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

4.1.

T chc

Organization

4.2.

H thng qun l

Management system

4.3.

Kim sot ti liu

Document control

4.3.1

Yu cu chung

General

4.3.2

Ph duyt v ban hnh ti liu

Document approval and issue

4.3.3

Thay i ti liu

Document changes

4.4.

Xem xt cc yu cu, ngh v hp

Review of requests, tenders and contracts

Subcontracting of tests and calibrations

ng
4.5.

Hp ng ph v th nghim v hiu
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

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

chun v ph duyt phng php

Test and calibration methods and method

23

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

Assuring the quality of test and calibration

38

chun
5.9

m bo cht lng kt qu th
nghim v hiu chun

5.10

Bo co kt qu

results
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

Testing and calibration results obtained

44

5.10.6 Kt qa th nghim v hiu chun

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

Format of reports and certificates

44

Amendments to test reports and calibration

44

Hnh thc bin bn v giy chng

nhn

5.10.9

Sa i b xung th nghim hoc

giy chng nhn hiu chun.

cerificate

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

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

thut i vi loi php th v/hoc hiu chun m

competence

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

bodies

the
for

that

recognize

requirements
the

type

for
of

the

technical

tests

and/or

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

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

yu cu ca ISO 9001

management system within which the laboratory

imply

conformity

of

the

quality

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

tiu chun ny v nu PTN c cc t chc cng

laboratories

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
comply

should

be

with

this

facilitated

if

International

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

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

between

laboratories

and

standards and procedures.

other

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

CHUN
1. Phm vi p dng

1 Scope

1.1 Tiu chun ny qui nh cc yu cu chung v

1.1 This International Standard specifies the

nng lc thc hin cc php th v/hoc hiu

general requirements for the competence to carry

chun bao gm c vic ly mu. Tiu chun ny

out tests and/or calibrations, including sampling. It

cp n vic th nghim v hiu chun c thc

covers testing and calibration performed using

hin bng cc phng php tiu chun, khng tiu

standard methods, non-standard methods, and

chun v cc phng php do PTN t xy dng.

laboratory-developed methods.

1.2 Tiu chun ny p dng cho tt c cc t chc

1.2 This International Standard is applicable to all

thc hin vic th nghim v/hoc hiu chun. Cc

organizations performing tests and/or calibrations.

t chc ny bao gm, v d nh cc PTN bn th

These include, for example, first-, second- and

nht, bn th hai, bn th ba v cc PTN m vic

third-party laboratories, and laboratories where

th nghim v/hoc hiu chun l mt phn ca

testing and/or calibration forms part of inspection

hot ng gim nh v chng nhn sn phm.

and product certification.

Tiu chun ny p dng cho tt c cc PTN khng

This International Standard is applicable to all

ph thuc vo s lng nhn vin hay phm vi

laboratories regardless of the number of personnel

hot ng th nghim v/hoc hiu chun. Khi mt

or the extent of the scope of testing and/or

PTN khng thc hin mt hoc nhiu hot ng

calibration activities. When a laboratory does not

c quy nh trong tiu chun ny, nh ly mu

undertake one or more of the activities covered by

v thit k/pht trin cc phng php mi, th cc

this International Standard, such as sampling and

yu cu thuc cc iu khng cn p dng

the design/development of new methods, the

requirements of those clauses do not apply.

1.3 Cc ch thch c a ra lm r ni dung,

1.3 The notes given provide clarification of the text,

cc v d v hng dn. Ch thch ny khng phi

examples and guidance. They do not contain

l cc yu cu v khng to thnh mt phn ca

requirements and do not form an integral part of

tiu chun ny.

this International Standard.

1.4 Tiu chun ny s dng cho cc PTN trong

1.4 This International Standard is for use by

vic xy dng h thng qun l v hot ng k

laboratories

thut, hnh chnh v cht lng. Khch hng ca

system for quality, administrative and technical

PTN, c quan c thm quyn v cc c quan cng

operations.

nhn cng c th s dng tiu chun ny xc

authorities and accreditation bodies may also use it

nhn hoc tha nhn nng lc ca cc PTN. Tiu

in confirming or recognizing the competence of

chun quc t ny khng c s dng l chun

laboratories. This International Standard is not

mc chng nhn PTN.

intended to be used as the basis for certification of

in

developing

Laboratory

their

management

customers,

regulatory

laboratories.
Ch thch 1: Thut ng H thng qun l trong

NOTE 1 The term 'management system' in this

tiu chun ny c ngha l h thng k thut, hnh

International

chnh v cht lng iu hnh hot ng ca mt

administrative and technical systems that govern

PTN.

the operations of a laboratory.

Ch thch 2: Chng nhn mt h thng qun l

NOTE 2 Certification of a management system is

cng thng c gi l ng k.

sometimes also called registration.

1.5 Vic tun th cc yu cu v an ton trong hot

1.5

ng ca cc PTN khng thuc phm vi tiu chun

requirements on the operation of laboratories is not

Standard

Compliance

with

means

regulatory

the

quality,

and

safety

ny.

covered by this International Standard.

1.6 Nu cc phng th nghim v hiu chun tun

1.6 If testing and calibration laboratories comply

th cc yu cu ca tiu chun ny th PTN s hot

with the requirements of this International Standard,

ng theo mt h thng qun l cht lng trong

they will operate a quality management system for

cc hot ng th nghim v hiu chun p ng

their testing and calibration activities that also

c cc yu cu ca ISO 9001. Ph lc A a ra

meets the principles of ISO 9001. Annex A provides

ch dn i chiu tiu chun ny vi ISO 9001. Tiu

nominal cross-references between this International

chun ny cp n cc yu cu nng lc k

Standard

thut m khng cp trong ISO 9001.

Standard

and

ISO

9001.

covers

This

technical

International
competence

requirements that are not covered by ISO 9001.

Ch thch 1 -Cn thit phi gii thch hoc din gii

NOTE 1 It might be necessary to explain or

mt s yu cu trong tiu chun ny m bo

interpret certain requirements in this International

cc yu cu c p dng mt cch nht qun.

Standard to ensure that the requirements are

Hng dn cho vic p dng trong cc lnh vc c

applied in a consistent manner. Guidance for

th, c bit l cho cc c quan cng nhn [xem

establishing

ISO/IEC 17011) c trnh by trong ph lc B.

especially for accreditation bodies (see ISO/IEC

applications

for

specific

fields,

17011) is given in Annex B.

Ch thch 2 -Nu PTN mong mun c cng nhn

NOTE 2 If a laboratory wishes accreditation for part

mt phn hoc tt c cc hot ng th nghim v

or all of its testing and calibration activities, it should

hiu chun th PTN nn chn mt c quan cng

select an accreditation body that operates in

nhn hot ng ph hp vi ISO/IEC 17011.

accordance with ISO/IEC 17011.

2 Tiu chun trch dn

2 Normative references

Cc ti liu vin dn sau l khng th thiu c

The

khi p dng tiu chun ny. i vi ti liu tham

indispensable for the application of this document.

chiu khng r thi gian ban hnh th s p dng

For dated references, only the edition cited applies.

ti liu vin dn (bao gm c cc sa i) c

For undated references, the latest edition of the

ban hnh gn y nht.

referenced document (including any amendments)

following

referenced

documents

are

applies.
ISO 17000, nh gi s ph hp Thut ng

ISO/IEC

chung v nh ngha.

Vocabulary and general principles

VIM, o lng hc. Thut ng chung v c bn

VIM, International vocabulary of basic and general

trong o lng, do BIPM, IEC, IFCC, ISO, IUPAC,

terms in metrology, issued by BIPM, IEC, IFCC,

IUPAP

ISO, IUPAC, IUPAP and OIML

Ch thch -Cc tiu chun, hng dn lin quan

NOTE Further related standards, guides, etc. on

khc... v cc ch ca tiu chun ny c nu

subjects included in this International Standard are

trong danh mc ti liu tham kho

given in the Bibliography.

3 Thut ng v nh ngha

3 Terms and definitions

Cc thut ng v nh ngha trnh by trong

For the purposes of this document, the relevant

ISO/IEC 17000 v VIM -c s dng cho tiu

terms and definitions given in ISO/IEC 17000 and

chun ny.

VIM apply.

Ch thch -Cc nh ngha chung lin quan ti cht

NOTE General definitions related to quality are

lng c trnh by trong ISO 9000 cn ISO/IEC

given in ISO 9000, whereas ISO/IEC 17000 gives

17000 nu ra cc nh ngha c th lin quan n

17000,

Conformity

assessment

definitions specifically related to certification and

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

nh ngha trong ISO 17000 v VIM.

17000 and VIM are preferred.

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.

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.

10

4. Cc yu cu v qun l

Management requirements

4.1 T chc

4.1 Organization

4.1.1 PTN hoc t chc m PTN l mt b phn,

4.1.1 The laboratory or the organization of which it

phi l mt thc th c kh nng chu trch nhim

is part shall be an entity that can be held legally

v mt php l.

responsible.

4.1.2 PTN c trch nhim thc hin cc hot ng

4.1.2 It is the responsibility of the laboratory to

th nghim v hiu chun sao cho p ng c

carry out its testing and calibration activities in

tt c cc yu cu ca tiu chun ny v tho mn

such a way as to meet the requirements of this

yu cu ca khch hng, c quan c thm quyn

International Standard and to satisfy the needs of

hoc cc c quan cng nhn.

the

customer,

the

regulatory

authorities

or

organizations providing recognition.

4.1.3 H thng qun l phi bao qut cc hot

4.1.3 The management system shall cover work

ng c thc hin ti c s c nh ca PTN,

carried out in the laboratorys permanent facilities,

ti hin trng ngoi c s c nh hoc ti c s

at sites away from its permanent facilities, or in

tm thi hay di ng.

associated temporary or mobile facilities.

4.1.4 Nu PTN l b phn ca mt t chc thc

4.1.4 If the laboratory is part of an organization

hin cc hot ng khc vi vic th nghim

performing activities other than testing and/or

v/hoc hiu chun th phi nh r trch nhim

calibration, the responsibilities of key personnel in

ca mi nhn vin ch cht c lin quan hoc c

the organization that have an involvement or

nh hng ti cc hot ng th nghim v/hoc

influence on the testing and/or calibration activities

hiu chun ca PTN nhn bit cc mu thun

of the laboratory shall be defined in order to

tim n v quyn li.

identify potential conflicts of interest.

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.

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.

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.

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 PTN phi:

4.1.5 The laboratory shall

a) c nhn vin qun l v k thut, ngoi cc trch

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

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

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

and
of

improvement
departures

of

the

from

the

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

management and personnel are free from any

hoc bn ngoi v thng mi, ti chnh v mi p

undue internal and external commercial,

lc khc c th nh hng xu n cht lng

financial and other pressures and influences

cng vic ca h;

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

th tc bo v vic lu gi v truyn cc kt

information and proprietary rights, including

qu bng in t;

procedures

for

customers'

protecting

confidential

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

nh tnh trung thc hoc tnh nht qun hot ng

impartiality, judgement or operational integrity;

confidence

in

its

competence,

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,

personnel

who

interrelationships

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)

all

and

qua li ca tt c cc nhn vin qun l, thc hin

g) thc hin vic gim st mt cch tha ng i

of

authority

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

ngi am hiu cc phng php v th tc th

purpose of each test and/or calibration, and

with

methods

and

procedures,

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

h)

have technical management which has overall

chung v cc hot ng k thut v vic cung cp

responsibility for the technical operations and

cc ngun lc cn thit m bo cht lng

the provision of the resources needed to

cc hot ng ca PTN;

ensure the required quality of laboratory

operations;

i) b nhim mt ngi trong PTN lm qun l cht

i)

appoint a member of staff as quality manager

lng (hoc di mt chc danh khc). Ngi

(however named) who, irrespective of other

ny ngoi cc trch nhim v nhim v khc, phi

duties and responsibilities, shall have defined

c trch nhim v quyn hn r rng m bo

responsibility and authority for ensuring that

rng h thng qun l lin quan ti cht lng

the management system related to quality is

lun c thc hin v tun th. Ngi qun l

implemented and followed at all times; the

cht lng phi lin h trc tip vi lnh o cao

quality manager shall have direct access to

nht c thm quyn a ra cc quyt nh v

the highest level of management at which

chnh sch v ngun lc ca PTN.

decisions are made on laboratory policy or

resources;

j) b nhim cc cp ph cho cc chc danh qun

j)

(see Note);

l ch cht (xem ch thch).

k) m bo rng nhn vin PTN nhn thc c

appoint deputies for key managerial personnel

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

qu trnh thng tin thch hp c thit lp trong

appropriate

PTN v c s trao i thng tin v hiu lc ca h

established

thng qun l.

communication

shall

communication
within

the

takes

ensure

that

processes

are

laboratory
place

and

that

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

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

and

instructions

communicated

to,

to

the

extent

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

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,

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:

The

laboratory's

and

shall

management

be

system

reviewed

during

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

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

and

calibration

activities

within

the

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

14

larger

phn ca mt t chc ln th mt s yu t ca

organization, some quality policy elements may

chnh sch cht lng c th c nu trong cc

be in other documents.

ti liu khc.

4.2.3 Lnh o cao nht phi cung cp bng

4.2.3 Top management shall provide evidence of

chng v cam kt i vi vic xy dng, thc hin

commitment

v thng xuyn nng cao hiu lc ca h thng

implementation of the management system and to

qun l.

continually improving its effectiveness.

