VN PHNG CNG NHN CHT LNG

Bureau of Accreditation (BoA)

TH TC
NH GI CNG NHN PHNG TH NGHIM
ACCREDITATION ASSESSMENT PROCEDURE
FOR LABORATORY
M s/Code: APL 01
Ln ban hnh/Issued number: 5.10
Ngy ban hnh/ Issued date: 12/2010

Th tc nh gi Cng nhn Phng th nghim

Accreditation Assessment Procedure for Laboratory

1.
Mc ch
Th tc ny c xy dng qui nh
trch nhim v trnh by qu trnh nh gi
cng nhn phng th nghim ca Vn phng
cng nhn cht lng - VILAS.

1.
Purpose
To define the responsibility and content of
accreditation assessment process for
laboratory of Bureau of Accreditation
VILAS.

2.
Phm vi
Th tc ny c p dng cho Vn phng
Cng nhn Cht lng - VILAS v cc
phng th nghim ng k cng nhn,
c cng nhn.

2.
Scope
This procedure is applied for Bureau of
Accreditation VILAS, applicants and
accredited laboratories

3.
Trch nhim
Mi nhn vin VPCNCL, chuyn gia nh
gi phi tun th theo qui nh ny;
Phng th nghim ng k cng nhn,
c cng nhn phi thc hin theo qui nh
trong th tc ny.

3.
Responsibility
All the staff of BoA, assessors must be
complied with regulation of this procedure;
All the applicants and accredited
laboratories must also be complied with
regulation of this procedure

4.

Ni dung

4.

4.1. nh ngha v Cc ch vit tt

APL 01

Ln ban hnh: 5.10

Content

4.1. Definition and Abbreviation

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Th tc nh gi Cng nhn Phng th nghim

Accreditation Assessment Procedure for Laboratory

VPCNCL

Vn phng Cng nhn Cht lng

BoA

Bureau of Accreditation

VILAS

H thng Cng nhn Phng th nghim Vit Nam

Vietnam Laboratory Accreditation Scheme
Phng th nghim (bao gm phng th nghim, phng hiu chun,
phng xt nghim y t, an ton sinh hc)

PTN
Laboratory

Laboratory (including testing/calibration, medical testing, biosafety

laboratory)
iu khng ph L nhng iu khng ph hp do khng p ng mt yu cu c th
hp nng
theo chun mc cng nhn, mang tnh h thng v tc ng trc tip
n tin cy ca kt qu th nghim/ hiu chun.
Major
non-conformity

The nonfulfilment of specified requirements that results in a failure to

comply with the accreditation criteria thus leading to the breakdown in,
or the inability to establish confidence in, the outcome of the
testing/calibration results.

iu khng ph L nhng iu khng ph hp n l khng ph hp vi chun mc

hp nh
cng nhn hay qui nh trong h thng qun l ca PTN v khng tc
ng trc tip n tin cy ca kt qu th nghim/ hiu chun.
Minor
non-conformity

A single failure to non-conformity with accreditation criteria, or with

the regulation in laboratories management system, which non-affection
to the reliability of testing/calibration results.
Ch thch: cc iu khng ph hp nh n l nu c lin quan vi nhau
v mang tnh h thng c th qui l mt iu khng ph hp nng.
Note: A number of minor but related to nonconformities, which
considered as a major nonconformity

Khuyn ngh

Pht hin trong qu trnh nh gi nhm mc ch ci tin.

Observation

An assessment finding that does not warrant nonconformity but is

identified by the assessment team as an opportunity for improvement.

APL 01

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Accreditation Assessment Procedure for Laboratory

4.2. Qu trnh cng nhn

Tip xc ban u

Xem xt ban u/ nh gi s b
(nu PTN yu cu )

PTN np n, STCL
v cc ti liu lin quan

Ch nh on chuyn gia nh gi

Khng t

Xem xt ti liu
t

Quyt nh thnh lp on nh gi
Khng t

nh gi ti PTN

Thc hin hnh ng khc phc

Thm xt
Khng t

Quyt nh cng nhn

M rng phm vi cng nhn

(theo nhu cu ca PTN)

Gim st PTN
(hng nm)

nh gi Cng nhn li
(sau 3 nm)

APL 01

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Th tc nh gi Cng nhn Phng th nghim

Accreditation Assessment Procedure for Laboratory

4.2

Accreditation process
Initial contact

Pre - assessment
(If necessary)

Applying for accreditation, Quality

manual and concerning document
(Procedures, in-house methods)

Assign assessment team

Not accepted

Document review

Decide official assessment team

Not accepted

On site Assessment

Corrective action taken

Not accepted

Record Review

Accreditation decision

Surveillance
(annual)

Extend assessment
(According to the Labs requirement)

Re-Assessment
(After 3 years)

APL 01

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Th tc nh gi Cng nhn Phng th nghim

Accreditation Assessment Procedure for Laboratory

4.3. Trnh t tin hnh nh gi cng

nhn

4.3. Accreditation assessment process

4.3.1. Tip xc ban u

Nu c nguyn vng xin cng nhn, PTN
c th lin h vi VPCNCL c c cc
thng tin v hng dn cn thit lin quan
n vic cng nhn nh:
Chun mc cng nhn: ISO/IEC
17025:2005 Yu cu chung v nng
lc ca phng th nghim v hiu
chun; yu cu b sung cng nhn
cho tng lnh vc c th, cc qui nh
ca VPCNCL v cc qui nh v php
lut trong phm vi hot ng ca PTN.

4.3.1. Initial contact

Laboratory should be provided necessary
information and guideline regarding to the
accreditation if laboratory has expectation of
accreditation:
ISO/IEC
17025:2005
General
Requirement for the competence of
testing and calibration laboratories;
Supplementary requirements for each
field, Boa regulations and others
legislation regulations relating to the
laboratory activities

Chun mc cng nhn phng xt

nghim l ISO 15189:2007, yu cu
ring v cc hng dn c lin quan
ca APLAC, ILAC

Medical laboratory accreditation criteria

are ISO 15189:2007, supplementary
requirements and related APLAC, ILAC
guidelines

Chun mc cng nhn phng an ton

sinh hc cp 3 l AGL 20 Yu cu
chung v nng lc ca phng th
nghim an ton sinh hc cp 3.

