NOTE 2 See Annex A for additional information on metrologicaltraceability. TCVN [SOIlEC 17025:2017 6.5.2 PhOng thl nghi~m phai dam bao rang cac k~t 6.5.2 qua do e6 thlllien measurement k~t tai Hi;! don vi quac t~ (SI) The laboratory results shall are ensure traceable to' thong qua: International System of Units (SI) through: a) a} calibration vi~e hi~u chuan dtrQ'e thl,l'c hi~n b6'i phong thl nghi~m c6 nang h,Yc;ho{lc provided by a that the competent laboratory; or CHO THlcH 1: cac phOng thl nghi~m dap erng cac yau NOTE 1 Laboratories fulfilling the requirements of this c~u cua tieu chu~n nay nay dlJ'Q'ccolla c6 nang IIlC. document are considered to be competent. b) cac gia trj dU'Q'cch(.l'ngnMn cua mau chu~n b) certified values of certified reference materials dLPQ'c ch(.l'ngnh~n do nM san xu§t c6 nang provided by a competent producer with stated IlIC cung ccipc6 lien k~t chu~n do lU'cmgt6'i SI metrologicaltraceabilityto the SI; or dLFQ'c cOngbO:ho~c CHU THlcH 2: Nha san xu~t m~u chu~n dap erng cac NOTE 2 Reference material producers fulfilling the yeu ~u cUa TCVN ISO 17034 dl1Q'ccoi lei c6 nang h/C. requirements of ISO 17034 are considered to be competent c) vi~c thll hi~n tnrc ti~p cac dO'nvi SI dU'Q'c c) direct realization of the SI units ensured by dam baa biing each so sanh, trvc tlep ho~c comparison, directly or indirectly, with national gian ti~p, vai chuan quOcgia ho~c qu6c t~; or internationalstandards. CHO THlcH 3: Chi ti~t v~ vi~c th~ hi~n thllc ttt eac djnh NOTE 3 Details of practical realization of the definitions nghia ella mQt s6 dO'n vi quan trQng dU'Q'cnau trong s6 of some Important units are given in the SI brochure. tay eua 51. 6.5.3 Khi lien k~t chuan do [liang d~n cac dO'nvj 6.5.3 When metrologicaltraceabilitY.to the SI units SI khong th~ thl,l'chl~n v€!m~t ky thl:l~t,phong thi is not technically possible, the laboratory shall nghl~m phSl chting t6 lien k~t chuan do Illang tal demonstrate metrological traceability to mQtmOequy chi~u thich hQ'pnhtr: appropriate referencesuch as: an a) cac gia trj dLPQ'cchCrngnh~n cua m~u chuan a) certified values of certified reference materials dLPQ'c chting nh~n do nha san xu~t co nang provided by a competentproducer;or IIICcung clp; horiic b) k~t qua cua cac thl) t!,lCdo quy chi~u, cac b) results of reference measurementprocedures, phLPO'ng phap quy djnh ho~c cac chuan d6ng specified methods or consensus standards thu~n dLPQ'c mo ta ro rang va dlJ'qc chApnMn that are clearly described and accepted as 113 cho ra cac k~t qua do phCrhQ'pvai vi~c sll providing measurement results fit for their dl,lngd§ dinh va dl1Q'cdam bac b~n9 phep so intended use and simh thfch hQ'p. comparison. ensured by suitable 21 TCVN ISOIIEC 17025:2017 6.6 Externally provided products and services 6.6 San ph~m va djch v....do bEm ngoal cung z cap 6.6.1 Phong thf nghi~m phai dam bao r~ng chl 6.6.1 The laboratoryshall ensure that only suitable nhling san pham va dlch vl,l thlch hQ'p do b€ln externally' provided products and services that ngoai cung cc1pco anh hU'cyngdEmhoat dOngthl affect laboratory activities are used, when such nghi~m mal dl1Q'cSIl dl,lng,khi nhung san pham productsand services: va dlch vI.)nay: a) nh~m muc dlch k~t hop vao cac heat dOng a) are Intended for incorporation into the laboratory'sown activities; eua chinh phongthi nghi~m; b) dl1Q'cphong thi nghi~m cung e!p tn,rc ti~p b) are provided, in part or in full, directly to the customer by the laboratory, as received from cho khach hang, mOtphan ho~c toan bQ,nhlY the externalprovider; nMn dll'Q'ctCPnha cunq cap ben ngoili; c) dl1Q'cSIl dvng d~ h6 trQ'hoat dOngcua phOng c) are used to support the operation of the laboratory. thi nghi~m. CHOTHlcH: Cac san phamco th~ bao gOm,vi dV, NOTE Products can include, for example, chuando Illang va cacthi~tbi do, thi~tbi phv trQ', cac measurementstandards and equipment, auxiliary v{it tll tieuhao va m~uchusn.Cacd!ch vI,! c6 th~ bao equipment, consumable materials and reference gam,vi dl,l,djch VI,! hi~u.chuan,dlch VI,! h~ymau,dich materials.Servicescaninclude,for example,calibration vIJ.thli nghi~m,dichV\I baatri thi~tbi, co sa v~t chAt, services,samplingservices,testing services,facility dichvI,! thlPnghi~mthanhthfilo,dichVI) canhgls. 6.6.2 Phongthi nghi~m phai c6 thu tl,lCva and equipment maintenance services, proficiency testingservicesandassessmentandauditingservices. 111U giCY 6.6.2 The laboratory shall have a procedure and retain recordsfor: cac h6 sa v8 vi~c: a) xac dinh, xem xet va phe duy~t cac yflu c~u a) defining, c.ua phOngthi nghi~m doi vai s~n pham vii dich VI) do ben ngoai cung cap; laboratory's and approving requirem.e.nts for the externally . provided products and services; . b) xac dinh cac tieu chI ch~ vi~c danh gia, lila b) defining the criteria for evaluation, selection, chQn,theo doi kEltqua thl,fC hien vii danh gh~ monitoring of performance and re-evaluation I~icac nha cung cap ben ngoai; of the external providers; c). dam M'o nlng cac san ph~m va dich 22 reviewing VI) do c) ensuringthat externally provided products and ben ngoai cung c§p phu hQ'pval cac yeu c§u services conform to the laboratory's d§ dU'Q'cthi~t lilIpeua phong thi nghi~m, ho~c established requirements, or when applicable, khi thich hQ'pvai cac yeu cau lien quan cua to the relevant requirementsof this document, tieu chuan nay, trU'ac khi chung dUQ'c sl) before they are used or directly providedto the .dvng ho~c cung c~p trllc ti~p cho khach customer; TCVN ISOIIEC 1702:'. hang; d) thuc hi{m mol hanh d9n9 nay sinh tl) vi~c d) taking any actions arising from evaluations, danh gia, thea doi k~t qua thl,l'c hi~n va danh monitoring of performance and re-evaluations gh3 J~i nha cung c§p ben nqoal, of the external providers. 6.6.3 PMng thl nghi~m phai trao dlli thOng tin vai 6.6.3 nha cung c~p b6n ngoai v~ cac yeu cAu cua rnlnh doi vai: requirements to external providers, for: a) cac san ph~m va dich b) chuan mire chap nh~n; c) nang h,c, bao gOm trinh dQ chuyen men din VI,I dU'Q'ccung cap; shall communicate its b) ,the acceptance criteria; c) competence, including any required qualification of personnel; cac hoat 09n9 rna pMng thl nghi~m. ho~c khach hang cua phong thi nghi~m, dl)' djnh thl,l'c hi~n t'ili laboratory a) the products and services to be provided; thi~t cua nhan Sl,I'; d) The CrJ so d) activities that the laboratory, or its customer, intends to perform at the external provider's cua nM eung clip ben premises. ngoid. 7 Yeu cclu va qua trinh 7.1 Xem xet yeu cau, 7 da nghl thau va hQ'p Process requirements 7.1 Review of requests, tenders and contracts d6ng 7.1.1 Phong thi nghi~m phal cO tM b,IC deSivai vi~c 7.1.1 The laboratory shall have a procedure for xem xet cac yeu cau, d~ nghj thau va hgp d6ng. the review of requests, tenders and contracts. The Thu t!,lC nay phai dam baa rang: procedure shall ensure that: a) a) the cac yeu cau dlJ'Q'c xac djnh, I~p tMnh van ban va hll!u mOt each day du; b) are adequately defined, documented and understood; ph6ng thr nghi~m co khc1nang va nguOn Il,I'c b) !he laboratory has the capability and resources o~ dap (mg cae yeu cau d6; c) requirements khi Str dl,mg nhi! to meet the requirements; cyng c§p ben "goai, thi cae yeu cau 0 6.6 phai oU'Q'cap dl,mg va pMng c) where external providers are used, the requirements of clause 6.6 are applied and the thi nghj~m thOng baa eho kMeh hang v~ cae laboratory advises the customer of the specific ho~t dQng thl nghi~m laboratory' activities to be performed by the CI) the se dlJ'Q'cthl,l'c hi~n bal nM cung c§p bEmngaid va d~t OlJ'Q'c Sl,!' chap thu~n cua khach hang; external provider and gains the customer's approval; CHU THicH 1: Cac hOl;ltd¢ng phong thi ng'hi~mdU'c;YcNOTE 1 It is recognized that externally provided cung cap bai ben ngold co Ihil xiiy ra khi: phOng thi nghi~m c6 nguOn It,lc va nang (llc d~ laboratoryactivities can OCcurwhen: the laboratory has the resources and competence 23 TCVN ISOIIEC 17025:2017 thl,l'c hii~ncac hoat OQng,tuy nhien, vi cac Iy do to perform the activities, however, for unforeseen khong Illang tl116'cnen khOngth~ thllc hi~n oU'Q'c reasonsis unable to undertakethese in part or full; mQtphan ho~ctoan bO vi~c do; phong thl nghi~m khong c6 nguOnhfC ho~c nang the laboratory does not have the resources or hlC d~ thV'chi~n cae heat dOng. competenceto perform the activities. d) cac phtronq phap hoac thu tuc thlch hQ'p d) the appropriate methods or procedures are oU'Q'clI,a chon va c6 khs nang oap (mg oU'Q'c selected and are capable of meeting the cac yeu cau cua khach Mng. customers' requirements. CHO THICH 2: £)61 val khflch himg nQibq hoac khach NOTE 2 For internal or routine customers, reviews of hangthllang xuyen, vi~c xem xet yeu du, dll nghi thau requests, tenders and contracts can be performed in a va hQ'p66n9 c6 th6 dllQ'cthV'chli~nthea each een gian simplif.edway. han. 7.1.2 Phong thf nghi~m phal thOng baa cho kMch 7.1.2 The laboratory shall inform the customer Mng ·khi phU'O'ngphap khach hang yeu cau dU'Q'c when the method requested by the customer is considered to be inappropriate or out of date. coi la khOng phu hQ'pho~c ds 16ithai. 7.1.3 Khi kMch hang yeu clu cOng bO v~ phU 7.1.3 When the customer requests a statement of Sl,!' hQ'pvat mOt quy djnh ky thu~t hay m¢t tieu chuan conformity to a specification or standard for the v~ ·thu nghi~m hay hi~u chu~n (vi dV d~tJkhOng test or calibration {e.g. pass/fail. in-tolerance/outd~t, nam trong dung sailnam ngoai dung 5ai) thi quy djnh k9 thu~t hay tieu chuan d9 va quy tac ra quy~t djnh phai dU'Q'cxac djnh r6 rang. TriP khi dii of-tolerance) the specification or standard, and the decision rule shall be clearly defined. Unless inherent in the requested specification or -c6 trong quy djnh k9 thu~t ho~c 1ieu chuan dllQ'C standard. the decision rule selected shall be d~ nghi, quy t~c ra quy~t djnh dlYQ'cchQn phsi communicated to, and agreed with. the customer. dU'Q'cthOng bao va thOng nhat voi kMch hang. CHO THicH: HII&ng dan them v~ tuyen b6 v~ SIf ph\) NOTE For further statements of confonnlty, see I~OGuide 98-4. hQ'P.xem ISO .Gulde98-4. 7.1.4 MQi khac bi~t· gifra yeu guidance on cau ho~c de nghi 7.1.4 Any differences between the request or thau va hQ'pdOng phai dllQ'C gi"ai quy~t trllac khi tender and the contract shall be resolved before b~t dau cac ho:;:!td¢ng thi nghi~m. Tung hQ'pdong laboratory activities commence. pMi dU'Q'cca pMng thi nghi~m va kMch hang shall be acceptable both to the laboratory and the cung ch~p nMn. Cac sal I~ch do khach hang yeu customer. Deviations requested by the cilstomer cau khang dU'Q'canh hU'ang d~n shall not impact the integrity of the laboratory or 51,1' nhat quan Each contract cua phong thi nghi~m ho~c gia trj Slr dl,lng cua k~t the validity of the results. qua. 7.1.5 Khach hang phai dU'Q'cthong bao v~ mQi sai 7.1.5 Th~ customer shall be informed of any I~ch.so voi hQ'pdOng. 24 deviation from the contract. TCVN ISO/IEC 17025:2017 7.1.6 Neu hop d6ng dll'Q'c sCra d6i sau khi cong vi~c da b~t d§u, thl vl~c xem xet 7.1.6 If a contract is amended after work has hop d6ng phai commenced, the contract review shall be repeated dll'Q'c I~p Ifill va mol sCra dol phal all'Q'c thong bao and any amendments shall be communicated to cho t~t ca all affected personnel. cac nhan vien bi anh hll'ang. 7.1.7 Phong thi nghi~m phal hop tao vai khach hang ho~c afili di~n cua ho d~ lam ro 7.1.7 The laboratory shall cooperate with customers or their representatives in clarifying the cac yeu c§u cua khach hang va theo doi k~t qua customer's request and in monitoring the thtrc hj~n cua phOng thl nghi~m lien quan a~n laboratory's performance In relation to the work cong vi~c dll'Q'c thoc hi~n. performed. CHOTHlcH: Vi~c hop tac nay c6 thA bao gam: NOTE Such cooperation can Include: a) b) cho pMp ti~p c~n hOOp Iy cac khu VIIC lien quan ella pMng fhi nghl~m d~kMch hang ehling ki~n the cac hoat CJQngthi nghiem cu th8 cho khflch Mng. laboratoryactivities; laboratory to witness customer-specific vi~c chuan b], d6ng g6i, chuylm cac oOi tU'llng b) preparation, packaging, and dispatch of items khaeh hang can cho ml)c dich kiAmtra xac nMn. 7.1.8 Phai lU'u giCi'cac h6 sO' xem xet, g6m thay a) providing reasonable access to relevant areas of ca mQi needed by the customer for verificationpurposes. 7.1.8 Records of reviews, Including any significant d61 aang k~. H6 sO' v~ cac cUQc thao lu~n changes, shall be retained. Records shall also be thrch hgp vai khach hang v~ cae yeu c§u clla hQ retained of pertinent discussions with a customer ho~c k~t qua cua ho~t aQng phOng thr nghi~m relating to the customer's cOng phai dll'Q'c IlYUgiO>. results of the laboratory activities. 