4.2.4 Lnh o cao nht phi truyn t cho PTN

4.2.4 Top management shall communicate to the

tm quan trng ca vic p ng cc yu cu ca

organization the importance of meeting customer

khch hng cng nh cc yu cu ca php lut

requirements as well as statutory and regulatory

v ch nh.

requirements.

4.2.5 STCL phi bao gm hoc phi vin dn cc

4.2.5 The quality manual shall include or make

th tc h tr k c th tc k thut. STCL phi

reference to the supporting procedures including

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.

of the documentation used in the management

to

the

development

and

system.
4.2.6 Vai tr v trch nhim ca ngi lnh o k

4.2.6 The roles and responsibilities of technical

thut v ngi qun l cht lng, k c cc trch

management and the quality manager, including

nhim m bo s ph hp vi tiu chun ny

their responsibility for ensuring compliance with

phi c xc nh trong s tay cht lng.

this International Standard, shall be defined in the

quality manual.

4.2.7 Lnh o cao nht phi m bo tnh nht

4.2.7 Top management shall ensure that the

qun ca h thng qun l c duy tr khi cc

integrity of the management system is maintained

thay i i vi h thng qun l c hoch nh

when changes to the management system are

v thc hin.

planned and implemented.

4.3 Kim sot ti liu

4.3 Document control

4.3.1 Yu cu chung

4.3.1 General

PTN phi thit lp v duy tr cc th tc kim sot

The laboratory shall establish and maintain

tt c cc ti liu thuc h thng qun l (cc ti

procedures to control all documents that form part

liu ni b hoc c ngun gc t bn ngoi) nh:

of its management system (internally generated or

cc ch nh, tiu chun, ti liu chun ha khc,

from external sources), such as regulations,

phng php th v/hoc hiu chun cng nh

standards, other normative documents, test and/or

cc bn v, phn mm, qui nh k thut, hng

calibration methods, as well as drawings, software,

dn v s tay.

specifications, instructions and manuals.

Ch thch 1 - Trong iu ny "ti liu" c th l

NOTE 1 In this context document could be policy

nhng cng b v chnh sch, cc th tc, qui

statements,

nh k thut, bng hiu chun, s , sch p

calibration tables, charts, text books, posters,

phch, cc thng bo, bn ghi nh, phn mm,

notices, memoranda, software, drawings, plans,

bn v, k hoch... Cc ti liu ny c th c

etc. These may be on various media, whether

procedures,

specifications,

15

nhiu phng thc th hin khc nhau, hoc l

hard copy or electronic, and they may be digital,

bn in giy hoc in t v thng tin c th

analog, photographic or written.

dng k thut s, k thut analog, dng nh hoc

NOTE 2 The control of data related to testing and

ch.

calibration is covered in 5.4.7. The control of

Ch thch 2 -Kim sot d liu lin quan n th

records is covered in 4.13.

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 Document approval and issue

4.3.2.1 Tt c cc ti liu cho cc nhn vin PTN

4.3.2.1 All documents issued to personnel in the

s dng nh l mt phn ca h thng qun l

laboratory as part of the management system shall

phi c ngi c thm quyn xem xt v ph

be reviewed and approved for use by authorized

chun trc khi s dng. PTN phi thit lp mt

personnel prior to issue. A master list or an

danh mc gc hoc mt th tc kim sot ti liu

equivalent document control procedure identifying

tng ng bit c tnh trng ban hnh

the current revision status and distribution of

hin thi, s phn phi ti liu trong h thng

documents in the management system shall be

qun l. Danh mc gc hoc th tc ny phi

established and shall be readily available to

c thit lp v phi lun sn c trnh s

preclude the use of invalid and/or obsolete

dng cc ti liu khng cn hiu lc v/hoc li

documents.

thi.
4.3.2.2 Th tc c xt duyt phi m bo rng:

4.3.2.2 The procedure(s) adopted shall ensure

that:

a) cc bn c ph duyt ca cc ti liu thch

a)

authorized editions of appropriate documents

hp phi lun sn c tt c nhng ni thc hin

are available at all locations where operations

cc hot ng ch yu c tc ng n vn hnh

essential to the effective functioning of the

c hiu lc ca PTN;

laboratory are performed;

b) ti liu c nh k xem xt v, nu cn thit,

b)

documents are periodically reviewed and,

c sa i m bo rng chng tip tc ph

where necessary, revised to ensure continuing

hp v tun th theo cc yu cu c p dng;

suitability and compliance with applicable

requirements;

c) tt c cc ti liu khng cn hiu lc hoc li

c)

invalid or obsolete documents are promptly

thi phi b thu hi tt c cc ni ban hnh hoc

removed from all points of issue or use, or

s dng, hoc bng cch khc nhm m bo

otherwise assured against unintended use;

khng cho s dng li mt cch v tnh;

d) ti liu li thi c lu gi do yu cu php l

d)

obsolete documents retained for either legal or

hoc v mc ch lu li thng tin phi c nh

knowledge preservation purposes are suitably

du thch hp.

marked.

4.3.2.3 Ti liu ca h thng qun l do PTN ban

4.3.2.3 Management system documents generated

hnh phi c nhn bit r rng. Vic nhn bit

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

4.3.3.1 Changes to documents shall be reviewed

ca ti liu phi do chnh b phn thc hin

and approved by the same function that performed

xem xt ban u tin hnh, tr khi c ch nh c

the original review unless specifically designated

bit khc. B phn c ch nh phi c iu kin

otherwise. The designated personnel shall have

tip cn cc thng tin c bn thch hp lm c s

access to pertinent background information upon

cho vic xem xt v ph chun.

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

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

Procedures

shall

be

established

to

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

cu;

b)

the

laboratory

has

the

capability

resources to meet the requirements;

17

and

c) phng php th v/hoc hiu chun thch hp

c)

the appropriate test and/or calibration method

c la chn v c kh nng p ng yu cu

is selected and is capable of meeting the

ca khch hng (xem 5.4.2).

customers' requirements (see 5.4.2).

Bt c s khc bit no gia yu cu hoc mi

Any differences between the request or tender and

thu v hp ng phi c gii quyt trc khi

the contract shall be resolved before any work

bt u cng vic. Mi hp ng phi c c hai

commences. Each contract shall be acceptable

bn PTN v khch hng chp nhn.

both to the laboratory and the customer.

Ch thch 1 - Vic xem xt yu cu, ngh v hp

NOTE 1 The request, tender and contract review

ng phi thc hin mt cch c hiu qu, thc

should be conducted in a practical and efficient

t v phi tnh n tc ng ca cc kha cnh

manner, and the effect of financial, legal and time

thi hn thc hin, tnh php l v ti chnh. i

schedule aspects should be taken into account.

vi khch hng ni b, vic xem xt cc yu cu,

For internal customers, reviews of requests,

mi thu v hp ng c th c thc hin n

tenders and contracts can be performed in a

gin hn.

simplified way.

Ch thch 2 -Vic xem xt nng lc cn m bo

NOTE 2 The review of capability should establish

xc minh c rng PTN c y ngun lc

that the laboratory possesses the necessary

vt cht, con ngi v thng tin, v nhn vin

physical, personnel and information resources,

ca PTN c k nng cng nh chuyn mn cn

and that the laboratory's personnel have the skills

thit thc hin php th v/hoc hiu chun

and expertise necessary for the performance of

cn thc hin. Vic xem xt c th bao gm cc

the tests and/or calibrations in question. The

kt qu tham gia so snh lin phng hoc th

review may also encompass results of earlier

nghim thnh tho trc v/hoc thc hin

participation in interlaboratory comparisons or

cc php th s b hoc cc chng trnh hiu

proficiency testing and/or the running of trial test

chun s dng cc mu hoc cc mu bit

or calibration programmes using samples or

trc gi tr xc nh khng m bo o,

items of known value in order to determine

cc gii hn pht hin, gii hn tin cy...

uncertainties of measurement, limits of detection,

confidence limits, etc.

Ch thch 3 -Mt hp ng c th l bt c tho

NOTE 3 A contract may be any written or oral

thun no bng vn bn hoc bng ming v

agreement to provide a customer with testing

vic cung cp cho khch hng dch v th

and/or calibration services.

nghim v/hoc hiu chun.

4.4.2 H s xem xt, bao gm c mi thay i

4.4.2 Records of reviews, including any significant

quan trng, phi c lu gi. H s cng phi

changes, shall be maintained. Records shall also

lu gi nhng tho lun vi khch hng lin quan

be maintained of pertinent discussions with a

n yu cu ca khch hng hoc kt qu cng

customer relating to the customer's requirements

vic trong thi gian thc hin hp ng.

or the results of the work during the period of

execution of the contract.

Ch thch - i vi vic xem xt cng vic hng

NOTE For review of routine and other simple tasks,

ngy hoc cng vic n gin khc th vic ghi

the date and the identification (e.g. the initials) of

ngy thng v ngi (v d nh k tn) chu trch

the person in the laboratory responsible for

18

nhim tin hnh cng vic trong hp ng c

carrying out the contracted work are considered

coi l ph hp. i vi cc cng vic hng ngy

adequate. For repetitive routine tasks, the review

lp i lp li, yu cu xem xt ny ch cn thc

need be made only at the initial enquiry stage or

hin giai on u tin hoc khi chp nhn hp

on granting of the contract for on-going routine

ng cc cng vic hng ngy c thc hin

work performed under a general agreement with

ng tho thun chung vi khch hng min l

the customer, provided that the customer's

cc yu cu ca khch hng khng thay i. i

requirements

vi cng vic th nghim v/hoc hiu chun

complex or advanced testing and/or calibration

mi, tin tin hn hoc phc tp th PTN cn

tasks, a more comprehensive record should be

phi duy tr mt h s ton din hn.

maintained.

remain

unchanged.

For

new,

4.4.3 Vic xem xt cng phi p dng cho mi

4.4.3 The review shall also cover any work that is

cng vic thuc hp ng ph ca PTN.

subcontracted by the laboratory.

4.4.4 Khch hng phi c thng bo v mi

4.4.4 The customer shall be informed of any

thay i so vi hp ng.

deviation from the contract.

4.4.5 Nu hp ng cn sa i sau khi cng vic

4.4.5 If a contract needs to be amended after work

bt u thc hin th phi lp li qu trnh xem

has commenced, the same contract review

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

shall be communicated to all affected personnel.

quan.
4.5 Hp ng ph v th nghim v hiu

4.5 Subcontracting of tests and calibrations

chun
4.5.1 Khi mt PTN s dng hp ng ph v mt

4.5.1 When a laboratory subcontracts work,

l do ngoi d kin (v d: cng vic qu ti, yu

whether because of unforeseen reasons (e.g.

cu cn c k nng cao hn hoc tm thi khng

workload, need for further expertise or temporary

nng lc) hoc do thng xuyn cn (v d:

incapacity) or on a continuing basis (e.g. through

thng qua hp ng ph, qua i l c nh hoc

permanent subcontracting, agency or franchising

qua tho thun c quyn kinh doanh) th cc

arrangements), this work shall be placed with a

cng vic ny phi c giao. Cho mt nh thu

competent

ph c nng lc thc hin. Nh thu ph c nng

subcontractor is one that, for example, complies

lc, v d, l nh thu ph, ph hp vi tiu chun

with this International Standard for the work in

ny i vi cc cng vic c yu cu.

question.

4.5.2 PTN phi thng bo cho khch hng bng

4.5.2 The laboratory shall advise the customer of

vn bn v tho thun c s dng hp ng ph

the arrangement in writing and, when appropriate,

v khi thch hp phi c c s ng ca

gain the approval of the customer, preferably in

khch hng tt nht l bng vn bn.

writing.

4.5.3 PTN chu trch nhim i vi khch hng v

4.5.3 The laboratory is responsible to the customer

cng vic ca nh thu ph ngoi tr trng hp

for the subcontractors work, except in the case

subcontractor.

competent

19

khch hng hoc c quan php ch c thm

where the customer or a regulatory authority

quyn ch nh nh thu ph cn c s dng.

specifies which subcontractor is to be used.

4.5.4 PTN phi c bn danh sch ng k tt c

4.5.4 The laboratory shall maintain a register of all

cc nh thu ph s dng cho cc php th

subcontractors that it uses for tests and/or

v/hoc hiu chun v phi c h s chng minh

calibrations and a record of the evidence of

cc nh thu ph ph hp vi tiu chun ny i

compliance with this International Standard for the

vi cng vic c yu cu.

work in question.

4.6 Mua dch v v cung cp

4.6 Purchasing services and supplies

4.6.1 PTN phi c chnh sch v th tc v la

4.6.1 The laboratory shall have a policy and

chn v mua cc dch v v cung cp c nh

procedure(s) for the selection and purchasing of

hng n cht lng php th v/hoc hiu

services and supplies it uses that affect the quality

chun. Cc th tc ny phi p dng cho vic

of the tests and/or calibrations. Procedures shall

mua, tip nhn, lu kho thuc th v cc vt liu

exist for the purchase, reception and storage of

tiu th ca PTN lin quan n th nghim v hiu

reagents and laboratory consumable materials

chun.

relevant for the tests and calibrations.