Level
3
Biosafety
laboratory
accreditation criteria are AGL 20
General
requirement
for
the
competence of Level 3 Biosafety
laboratory.

PTN c cung cp b ti liu lin

Laboratory is provided documents

concerning accreditation including:

General
requirement
of
Accreditation - AP 01;

Classify of testing fields AGL

09;

Accreditation
assessment
procedures for laboratory APL
01; APL 02; APL 03; APL 05;

quan n vic cng nhn bao gm:

Qui nh chung v cng nhn

AP 01;

Phn loi lnh vc th

nghim/hiu chun AGL 09;

Th tc v chnh sch lin quan

nh gi cng nhn PTN
APL 01; APL 02; APL 03;
APL 04;

Qui nh v s dng biu tng

cng nhn AG 01;

Th tc gii quyt phn nn AP 02;

Th tc gii quyt yu cu xem
xt li (appeal) - AP 03;

Regulation
for
using
of
accreditation logo and symbol
AG 01;
Complaints procedure - AP 02;

Appeals procedure - AP 03;

APL 01

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Accreditation Assessment Procedure for Laboratory

Qui nh v bo mt;
Qui nh chi ph nh gi
AGL10;
Phiu hi AFL 01.02;
Mu n ng k cng nhn
AF11.01;

Regulation of Confidentiality;
Accreditation fees - AGL10;

Questionnaire AFL 01.02;

Application form AF 11.01 ;

Phng th nghim cn nghin cu k cc ti

liu trn trc khi np n xin cng nhn.

The laboratory should consider carefully

these documents before submitting an
application

4.3.2. Xem xt ban u/ nh gi s b

4.3.2. Pre-assessment

Nu PTN c yu cu, VPCNCL c th tin

hnh nh gi s b trc khi nh gi
chnh thc. Ni dung nh gi s b theo
yu cu ca PTN v tho thun trc vi
VPCNCL. Cuc xem xt ny khng bt
buc i vi PTN v c th tin hnh trc
hoc sau khi np n ng k cng nhn.

BoA will carry out pre-assessment before

official assessment (if laboratory has
required). The content of pre-assessment
bases on laboratory requirement and the
agreement between two sides. These
assessments are not forced to the laboratory
and can be carried out before or after
submitting an application.

4.3.3. Np n ng k cng nhn

4.3.3. Application for accreditation

Trc khi np n ng k cng nhn PTN

phi m bo hon thnh xy dng v
p dng h thng qun l theo chun mc
cng nhn (ISO/IEC 17025:2005; ISO/IEC
15189; AGL 20) t nht l 3 thng (c h
s cho cc hot ng c thc hin) v
h thng qun l c xc nh l c hiu
qu thng qua vic nh gi ni b, xem
xt ca lnh o

The laboratory must apply the management

system according to the accreditation criteria
(ISO/IEC 17025:2005; ISO/IEC 15189;
AGL 20) at least 3 months before submit an
application for accreditation (the records
must be fulfilled) and it is certified that these
records are effective through the internal
audits and management reviews

PTN p ng yu cu nu trong AP 01 Qui

nh chung v Cng nhn u c th np
n ng k cng nhn ti VPCNCL. n
ng k cng nhn (theo mu AF 11.01)
cn c gi cng vi cc ti liu sau:

S tay cht lng;

Phiu hi c in y (AFL
01.02);

Laboratories meet requirements relating to

the AP 01 General requirement of
accreditation. The application form (AF
11.01) need to submit to BoA these
following documents:

Quality Manual;

Questionnaire (AFL 01.02);

APL 01

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Accreditation Assessment Procedure for Laboratory

Php th/ hiu chun ni b (nu c)

bao gm bo co tng hp d liu
xc nhn gi tr s dng ca phng
php; tnh khng m bo o (i
vi phng hiu chun);

In-house testing/calibration methods

(if any) including method validation
records;
estimation
of
the
measurement capability (for the
calibration);

Tng hp d liu v bo co xc
nhn gi tr s dng ca phng php
i vi cc phng php c thay i
so vi phng php tiu chun.

Method validation report if lab have

any
changed
reference
method/standard method

Danh mc ti liu kim sot ca

PTN;
H s nh gi ni b v xem xt ca
lnh o chu k gn nht
Bo co th nghim thnh tho theo
mu AFL 01.01;
Thng k cc ch tiu th
nghim/hiu chun ng k cng
nhn thc hin t hn 4 ln trong 1
nm; v
Mt s ti liu c lin quan khc (khi
c yu cu).

The list of controlled documents ;

The nearest internal audit and

management review records ;
The proficiency testing report
according the form AFL 01.01;
Statistics
frequency
of
each
test/calibration
applied
for
accreditation to do the test less than 4
time/a year; and
Others relevant documents (if
required)

Mt t chc c th ng k cng nhn vi

mt s hiu cho nhiu lnh vc th nghim,
nhiu phng th nghim trong mt t chc
hoc nhiu a im khc nhau. Trong
trng hp ny, VPCNCL s ln k hoch,
chng trnh nh gi theo tho thun c
th vi PTN theo cch thc c nu chi
tit trong iu 4.3.4 .

One organization could require application

for accreditation for many scope or
laboratories or for many locations with same
BoA logo. In this case, BoA will make plan,
assessment schedule comply with the
specific requirements of Organization and
this is detail mention in clause 4.3.4.

Khi nhn c n ng k cng nhn,

VPCNCL s xem xt, nh gi mc y
v chnh xc ca cc thng tin.
VPCNCL c th yu cu PTN b sung
thng tin hoc lm r mt s im no
khi cn thit.

When received the application for

accreditation, BoA will review the
informations adequacy and accuracy. BoA
can request the laboratory to provide the
amendment information (if necessary).