7.2 Ll!a ch~n, kl~m tra xac nMn va xac nhin 7:2 Selection, verification and validation of gia trl SLr dl:mg cua phU'O'ngphap requirements or the methods 7.2.1 Ll)'a chQn va ki~m tra xac nh~n phU'o-ng 7.2.1 Selection and verification of methods philp 7.2.1.1 PhOng thi nghi~m phill sly dvng cae phll'O'ng phap va thu tl,JCthrch hQ'p dOi vai tat ca 7.2.1.1 methods The and laboratory shall procedures for use all appropriate laboratory cac hD<;ltdQng thr nghi~m va, khi thrch hQ'p, d6Jvai aptivities and, where appropriate, for evaluation of vi~c aanh gia aO khOng aam baa do cung nhLPcae the measurement uncertainty as well as statistical ky thu;tit thc5ngke all techniques for analysis of data. pMn Uch dCrlieu. CHU THlcH: "PhU'cmgphap· sli dl,lngtrong ~eu chuan NOTE "Method" as used in this document can be nay co thA dU'QccoilA dCingnghTavai "quy trinh do" considered synonymous with the term "measurement OLPqcdinh nghTatrong TCVN 6165. procedure· as defined in the ISO Guide 99. 7.2.1.2 Tat ca cac phU'O'ng phap, quy trlnh va tai 7.2.1.2 All methods, procedures and supporting. Ii~u h6 trQ', ch~ng h;im nhll' cae hll'ang dan, lieu documentation, such as instructions, standards, chu§n, s6 tay'va dCr Ii~u quy chieu lien quan a~n manuals reference and data relevant to the 25 TCVN ISO/IEC 17025:2017 cac hoat de;,n9thl nghi~m phai dLPQ'c c~p nh~t va laboratory.activities.shall be kept up to date and shallbemadereadilyavailableto personnel(see8.3). san co cho nhan SII (xem 8.3). 7.2.1.~ Phong thi nghi~m phal dam bao SLP dl,lng 7.2.1.3 The laboratoryshall ensure that it uses the phlen ban eo hi~u IIlC mel nhefttcua phlYO'ngphap latest valid version of a method unless It Is not triP khi °n6 khong thlch hop hoac khOng~hl! thllc appropriateor possibleto do so. When necessary. hiE;lnoU'Q'conhLP vf}.y.Khi can thiet, vi~c ap dl)Jig the application of the method shall be mot phLPO'ng phap phal kernthea nhling chi ti~t b6 supplemented with additional details to ensure sungd~ oam bao vlE;lcap dl,mgnhc1tquan, consistentapplication. CHO THicH: Cac tieu chu~n qu6c t~. khu VIlC, qu6c NOTE International, regional or national standards or gia ho~c cac quy dinh ky thu~t de dU'Q'Cthl1a nMn other recognized specifications that contain sufficient khac c6 chua thong tin d~y au va chinh xac v~ each and concise Information on how to perform laboratory thllc hi~n cac neat d¢ng thl nghi~m thl khOng cAn bO activities do not need to be supplemented or rewritten sung hoi;icv~t IC;lithanh cac quy trinh nQibi) n~u nhCi'ng as internal procedures if these standards are written in tieu chuan nay dlYQ'c vi~t theo each rna nhan Sl! tac a way that they can be used by the operating personnel nghi~p cua phong thl nghi~m co th~ su. dr,mg.C6 th~ in a laboratory. It can be necessary to provide C<1ncung c~p tai Ii~u b~ sung cho cac bU'ac tllY chQn additional documentation for optional steps in the trong phU'O'ng phap ho~c cac chi tiilt b5 sung. method or additional details. 7.2.1.4 Khi khach hang khong quy djnh phlFO'ng 7.2.1.4 When the customer does not specify the phap OlPQ'c SLPdl,mg,thl phOngthi nghl~m phai Il;I'a method to be used. the laboratory shall select an chQ,nphLPO'ng phap thich hQ'pva thOng bao cho appropriate method and inform the customer of kMch hang v~ phlPO'ngphap da chQn. Khuy~n the method chosen. Methods published either in nghj su dl,mgcae phU'O'ngphap dU'Q'c-xuatban international,regional or national standards, or by thea tieu .chu§nqu6c te, khu VIlC ho~c qu6c gia, -reputable technical organizations. or in relevant ho~c boi dic t6 ch(rc ky thu~t co uy tin, hay trong scientific texts or journals, or as specified by the cac bai bao ho~c t;;lP chi khoa hQCco lien quan. manufacturerof the equipment are recommended. ho~c theo quy djnh cua nha san xuat thi~t bi. Laboratorypdevelopedor modified methods can COngco th~ SlYdl,lngcac phU'O'ngphap do phOng also be used. thi nghi~mxay dllng ho~cslYadeSi. 7.2.1.5 TrlFac khi dLPavao SlY dl,lng. phong thi 7.2.1.5 The laboratory shall verify that it can nghi~m phai ki€!mtra xac nMn r~ng minh co th~ properly perform methods before introducingthem 0 thl,Fchi~n dung cac phLPO'ng phap b~ng each oam by ensuring that it can achieve the required bao rang phong thi nghi~m co th~ ol;lt oU'Q'ck~t performance. Records of the verification shall be qua c~n thi€!t.H6 sO'ki~m tra xac nh~n miy phai retained. If the methOdis, revised by the issuing dLPQ'cIlFUgiCY.Khi phU'O'ngphap nay oU'Q'cCO' body. verifICationshall be repeated to the extent quan ban hanh sua oBi,thi vi~c ki~m tra X8C nh~n necessary. phai dLPQ'c I~p l~i CJ mQtmuc de;,din thi~t. 7.2.·1.6 Khi c~n xay dl,mg phLYO'ng phap, thi vi(!c 7.2.1.6 When method development is required, 26 TCVN ISO/IEC 17025:2017 nay phai Ie m1;lthoat 01;lngoU'Q'choaoh djnh va this shall be a planned activity and shall be phai OLl'c;>'c giao cho cac nhan 51)' c6 nang h,C, assigned to competent personnel equipped.with dU'c;>'c trang bl nguOn Il)'c d€.y duo Khi vi~c xay adequate resources. As method development dl,mg phU'O'ngphap dU'Q'cti~n hanh, vi~e xem xet proceeds, periodic review shall be carried out to dinh ky phai dl1Q'cthlfc hi~n o~ xac nhan rang nhu confirm that the needs of the customer are still ca~ cua khach hang v~n dang dl1Q'coap (Png.~cit being ky fulfilled. Any sLPadOi nao 001v6'1kll hoach xay dlfng cOng development plan phai dl1Q'cphe duy~t va dl1Q'Cchap thu~n. modifications to shall be the approved and authorized. 7.2.1.7 eOi v6'i tat ca hoat d1;lngthf nghi~m,nhCing 7.2.1.7 Deviationsfrom methods for all laboratory sai I~ch khoi phl1O'ngphap chi dl1Q'cxay ra n~u activities shall occur only if the deviation has been sai I~ch d6 Ol1c;>'c I~p thanh van ban, dl1Q'c[y giai documented, technically justified, authorized, and ve m~t ky thu~t, dl1Q'ccho phep va dl1Q'ckhach accepted by the customer. hfmg chap nh~n. CHOTHlcH: Vil)c chc1pnMn cua khachMng dOiv6'i NOTE Customeracceptanceof deviationscan be saiI~ch~n dU'Q'c thoathuantrucl'CtronghQ'pdOng. agreedin advanceinthecontract. 7.2.2 Xae nh,n gia trj SLPd ...ng ella phllO'ng 7.2.2 Validation of methods phap 7.2.2.1 PhOngthi nghi~m pMi xac nMn gia trj sll 7.2.2.1 The laboratory shall validate non-standard dl,mg cUa cac phl1O'ngphap khong tieu chuan, methods, laboratory-developed methods and phU'O'ngphap do ph6ng thi nghi(lm xay dl,rng va standard methods used outside their intended cac phuO'ngphap tieu chuan duQ'csli dl,lngngoai scope or otherwise modified. The validation shall phGlmvi d1,J' ki~n ho~c dl1Q'cslIa d6L Vi~c xac be as extensiveas is necessaryto meet the needs nh~n gia trj sl) dl,lng phal dap (J'ngcae nhu cau a muc dO can thi~t d~ of the given applicationor field of application. ap dl,lng da djnh hay ITnh Vile ap d1,lng. CHOTHlcH 1: Xac nh~ngia trj Sll'dl,lngc6 thA baa NOTE 1 Validation can include procedures for gOmcac thu b,lcIc~ymau,xl) 15' va v~nchuy~ncacd61 sampling, handling and transportationof test or calibrationitems. tl1Q'ng thll' nghi~mho~chi~uchuAn. CHOTHicH 2: Cae ky thu~t QU'Q'c Sll' d\lng oA xac NOTE2 Thetechniquesusedfor methodvalidationcan nh~ngia trj Slr dl,lngcua phU'O'ng phSpc6 thll Is mOt beoneof,or a combinationof,thefollowing: ho~ckftt hQ'pcua: a) hi~uchu~nho~cdfmh gili dOch~chva dOchvm a) bang vi(ic Sll' dt,mgcac chuan chlnh ho~c mau calibrationor evaluationof bias and precision usingreferencestandardsor referencematerials; chu~n; b) dsnh gia co M th5ng cac y~u t6 anh huang d~n b) kllt qua; systematicassessmentof the factorsinfluencing theresult; 27 TCVN ISOIIEC 17025:2017 c) thli nghi~m dO bn djnh cua phllO'ng phcip qua sl! lesting method robustness through variation of bien d¢ng cua cac thOng sO dll'Q'c kiilm soat nhll controlled nhi~tdQ tli am. thl! tich do•...; temperature,volume dispensed,etc.; so sanh cac k~t qua d<;ltdlJ'qc bOl cac phU'cmg d) comparison of phap kMc <Ia dlJ'qcxac nh~n gia trj sUod',mg; validated methods; d) e) e) so sanh lien phong; f) e) parameters such results as incubator achieved with other interlaboratorycomparisons; danh ghl dO khong dam baa do eua cac kat qua f) evaluation of measurement uncertainty of the dva tren sl,l'hi~u bi~t v~ cac nguyen Iy results based on an understanding of the phap va cua phU'O'ng theoretical principles of the method and practical kinh nghi~m thl,l'Ct~ v~ vi~c thV'Chii~n experience.of the performance of the sampling or phllO'ngphap lay mAuho~ethll nghi~m. test method. 7.2.2.2 Khi thllc hii~n cac thay dll! dOi vai mOt 7.2.2.2 When changes are made to a validated phlfO'ng phap da dU'Q'cxac nh~n gia trj sUr d',mg, method, the influence of such changes shall be thi phai xac dinh anh hlfcmg cua nhiing thay doi determined and where they are found to affect the nay va n~u chUng dlfQ'e phat hi~n lei c6 anh original validation, a new method validation shall huang d~n vi~c xac nh~n gla tli sUodl,lng ban (Sau, be performed. thi phai ti~n h~mh mQt xac nh~n gia trj sUodl,mg moi d6i v6'i phlfO'ng phap. 7.2.2.3 Cac thong s6 d~c trU'ng eua phU'O'ngphap 7.2.2.3 The performance characteristics of d§ dlfQ'Cxae nh~n gia trj sli dl,lng khi danh gia eho validated methods as assessed for the intended vi~c sli dl,lng d§ dinh, phcii thieh hQ'p vai nhu eua khach Mng va nhat quan v6i cae yeu ~u cau xac use, shall be relevant to the customers' needs and consistent with specified requirements. djnh. CHO THlcH: Cae thong s6 d~e trung c6 -th~ bao ge,m, NOTE Performancecharacteristics can include, but are nhllng khong giai h~n (1, ph~m vi do, di) chlnh xac. dQ not limited to, measurement range, accuracy, khong dam baa do cua k~t qua, giai h~n phat hi~n, gi&i measurement uncertainty of the results, limit bf h~n dinh IlIqng, cl) chQn IQc cUa phllong philp, cl) detection, limit of quantification, selectivity of the tuy~n tinh, d¢ I~p I~i ho~c cl} tai i~PJdl) 6n cinh dOivai method. linearity, repeatability or reproducibility, cac anh hlJ'(ingban ngoai ho;\icdO nh~y val nhi~u tLl' robustness against external influences· or crosssensitivity against interference from the matrix of the ch~t n~ncua miiu ho~c dOitlJ'qngthUova dl) eti~ch. sample or test object, and bias. 7.2.2.4 Phong thi nghii;m phai lU'u giCr cae h6 sO' 7.2.2.4 xac nh~n gia trj SlPdl,mg sau: Slf dl,lng dlfQ'C dung; a) thu tl,le xac nh~n gia trj b) quy djnh k9 thu;\it v~ cae yeu cfiu: c) . xac dinh cac thOng s6 dclictflrng cua phlfO'ng 28 The laboratory shali retain the following records of validation: a) the validation procedure used; b) specification of the requirements; e) determination of the performance TCVN ISOIIEC 17025:2017 characteristicsof the method; phap; d) kllt qua thu dllQ'c; e) cong b5 v~ gia trl SLPdl,lngcua phllO'ngphap, e) a statement on the validity of the method, neu chi ti~t v~ SV'phu hop cua phLYO'ng phap detailing Its fitness for the intendeduse. vol muc dieh SLPdl,lng. d) results obtained; mc1u 7.3liy 7.3 Sampling 7.3.1 PMng thl nghi~m phSi co k~ hoach va 7.3.1 The laboratory shall have a sampling plan' phLYO'ng phap lay m~u khi th~nhanh lay m~u cac and method when it carries out sampling of chat, v~t Ii(:luho~e san ph~m d~ thLPnghi~m hoac substances, materials or products for subsequent hi~u chuan sau do. PhLYO'ng phap lay m~u ph8; d~ testing or calibration. The sampling method shall cap d~n cac y~u t6 can dU'Q'cki~m soat d~ dam address the factors to be controlled to ensure the bao gia tri SLPdl,lng cua cac k~t qua thli nghi~m validity of subsequenttesting or calibrationresults. hoac hi~u chuan sau do. Ke hoach va phllO'ng The sampling plan and method shall be available phap lay mau phai c6 san tal dia di~m mau dLYQ'cat the site where sampling is undertaken. lay. Cac k~ hoach lay mau phai dV'a tren cac Sampling plans shall, whenever reasonable, be phllO'ngphap thOngke thich hep, n~u hQ'pIY. based on appropriatestatisticalmethods. 7.3.2 PhlJ'O'ngphap hiy m§u phai quy d!nh: 7.3.2 a) vi~c lila chQnmau ho~c dja di~m; a) the selectionof samples or sites; The sampling method shall describe: b) the sampling plan; c) vi~c chuan bi va xli Iy (cae) mau tCrmot chat, c) v~t Ii~u hoi;icsan ph~m thu dllQ'c dOitLYQ'ng substance, material or product to yield the can thiet cho vi~c thlr nghi~m ho~c hl~u chu~n required item for subsequent testing or ti~p theo. calibration. de CHO THicH: Khi ti~p nh~nvao phOngthf nghi~m, c6 th~ can OLPQ'cxli 19 them theo yeu cAu 7.4. a preparationand treatment of sample(s)from a NOTE When received into the laboratory, further handling can be required as specified in 7.4. 