BN DCH Tiu chun

(Dng cho o to, cp nht kin thc)

ISO/IEC 17025 : 2005

YU CU CHUNG V NNG LC CA PHNG

TH NGHIM V HIU CHUN

GENERAL REQUIREMENTS FOR THE

COMPETENCE OF TESTING AND CALIBRATION
LABORATORIES

H NI 2005
 Mc lc

Li gii thiu Introduction

1. Phm vi p dng Scope
2. Tiu chun trch dn Normative references
3. Thut ng v nh ngha Terms and definitions
4. Cc yu cu v qun l Management requirements 1
4.1. T chc Organization 1
4.2. H thng qun l Management system 3
4.3. Kim sot ti liu Document control 5
4.3.1 Yu cu chung General 5
4.3.2 Ph duyt v ban hnh ti liu Document approval and issue 6
4.3.3 Thay i ti liu Document changes 7
4.4. Xem xt cc yu cu, ngh v hp Review of requests, tenders and contracts 7
ng
4.5. Hp ng ph v th nghim v hiu Subcontracting of tests and calibrations 9
chun
4.6. Mua dch v v cung cp Purchasing servieces and supplies 10
4.7. Dch v i vi khch hng Service to the customer 11
4.8. Phn nn Complaints 12
4.9. Kim sot vic th nghim v hiu Control of nonconforming testing and/or 12
chun khng ph hp calibration work
4.10. Ci tin Improvement 13
4.11. Hnh ng khc phc Corrective action 13
4.11.1 Yu cu chung General 13
4.11.2 Phn tch nguyn nhn Cause analysis 14
4.11.3 La chn v thc hin hnh ng Selection and implementation of corrective 14
khc phc actions
4.11.4 Theo di hnh ng khc phc Monitoring of corrective actions 14
4.11.5 nh gi b xung Additional audits 14
4.12. Hnh ng phng nga Preventive action 15
4.13. Kim sot h s Control of records 15
4.13.1 Yu cu chung General 15
4.13.2 H s k thut Technical record 16
4.14. nh gi ni b Internal audits 17
4.15. Xem xt ca lnh o Management reviews 18
5. Cc yu cu k thut Technical requirements 19
5.1 Yu cu chung General 19

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5.2 Nhn s Personnel 19
5.3 Tin nghi v iu kin mi trng Accommodation and environmental 21
conditions
5.4 Phng php th nghim v hiu Test and calibration methods and method 23
chun v ph duyt phng php validation
5.4.1 Yu cu chung General 23
5.4.2 La chn phng php Selection of methods 23
5.4.3 Phng php do PTN xy dng Laboratory-developed methods 24
5.4.4 Cc phng php khng tiu chun Non-standard methods 24
5.4.5 Ph duyt phng php Validation of methods 25
5.4.6 nh gi khng m bo o Estimation of uncertainty of measurement 27
5.4.7 Kim sot d liu Control of data 28
5.5 Thit b Equipment 29
5.6 Lin kt chun Measurement traceability 32
5.6.1 Khi qut General 32
5.6.2 Cc yu cu c th Specific requirements 32
5.6.3 Chun chnh v mu chun Reference standards and reference 35
materials
5.7 Ly mu Sampling 36
5.8 Qun l mu th nghim v hiu Handling of test and calibration items 37
chun
5.9 m bo cht lng kt qu th Assuring the quality of test and calibration 38
nghim v hiu chun results
5.10 Bo co kt qu Reporting the results 39
5.10.1 Yu cu chung General 39
5.10.2 Bin bn th nghim v giy chng Test reports and calibration certificates 40
nhn hiu chun
5.10.3 Bin bn th nghim Test reports 41
5.10.4 Chng ch hiu chun Calibration certificates 42
5.10.5 Nhn xt v din gii Opinions and interpretations 43
5.10.6 Kt qa th nghim v hiu chun Testing and calibration results obtained 44
nhn c t nh thu ph from subcontractors
5.10.7 Chuyn giao kt qu bng in t Electronic transmission of results 44
5.10.8 Hnh thc bin bn v giy chng Format of reports and certificates 44
nhn
5.10.9 Sa i b xung th nghim hoc Amendments to test reports and calibration 44
giy chng nhn hiu chun. cerificate

3
Li gii thiu Foreword
Phin bn ln th nht (1999) ca tiu chun ny The first edition (1999) of this International
c ban hnh l kt qu c kt t kinh nghim Standard was produced as the result of extensive
chung trong vic thc hin ISO/IEC Guide 25 v experience in the implementation of ISO/IEC
EN 45001 v thay th c hai tiu chun ny. Tiu Guide 25 and EN 45001, both of which it replaced.
chun ny bao gm cc yu cu m cc phng th It contained all of the requirements that testing and
nghim v hiu chun phi p ng nu mun calibration laboratories have to meet if they wish to
chng minh rng phng th nghim v hiu chun demonstrate that they operate a management
(sau y gi tt l PTN) ang p dng mt h system, are technically competent, and are able to
thng cht lng, rng PTN c nng lc k thut v generate technically valid results.
c th cung cp cc kt qu c gi tr v mt k
thut.
Phin bn ln th nht ca tiu chun ny tham The first edition referred to ISO 9001:1994 and
chiu ti ISO/IEC 9001:1994 v ISO 9002:1994. ISO 9002:1994. These standards have been
Hai tiu chun ny c thay th bng tiu superseded by ISO 9001:2000, which made an
chun ISO/IEC 9001:2000, c kt hp vi ISO/IEC alignment of ISO/IEC 17025 necessary. In this
17025. Trong phin bn ln th hai ca tiu chun second edition, clauses have been amended or
ISO/IEC 17025, cc iu ca tiu chun c sa added only when considered necessary in the light
i v b sung ch khi cn thit ph hp vi ISO of ISO 9001:2000.
9001:2000. Accreditation bodies that recognize the
Cc t chc cng nhn tha nhn nng lc ca competence of testing and calibration laboratories
cc phng th nghim v hiu chun cn s dng should use this International Standard as the basis
tiu chun ny nh-l c s cho vic cng nhn. for their accreditation. Clause 4 specifies the
iu 4 qui nh cc yu cu cn c cho vic qun l requirements for sound management. Clause 5
tt. iu 5 qui nh cc yu cu v nng lc k specifies the requirements for technical
thut i vi loi php th v/hoc hiu chun m competence for the type of tests and/or
PTN thc hin. calibrations the laboratory undertakes.
Vic s dng ngy cng rng ri h thng cht Growth in the use of management systems
lng nhn chung lm tng nhu cu m bo generally has increased the need to ensure that
cho cc PTN l trc thuc mt t chc ln hn laboratories which form part of larger organizations
hoc l PTN cung cp cc dch v khc, c th or offer other services can operate to a quality
hot ng theo mt h thng cht lng ph hp management system that is seen as compliant
vi TCVN ISO 9001 v tiu chun ny. V vy, with ISO 9001 as well as with this International
ngi ta thn trng sp nhp tt c nhng yu Standard. Care has been taken, therefore, to
cu ca TCVN ISO 9001 c lin quan n phm vi incorporate all those requirements of ISO 9001
cc dch v th nghim v hiu chun thuc h that are relevant to the scope of testing and
thng cht lng PTN. calibration services that are covered by the
V vy cc PTN p ng c tiu chun ny s laboratory's management system.
hot ng ph hp vi TCVN ISO 9001. Testing and calibration laboratories that comply
with this International Standard will therefore also
operate in accordance with ISO 9001.
S ph hp ca mt h thng qun l cht lng Conformity of the quality management system
trong PTN ang hot ng theo cc yu cu ca within which the laboratory operates to the
ISO 9001 bn thn n khng chng t nng lc requirements of ISO 9001 does not of itself
ca PTN cung cp cc kt qu v d liu c gi tr demonstrate the competence of the laboratory to

4
v mt k thut. S ph hp i vi ISO/IEC 17025 produce technically valid data and results. Nor
cng khng c ngha l h thng qun l cht does demonstrated conformity to this International
lng PTN ang s dng ph hp vi tt c cc Standard imply conformity of the quality
yu cu ca ISO 9001 management system within which the laboratory
operates to all the requirements of ISO 9001.
S chp nhn kt qu th nghim v hiu chun The acceptance of testing and calibration results
gia cc nc s li hn nu cc PTN tun th between countries should be facilitated if
tiu chun ny v nu PTN c cc t chc cng laboratories comply with this International
nhn tham gia tho c tha nhn ln nhau vi Standard and if they obtain accreditation from
cc t chc tng ng ca cc quc gia khc bodies which have entered into mutual recognition
s dng tiu chun ny cng nhn. agreements with equivalent bodies in other
countries using this International Standard.
Vic s dng tiu chun ny s to iu kin cho The use of this International Standard will facilitate
s hp tc gia cc PTN v cc t chc khc cooperation between laboratories and other
nhm h tr vic trao i thng tin v kinh nghim bodies, and assist in the exchange of information
v lm hi ho cc tiu chun v th tc. and experience, and in the harmonization of
standards and procedures.

5
 YU CU CHUNG V NNG LC CA PHNG TH NGHIM V HIU
CHUN
1. Phm vi p dng
1.1 Tiu chun ny qui nh cc yu cu chung v
nng lc thc hin cc php th v/hoc hiu
chun bao gm c vic ly mu. Tiu chun ny
cp n vic th nghim v hiu chun c thc
hin bng cc phng php tiu chun, khng tiu
chun v cc phng php do PTN t xy dng.
1.2 Tiu chun ny p dng cho tt c cc t chc
thc hin vic th nghim v/hoc hiu chun. Cc
t chc ny bao gm, v d nh cc PTN bn th
nht, bn th hai, bn th ba v cc PTN m vic
th nghim v/hoc hiu chun l mt phn ca
hot ng gim nh v chng nhn sn phm.
Tiu chun ny p dng cho tt c cc PTN khng
ph thuc vo s lng nhn vin hay phm vi
hot ng th nghim v/hoc hiu chun. Khi mt
PTN khng thc hin mt hoc nhiu hot ng
c quy nh trong tiu chun ny, nh ly mu
v thit k/pht trin cc phng php mi, th cc
yu cu thuc cc iu khng cn p dng
1.3 Cc ch thch c a ra lm r ni dung,
cc v d v hng dn. Ch thch ny khng phi
l cc yu cu v khng to thnh mt phn ca
tiu chun ny.
1.4 Tiu chun ny s dng cho cc PTN trong
vic xy dng h thng qun l v hot ng k
thut, hnh chnh v cht lng. Khch hng ca
PTN, c quan c thm quyn v cc c quan cng
nhn cng c th s dng tiu chun ny xc
nhn hoc tha nhn nng lc ca cc PTN. Tiu
chun quc t ny khng c s dng l chun
mc chng nhn PTN.
Ch thch 1: Thut ng H thng qun l trong
tiu chun ny c ngha l h thng k thut, hnh
chnh v cht lng iu hnh hot ng ca mt
PTN.
Ch thch 2: Chng nhn mt h thng qun l
cng thng c gi l ng k.
1.5 Vic tun th cc yu cu v an ton trong hot
ng ca cc PTN khng thuc phm vi tiu chun
1 Scope
1.1 This International Standard specifies the
general requirements for the competence to carry
out tests and/or calibrations, including sampling. It
covers testing and calibration performed using
standard methods, non-standard methods, and
laboratory-developed methods.
1.2 This International Standard is applicable to all
organizations performing tests and/or calibrations.
These include, for example, first-, second- and
third-party laboratories, and laboratories where
testing and/or calibration forms part of inspection
and product certification.
This International Standard is applicable to all
laboratories regardless of the number of personnel
or the extent of the scope of testing and/or
calibration activities. When a laboratory does not
undertake one or more of the activities covered by
this International Standard, such as sampling and
the design/development of new methods, the
requirements of those clauses do not apply.
1.3 The notes given provide clarification of the text,
examples and guidance. They do not contain
requirements and do not form an integral part of
this International Standard.
1.4 This International Standard is for use by
laboratories in developing their management
system for quality, administrative and technical
operations. Laboratory customers, regulatory
authorities and accreditation bodies may also use it
in confirming or recognizing the competence of
laboratories. This International Standard is not
intended to be used as the basis for certification of
laboratories.
NOTE 1 The term 'management system' in this
International Standard means the quality,
administrative and technical systems that govern
the operations of a laboratory.
NOTE 2 Certification of a management system is
sometimes also called registration.
1.5 Compliance with regulatory and safety
requirements on the operation of laboratories is not
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ny.
1.6 Nu cc phng th nghim v hiu chun tun
th cc yu cu ca tiu chun ny th PTN s hot
ng theo mt h thng qun l cht lng trong
cc hot ng th nghim v hiu chun p ng
c cc yu cu ca ISO 9001. Ph lc A a ra
ch dn i chiu tiu chun ny vi ISO 9001. Tiu
chun ny cp n cc yu cu nng lc k
thut m khng cp trong ISO 9001.
Ch thch 1 -Cn thit phi gii thch hoc din gii
mt s yu cu trong tiu chun ny m bo
cc yu cu c p dng mt cch nht qun.
Hng dn cho vic p dng trong cc lnh vc c
th, c bit l cho cc c quan cng nhn [xem
ISO/IEC 17011) c trnh by trong ph lc B.
Ch thch 2 -Nu PTN mong mun c cng nhn
mt phn hoc tt c cc hot ng th nghim v
hiu chun th PTN nn chn mt c quan cng
nhn hot ng ph hp vi ISO/IEC 17011.
2 Tiu chun trch dn
Cc ti liu vin dn sau l khng th thiu c
khi p dng tiu chun ny. i vi ti liu tham
chiu khng r thi gian ban hnh th s p dng
ti liu vin dn (bao gm c cc sa i) c
ban hnh gn y nht.
ISO 17000, nh gi s ph hp Thut ng
chung v nh ngha.
VIM, o lng hc. Thut ng chung v c bn
trong o lng, do BIPM, IEC, IFCC, ISO, IUPAC,
IUPAP
Ch thch -Cc tiu chun, hng dn lin quan
khc... v cc ch ca tiu chun ny c nu
trong danh mc ti liu tham kho
3 Thut ng v nh ngha
Cc thut ng v nh ngha trnh by trong
ISO/IEC 17000 v VIM -c s dng cho tiu
chun ny.
Ch thch -Cc nh ngha chung lin quan ti cht
lng c trnh by trong ISO 9000 cn ISO/IEC
17000 nu ra cc nh ngha c th lin quan n
covered by this International Standard.
1.6 If testing and calibration laboratories comply
with the requirements of this International Standard,
they will operate a quality management system for
their testing and calibration activities that also
meets the principles of ISO 9001. Annex A provides
nominal cross-references between this International
Standard and ISO 9001. This International
Standard covers technical competence
requirements that are not covered by ISO 9001.
NOTE 1 It might be necessary to explain or
interpret certain requirements in this International
Standard to ensure that the requirements are
applied in a consistent manner. Guidance for
establishing applications for specific fields,
especially for accreditation bodies (see ISO/IEC
17011) is given in Annex B.
NOTE 2 If a laboratory wishes accreditation for part
or all of its testing and calibration activities, it should
select an accreditation body that operates in
accordance with ISO/IEC 17011.
2 Normative references
The following referenced documents are
indispensable for the application of this document.
For dated references, only the edition cited applies.
For undated references, the latest edition of the
referenced document (including any amendments)
applies.
ISO/IEC 17000, Conformity assessment
Vocabulary and general principles
VIM, International vocabulary of basic and general
terms in metrology, issued by BIPM, IEC, IFCC,
ISO, IUPAC, IUPAP and OIML
NOTE Further related standards, guides, etc. on
subjects included in this International Standard are
given in the Bibliography.
3 Terms and definitions
For the purposes of this document, the relevant
terms and definitions given in ISO/IEC 17000 and
VIM apply.
NOTE General definitions related to quality are
given in ISO 9000, whereas ISO/IEC 17000 gives
definitions specifically related to certification and
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chng nhn v cng nhn PTN. Trong trng hp laboratory accreditation. Where different definitions
ISO 9000 a ra nh ngha khc th s s dng are given in ISO 9000, the definitions in ISO/IEC
17000 and VIM are preferred.
nh ngha trong ISO 17000 v VIM.

8
YU CU CHUNG V NNG LC CA PHNG TH NGHIM V HIU
CHUN

1. Phm vi p dng

1.1 Tiu chun ny qui nh cc yu cu chung v nng lc thc hin cc php th v/hoc
hiu chun bao gm c vic ly mu. Tiu chun ny cp n vic th nghim v hiu
chun c thc hin bng cc phng php tiu chun, khng tiu chun v cc phng
php do PTN t xy dng.

1.2 Tiu chun ny p dng cho tt c cc t chc thc hin vic th nghim v/hoc hiu
chun. Cc t chc ny bao gm, v d nh cc PTN bn th nht, bn th hai, bn th ba
v cc PTN m vic th nghim v/hoc hiu chun l mt phn ca hot ng gim nh v
chng nhn sn phm.

Tiu chun ny p dng cho tt c cc PTN khng ph thuc vo s lng nhn vin hay
phm vi hot ng th nghim v/hoc hiu chun. Khi mt PTN khng thc hin mt hoc
nhiu hot ng c quy nh trong tiu chun ny, nh ly mu v thit k/pht trin cc
phng php mi, th cc yu cu thuc cc iu khng cn p dng

1.3 Cc ch thch c a ra lm r ni dung, cc v d v hng dn. Ch thch ny

khng phi l cc yu cu v khng to thnh mt phn ca tiu chun ny.

1.4 Tiu chun ny s dng cho cc PTN trong vic xy dng h thng qun l v hot ng
k thut, hnh chnh v cht lng. Khch hng ca PTN, c quan c thm quyn v cc c
quan cng nhn cng c th s dng tiu chun ny xc nhn hoc tha nhn nng lc
ca cc PTN. Tiu chun quc t ny khng c s dng l chun mc chng nhn
PTN.

Ch thch 1: Thut ng H thng qun l trong tiu chun ny c ngha l h thng k thut,
hnh chnh v cht lng iu hnh hot ng ca mt PTN.

Ch thch 2: Chng nhn mt h thng qun l cng thng c gi l ng k.

1.5 Vic tun th cc yu cu v an ton trong hot ng ca cc PTN khng thuc phm vi
tiu chun ny.

1.6 Nu cc phng th nghim v hiu chun tun th cc yu cu ca tiu chun ny th

PTN s hot ng theo mt h thng qun l cht lng trong cc hot ng th nghim v
hiu chun p ng c cc yu cu ca ISO 9001. Ph lc A a ra ch dn i chiu tiu
chun ny vi ISO 9001. Tiu chun ny cp n cc yu cu nng lc k thut m
khng cp trong ISO 9001.

9
Ch thch 1 -Cn thit phi gii thch hoc din gii mt s yu cu trong tiu chun ny
m bo cc yu cu c p dng mt cch nht qun. Hng dn cho vic p dng trong
cc lnh vc c th, c bit l cho cc c quan cng nhn [xem ISO/IEC 17011) c trnh
by trong ph lc B.

Ch thch 2 -Nu PTN mong mun c cng nhn mt phn hoc tt c cc hot ng th
nghim v hiu chun th PTN nn chn mt c quan cng nhn hot ng ph hp vi
ISO/IEC 17011.

2 Tiu chun trch dn

Cc ti liu vin dn sau l khng th thiu c khi p dng tiu chun ny. i vi ti liu
tham chiu khng r thi gian ban hnh th s p dng ti liu vin dn (bao gm c cc sa
i) c ban hnh gn y nht.