Khi thy thng tin cung cp y v

PTN sn sng cho vic cng nhn,
VPCNCL s thng bo cho PTN v vic
chp nhn n ng k cng nhn v vo
m s nhn n cho PTN.

When the information is enough and the

laboratory is ready for accreditation, BoA
will announce the approval of application
and give a code for applicant.

APL 01

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Accreditation Assessment Procedure for Laboratory

VPCNCL s lp hp ng nh gi vi
PTN theo qui nh v vi chi ph c tnh
theo Qui nh v chi ph nh gi cng
nhn phng th nghim AGL 10

BoA will make the assessment contract to

the laboratory according to Procedure
Laboratory accreditation assessment fee
regulation AGL 10.

Thi gian t khi tip nhn thng tin ca

PTN n khi Vn phng ra thng bo nh
gi trong vng 30 ngy (ty thuc vo s
chun b ca PTN).

The duration from accepting information of

applicant up to assessment announcement is
about 30 days (based on laboratory
preparation).

Nu PTN np n m sau 6 thng PTN

cha sn sng cho nh gi ti ch th h
s ng k cng nhn khng cn gi tr
Khi np n ng k cng nhn PTN cn
lu :

If laboratory has applied for accreditation,

over 6 months, laboratory is not ready for
onsite assessment; laboratorys applicant is
not valid.
When submit an application, Laboratory
must be pay attention to:

Phm vi cng nhn

Qui nh r lnh vc th nghim xin cng
nhn ph hp vi AGL 09 Phn loi
lnh vc th nghim.

Scope:
Define clearly field of testing/calibration to
apply for accreditation in conformity with
the AGL 09 Classification of testing fields

PTN c th xin cng nhn cho mt hoc

nhiu lnh vc th nghim nu trong AGL
09.
PTN c th xin cng nhn cho mt hoc
nhiu v tr/c s th nghim.

Laboratory can apply the accreditation for

one or more fields of testing in AGL 09

Ngi c thm quyn k

Ngi c thm quyn k ngh trong n
ng k cng nhn l ngi k vo cc bo
co kt qu th nghim/hiu chun chu
trch nhim v tnh chnh xc ca kt qu
th nghim/hiu chun.

Approved Signatories
Approved signatories who mentioned in the
applicant are persons who sign in the
test/calibration result reports and have
responsibility for the accuracy of
test/calibration results in the field of
accreditation.

4.3.4. Ch nh on nh gi v chun
b chng trnh nh gi

4.3.4. Assignment of Assessment team

and preparation for assessment schedule

Ch nh on: Cn c vo nhu cu nh
gi mi v k hoch nh gi nh k m
b phn h tr lp k hoch nh gi hng
thng c d kin on chuyn gia nh gi

Assignment of Assessment team: Based on

the assessment requirement and regularly
assessment schedule, scheduling personnel
will propose an assessment team for

APL 01

Ln ban hnh: 5.10

Laboratory can apply the accreditation for

one or more testing places/locations

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Accreditation Assessment Procedure for Laboratory

trnh Lnh o VPCNCL duyt.

submitting the
management.

Thnh vin on nh gi cng nhn c

la chn trn c s khng b bt c mt
sc p hoc xung t v quyn li kinh t,
chnh tr, tnh cm, c nng lc theo
AG 02 Yu cu chung i vi Chuyn gia
nh gi cng nhn v ph hp vi lnh
vc c nh gi.

Member of assessment team is a person who

is free from any pressure or conflict of
interest of finance, politics... ; be capable
followed to the AG 02 Criteria for
Assessor and be conformed to the field of
assessment.

Xem xt ti liu
on nh gi tin hnh xem xt tnh y
ca ti liu xin cng nhn tun th theo
th tc AP 13 th tc xem xt ti liu

Document Review
The assessment team will review the
adequacy of the applicants documents
following AP 13 Document review.

Nu ti liu khng t yu cu th on
nh gi phi thng bo cho PTN trong
vng 10 ngy sau khi nhn ti liu ca PTN
PTN thc hin khc phc theo biu AFL
01.05.

If the applicant documents are not met

requirements, the assessment team will
announce to the laboratory not exceed 10
days when receiving the document by form
AFL 01.05.

Chun b chng trnh:

Khi ti liu ca PTN p ng yu cu th
Trng on lp chng trnh nh gi chi
tit v gi ti PTN.

Preparation for assessment schedule:

When laboratory comply with BoA
requirement, Team leader set up the
assessment schedule and send it to
laboratory.

Trng hp t chc ng k nhiu PTN,

a im th chng trnh nh gi cn tho
thun vi PTN sao cho thch hp nht theo
cc nguyn tc:
- Nu nh gi trong cng khong thi
gian cho nhiu lnh vc v a im th
VPCNCL c th ch nh 1 Trng on
nh gi
- nh gi khng cng khong thi gian
th s ch nh mi a im hoc PTN
mt trng on nh gi

In case, one organization apply for many

laboratories or locations, BoA should
discuss with laboratory to make suitable
assessment schedule basing on principle:
- If assessment could conduct in same time
for all laboratories or locations, BoA
priority to assign one lead assessors.

PTN c th ngh thay i chng trnh

nh gi, chuyn gia nh gi khi c l do
chnh ng v d nh chuyn gia khng

Laboratory can change the schedule,

assessors in the case of having when having
proper reason. For example: the assessor is

APL 01

Ln ban hnh: 5.10

approval

of

BoAs

- If Assessment could not conduct in same

time for all laboratories or locations, BoA
could assign more than one lead assessor

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Accreditation Assessment Procedure for Laboratory

m bo yu cu nh nu trn.
Chng trnh chi tit bao gm:

Ni dung nh gi

Phm vi nh gi: lnh vc, v tr

nh gi bao gm tt c cc v tr ca
PTN khi PTN c nhiu c s th
nghim

Thi gian, phn cng nhim v cho

tng chuyn gia nh gi

Cc php th/hiu chun quan st

(nu thch hp)

nh gi o lng (i vi phng
hiu chun)

not ensuring to suitable with requirement as

above-mentioned.
The detail schedule included:

Content of assessment

Scope: field of assessment, location

including all of laboratory location
when laboratory apply for more than
one location

Time and assignment for member of

assessment team

Test/calibration
observed
(If
necessary)

Measurement audit (for the calibration

laboratories)

S ngy nh gi ti ch s ty thuc vo
phm vi ng k cng nhn ca PTN.