7.3.3 PhOngthl nghi~m phallLPUgill he,sO'v~ dll 7.3.3 The . laboratory shall retain records of litilu I§y mllu lei mOt phan thCrngh'i~mho~c hi~u .sampling data that forms part of the testing or chuan dllQ'c thl,l'c hi{m. Khi thlch hQ'p,nhOrng he, calibrationthat is undertaken.These records shall sO'nay phal bao g6m: include,where relevant: a) vi~n dan t&i phLYO'ng phap liiy mau dLYQ'c Slr a) referenceto the sampling method used; dl,lng; b) ngay va gia lay mau; b) date and time of sampling; c) diP Ii~u d~ nh~n bi~t va mO ta miiu (vi dl,l s6 c) • IlJ'Q'ng , 1lJ'Q'ng, ten): data to identify and describe the sample (e.g. number,amount,name); 29 TCVN ISOIIEC 17025:2017 d) identification of the personnel performing sampling; e) nhan bi~t thl~t b! dU'Q'csli dl,lng; e) Identificationof the equipmentused; f) cac dil!u ki~n moi trU'angho~c v?onchuy~n; f) environmentalor transport conditions; g) so db hoac cac each tU'O'ngdl1O'ngkhac d{: g) diagramsor other equivalentmeansto Identify nh~nbi~t v[ trr Ic~ymau, khi thfch hcp: va the sampling locationwhen appropriate;and h) nhCi'ngsal I~ch. b6 sung ho~c IOlili tru khOi h) deviations. additions to or exclusionsfrom the phU'O'ng phap I§y mau va k~ hoach lay mAu. 7.4 Xu. Iy a6i tU'Q'ng thCr nghi~m ho~c hi~u sampling methodand sampling plan. 7.4 Handling of test or calibration items chuan 7.4.1 Phongthi nghi~mphai co thll tuc dOivai viec 7.4.1 The laboratory shall have a procedure for v~n chuy~n.ti~p nhan, xl} IY. bao ve, bao quart, the transportation. receipt. handling. protection. luu giiY. huy be) hay tra I~i cac dOi tlJ'Q'ngthti storage. retention. and disposal or return of test or nghi~m ho~c hieu chuan, bao g6m t§t ca cac quy calibration items. including all provisions ajnh cAn thi~t a~ bao ve 51! toan ven cua aOi necessary to protect the integrity of the test or tU'Q'ngthli nghi~m ho~c hieu chu~n va dl: bao v~ calibration item, and to protect the inte~~stsof the lQ'iich cua phOngthi nghiem va kMch hang. Phai laboratory and the customer. Precautionsshall be th~n trQngd~ tranh SI! hLPhong. nhi~m b§n. mat taken to avoid deterioration,contamination,loss or mat hay ton h~i coi tLPQ'ng nay trong qua trinh xli damage to the item during handling. transporting. JY. ~n storing/waiting. and preparation for. testing or chuy~n.ILPU giiY/chadQ'iva chuan bi d~ thl) nghi~mho~c hiiiluchUiln.Phai tU8nthu cac hLPang calibration.Handling instructions provided with the dan xli Iy aU'ara vai doi tU'Q'ngdo. Item shall be followed. 7.4.2 PhOngthi nghi~m phiti c6 mQt h~ thc3ngd~ 7.4.2 The laboratory shall have a system for the nh~n biet mi;>teach ro rang v~ cac doi tlJ'Q'ngtbli .. unambiguous idel,ltjflcatipn of test or calibration nghi~m ho~c hi~u' chuan. Vi~c nMn 'bi~tphcii . items.The identificati~~shall be retainedwhile the dLPQ'c duy tri chlmg nao cac dOitU'Q'ngcon thuQc item is under the responsibility of the laboratory. trach nhi/f!mcua phong thr nghi~m. H~ th6ng nay The system shall ensure that items will not be phai dam bao rc1,ngcae dOl tllQ'ng sa khong bi confused physically or when referred to in nh§m (fin v~ m~t v~t Iy ho~c nham Ian khi dU'Q'c records or other documents. The system shall. if dan chi~u trong cac h6 sO'hay cac tai Ii~u khac. appropriate. accommodate a sub-division of an Khi thich hQ'P.h~ thong nh~n bl~t nay phai h6 trQ' item or groups of items and the transfer of items. vi~c pMn nho doi tLPQ'ngho~c cac nhom doi tU'Q'ngva 51! chuy~ndich cac dElitU'Q'ng. 7.4.3 Ngay khi nMn dElitlJ'Q'ngthl} nghi~m hoclic 7.4.3 Upon receipt of the test or calibration item, hj~u' chu§n, phai ghi nh:\3nv€JnhiYngsai I~ch so deviations from specified conditions shall be 30 TCVN ISOllEe 17025:2017 vo-icac di~u ki~n quy djnh. Khi c6 nghi nga v~ Sl! recorded.When there is doubt about the suitability thich hop cua d6i tU'gng thLPnghi~m ho~c hi~u of an item for test or calibration, or when an item ohuan, ho~c khi d6i tU'gng khang phu hop vo-ime> does not conform to the description provided, the ta da dU'Q'ccung cap, phong thf nghi~m phal tham laboratory shall consult the customer for further van khach hang v(, nhung chi d~n ti~p thea tnroc Instructions before proceeding and shall record khi ti~n hanh va phai ghi nhan k~t qua cua vi~c the results of this consultation.When the customer tham van nay. Khi khach hang yeu cc\u thLP requires the item to be tested or calibrated nghi~rnho~c hi~u chuAndt.i tU'c,mgdU'Q'C ghi nh~n acknowledging a c6 Sl! sai Il;lch so v6'i cac d1~u kl~n quy djnh, conditions, the deviation from laboratory shall specified include a ph6ng thl nghili!mphal dU'aV80 baa cao tuyen b6 disclaimer in the report indicating which results khOngchlu trach nhit;lm,trong d6 chi ra nhOngket may be affected by the deviation. qua c6 th~ bj snh hU'ongboi sai I~chd6. 7.4.4 Khi cac d6i tlJ'gng can dlfQ'CILPUgili hoac 7.4.4 When items need to be stored or conditioned dU'gc on d!nh trong nhung di~u ki~n moi wang under specified environmental conditions, these nhat dinh, thi nhrmg di~u ki~n nay phcii<JlJ'Q'c duy conditions shall be maintained, monitored and trl, theo doi va llJ'uh6 50'. recorded. 7.5 He. sO' ky thu~t 7.5 Technical records 7.5.1 Ph6ng thi ngh!{lm pMi dam bao r~ng cac hO 7.5.1 The laboratory shall ensure that technical sO'ky thu~it cho bing ho~t dQngthi nghi~m d~u records for each laboratory activity contain the phil! bao gOmcac kilt qua, bao cao va thong tin results, report and sufficient Information to d~y du d~ tiilo thuan lQ'i,khi c6 th~, cho vi~c nMn facilitate, if possible, identification of factors bi8t cae y~u t6 anh hlJ'ong<Janket qua do va de;, affecting the measurement result· and its khOngdam bao do kern theo va t90 kha nang d~ associated measurement uncertainty and enable I~p Iiii! h09t dQngthi nghil;lm nay trong di~u ki~n the ,repetition of the laboratory activity under giong nh&t co th~ so vo-i di~u kil;ln ban <Jau.Cac conditionsas close as possibleto the Original.The ho sO' ky thu~t phai bao gllm thai gian va vili!c technical records shall include the date and the nh~n bi~t nhan 51,1' chiu trach nhi~m <Jaival mOi identity of personnel responsible for each hOiiltde;,ngthi nghi~m va cho vi~c ~i~m tra dCl'Jililu laboratory activity and for checking data and va k~t qua. Cac quan troic,dli Ii~u g6c va cac tinh results. Original o~servations. data and toan phal <JLPQ'c ghi nhan tOilithai <Ji~mchUng<JlJ'Q'ccalculations shall be recorded at the time they are thl,J'chi~n va phcii c6 khil nang nh~n biltt c:76i val made and shall be identifiable with the specific nhi~m VI,J ct,Jthil. task. 7.5.2 PMng thi nghi~m phili <Jambao r~ng nhCl'ng 7.5.2 The laboratory shall ensure that 5lia dOi d6i val hO 50' ky thu(it c6 th~ truy xuat amendments to technical records can be tracked <JU'Q'c to-I cac phien ban tl1l'ac do ho~c tai cac to previous versions or to original observations. . quan trac 96c. Ccl dCl'lifilu gac va du Ii~u dlJ'Q'c 80th the original and amended data and flies shall SUta d6i d~u phai dU'Q'clU'ugiCl', bao gbm ca ngay be retained, including the date of alteration, an 31 TCVN ISO/IEC 17025:2017 thay dOi. chi ra cac khTa canh dlPQ'c thay dbi va indication of the altered aspects and the personnel nhan 51,1' chju trach nhi~m v~ nhii'ng thay dOl. responsible for the alterations. 7.6 f)anh gia d9 khang dam bao do. 7.6 Evaluation 7.6.1 PMng thl nghi~m phai nhan biltt cac thanh 7.6.1 Laboratories shall ~dentify the contributions ph§n do khang dam bao do; Khl danh gia do to measurement kh6ng dam bao do, mol thanh phan d6ng g6p measurement uncertainty all contributions that are dang k~, kll of measurement cci nhCfng thanh phan nay sinh tif vi~c of significance, uncertainty. be taken into account phlPO'ngphap pMn tich thich hop. appropriate methods of analysis. 7.6.2 Phong thl nghi~m thl,l'c hi~n hi~u chuan, k6 7.6.2 cci hi~u chuan thl~t bl evaluating those sampling, A When including I§y mau, d~u phal dlPQ'ctfnh dl!n nhO' sli dl,mg cac shall uncertainty laboratory arising performing from using calibrations, caa minh, phai danh gia dO including of its own equipment, shall evaluate the kh6ng dam bao do d6i vai tilt ca cac phep hl~u measurement uncertainty for all calibrations. chuan, 7.6.3 Ph6ng thi nghi~m tiijn hanh thli nghi~m pMi dfmh gia dO khang dam bao do. thli khOng th~ danh gia chlnh xae d9 cae nguyen t~c Iy thuy~t laboratory performing testing shall Khl phlPO'ngphap evaluate measurement uncertainty. Where the test khOng dam' method bao do, thl pMi U'ac 1U'Q'ngn6 dl,l'a tren 51! hieu bi~t v~ 7.6.3 A ho~c kinh nghi~m thl,l'c t~ v~ kflt qua thl,l'Chi~n cua phlPO'ngphap d6. 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. CHO THlcH 1: Trong trU'cmg hc;Yp, phllO'ngphilp thit d~ NOTE 1 In those cases where a well-recognized test dU'Q'cthCYanh~n rQngrai, quy djnh gloi hqn cac gia trj method specifies limits to the values of the major cua ngu6n khOngdam bao do chinh va quy djnh hlnh sources of measurement uncertainty and specifies the thuc th8 hi~n cac k~t qua tlnh toan, thl phong -thl form of presentation of the calculated results, the nghi~m dlJ'Q'cxem lei thoa man 7.6.3 khi tutin thea laboratory is considered to have satisfied clause 7.6.3 phuO'ngphilipttlli va cae hllang dAn baa cao nay. by following the test method and reporting instructions. CHOTHICH 2: £>61 val mQtphllO'ngphap C1,I th~ rna dQ NOTE 2 For a particular method where the khong dam baa do cua cae k~t qua da dU'c;YC thl~t I~p measurement uncertainty of the results has been va ki~m tra XBC nMn, thl khong can danh gia dQkhong established and verified, there is no need to evaluate dam baa do cho tflng k~t qua, m~uphong'thi nghl~m c6 th~ chung to r~ng cac yflu measurement uncertainty for each result, if the t6 snh hU'ang quan trQng laboratory can demonstrate that the identified critical dU'Q'cnh~nbiet d~u dlPQ'cki8m soat. influencingfactors are under control. CHU THlcH 3: Thong tin them, xem TCVN 9595-3, b{l NOTE 3 tieu chuclnTCVN 6910 va TCVN 10861. 98-3, ISO 5725 and ISO 21748 series. 7.7 -£lambao gici trl siP dIJng eua k~t qua 7.7 Ensuring 7.7.1 Phong thT nghiem phai c6 quy trlnh theo doi 7.7.1 The laboratory shall have a procedure for 32 For further information see ISO/IEC Guide the validity of results TCVN ISO/lEe 17025:2017 giil trj Slr dl,lng cua cac k~t qua. OQ> Ii~u t90 ra monitoring the validity of results. The resulting phai dU'Q'cluu he, SO'sao. cho e6 kha nang phat data shall be recorded in such a way that trends hi~n dl1Q'c cac xu hlP&ng va khi co th~, phai ap are detectable and, where practicable, statistical dl,mg cac ky thu~t thOng ke df! xem xet k~t qua. techniques shall be applied to review the results. Vi~c thea doi nay phai dU'Q'c hoach djnh va xem This monitoring shall be planned and reviewed xet va khi thlch hop phai baa gbm, nhU'ng khang and shall include. where appropriate, but not be gi&i han &: limited to: a) vit?c Slr dvng mau chu~n ho~c cac v~t Ii~u a) ki~m scat chat 1U'Q'ng; use of reference materials or quality control materials; b) vi~c Slr dl,Jng thi~t b] thay th~ da dU'Q'chi~u b) use of alternative instrumentation that has been calibrated to provide traceable results; chuan d~ cung cap cac kat qua cO khcll nang lien k~t chuAn; . c) (cac) ki~m tra v{} van hanh coa thillt bl do c) lU'cYngva thlr nghi~m; functional check(s) of measuring and testing equipment; d) Slr dl,lng cac chuAn killm tra ho~c chuan .cOng d) tac cung vai cac bi~u dO ki~m soat, n8u c6 th~ use of check or working standards with control charts, where applicable; ap dvng; e) intermediate checks on measuring equipment; hili b~ng cach f) replicate tests or calibrations using the same e) kl~m tra giQsaky thi8t bi do lU'cYng; f) thlP nghi~m ho~c hl~u chuan lijp Slr d\mg cung m¢t phlPO'ng phap hay phl1O'ng or different methods; phap kMc; g) thli nghi~m ho~c hi~u chuAn i:;ti trEmd6i tuQ'ng g) retesting or recalibration of retained items; dU'Q'clU'u; h) m6i tl1O'ng quan giCia cac k~t qua v~ cac d~c h) correlation of results I) review of reported results; j) so sanh trong nQi be;,phong thi ngh!~m; j) intra-laboratory cOf!1parisons; k) thli nghl~m (cac) mdu mu. k) testing of blind sample(s). xem xet k~t qua dU'Q'Cbao cao; different characteristics of an item; tinh khac nhau cua cung me;,tdOi tLPc;mg; i) for 7.7.2 PhOng thl nghl~m phai thea do! k~tqua thl,l'c 7.7.2 The laboratory shall monitor its performance hi~n -eua minh thang qua vic}c so sanh vOi k~t -qua by comparison with results of other laboratories, cua cae ph6ng thi nghlc}m khac. khl s~n c6 va where available and appropriate. This monitoring thich hQ'p.Vi~c thea dol nay pMi dU'Q'c'ho~ch djnh shall be planned and reviewed and shall include, va xem xet va phai baa gllm, nhU'ng khang giai but not be limited to either or both of the following: h9n a vi~c Iva chQn ml)t ho~c ca hal cach sau: 33 TCVN ISO/IEC 17025:2017 a) tham gia thir nghi~mthanh thao; a) participationin proficiencytesting; CHU THlcH: TCVN ISO/IEC 17043 bao Q6mthong tin NOTE ISO/IEC 17043 contains additional information bi) sung v~ thLPnghi~mtnanh thao va cac nM cung cAp on proficiency tests and proficiency testing providers. thli nghil)m thanh thao. Cac nM cung c¬ iip thlt nghi~m Proficiency testing providers that meet the thanh th90 dap (fng cac yeu ~u cua TCVN ISO/IEC requirements of ISOIIEC 17043 are considered to be 17043 dtlQ'ccol If:!c6 nang IIIC. competent. b) tham gia cac hlnh th(rc so sanh IiAn phong thl b) participation in interlaboratory comparisons nghi~mkhac ngoai thti nghi~m tMnh thao. other than proficiencytesting. 