ISO 17000, nh gi s ph hp Thut ng chung v nh ngha.

VIM, o lng hc. Thut ng chung v c bn trong o lng, do BIPM, IEC, IFCC, ISO,
IUPAC, IUPAP

Ch thch -Cc tiu chun, hng dn lin quan khc... v cc ch ca tiu chun ny
c nu trong danh mc ti liu tham kho

3 Thut ng v nh ngha

Cc thut ng v nh ngha trnh by trong ISO/IEC 17000 v VIM -c s dng cho tiu
chun ny.

Ch thch -Cc nh ngha chung lin quan ti cht lng c trnh by trong ISO 9000 cn
ISO/IEC 17000 nu ra cc nh ngha c th lin quan n chng nhn v cng nhn PTN.
Trong trng hp ISO 9000 a ra nh ngha khc th s s dng nh ngha trong ISO
17000 v VIM.

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4. Cc yu cu v qun l
4.1 T chc
4.1.1 PTN hoc t chc m PTN l mt b phn,
phi l mt thc th c kh nng chu trch nhim
v mt php l.
4.1.2 PTN c trch nhim thc hin cc hot ng
th nghim v hiu chun sao cho p ng c
tt c cc yu cu ca tiu chun ny v tho mn
yu cu ca khch hng, c quan c thm quyn
hoc cc c quan cng nhn.
4.1.3 H thng qun l phi bao qut cc hot
ng c thc hin ti c s c nh ca PTN,
ti hin trng ngoi c s c nh hoc ti c s
tm thi hay di ng.
4.1.4 Nu PTN l b phn ca mt t chc thc
hin cc hot ng khc vi vic th nghim
v/hoc hiu chun th phi nh r trch nhim
ca mi nhn vin ch cht c lin quan hoc c
nh hng ti cc hot ng th nghim v/hoc
hiu chun ca PTN nhn bit cc mu thun
tim n v quyn li.
Ch thch 1 - Nu PTN l mt b phn trong mt t
chc ln th nn sp xp t chc sao cho cc b phn
c lin quan v li ch nh: sn xut kinh doanh, tip
th hoc ti chnh s khng gy ra nh hng bt li
n s ph hp ca PTN theo cc yu cu cu tiu
chun ny.
Ch thch 2 -Nu mt PTN mong mun c tha
nhn l PTN ca bn th ba th s phi chng minh
rng PTN l khch quan, rng nhn vin ca PTN
khng b p lc no v thng mi, ti chnh v p
lc khc c th nh hng n cc quyt nh c tnh
k thut. Phng th nghim hoc hiu chun bn th
ba khng c tham gia bt c cc hot ng no c
th tn hi n tin cy, tnh c lp ca cc quyt
nh v tnh trung thc lin quan n hot ng th
nghim hoc hiu chun ca PTN.
4.1.5 PTN phi:
a) c nhn vin qun l v k thut, ngoi cc trch
4 Management requirements
4.1 Organization
4.1.1 The laboratory or the organization of which it
is part shall be an entity that can be held legally
responsible.
4.1.2 It is the responsibility of the laboratory to
carry out its testing and calibration activities in
such a way as to meet the requirements of this
International Standard and to satisfy the needs of
the customer, the regulatory authorities or
organizations providing recognition.
4.1.3 The management system shall cover work
carried out in the laboratorys permanent facilities,
at sites away from its permanent facilities, or in
associated temporary or mobile facilities.
4.1.4 If the laboratory is part of an organization
performing activities other than testing and/or
calibration, the responsibilities of key personnel in
the organization that have an involvement or
influence on the testing and/or calibration activities
of the laboratory shall be defined in order to
identify potential conflicts of interest.
NOTE 1 Where a laboratory is part of a larger
organization, the organizational arrangements should
be such that departments having conflicting interests,
such as production, commercial marketing or financing
do not adversely influence the laboratory's compliance
with the requirements of this International Standard.
NOTE 2 If the laboratory wishes to be recognized as a
third-party laboratory, it should be able to demonstrate
that it is impartial and that it and its personnel are free
from any undue commercial, financial and other
pressures which might influence their technical
judgement. The third-party testing or calibration
laboratory should not engage in any activities that may
endanger the trust in its independence of judgement
and integrity in relation to its testing or calibration
activities.
4.1.5 The laboratory shall
a) have managerial and technical personnel who,
11
nhim khc c giao quyn hn v cc ngun irrespective of other responsibilities, have the
lc cn thit thc hin cc nhim v, bao gm authority and resources needed to carry out
thc hin, duy tr v ci tin h thng qun l, v their duties, including the implementation,
xc nh vn pht sinh do chch hng h maintenance and improvement of the
thng qun l hoc cc th tc tin hnh php th management system, and to identify the
nghim v/hoc hiu chun v xut cc occurrence of departures from the
hnh ng phng nga hoc gim thiu cc vn management system or from the procedures
(xem 5.2); for performing tests and/or calibrations, and to
initiate actions to prevent or minimize such
departures (see also 5.2);

b) c s sp xp m bo rng lnh o v nhn b) have arrangements to ensure that its

vin PTN khng chu bt k p lc no ca ni b
hoc bn ngoi v thng mi, ti chnh v mi p
lc khc c th nh hng xu n cht lng
cng vic ca h;
management and personnel are free from any
undue internal and external commercial,
financial and other pressures and influences
that may adversely affect the quality of their
work;

c) c cc chnh sch v th tc bo mt cc c) have policies and procedures to ensure the

thng tin v quyn s hu ca khch hng k c protection of its customers' confidential
th tc bo v vic lu gi v truyn cc kt information and proprietary rights, including
qu bng in t; procedures for protecting the electronic
storage and transmission of results;

d) c cc chnh sch v th tc nhm trnh lin d) have policies and procedures to avoid
quan vo bt c hot ng no c th lm gim involvement in any activities that would
s tin cy v nng lc, tnh khch quan, quyt diminish confidence in its competence,
nh tnh trung thc hoc tnh nht qun hot ng impartiality, judgement or operational integrity;
ca PTN;

e) xc nh c cu t chc v qun l ca PTN v e) define the organization and management

v tr ca PTN trong t chc ch qun v cc mi structure of the laboratory, its place in any
quan h gia qun l cht lng, hot ng k parent organization, and the relationships
thut v dch v h tr; between quality management, technical
operations and support services;

f) quy nh trch nhim, quyn hn v mi quan h f) specify the responsibility, authority and
qua li ca tt c cc nhn vin qun l, thc hin interrelationships of all personnel who
hoc kim tra cng vic c nh hng n cht manage, perform or verify work affecting the
lng ca php th nghim v/hoc hiu chun; quality of the tests and/or calibrations;

g) thc hin vic gim st mt cch tha ng i g) provide adequate supervision of testing and
vi nhn vin th nghim v hiu chun, k c calibration staff, including trainees, by persons
cc nhn vin ang tp s, thng qua nhng familiar with methods and procedures,
ngi am hiu cc phng php v th tc th purpose of each test and/or calibration, and

12
nghim v/hoc hiu chun, mc ch ca mi with the assessment of the test or calibration
php th nghim v/hoc hiu chun bng cch results;
nh gi cc kt qu th nghim v/hoc hiu
chun;

h) c ngi qun l k thut chu trch nhim
chung v cc hot ng k thut v vic cung cp
cc ngun lc cn thit m bo cht lng
cc hot ng ca PTN;
h) have technical management which has overall
responsibility for the technical operations and
the provision of the resources needed to
ensure the required quality of laboratory
operations;

i) b nhim mt ngi trong PTN lm qun l cht
lng (hoc di mt chc danh khc). Ngi
ny ngoi cc trch nhim v nhim v khc, phi
c trch nhim v quyn hn r rng m bo
rng h thng qun l lin quan ti cht lng
lun c thc hin v tun th. Ngi qun l
cht lng phi lin h trc tip vi lnh o cao
nht c thm quyn a ra cc quyt nh v
chnh sch v ngun lc ca PTN.
i) appoint a member of staff as quality manager
(however named) who, irrespective of other
duties and responsibilities, shall have defined
responsibility and authority for ensuring that
the management system related to quality is
implemented and followed at all times; the
quality manager shall have direct access to
the highest level of management at which
decisions are made on laboratory policy or
resources;

j) b nhim cc cp ph cho cc chc danh qun j) appoint deputies for key managerial personnel
l ch cht (xem ch thch). (see Note);

k) m bo rng nhn vin PTN nhn thc c k) ensure that its personnel are aware of the
mi lin quan v tm quan trng ca cc hot relevance and importance of their activities
ng ca h v h ng gp nh th no i vi and how they contribute to the achievement of
vic t c cc mc tiu ca h thng qun l. the objectives of the management system.

Ch thch -Cc c nhn c th c mt hoc nhiu NOTE Individuals may have more than one function
chc nng v s khng thc t nu b nhim and it may be impractical to appoint deputies for
cp ph cho mi chc nng. every function.

4.1.6 Lnh o cao nht phi m bo rng cc 4.1.6 Top management shall ensure that
qu trnh thng tin thch hp c thit lp trong appropriate communication processes are
PTN v c s trao i thng tin v hiu lc ca h established within the laboratory and that
thng qun l. communication takes place regarding the
effectiveness of the management system.

4.2 H thng qun l 4.2 Management system

4.2.1 PTN phi thit lp, thc hin v duy tr mt 4.2.1 The laboratory shall establish, implement
h thng qun l ph hp vi phm vi hot ng. and maintain a management system appropriate to
PTN phi lp thnh vn bn cc chnh sch, h the scope of its activities. The laboratory shall

13
thng, chng trnh, th tc v hng dn trong document its policies, systems, programmes,
phm vi cn thit m bo cht lng kt qu procedures and instructions to the extent
th nghim v/hoc hiu chun. Ti liu ca h necessary to assure the quality of the test and/or
thng phi c ph bin, hiu r, lun sn c v calibration results. The systems documentation
c nhn vin thch hp p dng. shall be communicated to, understood by,
available to, and implemented by the appropriate
personnel.

4.2.2 Cc chnh sch ca h thng qun l PTN 4.2.2 The laboratory's management system
lin quan ti cht lng, bao gm mt bn cng policies related to quality, including a quality policy
b v chnh sch cht lng phi c xc nh statement, shall be defined in a quality manual
trong s tay cht lng (STCL) (hoc di mt (however named). The overall objectives shall be
tn gi khc). Cc mc tiu chung phi c thit established, and shall be reviewed during
lp v phi c xem xt trong hp xem xt ca management review. The quality policy statement
lnh o. Bn cng b chnh sch cht lng ny shall be issued under the authority of top
phi c ban hnh theo thm quyn ca lnh management. It shall include at least the following:
o cao nht v bao gm t nht cc thng tin sau:

a) cam kt ca lnh o PTN v thc hnh chuyn a) the laboratory management's commitment to
mn tt, v cht lng dch v th nghim v hiu good professional practice and to the quality of its
chun i vi khch hng; testing and calibration in servicing its customers;

b) cng b ca lnh o v tiu chun dch v ca b) the managements statement of the laboratory's
PTN; standard of service;

c) mc ch ca ca h thng qun l lin quan ti c) the purpose of the management system related
cht lng; to quality;

d) yu cu tt c nhn vin PTN c lin quan ti d) a requirement that all personnel concerned with
cc hot ng th nghim v hiu chun phi hiu testing and calibration activities within the
r h thng ti liu cht lng v p dng cc laboratory familiarize themselves with the quality
chnh sch v th tc trong cng vic ca mnh, v documentation and implement the policies and
procedures in their work; and

e) cam kt ca lnh o PTN v tun th tiu e) the laboratory management's commitment to

chun quc t ny v thng xuyn ci tin hiu comply with this International Standard and to
lc ca h thng qun l. continually improve the effectiveness of the
management system.

Ch thch -Cng b v chnh sch cht lng phi NOTE The quality policy statement should be
ngn gn v c th bao gm cc yu cu rng concise and may include the requirement that
cc php th nghim v/hoc hiu chun phi tests and/or calibrations shall always be carried
thng xuyn c thc hin theo cc phng out in accordance with stated methods and
php c cng b v yu cu ca khch hng. customers' requirements. When the test and/or
Khi phng th nghim v hiu chun l mt b calibration laboratory is part of a larger

14
 phn ca mt t chc ln th mt s yu t ca
chnh sch cht lng c th c nu trong cc
ti liu khc.
4.2.3 Lnh o cao nht phi cung cp bng
chng v cam kt i vi vic xy dng, thc hin
v thng xuyn nng cao hiu lc ca h thng
qun l.
4.2.4 Lnh o cao nht phi truyn t cho PTN
tm quan trng ca vic p ng cc yu cu ca
khch hng cng nh cc yu cu ca php lut
v ch nh.
4.2.5 STCL phi bao gm hoc phi vin dn cc
th tc h tr k c th tc k thut. STCL phi
a ra cc cu trc ca h thng ti liu c s technical procedures. It shall outline the structure
dng trong h thng qun l.
4.2.6 Vai tr v trch nhim ca ngi lnh o k
thut v ngi qun l cht lng, k c cc trch
nhim m bo s ph hp vi tiu chun ny
phi c xc nh trong s tay cht lng.
4.2.7 Lnh o cao nht phi m bo tnh nht
qun ca h thng qun l c duy tr khi cc
thay i i vi h thng qun l c hoch nh when changes to the management system are
v thc hin.
4.3 Kim sot ti liu
4.3.1 Yu cu chung
PTN phi thit lp v duy tr cc th tc kim sot
tt c cc ti liu thuc h thng qun l (cc ti
liu ni b hoc c ngun gc t bn ngoi) nh:
cc ch nh, tiu chun, ti liu chun ha khc,
phng php th v/hoc hiu chun cng nh
cc bn v, phn mm, qui nh k thut, hng
dn v s tay.
Ch thch 1 - Trong iu ny "ti liu" c th l
nhng cng b v chnh sch, cc th tc, qui
nh k thut, bng hiu chun, s , sch p
phch, cc thng bo, bn ghi nh, phn mm,
bn v, k hoch... Cc ti liu ny c th c
organization, some quality policy elements may
be in other documents.
4.2.3 Top management shall provide evidence of
commitment to the development and
implementation of the management system and to
continually improving its effectiveness.
4.2.4 Top management shall communicate to the
organization the importance of meeting customer
requirements as well as statutory and regulatory
requirements.
4.2.5 The quality manual shall include or make
reference to the supporting procedures including
of the documentation used in the management
system.
4.2.6 The roles and responsibilities of technical
management and the quality manager, including
their responsibility for ensuring compliance with
this International Standard, shall be defined in the
quality manual.
4.2.7 Top management shall ensure that the
integrity of the management system is maintained
planned and implemented.
4.3 Document control
4.3.1 General
The laboratory shall establish and maintain
procedures to control all documents that form part
of its management system (internally generated or
from external sources), such as regulations,
standards, other normative documents, test and/or
calibration methods, as well as drawings, software,
specifications, instructions and manuals.
NOTE 1 In this context document could be policy
statements, procedures, specifications,
calibration tables, charts, text books, posters,
notices, memoranda, software, drawings, plans,
etc. These may be on various media, whether
15
 nhiu phng thc th hin khc nhau, hoc l
bn in giy hoc in t v thng tin c th
dng k thut s, k thut analog, dng nh hoc
ch.
Ch thch 2 -Kim sot d liu lin quan n th
nghim v hiu chun c cp trong 5.4.7.
Kim sot h s c cp trong 4.13.
4.3.2 Ph duyt v ban hnh ti liu
4.3.2.1 Tt c cc ti liu cho cc nhn vin PTN
s dng nh l mt phn ca h thng qun l
phi c ngi c thm quyn xem xt v ph
chun trc khi s dng. PTN phi thit lp mt
danh mc gc hoc mt th tc kim sot ti liu
tng ng bit c tnh trng ban hnh
hin thi, s phn phi ti liu trong h thng
qun l. Danh mc gc hoc th tc ny phi
c thit lp v phi lun sn c trnh s
dng cc ti liu khng cn hiu lc v/hoc li
thi.
4.3.2.2 Th tc c xt duyt phi m bo rng:
a) cc bn c ph duyt ca cc ti liu thch
hp phi lun sn c tt c nhng ni thc hin
cc hot ng ch yu c tc ng n vn hnh
c hiu lc ca PTN;
b) ti liu c nh k xem xt v, nu cn thit,
c sa i m bo rng chng tip tc ph
hp v tun th theo cc yu cu c p dng;
c) tt c cc ti liu khng cn hiu lc hoc li
thi phi b thu hi tt c cc ni ban hnh hoc
s dng, hoc bng cch khc nhm m bo
khng cho s dng li mt cch v tnh;
d) ti liu li thi c lu gi do yu cu php l
hoc v mc ch lu li thng tin phi c nh
du thch hp.
4.3.2.3 Ti liu ca h thng qun l do PTN ban
hnh phi c nhn bit r rng. Vic nhn bit
hard copy or electronic, and they may be digital,
analog, photographic or written.
NOTE 2 The control of data related to testing and
calibration is covered in 5.4.7. The control of
records is covered in 4.13.
4.3.2 Document approval and issue
4.3.2.1 All documents issued to personnel in the
laboratory as part of the management system shall
be reviewed and approved for use by authorized
personnel prior to issue. A master list or an
equivalent document control procedure identifying
the current revision status and distribution of
documents in the management system shall be
established and shall be readily available to
preclude the use of invalid and/or obsolete
documents.
4.3.2.2 The procedure(s) adopted shall ensure
that:
a) authorized editions of appropriate documents
are available at all locations where operations
essential to the effective functioning of the
laboratory are performed;
b) documents are periodically reviewed and,
where necessary, revised to ensure continuing
suitability and compliance with applicable
requirements;
c) invalid or obsolete documents are promptly
removed from all points of issue or use, or
otherwise assured against unintended use;
d) obsolete documents retained for either legal or
knowledge preservation purposes are suitably
marked.
4.3.2.3 Management system documents generated
by the laboratory shall be uniquely identified. Such
16
ny phi bao gm ngy ban hnh v/hoc ln sa identification shall include the date of issue and/or
i, nh s trang, tng s trang hoc k hiu revision identification, page numbering, the total
nh du kt thc ti liu v thm quyn ban number of pages or a mark to signify the end of
hnh. the document, and the issuing authority(ies).

4.3.3 Thay i ti liu 4.3.3 Document changes

4.3.3.1 Vic xem xt v ph chun cc thay i
ca ti liu phi do chnh b phn thc hin
xem xt ban u tin hnh, tr khi c ch nh c
bit khc. B phn c ch nh phi c iu kin
tip cn cc thng tin c bn thch hp lm c s
cho vic xem xt v ph chun.
4.3.3.1 Changes to documents shall be reviewed
and approved by the same function that performed
the original review unless specifically designated
otherwise. The designated personnel shall have
access to pertinent background information upon
which to base their review and approval.

4.3.3.2 Nu c th, ni dung thay i hoc ni 4.3.3.2 Where practicable, the altered or new text
dung mi phi c xc nh trong ti liu hoc shall be identified in the document or the
cc ti liu nh km thch hp. appropriate attachments.

4.3.3.3 Nu h thng kim sot ti liu ca PTN 4.3.3.3 If the laboratory's document control system
cho php sa i cc ti liu bng tay trong khi allows for the amendment of documents by hand
ch i ban hnh li ti liu th PTN phi xc pending the re-issue of the documents, the
nh c th tc v thm quyn sa i nh procedures and authorities for such amendments
trn. Vic sa i phi nh du r rng, k xc shall be defined. Amendments shall be clearly
nhn v ghi ngy. Mt ti liu c sa i marked, initialled and dated. A revised document
phi chnh thc ban hnh li cng sm cng tt. shall be formally re-issued as soon as practicable.

4.3.3.4 PTN phi thit lp th tc miu t cch 4.3.3.4 Procedures shall be established to
thc thc hin v kim sot cc thay i trong ti describe how changes in documents maintained in
liu c lu gi trong h thng my tnh. computerized systems are made and controlled.

4.4 Xem xt cc yu cu, ngh v hp ng 4.4 Review of requests, tenders and contracts

4.4.1 PTN phi thit lp v duy tr th tc xem xt 4.4.1 The laboratory shall establish and maintain
cc yu cu, mi thu v hp ng. Chnh sch procedures for the review of requests, tenders and
v th tc xem xt quyt nh hp ng v th contracts. The policies and procedures for these
nghim v/hoc hiu chun phi m bo rng: reviews leading to a contract for testing and/or
calibration shall ensure that:

a) cc yu cu, bao gm c phng php s dng a) the requirements, including the methods to be
c xc nh y , lp thnh vn bn v c used, are adequately defined, documented
hiu r (xem 5.4.2); and understood (see 5.4.2);

b) PTN c nng lc v ngun lc p ng mi yu b) the laboratory has the capability and

cu; resources to meet the requirements;

17
c) phng php th v/hoc hiu chun thch hp
c la chn v c kh nng p ng yu cu
ca khch hng (xem 5.4.2).
Bt c s khc bit no gia yu cu hoc mi
thu v hp ng phi c gii quyt trc khi
bt u cng vic. Mi hp ng phi c c hai
bn PTN v khch hng chp nhn.
Ch thch 1 - Vic xem xt yu cu, ngh v hp
ng phi thc hin mt cch c hiu qu, thc
t v phi tnh n tc ng ca cc kha cnh
thi hn thc hin, tnh php l v ti chnh. i
vi khch hng ni b, vic xem xt cc yu cu,
mi thu v hp ng c th c thc hin n
gin hn.
Ch thch 2 -Vic xem xt nng lc cn m bo
xc minh c rng PTN c y ngun lc
vt cht, con ngi v thng tin, v nhn vin
ca PTN c k nng cng nh chuyn mn cn
thit thc hin php th v/hoc hiu chun
cn thc hin. Vic xem xt c th bao gm cc
kt qu tham gia so snh lin phng hoc th
nghim thnh tho trc v/hoc thc hin
cc php th s b hoc cc chng trnh hiu
chun s dng cc mu hoc cc mu bit
trc gi tr xc nh khng m bo o,
cc gii hn pht hin, gii hn tin cy...
Ch thch 3 -Mt hp ng c th l bt c tho
thun no bng vn bn hoc bng ming v
vic cung cp cho khch hng dch v th
nghim v/hoc hiu chun.
4.4.2 H s xem xt, bao gm c mi thay i
quan trng, phi c lu gi. H s cng phi
lu gi nhng tho lun vi khch hng lin quan
n yu cu ca khch hng hoc kt qu cng
vic trong thi gian thc hin hp ng.
Ch thch - i vi vic xem xt cng vic hng
ngy hoc cng vic n gin khc th vic ghi
ngy thng v ngi (v d nh k tn) chu trch
c) the appropriate test and/or calibration method
is selected and is capable of meeting the
customers' requirements (see 5.4.2).
Any differences between the request or tender and
the contract shall be resolved before any work
commences. Each contract shall be acceptable
both to the laboratory and the customer.
NOTE 1 The request, tender and contract review
should be conducted in a practical and efficient
manner, and the effect of financial, legal and time
schedule aspects should be taken into account.
For internal customers, reviews of requests,
tenders and contracts can be performed in a
simplified way.
NOTE 2 The review of capability should establish
that the laboratory possesses the necessary
physical, personnel and information resources,
and that the laboratory's personnel have the skills
and expertise necessary for the performance of
the tests and/or calibrations in question. The
review may also encompass results of earlier
participation in interlaboratory comparisons or
proficiency testing and/or the running of trial test
or calibration programmes using samples or
items of known value in order to determine
uncertainties of measurement, limits of detection,
confidence limits, etc.
NOTE 3 A contract may be any written or oral
agreement to provide a customer with testing
and/or calibration services.
4.4.2 Records of reviews, including any significant
changes, shall be maintained. Records shall also
be maintained of pertinent discussions with a
customer relating to the customer's requirements
or the results of the work during the period of
execution of the contract.
NOTE For review of routine and other simple tasks,
the date and the identification (e.g. the initials) of
the person in the laboratory responsible for
18
 nhim tin hnh cng vic trong hp ng c
coi l ph hp. i vi cc cng vic hng ngy
lp i lp li, yu cu xem xt ny ch cn thc
hin giai on u tin hoc khi chp nhn hp
ng cc cng vic hng ngy c thc hin
ng tho thun chung vi khch hng min l
cc yu cu ca khch hng khng thay i. i
vi cng vic th nghim v/hoc hiu chun
mi, tin tin hn hoc phc tp th PTN cn
phi duy tr mt h s ton din hn.
4.4.3 Vic xem xt cng phi p dng cho mi
cng vic thuc hp ng ph ca PTN.
4.4.4 Khch hng phi c thng bo v mi
thay i so vi hp ng.
4.4.5 Nu hp ng cn sa i sau khi cng vic
bt u thc hin th phi lp li qu trnh xem
xt hp ng nh trc v mi sa i phi process shall be repeated and any amendments
c thng bo cho tt c cc nhn vin lin
quan.
4.5 Hp ng ph v th nghim v hiu
chun
4.5.1 Khi mt PTN s dng hp ng ph v mt
l do ngoi d kin (v d: cng vic qu ti, yu
cu cn c k nng cao hn hoc tm thi khng
nng lc) hoc do thng xuyn cn (v d:
thng qua hp ng ph, qua i l c nh hoc
qua tho thun c quyn kinh doanh) th cc
cng vic ny phi c giao. Cho mt nh thu
ph c nng lc thc hin. Nh thu ph c nng
lc, v d, l nh thu ph, ph hp vi tiu chun
ny i vi cc cng vic c yu cu.
4.5.2 PTN phi thng bo cho khch hng bng
vn bn v tho thun c s dng hp ng ph
v khi thch hp phi c c s ng ca
khch hng tt nht l bng vn bn.
4.5.3 PTN chu trch nhim i vi khch hng v
cng vic ca nh thu ph ngoi tr trng hp
carrying out the contracted work are considered
adequate. For repetitive routine tasks, the review
need be made only at the initial enquiry stage or
on granting of the contract for on-going routine
work performed under a general agreement with
the customer, provided that the customer's
requirements remain unchanged. For new,
complex or advanced testing and/or calibration
tasks, a more comprehensive record should be
maintained.
4.4.3 The review shall also cover any work that is
subcontracted by the laboratory.
4.4.4 The customer shall be informed of any
deviation from the contract.
4.4.5 If a contract needs to be amended after work
has commenced, the same contract review
shall be communicated to all affected personnel.
4.5 Subcontracting of tests and calibrations
4.5.1 When a laboratory subcontracts work,
whether because of unforeseen reasons (e.g.
workload, need for further expertise or temporary
incapacity) or on a continuing basis (e.g. through
permanent subcontracting, agency or franchising
arrangements), this work shall be placed with a
competent subcontractor. A competent
subcontractor is one that, for example, complies
with this International Standard for the work in
question.
4.5.2 The laboratory shall advise the customer of
the arrangement in writing and, when appropriate,
gain the approval of the customer, preferably in
writing.
4.5.3 The laboratory is responsible to the customer
for the subcontractors work, except in the case
19
khch hng hoc c quan php ch c thm
quyn ch nh nh thu ph cn c s dng.
4.5.4 PTN phi c bn danh sch ng k tt c
cc nh thu ph s dng cho cc php th
v/hoc hiu chun v phi c h s chng minh
cc nh thu ph ph hp vi tiu chun ny i
vi cng vic c yu cu.
4.6 Mua dch v v cung cp
4.6.1 PTN phi c chnh sch v th tc v la
chn v mua cc dch v v cung cp c nh
hng n cht lng php th v/hoc hiu
chun. Cc th tc ny phi p dng cho vic
mua, tip nhn, lu kho thuc th v cc vt liu
tiu th ca PTN lin quan n th nghim v hiu
chun.
4.6.2 PTN phi m bo rng cung ng, thuc
th v vt liu tiu th c mua c nh hng
ti cht lng ca cc php th v/hoc hiu
chun s khng c s dng cho n khi chng
c kim tra hoc c xc nhn l ph hp otherwise verified as complying with standard
vi quy nh k thut tiu chun hoc cc yu cu
c quy nh trong cc phng php th
v/hoc hiu chun lin quan. Cc dch v v
hng cung cp c s dng phi tun th theo
yu cu qui nh. H s v hot ng kim tra s
ph hp phi c lu gi.
4.6.3 Ti liu v mua cc vt phm nh hng ti
cht lng u ra ca PTN phi bao gm cc d
liu m t dch v v ngun cung cp t hng.
Ti liu v mua phi c xem xt v ph chun
v ni dung k thut trc khi s dng.
Ch thch -Vic m t c th bao gm chng loi,
cp, hng, nhn dng chnh xc, qui nh k
thut, bn v, hng dn kim tra, s liu k
thut khc bao gm c vic ph chun cc kt
qu th nghim, cht lng c yu cu v tiu
chun h thng qun l c p dng to ra
vt phm.
4.6.4 PTN phi nh gi nh cung ng vt liu tiu
where the customer or a regulatory authority
specifies which subcontractor is to be used.
4.5.4 The laboratory shall maintain a register of all
subcontractors that it uses for tests and/or
calibrations and a record of the evidence of
compliance with this International Standard for the
work in question.
4.6 Purchasing services and supplies
4.6.1 The laboratory shall have a policy and
procedure(s) for the selection and purchasing of
services and supplies it uses that affect the quality
of the tests and/or calibrations. Procedures shall
exist for the purchase, reception and storage of
reagents and laboratory consumable materials
relevant for the tests and calibrations.
4.6.2 The laboratory shall ensure that purchased
supplies and reagents and consumable materials
that affect the quality of tests and/or calibrations
are not used until they have been inspected or
specifications or requirements defined in the
methods for the tests and/or calibrations
concerned. These services and supplies used
shall comply with specified requirements. Records
of actions taken to check compliance shall be
maintained.
4.6.3 Purchasing documents for items affecting the
quality of laboratory output shall contain data
describing the services and supplies ordered.
These purchasing documents shall be reviewed
and approved for technical content prior to release.
NOTE The description may include type, class,
grade, precise identification, specifications,
drawings, inspection instructions, other technical
data including approval of test results, the quality
required and the management system standard
under which they were made.
4.6.4 The laboratory shall evaluate suppliers of
20
th, cung cp v dch v ch yu c nh hng
n cht lng ca th nghim v hiu chun, v
phi v duy tr cc h s nh gi, danh sch nh
cung cp c ph chun.
4.7 Dch v i vi khch hng
4.7.1 PTN phi sn sng hp tc vi khch hng
hoc i din ca khch hng lm r cc yu
cu ca khch hng v theo di hot ng ca
PTN c lin quan n cng vic c thc hin
nhng phi m bo c tnh bo mt i vi performed, provided that the laboratory ensures
khch hng khc.
Ch thch 1 - S hp tc nu trn c th bao gm:
a) to iu kin cho khch hng hoc i din ca
khch hng tip cn nhng ni c lin quan ca
PTN chng kin vic thc hin cc php th
v/hoc hiu chun cho khch hng;
b) vic chun b, ng gi v gi tr cc mu th
v/hoc hiu chun do khch hng yu cu
kim tra xc nhn;
Ch thch 2 -Khch hng nh gi cao s duy tr
tt vic trao i thng tin, t vn v hng dn
nhng vn k thut, kin v din gii da
vo kt qu. Vic trao i thng tin vi khch
hng, c bit khi khi lng cng vic nhiu,
phi c duy tr trong sut thi gian thc hin
cng vic. PTN phi thng bo cho khch hng
bt c s chm tr hoc c sai lch ln no khi
thc hin cc php th nghim v/hoc hiu
chun.
4.7.2 PTN phi tm kim cc thng tin phn hi, k
c tch cc v tiu cc, t khch hng. Cc thng
tin ny phi c s dng v phi c phn tch feedback shall be used and analysed to improve
ci tin h thng qun l, cc hot ng th
nghim, hiu chun v phc v i vi khch
hng.
Ch thch Cc v d v cc loi phn hi bao gm
kho st s tha mn ca khch hng v xem
xt cc bo co th nghim/hiu chun cng vi
khch hng.
critical consumables, supplies and services which
affect the quality of testing and calibration, and
shall maintain records of these evaluations and list
those approved.
4.7 Service to the customer
4.7.1 The laboratory shall be willing to cooperate
with customers or their representatives in clarifying
the customer's request and in monitoring the
laboratorys performance in relation to the work
confidentiality to other customers.
NOTE 1 Such cooperation may include:
a) providing the customer or the customer's
representative reasonable access to relevant areas
of the laboratory for the witnessing of tests and/or
calibrations performed for the customer;
b) preparation, packaging, and dispatch of test and/or
calibration items needed by the customer for
verification purposes.
NOTE 2 Customers value the maintenance of good
communication, advice and guidance in technical
matters, and opinions and interpretations based
on results. Communication with the customer,
especially in large assignments, should be
maintained throughout the work. The laboratory
should inform the customer of any delays or
major deviations in the performance of the tests
and/or calibrations.
4.7.2 The laboratory shall seek feedback, both
positive and negative, from its customers. The
the management system, testing and calibration
activities and customer service.
NOTE Examples of the types of feedback include
customer satisfaction surveys and review of test
or calibration reports with customers.
21
4.8 Phn nn
PTN phi c chnh sch v th tc gii quyt
cc phn nn ca khch hng hoc cc bn khc.
PTN phi lu gi h s ca tt c cc phn nn
v cc ln iu tra cng nhhnh ng khc phc
do PTN tin hnh (xem 4.11).
4.9 Kim sot vic th nghim v/hoc hiu
chun khng ph hp
4.9.1 PTN phi c chnh sch v p dng th tc
khi c bt c cc kha cnh v kt qu no ca
vic th nghim v/hoc hiu chun, hoc kt qu
ca cng vic khng ph hp vi cc th tc ca
PTN hoc yu cu tho thun vi khch hng.
Chnh sch v th tc ny phi m bo:
a) n nh trch nhim v quyn hn qun l vic
khng ph hp v xc nh cc hnh ng (bao
gm c: tm dng cng vic, gi li bo co th
nghim v giy chng nhn hiu chun, khi cn
thit) khi xc nh c cng vic khng ph hp;
b) thc hin nh gi mc cng vic khng
ph hp;
c) thc hin ngay s khc phc cng vi mi
quyt nh v kh nng chp nhn cng vic
khng ph hp;
d) PTN phi thng bo cho khch hng v thu hi
li kt qu cng vic khng ph hp khi cn thit;
e) nh r c trch nhim v quyn hn cho
php tip tc cng vic.
4.8 Complaints
The laboratory shall have a policy and procedure
for the resolution of complaints received from
customers or other parties. Records shall be
maintained of all complaints and of the
investigations and corrective actions taken by the
laboratory (see also 4.11).
4.9 Control of nonconforming testing and/or
calibration work
4.9.1 The laboratory shall have a policy and
procedures that shall be implemented when any
aspect of its testing and/or calibration work, or the
results of this work, do not conform to its own
procedures or the agreed requirements of the
customer. The policy and procedures shall ensure
that:
a) the responsibilities and authorities for the
management of nonconforming work are
designated and actions (including halting of
work and withholding of test reports and
calibration certificates, as necessary) are
defined and taken when nonconforming work
is identified;
b) an evaluation of the significance of the
nonconforming work is made;
c) correction is taken immediately, together with
any decision about the acceptability of the
nonconforming work;
d) where necessary, the customer is notified and
work is recalled;
e) the responsibility for authorizing the
resumption of work is defined.
22
 Ch thch -Vic pht hin ra cng vic khng ph NOTE Identification of nonconforming work or
hp hoc cc vn pht sinh trong h thng problems with the management system or with
qun l hoc trong cc hot ng th nghim testing and/or calibration activities can occur at
v/hoc hiu chun c th xy ra ti nhiu ni various places within the management system
khc nhau trong h thng qun l hoc trong cc and technical operations. Examples are customer
hot ng k thut . V d: phn nn ca khch complaints, quality control, instrument calibration,
hng, vic kim sot cht lng, hiu chun thit checking of consumable materials, staff
b, kim tra cc vt liu tiu th, gim st nhn observations or supervision, test report and
vin, kim tra bin bn th nghim v giy chng calibration certificate checking, management
nhn hiu chun, vic xem xt ca lnh o v reviews and internal or external audits.
cc cuc nh gi ni b hoc bn ngoi.

4.9.2 Khi vic nh gi ch ra rng cng vic
khng ph hp c th li xy ra hoc c nghi ng
v s ph hp ca cc hot ng so vi cc chnh
sch v cc th tc ca PTN phi thc hin ngay
th tc hnh ng khc phc nu 4.11.
4.9.2 Where the evaluation indicates that the
nonconforming work could recur or that there is
doubt about the compliance of the laboratory's
operations with its own policies and procedures,
the corrective action procedures given in 4.11 shall
be promptly followed.

4.10 Ci tin 4.10 Improvement

PTN phi ci tin thng xuyn hiu lc ca h
thng qun l thng qua vic s dng chnh sch
cht lng, cc mc tiu cht lng, cc kt qu
nh gi, phn tch d liu, cc hnh ng khc
phc, phng nga v xem xt ca lnh o.
The laboratory shall continually improve the
effectiveness of its management system through
the use of the quality policy, quality objectives,
audit results, analysis of data, corrective and
preventive actions and management review.

4.11 Hnh ng khc phc 4.11 Corrective action

4.11.1 Yu cu chung 4.11.1 General

PTN phi xy dng chnh sch, th tc v n nh The laboratory shall establish a policy and a
cc quyn hn thch hp thc hin hnh ng procedure and shall designate appropriate
khc phc khi xc nh c cng vic khng ph authorities for implementing corrective action when
hp hoc cc sai khc so vi chnh sch v th nonconforming work or departures from the
tc trong h thng qun l hoc cc hot ng k policies and procedures in the management
thut. system or technical operations have been
identified.
Ch thch -Vn tn ti ca h thng qun l NOTE A problem with the management system or
hoc cc hot ng k thut ca PTN c th with the technical operations of the laboratory
c xc nh qua nhiu hot ng khc nhau may be identified through a variety of activities,
nh: kim sot cng vic khng ph hp, nh such as control of nonconforming work, internal
gi ni b hoc bn ngoi, xem xt ca lnh o, or external audits, management reviews,
thng tin phn hi t khch hng v t gim st feedback from customers and from staff
nhn vin. observations.

23
4.11.2 Phn tch nguyn nhn
Th tc v hnh ng khc phc phi c bt
u bng mt cuc iu tra xc nh cc
nguyn nhn chnh ca vn .
Ch thch -Phn tch nguyn nhn l phn chnh v
i khi l phn kh nht trong th tc v hnh
ng khc phc. Thng thng nguyn nhn
chnh li khng r rng v v th i hi cn phn
tch cn thn tt c cc nguyn nhn tim n c
th xy ra. Cc nguyn nhn tim n c th bao
gm: mu, cc yu cu ca khch hng, qui nh
k thut v mu, phng php v th tc, tay
ngh v o to nhn vin, vt liu tiu th hoc
thit b v vic hiu chun thit b.
4.11.3 La chn v thc hin hnh ng khc
phc
Khi cn phi c hnh ng khc phc th PTN
phi xc nh cc hnh ng khc phc c th c.
PTN phi la chn v thc hin hnh ng khc
phc c nhiu kh nng nht loi tr vn tn
ti v ngn chn vn ti din.
Cc hnh ng khc phc phi c xem xt
tng xng vi mc quan trng v s nguy
him ca vn .
PTN phi lp vn bn v p dng mi thay i
c yu cu xut pht t vic iu tra nghin
cu v hnh ng khc phc.
4.11.4 Theo di hnh ng khc phc
PTN phi theo di kt qu m bo hnh ng
khc phc thc hin l c hiu lc.
4.11.5 nh gi b sung
Khi pht hin c s khng ph hp hoc sai khc
gy nghi ng v s ph hp ca PTN vi chnh
sch v th tc, hoc nghi ng v s ph hp ca
4.11.2 Cause analysis
The procedure for corrective action shall start with
an investigation to determine the root cause(s) of
the problem.
NOTE Cause analysis is the key and sometimes the
most difficult part in the corrective action
procedure. Often the root cause is not obvious
and thus a careful analysis of all potential causes
of the problem is required. Potential causes could
include customer requirements, the samples,
sample specifications, methods and procedures,
staff skills and training, consumables, or
equipment and its calibration.
4.11.3 Selection and implementation of
corrective actions
Where corrective action is needed, the laboratory
shall identify potential corrective actions. It shall
select and implement the action(s) most likely to
eliminate the problem and to prevent recurrence.
Corrective actions shall be to a degree appropriate
to the magnitude and the risk of the problem.
The laboratory shall document and implement any
required changes resulting from corrective action
investigations.
4.11.4 Monitoring of corrective actions
The laboratory shall monitor the results to ensure
that the corrective actions taken have been
effective.
4.11.5 Additional audits
Where the identification of nonconformities or
departures casts doubts on the laboratory's
compliance with its own policies and procedures,
24
PTN vi tiu chun ny th PTN phi m bo
rng cc lnh vc hot ng tng ng phi c
nh gi ph hp vi 4.14 cng sm cng tt.
Ch thch -Vic nh gi b sung nh th thng
din ra tip theo sau vic thc hin hnh ng
khc phc xc nhn hiu qu ca hnh ng
ny. Ch cn c nh gi b sung khi pht hin ra
vn nghim trng hoc ri ro i vi cng
vic.
4.12 Hnh ng phng nga
4.12.1 Nhng ci tin cn thit v ngun gc tim
tng ca s khng ph hp v k thut hoc h
thng qun l phi c xc nh. Khi cc c hi
ci tin c pht hin hoc nu hnh ng
phng nga l cn thit th phi xy dng thc
hin v theo di cc k hoch hnh ng, gim
kh nng c th xy ra s khng ph hp v tn
dng c hi ci tin.
4.12.2 Th tc v hnh ng phng nga phi bao
gm cc xut hnh ng v kim sot m
bo cc hnh ng ny c hiu lc.
Ch thch 1 -Hnh ng phng nga l mt qu
trnh thin v ch ng xc nh cc c hi ci
tin hn l s phn ng li vn pht sinh hoc
phn nn;
Ch thch 2 -Ngoi vic xem xt cc th tc hot
ng, hnh ng phng nga c th i hi vic
phn tch d liu gm phn tch cc xu hng, ri
ro v kt qu th nghim thnh tho.
4.13 Kim sot h s
4.13.1 Yu cu chung
4.13.1.1 PTN phi thit lp v duy tr cc th tc
nhn bit, tp hp, nh s, tip cn, lp file
(tp), lu tr, duy tr v thanh l cc h s cht
lng v k thut. H s cht lng phi bao gm
or on its compliance with this International
Standard, the laboratory shall ensure that the
appropriate areas of activity are audited in
accordance with 4.14 as soon as possible.
NOTE Such additional audits often follow the
implementation of the corrective actions to
confirm their effectiveness. An additional audit
should be necessary only when a serious issue
or risk to the business is identified.
4.12 Preventive action
4.12.1 Needed improvements and potential
sources of nonconformities, either technical or
concerning the management system, shall be
identified. When improvement opportunities are
identified or if preventive action is required, action
plans shall be developed, implemented and
monitored to reduce the likelihood of the
occurrence of such nonconformities and to take
advantage of the opportunities for improvement.
4.12.2 Procedures for preventive actions shall
include the initiation of such actions and the
application of controls to ensure that they are
effective.
NOTE 1 Preventive action is a pro-active process to
identify opportunities for improvement rather than
a reaction to the identification of problems or
complaints.
NOTE 2 Apart from the review of the operational
procedures, the preventive action might involve
analysis of data, including trend and risk
analyses and proficiency-testing results.
4.13 Control of records
4.13.1 General
4.13.1.1 The laboratory shall establish and
maintain procedures for identification, collection,
indexing, access, filing, storage, maintenance and
disposal of quality and technical records. Quality
25
cc bo co nh gi ni b v xem xt ca lnh
o cng nh h s ca cc hot ng phng
nga v hnh ng khc phc.
4.13.1.2 Tt c cc h s phi r rng, phi c
bo qun v c lu gi theo cch sao cho c
th d dng truy tm v c lu gi trong mt
mi trng thch hp ngn chn h hng hoc
xung cp cng nh phng nga mt mt. Thi
gian lu gi cc h s phi c quy nh.
Ch thch -Cc h s c th l bt c phng
thc no v d bn in hoc bn lu in t.
4.13.1.3 Tt c cc h s phi c lu gi an
ton v m bo tnh bo mt.
4.13.1.4 PTN phi c cc th tc bo v v sao
li h s lu gi trong my tnh v ngn nga vic
truy cp khng c php hoc sa i h s
ny.
4.13.2 H s k thut
4.13.2.1 PTN phi lu gi h s ca cc quan
trc gc, s liu x l v thng tin cn thit
thit lp cuc nh gi, h s hiu chun, h s
nhn vin v mt bn sao ca mi bo co th
nghim hoc giy chng nhn hiu chun ban
hnh trong mt thi gian nht nh. H s i vi
mi php th hoc hiu chun phi lu gi y
cc thng tin nu c th to iu kin nhn bit
cc yu t nh hng n khng m bo o
to iu kin cho cc php th v hiu chun
c lp li trong iu kin gn vi iu kin ban
u nht. Cc h s phi bao gm c du hiu
nhn bit ngi chu trch nhim ly mu, thc
hin tng php th v/hoc hiu chun v ngi
kim tra kt qu.
Ch thch 1 -Trong mt s lnh vc nht nh vic
lu gi cc h s ca tt c cc quan trc gc c
th khng thc hin c hoc khng thc t.
records shall include reports from internal audits
and management reviews as well as records of
corrective and preventive actions.
4.13.1.2 All records shall be legible and shall be
stored and retained in such a way that they are
readily retrievable in facilities that provide a
suitable environment to prevent damage or
deterioration and to prevent loss. Retention times
of records shall be established.
NOTE Records may be in any media, such as hard
copy or electronic media.
4.13.1.3 All records shall be held secure and in
confidence.
4.13.1.4 The laboratory shall have procedures to
protect and back-up records stored electronically
and to prevent unauthorized access to or
amendment of these records.
4.13.2 Technical records
4.13.2.1 The laboratory shall retain records of
original observations, derived data and sufficient
information to establish an audit trail, calibration
records, staff records and a copy of each test
report or calibration certificate issued, for a defined
period. The records for each test or calibration
shall contain sufficient information to facilitate, if
possible, identification of factors affecting the
uncertainty and to enable the test or calibration to
be repeated under conditions as close as possible
to the original. The records shall include the
identity of personnel responsible for the sampling,
performance of each test and/or calibration and
checking of results.
NOTE 1 In certain fields it may be impossible or
impractical to retain records of all original
observations.
26
 Ch thch 2 -H s k thut l tp hp d liu (xem
5.4.7) v thng tin c c khi thc hin cc
php th v/hoc hiu chun v ch ra liu thng
s ca qu trnh v cht lng qui nh c t
c hay khng. H s k thut c th bao gm
cc biu mu, hp ng, phiu lm vic, s ghi
chp, t ri kim tra, s ghi chp cng vic,
th kim sot, bin bn v giy chng nhn hiu
chun ni b v bn ngoi, lu , cng vn v
thng tin phn hi ca khch hng.
4.13.2.2 Cc quan trc, d liu v vic tnh ton
phi thng xuyn c ghi li khi thc hin v
phi phn bit c theo cng vic c th.
4.13.2.3 Khi trong cc h s c sai li, phi gch
ln sai li , khng c ty xo, lm cho kh
c hoc xo b v phi ghi gi tr ng bn cnh. illegible or deleted, and the correct value entered
Tt c cc thay i trong cc h s phi c
chnh ngi sa cha k xc nhn hoc vit tt
tn. Trong trng hp h s c lu gi trong
my tnh, phi c bin php tng xng trnh
mt mt hoc thay i s liu gc.
4.14 nh gi ni b
4.14.1 PTN phi nh k thc hin nh gi ni b
cc hot ng ca PTN tun th mt k hoch v
th tc xc nh nhm kim tra xc nhn xem
cc hot ng ca PTN cn tip tc tun th cc
yu cu ca h thng qun l v ca tiu chun
ny hay khng. Chng trnh nh gi ni b phi
cp n tt c cc yu t ca h thng qun l, programme shall address all elements of the
bao gm c cc hot ng th nghim v/hoc
hiu chun. Ngi ph trch cht lng c trch
nhim lp k hoch v t chc nh gi theo k
hoch v theo yu cu ca lnh o. Vic nh
gi ny phi c nhng ngi qua o to v management. Such audits shall be carried out by
c trnh chuyn mn thc hin, v nu ngun
lc cho php, nhng ngi ny phi c lp vi
hot ng c nh gi.
Ch thch - Chu trnh nh gi ni b thng thng
c hon tt trong mt nm.
NOTE 2 Technical records are accumulations of
data (see 5.4.7) and information which result
from carrying out tests and/or calibrations and
which indicate whether specified quality or
process parameters are achieved. They may
include forms, contracts, work sheets, work
books, check sheets, work notes, control graphs,
external and internal test reports and calibration
certificates, customers' notes, papers and
feedback.
4.13.2.2 Observations, data and calculations shall
be recorded at the time they are made and shall
be identifiable to the specific task.
4.13.2.3 When mistakes occur in records, each
mistake shall be crossed out, not erased, made
alongside. All such alterations to records shall be
signed or initialled by the person making the
correction. In the case of records stored
electronically, equivalent measures shall be taken
to avoid loss or change of original data.
4.14 Internal audits
4.14.1 The laboratory shall periodically, and in
accordance with a predetermined schedule and
procedure, conduct internal audits of its activities
to verify that its operations continue to comply with
the requirements of the management system and
this International Standard. The internal audit
management system, including the testing and/or
calibration activities. It is the responsibility of the
quality manager to plan and organize audits as
required by the schedule and requested by
trained and qualified personnel who are, wherever
resources permit, independent of the activity to be
audited.
NOTE The cycle for internal auditing should normally be
completed in one year.
27
4.14.2 Khi cc pht hin nh gi dn n nghi 4.14.2 When audit findings cast doubt on the
ng v hiu lc hot ng hoc tnh chnh xc, effectiveness of the operations or on the
hoc tnh ng n ca cc kt qu th nghim correctness or validity of the laboratory's test or
hoc hiu chun th PTN phi ngay lp tc thc calibration results, the laboratory shall take timely
hin hnh ng khc phc v phi thng bo corrective action, and shall notify customers in
bng vn bn cho khch hng nu vic iu tra writing if investigations show that the laboratory
cho thy kt qu ca PTN a ra c th b nh results may have been affected.
hng.

4.14.3 Phi lu h s lnh vc hot ng c 4.14.3 The area of activity audited, the audit
nh gi, cc pht hin khi nh gi v cc hnh findings and corrective actions that arise from
ng khc phc pht sinh t ln nh gi ny. them shall be recorded.

4.14.4 PTN phi kim tra xc nhn cc hot ng 4.14.4 Follow-up audit activities shall verify and
sau khi nh gi ni b v ghi li vic thc hin v record the implementation and effectiveness of the
hiu lc ca hnh ng khc phc thc hin corrective action taken.

4.15 Xem xt ca lnh o 4.15 Management reviews

4.15.1 Lnh o PTN phi nh k thc hin mt 4.15.1 In accordance with a predetermined
cuc xem xt h thng qun l ca PTN v cc schedule and procedure, the laboratorys top
hot ng th nghim v/hoc hiu chun theo k management shall periodically conduct a review of
hoch v th tc xc nh, m bo h the laboratory's management system and testing
thng ny ang tip tc thch hp, c hiu lc, v and/or calibration activities to ensure their
a ra nhng thay i hoc ci tin cn thit. continuing suitability and effectiveness, and to
Vic xem xt ny phi cp ti: introduce necessary changes or improvements.
The review shall take account of:
- S thch hp ca chnh sch v cc th tc; - the suitability of policies and procedures;
- Cc bo co ca ngi qun l v gim st; - reports from managerial and supervisory
- Kt qu ca nh gi ni b va qua; personnel;
- Hnh ng khc phc v phng nga; - the outcome of recent internal audits;
- Cc cuc nh gi ca cc t chc bn ngoi; - corrective and preventive actions;
- Kt qu so snh lin phng hoc th nghim - assessments by external bodies;
thnh tho; - the results of interlaboratory comparisons or
- Cc thay i v khi lng, loi hnh cng proficiency tests;
vic; - changes in the volume and type of the work;
- Thng tin phn hi t khch hng; - customer feedback;
- Cc phn nn; - complaints;
- Cc khuyn ngh v ci tin; - recommendations for improvement;
- Cc yu t lin quan khc nh: cc hot ng - other relevant factors, such as quality control
kim sot cht lng, ngun lc v o to activities, resources and staff training.
nhn vin.

Ch thch 1 -Chu k thc hin xem xt ca lnh NOTE 1 A typical period for conducting a
o thng l 12 thng mt ln. management review is once every 12 months.

28
 Ch thch 2 -Cc kt qu ny l c s cho h thng
hoch nh ca PTN v phi bao gm mc ch,
mc tiu v k hoch hnh ng trong nm ti.
Ch thch 3 -Xem xt ca lnh o cn bao gm c
vic xem xt cc vn c lin quan ti cuc
hp thng k ca lnh o.
4.15.2 Phi ghi li mi pht hin t cuc xem xt
ca lnh o v cc hot ng pht sinh t cuc
xem xt ny. Lnh o phi m bo sao cho cc
hot ng ny thc hin theo tin thi gian
thch hp v c tho thun.
5.Cc yu cu k thut
5.1.Yu cu chung
5.1.1 C nhiu yu t quyt nh mc chnh
xc v tin cy ca php th v/hoc hiu chun
do PTN thc hin. Cc yu t ny bao gm:
-yu t con ngi (5.2);
-tin nghi v iu kin mi trng (5.3);
-phng php th, hiu chun v hiu lc ca
phng php (5.4);
-thit b (5.5);
-tnh lin kt chun o lng (5.6);
-ly mu (5.7);
-qun l mu th nghim v hiu chun (5.8).
5.1.2 Mc m cc yu t ni trn gp phn to
ra khng m bo o tng hp c s khc
nhau ng k gia cc (loi) php th v cc
(loi) php hiu chun. PTN phi tnh n cc yu
t ny khi xy dng cc phng php v th tc
th nghim v hiu chun, vic o to v trnh
ca nhn vin cng nh vic la chn v hiu
chun thit b m PTN s dng.
5.2 Nhn s
5.2.1 Lnh o PTN phi m bo nng lc ca
tt c nhng ngi vn hnh cc thit b c th,
nhng ngi thc hin th nghim, hiu chun,
nh gi kt qu v k duyt bo co th nghim
NOTE 2 Results should feed into the laboratory
planning system and should include the goals,
objectives and action plans for the coming year.
NOTE 3 A management review includes
consideration of related subjects at regular
management meetings.
4.15.2 Findings from management reviews and the
actions that arise from them shall be recorded. The
management shall ensure that those actions are
carried out within an appropriate and agreed
timescale.
5 .Technical requirements
5.1 General
5.1.1 Many factors determine the correctness and
reliability of the tests and/or calibrations performed
by a laboratory. These factors include
contributions from:
-human factors (5.2);
-accommodation and environmental conditions
5.3);
-test and calibration methods and method
validation (5.4);
-equipment (5.5);
-measurement traceability (5.6);
-sampling (5.7);
-the handling of test and calibration items (5.8).
5.1.2 The extent to which the factors contribute to
the total uncertainty of measurement differs
considerably between (types of) tests and between
(types of) calibrations. The laboratory shall take
account of these factors in developing test and
calibration methods and procedures, in the training
and qualification of personnel, and in the selection
and calibration of the equipment it uses.
5.2 Personnel
5.2.1 The laboratory management shall ensure the
competence of all who operate specific equipment,
perform tests and/or calibrations, evaluate results,
and sign test reports and calibration certificates.
29
v giy chng nhn hiu chun. Khi PTN s dng
nhn vin ang c o to th phi c s gim
st thch hp. Cc nhn vin thc hin cc nhim
v c th phi l
ngi c trnh da trn c s gio dc, o
to, kinh nghim thch hp v/hoc th hin c
cc k nng theo yu cu.
Ch thch 1 - Trong mt s lnh vc k thut (v d: th
nghim khng ph hu) i hi nhng ngi thc hin
cc nhim v c th phi l nhng ngi c chng
nhn hnh ngh. PTN phi chu trch nhim p ng
cc yu cu cn chng nhn hnh ngh. Cc yu cu
v chng nhn hnh ngh c th l bt buc k c cc
tiu chun v lnh vc k thut c th hoc do khch
hng yu cu...
Ch thch 2 - Nhn vin chu trch nhim v cc nhn
xt v din gii trong bo co th nghim phi c trnh
, c o to, c kinh nghim ph hp v c kin to the appropriate qualifications, training, experience
thc thch hp v php th c thc hin v cng cn
c:
- kin thc cn c v cng ngh thch hp ch to
cc vt phm, vt liu, cc sn phm...c th hoc
cch thc s dng hoc nh s dng cc mu, vt liu,
cc sn phm s dng v phi bit v cc khim
khuyt v s gim gi tr c th xy ra trong khi a vo
s dng;
- kin thc v cc yu cu chung do lut php v cc
tiu chun qui nh;
-hiu bit v ngha quan trng ca nhng sai lch
c pht hin lin quan n vic s dng bnh thng
cc i tng, vt liu, sn phm...
5.22 Lnh o PTN phi xy dng mc tiu v
hun luyn, o to v k nng ca nhn vin
PTN. PTN phi c chnh sch v th tc xc
nh nhu cu o to v vic t chc o to cho
nhn vin. Chng trnh o to phi ph hp
vi cc nhim v hin ti v tng lai PTN.
Hiu qu ca hot ng o to nn c nh
gi
When using staff who are undergoing training,
appropriate supervision shall be provided.
Personnel performing specific tasks shall be
qualified on the basis of appropriate education,
training, experience and/or demonstrated skills, as
required.
NOTE 1 In some technical areas (e.g. non-destructive
testing) it may be required that the personnel performing
certain tasks hold personnel certification. The laboratory
is responsible for fulfilling specified personnel
certification requirements. The requirements for
personnel certification might be regulatory, included in
the standards for the specific technical field, or required
by the customer.
NOTE 2 The personnel responsible for the opinions and
interpretation included in test reports should, in addition
and satisfactory knowledge of the testing carried out,
also have:
-relevant knowledge of the technology used for the
manufacturing of the items, materials, products, etc.
tested, or the way they are used or intended to be used,
and of the defects or degradations which may occur
during or in service;
-knowledge of the general requirements expressed in
the legislation and standards; and
-an understanding of the significance of deviations
found with regard to the normal use of the items,
materials, products, etc. concerned.
5.2.2 The management of the laboratory shall
formulate the goals with respect to the education,
training and skills of the laboratory personnel. The
laboratory shall have a policy and procedures for
identifying training needs and providing training of
personnel. The training programme shall be
relevant to the present and anticipated tasks of the
laboratory. The effectiveness of the training
actions taken shall be evaluated.
30
5.2.3 PTN phi s dng nhng ngi lm vic di
hn hoc hp ng vi PTN. Khi s dng nhn
vin k hp ng, nhn vin h tr chnh v nhn
vin k thut b sung, PTN phi m bo nhng
nhn vin ny c gim st, c nng lc v
nhng ngi ny lm vic ph hp vi h thng
qun l ca PTN.
5.2.4 PTN phi duy tr bn m t cng vic hin ti
ca ngi qun l, nhn vin k thut v nhn vin
h tr chnh tham gia th nghim v/hoc hiu
chun.
Ch thch - Bn m t cng vic c xy dng bng
nhiu cch thc. Ti thiu cc thng tin sau phi c
xc nh:
- trch nhim lin quan n vic thc hin php th
nghim v/hoc hiu chun;
- trch nhim lin quan n vic lp k hoch th
nghim v/hoc hiu chun v nh gi kt qu;
- trch nhim v vic bo co v din gii;
- trch nhim lin quan n sa i, trin khai v ph
duyt cc phng php mi;
- yu cu v nng lc chuyn su v kinh nghim;
- trnh v chng trnh o to;
- trch nhim v qun l.
5.2.5 Lnh o phi giao trch nhim c th cho
ngi thc hin vic ly mu, th nghim v/hoc
hiu chun, v ngi cp giy chng nhn th
nghim v/hoc hiu chun, ngia ra cc
nhn xt v din gii v nhng ngi vn hnh
cc thit b c bit. PTN phi duy tr h s v
quyn hn, nng lc, hc vn trnh chuyn
mn, k nng v kinh nghim thch hp ca tt c
cc nhn vin k thut k c nhn vin hp ng.
Thng tin phi lun sn c v phi ghi ngy giao
trch nhim v/hoc ngy xc nhn nng lc.
5.3 Tin nghi v iu kin mi trng
5.2.3 The laboratory shall use personnel who are
employed by, or under contract to, the laboratory.
Where contracted and additional technical and key
support personnel are used, the laboratory shall
ensure that such personnel are supervised and
competent and that they work in accordance with
the laboratory's management system.
5.2.4 The laboratory shall maintain current job
descriptions for managerial, technical and key
support personnel involved in tests and/or
calibrations.
NOTE Job descriptions can be defined in many ways.
As a minimum, the following should be defined:
- the responsibilities with respect to performing tests
and/or calibrations;
- the responsibilities with respect to the planning of tests
and/or calibrations and evaluation of results;
- the responsibilities for reporting opinions and
interpretations;
- the responsibilities with respect to method modification
and development and validation of new methods;
- expertise and experience required;
- qualifications and training programmes;
- managerial duties.
5.2.5 The management shall authorize specific
personnel to perform particular types of sampling,
test and/or calibration, to issue test reports and
calibration certificates, to give opinions and
interpretations and to operate particular types of
equipment. The laboratory shall maintain records
of the relevant authorization(s), competence,
educational and professional qualifications,
training, skills and experience of all technical
personnel, including contracted personnel. This
information shall be readily available and shall
include the date on which authorization and/or
competence is confirmed.
5.3 Accommodation and environmental
conditions
31
5.3.1 Cc tin nghi ca PTN th nghim 5.3.1 Laboratory facilities for testing and/or
v/hoc hiu chun bao gm: ngun nng lng, calibration, including but not limited to energy
nh sng v cc iu kin mi trng phi m sources, lighting and environmental conditions,
bo thc hin chnh xc vic th nghim shall be such as to facilitate correct performance of
v/hoc hiu chun. Ngoi yu t trn c th c the tests and/or calibrations.
thm cc yu t khc.

PTN phi m bo sao cho iu kin mi trng

The laboratory shall ensure that the environmental
khng nh hng n kt qu hoc nh hng
conditions do not invalidate the results or
bt li n cht lng ca cc php o no. PTN
adversely affect the required quality of any
phi c bit quan tm khi ly mu,th nghim
measurement. Particular care shall be taken when
v/hoc hiu chun thc hin ti v tr khc vi v
sampling and tests and/or calibrations are
tr c nh ca PTN. PTN phi lp thnh vn bn
undertaken at sites other than a permanent
cc yu cu k thut v tin nghi v iu kin mi
laboratory facility. The technical requirements for
trng c th nh hng n kt qu th nghim
accommodation and environmental conditions that
v/ hoc hiu chun.
can affect the results of tests and calibrations shall
be documented.

5.3.2 PTN phi gim st, kim sot v ghi chp
cc iu kin mi trng theo yu cu ca qui
nh k thut, cc phng php v th tc lin
quan hoc ni cc iu kin mi trng c th
nh hng ti cht lng kt qu. V d, PTN
phi quan tm n: v trng sinh hc, bi, nhiu
in t, bc x, m, ngun cung cp in,
nhit v mc n v rung thch hp vi cc hot
ng k thut lin quan. Phi dng ngay vic th
nghim v hiu chun khi cc iu kin mi
trng xu nh hng n kt qu ca php th
nghim v/hoc hiu chun.
5.3.2 The laboratory shall monitor, control and
record environmental conditions as required by the
relevant specifications, methods and procedures
or where they influence the quality of the results.
Due attention shall be paid, for example, to
biological sterility, dust, electromagnetic
disturbances, radiation, humidity, electrical supply,
temperature, and sound and vibration levels, as
appropriate to the technical activities concerned.
Tests and calibrations shall be stopped when the
environmental conditions jeopardize the results of
the tests and/or calibrations.

5.3.3 PTN phi c s ngn cch c hiu qu gia 5.3.3 There shall be effective separation between
cc khu vc c cc hot ng khng tng thch neighbouring areas in which there are
gn nhau, v PTN phi thc hin cc bin php incompatible activities. Measures shall be taken to
ngn nga nhim bn cho. prevent cross-contamination.

5.3.4 PTN phi kim sot kh nng tip cn v 5.3.4 Access to and use of areas affecting the
kim sot vic s dng cc khu vc c gy nh quality of the tests and/or calibrations shall be
hng ti cht lng th nghim v/hoc hiu controlled. The laboratory shall determine the
chun. PTN phi xc nh mc kim sot da extent of control based on its particular
vo iu kin c th ca PTN. circumstances.

5.3.5 PTN phi a ra cc bin php m bo v 5.3.5 Measures shall be taken to ensure good
sinh cng nghip tt. PTN phi chun b th tc housekeeping in the laboratory. Special
c bit khi cn thit. procedures shall be prepared where necessary.

32
5.4 Phng php th nghim v hiu chun v
ph duyt phng php
5.4.1 Yu cu chung
PTN phi s dng cc phng php v cc th
tc thch hp cho tt c php th nghim v/hoc
hiu chun trong phm vi ca PTN. iu ny bao
gm vic ly mu, bo qun, vn chuyn, lu gi
v chun b cc mu th nghim v/hoc hiu
chun, v khi thch hp, xc nh khng m
bo o cng nh p dng k thut thng k
phn tch d liu th nghim v/hoc hiu chun.
PTN phi c cc hng dn s dng v vn hnh
cho tt c thit b lin quan cng nh hng dn
v bo qun, chun b mu th nghim v/hoc
hiu chun hoc hng dn v c hai vic m nu
thiu nhng hng dn ny c th lm nh hng
n kt qu th nghim v/hoc hiu chun. Tt
c hng dn, tiu chun, s tay v cc d liu
tham kho lin quan n cng vic ca PTN phi
duy tr cp nht v lun sn c cho cc nhn vin
s dng (xem 4.3). Cc thay i so vi phng
php th nghim v/hoc hiu chun ch c p
dng khi cc thay i ny c lp thnh vn
bn, c chng minh v mt k thut l ng,
c php s dng v c khch hng chp
nhn.
Ch thch - Cc tiu chun quc gia, khu vc hoc
quc t hoc cc qui nh k thut khc c tha nhn
bao gm thng tin y v sc tch v cch thc
thc hin cc php th v/hoc hiu chun th khng
cn phi b sung hoc vit li thnh th tc ni b nu
tiu chun ban hnh c th s dng c cho cc nhn
vin ca PTN. C th cn cung cp ti liu b sung cho
cc bc khng bt buc trong phng php hoc cc
chi tit thm vo.
5.4.2 La chn phng php
PTN phi s dng cc phng php th nghim
v/hoc hiu chun, k c phng php ly mu,
p ng theo yu cu ca khch hng v thch
hp i vi php th v/hoc hiu chun m PTN
thc hin;uu tin s dng phng php c
5.4 Test and calibration methods and method
validation
5.4.1 General
The laboratory shall use appropriate methods and
procedures for all tests and/or calibrations within
its scope. These include sampling, handling,
transport, storage and preparation of items to be
tested and/or calibrated, and, where appropriate,
an estimation of the measurement uncertainty as
well as statistical techniques for analysis of test
and/or calibration data.
The laboratory shall have instructions on the use
and operation of all relevant equipment, and on the
handling and preparation of items for testing
and/or calibration, or both, where the absence of
such instructions could jeopardize the results of
tests and/or calibrations. All instructions,
standards, manuals and reference data relevant to
the work of the laboratory shall be kept up to date
and shall be made readily available to personnel
(see 4.3). Deviation from test and calibration
methods shall occur only if the deviation has been
documented, technically justified, authorized, and
accepted by the customer.
NOTE International, regional or national standards or
other recognized specifications that contain sufficient
and concise information on how to perform the tests
and/or calibrations do not need to be supplemented or
rewritten as internal procedures if these standards are
written in a way that they can be used as published by
the operating staff in a laboratory. It may be necessary
to provide additional documentation for optional steps in
the method or additional details.
5.4.2 Selection of methods
The laboratory shall use test and/or calibration
methods, including methods for sampling, which
meet the needs of the customer and which are
appropriate for the tests and/or calibrations it
undertakes. Methods published in international,
33
ban hnh di hnh thc l tiu chun quc t,
quc gia hoc khu vc. PTN phi m bo s
dng bn tiu chun mi nht tr khi bn tiu
chun ny khng ph hp hoc khng th thc
hin. Khi cn thit, tiu chun phi c b sung
thm cc chi tit m bo p dng nht qun.
Khi khch hng khng xc nh r phng php
s dng th PTN phi la chn cc phng php
thch hp c cng b trong tiu chun quc
t, quc gia hoc khu vc, hoc c cc t chc
k thut c uy tn ban hnh, hoc trong cc tp ch,
bi bo khoa hc thch hp hoc c nh sn
xut qui nh. Cc phng php do PTN thit lp
hoc chp nhn cng c th c s dng nu
cc phng php ny l thch hp vi mc ch
s dng v nu phng php ny c ph
duyt. Khch hng phi c thng bo v
phng php s dng. PTN phi khng nh c
th p dng ng phng php tiu chun trc
khi bt u th nghim v/hoc hiu chun. Nu
phng php tiu chun thay i th PTN phi lp
li vic xc nhn.
PTN phi thng bo cho khch hng khi cc
phng php do khch hng yu cu l khng
ph hp hoc li thi.
5.4.3 Cc phng php do PTN xy dng
Vic a cc phng php th v hiu chun do
PTN xy dng s dng ni b phi l mt hot
ng c k hoch v phi phn cng cho nhn
vin c nng lc, c trang b cc ngun lc cn
thit.
Cc k hoch phi c cp nht trong qu trnh
xy dng v PTN phi m bo vic trao i thng
tin c hiu qu gia tt c cc nhn vin tham gia.
5.4.4 Cc phng php khng tiu chun
Khi cn s dng cc phng php khng phi l
phng php tiu chun, cc phng php
nyphi c tho thun vi khch hng v phi
c cc qui nh r rng v yu cu ca khch
hng v mc ch ca php th v/hoc hiu
chun. Phng php c xy dng phi c
ph duyt thch hp trc khi s dng.
regional or national standards shall preferably be
used. The laboratory shall ensure that it uses the
latest valid edition of a standard unless it is not
appropriate or possible to do so. When necessary,
the standard shall be supplemented with additional
details to ensure consistent application.
When the customer does not specify the method to
be used, the laboratory shall select appropriate
methods that have been published either in
international, regional or national standards, or by
reputable technical organizations, or in relevant
scientific texts or journals, or as specified by the
manufacturer of the equipment. Laboratory-
developed methods or methods adopted by the
laboratory may also be used if they are appropriate
for the intended use and if they are validated. The
customer shall be informed as to the method
chosen. The laboratory shall confirm that it can
properly operate standard methods before
introducing the tests or calibrations. If the standard
method changes, the confirmation shall be
repeated.
The laboratory shall inform the customer when the
method proposed by the customer is considered to
be inappropriate or out of date.
5.4.3 Laboratory-developed methods
The introduction of test and calibration methods
developed by the laboratory for its own use shall
be a planned activity and shall be assigned to
qualified personnel equipped with adequate
resources.
Plans shall be updated as development proceeds
and effective communication amongst all
personnel involved shall be ensured.
5.4.4 Non-standard methods
When it is necessary to use methods not covered
by standard methods, these shall be subject to
agreement with the customer and shall include a
clear specification of the customer's requirements
and the purpose of the test and/or calibration. The
method developed shall have been validated
appropriately before use.
34
Ch thch - i vi cc phng php th NOTE For new test and/or calibration methods,
nghimv/hoc hiu chun mi phi thit lp th tc th procedures should be developed prior to the tests
nghim v/hoc hiu chun trc khi thc hin php and/or calibrations being performed and should contain
th nghim v/hoc hiu chun v th tc phi bao at least the following information:
gm t nht cc thng tin sau:

a) s nhn bit thch hp;

a) appropriate identification;
b) phm vi p dng;
b) scope;
c) m t chng loi mu c th nghim hoc hiu
c)description of the type of item to be tested or
chun;
calibrated;
d) cc thng s, cc i lng v khong phi xc nh;
d)parameters or quantities and ranges to be
e) dng c v thit b k c cc yu cu v tnh nng k determined;
thut;
e)apparatus and equipment, including technical
f) yu cu v chun chnh, mu chun cn thit; performance requirements;

g) yu cu v iu kin mi trng v mt s yu cu f) reference standards and reference materials required;

v thi gian n nh;
g)environmental conditions required and any
h) m t th tc bao gm c: stabilization period needed;

- gii m du hiu nhn bit mu, bo qun, vn h)description of the procedure, including
chuyn, lu gi v chun b mu th;
-affixing of identification marks, handling, transporting,
- thc hin kim tra trc khi bt u cng vic; storing and preparation of items,

- kim tra m bo rng thit b lm vic l ng n
v, khi c yu cu, thit b phi c hiu chun v
hiu chnh trc mi ln s dng,
- phng php ghi li cc d liu quan trc v kt qu;
-checks to be made before the work is started,
-checks that the equipment is working properly and,
where required, calibration and adjustment of the
equipment before each use,

- cc bin php o an ton cn chp hnh; -the method of recording the observations and results,

i) chun mc v/hoc yu cu ph duyt/bc b; -any safety measures to be observed;

j) d liu c lu v phng php phn tch v cch
trnh by d liu;
k) khng m bo hoc phng php c lng
khng m bo o.
i)criteria and/or requirements for approval/rejection;
j)data to be recorded and method of analysis and
presentation;
k)the uncertainty or the procedure for estimating
uncertainty.

5.4.5 Ph duyt phng php th 5.4.5 Validation of methods

5.4.5.1 Ph duyt l vic khng nh bng kim tra 5.4.5.1 Validation is the confirmation by
v cung cp bng chng khch quan rng cc yu examination and the provision of objective
cu xc nh cho vic s dng c th c p evidence that the particular requirements for a
ng. specific intended use are fulfilled.

5.4.5.2 PTN phi ph duyt phng php khng 5.4.5.2 The laboratory shall validate non-standard

35
tiu chun, cc phng php do PTN xy dng
hoc thit k, cc phng php tiu chun c
s dng nm ngoi phm vi d kin v vic m
rng cng nh thay i cc phng php tiu
chun xc nhn rng phng php ny l ph
hp vi mc ch s dng d kin. Vic ph duyt
ny phi bao qut khi cn thit p ng cc
yu cu p dng hoc lnh vc p dng nh.
PTN phi ghi li kt qu c c, th tc s
dng ph duyt v cng b rng phng php
ny ph hp vi mc ch s dng.
methods, laboratory-designed/developed methods,
standard methods used outside their intended
scope, and amplifications and modifications of
standard methods to confirm that the methods are
fit for the intended use. The validation shall be as
extensive as is necessary to meet the needs of the
given application or field of application. The
laboratory shall record the results obtained, the
procedure used for the validation, and a statement
as to whether the method is fit for the intended
use.

Ch thch 1 - Ph duyt c th bao gm cc th tc v NOTE 1 Validation may include procedures for

ly mu, bo qun v vn chuyn mu. sampling, handling and transportation.

Ch thch 2 - K thut dng xc nh tnh nng s NOTE 2 The techniques used for the determination of
dng mt phng php phi l mt hoc mt tp hp the performance of a method should be one of, or a
cc k thut sau: combination of, the following:

- s dng chun chnh hoc mu chun hiu chun;
- so snh kt qu t c vi cc phng php khc;
- so snh lin phng th nghim;
- nh gi c h thng cc yu t nh hng n kt
qu;
- nh gi khng m bo ca kt qu da vo hiu
bit khoa hc v nguyn tc l thuyt ca phng php
v kinh nghim thc t.
-calibration using reference standards or reference
materials;
-comparison of results achieved with other methods;
-interlaboratory comparisons;
-systematic assessment of the factors influencing the
result;
-assessment of the uncertainty of the results based on
scientific understanding of the theoretical principles of
the method and practical experience.

Ch thch 3 - Khi c mt s thay i trong cc phng NOTE 3 When some changes are made in the validated
php khng tiu chun c ph duyt th nh non-standard methods, the influence of such changes
hng ca cc thay i ny phi c lp thnh vn should be documented and, if appropriate, a new
bn v cn phi c ph duyt li, nu thch hp. validation should be carried out.

5.4.5.3 Phm vi v chnh xc ca cc gi tr c 5.4.5.3 The range and accuracy of the values
c t phng php c ph duyt hi ph obtainable from validated methods (e.g. the
hp vi cc yu cu ca khch hng khi nh gi uncertainty of the results, detection limit, selectivity
mc ch d nh s dng nh (v d: of the method, linearity, limit of repeatability and/or
khng m bo ca kt qu, gii hn pht hin, reproducibility, robustness against external
chn phng php, tuyn tnh, sai s th do influences and/or cross-sensitivity against
tc ng t bn ngoi, gii hn lp li v/hoc interference from the matrix of the sample/test
ti lp v/hoc nhy i vi tnh cn tr t object), as assessed for the intended use, shall be
cc thnh phn mu/i tng th). relevant to the customers' needs.

Ch thch 1 - Ph duyt bao gm qui nh cc yu cu, NOTE 1 Validation includes specification of the

36
xc nh c tnh ca phng php kim tra xem cc
yu cu c th thc hin bng cch s dng cc
phng php v cng b v gi tr s dng.
Ch thch 2 - Trong qu trnh xy dng phng php,
PTN cn phi thc hin xem xt thng xuyn kim
tra xc nhn cc yu cu ca khch hng vn ang
c p ng. Mi thay i trong cc yu cu i hi
nhng sa i trong k hoch xy dng phng php
phi c ph chun v cho php.
Ch thch 3 - Vic ph duyt thng c da trn s
cn bng gia chi ph, ri ro v cc kh nng k thut.
Trong rt nhiu trng hp, phm vi v khng m
bo ca cc gi tr (v d: chnh xc, gii hn pht
hin, chn lc, tuyn tnh, lp li, ti lp, sai
s th v nhy tng tc) ch c th c a ra
mt cch n gin do thiu thng tin.
5.4.6 nh gi khng m bo o
5.4.6.1 Phng hiu chun hoc phng th nghim
thc hin hiu chun ni b phi c v phi p
dng th tc nh gi khng m bo o cho
tt c cc php hiu chun v hnh thc hiu
chun.
5.4.6.2 Phng th nghim phi c v phi p dng
th tc nh gi khng m bo o. Trong
mt s trng hp nht nh, bn cht ca
phng php th c th hn ch vic tnh ton
nghim ngt v phng din o lng v thng
k khng m bo o. Trong nhng trng
hp ny, PTN t nht phi c gng xc nh tt c
thnh phn khng m bo o, thc hin nh
gi hp l v phi m bo rng hnh thc thng
bo kt qu khng c gy n tng sai v
khng m bo o. Vic nh gi hp l phi da
trn kin thc v tnh nng ca phng php v
lnh vc o, v phi s dng, v d, kinh nghim
trc v d liu c gi tr.
Ch thch 1 - Mc nghim ngt cn thit nh
gi khng m bo o tu thuc vo cc yu t nh:
- yu cu ca phng php th;
requirements, determination of the characteristics of the
methods, a check that the requirements can be fulfilled
by using the method, and a statement on the validity.
NOTE 2 As method-development proceeds, regular
review should be carried out to verify that the needs of
the customer are still being fulfilled. Any change in
requirements requiring modifications to the development
plan should be approved and authorized.
NOTE 3 Validation is always a balance between costs,
risks and technical possibilities. There are many cases
in which the range and uncertainty of the values (e.g.
accuracy, detection limit, selectivity, linearity,
repeatability, reproducibility, robustness and cross-
sensitivity) can only be given in a simplified way due to
lack of information.
5.4.6 Estimation of uncertainty of measurement
5.4.6.1 A calibration laboratory, or a testing
laboratory performing its own calibrations, shall
have and shall apply a procedure to estimate the
uncertainty of measurement for all calibrations and
types of calibrations.
5.4.6.2 Testing laboratories shall have and shall
apply procedures for estimating uncertainty of
measurement. In certain cases the nature of the
test method may preclude rigorous, metrologically
and statistically valid, calculation of uncertainty of
measurement. In these cases the laboratory shall
at least attempt to identify all the components of
uncertainty and make a reasonable estimation,
and shall ensure that the form of reporting of the
result does not give a wrong impression of the
uncertainty. Reasonable estimation shall be based
on knowledge of the performance of the method
and on the measurement scope and shall make
use of, for example, previous experience and
validation data.
NOTE 1 The degree of rigor needed in an estimation of
uncertainty of measurement depends on factors such
as:
37
- yu cu ca khch hng; -the requirements of the test method;

- cc gii hn lm c s quyt nh v s ph hp - the requirements of the customer;

vi qui nh k thut.
-the existence of narrow limits on which decisions on
conformity to a specification are based.

Ch thch 2 - Trong nhng trng hp khi mt phng NOTE 2 In those cases where a well-recognized test
php th nghim c cng nhn rng ri qui nh method specifies limits to the values of the major
gii hn gi tr ca cc ngun ch yu gy nn sources of uncertainty of measurement and specifies
khng m bo o v qui nh cch thc trnh by kt the form of presentation of calculated results, the
qu tnh ton, PTN c coi l p ng c cc laboratory is considered to have satisfied this clause by
iu ny khi tun theo phng php th v cc hng following the test method and reporting instructions (see
dn lp bo co (xem 5.10). 5.10).

5.4.6.3 Khi nh gi khng m bo o, tt c 5.4.6.3 When estimating the uncertainty of

cc thnh phn khng m bo c xem l measurement, all uncertainty components which
quan trng trong cc tnh hung c th cn phi are of importance in the given situation shall be
c tnh n bng s dng phng php phn taken into account using appropriate methods of
tnh thch hp analysis.

Ch thch 1 - Cc yu t gp phn vo khng m NOTE 1 Sources contributing to the uncertainty

bo o bao gm nhng khng gii hn , chun chnh
v mu chun s dng, phng php v thit b s
dng, iu kin mi trng, c tnh v iu kin ca
mu th hoc hiu chun v ngi thao tc.
include, but are not necessarily limited to, the
reference standards and reference materials used,
methods and equipment used, environmental
conditions, properties and condition of the item
being tested or calibrated, and the operator.

Ch thch 2 - S bin i lu di c d on trc NOTE 2 The predicted long-term behaviour of the tested
ca mu th v/hoc hiu chun thng thng khng and/or calibrated item is not normally taken into account
c tnh n khi nh gi khng m bo o. when estimating the measurement uncertainty.

Ch thch 3 - bit thm thng tin, hy tham kho NOTE 3 For further information, see ISO 5725 and the
TCVN 4550-88 (ISO 5725) v Hng dn v trnh by Guide to the Expression of Uncertainty in Measurement
khng m bo o (xem danh mc ti liu tham (see Bibliography).
kho).

5.4.7 Kim sot d liu 5.4.7 Control of data

5.4.7.1 Vic tnh ton v truyn d liu phi c 5.4.7.1 Calculations and data transfers shall be
kim tra thch hp theo cch thc c h thng. subject to appropriate checks in a systematic
manner.

5.4.7.2 Khi s dng my tnh hoc trang thit b t 5.4.7.2 When computers or automated equipment
ng ho thu nhn, x l, ghi li, boco, lu are used for the acquisition, processing, recording,
tr, hoc tra cu cc d liu th nghim hoc hiu reporting, storage or retrieval of test or calibration
chun PTN phi m bo: data, the laboratory shall ensure that:

a) phn mm my tnh do ngi s dng xy a)computer software developed by the user is

38
dng phi c lp vn bn y , chi tit v
c ph duyt l thch hp s dng.
b) phi thit lp v p dng th tc bo v d
liu, th tc phi bao gm, nhng khng c
gii hn tnh ton vn, tnh bo mt khi nhp
hoc thu thp d liu, lu gi d liu, truyn v x
l d liu.
c) My tnh v cc thit b t ng ho phi c
bo tr m bo hot ng tt trong cc iu
kin mi trng v iu kin hot ng cn thit
duy tr tnh ton vn ca d liu th nghim v
hiu chun.
Ch thch - Phn mm c mua t cc nh sn xut
(v d: chng trnh x l t ng, c s d liu,
chng trnh thng k) c th c coi nh c in general use within their designed application range
ph duyt s dng.Tuy nhin, cc sa i/thay cu
hnh, cc phn mm ca PTN phi c ph duyt nh
nu ti 5.4.7.2.a.
5.5 Thit b
5.5.1 PTN phi c trang b y mi thit b
ly mu, o v th nghim cn thit thc
hin chnh xc cng vic th nghim v/hoc hiu
chun (bao gm ly mu, chun b cc mu th
hoc hiu chun, x l v phn tch d liu th
nghim v/hoc hiu chun).
Trong nhng trng hp PTN cn s dng thit b
nm ngoi phm vi kim sot thng xuyn
PTN phi m bo nhng yu cu ca tiu chun
ny vn c p ng.
5.5.2 Thit b v phn mm ca thit b c s
dng th nghim, hiu chun v ly mu phi
c kh nng t c chnh xc cn thit v
phi ph hp vi qui nh k thut lin quan n
th nghim v/hoc hiu chun tng ng.
Chng trnh hiu chun phi c thit lp cho
cc i lng hoc gi tr chnh ca thit b khi cc
c tnh c nh hng ng k n kt qu.
Trc khi a vo s dng thit b (bao gm c
thit b dng ly mu) phi c hiu chun
hoc kim tra khng nh rng thit b p ng
documented in sufficient detail and is suitably
validated as being adequate for use;
b)procedures are established and implemented for
protecting the data; such procedures shall include,
but not be limited to, integrity and confidentiality of
data entry or collection, data storage, data
transmission and data processing;
c)computers and automated equipment are
maintained to ensure proper functioning and are
provided with the environmental and operating
conditions necessary to maintain the integrity of
test and calibration data.
NOTE Commercial off-the-shelf software (e.g.
wordprocessing, database and statistical programmes)
may be considered to be sufficiently validated. However,
laboratory software configuration/modifications should
be validated as in 5.4.7.2 a).
5.5 Equipment
5.5.1 The laboratory shall be furnished with all
items of sampling, measurement and test
equipment required for the correct performance of
the tests and/or calibrations (including sampling,
preparation of test and/or calibration items,
processing and analysis of test and/or calibration
data).
In those cases where the laboratory needs to use
equipment outside its permanent control, it shall
ensure that the requirements of this International
Standard are met.
5.5.2 Equipment and its software used for testing,
calibration and sampling shall be capable of
achieving the accuracy required and shall comply
with specifications relevant to the tests and/or
calibrations concerned. Calibration programmes
shall be established for key quantities or values of
the instruments where these properties have a
significant effect on the results. Before being
placed into service, equipment (including that used
for sampling) shall be calibrated or checked to
establish that it meets the laboratory's specification
39
cc yu cu qui nh k thut ca PTN v tun th
theo qui nh k thut tiu chun tng ng. Thit
b phi c kim tra v/hoc c hiu chun
trc khi s dng (xem 5.6).
5.5.3 Ch nhng ngi c php mi c quyn
s dng thit b. PTN phi lun sn c hng dn
v s dng v bo tr trang thit b cp nht
(bao gm ti liu hng dn s dng thit b do
nh sn xut cung cp) cho nhn vin thch hp
ca PTN s dng.
5.5.4 Mi hng mc ca thit b v phn mm ca
thit b s dng th nghim v hiu chun v
c ngha quan trng i vi kt qu phi c
m ho nhn bit r rng, khi thch hp.
5.5.5 PTN phi duy tr h s cho mi hng mc
thit b v cho phn mm c ngha quan trng
i vi php th hoc hiu chun thc hin. H
s phi bao gm ti thiu cc thng tin sau:
a) nhn bit hng mc thit b v phn mm ca
thit b ;
b) tn ca nh sn xut, s sri hoc s phn nh
r rng khc;
c) kim tra thit b ph hp vi qui nh k thut
(xem 5.5.2);
d) v tr hin ti ca thit b, khi thch hp;
e) hng dn ca nh sn xut nu c, hoc vin
dn ni c th tm c ti liu hng dn ca reference to their location;
nh sn xut;
f) ngy, kt qu v bn sao ca bin bn hoc
giy chng nhn ca tt c cc ln hiu chun v
hiu chnh, chun mc chp nhn, ngy thng
hiu chun ln ti.
g) k hoch bo tr nu thch hp v vic bo tr
thc hin theo k hoch.
h) mi h hng, s c, sa cha, thay i i vi
thit b.
5.5.6 PTN phi c cc th tc v bo qun, vn
chuyn, lu gi, s dng an ton v bo tr theo
k hoch thit b o m bo cho thit b hot
requirements and complies with the relevant
standard specifications. It shall be checked and/or
calibrated before use (see 5.6).
5.5.3 Equipment shall be operated by authorized
personnel. Up-to-date instructions on the use and
maintenance of equipment (including any relevant
manuals provided by the manufacturer of the
equipment) shall be readily available for use by the
appropriate laboratory personnel.
5.5.4 Each item of equipment and its software
used for testing and calibration and significant to
the result shall, when practicable, be uniquely
identified.
5.5.5 Records shall be maintained of each item of
equipment and its software significant to the tests
and/or calibrations performed. The records shall
include at least the following:
the identity of the item of equipment and its
software;
b) the manufacturer's name, type identification,
and serial number or other unique identification;
c) checks that equipment complies with the
specification (see 5.5.2);
d) the current location, where appropriate;
e) the manufacturer's instructions, if available, or
f) dates, results and copies of reports and
certificates of all calibrations, adjustments,
acceptance criteria, and the due date of next
calibration;
g) the maintenance plan, where appropriate, and
maintenance carried out to date;
h) any damage, malfunction, modification or repair
to the equipment.
5.5.6 The laboratory shall have procedures for
safe handling, transport, storage, use and planned
maintenance of measuring equipment to ensure
40
ng tt v nhm ngn nga s nhim bn
hoc trnh xung cp.
Ch thch - Cc th tc b sung c th cn thit khi
thit b o c s dng bn ngoi PTN th
nghim, hiu chun hoc ly mu.
5.5.7 Thit b b qu ti, qun l ti hoc cho
nhng kt qu nghi ng, hoc cho thy c
khuyt tt hoc kt qu nm ngoi gii hn qui
nh cho php khng c s dng. Thit b phi
c ring hoc phi c dn nhn r rng shall be isolated to prevent its use or clearly
hay nh du l khng c s dng trnh
vic s dng cho n khi thit b trn c sa
cha v vic th nghim v hiu chun ch ra l
thc hin chnh xc.
PTN phi kim tra nh hng ca cc khuyt tt
hoc sai lch so vi gii hn qui nh v php
th nghim v/hoc hiu chun trc v PTN
phi p dng th tc "kim sot cng vic khng
ph hp" (xem 4.9).
5.5.8 Khi c th, tt c thit b t di s kim
sot ca PTN v thit b yu cu hiu chun phi
c dn nhn, hoc c m ho hay c cch
nhn bit khc ch ra tnh trng hiu chun k
c ngy thng hiu chun ln cui v thi gian
hoc thi hn yu cu hiu chun li.
5.5.9 Khi v mt l do no , thit b nm ngoi
tm kim sot trc tip ca PTN th PTN phi
m bo chc nng v tnh trng hiu chun ca
thit b c kim tra v t yu cu trc khi
thit b ny c s dng li.
5.5.10 Khi vic kim tra gia k hiu chun l cn
thit duy tr mc tin cy v tnh trng hiu
chun ca thit b, vic kim tra gia k ny phi
c thc hin theo mt th tc qui nh.
5.5.11 Nu hiu chun pht sinh mt lot cc yu
t cn hiu chnh, PTN phi c cc th tc m
bo sao cho cc phin bn (v d: trong phn mm
proper functioning and in order to prevent
contamination or deterioration.
NOTE Additional procedures may be necessary
when measuring equipment is used outside the
permanent laboratory for tests, calibrations or
sampling.
5.5.7 Equipment that has been subjected to
overloading or mishandling, gives suspect results,
or has been shown to be defective or outside
specified limits, shall be taken out of service. It
labelled or marked as being out of service until it
has been repaired and shown by calibration or test
to perform correctly.
The laboratory shall examine the effect of the
defect or departure from specified limits on
previous tests and/or calibrations and shall
institute the Control of nonconforming work
procedure (see 4.9).
5.5.8 Whenever practicable, all equipment under
the control of the laboratory and requiring
calibration shall be labelled, coded or otherwise
identified to indicate the status of calibration,
including the date when last calibrated and the
date or expiration criteria when recalibration is
due.
5.5.9 When, for whatever reason, equipment goes
outside the direct control of the laboratory, the
laboratory shall ensure that the function and
calibration status of the equipment are checked
and shown to be satisfactory before the equipment
is returned to service.
5.5.10 When intermediate checks are needed to
maintain confidence in the calibration status of the
equipment, these checks shall be carried out
according to a defined procedure.
5.5.11 Where calibrations give rise to a set of
correction factors, the laboratory shall have
procedures to ensure that copies (e.g. in computer
41
my tnh) c cp nht chnh xc. software) are correctly updated.

5.5.12 Thit b th nghim v hiu chun bao gm 5.5.12 Test and calibration equipment, including
c phn cng v phn mm phi c bo v both hardware and software, shall be safeguarded
trnh iu chnh c th lm mt tnh ng n ca from adjustments which would invalidate the test
cc kt qu th nghim v/hoc hiu chun. and/or calibration results.

5.6 Tnh lin kt chun o lng 5.6 Measurement traceability

5.6.1 Khi qut 5.6.1 General

Tt c cc thit b s dng cho cng vic th
nghim v/hoc hiu chun, k c cc thit b o
ph (v d: xc nh iu kin mi trng) c
nh hng ng k n chnh xc hoc tnh
ng n ca kt qu hiu chun, th nghim
hoc ly mu phi c hiu chun trc khi a
vo s dng. PTN phi xy dng chng trnh v
th tc hiu chun thit b.
All equipment used for tests and/or calibrations,
including equipment for subsidiary measurements
(e.g. for environmental conditions) having a
significant effect on the accuracy or validity of the
result of the test, calibration or sampling shall be
calibrated before being put into service. The
laboratory shall have an established programme
and procedure for the calibration of its equipment.

Ch thch - Chng trnh cn bao gm h thng NOTE Such a programme should include a system for
la chn, s dng, hiu chun, kim tra, kim sot, bo selecting, using, calibrating, checking, controlling and
tr cc chun o lng, cc mu chun c s dng maintaining measurement standards, reference
nh l cc chun o lng, thit b o v th nghim materials used as measurement standards, and
c s dng thc hin cc php th nghim v measuring and test equipment used to perform tests
hiu chun. and calibrations.