The number of on-site assessment days

depend on the scope of applicant

4.3.5. Thnh lp on nh gi chnh

thc
Sau khi kt qu xem xt ti liu t yu cu
v thng nht vi PTN v chng trnh
nh gi, chuyn gia nh gi, VPCNCL ra
quyt nh thnh lp on nh gi chnh
thc bao gm trng on v cc chuyn
gia nh gi. S lng cc chuyn gia nh
gi trong on nh gi ph thuc qui m,
c cu hot ng ca PTN v phm vi lnh
vc th nghim/hiu chun nghim ng
k cng nhn.
on nh gi c trch nhim chun b mi
iu kin nh gi theo qui nh ca
VPCNCL

4.3.5. Assignment of official assessment

team
After reviewing the applicant document and
fulfilling the requirements of accreditation
as well as having an agreement on the
assessment schedule between laboratory and
BoA, BoA will make decision to assign the
formal assessment team, including team
leader and assessors. The number of
assessor in the assessment team depends on
the size of laboratory and the fields of
test/calibration apply for accreditation.
Assessment team is responsible for
preparing all the condition for assessment
relating to the assessment process

4.3.6. Tin hnh nh gi

Hp khai mc: on nh gi tin hnh
cuc hp khai mc ti PTN khng nh
li ni dung nh gi (phm vi, chun mc,
thi gian nh gi, php th ngh quan
st).

4.3.6. Assessment
Opening meeting: Assessment team carries
out the opening meeting in laboratory to
confirm the content of assessment (scope,
criteria, timetable, and test to be
witnessed...)

PTN c th thu hp hoc xin m rng thm

phm vi ng k cng nhn cuc hp

Laboratory can limit or expand the scope of

accreditation at the opening meeting,

APL 01

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Accreditation Assessment Procedure for Laboratory

khai mc nhng khng c m rng lnh

vc, v tr PTN th nghim/ hiu chun.
Phm vi m rng ph thuc s chp nhn
ca on CGG ph hp vi kh nng
nh gi ca on.

however, the field of accreditation, the

location of testing/calibration will be not
allowed. The extension scope depends on
assessment team to comply with assessment
team abilities.

Thc hin nh gi: Vic nh gi PTN

gm 2 hnh thc sau : Thu thp thng tin v
nh gi chng kin:

Assessment: The assessment includes 2

stages: Collect information and witness
assessment

Thu thp thng tin: on nh gi

thu thp thng tin qua phng vn cn
b PTN, xem xt h thng ti liu, h
s, quan st hot ng trong PTN
c bng chng khch quan khng
nh h thng qun l cht lng ca
PTN ph hp chun mc cng nhn.

nh gi chng kin: Chuyn gia

k thut, chuyn gia t vn k thut
s chng kin cc php th/hiu
chun trong phm vi lnh vc ng
k cng nhn do cc th nghim vin
tin hnh (s lng cc php th/hiu
chun ngh quan st do on
chuyn gia nh gi xc nh v la
chn theo nguyn tc qui nh trong
AG 22 Hng dn cho chuyn gia
k thut nh gi PTN m bo
kt qu nh gi l in hnh cho
nng lc ng k cng nhn ca
PTN). nh gi chng kin c th
thc hin ti PTN hoc hin trng
tu thuc phm vi thc hin php
th/hiu chun ca PTN.
on nh gi phi m bo tin nh
gi theo chng trnh nh.

Hp kt thc nh gi: Kt qu nh gi
c cp y trong bo co nh gi
AFL 01.08 v c thng bo vi PTN ti
cuc hp kt thc nh gi. Bo co nh

Assessment team must ensure the

assessment progress to follow the agreement
schedule.
Closing meeting: The result of assessment is
shown in the assessment report AFL 01.08
and is announced to laboratory at the closing
meeting. Assessment report proposes BoA

APL 01

Ln ban hnh: 5.10

Ln sot xt:1.11

Collect information: Assessment team

collects information through staff
interview, documents and record
review, the laboratorys activity
observation in order to collect the
objective evidence to confirm that the
quality
management
system
complying with the accreditation
criteria.
Witness
assessment:
Technical
assessor, technical expert will witness
the tests covered in the scope of
applicant are carried out by the tester
(the number of test/calibration to be
witnessed will be decided by
assessment team based on AG 22
Guidelines for assessment laboratory
of technical assessors) for ensure that
the result of assessment is typical for
competence of laboratory. Witness
assessment can be carried out in or out
laboratory depend range to conduct
test/calibration of laboratory.

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Accreditation Assessment Procedure for Laboratory

gi ngh ln VPCNCL mt trong 3 hnh

thc sau:

Khng ngh cng nhn PTN;

ngh cng nhn vi iu kin c

nh gi b sung (follow up) ti
PTN;

ngh cng nhn; ngh cng

nhn sau khi khc phc cc iu
khng ph hp.

one of three mode:

Bo co nh gi phi bao gm: nhn xt

chung, nhng im khng ph hp v
khuyn ngh c pht hin trong qu trnh
nh gi, ngh ln VPCNCL gm: phm
vi ngh cng nhn bao gm s lng
php th/hiu chun ngh, lnh vc,
phm vi, ngi c thm quyn k.

Assessment report has to include:

conclusion,
non-conformities
and
observations are found in the assessment
process that proposed BoA includes: the
number of testing/calibration, scope, field of
testing/calibration, approved signatories.

Cc im khng ph hp c phn loi

thnh loi nng (1) hoc loi nh (2) v yu
cu PTN thc hin hnh ng khc phc.
Cc im khuyn ngh khng yu cu bt
buc PTN phi c hnh ng khc phc.

Non-conformities are classified: the major

(1) and minor (2) non-conformity.
Laboratory must carry out the corrective
action.
These observations are not required to take
corrective action.

PTN phi thc hin hnh ng khc phc

v gi km bng chng cho VPCNCL
trong thi hn tho thun vi on chuyn
gia nh gi, ti a khng qu 3 thng k
t ngy nh gi cng nhn i vi trng
hp nh gi ln u. Trng hp nh gi
li v nh gi gim st, nh gi m rng
thi hn thc hin hnh ng khc phc ti
a khng qu 2 thng.

Laboratory must carry out corrective action

attached with the evidence basing on the
agreement with assessment team but not
exceed 3 months since the assessment in
case of the initial assessment. In the case of
reassessment,
surveillance,
extend
assessment, the time for corrective action
bases on the requirements not exceed 2
months.

Sau thi hn ti a qui nh thc hin

khc phc nu trn nu PTN khng gi h
s hnh ng khc phc ti VPCNCL th
h s qu trnh nh gi khng cn hiu
lc ngh cng nhn.
Trng hp PTN phi nh gi b sung th
thi gian nh gi b sung ti PTN c
tho thun vi on CGG nhng cng

After time for corrective action taken as

above, if laboratory doesnt send corrective
action reports to BoA, the assessment report
will not have validity for accreditation.
In case of needing to have followed up
assessment, laboratory agreement with
assessment team for schedule of follows up
assessment but not exceeds 3 months.

APL 01

Ln ban hnh: 5.10

Ln sot xt:1.11

Not suggest to accredit;

Suggest to accredit on condition that
conduct a follow up assessment in
laboratory;
Suggest
accrediting;
suggest
accrediting after the corrective action
taken of nonconformity.

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Accreditation Assessment Procedure for Laboratory

khng qu 3 thng k t ngy nh gi.

4.3.7. Thm xt, ra quyt nh Cng
nhn
Sau khi thm xt hnh ng khc phc t
yu cu on CGG tp hp ton b h s
nh gi, lp ngh cng nhn v chuyn
h s ln Ban thm xt.

4.3.7. Review, accreditation decision

Trong qu trnh thm xt, cc thnh vin

Ban thm xt c th yu cu on nh gi
cng nhn gii thch hoc cung cp thm
thng tin lm r vn no .
Thnh vin Ban thm xt c quyn t chi
ngh cng nhn nu xt thy qu trnh
nh gi cng nhn khng tun th ng
cc qui nh chung v cng nhn.

In the review process, member of Review

Panel can require the assessment team to
clarify more the result of assessment and
other concerned matters.
Member of Review Panel has right to refuse
the accreditation result if the accreditation
assessment process is not followed to the
accreditation requirement

Cn c theo ngh ca Ban thm xt v

h s qu trnh nh gi cng nhn, Gim
c Vn phng cng nhn s ra quyt nh
cng nhn.

Based on the proposal of the Review Panel

and the assessment records, Director of BoA
will make the decision on accreditation.

Thi gian thm xt, ra quyt nh cng

nhn khng qu 15 ngy lm vic.

Duration for record review and accreditation

decision is not exceeding 15 working days.

Trng hp t chc ng k nhiu a

im hoc nhiu PTN th PTN hoc a
im no hon thnh h s trc s nhn
c quyt nh cng nhn trc v m
bo ton b cc v tr v cc PTN u c
cng s hiu

In case, the organization apply for many

locations or laboratories if any laboratory or
location have completed assessment record
then it will be received decision and still
ensure that all laboratories or locations have
same VILAS code.

H s cng nhn gi PTN bao gm: quyt

nh cng nhn km ph lc cng nhn bao
gm phm vi c cng nhn, ngi c
thm quyn k v cc iu kin c th
khc, chng ch cng nhn, du VILAS c
m s ring ca PTN.

Accreditation records will be sent to

laboratory
including:
decision
on
accreditation with appendix included: scope
of accreditation, approved signatories and
others specific conditions, certificate of
accreditation, and VILAS logo with the
laboratorys code.

4.3.8. Gim st sau cng nhn

Trong thi gian hiu lc cng nhn, nh
k 12 thng, VPCNCL tin hnh nh gi

4.3.8. Surveillance
BoA conducts periodically surveillance
assessment at the accredited organizations

APL 01

Ln ban hnh: 5.10

After reviewing and closing all the

corrective actions, the team leader will
propose all the records of assessment to
Review Panel

Ln sot xt:1.11

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Accreditation Assessment Procedure for Laboratory

gim st PTN m bo rng PTN c

cng nhn vn duy tr s ph hp vi
chun mc cng nhn v cc qui nh ca
VPCNCL.
Trc cuc nh gi gim st PTN phi
np h s theo di chng trnh th
nghim thnh tho/so snh lin phng
trong nm theo mu AFL 01.01 n Vn
phng Cng nhn Cht lng.

once a year in order to ensure that the

laboratory always maintain in conformity
with accreditation standard and BoA
regulation.
Before surveillance, the laboratory must
send to BoA the PT list in this year
following the form AFL 01.01.

VP CNCL cng c th tin hnh nh gi

t xut trong cc trng hp sau:

nh gi khi c s thay i ca t
chc c cng nhn m thay i
c nh hng ti nng lc hot ng
ca t chc trong phm vi c cng
nhn;

nh gi t xut (do khiu ni, do

yu cu ca c quan qun l, do yu
cu ca cc t chc Quc t v cng
nhn m VPCNCL l thnh vin);

nh gi o lng i vi cc phng
hiu chun.

BoA can conduct unforeseen assessment in

case of:

Organization changes that effect to

capabilities of accredited scope of
laboratory;

Trng hp nh gi gim st hoc t

xut nu on CGG pht hin nhng iu
khng ph hp nghim trng, nh hng
ti cht lng, khch quan, trung thc,
mc tin cy trong phm vi cng nhn th
on CGG c th ngh nh ch cng
nhn PTN hoc nh ch phm vi c th.