7.7.3 DCP li~u tli cac hoat d¢ng theo doi phal dU'Q'c 7.7.3 Data from monitoring activities shall be phan tieh va SlYdl,mgd~ ki~m scat va nllu c6 th~, analysed and used to control, and if applicable, cai ti~n cac hoat ,dQngcUa phong thi nghi~m. Khi improve the laboratory's activities. If the results of k~t qua phan tlch dCi>li~u tli hoat d,{lng theo doi the analysis of data from monitoring activities are cho thay n6 nam ngoai cac lieu chf da dllQ'c xac found to be outside pre-defined criteria, djnh, thi phal thllc hi~n hanh d¢ng thrch hQ'pd8 appropriate action shall be taken to prevent ngan ngCravi~c baa cao cac k~t qua sai. incorrectresultsfrom being reported. 7.8 Bao cao ket qua 7.8 Reporting of results 7.8.1 Yeu cau chung 7.8.1 General 7.8.1.1 Cac k';t qua phai dllQ'Cxem xllt va phe 7.8.1.1 The results shall be, reviewed and duy~ttruO'ckhi cilia ra. authorizedprior to release. 7.8.1.2 Cac ket qua phai dllQ'Ccung cap mot cach 7.8.1.2 The results shall be provided accurately, chinh xac, ra rang. khong gay hi8u sai va khach clearly, unambiguouslyand objectively, usually in quan, thllcmg la d~ng bao cao (vi dl,l bao cao thll' a report (e.g. test report or a calibration certificate nghi~m ho~c gh~ychlmg nh~n hi~u chu~n ho~c or report of sampling) and shall include all the baa cao lay maul va phai baa gOm tat cs cac information agreed with the customer and thong tin thoa thu~n vO'ikMch hc:mg va c§n thiet necessaryfor the i!1terpretationof the results and cho vi~c giai thich ket qua va mQithOng tin theo all information required by the metho~ .u,se.d .. AlI yeu cau cua phllO'ngphap dLPQ'c SlY dl.mg.Tiit ca i,ssued reports shall be retained as technical cac baa cao da dU'Q'cban hanh pMl dU'Q'clU'ugiQt records. dU'&idGlnghOsO'ky thw)t. CHU THlcH 1: Vcri ml,lCdich cua tieu chuan nay. baa. NOTE 1 For the purpose of this document. test reports cao thLPnghi~mva giAychli'ng nh~n hi~u chu~n aoi khi and calibrationcertificates are sometimes referred to as I~i OlJ'Q'c gQila giay ch(fng nh~nthLPnghi~m va baD cao test certificatesand calibration reports, respectively. hi~u chuan, CHU THlcH 2: Cae bao cao cO th8 oU'Q'cphSt hanh NOTE 2 Reports can be issued as hard copies or by dtlai d~ng ban c(fng ho~c bang cac phtlO'ng ti~n di~n electronicmeans. provided that th~ requirementsof this hi. vcr; dil3U kitilndap (fng cae yeu c~u cua lieu chu~n documentare met. 34 TCVN ISO/IEC 17025:2017 nay. 7.8.1.3 Khi dlJ'Q'ckhach hang d6ng '1, cac k~t qua 7.8.1.3 When agreed with the customer/ the co th~ dlJ'Q'cbao cao m{lt each don gfan. MQI results may be reported in a simplified way. Any thong tin dU'Q'cneu trong 7.8.2 d~n 7.8.7 rna information '!lsted in 7.8.2 to 7.8.7 that Is not khOngdllQ'c bao cao cho khach hang d~u phal c6 reportedto the customershall be readilyavailable. e san. 7.8.2 Sao eae (thli nghj~m, hi~u chuAn hOfC 7.8.2 Reports (test, calibration or sampling) lay mAu)- Cac yeu cAu chung - common requirements 7.8.2.1 Moi bao cao phai bao gOm It nhat cac 7.8.2.1 Each report shall Include at least the thong tin sau, tn) khi phong thi nghi~m c6 nhfrng following Information, unless the laboratory has ['1 do hQ'P[~ d~ khong [am nhu v~y, b~ng each d6 valid reasons for not doing so, thereby minimizing se giam thillu bat kY kha nang hieu nham ho~c sUo any possibilityof misunderstandingor misuse: dl,mgsai: a) tieu d~ (vi du "Bao cao thl) nghi~m", "Giay a) a title (e.g. "Test Report", "Calibration Certificate" or ~Reportof SampJing~); chlmg nhan hi~u 'chu§n" hoac "Bao cao lay mau"); b) ten va dia chi phong thi nghi~m; c) vi tff thl,l'Chh}ncac hoat dOngthl nghi~m,ke ca b) the name and address of the laboratory; c) the location of performance of the laboratory khi thl,l'chi~n t~1CO' sa cua khach hang ho~c activities, including when performed at a t~1icac dia diem cach xa cO'sa thU'cyngxuyen customer facility or at sites away from the cua.phong thi nghi~m, ho~c a cac 00 sett9m laboratory's thai lien quan ho~c cO'sa di oQng; associatedtemporary or mobilefacilities; permanent facilities, or in d) nh~n bi~t duy nhat tat ca cac phan cua bao d) unique identification that all tts components cao dllQ'c ghi nMn la mQt phan eua bilo cao are recognized as a portion of a complete hoan chinh va nMn billt ro ph§n kllt thUc cua report and a clear identificationof the end; bao cao; e) ten va thong tin lien h~ eua khachhang; . e) the name and contact information of the customer; f) nh~n bi~t phllO'ngphap stYdl,lng; f) g) rna ta, nh~n billt ro rang, va khi -can. di~u g) ki~n/tinh tr~ng cua d6i tllgng; identificationof the methodused; a description. unambiguous identification. and, when necessary. the condition of the item; h) ngay nh~n (cac) dOi tllQ'ng thlP nghi~m hociic h) the date of receipt of the test or calibration hi~u chuAn. ngay lay m~u. n~u di~u nay la item(s), and the date of sampling.where this quan trc;>ng deSivai gla trj sUodl)ng va vi~c (l'n9 is critical -tothe validity and applicationof the 35 TeVN ISOllEe 17025:2017 dl.lngk~t qua; i) results; ngaythV'chi~n heat dOngthl nghi~m; i) the date(s) of performance of the laboratory activity; j) ngay phat hanh bao cao: 1) the date of Issue of the report; k) vi~n dan alln k~ hoach va phU'oongphap I~y k) referenceto the sampling plan and sampling mau dU'Q'cphong thl nghi~m ho~c cac t6 chlic method used by the laboratory or other khac Slr dlJng n~u nhQlngdi~u nay c6 Ii~n bodies where these are relevant to the quan d~n gia trj sl) dl)ng ho~c vi~c emg dl,lng validityor application of the results; k~t qua; I) tuyen b6 v~ hi~u h,C r~ng'cac k8t qua chi lien I) a statement to the effect that' the results quan o~n dOl tll'Q'ngdU'Q'cthl) nghi~m, hl~u' relate only to the items tested, calibrated or chu~n hoac lay m~u; sampled; m) k~t qua g~n vai don vi do, khi thieh hop; m) the results with, where appropriate, the units of measurement; n) cac bOsung dOival phllO'ng phap, nhling sai n) I~chho~c cac lo~j tn) khoi phU'O'ngphap; additions to, deviations, or exclusions from the method; 0) nhan bi~t (nhling) ngLFaiphe duyet bao cao: 0) identification of the person(s) authorizing the report; p) nh~n bl~t ra nhling k~t qua lei eua nha eung p) ~p ben ngoai. clear identification when results are from externalproviders. CHO THlcH: Ell/a ra mQttuyen b6 quy dinh rAng "bao NOTE Including a statement specifying that "the report cao khong dl/Q'csao chep mQtcach khOng day du va shall not be reproduced except in full, without approval khong co sif ch§p thu~n cua phong thi nghj~m" co th~ of the laboratory"can provide assurance that parts of a mang 19iSlf dam bac r~ng cac phan trong bao cao reportare not taken out of context. kh6ng bl tach khoi ngC;canh. 7.8.2.2 Phongthl nghi~m phai chju trach nhi~m v~ 7.8.2.2 The laboratory shall be responsible for aU tcit ca cac thong tin neu trong bao cao, tn) khi d6 the Information provided in the report, except la thong tin QU'gccung c§p bZYikhach hang. Dii when Information is provided by the customer. li~u dU'Q'ccung cap bOoikhach hang phai dU'Q'c Data provided by a customer shall be clearly nh~n bi~t ro rang. Ngoai ra, tuyen b6 til ch61trach identified. In addition, a disclaimer shall be put on nhi~m phai OllQ'Cneu trong bao cao khi thOngtin the report when the information is supplied by the dU'Q'ccung cap bOoikhach hang c6 th~ anh hLl'ang .customer and can affect the validity of results. d~n gia trt Slr dlJrig cua ket qua. N~u phong thi Where the laboratory has not been responsiblefor nghj~mkhOngchiu trach nhi~m trong giai do~n lay the sampling stage (e.g. the sample has been mAu (vi dl.l mau Oll'Q'c 'kMch hang cung cap), thl provided by the customer), it shall state in the 36 TCVN ISO/lEe 17025:2017 phai neu trong bao cao r~ng cac kilt qua dU'Q'C ap report that the results apply to the sample as received. dl,1n9cho m§u nhan dU'Q'c. 1.8.3 Yeu c~u Cl,I th~ dai v6ti bao cao thiP 7.8.3 Specific requirements for test reports nghi~m 1.8.3.1 Ngoai cac yeu diu neu trong 7.8.2, bao 7.8.3.1 In addition to the requirements listed in cao thLPnghi~m phal, khi clm giai thich kilt qua 7.B.2, test reports shall, where necessary for the thLP nghi~m,bao gcm: interpretation of the test results, include the following: a) thang tin v~ di~u ki~n thli nghi~m ch~ng han cac diau ki~n mol trU'ong; b) khi co lien quan, tuyen bO v~ 51,1' cv th~, a) information on specific test conditions, such ., as environmentalcondItions; ph(! hop val b) where relevant, a statement of conformitywith yeu c~u hoac cac quy dinh ky thu~t (7.B.6); requirementsor specltlcations (7.8.6); c) khi co th~, de;,khang dam baa do dl1Q'ctrinh c) where vi tuO'ngd6i cua d~i 1U'Q'ng dl1Q'cdo (vi du nhu ph~n tram) khi: - - the measurernent : uncertainty presented In the same unit as that bay thea clmg mQtdO'nvi cua d~i 111Q'ng dl1Q'c do h~c theo dan applicable, of the measurand or in a term relative to the measurand(e.g. percent)when: n6 lien quan d~n gia trj Slr dVng ho~c vi~c it is relevant to the validity or application LPngd',mg cac k~t qua thlr nghi~m; of the test results; mQtchi dan caa khach hang mang tinh yeu a customer'sinstructionso requires,or cau,ho~c - dQ khang dam baa do anh hl1ang dlln sl! the measurement uncertainty affects phCrhQ'pvai mt')tgi&i h,;lnk9 thu~t; conformityto a specificationlimit; d) khi thich hQ'p, nau y kiiln va dien giai (xem d) where 7.8.7); appropriate, opinions and interpretations(see 7.8.7); e) thOng tin bO sung .co th~ thea yeu du eua e) additional informationwhich may be required phlPO'ng,phap. cO' quan quan.IY, khach hang by specific methods. authorities, customers hay nhom kMch hang CI,I th€!. or groups of custQmers. 7.8.3.2 Truong hQ'p'phOngthl nghi~m chju trach 7.8.3.2 Where the laboratory is responsiblefor the nhi~m v~ h09t d(lng lay m~u. bao cao ~!) nghi~m sampling activity, test reports shall meet the phai dap Lingcac yeu du neu trong 7.8.5 khi can requirements listed in 7.8.5 where necessary for d8 giai thich cac kilt qua thlr 1.8.4 Yeu nghi~m. cAu cv th' dbi v6ti glay cilllng nh,n hi~u chu&n the interpretationof test results. 7.8.4 Specific reqUirements for calibration certificates 7.8.4.1 Ngoai cac yeu cau neu trong 7.8.2. glay 7.8.4.1 In addition to the requirements listed in 37 TCVN ISO/IEC 17025:2017 ch(fng nh~n hi~u chuan phal baa g6m: 7.8.2, . calibration certificates shall include the following: a) dQ khong dam bao do cua k~t qua do dllgc a) the measurement uncertainty of the trlnh bay theo cung mi?tdon vj cua dlili IlIQ'ng measurement result presented in the same dllQ'c do ho~c thea don vi tllO'ng dOi cua d~1 unit as that of the measurand or in a term 1U'Q'ng dllQ'cdo (vi dl,lnhll ph~ntram); relativeto the measurand(e.g. percent); CHI) THlcH: Theo TCVN 6165, mOtk~t qua do thllcmg NOTE According to ISOIIEC Guide 99, a measurement dllQ'cbi~u di~n dllai d9ng mQtgia trj d;;tilU'Q'ngdo dan result Is generally expressed as a single measured ca dO'nvi c:Jova oQkhong dam bao do. bao gOm quantity value including unit of measurement and a measurementuncertainty, mol trucmg) trong d6 b) the conditions (e.g. environmental) under vi~c hi~u chuan da dtJQ'cthl,l'c hi~n c6 anh which the calibrations were made that have hl1Qrngd~n cac k~t qua do; . an influence on the measurementresults; b) cac dl~u ki~n (vi dl,l nhtr c) tuyen b6 xac dinh cac phep do c6 lien k~t c) a chuan00 Illong nhu th~ nao (xem Phl,lllJcA); statement identifying how the measurements are metrologically traceable (see AnnexA); d) cac k~t qua trlPaCva sau khi hiiju chinh hoiiic d) the results before and after any adjustmentor SUB repair, if available; chua, neu c6; e) khi c6 lien quan, tuyen b6 v€!Sl! phU hQ'pval e) where relevant, a statement of conformitywith yeu cAuho~c cac quy dinh ky thu~t (7.8.6); requirementsor specifications(7.8.6); f) khi thich hQ'p,nau y ki~n va di~n giai (xem f) 7.8.7). where appropriate, opinions and interpretations(see 7.8.7). 7.8.4.2 Trl1cmghQ'pphOngthi nghi~m chju trach 7.8.4.2 Where the laboratory is responsiblefor the nhi~m v~ hOliltdQng I§y m§u, thi khi c§n gi§y sampling activity, calibrationcertificatesshall meet ch(Pngn~~nhi~u ~huanpbai dap ling ca,cyau cau the requirements listed in 7.8.5 wh~re necessary nau a 7.8;5 of, di~n giai cac k~t qua hi~u chu§n. for the interpretationof test results. 