a69ujfgl_apl 01 Cong Nhan Ptn 11 2011

8/21/2019 a69ujfgl_apl 01 Cong Nhan Ptn 11 2011

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VN PHNG CNG NHN CHT LNGBureau of Accreditation (BoA)

THTC

NHGI CNG NHNPHNG TH NGHIM

ACCREDITATION ASSESSMENT PROCEDURE

FOR LABORATORY

M s/Code: APL 01Ln ban hnh/I ssued number: 5.10

Ngy ban hnh/ I ssued date: 12/2010


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Th tc nh gi Cng nhn Phng th nghimAccreditation Assessment Procedure for Laboratory

APL 01 Ln ban hnh: 5.10 Ln sot xt:1.11 Trang: 2/21

1. Mc chTh tc ny c xy dng qui nhtrch nhim v trnh by qu trnh nh gicng nhn phng th nghim ca Vn phng

cng nhn cht lng - VILAS.

2. Phm viTh tc ny c p dng cho Vn phngCng nhn Cht lng - VILAS v cc

phng th nghim ng k cng nhn, c cng nhn.

3. Trch nhim

Mi nhn vin VPCNCL, chuyn gia nhgi phi tun th theo qui nh ny;Phng th nghim ng k cng nhn, c cng nhn phi thc hin theo qui nhtrong th tc ny.

4. Ni dung

4.1. nh ngha v Cc ch vit tt

1. PurposeTo define the responsibility and content of

accreditation assessment process for

laboratory of Bureau of Accreditation

VILAS.

2. ScopeThis procedure is applied for Bureau of

Accreditation VILAS, applicants andaccredited laboratories

3. Responsibility

All the staff of BoA, assessors must becomplied with regulation of this procedure;

All the applicants and accredited

laboratories must also be complied with

regulation of this procedure

4. Content

4.1. Definition and Abbreviation


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VPCNCL

BoA

Vn phng Cng nhn Cht lng

Bureau of Accreditation

VILAS H thng Cng nhn Phng th nghim Vit Nam

Vietnam Laboratory Accreditation Scheme

PTN

Laboratory

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

Laboratory (including testing/calibration, medical testing, biosafety

laboratory)

iu khng phhp nng

Majornon-conformity

L nhng iu khng ph hp dokhng p ng mt yu cu c ththeo chun mc cng nhn, mang tnh h thng v tc ng trc tipn tin cy ca kt qu th nghim/ hiu chun.

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 phhpnh

Minornon-conformity

L nhng iu khng ph hp n l khng ph hp vi chun mccng nhn hay qui nh trong h thng qun l ca PTN v khng tcng trc tip n tin cy ca kt qu th nghim/ hiu chun.

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 hpnh n l nu c lin quan vi nhauv 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

KhuynnghObservation

Pht hin trong qu trnh nh gi nhm mc ch ci tin.An assessment finding that does not warrant nonconformity but is

identified by the assessment team as an opportunity for improvement.


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4.2. Qu trnh cng nhn

Tip xc ban u

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

PTN np n, STCLv cc ti liu lin quan

Ch nh on chuyn gia nh gi

Xem xt ti liu

Quytnhthnh lp on nh gi

nh gi ti PTN

Quyt nh cng nhn

nh gi Cng nhn li(sau 3 nm)

Khng t

Thm xt

M rng phm vi cng nhn(theo nhu cu ca PTN)

Gim st PTN

(hng nm)

t

Khng t

Thc hin hnh ng khc phc

Khng t


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4.2 Accreditation process

Initial contact

Pre - assessment(If necessary)

Applying for accreditation, Qualitymanual and concerning document(Procedures, in-house methods)

Assign assessment team

Document review

Decide official assessment team

On site Assessment

Accreditation decision

Re-Assessment(After 3 years)

Not accepted

Record Review

Extend assessment

(According to the Labs requirement)Surveillance

(annual)

Corrective action taken

Not accepted

Not accepted


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4.3. Trnh t tin hnh nh gi cngnhn

4.3.1. Tip xcban u

Nu c nguyn vng xin cng nhn, PTNc th lin h vi VPCNCL c c ccthng tin v hng dn cn thit lin quann vic cng nhn nh:

Chun mc cng nhn: ISO/IEC17025:2005Yu cu chung v nnglc ca phng th nghim v hiuchun; yu cu b sung cng nhncho tng lnh vc c th, cc qui nh

ca VPCNCL v cc qui nh v phplut trong phm vi hot ng ca PTN.

Chun mc cng nhn phng xtnghim l ISO 15189:2007, yu curing v cc hng dn c lin quanca APLAC,ILAC

Chun mc cng nhn phng an tonsinh hc cp 3 l AGL 20 Yu cuchung v nng lc ca phng th

nghim an ton sinh hc cp 3.

PTN c cung cp b ti liu linquan n vic cng nhn bao gm: Qui nh chung v cng nhn

AP 01; Phn loi lnh vc th

nghim/hiu chunAGL 09;

Th tcv chnh sch lin quannh gi cng nhn PTN APL 01; APL 02; APL 03;APL 04;

Qui nh v s dng biu tngcng nhnAG 01;

Th tc gii quyt phn nn -

AP 02; Th tc gii quyt yu cu xemxt li(appeal) - AP 03;

4.3. Accreditation assessment process

4.3.1.Initial contact

Laboratory should be provided necessaryinformation and guideline regarding to the

accreditation if laboratory has expectation of

accreditation:

ISO/IEC 17025:2005 GeneralRequirement for the competence of

testing and calibration laboratories;Supplementary requirements for each

field, Boa regulations and others

legislation regulations relating to thelaboratory activities

Medical laboratory accreditation criteria

are ISO 15189:2007, supplementary

requirements and related APLAC, ILAC

guidelines

Level 3 Biosafety laboratory

accreditation criteria are AGL 20

General requirement for the

competence of Level 3 Biosafety

laboratory.

Laboratory is provided documents

concerning accreditation including:

General requirement of

Accreditation - AP 01; Classify of testing fieldsAGL

09;

Accreditation assessmentprocedures for laboratory APL01; APL 02; APL 03; APL 05;

Regulation for using of

accreditation logo and symbol AG 01;

Complaints procedure - AP 02;

Appeals procedure - AP 03;


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Qui nh v bo mt; Qui nh chi ph nh gi

AGL10;

Phiu hiAFL 01.02;

Mu n ng k cng nhnAF11.01;

Phng th nghim cn nghin cu k cc tiliu trn trc khi np n xin cng nhn.

4.3.2. Xem xt ban u/ nh gi s b

Nu PTN c yu cu, VPCNCL c th tinhnh nh gi s b trc khi nh gichnh thc. Ni dung nh gi s b theoyu cu ca PTN v tho thun trc viVPCNCL. Cuc xem xt ny khng bt

buc i vi PTN v c th tin hnh trchoc sau khi np n ng k cng nhn.

4.3.3.

Np n ng k cng nhn

Trc khi np n ng k cng nhn PTNphi m bo hon thnh xy dng vp dng h thng qun l theo chun mccng nhn(ISO/IEC 17025:2005; ISO/IEC15189; AGL 20) t nht l 3 thng (c hs chocc hot ng c thc hin) vh thng qun l c xc nh l c hiu

qu thng qua vic nh gi ni b, xemxt ca lnh o

PTN p ng yu cu nu trong AP 01 Quinh chung v Cng nhn u c th npn ng k cng nhn ti VPCNCL. nng 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 (AFL01.02);

Regulation of Confidentiality;

Accreditation fees - AGL10;

QuestionnaireAFL 01.02;

Application formAF 11.01;

The laboratory should consider carefully

these documents before submitting an

application

4.3.2.Pre-assessment

BoA will carry out pre-assessment before

official assessment (if laboratory has

required). The content of pre-assessment

bases on laboratory requirement and theagreement 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.

Application for accreditation

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

Laboratories meet requirements relating to

the AP 01 General requirement ofaccreditation. The application form (AF11.01) need to submit to BoA these

following documents:

Quality Manual;

Questionnaire (AFL 01.02);


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Php th/ hiu chun ni b(nu c)bao gm bo co tng hp d liuxc nhn gi tr s dng caphng

php; tnh khng m bo o (i

vi phng hiu chun);

Tng hp d liu v bo co xcnhn gi tr s dng ca phng phpi vi cc phng php c thay iso vi phng php tiu chun.

Danh mc ti liu kim sot caPTN;

H s nh gi ni b v xem xt calnh o chu k gn nhtBo co th nghim thnh tho theomu AFL 01.01;Thng k cc ch tiu thnghim/hiu chun ng k cngnhn thc hin t hn 4 ln trong 1nm; vMt s ti liu c lin quan khc (khic yu cu).

Mt t chcc th ng k cng nhn vimt s hiu cho nhiu lnh vc th nghim,nhiu phng th nghim trong mt t chchoc nhiu a im khc nhau. Trongtrng hp ny, VPCNCL s ln k hoch,chng trnh nh gi theo tho thun cth vi PTN theo cch thc c nu chitit trong iu 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 sungthng tin hoc lm r mt s im no khi cn thit.

Khi thy thng tincung cp y vPTN sn sng cho vic cng nhn,

VPCNCL s thng bo cho PTN v vicchp nhn n ng k cng nhn v vom s nhn n cho PTN.

In-house testing/calibration methods

(if any) including method validation

records; estimation of the

measurement capability (for the

calibration);

Method validation report if lab have

any changed reference

method/standard method

The list of controlled documents ;

The nearest internal audit andmanagement 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)

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.

When received the application for

accreditation, BoA will review the

informations adequacy and accuracy. BoAcan request the laboratory to provide the

amendment information (if necessary).

When the information is enough and the

laboratory is ready for accreditation, BoA

will announce the approval of applicationand give a code for applicant.


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VPCNCL s lp hp ng nh gi viPTN theo qui nh v vi chi ph c tnhtheo Qui nh v chi ph nh gi cngnhn phng th nghim AGL 10

Thi gian t khi tip nhn thng tin caPTN n khi Vn phng ra thng bo nhgi trong vng 30 ngy (ty thuc vo schun b ca PTN).

Nu PTN np n m sau 6 thng PTNcha sn sng cho nh gi ti ch th hs ng k cng nhn khng cn gi tr

Khi np n ng k cng nhn PTN cnlu :

Phm vi cng nhnQui nh r lnh vc th nghim xin cngnhn ph hp vi AGL 09 Phn loilnh vc th nghim.

PTN c th xin cng nhn cho mt hocnhiu lnh vc th nghim nu trong AGL09.

PTN c th xin cng nhn cho mt hocnhiu v tr/c s thnghim.

Ngi c thm quyn kNgi c thm quyn k ngh trong nng k cng nhn l ngi k vo cc boco kt qu th nghim/hiu chun chu

trch nhim v tnh chnh xc ca kt quth nghim/hiu chun.

4.3.4. Ch nh on nh gi v chunb chng trnh nh gi

Ch nh on:Cn c vo nhu cu nhgi mi v k hoch nh gi nh k m

b phn h tr lpk hoch nh gihngthng c d kin on chuyn gia nh gi

BoA will make the assessment contract to

the laboratory according to Procedure

Laboratory accreditation assessment feeregulation AGL 10.

The duration from accepting information of

applicant up to assessment announcement is

about 30 days (based on laboratorypreparation).

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:

Scope:Define clearly field of testing/calibration to

apply for accreditation in conformity with

the AGL 09 Classification of testing fields

Laboratory can apply the accreditation for

one or more fields of testing in AGL 09

Laboratory can apply the accreditation for

one or more testing places/locations

Approved SignatoriesApproved 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. Assignment of Assessment teamand preparation for assessment schedule

Assignment of Assessment team: Based on

the assessment requirement and regularly

assessment schedule, scheduling personnelwill propose an assessment team for


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trnh Lnh o VPCNCL duyt.

Thnh vin on nh gi cng nhn c

la chn trn c s khng b bt c mtsc p hoc xung t v quyn li kinh t,chnh tr, tnh cm, c nng lc theoAG 02 Yu cu chung i vi Chuyn gianh gi cng nhn v ph hp vi lnhvc c nh gi.

Xem xt ti liuon nh gi tin hnh xem xt tnh y

ca ti liu xin cng nhn tun th theoth tc AP 13 th tc xem xt ti liu

Nu ti liu khng t yu cu th onnh gi phi thng bo cho PTN trongvng 10 ngy sau khi nhn ti liu ca PTN PTN thc hin khc phc theo biu AFL01.05.

Chun b chng trnh:Khi ti liu ca PTN p ng yu cu th Trng on lp chng trnh nh gi chitit v gi ti PTN.

Trng hp t chc ng k nhiu PTN,a im th chng trnh nh gi cn thothun vi PTN sao cho thch hp nht theocc nguyn tc:

-

Nu nh gi trong cng khong thigian cho nhiu lnh vc v a im thVPCNCL c th ch nh 1 Trng onnh gi

- nh gi khng cng khong thi gian

th s ch nh mi a imhocPTNmt trng on nh gi

PTN c th ngh thay i chng trnh

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

submitting the approval of BoAsmanagement.

Member of assessment team is a person who

is free from any pressure or conflict ofinterest of finance, politics... ; be capable

followed to the AG 02 Criteria forAssessor and be conformed to the field ofassessment.

Document Review

The assessment team will review the

adequacy of the applicants documentsfollowing AP 13 Document review.

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.

Preparation f or assessment schedule:

When laboratory comply with BoA

requirement, Team leader set up the

assessment schedule and send it to

laboratory.

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.

-

If Assessment could not conduct in same

time for all laboratories or locations, BoA

could assign more than one lead assessor

Laboratory can change the schedule,

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


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m bo yu cu nh nu trn.

Chng trnh chi tit bao gm:Ni dung nh gi

Phm vi nh gi: lnh vc, v trnh gi bao gm tt c cc v tr caPTN khi PTN c nhiu c s thnghimThi gian, phn cng nhim v chotng chuyn gia nh giCc php th/hiu chun quan st(nu thch hp)nh gi o lng (i vi phng

hiu chun)

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

4.3.5. Thnh lp on nh gi chnhthcSau khi kt qu xem xt ti liu t yu cuv thng nht vi PTN v chng trnhnh gi, chuyn gia nh gi,VPCNCL raquyt nh thnh lp on nh gi chnhthcbao gm trng on v cc chuyngia nh gi. S lng cc chuyn gia nhgi trong on nh gi ph thuc qui m,c cu hot ng ca PTN v phm vi lnhvc th nghim/hiu chun nghim ngk cng nhn.on nh gi c trch nhim chun b miiu kin nh gi theo qui nh ca

VPCNCL

4.3.6. Tin hnh nh giHp khai mc: on nh gi tin hnhcuc hp khaimc ti PTN khng nhli ni dung nh gi (phm vi, chun mc,thi gian nh gi, php th ngh quanst).

PTN c th thu hp hoc xin m rng thmphm vi ng k cng nhn cuc hp

not ensuring to suitable with requirement as

above-mentioned.

The detail schedule included:

Content of assessment

Scope: field of assessment, locationincluding 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)

The number of on-site assessment days

depend on the scope of applicant

4.3.5. Assignment of official assessmentteamAfter 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. AssessmentOpening meeting: Assessment team carries

out the opening meeting in laboratory to

confirm the content of assessment (scope,

criteria, timetable, and test to be

witnessed...)

Laboratory can limit or expand the scope ofaccreditation at the opening meeting,


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khai mc nhng khng c m rng lnhvc, v tr PTN th nghim/ hiu chun.Phm vi m rng ph thuc s chp nhnca on CGG ph hp vi kh nng

nh gi ca on.

Thc hin nh gi: Vic nh gi PTNgm 2 hnh thc sau : