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
.
FIGVRE81 Example of a possible schematic representation ofthe operational processes
.
of a laboratory as described in the Clause 7
58
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TCVN ISO/IEC 17025:2017
chung
va nguyen tiic thc3ng k{J d6i va; hOf,lt dQng General and statistical princIples for certification
ch&ng nh~n
[26] ISO Guide 80, Hoong dan chulm bi mau
[26] ISO Guide 80, Guidance for the in-house
ki{Jm soat ch~t lU'Q'ngnQi bQ (QCMs)
preparation of quality control materials (OCMs)
[271 TCVN 9595-3, DQ khong dam bilO do - Ph~n
[27] ISO Guide 98-3, Uncertainty of measurement
3: HU'(yng dan trinh bay dQ khOng dam Mo do
-
(GUM: 1995)
measurement (GUM:1995)
Part
3: Guide to the expression of uncertainty in
[28] ISOIIEe Guide 98-4, £)Q khOng dam Mo do [28] ISOIIEC
- Ph<1n4: Vai tro cua dQ khOng dam Mo do trong
danh gia
sv phD hQ'p
do trong hOf,ltdQng dtmh gia
sv pM
hqp trong linh
we IcY thu~t di~n
b6
T6
chung cua BIPM, OIML, ILAC va
chuc hop
Uncertainty
ot :
4: Role of measurement
- Part
[29] IEC Guide 115, Application of uncertainty of
measurement to confonnity assessment activities
in the electrotechnlcal sector
ISO v~ liim k~t chulm do loong, 20112)
[31]
98-4,
uncertainty In confonnityassessment
[29] IEC Guide 115, Ap dl,mg dt) khOng dam Mo
[30] Cong
measurement
Guide
[30) Joint BIPM, OIML, ILAC and ISO declaration
on metrological traceability, 2011
tao v6 c6ng nh~n phong thi {31] International
nghi~m qu6e t~ (ILAC) 3)
{321 Thu~t ngfi' qu6c
t6
Laboratory
Accreditation
Cooperation (ILAC)
vE} do li.nYngphfJp quy§n
(VIML), OIML V1:2013
.{32] Intemational Vocabulary of Terms in Legal
Metrology (VIML), OIML V1:2013
[33] JCGM 106:2012, fJanh gia dt} li~u do lU'&ng [33] JCGM 106:2012, Evaluation of measurement
- Vai tro cua dt')khOng dam bao do trong danh gia
data -
sv phD h9'P
conformity assessment.
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