7.8.4.3 Giay chling nh~n ho~c tern hi~u chuan 7.8.4.3 A calibration certificate or calibration label khOngOl1Q'cchlia bat ky dll xu§t nao v~ khoang shall not contain any recommendation on the thai gian hi~u chuan ngoGlitni' dil~u d6 da dU'Q'c calibration Interval except where this has been thoathu~n val kh.kh hang. agreedwith the customer. 7.8.5 Bao cao I~y mau - cac yeu cfiu c....th~ 7.8.5 Reporting sampling specific requirements Trll(mg hqp phongthi nghi~m chju trach nhi~m v€! Where the laboratory Is responsible for the hO<;lt dOngI§y mau, ngoai cac yeu c§u .neu trang sampling activity, in addition to the requi~ements 7.8:2, baa cao phai baa g6m nhOongdi~u sau, khi listed In 7.8.2, reports shall include the following, 38 TCVN ISO/IEC 17025:2017 cl1n,d~ giai thich kilt qua: where necessaryfor the interpretationof results: a) ngay h~ym~u; a) the date of sampling;. b) nh~n bi@t duy nh~t aal tLPQ'nghoac v{it Ii~u b) unique identification of the Item or material dlJ'Q'cIlly mau (bao gbm ten cua nha san xu&t, sampled (including the model hay ki~u loal chl dinh va 56 serl khi manufacturer, the thich hop): designation and name of the model or type of serial numbers as appropriate); c) dia dillm I§y mau, baa g6m b&t ky sa db, phac c) hoa ho~c hlnh anh nao: the location of sampling, including any diagrams,sketchesor photographs; d) vi~n dan k6 hoach lAy mau va phLPO'ng phap d) a.referenceto the sampling plan and sampling method; h~ymau; e) chi ti~t v~ mol dll:lu kl~n moi trucmg trong qua e) details of any.environmentalconditionsduring trinh I§y mau co anh hlJ'ongd~n vi~c giai thich sampling that affect the lnterpretatlon of the k~t qua thti nghi~m; test results; f) thong tin can thi~t d~ danh ghfl dO khOngdam f) information required to evaluate bao do cho vi~c thli nghi~m hoac hi~u chu~n measurement uncertainty for subsequent ti~p thea. testing or calibration. 7.8.6. Bao cao cae tuyen b6 v~ sl! phu h9'P 7.8.6 Reporting statements of conformity 7.8.6.1 Khi tUYElnbo v~ 5'1 phU hop val mot quy 7.8.6.1 When a statement of conformity to a dinh ky thu~t hay tieu chuan dU'Q'cdU'ara, phong specification or standard is provided, the thi nghi~m phai I~p th~mhvan ban quy tac quyllt laboratory shall document the decision rule dinh dU'Q'cap dl,lng, co tinh den mlFe dQ nii ro employed, taking into account the level of risk (nhli ch§p nh~n sai, bac bo sai va cac gia dinh (such as false accept and false reject and th6ng ke sail lien quan den quy tcic quyet dinh statistical assumptions} associated with the dlJ'Q'cap dl,mgva vi~c ap dl,lngquy tac quyet djnh decision rule employed and apply the decision rule. nay. CHO TH!CH: Khi quy cic ra quyAt djnh dl1Q'c quy djnh NOTE Where the decision rule is prescribed by the boi kMch hang, ch~ djnh hay tai Ii~u ·quy dinh, thi customer, regulations or normative documents, a khOng can xem xet them ve m(lcdQ rUlro nCl'a. further consideration of the level of risk is not necessary. 7.8.6.2 PhOngthi nghi~m phai baa cao tuyen bo 7.8.6.2 v~ sl,!'phu hgp va tuyen b6 do nh~n biat ra: The laboratory shall report on the statement of conformity such that the statement clearly identifies: a) tuyen ba v~ Sl)' phil hQ'pap dl,lng cho nhCPnga) k@tqua nao; to which JesuIts the statement of conformity applies; 39 TCVN ISOIIEC 17025:2017 b) cac quy dlnh k9 thuat, tieu chu~n hay phan b) which specifications, standards or parts thereof are met or not met; and quy dinh ky thuat, tieu chu~n nao dU'gc dap (l'ng hay khOngdllQ'cdap (fng; c) quy t~c ra quyet dinh dU'Q'cap dl,mg(tnr km no c) da c6 trong quy djnh ky thu~t hay tieu chuan the decision rule applied (unless it is Inherent in the requestedspecificationor standard). lien quan). CHU THlcH Thongtin them, xem ISO/lEG Guide 98-4. 7.8.7 Bao eao cae y ki6n va diAn gl3i 7.8.7.1 Khi phciith~ hi~n cac y NOTE For further information, see ISOIIEC Guide 98-4. 7.8.7 Reporting opinions and Interpretations ki~n va di~n glai. 7.8.7.1 When' opinions and interpretations are phOngthi nghi~mphai dam bao r.1ngchi nhan S1,l' expressed, the laboratory shall ensure that only dU'Q'ctrao quy~n th~ hi~n y ki~n va di~n gial mal dU'Q'cClU'ara tuyen b5 personnel authorized for the expression of tU'O'ng(mg. Phong thl opinions nghi~m phai I~p thanh van ban can c(P and interpretations thea d6 respective statement. cac y ki~n va dien giai dl1Q'Cth1,l'chi~n. The releases laboratory the shall document the basis upon which the opinions and interpretationshave been made. GHU THlcH: Quan trQng la phan bi~t gilia y kl~n va NOTE It Is important to distinguish opinions and di~n gicii v&i cac tuyen b6 v~ giam djnh va chling nh~n Interpretations from statements of inspections and san ph~m nhlP neu trong TCVN ISO/lEG 17020 va TCVN ISO/IEC 17065, cling nhl1 val 51,!' cae tuyen b6 vlt a phu hQ'pneu 7.B.6. 7.8.7.2 Cac y product certificationsas intended in ISO/IEC 17020 and ISO/IEC 17065, and from statements of conformity as referred to in 7.B.6. ki~n va di~n giai dLFQ'C trinh bay 7.8.7.2 The opinions and interpretations trong cac bao cao phcii dl,Patren cac k~t qua thu expressedin reports shall be based on the results dllQ'c ter dOitU'Q'ngda dLFQ'C thl) nghi~m ho~c hi~u chuc1nva phai dU'Q'cnh~n bi~t tMt TO rang. obtained from the tested or calibrated item and shall be clearly Identifiedas such. 7.8.7.3 Khi Y kien va dien giai dU'Q'Ctrao doi trl,l'C 7.8.7.3 When opinions and interpretations are tiep vai khach hang bang ClOith09i, phai ILFU hO sO' directly communicated by dialogue with the v~ dOltho~iCl6. customer, a record of the dialogue shall be retained. 7.8.8 Slia aOi bao cao 7.8.8 Amendments to reports 7.8.8.1 Khi mQtbao cao da ban Mnh can dU'Q'C7.8.8.1 When an issued report needs to be thay dlli hay slia dlli ho~c c§p l<;1ithl b§t ky S1,l' changed, amended or re-Issued any change of thay d6i thong tin nao cOngphai ClU'Q'c nMn biet ra information shall be clearly identified and, where va khi thich hQ'p,neu Iy do thay doi trong bao cao. appropriate,the reason for the change included in . 7.8.8.2 Vi~c slia doi m(>tbao cao sau khi phat the report. 40 . 7.8.8.2 Amendments to a report after issue shall TCVN ISOllEe 17025:2017 hanh chi oU'Q'cth!)'c hi~mdl1ai hinh thoc cUa mOt be made only In the fonn of a further document,or tai Ii~u ti~p thea, hoac mQt each chuylm dO>Ii~u, data transfer, which Includes the statement n6 phal baa gom tuyE'mbo: "Slia dlli Bao cao, sO "Amendment to Report, serial number... [or as serl... [ho~c duoc nMn bi~t thea each khac]", otherwise Identifiedr, or an equivalent form of hoijc mQthlnh th(Fcdl~n d~t b~ng ill' ngfr tlFO'ng wording. dLPO'ng. NhO>ngslia dlli nay phai oap (mg t1\t ca cac yeu of this document. du cua tieu chuan nay. 7.S.8.3 Khi c§n ban hanh Such amendmentsshall meet all the requirements mot baa cao hoan toan 7.8.8.3 When it is necessary to Issue a complete mol, thi baa cao nay phai dU'Q'cnhan bi~t duy nh§t new' report, this shall be uniquely identified and va phai bao gOm vj~n dan d~n ban g6c ma n6 shall contain a reference to the original that It thay th~. replaces. 7.9 Khi~u n~li 7.9 Complaints 7.9.1 PhOng thl nghi~m phai c6 qua trlnh d~ng 7.9.1 The laboratory shall have a documented van ban dol val vi~c tiep nh~n, dfmh gia va ra process to receive, evaluate and make decisions quy~tdjnh v~ khi~u nai, on complaints. 7.9.2 Ban ma ta qua trinh xl} ly khi~u n~i phal s~n 7.9.2 A description of the handling process for c6 cho bat ky ben quan tam nao khi c6 yeu cau. complaints shall be available to any. interested Ngay khi nMn dllQ'Ckhleu n~i, ph6ng thi nghl~m party on request. Upon receipt of a complaint,the phciiX8Cnhliinxem khi~u n9i c6 liem quan cl~ncac laboratory shall confinn whether the complaint hoc;ttdQngthi nghiem rna minh chiu trach nhiem relates to laboratory activities that it is responsible hay khong va nllu co, se xl} Iy khi~u n9i d6. Phong for and, if so, shall deal with it. The laboratory thi nghi~m phai chju tr8ch nhi~rn v~ mQi quy~t shall be responsiblefor all decisionsat all levelsof djnh (J tat ca ·cac cap trong qua trinh .giai quy~t the handling processfor complaInts. khi~u mill. 7.9.3 Qua trinh xli Iy khi~u n~i phai bao g6m it 7.9.3 The process for handling complaints shall nhat caey~u t6 va phllO'ngphap sau: include at least the following elements and methods: a) rna ta qua trinh ti~p nh~n, killm tra tfnh chrnh a) description of the process for receiving, X8C,di~u tra khi~u n~i va quy~t cljnh nhfrng validating, investigating the complaint, and hanh clQngnao dU'Q'cthl)'c hi~n d~'clap (Fng deciding what actions are to be taken in khillu n~li; responseto it; b) thea doi va I~p h6 sO'cae khi~u n;:,:li, k~ cs cae b) tracking and recording complaints, including hanh dQngdU'Q'cti~n Mnh dll giai quy~t khi~u actions undertakento resolvethem; n~l; 41 TCVN ISOIIEC 17025:2017 c) dam baa hanh hanh dQng thlch hop dLPQ'cc} ensuring that any appropriate action is taken. thl,l'C hi~n. 7.9.4 PhOngthl nghi~m nh~n khi~u n~i phai c6 7.9.4 The laboratory receiving the complaint shall trach nhi~mthu th~p va xac minh t~t ca thOngtin be responsible for gathering and verifying all dn thillt d~ kiAm tra tfnh chfnh xac cua khi~u nai; necessaryinformationto valld~te the complaint. 7.9.5 Ngay khl co th~, phOng thl nghl~m phai 7.9.5 Whenever possible, the laboratory shall chfnh thuc xac nh(jn nh~n oUQ'ckhi~u nal va cung acknowledgereceipt of the complaint, and provide ~p cho ben khi~u nal cac baa cao ti~n dOva k~t the complainant with progress reports and the qua. outcome. 7.9.6 Cac k~t qua dLPQ'c trao dOithOngtin vai ben 7.9.6 The outcomes to be communicated to the khi~u nal phai OLPQ'c l(jp, hoac dllQ'c xem xet va complainant shall be made by, or reviewed and pM duy~t bc}i (cac) ca nhan khOngtham gia vao approved by, individual(s) not Involved in the cac heat dQngthl nghl~m ban d~u dang xem xet, original laboratoryactivities in question. CHU THrCH t)i~unay c6 th8 OlJ'Q'cthllc hj~n bai nhan NOTE This can be performed by external personnel. 51,1' ben ngoaL 7.9.7 Ngay khi c6 th~, pMng thi nghi~m phai dU'a 7.9.7 Whenever possible, the laboratory shall give ra thOng baa chinh thuc v~ vi~c k~t thuc xli Iy formal notice of the end of the complaint handling to the complainant. 7.10 Cang vi~c khang phu hQ'p 7.10 Nonconforming work 7.10.1 PhOngthi nghi~mphai cO mOtthu ttJcOllQ'C 7.10.1 The laboratory shall have a procedure that thvc hi(ln khi bat ky khfa CCilnh nao CU~ hm~td~ng shall be implemented when any aspect of its thi nghi(lm ho~c k~t qua cua cong vi~c nay khang laboratory activities or results of this work do not phu hQ'pvai cae tM tl,locua phOngthi nghi~m hay conform to its own procedures or the agreed vai cac yeu CBU cua khach hang da OllQ'CthOng requirements of the customer (e.g. equipment or nhcit(vi dl,l thiet bl ho~c cac di~u ki~n moi truiYf!g enyironmental conditions are o.ut of specified . n~m ngoili gial hq.n quy djnh,. k{,t qua thea doi limits, results.of monitOringfail to meet specified khong o~t oU'Q'cchu~n mlfC da djnh). Thu tl,lc nay criteria).The procedure shall ensurethat: dam baa r~ng: a) cac trilch nhi~m va quy~n hCilndOi vai vi~c a) the responsibilities and authorities for the quan Iy cong vi~c khong phu hQ'p d~u Oll'Q'c management of nonconforming work are xac djnh; defined; b) cae hanh dQng(baa g6m vi~c t<;lmdling ho~c b) actions (including halting or repeating of work I~pIc;lieong vi~e n~u cln, dlnh llili cac baa and withholding of reports, as necessary) are cao) d~u dl,l'a tran m(Fc d~ rui ro do phong thl based upon the risk levels established by the va nghi~mthlet I~p; 42 . laboratory; TCVN ISOIIEC 17025:2017 c) thl,l'c hi~mdfmh gia rrnrc dl} nghiem trQngcua c) an evaluation is made of the significance of cong vi~c khong phu hop, bao gllm ca phan the nonconforming work, including an impact tich tac dQngdOivai cac k~t qua trU'acd6; analysis on previous results; d) thl!c hli~nquyet dinh va kha nang chap nMn d) a decision is taken on the acceptabilityof the nonconformingwork; cOngvi~c khOngphUhop: e) khi can, khach hBng sa dLPQ'c. thOng bao va e) where necessary, the customerIs notifiedand cOngvi~c dLPQ'c thu hai; work is recalled; f) xac djnh trach nhi~m cho phep khOl phuc I~i f) the responsibility for authorizing the resumptionof work is defined. cong vi~c. 7.10.2 Phong thi nghi~m phai ILPUgiCi'cac hOso 7.10.2 The laboratory shall retain records of v~ cong vi~c khang phu hop va cac hanh dOng nonconforming work and actions as specified in nhLPquy djnh tal 7.10.1, di~m bf d~n f). 7.10.1, b) to f). 7.10.3 Trong tmang hop danh gia chi fa rc1ng 7.10.3 Where the evaluation indicates that the cong vi~c khang phu hop c6 thi! tid di~n ho~c c6 nonconforming work could recur or that there is nghi nga v6 Sl,l'phu hop cua ho1;ttdOngcua phong doubt about the conformity of the laboratory's thi nghi~m v6>ihilithOngquan Iy cLlan6, thi phong operations with its own managementsystem, the thi nghi~mphfli thl,l'chi~n hfmh dOngkhac phvc. laboratoryshall implementcorrectiveaction. 