4.6.2 PTN phi m bo rng cung ng, thuc

4.6.2 The laboratory shall ensure that purchased

th v vt liu tiu th c mua c nh hng

supplies and reagents and consumable materials

ti cht lng ca cc php th v/hoc hiu

that affect the quality of tests and/or calibrations

chun s khng c s dng cho n khi chng

are not used until they have been inspected or

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

specifications or requirements defined in the

c quy nh trong cc phng php th

methods

v/hoc hiu chun lin quan. Cc dch v v

concerned. These services and supplies used

hng cung cp c s dng phi tun th theo

shall comply with specified requirements. Records

yu cu qui nh. H s v hot ng kim tra s

of actions taken to check compliance shall be

ph hp phi c lu gi.

maintained.

4.6.3 Ti liu v mua cc vt phm nh hng ti

4.6.3 Purchasing documents for items affecting the

cht lng u ra ca PTN phi bao gm cc d

quality of laboratory output shall contain data

liu m t dch v v ngun cung cp t hng.

describing the services and supplies ordered.

Ti liu v mua phi c xem xt v ph chun

These purchasing documents shall be reviewed

v ni dung k thut trc khi s dng.

and approved for technical content prior to release.

Ch thch -Vic m t c th bao gm chng loi,

for

the

tests

and/or

calibrations

NOTE The description may include type, class,

cp, hng, nhn dng chnh xc, qui nh k

grade,

precise

identification,

specifications,

thut, bn v, hng dn kim tra, s liu k

drawings, inspection instructions, other technical

thut khc bao gm c vic ph chun cc kt

data including approval of test results, the quality

qu th nghim, cht lng c yu cu v tiu

required and the management system standard

chun h thng qun l c p dng to ra

under which they were made.

vt phm.

4.6.4 PTN phi nh gi nh cung ng vt liu tiu

4.6.4 The laboratory shall evaluate suppliers of

20

th, cung cp v dch v ch yu c nh hng

critical consumables, supplies and services which

n cht lng ca th nghim v hiu chun, v

affect the quality of testing and calibration, and

phi v duy tr cc h s nh gi, danh sch nh

shall maintain records of these evaluations and list

cung cp c ph chun.

those approved.

4.7 Dch v i vi khch hng

4.7 Service to the customer

4.7.1 PTN phi sn sng hp tc vi khch hng

4.7.1 The laboratory shall be willing to cooperate

hoc i din ca khch hng lm r cc yu

with customers or their representatives in clarifying

cu ca khch hng v theo di hot ng ca

the customer's request and in monitoring the

PTN c lin quan n cng vic c thc hin

laboratorys performance in relation to the work

nhng phi m bo c tnh bo mt i vi

performed, provided that the laboratory ensures

khch hng khc.

confidentiality to other customers.

Ch thch 1 - S hp tc nu trn c th bao gm:

a) to iu kin cho khch hng hoc i din ca

NOTE 1 Such cooperation may include:

a) providing

the

customer

or

the

customer's

khch hng tip cn nhng ni c lin quan ca

representative reasonable access to relevant areas

PTN chng kin vic thc hin cc php th

of the laboratory for the witnessing of tests and/or

v/hoc hiu chun cho khch hng;

calibrations performed for the customer;

b) vic chun b, ng gi v gi tr cc mu th

b) preparation, packaging, and dispatch of test and/or

v/hoc hiu chun do khch hng yu cu

calibration items needed by the customer for

kim tra xc nhn;

verification purposes.

Ch thch 2 -Khch hng nh gi cao s duy tr

NOTE 2 Customers value the maintenance of good

tt vic trao i thng tin, t vn v hng dn

communication, advice and guidance in technical

nhng vn k thut, kin v din gii da

matters, and opinions and interpretations based

vo kt qu. Vic trao i thng tin vi khch

on results. Communication with the customer,

hng, c bit khi khi lng cng vic nhiu,

especially in large assignments, should be

phi c duy tr trong sut thi gian thc hin

maintained throughout the work. The laboratory

cng vic. PTN phi thng bo cho khch hng

should inform the customer of any delays or

bt c s chm tr hoc c sai lch ln no khi

major deviations in the performance of the tests

thc hin cc php th nghim v/hoc hiu

and/or calibrations.

chun.

4.7.2 PTN phi tm kim cc thng tin phn hi, k

4.7.2 The laboratory shall seek feedback, both

c tch cc v tiu cc, t khch hng. Cc thng

positive and negative, from its customers. The

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

the management system, testing and calibration

nghim, hiu chun v phc v i vi khch

activities and customer service.

hng.
Ch thch Cc v d v cc loi phn hi bao gm

NOTE Examples of the types of feedback include

kho st s tha mn ca khch hng v xem

customer satisfaction surveys and review of test

xt cc bo co th nghim/hiu chun cng vi

or calibration reports with customers.

khch hng.

21

4.8 Phn nn

4.8 Complaints

PTN phi c chnh sch v th tc gii quyt

The laboratory shall have a policy and procedure

cc phn nn ca khch hng hoc cc bn khc.

for the resolution of complaints received from

PTN phi lu gi h s ca tt c cc phn nn

customers or other parties. Records shall be

v cc ln iu tra cng nhhnh ng khc phc

maintained

do PTN tin hnh (xem 4.11).

investigations and corrective actions taken by the

of

all

complaints

and

of

the

laboratory (see also 4.11).

4.9 Kim sot vic th nghim v/hoc hiu

4.9 Control of nonconforming testing and/or

chun khng ph hp

calibration work

4.9.1 PTN phi c chnh sch v p dng th tc

4.9.1 The laboratory shall have a policy and

khi c bt c cc kha cnh v kt qu no ca

procedures that shall be implemented when any

vic th nghim v/hoc hiu chun, hoc kt qu

aspect of its testing and/or calibration work, or the

ca cng vic khng ph hp vi cc th tc ca

results of this work, do not conform to its own

PTN hoc yu cu tho thun vi khch hng.

procedures or the agreed requirements of the

Chnh sch v th tc ny phi m bo:

customer. The policy and procedures shall ensure

that:

a) n nh trch nhim v quyn hn qun l vic

a)

the responsibilities and authorities for the

khng ph hp v xc nh cc hnh ng (bao

management of nonconforming work are

gm c: tm dng cng vic, gi li bo co th

designated and actions (including halting of

nghim v giy chng nhn hiu chun, khi cn

work and withholding of test reports and

thit) khi xc nh c cng vic khng ph hp;

calibration certificates, as necessary) are

defined and taken when nonconforming work
is identified;

b) thc hin nh gi mc cng vic khng

b)

nonconforming work is made;

ph hp;
c) thc hin ngay s khc phc cng vi mi

an evaluation of the significance of the

c)

correction is taken immediately, together with

quyt nh v kh nng chp nhn cng vic

any decision about the acceptability of the

khng ph hp;

nonconforming work;

d) PTN phi thng bo cho khch hng v thu hi

d)

work is recalled;

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.

where necessary, the customer is notified and

e)

the

responsibility

for

authorizing

resumption of work is defined.

22

the

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

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

nhn hiu chun, vic xem xt ca lnh o v

reviews and internal or external audits.

of

consumable

certificate

materials,

checking,

staff

management

cc cuc nh gi ni b hoc bn ngoi.

4.9.2 Khi vic nh gi ch ra rng cng vic

4.9.2 Where the evaluation indicates that the

khng ph hp c th li xy ra hoc c nghi ng

nonconforming work could recur or that there is

v s ph hp ca cc hot ng so vi cc chnh

doubt about the compliance of the laboratory's

sch v cc th tc ca PTN phi thc hin ngay

operations with its own policies and procedures,

th tc hnh ng khc phc nu 4.11.

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

The laboratory shall continually improve the

thng qun l thng qua vic s dng chnh sch

effectiveness of its management system through

cht lng, cc mc tiu cht lng, cc kt qu

the use of the quality policy, quality objectives,

nh gi, phn tch d liu, cc hnh ng khc

audit results, analysis of data, corrective and

phc, phng nga v xem xt ca lnh o.

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

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

and

or

shall

technical

designate

appropriate

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

thng tin phn hi t khch hng v t gim st

feedback

nhn vin.

observations.

external

audits,

from

management

customers

and

23

reviews,

from

staff

4.11.2 Phn tch nguyn nhn

4.11.2 Cause analysis

Th tc v hnh ng khc phc phi c bt

The procedure for corrective action shall start with

u bng mt cuc iu tra xc nh cc

an investigation to determine the root cause(s) of

nguyn nhn chnh ca vn .

the problem.

Ch thch -Phn tch nguyn nhn l phn chnh v

NOTE Cause analysis is the key and sometimes the

i khi l phn kh nht trong th tc v hnh

most difficult part in the corrective action

ng khc phc. Thng thng nguyn nhn

procedure. Often the root cause is not obvious

chnh li khng r rng v v th i hi cn phn

and thus a careful analysis of all potential causes

tch cn thn tt c cc nguyn nhn tim n c

of the problem is required. Potential causes could

th xy ra. Cc nguyn nhn tim n c th bao

include customer requirements, the samples,

gm: mu, cc yu cu ca khch hng, qui nh

sample specifications, methods and procedures,

k thut v mu, phng php v th tc, tay

staff

ngh v o to nhn vin, vt liu tiu th hoc

equipment and its calibration.

skills

and

training,

consumables,

or

thit b v vic hiu chun thit b.

4.11.3 La chn v thc hin hnh ng khc

4.11.3

Selection

and

implementation

of

phc

corrective actions

Khi cn phi c hnh ng khc phc th PTN

Where corrective action is needed, the laboratory

phi xc nh cc hnh ng khc phc c th c.

shall identify potential corrective actions. It shall

PTN phi la chn v thc hin hnh ng khc

select and implement the action(s) most likely to

phc c nhiu kh nng nht loi tr vn tn

eliminate the problem and to prevent recurrence.

ti v ngn chn vn ti din.

Cc hnh ng khc phc phi c xem xt

Corrective actions shall be to a degree appropriate

tng xng vi mc quan trng v s nguy

to the magnitude and the risk of the problem.

him ca vn .
PTN phi lp vn bn v p dng mi thay i

The laboratory shall document and implement any

c yu cu xut pht t vic iu tra nghin

required changes resulting from corrective action

cu v hnh ng khc phc.

investigations.

4.11.4 Theo di hnh ng khc phc

4.11.4 Monitoring of corrective actions

PTN phi theo di kt qu m bo hnh ng

The laboratory shall monitor the results to ensure

khc phc thc hin l c hiu lc.

that the corrective actions taken have been

effective.

4.11.5 nh gi b sung

4.11.5 Additional audits

Khi pht hin c s khng ph hp hoc sai khc

Where the identification of nonconformities or

gy nghi ng v s ph hp ca PTN vi chnh

departures casts doubts on the laboratory's

sch v th tc, hoc nghi ng v s ph hp ca

compliance with its own policies and procedures,

24

PTN vi tiu chun ny th PTN phi m bo

or on its compliance with this International

rng cc lnh vc hot ng tng ng phi c

Standard, the laboratory shall ensure that the

nh gi ph hp vi 4.14 cng sm cng tt.

appropriate areas of activity are audited in

accordance with 4.14 as soon as possible.

Ch thch -Vic nh gi b sung nh th thng

NOTE Such additional audits often follow the

din ra tip theo sau vic thc hin hnh ng

implementation of the corrective actions to

khc phc xc nhn hiu qu ca hnh ng

confirm their effectiveness. An additional audit

ny. Ch cn c nh gi b sung khi pht hin ra

should be necessary only when a serious issue

vn nghim trng hoc ri ro i vi cng

or risk to the business is identified.

vic.

4.12 Hnh ng phng nga

4.12 Preventive action

4.12.1 Nhng ci tin cn thit v ngun gc tim

4.12.1

tng ca s khng ph hp v k thut hoc h

sources of nonconformities, either technical or

thng qun l phi c xc nh. Khi cc c hi

concerning the management system, shall be

ci tin c pht hin hoc nu hnh ng

identified. When improvement opportunities are

phng nga l cn thit th phi xy dng thc

identified or if preventive action is required, action

hin v theo di cc k hoch hnh ng, gim

plans shall be developed, implemented and

kh nng c th xy ra s khng ph hp v tn

monitored

dng c hi ci tin.

occurrence of such nonconformities and to take

Needed

to

improvements

reduce

the

and

likelihood

potential

of

the

advantage of the opportunities for improvement.

4.12.2 Th tc v hnh ng phng nga phi bao

4.12.2 Procedures for preventive actions shall

gm cc xut hnh ng v kim sot m

include the initiation of such actions and the

bo cc hnh ng ny c hiu lc.

application of controls to ensure that they are

effective.

Ch thch 1 -Hnh ng phng nga l mt qu

NOTE 1 Preventive action is a pro-active process to

trnh thin v ch ng xc nh cc c hi ci

identify opportunities for improvement rather than

tin hn l s phn ng li vn pht sinh hoc

a reaction to the identification of problems or

phn nn;

complaints.

Ch thch 2 -Ngoi vic xem xt cc th tc hot

NOTE 2 Apart from the review of the operational

ng, hnh ng phng nga c th i hi vic

procedures, the preventive action might involve

phn tch d liu gm phn tch cc xu hng, ri

analysis of data, including trend and risk

ro v kt qu th nghim thnh tho.

analyses and proficiency-testing results.