If assessment team found nonconformity

during
surveillance
or
unforeseen
assessment that critical effect
to
tests/medical/calibration result, quality of
tests/medical/calibration, objective, honest
in accreditation scope, assessment team
could suggest to BoA temporary suspension
for laboratory
Non-conformities of surveillance must be
corrected immediately and time of closing
NC need to agree with assessment team but
not exceed 2 months since assessment.

Nhng iu khng ph hp pht hin trong

qu trnh nh gi gim st phi c PTN
khc phc ngay v thi hn hon thnh
c tha thun vi on CGG nhng
khng qu 2 thng k t ngy tin hnh
nh gi gim st.
Nu qu 2 thng m PTN khng thc hin
xong hnh ng khc phc cc iu khng
ph hp, VPCNCL s ra thng bo tm
thi nh ch hiu lc cng nhn PTN v
khong thi gian tm thi nh ch hiu lc
cng nhn t nht l 6 thng. Sau thi gian
APL 01

Ln ban hnh: 5.10

Unforeseen assessment due to

(complaints, authorized organization
and
international
organization
requirement that BoA is a member);
Measurement audit for calibration
laboratory.

After 2 months, if laboratory has not

finished the corrective action of all
nonconformities,
BoA
will
give
announcement for temporary suspension.
The suspension period is at least 6 months.
After suspension, if laboratory does not

Ln sot xt:1.11

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Accreditation Assessment Procedure for Laboratory

nh ch nu PTN khng cung cp cho

VPCNCL bng chng v hnh ng khc
phc, VPCNCL s quyt nh hy b hiu
lc cng nhn.
n thi hn nh gi gim st, v l do
chnh ng, PTN phi gi vn bn ngh
hon lch gim st. Thi gian hon ti a
khng qu 2 thng.
Trng hp qu 2 thng m PTN vn
khng th b tr tin hnh nh gi gim
st hoc ht thi hn tm thi nh ch
(trng hp PTN khng thc hin trong
vng 2 thng hnh ng khc phc sau
cuc nh gi gim st) th VPCNCL s ra
quyt nh hy b hiu lc cng nhn.
Trong mt s trng hp c th, gim c
VPCNCL quyt nh.

provide BoA the evidence of taken

corrective actions, BoA will decide to
withdraw the laboratorys validity of
accreditation.
Laboratory can change the time of
surveillance due to the adequate reason.
Laboratory must send a formal writing to
BoA for the surveillance delay. Delay period
is not exceeded 2 months.
If over 2 months, laboratory could not
arrange the surveillance or over period of
suspend temporary (in case laboratory has
not finished the corrective action that found
during the surveillance visit) that BoA will
withdraw the validity of accreditation. In
special case, BoA director will make the
final decision.

4.3.9. M rng phm vi cng nhn

Khi PTN c nhu cu m rng phm vi
cng nhn nh m rng php th/hiu
chun, thm quyn k, lnh vc, v tr, PTN
lm n ng k cng nhn theo mu gi
ti VP CNCL ngh nh gi m rng.

4.3.9. Extend scope

When laboratory needs to expend the
accreditation scope such as test/calibration,
field of accreditation, signatories, location
laboratory should apply the accreditation
application to BoA for expanding the scope.

VPCNCL s xem xt h s v b tr nh
gi m rng ti PTN. Qu trnh nh gi
m rng tng t nh nh gi ban u i
vi phm vi ng k m rng

BoA will review record and conduct an

extend assessment on laboratory. Procedure
for extend scope same as initial assessment.

Trng hp m rng thm quyn k, cp

nht mi phng php, m rng thm
phm vi phng php th/hiu chun
cng nhn VPCNCL c th xem xt
quyt nh da trn h s nng lc ca
PTN.

In case extend for signatories, update

methods, extend scope (range, LOD,
CMC) of accredited test/calibration, BoA
could review and decide base on capabilities
of laboratory record.

4.3.10. Thu hp phm vi cng nhn

PTN c th ch ng gi cng vn thng
bo ti BoA ngh thu hp phm vi
c cng nhn. BoA s ra quyt nh thu
hp hoc thu hi quyt nh cng nhn tu

4.3.10. Reduce accreditation scope

PTN could initiative send a letter to BoA for
reduction of accredited scope. BoA will
review and send to laboratory reduce scope
or withdraw accreditation decision base on

APL 01

Ln ban hnh: 5.10

Ln sot xt:1.11

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Accreditation Assessment Procedure for Laboratory

vo phm vi ngh ca PTN.

suggest of laboratory.

BoA s ch ng thu hp phm vi cng

nhn ca PTN trong trng hp thng qua
nh gi gim st, nh gi t xut, kt
qu tham gia PT ca PTN khng p ng
yu cu duy tr cng nhn.

BoA could initiative reduce accredited scope

base on surveillance, unforeseen assessment,
laboratory PT results are not satisfy of
accreditation requirement.

4.3.11. nh gi li
Khi ht hn hiu lc cng nhn (3 nm)
nu PTN mun tip tc duy tr cng nhn
th PTN np n ng k cng nhn li cho
VPCNCL. Thi gian np n v tin hnh
nh gi cng nhn li l 2 thng trc khi
ht hiu lc cng nhn.

4.3.11. Reassessment
When the accreditation expires (3 years), if
laboratory wish to maintain the accreditation
validation, laboratory shall send the
applicant for accreditation to BoA.
Laboratory has to submit application for reassessment during 2 months before the
validity of accreditation comes to an end.

Trng hp sau khi ht hn hiu lc cng

nhn m PTN khng np n ng k cng
nhn li th sau 3 thng Vn phng CNCL
s thng bo cho cc bn c lin quan v
cng b trn website ca VP CNCL v vic
ht hiu lc cng nhn ca PTN.

In case the accreditation expires, after 3

months, if laboratory doesnt submit an
application, the suspension shall be
informed by the BoA to the related bodies
and posted to Boas website.