7.11 Ki~m soat dD>Ii~u - Quan Iy thong tin 7.11 Control of data - Information management 7.11.1 PhOngthi nghi~m phai c6 Sl! ti~p c~n de; 7.11.1 The laboratory shall have access to the Ii~u va thOngtin can thi~t d~ thl!C hi~n h09t dQng data and informationneeded to performlaboratory thi nghi(!m. activities. 7.11.2 (Cac) h~ th6ng quan Iy thong tin phong thi 7.11.2 The laboratory information management nghi~m dLPQ'c SLP dVng dll thu th~p, XLP Iy, ILPUhE> system(s) used for the collection, processing, sO', bao cao, baa quan ho;}c khai phl,lc dOtJi(lu recording, reporting. storage or retrieval of data phai dLPQ'c phOngthi nghi~m xac nMn gia trj su. shall be validated for functionality, including the dl,lng v~ tinh nang, bao gbm vi~c·v~n hanh dung proper functioning of Interfaces within the chi.Ycnang eua cac giao di~n trong M th6ng qulm laboratory information management system(s) by Iy thong tin phong thl nghl~m tru6>ckhi dLPavilo the laboratorybefore introduction.Wheneverthere SLYdVng.Khi co b~t ky Sl,l'thay dOinao, k~ cci cau are any changes, including laboratory software hlnh phc1nm~m eua phOngthl nghi(lm hay mQiSl! configuration or modifications to commercial offslia dlli ph§n m~m thU'ang m~i ban san, thi the-shelf software, they shall be authorized, nhfYngthay dOi nay d~u phai dLPQ'c· cho philp, documentedand validated before implementation. dU'Q'cI~p thanh van ban va X8C nMn gia trj SLY dl,mgtrLPaekhi thl,l'Chi~n. 43 TCVN ISO/IEC 17025:2017 CHO THlcH 1: Trang lieu chua.nnay ·h~ thong quan 19 NOTE 1 In this document "laboratory information 19 dCi management system{s)" includes the management of li~u va thong tin trong ca h~ thOng may tlnh va nlim data and information contained In both computerized thOngtin ph6ng thf nghi.m· bao gOmvi~c quan ngoili hQ thOng may tinh. MQI s6 yeu cc\u c6 th~ ap dl,lngdLPQ'c nhi~u hon cho eac M thOngmay tfnh so val and non-computerized systems. Some of the requirements can be more applicable to computerized cac h~ thOngkhong dLPQ'c may tinh h6a. systems than to non-computerizedsystems. CHOTHlcH 2: Ph~n m~m thuO'ngmal ban san thllang NOTE 2'Commercial off-the-shelf software in general dllQc so dl,mgtrang mOt pharn vi (Fngdl,lng CIACIU'O'cuse within its designed application range can chTCIjnhva c6 th~ dllQ'c coi Is CIadU'O'cxac nh~n gift Irj be consideredto be sufficiently validated. so dl,lngd~y duo 7.11.3 H~ thOng quan Iy thOng tin phong thi 7.11.3 The laboratory information management ngh;~mphai: system(s)shall: a) dl1Q'cbao v~ kho; Sl!truy c~p trai phep: a) be protectedfrom unauthorizedaccess; b) dl1Q'cbao v~ ch5ng I~i Sl!gia m90 va mc1tmat; b) be safeguardedagainst tamperingand loss; c) dl1Q'cv~n hanh trong moi troang phil hop voi c) be operated in an environment that complies ky thw;it cua with provider or laboratoryspecificationsor, In phong thl nghi~m ho~c trong tnJ'ung hQ'pcae the' case of non~computerized systems, h~ thc5ngkhOngsu>dl,mg may tfnh, cung c§p provides conditions which safeguard the nha cung cap ho~c cac quy djnh cac di€lu ki~n baa v~ trnh chfnh xac eua vi~c accuracy of manual recording and transcription; I~p he,sO' hay sao chep thu cong; d) dl1Q'cduy trt thea cach dam bao tinh toan v~n d) be maintained In a manner that ensures the cua dfr Ii~uva thong tin; va integrityof the data and information; e) baa g5m vi~c l~p hOsa v~ cac sai loi h~ thOng e) include recording system failures and the va cac hfmh dQngtlic thai thich hQ'phay cae appropriateimmediate and correctiveactions. hanh dQngkhcicphl,lc. 7.11.4 Khi h~ thOng quan-Iy thong tin phOngthi 7.11.4 When laboratory information management nghi~mdl1Q'cquan Iy va duy trl tl) ben ngoai ho~c system(s) is managed and maintained off~siteor qua nhe) cung cap b~n ngoai, phOng thl nghi~m through an external provider, the laboratory shall phai dam bao rang nha cung c~p ho~c nguai v~n ensure that the provider or operator of the hfmh M th6ng tU8n thu t§t ca cac yeu c§u dl1Q'c system(s) ap dl)ng dU'Q'ccua lieu chu~n nay. complies with all applicable requirementsof this document. 7.11.5 Phong thf nghiEf!mphai dam bao rang cac 7.11.5 The laboratory shall ensure that hU'ongddn, s6 tay va d(i Ii~utham khao lien quan instructions, manuals and reference data relevant d~n hi[!thang quan Iy thong tin phong thi nghi~m to d~u s~n c6 cho nhan vien. 44 the laboratory information management .system(s)are made readily available to personnel. TCVN ISO/IEC 17025:2011 7.11.6 Vi{lc tinh toan va truy€m dQt Ii~u phai dllQ'c 7.11.6 Calculations and data transfers shall be ki~m tra mot each thlch hop va co h~ th6ng. checked in an appropriate and systematic mariner. 8 Yeu cau ht th6ng quan Iy 8 Management 8.1 Cae It!a chon 8.1 Options 8.1.1 Khai quat 8.1.1 General Phong system requirements thr nghi~m phai thi~t I~p, I?p thanh van The laboratory shall establish, document, thuo hi~n va duy trl M thOng quan Iy co khci nang h6 trQ' va chwng to vl~c d~t dllQ'c m(lt each that is capable of supporting and demonstrating nh§t quan cac yeu cau cUa tieu chu~n nay va dam the consistent achievement of the requirements of ban, implement and maintain a management system bao chat 1ll'Q'ngcac k~t qua thi nghi~m. Ngoai vi~e this document and assuring the quality of the dap (Fng yeu cau tli' d~u 4 dim di~u7 cua tieu laboratory results. In addition to meeting the chu~n nay, phong thi nghi~m phcii ap dt.mg mOt requirements of clauses 4 to 7, the laboratory shall thOng quan Iy thea Ilfa chon A ho~c h,a chon B. implement a management system in accordance with option A or option B. CHO THlcH: Thong tin them xem Phl,llvc B. NOTE See Annex B for more information. 8.1.2 Llfa chQn A 8.1.2 T6i thi~u h~ th6ng quan Iy cua phOng thf nghi~m As a minimum the management system of the phai giai quy~t cac van de sau: laboratory shall address the following: - tai Ii~u M th6ng quan ki~m 15'(xem 8.2); 50at tai Iifilu h~ thong quan Iy (xem 8.3); Option A management system documentation (see 8.2) control of management system documents (see 8.3) - ki~m soat hO sO'(xem 8.4); - control of records (see 8.4) - hanh oQng o~ giai quyllt rui ro va cO' hoi (xem - actions to address risks and opportunities (see 8.5); 8.5) cai ti~n (xem 8.6); improvement (see - Mnh o(lng kh!c phl,lc·(xem 8.7); - oimh gia - xem xet cua lanh d~o (xem 8.9); ne;,i·be;,(xem 8.8): 8.6) - corrective action (see 8.7) - internal audits {see 8.8) - management reviews (see 8.9) 8.1.3 Option B 8.1.3 Ll,I'a chQn B Phong thi nghi~m da thi~t I~p va duy tri hi; thOng A laboratory that has established and maintains a quan IY. phu hQ'p vai cac yeu cau cua TCVN ISO 9001 va M thong nay co kha nang h6 trQ', chwng management system, in accordance with the requirements of ISO 9001, and that is capable of 45 I\,VN I\lVIU:{; 11025:2017 to s{,pdap (l'ng day dt) nhat quan cac yeu cau tll supporting and demonstrating the consistent di~u tll' 4 d~n di~u 7, cOng nhU' dap (PngIt nhat fulfilment of the requirements of clauses 4 to 7, rnuc dich cua cac yeu c~u v~ h(l thc5ngquan Iy also fulfils at least the Intent of the management dLPQ'c quy djnh a 8.2 d~n 8.9, system requirementsspecified In B.2 to B.9. 8.2 Tai li~u h~ th6ng quan Iy (Ll}'8 ch9n A) 8.2 Ma~agement system documentation (Option A) 8.2.1 Quan 19 pMng thl nghi~m phal thi~t I~p, I~p 8.2.1 laboratory management shall establish, thanh Van ban va duy trl cac chfnh saeh va mec document,and maintain policies and objectivesfor tieu d~ dap (l'ng muc dlch cua tieu chuan nay va the fulfilmellt of the purpose of this document and phai dam baa r~ng cac chfnh sach va muc fieu shall ensure that the policies and objectives are duQ'cghi nhtin va th{,pChi(ln chlic cua pMng thi nghi~m. a tat ca eac cap t6 acknowledgedand implementedat all levels of the laboratoryorganiz~tion. 8.2.2 Oac chinh sach va rnuc tieu phSi d~ ~p d~n 8.2.2 The policies and objectives shall addressthe nang It!C, tinh khach quan va vi~c th{,pchi~n nhat competence, impartiality and consistent operation quan cua pMng thi nghi~m. of the laboratory. 8.2.3 QUEInIy pMng thi nghi~m pMI cung cap 8.2.3 Laboratory management shall provide b~ng chCrng v~ cam k~t xay ap dvng h~ th6ng quan Iy va d~ hi~uIile eua h~ th6ng. 8.2.4T~t d{,png va evidence of commitment to the development and cal fi~n lien b,lc implementationof the managementsystem and to continuallyimprovingits effectiveness. ca tili J1~u,qua trinh, h~ thong, hOsO'lien 8.2.4 All documentation, processes, systems, quan vi~c dap ling cac yeu cau cua tleu chu~n records, related to the fulfilment of the nay pMi co trong, l1uQ'cvi~n dan fli hay l1uQ'ck~t requirements of this document shall be included noi d~n h~ thong quan 19 nay. in, referenced from, or linked to the management system. 8.2.5 T~t ca nhan vien tham gia VBOcac hOc;d dOngthi nghi~mphai c,oSI! ti~p ~~n cac phan c~a h~ thong tai li~u quan Iy va ~c thOng tin c6 lien quan cO th~ ap dr,lngcho cac trilch nhiem cua·hQ. 8.3 Ki~m soat (l.,a chQn A) talli~u h, thc5ngquan Iy 8.2.5 All personnel involved in laboratoryactivities shall have access to the parts of the management system documentation and related information that are applicableto theirresponsibilities. 8.3 Control of management system documents (Option A) 8,3.1 PhOngthr nghi~mphai k1~msoat cacta! Ii~u 8.3.1 The laboratory shall control the documents (nOjbOva ben ngoal) co lien quan l1~nvi~c l1ap (internal and external) that relate to the fulfilment ling tieu chu§n nay. of this document. CHU THicH: Trang b6i canh nay, tl) "tc'1i IiW' c6 thi! lit NOTE In this context "documenr can be policy cac tuyen h6 v~ chinh stich: tM tl)c, quy djnh ky thu~t, statements, procedures, specifications, manufacturer's 46 TCVN ISO/lEe 17025:2017 huang d~n ella nha san xuAt, hfmg hi~u chuAn, bi~u instructions, calibration tables, charts. text books, (ill, sach, ap phich, thOngbaa, ban ghi nho, ban va, k{, posters, notices, memoranda, drawings, plans., etc. hoach,... Chung c6 th~ CJ phl1O'ngti~n truy~n thong These can be on various media, such as hard copy or khac nhau nhu ban cling hay dq.ngs6 hoa, digital. 8.3.2 Phongthf nghi~m phai d,ir'n'baorang: 8.3.2 a) Ud 1i~udlJ'Q'cphe duy~t v~ 51! thoa dang bai a) documentsare approvedfor adequacyprior to The laboratoryshall ensurethat: issue by authorized personnel; nhan Sl! c6 tham quy~n trLJ'ackhi ban hanh; b) tai 1i~udLYQ'c xem xet dinh ky va c~p nh~t khi b) documents are periodically reviewed, and updated as necessary; can thi€!t; c) cac thay dOl va tinh tl11ngsoat xet hi~mthai c) cua cac tai Ii~udl1Q'cnh~n bi~t; changes and the current revision status of documentsare identified; d) cac phiElnban c6 lien quan cua cac tai Ii~u d) relevantversions of applicabledocumentsare hi~n hanh dm c6 s8n t'ili cac nol SlP dl,mgva available at points of use and, where khi cAn, v~c phan phOichung OlJ'Q'c ki~m 50at; e) cac tai Ii~u dLYQ'c nh~n bi~t mOtcach duy nhat; f) necessary,their distributionis controlled; e) documentsare uniquelyidentified; ngan ch~n OlJ'gcvi~ SlP dl,lngvO tlnh cac tal f) the unintended use of obsolete documents is Ii~u 161thai va ap dl,lng each nMn bi~t thich prevented, and suitable identification is hQ'pdOivai tai li~u 16ithai n~u chUngOlFQ'C gifr applied to them if they are retained for any I~ivi bat c(r ml,lcarch nao. purpose. 8.4 Ki~m soat h6 sO'( Llfa chqn A) 8.4 Control of records (Option A) 8.4.1 Phong thi nghi~m phai thillt I~p va JlJ'UgiCl' 8.4.1 The laboratory shall establish and retain cac hll sO'r6 rang d~ ch(rng to vi~c.dap.(rng d~y legible records to demonstrate fulfillment of the au cac yeu c~u trong tieu chuan nay. requirementsin this documenl 8.4.2 Phong thi nghi~m pMi ap dl,mg cac ki~m 8.4.2 The laboratory shall Implement the controls soat can thi6t dol vai vi~c nh$n bi~t, bao quan, needed for the Identification, storage, protection, bao v~, sao llJ'u,ILYUtrCl',phl,lc hlli, thai gian llJ'u back-up, archive, retrieval, retention time, and gifr va huy bo cac hll SO' cua mlnh. PhOngthi disposal of its records. The laboratory shall retain nghi~m phai IlJ'Ugil1 cac hOsO'trong mOtgiai ao~n records for a period consistentwith its contractual nh~t qu{m val nghTaVI,I hQ'pdOng. Vi~c ti~p ~n obligations. Access to these records shall be cac hOsO'nay phai nhat quan vai cac cam k~t bao consistent with the confidentiality commitments m~t va cae hOsO'phaf c6 s~n. and records shall be readilyavailable. CHU THlcH: Cac yeu cau b6 sung v~ ho. sO'k9 thu~t NOTE dl1Q'cneu a 7.5. Additional requirements regarding technical ·recordsare given in 7.5. 