4.13 Kim sot h s

4.13 Control of records

4.13.1 Yu cu chung

4.13.1 General

4.13.1.1 PTN phi thit lp v duy tr cc th tc

4.13.1.1

nhn bit, tp hp, nh s, tip cn, lp file

maintain procedures for identification, collection,

(tp), lu tr, duy tr v thanh l cc h s cht

indexing, access, filing, storage, maintenance and

lng v k thut. H s cht lng phi bao gm

disposal of quality and technical records. Quality

The

laboratory

shall

establish

25

and

cc bo co nh gi ni b v xem xt ca lnh

records shall include reports from internal audits

o cng nh h s ca cc hot ng phng

and management reviews as well as records of

nga v hnh ng khc phc.

corrective and preventive actions.

4.13.1.2 Tt c cc h s phi r rng, phi c

4.13.1.2 All records shall be legible and shall be

bo qun v c lu gi theo cch sao cho c

stored and retained in such a way that they are

th d dng truy tm v c lu gi trong mt

readily retrievable in facilities that provide a

mi trng thch hp ngn chn h hng hoc

suitable environment to prevent damage or

xung cp cng nh phng nga mt mt. Thi

deterioration and to prevent loss. Retention times

gian lu gi cc h s phi c quy nh.

of records shall be established.

Ch thch -Cc h s c th l bt c phng

NOTE Records may be in any media, such as hard

thc no v d bn in hoc bn lu in t.

copy or electronic media.

4.13.1.3 Tt c cc h s phi c lu gi an

4.13.1.3 All records shall be held secure and in

ton v m bo tnh bo mt.

confidence.

4.13.1.4 PTN phi c cc th tc bo v v sao

4.13.1.4 The laboratory shall have procedures to

li h s lu gi trong my tnh v ngn nga vic

protect and back-up records stored electronically

truy cp khng c php hoc sa i h s

and

ny.

amendment of these records.

4.13.2 H s k thut

4.13.2 Technical records

4.13.2.1 PTN phi lu gi h s ca cc quan

4.13.2.1 The laboratory shall retain records of

trc gc, s liu x l v thng tin cn thit

original observations, derived data and sufficient

thit lp cuc nh gi, h s hiu chun, h s

information to establish an audit trail, calibration

nhn vin v mt bn sao ca mi bo co th

records, staff records and a copy of each test

nghim hoc giy chng nhn hiu chun ban

report or calibration certificate issued, for a defined

hnh trong mt thi gian nht nh. H s i vi

period. The records for each test or calibration

mi php th hoc hiu chun phi lu gi y

shall contain sufficient information to facilitate, if

cc thng tin nu c th to iu kin nhn bit

possible, identification of factors affecting the

cc yu t nh hng n khng m bo o

uncertainty and to enable the test or calibration to

to iu kin cho cc php th v hiu chun

be repeated under conditions as close as possible

c lp li trong iu kin gn vi iu kin ban

to the original. The records shall include the

u nht. Cc h s phi bao gm c du hiu

identity of personnel responsible for the sampling,

nhn bit ngi chu trch nhim ly mu, thc

performance of each test and/or calibration and

hin tng php th v/hoc hiu chun v ngi

checking of results.

to

prevent

unauthorized

access

to

or

kim tra kt qu.

Ch thch 1 -Trong mt s lnh vc nht nh vic

NOTE 1 In certain fields it may be impossible or

lu gi cc h s ca tt c cc quan trc gc c

impractical to retain records of all original

th khng thc hin c hoc khng thc t.

observations.

26

Ch thch 2 -H s k thut l tp hp d liu (xem

NOTE 2 Technical records are accumulations of

5.4.7) v thng tin c c khi thc hin cc

data (see 5.4.7) and information which result

php th v/hoc hiu chun v ch ra liu thng

from carrying out tests and/or calibrations and

s ca qu trnh v cht lng qui nh c t

which indicate whether specified quality or

c hay khng. H s k thut c th bao gm

process parameters are achieved. They may

cc biu mu, hp ng, phiu lm vic, s ghi

include forms, contracts, work sheets, work

chp, t ri kim tra, s ghi chp cng vic,

books, check sheets, work notes, control graphs,

th kim sot, bin bn v giy chng nhn hiu

external and internal test reports and calibration

chun ni b v bn ngoi, lu , cng vn v

certificates,

thng tin phn hi ca khch hng.

feedback.

customers'

notes,

papers

and

4.13.2.2 Cc quan trc, d liu v vic tnh ton

4.13.2.2 Observations, data and calculations shall

phi thng xuyn c ghi li khi thc hin v

be recorded at the time they are made and shall

phi phn bit c theo cng vic c th.

be identifiable to the specific task.

4.13.2.3 Khi trong cc h s c sai li, phi gch

4.13.2.3 When mistakes occur in records, each

ln sai li , khng c ty xo, lm cho kh

mistake shall be crossed out, not erased, made

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

alongside. All such alterations to records shall be

chnh ngi sa cha k xc nhn hoc vit tt

signed or initialled by the person making the

tn. Trong trng hp h s c lu gi trong

correction.

my tnh, phi c bin php tng xng trnh

electronically, equivalent measures shall be taken

mt mt hoc thay i s liu gc.

to avoid loss or change of original data.

4.14 nh gi ni b

4.14 Internal audits

4.14.1 PTN phi nh k thc hin nh gi ni b

4.14.1 The laboratory shall periodically, and in

cc hot ng ca PTN tun th mt k hoch v

accordance with a predetermined schedule and

th tc xc nh nhm kim tra xc nhn xem

procedure, conduct internal audits of its activities

cc hot ng ca PTN cn tip tc tun th cc

to verify that its operations continue to comply with

yu cu ca h thng qun l v ca tiu chun

the requirements of the management system and

ny hay khng. Chng trnh nh gi ni b phi

this International Standard. The internal audit

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

management system, including the testing and/or

hiu chun. Ngi ph trch cht lng c trch

calibration activities. It is the responsibility of the

nhim lp k hoch v t chc nh gi theo k

quality manager to plan and organize audits as

hoch v theo yu cu ca lnh o. Vic nh

required by the schedule and requested by

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

trained and qualified personnel who are, wherever

lc cho php, nhng ngi ny phi c lp vi

resources permit, independent of the activity to be

hot ng c nh gi.

audited.

Ch thch - Chu trnh nh gi ni b thng thng

NOTE The cycle for internal auditing should normally be

c hon tt trong mt nm.

completed in one year.

In

the

case

of

records

27

stored

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

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.

of

the

operations

or

on

the

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

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

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.

In

accordance

calibration

with

activities

predetermined

to

ensure

their

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

Kt qu ca nh gi ni b va qua;

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

from

managerial

and

supervisory

personnel;

proficiency tests;

Cc thay i v khi lng, loi hnh cng

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
o thng l 12 thng mt ln.

NOTE

typical

period

for

conducting

management review is once every 12 months.

28

Ch thch 2 -Cc kt qu ny l c s cho h thng

NOTE 2 Results should feed into the laboratory

hoch nh ca PTN v phi bao gm mc ch,

planning system and should include the goals,

mc tiu v k hoch hnh ng trong nm ti.

objectives and action plans for the coming year.

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.

NOTE

management

review

includes

consideration of related subjects at regular

management meetings.

4.15.2 Phi ghi li mi pht hin t cuc xem xt

4.15.2 Findings from management reviews and the

ca lnh o v cc hot ng pht sinh t cuc

actions that arise from them shall be recorded. The

xem xt ny. Lnh o phi m bo sao cho cc

management shall ensure that those actions are

hot ng ny thc hin theo tin thi gian

carried out within an appropriate and agreed

thch hp v c tho thun.

timescale.

5.Cc yu cu k thut

5 .Technical requirements

5.1.Yu cu chung

5.1 General

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:

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:

-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).

-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 Mc m cc yu t ni trn gp phn to

5.1.2 The extent to which the factors contribute to

ra khng m bo o tng hp c s khc

the total uncertainty of measurement differs

nhau ng k gia cc (loi) php th v cc

considerably between (types of) tests and between

(loi) php hiu chun. PTN phi tnh n cc yu

(types of) calibrations. The laboratory shall take

t ny khi xy dng cc phng php v th tc

account of these factors in developing test and

th nghim v hiu chun, vic o to v trnh

calibration methods and procedures, in the training

ca nhn vin cng nh vic la chn v hiu

and qualification of personnel, and in the selection

chun thit b m PTN s dng.

and calibration of the equipment it uses.

5.2 Nhn s

5.2 Personnel

5.2.1 Lnh o PTN phi m bo nng lc ca

5.2.1 The laboratory management shall ensure the

tt c nhng ngi vn hnh cc thit b c th,

competence of all who operate specific equipment,

nhng ngi thc hin th nghim, hiu chun,

perform tests and/or calibrations, evaluate results,

nh gi kt qu v k duyt bo co th nghim

and sign test reports and calibration certificates.

29

v giy chng nhn hiu chun. Khi PTN s dng

When using staff who are undergoing training,

nhn vin ang c o to th phi c s gim

appropriate

st thch hp. Cc nhn vin thc hin cc nhim

Personnel performing specific tasks shall be

v c th phi l

qualified on the basis of appropriate education,

ngi c trnh da trn c s gio dc, o

to, kinh nghim thch hp v/hoc th hin c

supervision

shall

be

provided.

training, experience and/or demonstrated skills, as

required.

cc k nng theo yu cu.

Ch thch 1 - Trong mt s lnh vc k thut (v d: th

NOTE 1 In some technical areas (e.g. non-destructive

nghim khng ph hu) i hi nhng ngi thc hin

testing) it may be required that the personnel performing

cc nhim v c th phi l nhng ngi c chng

certain tasks hold personnel certification. The laboratory

nhn hnh ngh. PTN phi chu trch nhim p ng

is

cc yu cu cn chng nhn hnh ngh. Cc yu cu

certification

v chng nhn hnh ngh c th l bt buc k c cc

personnel certification might be regulatory, included in

tiu chun v lnh vc k thut c th hoc do khch

the standards for the specific technical field, or required

hng yu cu...

by the customer.

Ch thch 2 - Nhn vin chu trch nhim v cc nhn

NOTE 2 The personnel responsible for the opinions and

xt v din gii trong bo co th nghim phi c trnh

interpretation included in test reports should, in addition

, 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

and satisfactory knowledge of the testing carried out,

c:

also have:

- kin thc cn c v cng ngh thch hp ch to

-relevant knowledge of the technology used for the

cc vt phm, vt liu, cc sn phm...c th hoc

manufacturing of the items, materials, products, etc.

cch thc s dng hoc nh s dng cc mu, vt liu,

tested, or the way they are used or intended to be used,

cc sn phm s dng v phi bit v cc khim

and of the defects or degradations which may occur

khuyt v s gim gi tr c th xy ra trong khi a vo

during or in service;

s dng;
-

kin thc v cc yu cu chung do lut php v cc

tiu chun qui nh;

responsible

for

fulfilling

requirements.

specified

The

personnel

requirements

for

-knowledge of the general requirements expressed in

the legislation and standards; and
-an understanding of the significance of deviations

-hiu bit v ngha quan trng ca nhng sai lch

found with regard to the normal use of the items,

c pht hin lin quan n vic s dng bnh thng

materials, products, etc. concerned.

cc i tng, vt liu, sn phm...

5.22 Lnh o PTN phi xy dng mc tiu v

5.2.2 The management of the laboratory shall

hun luyn, o to v k nng ca nhn vin

formulate the goals with respect to the education,

PTN. PTN phi c chnh sch v th tc xc

training and skills of the laboratory personnel. The

nh nhu cu o to v vic t chc o to cho

laboratory shall have a policy and procedures for

nhn vin. Chng trnh o to phi ph hp

identifying training needs and providing training of

vi cc nhim v hin ti v tng lai PTN.

personnel. The training programme shall be

relevant to the present and anticipated tasks of the

Hiu qu ca hot ng o to nn c nh
laboratory. The effectiveness of the training
gi
actions taken shall be evaluated.

30

5.2.3 PTN phi s dng nhng ngi lm vic di

5.2.3 The laboratory shall use personnel who are

hn hoc hp ng vi PTN. Khi s dng nhn

employed by, or under contract to, the laboratory.

vin k hp ng, nhn vin h tr chnh v nhn

Where contracted and additional technical and key

vin k thut b sung, PTN phi m bo nhng

support personnel are used, the laboratory shall

nhn vin ny c gim st, c nng lc v

ensure that such personnel are supervised and

nhng ngi ny lm vic ph hp vi h thng

competent and that they work in accordance with

qun l ca PTN.

the laboratory's management system.

5.2.4 PTN phi duy tr bn m t cng vic hin ti

5.2.4 The laboratory shall maintain current job

ca ngi qun l, nhn vin k thut v nhn vin

descriptions for managerial, technical and key

h tr chnh tham gia th nghim v/hoc hiu

support

chun.

calibrations.

Ch thch - Bn m t cng vic c xy dng bng

NOTE Job descriptions can be defined in many ways.

nhiu cch thc. Ti thiu cc thng tin sau phi c

As a minimum, the following should be defined:

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;

personnel

involved

in

tests

and/or

- 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

- trch nhim v vic bo co v din gii;

interpretations;

- trch nhim lin quan n sa i, trin khai v ph

- the responsibilities with respect to method modification

duyt cc phng php mi;

and development and validation of new methods;

- yu cu v nng lc chuyn su v kinh nghim;

- expertise and experience required;

- trnh v chng trnh o to;

- qualifications and training programmes;

- trch nhim v qun l.

- managerial duties.

5.2.5 Lnh o phi giao trch nhim c th cho

5.2.5 The management shall authorize specific

ngi thc hin vic ly mu, th nghim v/hoc

personnel to perform particular types of sampling,

hiu chun, v ngi cp giy chng nhn th

test and/or calibration, to issue test reports and

nghim v/hoc hiu chun, ngia ra cc

calibration certificates, to give opinions and

nhn xt v din gii v nhng ngi vn hnh

interpretations and to operate particular types of

cc thit b c bit. PTN phi duy tr h s v

equipment. The laboratory shall maintain records

quyn hn, nng lc, hc vn trnh chuyn

of the relevant authorization(s), competence,

mn, k nng v kinh nghim thch hp ca tt c

educational

cc nhn vin k thut k c nhn vin hp ng.

training, skills and experience of all technical

Thng tin phi lun sn c v phi ghi ngy giao

personnel, including contracted personnel. This

trch nhim v/hoc ngy xc nhn nng lc.

information shall be readily available and shall

and

professional

qualifications,

include the date on which authorization and/or

competence is confirmed.
5.3 Tin nghi v iu kin mi trng

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
khng nh hng n kt qu hoc nh hng
bt li n cht lng ca cc php o no. PTN
phi c bit quan tm khi ly mu,th nghim
v/hoc hiu chun thc hin ti v tr khc vi v
tr c nh ca PTN. PTN phi lp thnh vn bn
cc yu cu k thut v tin nghi v iu kin mi
trng c th nh hng n kt qu th nghim
v/ hoc hiu chun.

The laboratory shall ensure that the environmental

conditions

do

not

invalidate

the

results

or

adversely affect the required quality of any

measurement. Particular care shall be taken when
sampling

and

tests

and/or

calibrations

are

undertaken at sites other than a permanent

laboratory facility. The technical requirements for
accommodation and environmental conditions that
can affect the results of tests and calibrations shall
be documented.

5.3.2 PTN phi gim st, kim sot v ghi chp

5.3.2 The laboratory shall monitor, control and

cc iu kin mi trng theo yu cu ca qui

record environmental conditions as required by the

nh k thut, cc phng php v th tc lin

relevant specifications, methods and procedures

quan hoc ni cc iu kin mi trng c th

or where they influence the quality of the results.

nh hng ti cht lng kt qu. V d, PTN

Due attention shall be paid, for example, to

phi quan tm n: v trng sinh hc, bi, nhiu

biological

in t, bc x, m, ngun cung cp in,

disturbances, radiation, humidity, electrical supply,

nhit v mc n v rung thch hp vi cc hot

temperature, and sound and vibration levels, as

ng k thut lin quan. Phi dng ngay vic th

appropriate to the technical activities concerned.

nghim v hiu chun khi cc iu kin mi

Tests and calibrations shall be stopped when the

trng xu nh hng n kt qu ca php th

environmental conditions jeopardize the results of

nghim v/hoc hiu chun.

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

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

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

c bit khi cn thit.

procedures shall be prepared where necessary.

of

sterility,

areas

control

in

dust,

in

based

the

electromagnetic

which

on

there

its

laboratory.

32

are

particular

Special

5.4 Phng php th nghim v hiu chun v

5.4 Test and calibration methods and method

ph duyt phng php

validation

5.4.1 Yu cu chung

5.4.1 General

PTN phi s dng cc phng php v cc th

The laboratory shall use appropriate methods and

tc thch hp cho tt c php th nghim v/hoc

procedures for all tests and/or calibrations within

hiu chun trong phm vi ca PTN. iu ny bao

its scope. These include sampling, handling,

gm vic ly mu, bo qun, vn chuyn, lu gi

transport, storage and preparation of items to be

v chun b cc mu th nghim v/hoc hiu

tested and/or calibrated, and, where appropriate,

chun, v khi thch hp, xc nh khng m

an estimation of the measurement uncertainty as

bo o cng nh p dng k thut thng k

well as statistical techniques for analysis of test

phn tch d liu th nghim v/hoc hiu chun.

and/or calibration data.

PTN phi c cc hng dn s dng v vn hnh

The laboratory shall have instructions on the use

cho tt c thit b lin quan cng nh hng dn

and operation of all relevant equipment, and on the

v bo qun, chun b mu th nghim v/hoc

handling and preparation of items for testing

hiu chun hoc hng dn v c hai vic m nu

and/or calibration, or both, where the absence of

thiu nhng hng dn ny c th lm nh hng

such instructions could jeopardize the results of

n kt qu th nghim v/hoc hiu chun. Tt

tests

c hng dn, tiu chun, s tay v cc d liu

standards, manuals and reference data relevant to

tham kho lin quan n cng vic ca PTN phi

the work of the laboratory shall be kept up to date

duy tr cp nht v lun sn c cho cc nhn vin

and shall be made readily available to personnel

s dng (xem 4.3). Cc thay i so vi phng

(see 4.3). Deviation from test and calibration

php th nghim v/hoc hiu chun ch c p

methods shall occur only if the deviation has been

dng khi cc thay i ny c lp thnh vn

documented, technically justified, authorized, and

bn, c chng minh v mt k thut l ng,

accepted by the customer.

and/or

calibrations.

All

instructions,

c php s dng v c khch hng chp

nhn.
Ch thch - Cc tiu chun quc gia, khu vc hoc

NOTE International, regional or national standards or

quc t hoc cc qui nh k thut khc c tha nhn

other recognized specifications that contain sufficient

bao gm thng tin y v sc tch v cch thc

and concise information on how to perform the tests

thc hin cc php th v/hoc hiu chun th khng

and/or calibrations do not need to be supplemented or

cn phi b sung hoc vit li thnh th tc ni b nu

rewritten as internal procedures if these standards are

tiu chun ban hnh c th s dng c cho cc nhn

written in a way that they can be used as published by

vin ca PTN. C th cn cung cp ti liu b sung cho

the operating staff in a laboratory. It may be necessary

cc bc khng bt buc trong phng php hoc cc

to provide additional documentation for optional steps in

chi tit thm vo.

the method or additional details.

5.4.2 La chn phng php

5.4.2 Selection of methods

PTN phi s dng cc phng php th nghim

The laboratory shall use test and/or calibration

v/hoc hiu chun, k c phng php ly mu,

methods, including methods for sampling, which

p ng theo yu cu ca khch hng v thch

meet the needs of the customer and which are

hp i vi php th v/hoc hiu chun m PTN

appropriate for the tests and/or calibrations it

thc hin;uu tin s dng phng php c

undertakes. Methods published in international,

33

ban hnh di hnh thc l tiu chun quc t,

regional or national standards shall preferably be

quc gia hoc khu vc. PTN phi m bo s

used. The laboratory shall ensure that it uses the

dng bn tiu chun mi nht tr khi bn tiu

latest valid edition of a standard unless it is not

chun ny khng ph hp hoc khng th thc

appropriate or possible to do so. When necessary,

hin. Khi cn thit, tiu chun phi c b sung

the standard shall be supplemented with additional

thm cc chi tit m bo p dng nht qun.

details to ensure consistent application.

Khi khch hng khng xc nh r phng php

When the customer does not specify the method to

s dng th PTN phi la chn cc phng php

be used, the laboratory shall select appropriate

thch hp c cng b trong tiu chun quc

methods that have been published either in

t, quc gia hoc khu vc, hoc c cc t chc

international, regional or national standards, or by

k thut c uy tn ban hnh, hoc trong cc tp ch,

reputable technical organizations, or in relevant

bi bo khoa hc thch hp hoc c nh sn

scientific texts or journals, or as specified by the

xut qui nh. Cc phng php do PTN thit lp

manufacturer

hoc chp nhn cng c th c s dng nu

developed methods or methods adopted by the

cc phng php ny l thch hp vi mc ch

laboratory may also be used if they are appropriate

s dng v nu phng php ny c ph

for the intended use and if they are validated. The

duyt. Khch hng phi c thng bo v

customer shall be informed as to the method

phng php s dng. PTN phi khng nh c

chosen. The laboratory shall confirm that it can

th p dng ng phng php tiu chun trc

properly

khi bt u th nghim v/hoc hiu chun. Nu

introducing the tests or calibrations. If the standard

phng php tiu chun thay i th PTN phi lp

method

li vic xc nhn.

repeated.

PTN phi thng bo cho khch hng khi cc

The laboratory shall inform the customer when the

phng php do khch hng yu cu l khng

method proposed by the customer is considered to

ph hp hoc li thi.

be inappropriate or out of date.

5.4.3 Cc phng php do PTN xy dng

5.4.3 Laboratory-developed methods

Vic a cc phng php th v hiu chun do

The introduction of test and calibration methods

PTN xy dng s dng ni b phi l mt hot

developed by the laboratory for its own use shall

ng c k hoch v phi phn cng cho nhn

be a planned activity and shall be assigned to

vin c nng lc, c trang b cc ngun lc cn

qualified

thit.

resources.

Cc k hoch phi c cp nht trong qu trnh

Plans shall be updated as development proceeds

xy dng v PTN phi m bo vic trao i thng

and

tin c hiu qu gia tt c cc nhn vin tham gia.

personnel involved shall be ensured.

5.4.4 Cc phng php khng tiu chun

5.4.4 Non-standard methods

Khi cn s dng cc phng php khng phi l

When it is necessary to use methods not covered

phng php tiu chun, cc phng php

by standard methods, these shall be subject to

nyphi c tho thun vi khch hng v phi

agreement with the customer and shall include a

c cc qui nh r rng v yu cu ca khch

clear specification of the customer's requirements

hng v mc ch ca php th v/hoc hiu

and the purpose of the test and/or calibration. The

chun. Phng php c xy dng phi c

method developed shall have been validated

ph duyt thch hp trc khi s dng.

appropriately before use.

of

the

operate
changes,

personnel

effective

equipment.

standard
the

Laboratory-

methods

confirmation

equipped

with

communication

before

shall

adequate

amongst

34

be

all

Ch

thch

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;
b) phm vi p dng;
c) m t chng loi mu c th nghim hoc hiu
chun;
d) cc thng s, cc i lng v khong phi xc nh;
e) dng c v thit b k c cc yu cu v tnh nng k
thut;

a) appropriate identification;
b) scope;
c)description of the type of item to be tested or
calibrated;
d)parameters

or

quantities

and

ranges

to

be

determined;
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

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;

and

-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

-checks to be made before the work is started,

v, khi c yu cu, thit b phi c hiu chun v

hiu chnh trc mi ln s dng,

any

-checks that the equipment is working properly and,

where required, calibration and adjustment of the

- phng php ghi li cc d liu quan trc v kt qu;

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

i)criteria and/or requirements for approval/rejection;

trnh by d liu;
k) khng m bo hoc phng php c lng
khng m bo o.

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

v cung cp bng chng khch quan rng cc yu

examination

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

Validation
and

is
the

the

confirmation

provision

of

35

by

objective

tiu chun, cc phng php do PTN xy dng

methods, laboratory-designed/developed methods,

hoc thit k, cc phng php tiu chun c

standard methods used outside their intended

s dng nm ngoi phm vi d kin v vic m

scope, and amplifications and modifications of

rng cng nh thay i cc phng php tiu

standard methods to confirm that the methods are

chun xc nhn rng phng php ny l ph

fit for the intended use. The validation shall be as

hp vi mc ch s dng d kin. Vic ph duyt

extensive as is necessary to meet the needs of the

ny phi bao qut khi cn thit p ng cc

given application or field of application. The

yu cu p dng hoc lnh vc p dng nh.

laboratory shall record the results obtained, the

PTN phi ghi li kt qu c c, th tc s

procedure used for the validation, and a statement

dng ph duyt v cng b rng phng php

as to whether the method is fit for the intended

ny ph hp vi mc ch s dng.

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;

-calibration using reference standards or reference

- 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

materials;
-comparison of results achieved with other methods;
-interlaboratory comparisons;
-systematic assessment of the factors influencing the
result;

bit khoa hc v nguyn tc l thuyt ca phng php

-assessment of the uncertainty of the results based on

v kinh nghim thc t.

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,

chn phng php, tuyn tnh, sai s th do

influences

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

robustness

and/or

against

external

cross-sensitivity

against

36

xc nh c tnh ca phng php kim tra xem cc

requirements, determination of the characteristics of the

yu cu c th thc hin bng cch s dng cc

methods, a check that the requirements can be fulfilled

phng php v cng b v gi tr s dng.

by using the method, and a statement on the validity.

Ch thch 2 - Trong qu trnh xy dng phng php,

NOTE 2 As method-development proceeds, regular

PTN cn phi thc hin xem xt thng xuyn kim

review should be carried out to verify that the needs of

tra xc nhn cc yu cu ca khch hng vn ang

the customer are still being fulfilled. Any change in

c p ng. Mi thay i trong cc yu cu i hi

requirements requiring modifications to the development

nhng sa i trong k hoch xy dng phng php

plan should be approved and authorized.

phi c ph chun v cho php.