5.6.2 Cc yu cu c th 5.6.2 Specific requirements

5.6.2.1 Hiu chun 5.6.2.1 Calibration

5.6.2.1.1 i vi cc phng hiu chun, PTN phi 5.6.2.1.1 For calibration laboratories, the
xy dng v thc hin chng trnh hiu chun programme for calibration of equipment shall be
thit b m bo cc php hiu chun v cc designed and operated so as to ensure that
php o do PTN thc hin c lin kt ti h calibrations and measurements made by the
n v quc t (SI). laboratory are traceable to the International
System of Units (SI) (Systme international
d'units).
Phng hiu chun thit lp tnh lin kt chun ca A calibration laboratory establishes traceability of
cc chun o lng v phng tin o cah ti its own measurement standards and measuring
h SI bng mt chui hiu chun hoc so snh instruments to the SI by means of an unbroken
khng t on, ni chun hoc phng tin o chain of calibrations or comparisons linking them
vi chun u tng ng ca cc n v SI. to relevant primary standards of the SI units of
Vic ni vi cc n v SI c th t c bng measurement. The link to SI units may be
cch dn v cc chun o lng quc gia. Chun achieved by reference to national measurement
o lng quc gia c th l chun u, chun ny standards. National measurement standards may
l s th hin cp u tin cc n v SI hoc be primary standards, which are primary
nhng i din c tha thun ca cc n v SI realizations of the SI units or agreed

42
da trn cc hng s vt l c bn. Chun quc
gia cng c th l chun th c cc Vin o
lng quc gia khc hiu chun. Khi PTN s dng
cc dch v hiu chun, t bn ngoi tnh lin kt
chun phi c m bo s dng cc dch v
hiu chun ch t cc PTN c nng lc, kh nng
o v m bo tnh lin kt chun. Giy chng
nhn hiu chun do cc PTN cp phi ghi kt qu
o gm c khng m bo o v/hoc cng b
ph hp vi mt qui nh v o lng xc nh
(xem 5.10.4.2).
Ch thch 1 - Cc Phng hiu chun p ng nhng
yu cu ca tiu chun ny c xem l c nng lc.
Giy chng nhn hiu chun mang biu tng ca c
quan cng nhn t mt phng hiu chun c cng
nhn theo tiu chun ny cho cc php hiu chun
tng ng l bng chng y v tnh lin kt chun
ca d liu hiu chun bo co.
Ch thch 2 - Tnh lin kt chun ti cc n v o
lng SI c th t c bng vic dn v mt chun
u ph hp [xem TCVN 6165:1996 (VM 1993. 6.4)]
hoc dn v mt hng s t nhin c gi tr bit theo
n v h SI tng ng v c i hi cn o v y relevant SI unit is known and recommended by the
ban cn o quc t (CPM v GPM) khuyn ngh.
Ch thch 3 - Cc phng hiu chun duy tr chun u
hoc chun i din ca cc n v
da vo hng s vt l c bn c th khng nh dn
xut vi h SI ch sau khi cc chun ny c so snh
trc tip hoc gin tip vi cc chun tng ng
khc ca mt Vin o lng quc gia.
Ch thch 4 - Thut ng "qui nh k thut o lng
xc nh" c ngha phi lm r trong giy chng nhn
hiu chun cc php o c so snh vi qui nh k
thut no bng cch nu ln hoc a ra vin dn r
rng v qui nh k thut.
Ch thch 5 - Khi thut ng "chun quc t" hoc
"chun quc gia" c s dng lin quan vi tnh dn
representations of SI units based on fundamental
physical constants, or they may be secondary
standards which are standards calibrated by
another national metrology institute. When using
external calibration services, traceability of
measurement shall be assured by the use of
calibration services from laboratories that can
demonstrate competence, measurement capability
and traceability. The calibration certificates issued
by these laboratories shall contain the
measurement results, including the measurement
uncertainty and/or a statement of compliance with
an identified metrological specification (see also
5.10.4.2).
NOTE 1 Calibration laboratories fulfilling the
requirements of this International Standard are
considered to be competent. A calibration certificate
bearing an accreditation body logo from a calibration
laboratory accredited to this International Standard, for
the calibration concerned, is sufficient evidence of
traceability of the calibration data reported.
NOTE 2 Traceability to SI units of measurement may be
achieved by reference to an appropriate primary
standard (see VIM:1993, 6.4) or by reference to a
natural constant, the value of which in terms of the
General Conference of Weights and Measures (CGPM)
and the International Committee for Weights and
Measures (CIPM).
NOTE 3 Calibration laboratories that maintain their own
SI primary standard or representation of SI units based on
fundamental physical constants can claim traceability to
the SI system only after these standards have been
compared, directly or indirectly, with other similar
standards of a national metrology institute.
NOTE 4 The term identified metrological specification
means that it must be clear from the calibration
certificate which specification the measurements have
been compared with, by including the specification or by
giving an unambiguous reference to the specification.
NOTE 5 When the terms international standard or
national standard are used in connection with
43
xut chun, c gi thit rng chun quc gia v
chun quc t ny p ng cc c tnh k thut ca
cc chun u c tha nhn trong h n v SI
Ch thch 6 - Lin kt n chun o lng quc gia
khng nht thit yu cu s dng Vin o lng quc
gia ca nc m ni PTN t tr s.
Ch thch 7 - Nu mt phng hiu chun mong mun
hoc c nhu cu nhn c s lin kt chun ca mt
Vin o lng quc gia khc th PTN phi la chn mt
Vin o lng quc gia tham gia tht s vo cc hot
ng ca BIPM hoc trc tip hoc thng cc cc nhm
khu vc.
Ch thch 8 - PTN c th t c chui hiu chun
hoc so snh khng gin on c th t c bng
mt s bc c thc hin do cc PTN khc nhau c
th chng minh c tnh lin kt chun thc hin.
5.6.2.1.2 C mt vi php hiu chun hin ti PTN
khng th thc hin hon ton theo cc n v SI.
Trong trng hp , vic hiu chun phi chng
minh mc tin cy trong php o bng vic thit
lp lin kt n cc chun o lng ph hp nh:
- s dng cc mu chun c chng nhn do
ngi cung ng c nng lc cung cp c c
tnh cht vt l hoc ho hc tin cy ca vt liu.
- s dng phng php qui nh v/hoc cc
chun tha thun c miu t r rng v c
tt c cc bn lin quan chp nhn.
Yu cu PTN tham gia chng trnh so snh lin
phng ph hp nu c th.
5.6.2.2 Th nghim
5.2.2.2.1 i vi cc phng th nghim p dng
cc yu cu a ra trong mc 5.6.2.1 cho cc thit
b o lng v th nghim c s dng i vi cc
chc nng o, tr khi chng minh c rng vic
hiu chun c tc ng khng ng k vo
khng m bo o tng hp ca kt qu th
nghim. Khi pht sinh tnh hung ny, PTN phi
traceability, it is assumed that these standards fulfil the
properties of primary standards for the realization of SI
units.
NOTE 6 Traceability to national measurement standards
does not necessarily require the use of the national
metrology institute of the country in which the laboratory
is located.
NOTE 7 If a calibration laboratory wishes or needs to
obtain traceability from a national metrology institute
other than in its own country, this laboratory should
select a national metrology institute that actively
participates in the activities of BIPM either directly or
through regional groups.
NOTE 8 The unbroken chain of calibrations or
comparisons may be achieved in several steps carried
out by different laboratories that can demonstrate
traceability.
5.6.2.1.2 There are certain calibrations that
currently cannot be strictly made in SI units. In
these cases calibration shall provide confidence in
measurements by establishing traceability to
appropriate measurement standards such as:
-the use of certified reference materials provided
by a competent supplier to give a reliable physical
or chemical characterization of a material;
-the use of specified methods and/or consensus
standards that are clearly described and agreed
by all parties concerned.
Participation in a suitable programme of
interlaboratory comparisons is required where
possible.
5.6.2.2 Testing
5.6.2.2.1 For testing laboratories, the requirements
given in 5.6.2.1 apply for measuring and test
equipment with measuring functions used, unless
it has been established that the associated
contribution from the calibration contributes little to
the total uncertainty of the test result. When this
situation arises, the laboratory shall ensure that
44
m bo rng thit b s dng c th cung cp
khng m bo o cn thit.
Ch thch - Mc PTN phi tun th cc yu cu
cp trong 5.6.2.1 ph thuc vo s ng gp tng i
ca khng m bo o trong php hiu chun vi
khng m bo o tng hp. Nu vic hiu chun l
yu t nh hng ln th cc yu cu trn phi c
tun th nghim ngt.
5.6.2.2.2 Khi dn xut ca php o n cc n v
SI l khng th v/hoc khng thch hp th cc
yu cu tng t v tnh lin kt chun v d, i
vi mu chun c chng nhn, cc phng
php tho thun, v/hoc chun tha thun cng
c yu cu nh i vi cc phng hiu chun
(5.6.2.1.2).
5.6.3 Chun chnh v mu chun
5.6.3.1 Chun chnh
PTN phi c chng trnh v th tc v hiu
chun cc chun chnh. Cc chun chnh phi
c hiu chun bi mt t chc c th cung cp
vic lin kt chun nh c miu t trong
5.6.2.1. Chun chnh PTN lu gi ch c s
dng hiu chun v khng c s dng cho
cc mc ch khc, tr phi PTN c th ch ra rng
tnh nng ca n nh chun chnh vn c hiu lc.
Cc chun chnh phi c hiu chun trc v
sau khi c bt c hiu chnh no.
5.6.3.2 Mu chun
Khi c th, cc mu chun phi dn xut ti cc
n v o lng SI hoc n cc mu chun c
chng nhn. Cc mu chun ni b phi c
kim tra n mc ti a khi iu kin kinh t v k
thut cho php.
5.6.3.3 Kim tra gia k
PTN phi tin hnh s kim tra cn thit theo cc
th tc v k hoch qui nh duy tr s tin
cy v tnh trng hiu chun ca chun chnh,
chun u, chun so snh hoc chun cng tc,
the equipment used can provide the uncertainty of
measurement needed.
NOTE The extent to which the requirements in 5.6.2.1
should be followed depends on the relative contribution
of the calibration uncertainty to the total uncertainty. If
calibration is the dominant factor, the requirements
should be strictly followed.
5.6.2.2.2 Where traceability of measurements to SI
units is not possible and/or not relevant, the same
requirements for traceability to, for example,
certified reference materials, agreed methods
and/or consensus standards, are required as for
calibration laboratories (see 5.6.2.1.2).
5.6.3 Reference standards and reference materials
5.6.3.1 Reference standards
The laboratory shall have a programme and
procedure for the calibration of its reference
standards. Reference standards shall be calibrated
by a body that can provide traceability as
described in 5.6.2.1. Such reference standards of
measurement held by the laboratory shall be used
for calibration only and for no other purpose,
unless it can be shown that their performance as
reference standards would not be invalidated.
Reference standards shall be calibrated before
and after any adjustment.
5.6.3.2 Reference materials
Reference materials shall, where possible, be
traceable to SI units of measurement, or to
certified reference materials. Internal reference
materials shall be checked as far as is technically
and economically practicable.
5.6.3.3 Intermediate checks
Checks needed to maintain confidence in the
calibration status of reference, primary, transfer or
working standards and reference materials shall
be carried out according to defined procedures
45
v mu chun.
5.6.4.4 Vn chuyn v lu gi
PTN phi c th tc qun l an ton, vn chuyn,
lu gi v s dng cc chun chnh v mu chun
phng nga nhim bn hoc h hng v
bo v tnh nguyn vn.
Ch thch - Cc th tc b sung c th l cn thit khi
cc chun chnh v mu chun c s dng bn
ngoi v tr c nh ca PTN th nghim, hiu chun
hoc ly mu.
5.7 Ly mu
5.7.1 PTN phi c k hoch v th tc ly mu khi
PTN thc hin ly mu cc cht, vt liu hoc sn
phm dng th nghim/hiu chun tip theo.
K hoch ly mu cng nh th tc ly mu phi
c sn ti v tr thc hin vic ly mu. K hoch
ly mu phi hp l v phi da vo phng php
thng k ph hp. Qu trnh ly mu phi ghi li
cc yu t c kim sot m bo hiu lc
ca kt qu th nghim/hiu chun.
Ch thch 1 - Ly mu l mt th tc xc nh nh
mt phn cht, vt liu hoc sn phm c ly
tin hnh th nghim/hiu chun mt mu i din
trong ton b mu. i vi cht, vt liu hoc sn phm
c th nghim hoc hiu chun cng c th i hi
vic ly mu theo qui nh k thut ph hp.
Trong mt s trng hp nht nh (VD phn tch mang
tnh php l) mu c th khng phi l i din nhng
phi c xc nh gi tr hiu lc.
Ch thch 2 - Th tc ly mu phi miu t vic la
chn, k hoch ly mu, thu hi v chun b mt mu
hoc cc mu t mt hp cht, vt liu hoc sn phm
c c thng tin cn thit.
5.7.2 Khi khch hng yu cu sa i, b sung
hoc loi bt nhng th tc ly mu c vn
and schedules.
5.6.3.4 Transport and storage
The laboratory shall have procedures for safe
handling, transport, storage and use of reference
standards and reference materials in order to
prevent contamination or deterioration and in order
to protect their integrity.
NOTE Additional procedures may be necessary
when reference standards and reference materials
are used outside the permanent laboratory for
tests, calibrations or sampling.
5.7 Sampling
5.7.1 The laboratory shall have a sampling plan
and procedures for sampling when it carries out
sampling of substances, materials or products for
subsequent testing or calibration. The sampling
plan as well as the sampling procedure shall be
available at the location where sampling is
undertaken. Sampling plans shall, whenever
reasonable, be based on appropriate statistical
methods. The sampling process shall address the
factors to be controlled to ensure the validity of the
test and calibration results.
NOTE 1 Sampling is a defined procedure whereby a
part of a substance, material or product is taken to
provide for testing or calibration of a representative
sample of the whole. Sampling may also be required by
the appropriate specification for which the substance,
material or product is to be tested or calibrated.
In certain cases (e.g. forensic analysis), the sample may
not be representative but is determined by availability.
NOTE 2 Sampling procedures should describe the
selection, sampling plan, withdrawal and preparation of
a sample or samples from a substance, material or
product to yield the required information.
5.7.2 Where the customer requires deviations,
additions or exclusions from the documented
46
bn ho th nhng yu cu ny phi c ghi
chp chi tit cng vi nhng d liu ly mu ph
hp v phi lu gi ton b ti liu lin quan n
kt qu th nghim/hiu chun cng nh phi
thng bo cho nhng ngi c lin quan.
5.7.3 PTN phi c th tc ghi li d liu ph hp
v cc hot ng lin quan n ly mu hnh
thnh nn mt phn hot ng th nghim hoc
hiu chun m PTN tin hnh. Cc h s phi
bao gm th tc ly mu c s dng, s nhn
bit ngi ly mu, iu kin mi trng (nu ph
hp) v cc biu hoc nhng cch tng t
xc nh v tr ly mu khi cn thit v nu ph hp
cc th tc ly mu, thng k c p dng.
5.8 Qun l mu th nghim v hiu chun
5.8.1 PTN phi c nhng th tc v vn chuyn,
tip nhn, qun l, lu gi, bo v, lu tr v hoc
thanh l cc mu th nghim v/hoc hiu chun
bao gm mi qui nh cn thit bo v tnh ton
vn ca mu th nghim v/hoc hiu chun v
bo v quyn li ca PTN v khch hng.
5.8.2 PTN phi c mt h thng m ho mu th
nghimv/hoc hiu chun. Vic m ho mu phi
c duy tr ti PTN trong sut thi gian mu tn
ti PTN. H thng m ho mu phi c thit
k v hot ng sao cho c th m bo mu
khng th b nhm ln trn thc t hoc khi c
vin dn n h s hoc cc ti liu khc. H
thng m ho ny phi cho php vic sp xp
thnh cc nhm mu nh hn hoc cho php vic
chuyn cc mu n hoc t PTN i nu ph hp.
5.8.3 PTN phi ghi vo h s khi nhn mu th
nghim v/hoc hiu chun khi thy c bt c
khc bit hoc c sai lch so vi cc iu kin
qui nh hoc trong cc phng php th nghim
hoc hiu chun. Khi c bt c nghi ng no v
s ph hp ca mu th nghim v/hoc hiu
chun hoc khi c mt mu khng ph hp vi s
miu t cung cp, cng nh php th hoc
sampling procedure, these shall be recorded in
detail with the appropriate sampling data and shall
be included in all documents containing test and/or
calibration results, and shall be communicated to
the appropriate personnel.
5.7.3 The laboratory shall have procedures for
recording relevant data and operations relating to
sampling that forms part of the testing or
calibration that is undertaken. These records shall
include the sampling procedure used, the
identification of the sampler, environmental
conditions (if relevant) and diagrams or other
equivalent means to identify the sampling location
as necessary and, if appropriate, the statistics the
sampling procedures are based upon.
5.8 Handling of test and calibration items
5.8.1 The laboratory shall have procedures for the
transportation, receipt, handling, protection,
storage, retention and/or disposal of test and/or
calibration items, including all provisions
necessary to protect the integrity of the test or
calibration item, and to protect the interests of the
laboratory and the customer.
5.8.2 The laboratory shall have a system for
identifying test and/or calibration items. The
identification shall be retained throughout the life of
the item in the laboratory. The system shall be
designed and operated so as to ensure that items
cannot be confused physically or when referred to
in records or other documents. The system shall, if
appropriate, accommodate a sub-division of
groups of items and the transfer of items within
and from the laboratory.
5.8.3 Upon receipt of the test or calibration item,
abnormalities or departures from normal or
specified conditions, as described in the test or
calibration method, shall be recorded. When there
is doubt as to the suitability of an item for test or
calibration, or when an item does not conform to
the description provided, or the test or calibration
required is not specified in sufficient detail, the
47
hiu chun c yu cu khng c qui nh chi laboratory shall consult the customer for further
tit, th PTN phi trao i kin vi khch hng v instructions before proceeding and shall record the
hng dn b sung trc khi tin hnh cng nh discussion.
phi ghi li cuc trao i kin ny.

5.8.4 PTN phi c th tc v phng tin ph hp 5.8.4 The laboratory shall have procedures and
trnh h hng, mt mt hoc tn hi n mu appropriate facilities for avoiding deterioration, loss
th nghim/hiu chun trong khi lu gi, qun l or damage to the test or calibration item during
v chun b. PTN phi p dng hng dn v storage, handling and preparation. Handling
qun l mu c cung cp cng mu. Khi mu instructions provided with the item shall be
phi lu gi trong cc iu kin mi trng qui followed. When items have to be stored or
nh th cc iu kin phi c duy tr, kim conditioned under specified environmental
sot v ghi chp li. PTN phi lu gi cn thn conditions, these conditions shall be maintained,
mu th nghim/hiu chun hoc cc phn ca monitored and recorded. Where a test or
mu, PTN phi c qui nh v lu gi v tnh an calibration item or a portion of an item is to be held
ton bo v tnh trng v tnh nguyn vn ca secure, the laboratory shall have arrangements for
mu v cc phn mu lin quan. storage and security that protect the condition and
integrity of the secured items or portions
concerned.

Ch thch 1 - Nu cc mu th nghim/hiu chun
c s dng li sau khi th nghim th PTN cn phi
c bit quan tm m bo cc mu ny khng b
ph hu hoc tn hi trong qu trnh qun l, th
nghim hoc trong qu trnh lu gi/ ch i.
NOTE 1 Where test items are to be returned into service
after testing, special care is required to ensure that they
are not damaged or injured during the handling, testing
or storing/waiting processes.

Ch thch 2 - Mt th tc ly mu v thng tin v lu NOTE 2 A sampling procedure and information on

gi v vn chuyn mu, bao gm c thng tin v cc storage and transport of samples, including information
yu t ly mu nh hng n kt qu th nghim/hiu on sampling factors influencing the test or calibration
chun cn c cung cp cho nhng ngi c trch result, should be provided to those responsible for
nhim v ly v vn chuyn mu. taking and transporting the samples.

Ch thch 3 - L do lu gi an ton mu hiu NOTE 3 Reasons for keeping a test or calibration item
chun/ th nghim c th l do h s yu cu, do i secure can be for reasons of record, safety or value, or
hi an ton hoc gi tr ca mu, hoc tin hnh cc to enable complementary tests and/or calibrations to be
php hiu chun/ th nghim c thc hin sau ny. performed later.

5.9 m bo cht lng kt qu th nghim v 5.9 Assuring the quality of test and calibration
hiu chun results

PTN phi c cc th tc kim sot cht lng
kim tra tnh hiu lc ca php th nghim v hiu
chun thc hin. D liu kt qu phi c ghi
chp sao cho c th nhn bit cc khuynh hng
din bin ca cc kt qu v nu c th cn phi
p dng k thut thng k xem xt cc kt qu.
Vic kim tra ny phi c ln k hoch, sot xt
5.9.1 The laboratory shall have quality control
procedures for monitoring the validity of tests and
calibrations undertaken. The resulting data shall
be recorded in such a way that trends are
detectable and, where practicable, statistical
techniques shall be applied to the reviewing of the
results. This monitoring shall be planned and

48
li v c th bao gm nhng khng gii hn :
a)s dng thng xuyn cc mu chun c
chng nhn v/hoc kim sot cht lng ni b
qua vic s dng cc mu chun th;
b) tham gia vo cc chng trnh so snh lin
phng v th nghim thnh tho;
c) thc hin li cc php th nghim hoc hiu
chun s dng cng mt phng php hoc cc
phng php khc nhau;
d) th nghim hoc hiu chun li cc mu lu;
e) tng quan ca kt qu t nhng c tnh khc
nhau ca mt mu.
Ch thch - Cc phng php phi ph hp vi chng
loi v khi lng cng vic thc hin
5.9.2 Cc d liu v kim sot cht lng phi
c phn tch v, khi nhng d liu ny nm
ngoi chun mc nh th phi c hnh ng
khc phc iu ny v ngn nga kt qa sai
c thng bo
5.10 Bo co kt qu
5.10.1 Yu cu chung
Cc kt qu ca mi php th nghim, hiu chun
hoc mt lot cc php th, hiu chun do PTN
thc hin phi c bo co chnh xc, r rng,
khng m h v khch quan cng nh phi ph
hp vi cc ch dn c th trong phng php th
nghim hoc hiu chun.
Thng thng cc kt qu phi c bo co
trong bo co th nghim hoc giy chng nhn
hiu chun (xem ch thch 1), v phi bao gm tt
c cc thng tin m khch hng yu cu v cn
din gii cc kt qu th nghim v hiu chun
cng nh tt c cc thng tin theo yu cu ca
phng php s dng. Thng tin ny thng
l cc ni dung c yu cu trong 5.10.2 v
5.10.3 hoc 5.10.4. Kt qu c th c bo co
theo cch n gin hn trong trng hp cc
php th hoc hiu chun c thc hin cho
reviewed and may include, but not be limited to,
the following:
a)regular use of certified reference materials
and/or internal quality control using secondary
reference materials;
b) participation in interlaboratory comparison or
proficiency-testing programmes;
c) replicate tests or calibrations using the same or
different methods;
d) retesting or recalibration of retained items;
e) correlation of results for different characteristics
of an item.
NOTE The selected methods should be appropriate for
the type and volume of the work undertaken.
5.9.2 Quality control data shall be analysed and,
where they are found to be outside pre-defined
criteria, planned action shall be taken to correct
the problem and to prevent incorrect results from
being reported.
5.10 Reporting the results
5.10.1 General
The results of each test, calibration, or series of
tests or calibrations carried out by the laboratory
shall be reported accurately, clearly,
unambiguously and objectively, and in accordance
with any specific instructions in the test or
calibration methods.
The results shall be reported, usually in a test
report or a calibration certificate (see Note 1), and
shall include all the information requested by the
customer and necessary for the interpretation of
the test or calibration results and all information
required by the method used. This information is
normally that required by 5.10.2, and 5.10.3 or
5.10.4. In the case of tests or calibrations
performed for internal customers, or in the case of
a written agreement with the customer, the results
may be reported in a simplified way. Any
49
khch hng ni b, hoc trong trng hp c mt
tho thun bng vn bn vi khch hng. Nu cc
thng tin lit k trong mc 5.10.2 n 5.10.4 khng
c thng bo ti khch hng th phi c sn
trong PTN ni thc hin th nghim v/ hoc hiu
chun.
information listed in 5.10.2 to 5.10.4 which is not
reported to the customer shall be readily available
in the laboratory which carried out the tests and/or
calibrations.

Ch thch 1 - Cc bo co th nghim v giy chng NOTE 1 Test reports and calibration certificates are
nhn hiu chun i khi cng c gi tng ng l sometimes called test certificates and calibration
giy chng nhn th nghim hoc bin bn hiu chun. reports, respectively.

Ch thch 2 - Cc bin bn th nghim hoc giy NOTE 2 The test reports or calibration certificates may
chng nhn hiu chun c th ban hnh di hnh thc be issued as hard copy or by electronic data transfer
l bn in trn giy hoc truyn d liu bng in t vi provided that the requirements of this International
iu kin l p ng cc yu cu ca tiu chun ny. Standard are met.

5.10.2 Bin bn th nghim v giy chng nhn 5.10.2 Test reports and calibration certificates
hiu chun

Mi bin bn th nghim hoc giy chng nhn Each test report or calibration certificate shall
hiu chun phi bao gm t nht cc thng tin sau, include at least the following information, unless
tr khi PTN c l do chnh ng khng tun the laboratory has valid reasons for not doing so:
theo:
a)a title (e.g. Test Report or Calibration
a) tiu , v d: bin bn th nghim hoc "giy Certificate);
chng nhn hiu chun";
b)the name and address of the laboratory, and the
b) tn v a ch ca PTN v v tr ni tin hnh location where the tests and/or calibrations were
th nghim hoc hiu chun nu khc vi a ch carried out, if different from the address of the
ca PTN; laboratory;

c) s m hiu thng nht ca bin bn th nghim
hoc giy chng nhn hiu chun (chng hn s
seri) v trn mi trang phi c m hiu m
bo rng trang c tha nhn nh l mt
phn ca bin bn th nghim hoc giy chng
nhn hiu chun v xc nh r rng phn kt thc
ca bin bn th nghim hoc giy chng nhn
hiu chun;
d) tn v a ch ca khch hng;
e) nu phng php s dng;
f) miu t, tnh trng v xc nh r rng mu unambiguous identification of the item(s) tested or
th nghim hoc hiu chun;
c)unique identification of the test report or
calibration certificate (such as the serial number),
and on each page an identification in order to
ensure that the page is recognized as a part of the
test report or calibration certificate, and a clear
identification of the end of the test report or
calibration certificate;
d)the name and address of the customer;
e)identification of the method used;
f)a description of, the condition of, and
calibrated;

g) ngy nhn mu th hoc hiu chun, trong g)the date of receipt of the test or calibration
trng hp iu l quan trng i vi hiu lc item(s) where this is critical to the validity and
v ng dng kt qu, ngy thng thc hin th application of

50
nghim hoc hiu chun; the results, and the date(s) of performance of the
test or calibration;
h) vin dn n k hoch v cc th tc ly mu
m PTN hoc cc t chc khc s dng nu c h) reference to the sampling plan and procedures
lin quan n hiu lc hoc ng dng ca cc kt used by the laboratory or other bodies where these
qu are relevant to the validity or application of the
results;
i) cc kt qu th nghim hoc hiu chun cng
vi cc n v o lng, nu thch hp i)the test or calibration results with, where
appropriate, the units of measurement;
j) tn, chc v, ch k hoc nhn dng tng
ng ca ngi c thm quyn cp giy j)the name(s), function(s) and signature(s) or
equivalent identification of person(s) authorizing
chng nhn hiu chun hoc bin bn th
the test report or calibration certificate;
nghim;
k)where relevant, a statement to the effect that the
k) khi thch hp, cng b v tnh hiu lc ca cc
results relate only to the items tested or calibrated.
kt qu ch lin quan n cc mu

c th nghim hoc hiu chun.

Ch thch 1 - Cc bn sao y bn chnh ca giy chng NOTE 1 Hard copies of test reports and calibration
nhn hiu chun hoc bin bn th nghim cng phi certificates should also include the page number and
bao gm s trang v tng s trang. total number of pages.

Ch thch 2 - Khuyn ngh rng, PTN nn c mt cng NOTE 2 It is recommended that laboratories include a
b ch ra rng bin bn th nghim hoc giy chng statement specifying that the test report or calibration
nhn hiu chun khng c sao chp li ngoi tr certificateshall not be reproduced except in full, without
ton b nu khng c s ng bng vn bn ca written approval of the laboratory.
PTN.

5.10.3 Bin bn th nghim 5.10.3 Test reports

5.10.3.1 B sung thm vo cc yu cu nu 5.10.3.1 In addition to the requirements listed in

trong 5.10.2 bin bn th nghim phi bao gm 5.10.2, test reports shall, where necessary for the
cc thng tin sau nu cn thit din gii cc kt interpretation of the test results, include the
qu th nghim: following:

a) cc sai khc t vic thm hoc bt i so vi a) deviations from, additions to, or exclusions from
phng php th nghim v thng tin v iu kin the test method, and information on specific test
th nghim c th nh: iu kin mi trng; conditions, such as environmental conditions;

b) khi thch hp, cng b s ph hp/khng ph b) where relevant, a statement of compliance/non-

hp so vi cc yu cu v/hoc cc qui nh k compliance with requirements and/or
thut; specifications;

c) khi thch hp, cng b khng m bo o c)where applicable, a statement on the estimated
c c lng; thng tin v khng m bo uncertainty of measurement; information on
o l cn thit trong cc bin bn th nghim khi uncertainty is needed in test reports when it is
c lin quan n hiu lc hoc ng dng ca kt relevant to the validity or application of the test
qu th nghim, khi khch hng yu cu hoc khi results, when a customer's instruction so requires,
khng m bo o nh hng ti s ph hp or when the uncertainty affects compliance to a

51
vi mt gii hn ca qui nh k thut; specification limit;

d) cc nhn xt v gii thch khi cn v cn thit d) where appropriate and needed, opinions and
v c yu cu ( xem 5.10.5); interpretations (see 5.10.5);

e) thng tin b sung m cc phng php c th, e) additional information which may be required by
khch hng hoc cc nhm khch hng c th yu specific methods, customers or groups of
cu. customers.

5.10.3.2 B sung vo cc yu cu nu trong 5.10.3.2 In addition to the requirements listed in

5.10.2 v 5.10.3.1, nu cn thit din gii cc 5.10.2 and 5.10.3.1, test reports containing the
kt qu th nghim th bo co th nghim bao results of sampling shall include the following,
gm thng tin sau: where necessary for the interpretation of test
results:

a) the date of sampling;

a) ngy ly mu;
b) unambiguous identification of the substance,
b) xc nh r rng v cht, vt liu hoc sn
material or product sampled (including the name of
phm c ly mu (bao gm tn ca nh sn
the manufacturer, the model or type of designation
xut, kiu hoc loi k hiu v s xeri, nu thch
and serial numbers as appropriate);
hp);
c) the location of sampling, including any
c) v tr ly mu bao gm cc biu , bn hoc
diagrams, sketches or photographs;
nh;
d) a reference to the sampling plan and
d) vin dn k hoch v th tc s dng ly procedures used;
mu;
e)details of any environmental conditions during
e) cc chi tit ca mi iu kin mi trng trong sampling that may affect the interpretation of the
qu trnh ly mu c th nh hng ti din gii test results;
kt qu th nghim;
f)any standard or other specification for the
f) mi tiu chun hoc qui nh k thut khc v sampling method or procedure, and deviations,
phng php hoc th tc ly mu v cc sai additions to or exclusions from the specification
khc thm vo hoc bt i so vi qui nh k thut concerned.
lin quan.

5.10.4 Giy chng nhn hiu chun 5.10.4 Calibration certificates

5.10.4.1 Ngoi cc yu cu nu trong 5.10.2 5.10.4.1 In addition to the requirements listed in

giy chng nhn hiu chun cn phi bao gm 5.10.2, calibration certificates shall include the
nhng thng tin sau, khi cn thit, din gii cc following, where necessary for the interpretation of
kt qu hiu chun: calibration results:

a) cc iu kin (v d mi trng) khi thc hin a) the conditions (e.g. environmental) under which
hiu chun m c nh hng ti cc kt qu o; the calibrations were made that have an influence
on the measurement results;
b) khng m bo o v/hoc cng b s ph
hp vi mt yu cu k thut o lng xc nh b)the uncertainty of measurement and/or a
hoc cc iu ca yu cu ; statement of compliance with an identified
metrological specification or clauses thereof;
c) bng chng rng cc php o c lin kt

52
chun (xem ch thch 2 trong 5.6.2.1.1)
5.10.4.2 Giy chng nhn hiu chun ch phi lin
quan ti cc i lng v kt qu ca cc php
th chc nng. Nu c cng b v s ph hp vi
mt qui nh k thut th cng b ny phi xc nh
r rng iu no ca qui nh k thut c p
ng v iu no khng. Khi a ra cng b v s
ph hp vi mt qui nh k thut b qua cc kt
qu o lng v khng m bo o km theo
th PTN phi ghi li cc kt qu ny v lu gi
chng c th vin dn li trong tng lai.
Khi a ra cng b v s ph hp th PTN phi
tnh n khng m bo o
5.10.4.3 Khi mt thit b hiu chun c hiu
chnh hoc c sa cha th cc kt qu hiu
chun trc v sau khi hiu chnh hoc sa cha
phi c ghi li nu c
5.10.4.4 Giy chng nhn hiu chun (hoc tem
hiu chun) khng c bao gm bt c khuyn
ngh no v thi hn hiu chun tr khi iu ny
c tho thun vi khch hng.
Yu cu ny c th c thay th bng cc qui
nh mang tnh php lut.
5.10.5 Nhn xt v din gii
Khi a ra nhn xt v din gii th PTN phi lp
thnh vn bn v c s a ra nhn xt v
din gii. Cc nhn xt v din gii phi c ghi
r rng nh trong bo co th nghim
Ch thch 1 - Khng nn c s nhm ln nhn xt v
din gii vi gim nh v chng nhn sn phm nh
c cp trong TCVN ISO/IEC 17020 v trong
ISO/IEC Guide 65
Ch thch 2 - Nhn xt v din gii trong bo co th
nghim c th bao gm, nhng khng gii hn cc
im sau:
c)evidence that the measurements are traceable
(see Note 2 in 5.6.2.1.1).
5.10.4.2 The calibration certificate shall relate only
to quantities and the results of functional tests. If a
statement of compliance with a specification is
made, this shall identify which clauses of the
specification are met or not met.
When a statement of compliance with a
specification is made omitting the measurement
results and associated uncertainties, the laboratory
shall record those results and maintain them for
possible future reference.
When statements of compliance are made, the
uncertainty of measurement shall be taken into
account.
5.10.4.3 When an instrument for calibration has
been adjusted or repaired, the calibration results
before and after adjustment or repair, if available,
shall be reported.
5.10.4.4 A calibration certificate (or calibration
label) shall not contain any recommendation on
the calibration interval except where this has been
agreed with the customer. This requirement may
be superseded by legal regulations.
5.10.5 Opinions and interpretations
When opinions and interpretations are included,
the laboratory shall document the basis upon
which the opinions and interpretations have been
made. Opinions and interpretations shall be clearly
marked as such in a test report.
NOTE 1 Opinions and interpretations should not
be confused with inspections and product
certifications as intended in ISO/IEC 17020 and
ISO/IEC Guide 65.
NOTE 2 Opinions and interpretations included in a test
report may comprise, but not be limited to, the following:
-an opinion on the statement of
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- nhn xt v s ph hp/khng ph hp ca cc kt
qu so vi cc yu cu
- vic p ng cc yu cu trong hp ng
- khuyn ngh v cch thc s dng kt qu
- hng dn i vi vic ci tin
Ch thch 3 - Trong nhiu trng hp vic thng bo
cc nhn xt v gii thch bng cch i thoi trc tip
vi khch hng c th l thch hp. S i thoi nh
vy phi c vit thnh vn bn.
5.10.6 Kt qu th nghim v hiu chun nhn
c t nh thu ph
Khi bin bn th nghim c cc kt qu th
nghim do nhng nh thu ph thc hin th cc
kt qu ny phi c ch ra mt cch r rng.
Nh thu ph phi thng bo kt qu th nghim
bng vn bn hoc qua cc phng tin in t.
Nu php hiu chun do nh thu ph thc hin
th nh thu ph phi cp giy chng nhn hiu
chun cho PTN ang hp ng.
5.10.7 Chuyn giao kt qu bng in t
Trong trng hp cc kt qu th nghim hoc
hiu chun c chuyn bng in thoi, telex,
my fax hoc cc phng tin in t hoc in
t khc th cc yu cu ca tiu chun ny phi
c p ng (xem 5.4.7).
5.10.8 Hnh thc bin bn v giy chng nhn
Hnh thc ca bin bn v giy chng nhn phi
c thit k ph hp vi mi loi php th hoc
hiu chun c tin hnh v gim ti a kh
nng hiu sai hoc lm dng.
Ch thch 1 - PTN phi quan tm ti cch trnh by
bo co th nghim v giy chng nhn hiu chun
c bit quan tm ti cch din gii d liu th nghim
hoc hiu chun v lm cho ngi c d tip thu.
Ch thch 2 - Cc tiu phi c tiu chun ho ti
a.
compliance/noncompliance of the results with
requirements;
- fulfilment of contractual requirements;
-recommendations on how to use the results;
- guidance to be used for improvements.
NOTE 3 In many cases it might be appropriate to
communicate the opinions and interpretations by direct
dialogue with the customer. Such dialogue should be
written down.
5.10.6 Testing and calibration results obtained
from subcontractors
When the test report contains results of tests
performed by subcontractors, these results shall
be clearly identified. The subcontractor shall report
the results in writing or electronically.
When a calibration has been subcontracted, the
laboratory performing the work shall issue the
calibration certificate to the contracting laboratory
5.10.7 Electronic transmission of results
In the case of transmission of test or calibration
results by telephone, telex, facsimile or other
electronic or electromagnetic means, the
requirements of this International Standard shall
be met (see also 5.4.7).
5.10.8 Format of reports and certificates
The format shall be designed to accommodate
each type of test or calibration carried out and to
minimize the possibility of misunderstanding or
misuse.
NOTE 1 Attention should be given to the lay-out of the
test report or calibration certificate, especially with
regard to the presentation of the test or calibration data
and ease of assimilation by the reader.
NOTE 2 The headings should be standardized as far as
possible.
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5.10.9 Sa i b sung th nghim hoc giy 5.10.9 Amendments to test reports and calibration
chng nhn hiu chun certificates

Vic sa i b sung ni dung bo co th Material amendments to a test report or calibration

nghim hoc giy chng nhn hiu chun sau khi certificate after issue shall be made only in the
ban hnh ch c thc hin di dng ca form of a further document, or data transfer, which
mt ti liu b sung hoc truyn d liu v cn includes the statement: Supplement to Test
km theo tuyn b: "B sung cho bin bn th Report [or Calibration Certificate], serial number...
nghim [hoc giy chng nhn hiu chun], s [or as otherwise identified], or an equivalent form
xri... [hoc cc nhn dng khc]" hoc hnh thc of wording.
nhn dng tng ng. Vic sa i nh vy
Such amendments shall meet all the requirements
phi p ng c tt c cc yu cu ca tiu
of this International Standard. When it is necessary
chun ny Khi cn ban hnh mt bo co th
to issue a complete new test report or calibration
nghim hoc giy chng nhn hiu chun hon
certificate, this shall be uniquelyidentified and shall
ton mi th bo co v giy chng nhn ny phi
contain a reference to the original that it replaces.
c nhn bit mt cch n nht v phi vin
dn ti bo co v giy chng nhn gc m n
thay th.

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