47 TCVN ISO/IEC 17025:2017 8.5 Himh dQngd~ glal quyAt rui ro vii cO'hQi 8.5 Actions to address risks and opportunities (Lila chon A) (OptionA) 8.5.1 Phong thl nghi~m phal xem xet cac nil ro va 8.5.1 The laboratory shall consider the risks and co hOI lien quan d~n cac hoat d¢ng thl nghl(!m opportunities associated with nh~m: the laboratory activitiesIn order to: a) dam bao r~ng h~ thang quan Iy d~t dl1Q'ck~t a) give assurance that the management system qua da dl)' killn cua n6; achievesits intended results; b) tang cLFcmgco hOid~ d<;ltdLFQ'C cac rnuc dlch b) enhance opportunities to achieve the purpose va muc tieu cua pMng thl nghi~m; and objectives of the laboratory; c) ngan ngCra, hoolic lam giam cac tac dQng c) prevent, or reduce, undesired Impacts and khang mong muOn va nhiing sal 151 ti~m ~n potential failures In the laboratory activities; trong cac hoat d(lng thl nghiem; va and d) d~t dU'Q'C 511cal ti~n. d) achieve improvement 8.5.2 PMng thl nghi~m phai hoach djnh: 8.5.2 a) cac hanh dQngd~ giai quy~t rui ro va co h(li; a) actions The laboratory shall plan: to address these risks and opportunities; b) eachthCrcde: - - b) howto: tich hop va thl,l'c hi~n cac hanh dOngvao integrate and implement the actions into M th6ng quan its managementsystem; Iy; danh gia hi~u hlc cua nhung Mnh d¢ng evaluate the effectiveness of these nay. actions. CHO THlcH: M~c dll tieu chuan nay quy djnh rang NOTE Although this document specifies that the phong thl nghi~m hOi[lchcljnh hfmh dQng dA gli3iquy~t laboratory pl~ns actions to address risks, there is no rui rOtnhung khOngyeu cau d5i vai cac' pht.rO'~gphap requirementfor formal methods for risk ma[lage~ent or" - • chinh thtic d~ quan 1'1 rid ro hay mQtqua trlnh quan 1'1 a documented risk management process. J,.aboratoi"ies rUi (0 ollgc I~pthanh van ban. Phong thl nghi~m c6 thA can decide whether or not to develop a more extensive quyet dinh xay dV'ngmi}t phuO'ngphflp lu~n quan 1'1 rui . (0 risk management methodology than is required by this clayd~ han yeu c~u cua lieu chuan nay hay khong, document. e.g. through the application of other vi dv th{)ng qua vif>cap dl,mg cae hl1&ngdelnho~c lieu guidance or standards. chu~nkMc. 8.5.3 HanhdOngd~ giai quy8t nii ro va cO'hOi phiii 8.5.3 Actions taken to address risks and tlJ'O'ngxCrngval tac dOng ti~m ~n tOo;gia tri sl) opportunitiesshall be proportional to the potential dl;lng cua cac k~t qua thl nghi~m. impact on the validity of laboratory results. CH(I THlcH 1: Cac It,!'achon d~ giai quy€!trui ro c6 th~ NOTE' 1 Options to address risks can include 48 TCVN ISO/IEC 17025:2017 bao gbm vi~c nhan bi~t va tranh cac m5i de dca, ch§p identifying and avoiding threats, taking risk in order to nh?n rui ro ail theo dulli coohoi, 10<;1ibe nguOnriii ro, thay cOi kha nang xay ra ho~c h~ qua, chla sa pursue an opportunity, eliminating the risk source, rUi ro changing the likelihood or consequences, sharing the hoac duy trl rui ro b&ngquy~t djnh dung d~n. risk, or retaining risk by informed decision. ma NOTE 2 Opportunities can lead to expandingthe scope rong pharn vi oac hoat dong thl nghi~m, ti~p cl)n cac of the laboratory activities, addressing new customers, khach hang met, Sll' dl,mg cong nghifl mai va cac kha using new technology and other possibilitiesto address nang khae 01\dap (mg nhu clu cua·khachhang. customer needs. 8.6 Cal ti~n (LY'a chen A) 8.6 Improvement (Option A) CHU THlcH 2: Cac coohOi c6 thil d~n d~n vlec 8.6.1 PhOngthl nghl~m ph<iinh~n'biet va Il)'achon 8.6.1. The laboratory shall identify and select oac C(J hC)id~ cai tien va thllc hi~n mol hanh dong opportunities for improvementand implementany necessaryactions. din thiet. 'CHU THlctI: Cac coo·hQicai ti~n c6 th~ ollgc nhM bi~~ NOTE Opportunitiesfor improvementcan be identified thOngqua vi~c xem xet cac tM tl,lC tac nghi~p, ap dl,lng through the review of the operational procedures, the cac chlnh sach, cae ml,lc tieu t6ng tM, cac k~t qua use of the poncies, overall objectives, audit results, danh gia, cac hflOhdong kh~c phl,lc.xem xet cua lanh corrective actions, management review, suggestions d;;lO,cac dE; xu~t tv nhan vi~m,danh gia riii ro, pMn from personnel, risk assessment, analysis of data, and Uchdti Ii~uva k~t qua thll' nghi~m·thanhthlilO. proficiencytesting results. 8.6.2 Phong thi nghi~m phai tim ki~m cac ·thong 8.6.2 The ·Iaboratory shall seek feedback, both tin phan hOi, ca Uch clfC va tieu evc, tLPkMch positiVe and negative, from its customers. The hang. ThOngtin phan hai pMi dlJ'Q'cphan Uchva feedback shall be analyzed and used to improve sti dl,mgdit cai ti~n M thong quan Iy, cac ho~t the management system, laboratoryactivities and dQngthi nghi~mva dich VI,.I khach hang. customerservice. CHO THlcH: C6c vi dV v~ 10~1hinh th6ng tin pMn hOi NOTE Examples of the types of feedback include baD.gam khao sat Sl! hal long clla kMch hang, hOsO' customer satisfaction surveys, communication records trao 06i-thongtin, xem xet cac bao cao voi kMch h~mg. and review of reportswith customers. 8.7 Hfmh dQng khac phlJc (LV'a chQn A) 8.7 Corrective action (Option A) 8.7.1 Khi mQtsl),"khOngphu hQ'pxay ra, phong thi 8.7.1 When a nonconformityoccurs,the laboratory nghi~m phai: shall: a) hanh d¢ng t:.rngph6 vai SI! khOng·phuhQ'pva, a) react to the nonconformityand, as applicable: khi c6th~: - thllc hi~n·hfmhd{lng dit ki~m soat va khck - take action to controland correct it; phl)c Sl,l' khong phu hQ'p; - gh~iquyet cac h~ qua; address the consequences; b) danh gia nhu tau doi vai Mnh dc;'lngd~ lo~i bo b) evaluate the need for action to eliminate the (cae) nguyen nMn 'cua 51)' khOngpM hQ'p,dll cause(s) of the nonconformity,in order that It 49 TCVN ISOllEe 17025:2017 no khong tai dien ho~c xay ra a does not recur or occur elsewhere,by: noi khac, b~ng each: - xem xllt va phan tlch 51,1' khang phU hop: - reviewing analysing and the .nonconformity; - xac d[nh nguyen nhan eua Sl,!'khang phu - hop: - determining the causes of the nonconformity; xac dlnh xem c6 Sl! khang phU hop tuO'ng - tl,!'hay khang hoijc c6 kha nang xay ra hay determining if similar nonconformities exist, or could potentiallyoccur; khang; c) thl,l'chii;lnmol hanh dOngdin thi~t; c) implementa~y action needed; d) xem xet hi~u Il,l'c cua mol hanh dQng khcic d) review the effectiveness of any corrective phuc dlJ'Q'cthl,l'chi~n: actiontaken; e) ~p nh~t cac n1i ro va co hOi dllQ'c xac djnh e) update risks and opportunities determined trong qua trinh hoach djnh, ntm can; f) thl,l'chi~n cac thay dbi dOivai h~ thOngquan , So ~ Iy, neu can. during planning, if necessary; f) make changes to the management system, if necessary. 8.7.2 Cac hanh dOngkhac phl.lcphai thich hcp vO'! 8.7.2 Correctiveactions shall be appropriateto the anh hlJ'cJng cua Sl,I' khong phU hop g~p phai. effects of the nonconformitiesencountered. 8.7.3 Phong thf nghi~m phai llJ'u gill' h6 sa lam 8.7.3 The laboratory shall retain records as bang chung ve: evidenceof: a) ban ch<1tcua 51,1' khang phu hgp, (cac) nguyen a) the nature of the nonconforrnities, cause(s) nhan va b§t ky hanh dQngti.§pthea nao dU'Q'c and any subsequent actionstaken; thl,l'chi~n; b) k~t qua eua b<1tky hanh dOngkh~c phl,lcnao. b) the results of any corrective action. S.8 flanh ghi ne}i be}(Lila chQn A) S.8 Internal audits (Option A) 8.8.1 Phong thf nghi~m phai ti~n hanh danh gia 8.8.1 The laboratory shall conduct internal audits ne>ibe>thee cac khoang thai gian dU'Q'C h91i1ch dinh at planned intervals to provide information on d~ cung cap thong tin v~ h~ th6ng quan Iy: whetherthe managementsystem: a) c6 phDhQ'pvai: a) conformsto: - cac yeu c~u cua chinh phOng thi nghi~m d6i vai h~ thang quan - 50 Iy cua minh, k~ ca the laboratory's own requirementsfor its management system, including the cac hOCiitd9ng thi nghi~m; laboratoryactivities; cae yeu c§u cua tieu chu§n nay; the requirementsof this document; TCVN ISO/IEC 17025:2017 b) dU'Q'cap dl,lng va duy tri mQt each hi~u h,Pc. b) is effectivelyimplementedand maintained. 8.8.2 PhOngthl nghi~m phal: 8.8.2 The laboratoryshan: a) hoach dinh, th!llt I~p, thl,l'c hi.;'mva duy trl a) plan, establish, implement and maintain an chU'O'ngtrinh danb gia baa gbm tltn suat, cac audit programme including the frequency, phU'O'ngphap, fraoh nhi~m, hoach djnh cac methods. yeu-c§uva I~p baa cao, ehU'O'ngtrinh nay phal requirements and reporting. which shall take tinh d~n moe dQquan tr9ng cua cac hoat dQng into consideration the importance of the thl nghl~m c6 lien quan, nhlJongthay dal anh laboratory hU'ong d~n ph6ng thi nghi~m va cac k~t qua cua cac cUQcdanh gia tmac d6; responsibilities. activities planning concerned. changes affecting the laboratory. and the results of previousaudits; b) xac djnh cac chuAn muc danh gia va pham vi b) define the audit criteria and scope for each cho tung cu<}cdanh gia; audit; c) dam bao rling cac k~t qua danh gi3 dllQ'c bao c) ensure that the results of the audits are cao cho cap quan Iy co lien quan; reportedto relevantmanagement; d) thuc hii~nkhOng ch~m tr~ vi~c kh~c phl,lCva d) implement cae hanh dQngkh~c phl,lcthlch hQ'p; appropriate correction and corrective actionswithout unduedelay; e) 11I'uhe)s0'1am bc1ngeh(l'ng v~ vi~c thl,t'chi~n e) retain records as evidence of the ehllO'ng trinh danh gia va cae k~t qua danh implementation of the audit programme and gia. the auditresults. CHO THlcH: TCVN ISO 19011 cung cap hl1(mgdan NOTE ISO 19011 providesguidancefor intemal audits. chocae cu{lc danh gia n{ll bQ. 8.9 Xem xet clIa lanh d\lo (Ll}'a chQn A) 8.9 Managemerit reviews (Option A) 8.9.1 Uinh d~o phOngthl nghi~m phsl xem xet h~ 8.9.1 The laboratory managementshall review its thOngquan Iy cua minh theo cae khoang thai gian management system at planned intervals. in da dinh nh~m dam bao sl,l' phi) hQ'plien tve. Sl! order to ensure its continuingsuitability. adequacy -thoa dimg va hi~u hfc cUa h~ thOng.bao gam cci and effectiveness, including the stated policies . cac chfnh Sikh va ml,lctieu dii dllgc tuyen bOlien and- objectives related to the fulfilment of this quan d~n vi~c dap (mg tieu chuan nay. document. 8.9.2 Cac dau vao xem xet cua lanh dlito phai 8.9.2 The inputs to managementreview shall be dll'Q'cllJ'u ha sO'va bao gam thOngtin iien quan recorded and shall include information related to dim: a) nhQ>ng thay d6i tron9 cac v§n the following: de nQib{l va ben ngoai c6 lien quan d~n phOngthi nghi~m; b) vi~c hoan thanh cae ml,lCtieu; a) changes in internal and external issues that are relevantto the laboratory; b) fulfilment of objectives; 51 TCVN ISO/IEC 17025:2017 c) Sl,l'phU hop cua cac chfnh sach va thu tuc; c) suitability of policies and procedures; d) tlnh tr<;lngcua cac hanh dQng tll' cac cuec xem d) status of actions from previous management xet cua lanh d90 tmac d6; reviews; e) k~t qua cua cac cuec danh gla nO; bO gan e) outeomeof recent Internalaudits; nh~t; f) cac hann dOngkh~e phuc; g) danh gia cua cac f) correctiveactions; to chuc ben ngoal; g) assessmentsby external bodies; h) nhling thay dOl v~ kh61 11IQ'ng va 10;;11 hinh h) changes in the volume and type of the work or congvii~choac pham vi heat dOngthl nghi~m; in the ra~ge of laboratoryactivities; i) j) phan hOicua khach hang va nhan vien; cac khi~u nal; k) hi~u h,e cua cac cal ti8n b~t customerand personnelfeedback; J) complaints; ky dU'Q'Cthl,l'c k) effectiveness hi~n; I) i) SI! day du cua cac nguOnh,C; m) k~t qua nh~n dien rui ro; of any implemented improvements; I) adequacyof resources; m) resultsof risk identification; n) k~t qua d§u ra cua viec dam bao gia trj Slr n) outcomes of the assurance of the validity of dl:mgcua cac ket qua; results;and 0) cac y8u t6lien quan khac, ch~ng h<;lnnhll hot;lt 0) other relevant factors, such as monitoring dQngthea dOiva dao t<;Io. activitiesand training. 8.9.3 8§u ra xem xet cua lanh d90 phc1ighi nh~n 8.9.3 The outputs from the management review t~t ca cae quy~t djnh va hanh dQngc6 lien quan shall record all decisions and actions related to at d~n It nh~t: least: a) tinh hj~u Il,l'ceua h~ thc5ngquan Iy va cae qua a) the effectiVenessof the management system trinh cua h~ thOng; and its processes; b) vi~c eai ti~n cae ho~t dQng thi nghi~m lien b) improvementof the laboratoryactivities related quan d~n viec thl,J'chi~n cae yeu cau cua tieu to the fulfilment of the requirements' of this chuan nay; document; c) cung ~p cac ngufin h,C cln thi~t; c) provisionof required resources; d) mQinhu ccliuthay d6i. d) any need for change. 52 TCVN ISOIIEe 17025:2017 AnnexA Phllll.lC A (tham khao) (!nformative) Uim k~t chuAn do Ill'cmg Metrological traceability A.1 General A.1 Khcii quat. PhI) luc nay cung cApthOngtin bOsung'v~ lien k~t This annex provides additional Information on chu§n do lU'ang, 18 m(lt kMf ni~m quan tr(;mgd~ metrological traceability, which Is an Important dam bao kha nang so sanh cac kilt qua do (j ca concept to ensure comparability of measurement trong nU'acva qu6c til. results both nationallyand internationally. A.2Thi~t I~plien k6t chuin do lU'o'ng A.2 Establishing metrological traceability A.2.1 Lien kilt chufln do lU'ongdU'Q'cthi~t I~pb~ng A.2.1 Metrological traceability is established by considering,and then ensuring,the following: eachxem xet va sau d6 dam bao: a) cac quy dinh kY thu~t cua d~i lU'qng do (d~i a) the specificationof the measurand(quantityto . be measured); 1U'Q'ng dU'qcdo); b) chuai hi~u chu~n khang dm do~mdU'Q'cI~p b) a documented unbroken chain of calibrations thanh van ban lien kllt t61cac m6c quy chillu going back to stated and appropriate thich hop da dU'qc ·cOngbO. Cac m6c quy references. Appropriate references include chleu thlch hop baa gllm chuAn qu6c gia, national or international standards, and qu6c ole va chu~n n{li bQ; intrinsicstandards; c) dO khOngdam bao do ~i tlrng b~c trong do c) that measurementuncertaintyfor each step in khang dam bao do cua '{;huol lien kilt chuan the traceability chain measurement dLFQ'C danh gia theo cac phU'O'I1g ph8p thOng uncertainty is evaluated according to agreed nhAt; methods; d) mOi b~c cua chu6i dU'Q'cthl,l'c hi~n theo cac d) that each step of the chain·is performed in phU'O'ng phap thfch hQ'pva cac k~t qua do va accordance with appropriate methods, and ac;. the measurement results and aSSOCiated, khOng dam bao do kern theo dU'Q'cghi nMn; va e) cic recordedmeasurementuncertainties;and phOng thl nghi~m thl,l'c hi{m mQt ho~ e) that the 1aboratoriesperforming one or more nhi~u b~c trong chu6i nay se cung c~p bang steps In the chain supply evidence for their .chung v~ nang Il,I'cky thu~itcua mlnh.. technical competence. A.2.2 Sai s6 do h~ thOng(dOl khi dLFqcgQila dO A.2.2 The systematic ch~h) cua mQtthiilt bi da dlJ'qc hi~u chuan dll'Q'c (,sometimes called trnh d~n khi Ian truy~n lien kilt chu~n do ILFongtai measurement error biaS) of the calibrated equipment is taken into account to disseminate cae k~t qua do trong phong thl nghiem. Hi~n san metrologicaltraceabifityto measurementresults in . c6 m(lt s6 CCI ch~ d~ tinh d~n cac sai s6 do h~ the laboratory. There are several mechanisms 53 TCVN ISOIlEC 17025:2017 th6ng trong vi~c Ian truy~n Ii~n k~t chuAn 00 available to take into account the systematic lliang cua phep do. measurement errors in the dissemination of measurementmetrologicaltraceability. A.2.3 Cac chuan do lliang c6 cac thOng tin dii A.2.3 Measurement standards that have reported oU'gc mot pMng thl nghi~m c6 nang IIfC baa cao information from a competent laboratory that chl bao g5m mQtcOngb6 v~ Slf pM hgp v&l quy Includes only a statement of conformity to a djnh ky thu~it {khOng c6 cac k~t qua do va dQ specification (omitting the measurement results khongdam baa kernthea) d61khl cOngalJ'gcdung and assocIateduncertainties)are sometimes used d~ Ian truy~n Ii~n k~t chuan do Iliang. Cach tl~p to disseminate metrological traceability. This ~n nay, tron9 d6 cac 9)&i han cua quy djnh ky approach, in which the specification limits are thu~t dligC all'a vito nhu la mQt nguOn cua dQ imported as khOngdam baa, phI,!thuQcvao: the source of uncertainty, is dependentupon: vi~c Slt df,lngml)t quy tc1cra quy~t djnh thich hop d~ thj~t l.;ipSlf phUhop; establishconformity; cac gi&i han cua quy dlnh ky thu~t dllgc xti Iy the specification limits subsequently being sau d6 theo giai phap ky thu~t thrch hgp trong bang thimh phc1ndOkhOngdam baa. _ the use of an appropriate decision rule to treated in a technically appropriate way in the uncertaintybudget. Ca s6' ky thu~t cho each ti~p c~n nay 13 Sll phu The technical basis for this approach is that the hgp dlJ'Q'ccong b6 dal v&i mot quy djnh ky thu~t declared conformance to a specificationdefines a sa xac djnh mOtgial cae gla trj do rna gia trj thr.rc range of measurement values, within which the dlf ki~n sa nc1mtrong d6, v&i muc tin ~y X8C true value Is expected to lie, at a specified level of dlnh, c6 tinh d~n ca dO chii!chso v&l gis trj thllc confidence, which considers both any bias from cung nhll dQkhOngdam baa do. the true value, as well as the measurement uncertainty. vI Dl): Vj~c sl) dl,lngcae qua c€mc~p R 111 cua OILM d~hi~uchu~ncan. to lien k~t chuAn dQJU'O-ng. A.3 Ch(Fng EXEMPLE The use of OIML R 111 class weights that are usedto calibrate a balance. A.3 Demonstrating metrological tracea~i1ity A.3.1 PMng thi 'nghi~mchju··trach nhi~m d6i vai A.3.1 laboratories are responsiblefor establishing vj~c thi~t I~p Ii~n k8t chuan do Iliang thea tieu metrological traceability in accordance with this chuan nay. K~t qua hi~u chuan cua cae pMng thl document. Calibration results from laboratories nghi~m pM hgp v&i tieu chuan nay S9 cung cap lien k~t chuan do llJ'ang.Cac gia trj dU'gc chting conforming with this document provide metrological traceability. Certified values of nh~n cua mclu chuc1ndU'gc chung nh~n do cac certified reference materials from reference nha san xuat mau chuan dap ling TCVN ISO material producers conforming with ISO 17034 17034 cOngcung cap Ii~n k~t chuan do rllang. C6 provide metrologicaltraceability.There are various nhi~ucachd~ ch~ng to Slf phIJhgp vai tieu chuan ways to demonstrate conformity with this nay, nghia Iii Slf thCr8 nh~n cua ben thLPba (vI dl) document, i.e. third party recognition {such as an 54 TCVN ISO/IEC 17025:2017 to clurc cong nhan), o{mh gia ben ngoal bal khach accreditation body). external assessment by - hang ho~c til oanh gia. Cac giai phap dLPQ'c qu6c customers or t~ chap nh~n bao gOm,nhLPngkhong giai han a: self-assessment. lnternatlonally accepted paths include. but are not limited to the following: a) Kha nang hi~u chuc1nva do h.pcYng dLPQ'c cung a) Calibration and measurement capabilities cap bai cac vl~n do ILPangquOc gia va cac provided by national metrology Institutes and vl~n dU'Q'cchi djnh la dOltLPQ'ng cua qua trlnh designated institutes that have been subject xem xet dOngd~ng thich hop. Vi~c xem xet to suitable peer-reviewprocesses.Such peer- d6ng d~ng duQ'c ti~n hanh thea CIPM MRA review is conducted under the CIPM MRA Uy ban (International Committee for Weights and can do qu6c t~). Cac djch VI,!cua CIPM MRA Measures Mutual Recognition Arrangement). c6 thll xem trong PhI,!h,lcC cua BIPM KCDB Services covered by the CIPM MRA can be (Co sa d[l' li~u so sanh co ban cua Van phong viewed in Appendix C of the BIPM KCDB can do qu6c t~). neu chi ti~t v~ pham vi va dQ (International Bureau khang dam baa do d6i vai tung djch VI,!dUQ'c Measures Key Comparison Database) which neu, details (Thoa thu~n thua nMn 1~n nhau cua the range of and Weights' and measurement uncertaintyfor each listedservice. b) Kha nang hi~u chuan va do ILPcmgda dl1Q'c b) Calibrationand measurementcapabilitiesthat ch(Fccong nMn tuan theo have .been accredited by an accreditation Thoa thu~n cua ILAC (TO chlic HQ'ptilc Cong ·body subject to -the lLAC (International nh~n Phong thi nghl~m QuOc-t~) ho~c cae Laboratory Thoa thu~n khu VIIC OlfQ'CILAC thlla nh~n da Arrangement or to Regional Arrangements chling to lien k~t chuan do IU'cmg.PhC[lm vi cua recognized by ILAC have demonstrated cac phOngthi nghier:ndlfQ'CcOng nh~n aU'Q'c metrologicaltraceability. Scopes of accredited cang nMn bal t6 cong bo .cong khai -tli cae to chlic cong nh~n tllang (Fng. Accreditation Cooperation) laboratoriesare publlcally available from their respectiveaccreditationbodies. A.3.2 Cong b6 chung gl[l'a BIPM. OIML (TO cl1(Fc A.3.2 The Joint BIPM. OIML (International Do 1lJ'()'ng 'PMp quy.enQu6c t~). ILAC va ISO v~ Organization of Legal .Metrology). ILAC and ISO lien k~t chudn do IU'o-ngaU'ara hU:&ngdan Cl,l th~ Declaration on Metrological Traceability provides khi -c6 nhu cau chling ·to -kha n~ng chc1pnMn specific guidance when there is a need to qu6c t~ v~ chuOllien k~t chuAndo luang. demonstrate International acceptability of the metrologicaltraceabilitychain.. 55 TCVN ISOIIEC 17025:2017 Phl,lll,lcB AnnexB (tham khao) (informative) Cac lI,a chon dOi vOi hi thOng quan Iy Management System Options B.1 Nhin chung, Sl! phat tri~n trang vi~c 51) dl,mg B.1 Growth in the use of management systems cac h~ th6ng quan 19 da thee day nhu cau dam generally has increased the need to ensure that baa r~ng cac phong thl nghi~m c6 tht\ v~n hanh laboratories can operate a management system h~ thOngquan Iy dLPQ'c coi la phu hop vai TCVN that is seen as conforming to ISO 9001 as well as ISO 9001 cOng nhLPval ti~u chuan nay. VI vi)y, with this document. As a result, this document tieu chuan dLPara hal h,a chon dOi vai cac y6u provides two options for the requirements related c~u lien quan d~n vi~e ap dl,lngh~thOngquan IY. to the implementatiorl'ofa managementsystem. B.2 Li,a chon A (xem 8.1.2) Ii~tke cac yeu cau tOi B.2 Option A (see 8.1.2) lists the minimum thi~u dOi vai vi~c ap dr,mgh~ thOngquail 19' trong requirementsfor implementationof a management phOngthi nghi~m. PMi thi)n trQngtrong vi~c kilt system in a laboratory. Care has been taken to hop tat cci cac yeu cau cua TCVN ISO 9001 co incorporate all those requirements of ISO 9001 lien quan (f~n pharn vi cac hoat dong thl nghi~n:' that are relevant to the scope of laboratory dl1Q'cbaa trUmtrong h~ thOngquan IY. Cac phOng activities that are covered by the management thr nghi~m tusn thu cac di~u tli 4 d~n 7 va thllC system. Laboratoriesthat comply with clauses4 to hi~n lr,Pachon A cua di~u 8 thea do cOngsa v~n 7 and implement optionA of clause 8 will therefore hanh thea cae nguyen tac cua TCVN ISO 9001. also operate generally In accordance with the principlesof ISO 9001. B.3 Ll,I'achQnB (xem 8.1.3) cho phep cac phOng B.3 Option B (see 8.1.3) allows laboratories to thf nghi~m thi8t I~p va duy trl h~ th6ng quan 19 establish and maintain a management system in phu hQ'pvai yeu cau cua TCVN ISO 9001 thea accordancewith the requirements of ISO 9001 in cach h6 trQ'va ch(fng t6 vif)c thllc hi~n nhat quan a manner that supports and demonstrates the cac di~u tli 4 d8n 7. Cac phOng thi nghi(!m ap consistent fulfilment" of clauses .4 to .7. dl)ng Ilia chon B eua di~u 8 thea do sa dl1Q'Cxem laboratories that implement option B of clause 8 la v~n hanh thea TCVN ISO 9001. SII phU hQ'p will therefore also operate in accordancewith ISO cua ht} th6ng quim Iy, trang d6 phong thi nghi~m 9001. Conformity of the management system ho~t dong, thea cae yeu c~u cua,TCVN ISO 9001, within which the laboratory operates to the til n6 khang th~ chlPng to dlJ'qc nang lI,I'c cua requirements of ISO 9001 does not, in itself, phOngthl nghi~mtrong vi~c t~o ra cac k~t qua va demonstrate the competence of the laboratory to dfr Ii~u c6 y nghia v~ m~t ky thu~it.Vi~c nay dLPqc produce technically valid data and results. This is thllc hi{!n thong qua vi~c tusn thu cac di~u tli 4 accomplished through compliance with clauses 4 d~n 7. to 7. 8.4 Cci hal Iva chc;md~u nh~m (fOilt dLPQ'c cung m(lt 56 B.4 Both options are-intended to achieve the same TCVN ISO/IEC 17025:2017 kat qua trong vi~c thl!c hl~n h~ thong qoan Iy va result in the performance of the management tuan thu cac diflu tCr4 d~n 7. system and compliancewith clauses4 to 7. CHU THlcH: Tal li~u, dli' li~u va hO so Is sac thanh NOTE Documents, data and records are components phan cua thong tin d~ng van ban cU'Q'csti dl,mgtrong of documented information as used in ISO 9001 and 'TCVN ISO 9001 va cac tieu chu§n khac vll M thOng other management system standards. Control of quan IY.Vi(i? ki~m soat cac tai lil;lu dllQ'c neu a 8.3. documents is covered in 8.3. The control of records Is Vi~c ki~m soat h6 so dllQ'c n~u (y 8.4 va 7.5. ViQcki~m covered in 8.4 and 7.5. The control of data related to soat dQoIil;luliim quan nau d~nheat dQngthl nghl~m dU'Q'c the laboratoryactivities is covered In 7.11. a 7.11. 8.5 Hinh ve trong trang k~ ti~p minh hoa ml)t vl dl,! 8.5 The Figure in the next page Illustrates an v~ each the hi~n mang tlnh so dO cac qua trinh example of a possibleschematic representationof hoat d¢ng cUa m¢t phOngthi nghi~m nhu nau dieu 7. a the operational processes of a laboratory as describedin Clause 7. 57 TCVN ISOIlEC 17025:2017 LAy. ti~p nhiiln. xli Iy cJ6i tl1Q'ng Tral9i ci61 tllc;mg Nllu6nlvc Hinh 61 - Vi dl:l viiso d6 th~ hiqn cac qua trinh thllC hi{!n ella theo quy dinh Resource phong thf nghi~m a di~u 7 ManageJ.!lent . 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Li,a chQn va SLP dl,Jng mau chu§n, [34] [34} EEElRMI062rev3, Eurachem 4) The role of measurement uncertainty in The Selection l35.I t~~(SI)BIPM5) Units (SI), BIPM www.bipm.ora/utils/common/pdf/BIPM-OiML-ILAC-ISO lolnt htto:ll 3) htlp:/lilac.orgl 4) https:ll 5) http://www.bipm.orq/enlpublicationslsi-brochure/ and use of Reference Materia/s, EEElRMl062rev3, Eurachem [35] S6 tay hU'&ng dan SI: H~ thong dO'n vi quoe 2) . SI Brochure: The Intemational System of declaration 2011.pdf www.eurachem.orglimages/storieslGuides/pdf/EEE_RM-062rev3.odf 61