Ch thch 3 - Vic ph duyt thng c da trn s

NOTE 3 Validation is always a balance between costs,

cn bng gia chi ph, ri ro v cc kh nng k thut.

risks and technical possibilities. There are many cases

Trong rt nhiu trng hp, phm vi v khng m

in which the range and uncertainty of the values (e.g.

bo ca cc gi tr (v d: chnh xc, gii hn pht

accuracy,

hin, chn lc, tuyn tnh, lp li, ti lp, sai

repeatability, reproducibility, robustness and cross-

s th v nhy tng tc) ch c th c a ra

sensitivity) can only be given in a simplified way due to

mt cch n gin do thiu thng tin.

lack of information.

5.4.6 nh gi khng m bo o

5.4.6 Estimation of uncertainty of measurement

5.4.6.1 Phng hiu chun hoc phng th nghim

5.4.6.1 A calibration laboratory, or a testing

thc hin hiu chun ni b phi c v phi p

laboratory performing its own calibrations, shall

dng th tc nh gi khng m bo o cho

have and shall apply a procedure to estimate the

tt c cc php hiu chun v hnh thc hiu

uncertainty of measurement for all calibrations and

chun.

types of calibrations.

5.4.6.2 Phng th nghim phi c v phi p dng

5.4.6.2 Testing laboratories shall have and shall

th tc nh gi khng m bo o. Trong

apply procedures for estimating uncertainty of

mt s trng hp nht nh, bn cht ca

measurement. In certain cases the nature of the

phng php th c th hn ch vic tnh ton

test method may preclude rigorous, metrologically

nghim ngt v phng din o lng v thng

and statistically valid, calculation of uncertainty of

k khng m bo o. Trong nhng trng

measurement. In these cases the laboratory shall

hp ny, PTN t nht phi c gng xc nh tt c

at least attempt to identify all the components of

thnh phn khng m bo o, thc hin nh

uncertainty and make a reasonable estimation,

gi hp l v phi m bo rng hnh thc thng

and shall ensure that the form of reporting of the

bo kt qu khng c gy n tng sai v

result does not give a wrong impression of the

khng m bo o. Vic nh gi hp l phi da

uncertainty. Reasonable estimation shall be based

trn kin thc v tnh nng ca phng php v

on knowledge of the performance of the method

lnh vc o, v phi s dng, v d, kinh nghim

and on the measurement scope and shall make

trc v d liu c gi tr.

use of, for example, previous experience and

detection

limit,

selectivity,

linearity,

validation data.
Ch thch 1 - Mc nghim ngt cn thit nh

NOTE 1 The degree of rigor needed in an estimation of

gi khng m bo o tu thuc vo cc yu t nh:

uncertainty of measurement depends on factors such

- yu cu ca phng php th;

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

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

include, but are not necessarily limited to, the

v mu chun s dng, phng php v thit b s

reference standards and reference materials used,

dng, iu kin mi trng, c tnh v iu kin ca

methods and equipment used, environmental

mu th hoc hiu chun v ngi thao tc.

conditions, properties and condition of the item

When

estimating

the

uncertainty

of

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

documented in sufficient detail and is suitably

c ph duyt l thch hp s dng.

validated as being adequate for use;

b) phi thit lp v p dng th tc bo v d

b)procedures are established and implemented for

liu, th tc phi bao gm, nhng khng c

protecting the data; such procedures shall include,

gii hn tnh ton vn, tnh bo mt khi nhp

but not be limited to, integrity and confidentiality of

hoc thu thp d liu, lu gi d liu, truyn v x

data entry or collection, data storage, data

l d liu.

transmission and data processing;

c) My tnh v cc thit b t ng ho phi c

c)computers

bo tr m bo hot ng tt trong cc iu

maintained to ensure proper functioning and are

kin mi trng v iu kin hot ng cn thit

provided with the environmental and operating

duy tr tnh ton vn ca d liu th nghim v

conditions necessary to maintain the integrity of

hiu chun.

test and calibration data.

Ch thch - Phn mm c mua t cc nh sn xut

NOTE

(v d: chng trnh x l t ng, c s d liu,

wordprocessing, database and statistical programmes)

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

may be considered to be sufficiently validated. However,

hnh, cc phn mm ca PTN phi c ph duyt nh

laboratory software configuration/modifications should

nu ti 5.4.7.2.a.

be validated as in 5.4.7.2 a).

5.5 Thit b

5.5 Equipment

5.5.1 PTN phi c trang b y mi thit b

5.5.1 The laboratory shall be furnished with all

ly mu, o v th nghim cn thit thc

items

hin chnh xc cng vic th nghim v/hoc hiu

equipment required for the correct performance of

chun (bao gm ly mu, chun b cc mu th

the tests and/or calibrations (including sampling,

hoc hiu chun, x l v phn tch d liu th

preparation

nghim v/hoc hiu chun).

processing and analysis of test and/or calibration

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.

and

automated

Commercial

of

sampling,

of

test

equipment

off-the-shelf

software

measurement

and/or

and

calibration

are

(e.g.

test

items,

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 Thit b v phn mm ca thit b c s

5.5.2 Equipment and its software used for testing,

dng th nghim, hiu chun v ly mu phi

calibration and sampling shall be capable of

c kh nng t c chnh xc cn thit v

achieving the accuracy required and shall comply

phi ph hp vi qui nh k thut lin quan n

with specifications relevant to the tests and/or

th nghim v/hoc hiu chun tng ng.

calibrations concerned. Calibration programmes

Chng trnh hiu chun phi c thit lp cho

shall be established for key quantities or values of

cc i lng hoc gi tr chnh ca thit b khi cc

the instruments where these properties have a

c tnh c nh hng ng k n kt qu.

significant effect on the results. Before being

Trc khi a vo s dng thit b (bao gm c

placed into service, equipment (including that used

thit b dng ly mu) phi c hiu chun

for sampling) shall be calibrated or checked to

hoc kim tra khng nh rng thit b p ng

establish that it meets the laboratory's specification

39

cc yu cu qui nh k thut ca PTN v tun th

requirements and complies with the relevant

theo qui nh k thut tiu chun tng ng. Thit

standard specifications. It shall be checked and/or

b phi c kim tra v/hoc c hiu chun

calibrated before use (see 5.6).

trc khi s dng (xem 5.6).

5.5.3 Ch nhng ngi c php mi c quyn

5.5.3 Equipment shall be operated by authorized

s dng thit b. PTN phi lun sn c hng dn

personnel. Up-to-date instructions on the use and

v s dng v bo tr trang thit b cp nht

maintenance of equipment (including any relevant

(bao gm ti liu hng dn s dng thit b do

manuals provided by the manufacturer of the

nh sn xut cung cp) cho nhn vin thch hp

equipment) shall be readily available for use by the

ca PTN s dng.

appropriate laboratory personnel.

5.5.4 Mi hng mc ca thit b v phn mm ca

5.5.4 Each item of equipment and its software

thit b s dng th nghim v hiu chun v

used for testing and calibration and significant to

c ngha quan trng i vi kt qu phi c

the result shall, when practicable, be uniquely

m ho nhn bit r rng, khi thch hp.

identified.

5.5.5 PTN phi duy tr h s cho mi hng mc

5.5.5 Records shall be maintained of each item of

thit b v cho phn mm c ngha quan trng

equipment and its software significant to the tests

i vi php th hoc hiu chun thc hin. H

and/or calibrations performed. The records shall

s phi bao gm ti thiu cc thng tin sau:

include at least the following:

a) nhn bit hng mc thit b v phn mm ca

the identity of the item of equipment and its

thit b ;

software;

b) tn ca nh sn xut, s sri hoc s phn nh

b) the manufacturer's name, type identification,

r rng khc;

and serial number or other unique identification;

c) kim tra thit b ph hp vi qui nh k thut

c) checks that equipment complies with the

(xem 5.5.2);

specification (see 5.5.2);

d) v tr hin ti ca thit b, khi thch hp;

d) the current location, where appropriate;

e) hng dn ca nh sn xut nu c, hoc vin

e) the manufacturer's instructions, if available, or

dn ni c th tm c ti liu hng dn ca

reference to their location;

nh sn xut;

f) dates, results and copies of reports and

f) ngy, kt qu v bn sao ca bin bn hoc

certificates

giy chng nhn ca tt c cc ln hiu chun v

acceptance criteria, and the due date of next

hiu chnh, chun mc chp nhn, ngy thng

calibration;

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

of

all

calibrations,

adjustments,

g) the maintenance plan, where appropriate, and

maintenance carried out to date;
h) any damage, malfunction, modification or repair
to the equipment.

thit b.
5.5.6 PTN phi c cc th tc v bo qun, vn

5.5.6 The laboratory shall have procedures for

chuyn, lu gi, s dng an ton v bo tr theo

safe handling, transport, storage, use and planned

k hoch thit b o m bo cho thit b hot

maintenance of measuring equipment to ensure

40

ng tt v nhm ngn nga s nhim bn

proper functioning and in order to prevent

hoc trnh xung cp.

contamination or deterioration.

Ch thch - Cc th tc b sung c th cn thit khi

NOTE Additional procedures may be necessary

thit b o c s dng bn ngoi PTN th

when measuring equipment is used outside the

nghim, hiu chun hoc ly mu.

permanent laboratory for tests, calibrations or

sampling.

5.5.7 Thit b b qu ti, qun l ti hoc cho

5.5.7 Equipment that has been subjected to

nhng kt qu nghi ng, hoc cho thy c

overloading or mishandling, gives suspect results,

khuyt tt hoc kt qu nm ngoi gii hn qui

or has been shown to be defective or outside

nh cho php khng c s dng. Thit b phi

specified limits, shall be taken out of service. It

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

labelled or marked as being out of service until it

vic s dng cho n khi thit b trn c sa

has been repaired and shown by calibration or test

cha v vic th nghim v hiu chun ch ra l

to perform correctly.

thc hin chnh xc.

PTN phi kim tra nh hng ca cc khuyt tt

The laboratory shall examine the effect of the

hoc sai lch so vi gii hn qui nh v php

defect or departure from specified limits on

th nghim v/hoc hiu chun trc v PTN

previous

phi p dng th tc "kim sot cng vic khng

institute the Control of nonconforming work

ph hp" (xem 4.9).

procedure (see 4.9).

5.5.8 Khi c th, tt c thit b t di s kim

5.5.8 Whenever practicable, all equipment under

sot ca PTN v thit b yu cu hiu chun phi

the control

c dn nhn, hoc c m ho hay c cch

calibration shall be labelled, coded or otherwise

nhn bit khc ch ra tnh trng hiu chun k

identified to indicate the status of calibration,

c ngy thng hiu chun ln cui v thi gian

including the date when last calibrated and the

hoc thi hn yu cu hiu chun li.

date or expiration criteria when recalibration is

tests

and/or

calibrations

and

shall

of the laboratory and requiring

due.
5.5.9 Khi v mt l do no , thit b nm ngoi

5.5.9 When, for whatever reason, equipment goes

tm kim sot trc tip ca PTN th PTN phi

outside the direct control of the laboratory, the

m bo chc nng v tnh trng hiu chun ca

laboratory shall ensure that the function and

thit b c kim tra v t yu cu trc khi

calibration status of the equipment are checked

thit b ny c s dng li.

and shown to be satisfactory before the equipment

is returned to service.

5.5.10 Khi vic kim tra gia k hiu chun l cn

5.5.10 When intermediate checks are needed to

thit duy tr mc tin cy v tnh trng hiu

maintain confidence in the calibration status of the

chun ca thit b, vic kim tra gia k ny phi

equipment, these checks shall be carried out

c thc hin theo mt th tc qui nh.

according to a defined procedure.

5.5.11 Nu hiu chun pht sinh mt lot cc yu

5.5.11 Where calibrations give rise to a set of

t cn hiu chnh, PTN phi c cc th tc m

correction factors, the laboratory shall have

bo sao cho cc phin bn (v d: trong phn mm

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

All equipment used for tests and/or calibrations,

nghim v/hoc hiu chun, k c cc thit b o

including equipment for subsidiary measurements

ph (v d: xc nh iu kin mi trng) c

(e.g. for environmental conditions) having a

nh hng ng k n chnh xc hoc tnh

significant effect on the accuracy or validity of the

ng n ca kt qu hiu chun, th nghim

result of the test, calibration or sampling shall be

hoc ly mu phi c hiu chun trc khi a

calibrated before being put into service. The

vo s dng. PTN phi xy dng chng trnh v

laboratory shall have an established programme

th tc hiu chun thit b.

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

nh l cc chun o lng, thit b o v th nghim

materials

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

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

measurement

used

as

For

standards,

measurement

calibration

reference

standards,

laboratories,

and

the

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

nhng i din c tha thun ca cc n v SI

realizations

primary

standards,
of

the

SI

which
units

are

primary

or

agreed

42

da trn cc hng s vt l c bn. Chun quc

representations of SI units based on fundamental

gia cng c th l chun th c cc Vin o

physical constants, or they may be secondary

lng quc gia khc hiu chun. Khi PTN s dng

standards which are standards calibrated by

cc dch v hiu chun, t bn ngoi tnh lin kt

another national metrology institute. When using

chun phi c m bo s dng cc dch v

external

hiu chun ch t cc PTN c nng lc, kh nng

measurement shall be assured by the use of

o v m bo tnh lin kt chun. Giy chng

calibration services from laboratories that can

nhn hiu chun do cc PTN cp phi ghi kt qu

demonstrate competence, measurement capability

o gm c khng m bo o v/hoc cng b

and traceability. The calibration certificates issued

ph hp vi mt qui nh v o lng xc nh

by

(xem 5.10.4.2).

measurement results, including the measurement

calibration

these

services,

laboratories

traceability

shall

contain

of

the

uncertainty and/or a statement of compliance with

an identified metrological specification (see also
5.10.4.2).
Ch thch 1 - Cc Phng hiu chun p ng nhng

NOTE

yu cu ca tiu chun ny c xem l c nng lc.

requirements

Giy chng nhn hiu chun mang biu tng ca c

considered to be competent. A calibration certificate

quan cng nhn t mt phng hiu chun c cng

bearing an accreditation body logo from a calibration

nhn theo tiu chun ny cho cc php hiu chun

laboratory accredited to this International Standard, for

tng ng l bng chng y v tnh lin kt chun

the calibration concerned, is sufficient evidence of

ca d liu hiu chun bo co.

traceability of the calibration data reported.

Ch thch 2 - Tnh lin kt chun ti cc n v o

NOTE 2 Traceability to SI units of measurement may be

lng SI c th t c bng vic dn v mt chun

achieved by reference to an appropriate primary

u ph hp [xem TCVN 6165:1996 (VM 1993. 6.4)]

standard (see VIM:1993, 6.4) or by reference to a

hoc dn v mt hng s t nhin c gi tr bit theo

natural constant, the value of which in terms of the

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.

General Conference of Weights and Measures (CGPM)

Calibration
of

this

laboratories
International

fulfilling

the

Standard

are

and the International Committee for Weights and

Measures (CIPM).

Ch thch 3 - Cc phng hiu chun duy tr chun u

NOTE 3 Calibration laboratories that maintain their own

hoc

SI

primary standard or representation of SI units based on

da vo hng s vt l c bn c th khng nh dn

fundamental physical constants can claim traceability to

xut vi h SI ch sau khi cc chun ny c so snh

the SI system only after these standards have been

trc tip hoc gin tip vi cc chun tng ng

compared, directly or indirectly, with other similar

khc ca mt Vin o lng quc gia.

standards of a national metrology institute.

Ch thch 4 - Thut ng "qui nh k thut o lng

NOTE 4 The term identified metrological specification

xc nh" c ngha phi lm r trong giy chng nhn

means that it must be clear from the calibration

hiu chun cc php o c so snh vi qui nh k

certificate which specification the measurements have

thut no bng cch nu ln hoc a ra vin dn r

been compared with, by including the specification or by

rng v qui nh k thut.

giving an unambiguous reference to the specification.

Ch thch 5 - Khi thut ng "chun quc t" hoc

NOTE 5 When the terms international standard or

"chun quc gia" c s dng lin quan vi tnh dn

national standard are used in connection with

chun

din

ca

cc

43

xut chun, c gi thit rng chun quc gia v

traceability, it is assumed that these standards fulfil the

chun quc t ny p ng cc c tnh k thut ca

properties of primary standards for the realization of SI

cc chun u c tha nhn trong h n v SI

units.

Ch thch 6 - Lin kt n chun o lng quc gia

NOTE 6 Traceability to national measurement standards

khng nht thit yu cu s dng Vin o lng quc

does not necessarily require the use of the national

gia ca nc m ni PTN t tr s.

metrology institute of the country in which the laboratory

is located.

Ch thch 7 - Nu mt phng hiu chun mong mun

NOTE 7 If a calibration laboratory wishes or needs to

hoc c nhu cu nhn c s lin kt chun ca mt

obtain traceability from a national metrology institute

Vin o lng quc gia khc th PTN phi la chn mt

other than in its own country, this laboratory should

Vin o lng quc gia tham gia tht s vo cc hot

select a national metrology institute that actively

ng ca BIPM hoc trc tip hoc thng cc cc nhm

participates in the activities of BIPM either directly or

khu vc.

through regional groups.

Ch thch 8 - PTN c th t c chui hiu chun

NOTE 8 The unbroken chain of calibrations or

hoc so snh khng gin on c th t c bng

comparisons may be achieved in several steps carried

mt s bc c thc hin do cc PTN khc nhau c

out by different laboratories that can demonstrate

th chng minh c tnh lin kt chun thc hin.

traceability.

5.6.2.1.2 C mt vi php hiu chun hin ti PTN

5.6.2.1.2 There are certain calibrations that

khng th thc hin hon ton theo cc n v SI.

currently cannot be strictly made in SI units. In

Trong trng hp , vic hiu chun phi chng

these cases calibration shall provide confidence in

minh mc tin cy trong php o bng vic thit

measurements

lp lin kt n cc chun o lng ph hp nh:

appropriate measurement standards such as:

by

establishing

traceability

to

- s dng cc mu chun c chng nhn do

-the use of certified reference materials provided

ngi cung ng c nng lc cung cp c c

by a competent supplier to give a reliable physical

tnh cht vt l hoc ho hc tin cy ca vt liu.

or chemical characterization of a material;

- s dng phng php qui nh v/hoc cc

-the use of specified methods and/or consensus

chun tha thun c miu t r rng v c

standards that are clearly described and agreed

tt c cc bn lin quan chp nhn.

by all parties concerned.

Yu cu PTN tham gia chng trnh so snh lin

Participation

in

suitable

programme

of

phng ph hp nu c th.

interlaboratory comparisons is required where

possible.

5.6.2.2 Th nghim

5.6.2.2 Testing

5.2.2.2.1 i vi cc phng th nghim p dng

5.6.2.2.1 For testing laboratories, the requirements

cc yu cu a ra trong mc 5.6.2.1 cho cc thit

given in 5.6.2.1 apply for measuring and test

b o lng v th nghim c s dng i vi cc

equipment with measuring functions used, unless

chc nng o, tr khi chng minh c rng vic

it has been established that the associated

hiu chun c tc ng khng ng k vo

contribution from the calibration contributes little to

khng m bo o tng hp ca kt qu th

the total uncertainty of the test result. When this

nghim. Khi pht sinh tnh hung ny, PTN phi

situation arises, the laboratory shall ensure that

44

m bo rng thit b s dng c th cung cp

the equipment used can provide the uncertainty of

khng m bo o cn thit.

measurement needed.

Ch thch - Mc PTN phi tun th cc yu cu

NOTE The extent to which the requirements in 5.6.2.1

cp trong 5.6.2.1 ph thuc vo s ng gp tng i

should be followed depends on the relative contribution

ca khng m bo o trong php hiu chun vi

of the calibration uncertainty to the total uncertainty. If

khng m bo o tng hp. Nu vic hiu chun l

calibration is the dominant factor, the requirements

yu t nh hng ln th cc yu cu trn phi c

should be strictly followed.

tun th nghim ngt.

5.6.2.2.2 Khi dn xut ca php o n cc n v

5.6.2.2.2 Where traceability of measurements to SI

SI l khng th v/hoc khng thch hp th cc

units is not possible and/or not relevant, the same

yu cu tng t v tnh lin kt chun v d, i

requirements for traceability to, for example,

vi mu chun c chng nhn, cc phng

certified reference materials, agreed methods

php tho thun, v/hoc chun tha thun cng

and/or consensus standards, are required as for

c yu cu nh i vi cc phng hiu chun

calibration laboratories (see 5.6.2.1.2).

(5.6.2.1.2).
5.6.3 Chun chnh v mu chun

5.6.3 Reference standards and reference materials

5.6.3.1 Chun chnh

5.6.3.1 Reference standards

PTN phi c chng trnh v th tc v hiu

The laboratory shall have a programme and

chun cc chun chnh. Cc chun chnh phi

procedure for the calibration of its reference

c hiu chun bi mt t chc c th cung cp

standards. Reference standards shall be calibrated

vic lin kt chun nh c miu t trong

by a body that can provide traceability as

5.6.2.1. Chun chnh PTN lu gi ch c s

described in 5.6.2.1. Such reference standards of

dng hiu chun v khng c s dng cho

measurement held by the laboratory shall be used

cc mc ch khc, tr phi PTN c th ch ra rng

for calibration only and for no other purpose,

tnh nng ca n nh chun chnh vn c hiu lc.

unless it can be shown that their performance as

Cc chun chnh phi c hiu chun trc v

reference standards would not be invalidated.

sau khi c bt c hiu chnh no.

Reference standards shall be calibrated before

and after any adjustment.

5.6.3.2 Mu chun

5.6.3.2 Reference materials

Khi c th, cc mu chun phi dn xut ti cc

Reference materials shall, where possible, be

n v o lng SI hoc n cc mu chun c

traceable to SI units of measurement, or to

chng nhn. Cc mu chun ni b phi c

certified reference materials. Internal reference

kim tra n mc ti a khi iu kin kinh t v k

materials shall be checked as far as is technically

thut cho php.

and economically practicable.

5.6.3.3 Kim tra gia k

5.6.3.3 Intermediate checks

PTN phi tin hnh s kim tra cn thit theo cc

Checks needed to maintain confidence in the

th tc v k hoch qui nh duy tr s tin

calibration status of reference, primary, transfer or

cy v tnh trng hiu chun ca chun chnh,

working standards and reference materials shall

chun u, chun so snh hoc chun cng tc,

be carried out according to defined procedures

45

v mu chun.

and schedules.

5.6.4.4 Vn chuyn v lu gi

5.6.3.4 Transport and storage

PTN phi c th tc qun l an ton, vn chuyn,

The laboratory shall have procedures for safe

lu gi v s dng cc chun chnh v mu chun

handling, transport, storage and use of reference

phng nga nhim bn hoc h hng v

standards and reference materials in order to

bo v tnh nguyn vn.

prevent contamination or deterioration and in order

to protect their integrity.

Ch thch - Cc th tc b sung c th l cn thit khi

NOTE Additional procedures may be necessary

cc chun chnh v mu chun c s dng bn

when reference standards and reference materials

ngoi v tr c nh ca PTN th nghim, hiu chun

are used outside the permanent laboratory for

hoc ly mu.

tests, calibrations or sampling.

5.7 Ly mu

5.7 Sampling

5.7.1 PTN phi c k hoch v th tc ly mu khi

5.7.1 The laboratory shall have a sampling plan

PTN thc hin ly mu cc cht, vt liu hoc sn

and procedures for sampling when it carries out

phm dng th nghim/hiu chun tip theo.

sampling of substances, materials or products for

K hoch ly mu cng nh th tc ly mu phi

subsequent testing or calibration. The sampling

c sn ti v tr thc hin vic ly mu. K hoch

plan as well as the sampling procedure shall be

ly mu phi hp l v phi da vo phng php

available at the location where sampling is

thng k ph hp. Qu trnh ly mu phi ghi li

undertaken.

cc yu t c kim sot m bo hiu lc

reasonable, be based on appropriate statistical

ca kt qu th nghim/hiu chun.

methods. The sampling process shall address the

Sampling

plans

shall,

whenever

factors to be controlled to ensure the validity of the

test and calibration results.
Ch thch 1 - Ly mu l mt th tc xc nh nh

NOTE 1 Sampling is a defined procedure whereby a

mt phn cht, vt liu hoc sn phm c ly

part of a substance, material or product is taken to

tin hnh th nghim/hiu chun mt mu i din

provide for testing or calibration of a representative

trong ton b mu. i vi cht, vt liu hoc sn phm

sample of the whole. Sampling may also be required by

c th nghim hoc hiu chun cng c th i hi

the appropriate specification for which the substance,

vic ly mu theo qui nh k thut ph hp.

material or product is to be tested or calibrated.

Trong mt s trng hp nht nh (VD phn tch mang

In certain cases (e.g. forensic analysis), the sample may

tnh php l) mu c th khng phi l i din nhng

not be representative but is determined by availability.

phi c xc nh gi tr hiu lc.

Ch thch 2 - Th tc ly mu phi miu t vic la

NOTE 2 Sampling procedures should describe the

chn, k hoch ly mu, thu hi v chun b mt mu

selection, sampling plan, withdrawal and preparation of

hoc cc mu t mt hp cht, vt liu hoc sn phm

a sample or samples from a substance, material or

c c thng tin cn thit.

product to yield the required information.

5.7.2 Khi khch hng yu cu sa i, b sung

5.7.2 Where the customer requires deviations,

hoc loi bt nhng th tc ly mu c vn

additions or exclusions from the documented

46

bn ho th nhng yu cu ny phi c ghi

sampling procedure, these shall be recorded in

chp chi tit cng vi nhng d liu ly mu ph

detail with the appropriate sampling data and shall

hp v phi lu gi ton b ti liu lin quan n

be included in all documents containing test and/or

kt qu th nghim/hiu chun cng nh phi

calibration results, and shall be communicated to

thng bo cho nhng ngi c lin quan.

the appropriate personnel.

5.7.3 PTN phi c th tc ghi li d liu ph hp

5.7.3 The laboratory shall have procedures for

v cc hot ng lin quan n ly mu hnh

recording relevant data and operations relating to

thnh nn mt phn hot ng th nghim hoc

sampling that forms part of the testing or

hiu chun m PTN tin hnh. Cc h s phi

calibration that is undertaken. These records shall

bao gm th tc ly mu c s dng, s nhn

include

bit ngi ly mu, iu kin mi trng (nu ph

identification

hp) v cc biu hoc nhng cch tng t

conditions (if relevant) and diagrams or other

xc nh v tr ly mu khi cn thit v nu ph hp

equivalent means to identify the sampling location

cc th tc ly mu, thng k c p dng.

as necessary and, if appropriate, the statistics the

the

sampling
of

the

procedure
sampler,

used,

the

environmental

sampling procedures are based upon.

5.8 Qun l mu th nghim v hiu chun

5.8 Handling of test and calibration items

5.8.1 PTN phi c nhng th tc v vn chuyn,

5.8.1 The laboratory shall have procedures for the

tip nhn, qun l, lu gi, bo v, lu tr v hoc

transportation,

thanh l cc mu th nghim v/hoc hiu chun

storage, retention and/or disposal of test and/or

bao gm mi qui nh cn thit bo v tnh ton

calibration

vn ca mu th nghim v/hoc hiu chun v

necessary to protect the integrity of the test or

bo v quyn li ca PTN v khch hng.

calibration item, and to protect the interests of the

receipt,

items,

handling,

including

protection,

all

provisions

laboratory and the customer.

5.8.2 PTN phi c mt h thng m ho mu th

5.8.2 The laboratory shall have a system for

nghimv/hoc hiu chun. Vic m ho mu phi

identifying test and/or calibration items. The

c duy tr ti PTN trong sut thi gian mu tn

identification shall be retained throughout the life of

ti PTN. H thng m ho mu phi c thit

the item in the laboratory. The system shall be

k v hot ng sao cho c th m bo mu

designed and operated so as to ensure that items

khng th b nhm ln trn thc t hoc khi c

cannot be confused physically or when referred to

vin dn n h s hoc cc ti liu khc. H

in records or other documents. The system shall, if

thng m ho ny phi cho php vic sp xp

appropriate,

thnh cc nhm mu nh hn hoc cho php vic

groups of items and the transfer of items within

chuyn cc mu n hoc t PTN i nu ph hp.

and from the laboratory.

5.8.3 PTN phi ghi vo h s khi nhn mu th

5.8.3 Upon receipt of the test or calibration item,

nghim v/hoc hiu chun khi thy c bt c

abnormalities

khc bit hoc c sai lch so vi cc iu kin

specified conditions, as described in the test or

qui nh hoc trong cc phng php th nghim

calibration method, shall be recorded. When there

hoc hiu chun. Khi c bt c nghi ng no v

is doubt as to the suitability of an item for test or

s ph hp ca mu th nghim v/hoc hiu

calibration, or when an item does not conform to

chun hoc khi c mt mu khng ph hp vi s

the description provided, or the test or calibration

miu t cung cp, cng nh php th hoc

required is not specified in sufficient detail, the

accommodate

or

departures

sub-division

from

normal

47

of

or

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,

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

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

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

handling

and

under
and

of

the

preparation.

specified

recorded.

secured

environmental

Where

items

Handling

or

test

or

portions

concerned.
Ch thch 1 - Nu cc mu th nghim/hiu chun

NOTE 1 Where test items are to be returned into service

c s dng li sau khi th nghim th PTN cn phi

after testing, special care is required to ensure that they

c bit quan tm m bo cc mu ny khng b

are not damaged or injured during the handling, testing

ph hu hoc tn hi trong qu trnh qun l, th

or storing/waiting processes.

nghim hoc trong qu trnh lu gi/ ch i.

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

5.9.1 The laboratory shall have quality control

kim tra tnh hiu lc ca php th nghim v hiu

procedures for monitoring the validity of tests and

chun thc hin. D liu kt qu phi c ghi

calibrations undertaken. The resulting data shall

chp sao cho c th nhn bit cc khuynh hng

be recorded in such a way that trends are

din bin ca cc kt qu v nu c th cn phi

detectable

p dng k thut thng k xem xt cc kt qu.

techniques shall be applied to the reviewing of the

Vic kim tra ny phi c ln k hoch, sot xt

results. This monitoring shall be planned and

and,

where

practicable,

48

statistical

li v c th bao gm nhng khng gii hn :

reviewed and may include, but not be limited to,

the following:

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;

a)regular use of certified reference materials

and/or internal quality control using secondary
reference materials;

b) participation in interlaboratory comparison or

b) tham gia vo cc chng trnh so snh lin
proficiency-testing programmes;
phng v th nghim thnh tho;
c) replicate tests or calibrations using the same or
c) thc hin li cc php th nghim hoc hiu
different methods;
chun s dng cng mt phng php hoc cc
d) retesting or recalibration of retained items;
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.

e) correlation of results for different characteristics

of an item.

Ch thch - Cc phng php phi ph hp vi chng

NOTE The selected methods should be appropriate for

loi v khi lng cng vic thc hin

the type and volume of the work undertaken.

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

5.9.2 Quality control data shall be analysed and,

5.10 Bo co kt qu

5.10 Reporting the results

5.10.1 Yu cu chung

5.10.1 General

Cc kt qu ca mi php th nghim, hiu chun

The results of each test, calibration, or series of

hoc mt lot cc php th, hiu chun do PTN

tests or calibrations carried out by the laboratory

thc hin phi c bo co chnh xc, r rng,

shall

khng m h v khch quan cng nh phi ph

unambiguously and objectively, and in accordance

hp vi cc ch dn c th trong phng php th

with any specific instructions in the test or

nghim hoc hiu chun.

calibration methods.

Thng thng cc kt qu phi c bo co

The results shall be reported, usually in a test

trong bo co th nghim hoc giy chng nhn

report or a calibration certificate (see Note 1), and

hiu chun (xem ch thch 1), v phi bao gm tt

shall include all the information requested by the

c cc thng tin m khch hng yu cu v cn

customer and necessary for the interpretation of

din gii cc kt qu th nghim v hiu chun

the test or calibration results and all information

cng nh tt c cc thng tin theo yu cu ca

required by the method used. This information is

phng php s dng. Thng tin ny thng

normally that required by 5.10.2, and 5.10.3 or

l cc ni dung c yu cu trong 5.10.2 v

5.10.4. In the case of tests or calibrations

5.10.3 hoc 5.10.4. Kt qu c th c bo co

performed for internal customers, or in the case of

theo cch n gin hn trong trng hp cc

a written agreement with the customer, the results

php th hoc hiu chun c thc hin cho

may be reported in a simplified way. Any

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.

be

reported

accurately,

49

clearly,

khch hng ni b, hoc trong trng hp c mt

information listed in 5.10.2 to 5.10.4 which is not

tho thun bng vn bn vi khch hng. Nu cc

reported to the customer shall be readily available

thng tin lit k trong mc 5.10.2 n 5.10.4 khng

in the laboratory which carried out the tests and/or

c thng bo ti khch hng th phi c sn

calibrations.

trong PTN ni thc hin th nghim v/ hoc hiu

chun.
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
laboratory;
ca PTN;
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;

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

f) miu t, tnh trng v xc nh r rng mu unambiguous identification of the item(s) tested or

calibrated;
th nghim hoc hiu chun;
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
are relevant to the validity or application of the
qu
results;
i) cc kt qu th nghim hoc hiu chun cng
i)the test or calibration results with, where
vi cc n v o lng, nu thch hp
appropriate, the units of measurement;
j) tn, chc v, ch k hoc nhn dng tng
j)the name(s), function(s) and signature(s) or
ng ca ngi c thm quyn cp giy
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

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

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

with

of

requirements

measurement;

and/or

information

51

on

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

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

methods,

customers

or

groups

of

results:

a) ngy ly mu;

a) the date of sampling;

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
the calibrations were made that have an influence
hiu chun m c nh hng ti cc kt qu o;
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
statement of compliance with an identified
hoc cc iu ca yu cu ;
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)

c)evidence that the measurements are traceable

(see Note 2 in 5.6.2.1.1).

5.10.4.2 Giy chng nhn hiu chun ch phi lin

5.10.4.2 The calibration certificate shall relate only

quan ti cc i lng v kt qu ca cc php

to quantities and the results of functional tests. If a

th chc nng. Nu c cng b v s ph hp vi

statement of compliance with a specification is

mt qui nh k thut th cng b ny phi xc nh

made, this shall identify which clauses of the

r rng iu no ca qui nh k thut c p

specification are met or not met.

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

When

statement

of

compliance

with

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 Khi mt thit b hiu chun c hiu

5.10.4.3 When an instrument for calibration has

chnh hoc c sa cha th cc kt qu hiu

been adjusted or repaired, the calibration results

chun trc v sau khi hiu chnh hoc sa cha

before and after adjustment or repair, if available,

phi c ghi li nu c

shall be reported.

5.10.4.4 Giy chng nhn hiu chun (hoc tem

5.10.4.4 A calibration certificate (or calibration

hiu chun) khng c bao gm bt c khuyn

label) shall not contain any recommendation on

ngh no v thi hn hiu chun tr khi iu ny

the calibration interval except where this has been

c tho thun vi khch hng.

agreed with the customer. This requirement may

Yu cu ny c th c thay th bng cc qui

be superseded by legal regulations.

nh mang tnh php lut.

5.10.5 Nhn xt v din gii

5.10.5 Opinions and interpretations

Khi a ra nhn xt v din gii th PTN phi lp

When opinions and interpretations are included,

thnh vn bn v c s a ra nhn xt v

the laboratory shall document the basis upon

din gii. Cc nhn xt v din gii phi c ghi

which the opinions and interpretations have been

r rng nh trong bo co th nghim

made. Opinions and interpretations shall be clearly

marked as such in a test report.

Ch thch 1 - Khng nn c s nhm ln nhn xt v

NOTE 1 Opinions and interpretations should not

din gii vi gim nh v chng nhn sn phm nh

be

c cp trong TCVN ISO/IEC 17020 v trong

certifications as intended in ISO/IEC 17020 and

ISO/IEC Guide 65

ISO/IEC Guide 65.

Ch thch 2 - Nhn xt v din gii trong bo co th

NOTE 2 Opinions and interpretations included in a test

nghim c th bao gm, nhng khng gii hn cc

report may comprise, but not be limited to, the following:

im sau:

-an

confused

opinion

with

on

inspections

the

and

product

statement

53

of

- nhn xt v s ph hp/khng ph hp ca cc kt

compliance/noncompliance

qu so vi cc yu cu

requirements;

- vic p ng cc yu cu trong hp ng

- fulfilment of contractual requirements;

- khuyn ngh v cch thc s dng kt qu

-recommendations on how to use the results;

- hng dn i vi vic ci tin

- guidance to be used for improvements.

Ch thch 3 - Trong nhiu trng hp vic thng bo

NOTE 3 In many cases it might be appropriate to

cc nhn xt v gii thch bng cch i thoi trc tip

communicate the opinions and interpretations by direct

vi khch hng c th l thch hp. S i thoi nh

dialogue with the customer. Such dialogue should be

vy phi c vit thnh vn bn.

written down.

5.10.6 Kt qu th nghim v hiu chun nhn

5.10.6 Testing and calibration results obtained

c t nh thu ph

from subcontractors

Khi bin bn th nghim c cc kt qu th

When the test report contains results of tests

nghim do nhng nh thu ph thc hin th cc

performed by subcontractors, these results shall

kt qu ny phi c ch ra mt cch r rng.

be clearly identified. The subcontractor shall report

Nh thu ph phi thng bo kt qu th nghim

the results in writing or electronically.

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.

of

the

results

with

When a calibration has been subcontracted, the

laboratory performing the work shall issue the
calibration certificate to the contracting laboratory

5.10.7 Chuyn giao kt qu bng in t

5.10.7 Electronic transmission of results

Trong trng hp cc kt qu th nghim hoc

In the case of transmission of test or calibration

hiu chun c chuyn bng in thoi, telex,

results by telephone, telex, facsimile or other

my fax hoc cc phng tin in t hoc in

electronic

t khc th cc yu cu ca tiu chun ny phi

requirements of this International Standard shall

c p ng (xem 5.4.7).

be met (see also 5.4.7).

5.10.8 Hnh thc bin bn v giy chng nhn

5.10.8 Format of reports and certificates

Hnh thc ca bin bn v giy chng nhn phi

The format shall be designed to accommodate

c thit k ph hp vi mi loi php th hoc

each type of test or calibration carried out and to

hiu chun c tin hnh v gim ti a kh

minimize the possibility of misunderstanding or

nng hiu sai hoc lm dng.

misuse.

Ch thch 1 - PTN phi quan tm ti cch trnh by

NOTE 1 Attention should be given to the lay-out of the

bo co th nghim v giy chng nhn hiu chun

test report or calibration certificate, especially with

c bit quan tm ti cch din gii d liu th nghim

regard to the presentation of the test or calibration data

hoc hiu chun v lm cho ngi c d tip thu.

and ease of assimilation by the reader.

Ch thch 2 - Cc tiu phi c tiu chun ho ti

NOTE 2 The headings should be standardized as far as

a.

possible.

or

electromagnetic

means,

54

the

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

phi p ng c tt c cc yu cu ca tiu
chun ny Khi cn ban hnh mt bo co th
nghim hoc giy chng nhn hiu chun hon
ton mi th bo co v giy chng nhn ny phi
c nhn bit mt cch n nht v phi vin

Such amendments shall meet all the requirements

of this International Standard. When it is necessary
to issue a complete new test report or calibration
certificate, this shall be uniquelyidentified and shall
contain a reference to the original that it replaces.

dn ti bo co v giy chng nhn gc m n

thay th.

55