Vic nh gi cng nhn li c tin hnh

nh nh gi ln u. H s ng k cng
nhn khng cn np phiu hi. PTN khng
cn np cc ti liu m PTN khng c thay
i so vi ln nh gi u. Nu c cc
thng tin thay i th Phng th nghim cn
cp nht thng tin thay i vo mu ph
lc D.

The accreditation reassessment shall be

carried out as initial assessment. Lab
Application record dont need to send
questionnaire. Laboratory doesnt need to
send any document that has not any change
with last assessment. If laboratory have any
change that laboratory shall fill in form
annex D

Nhng iu khng ph hp pht hin trong

qu trnh nh gi li/nh gi m rng
phi c PTN khc phc ngay v thi hn
hon thnh c tha thun vi on
CGG nhng khng qu 2 thng k t
ngy tin hnh nh gi.

Non-conformities of reassessment/ extend

assessment must be corrected immediately
and the finishing time will be agreed by
assessment team but not exceed 2 months
since the assessment.

Sau 2 thng nu PTN khng gi h s hnh

ng khc phc ti VPCNCL th h s qu
trnh nh gi khng cn hiu lc

After 2 months, if laboratory could not send

the corrective action records to BoA, the
assessment records will no longer validate.

APL 01

Ln ban hnh: 5.10

Ln sot xt:1.11

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Accreditation Assessment Procedure for Laboratory

ngh cng nhn.

4.4. Thi hn hiu lc cng nhn

4.4. Accreditation validity

Trng hp nh gi ln u: thi hn
hiu lc cng nhn l 3 nm tnh t ngy
k quyt nh cng nhn. Ngy cng nhn
ln u cng l ngy k quyt nh.

The first assessment for accreditation: the

accreditation validity period is 3 years from
the date to grant the accreditation. The first
accreditation is the date of accreditation
decision
For example: the date to grand the
accreditation is 3/4/2007 so that validity
period from 3/4/2007 to 3/4/2010 and the
first accreditation is 3/4/2007

V d: ngy k quyt nh cng nhn l

3/4/2007 th thi hn hiu lc cng nhn l
3/4/2007 n 3/4/2010 v ngy cng nhn
ln u l 3/4/2007
Trng hp nh gi m rng: thi hn
hiu lc ca quyt nh cng nhn m rng
s trng vi thi hn hiu lc cng nhn
ca quyt nh cng nhn ban u hoc
cng nhn li gn nht.
V d: ngy k quyt nh cng nhn ln
u l 3/4/2007 th thi hn hiu lc cng
nhn l 3/4/2007 n 3/4/2010. Ngy k
quyt nh m rng l 5/7/2008 th thi
hn hiu lc cng nhn ca quyt nh
cng nhn m rng l 5/7/2008 n
3/4/2010
Trng hp nh gi li: thi hn hiu
lc ca quyt nh cng nhn li c chia
lm 2 trng hp

Trng hp PTN thc hin nh gi

li ng thi hn qui nh ca
VPCNCL tnh hiu lc cng nhn l
3 nm nhng ly mc l ngy cng
nhn ln u
V d: ngy k quyt nh cng nhn ln
u l 5/7/2005 th thi hn hiu lc cng
nhn l 5/7/2005 n 5/7/2008. Ngy k
quyt nh li l bt c ngy no t
5/5/2008 n 5/10/2008 th thi hn hiu
lc cng nhn ca quyt nh cng nhn
li l t ngy k quyt nh n 5/7/2011
v ngy cng nhn ln u l 5/7/2005

Trng hp PTN thc hin nh gi

APL 01

Ln ban hnh: 5.10

The extend assessment for accreditation:

the accreditation validity period is the same
with the nearness accreditation decision of
the first accreditation or re-accreditation.
For example: the date to grand the first
accreditation is 3/4/2007 so that validity
period from 3/4/2007 to 3/4/2010. The date
to grant the accreditation extend is 5/7/2008
so validity period of the accreditation extend
from 5/7/2008 to 3/4/2010.
Re assessment: the accreditation validity
period has been divided into two situations:

Laboratory conducts re-assessment on

time with BoA requirements that
accreditation validity period is 3 years
by calculation as the same date with
the first accreditation.
For example: the first accreditation is
5/7/2005 that the accreditation validity
period from 5/7/2005 to 5/7/2008. The date
to grant re-accreditation is any date from
5/5/2008 to 5/10/2008 that the accreditation
validity period from the date to grant
reaccreditations to 5/7/2011 and the first
accreditation is 5/7/2005.

Laboratory conducts reassessment

Ln sot xt:1.11

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li khng theo thi hn qui nh ca

VPCNCL th thi hn hiu lc cng
nhn l 3 nm k t ngy k quyt
nh cng nhn li v ngy cng
nhn ln u l ngy k quyt nh
cng nhn.
V d: ngy k quyt nh cng nhn ln
u l 5/7/2005 th thi hn hiu lc cng
nhn l 5/7/2005 n 5/7/2008. Ngy k
quyt nh li l bt c ngy no t sau
5/10/2008 th thi hn hiu lc cng nhn
ca quyt nh cng nhn li l 3 nm k
t ngy k quyt nh v ngy cng nhn
ln u cng l ngy k quyt nh nh k
quyt nh ngy 8/11/2008 th thi hn
hiu lc l 8/11/2008 n 8/11/1010 v
ngy cng nhn ln u l 8/11/2008.

which is not suitable with BoA

requirements
that
accreditation
validity period is 3 years from the date
to grant reaccreditations and the first
accreditation is the date to grant reaccreditation.
For example: the first accreditation is
5/7/2005 that the accreditation validity
period from 5/7/2005 to 5/7/2008. The date
to grant re-accreditation is any date from
5/10/2008 that the accreditation validity
period is 3 years from the date to grant
reaccreditations and the first accreditation
is the date to grant reaccreditations; the
date to grant reaccreditations is 8/11/2008
that the accreditation validity period from
8/11/2008 to 8/11/1010 and the first
accreditation is 8/11/2008.

4.5. Phn nn, yu cu xem xt li

4.5. Complaints, Appeals

Cc t chc c cng nhn; cc t chc

ng k cng nhn; cc t chc v c nhn
s dng dch v ca cc t chc c cng
nhn hoc xin cng nhn; cc c quan qun
l v cc c nhn c quan tm u c
quyn phn nn v chnh sch, th tc, cc
quy nh v cc hot ng c th ca c
quan cng nhn. PTN c cng nhn hoc
ang ng k cng nhn c quyn yu cu
xem xt li cc kt lun ca on nh gi,
yu cu xem xt li cc quyt nh ca c
quan cng nhn.
Tt c cc yu cu xem xt li c
VPCNCL gii quyt theo Th tc gii
quyt yu cu xem xt li AP 03.

All parties includes: accredited bodies,

applicant, bodies who use services of
accredited CAB, management bodies and
individual... have right to complaint against
policy, procedures, regulations or activities
of BoA, activities of applicant CAB or
accredited CAB. Applicant CAB or
accredited CAB have right to appeal the
conclusion of assessment team or decision
of BoA.

Cc phn nn c gii quyt theo Th

tc gii quyt phn nn AP 02.

The complaints are related to procedure

The Complaints AP 02.

4.6. Chnh sch v s dng dch v hiu

chun thit b

4.6. Policy of equipment calibration

services

APL 01

Ln ban hnh: 5.10

The appeals against a decision of BoA that

is directly related to their accreditation status
will be preceded in accordance with
procedure The Appeal - AP 03.

Ln sot xt:1.11

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Accreditation Assessment Procedure for Laboratory

cp trong APL 02

Mention in APL 02

4.7. Chnh sch v th nghim thnh

tho/ so snh lin phng

4.7. Policy
of
Inter-laboratory
comparison/Proficiency
testing
programmers
Mention in APL 02

cp trong APL 03
Vi cc PTN c cng nhn, nu kt qu
thc hin chng trnh TNTT/SSLP nm
ngoi gii hn cho php v khng c hnh
ng khc phc ph hp th Gim c
VPCNCL s quyt nh thnh lp on
nh gi t xut xem xt cc hot ng
c cng nhn v c th a ra cc
quyt nh nh ch hoc hu b hiu lc
cng nhn ca PTN .
Cc PTN tham gia chng trnh
TNTT/SSLP phi c ngha v thc hin
y cc yu cu ca chng trnh.
Cc PTN c cng nhn phi c trch
nhim v ngha v tham gia cc chng
trnh TNTT/SSLP c lin quan n lnh
vc c cng nhn do VILAS lm u
mi hoc t chc trng hp PTN khng
tham gia TNTT/SSLP th PTN c th b
nh ch hoc hu b hiu lc cng nhn
ty thuc h s qu trnh tham gia
TNTT/SSLP.
PTN phi c chnh sch, k hoch, ni
dung c th i vi hot ng TNTT/SSLP
v lp h s y v kt qu hot ng
ny thng bo cho VPCNCL. Nu cc PTN
khng tham gia cc chng trnh
TNTT/SSLP

If the results of Proficiency testing programs

are exceed the limitation and without the
suitable corrective action, Directory of BoA
will assign an unforeseen assessment team
to check the accredited activities and decide
suspension or withdrawal accreditation of
that laboratory.

Laboratory is responsible for meeting all

requirements
of
proficiency
testing
programs.
Accredited laboratory has right and
responsibilities for joining the relevant fields
of Inter-laboratory comparison/Proficiency
testing program which are organized by
VILAS, if laboratory has been not attended
the PT program, the laboratory could be
suspended or withdraws the accreditation
validity depend on PT record of laboratory.
Laboratory should have a policy, procedure,
record and announcement to BoA.
Regarding
to
the
Inter-laboratory
comparison/Proficiency testing program.

4.8. Forms
4.8. Cc biu mu:

AF11.01

Mu n ng k cng
nhn

AFL 01.01

Phiu theo di PT

AFL 01.02

Phiu hi PTN

AFL 01.03

Yu cu xem xt ban u

APL 01

Ln ban hnh: 5.10

AFL 01.01

Application form

AFL 01.01

PT list

AFL 01.02

Questionnaire for laboratory

AFL 01.03

Initial review requirement

AFL 01.04

Initial review report

AFL 01.05

Document review report

Ln sot xt:1.11

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Th tc nh gi Cng nhn Phng th nghim

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AFL 01.04

Bo co xem xt ban u

AFL 01.05

Bo co xem xt ti liu

AFL 01.06

AFL 01.06

Witnessing the tests/calibration

report

Bo co quan st k nng

AFL 01.07

Finding report

AFL 01.07

Bo co nhng pht hin

AFL 01.08

Assessment report

AFL 01.08

Bo co nh gi

AFL 01.09

Accredited tests

Danh mc php th c
cng nhn

AFL 01.10

Accredited calibrations

AFL 01.09

AFLM 01.01

Questionnaire for laboratory

AFL 01.10

Danh mc php hiu

chun c cng nhn

Appendix G

Appendix of Application form

AFLM 01.02

Finding report

AFLM 01.03

Medical Technical Assessor

Assessment
checklist/Discipline:
Chemical/Hematology/Immuno
logy

AFLM 01.04

Medical Technical
Assessment
checklist/Discipline:
Microbiology

AFLM 01.05

Assessment report

AFLM 01.06

Accredited Medical Tests

AFLM 01.01

Phieu hoi

Ph lc G

Ph lc ca n ng k
cng nhn cho PXN

AFLM 01.02

Bo co Pht hin

AFLM 01.03

Bo co quan st k nng
dnh cho chuyn gia k
thut/lnh vc: Ha sinhHuyet hoc-Min dch

AFLM 01.04

Bo co quan st k nng
dnh cho chuyn gia k
thut/lnh vc: Vi sinh

AFLM 01.05

Bo co nh gi

AFLM 01.06

Danh mc ch tiu xt
nghim c cng nhn

APL 01

Ln ban hnh: 5.10

Ln sot xt:1.11

Trang: 21/21

Assessor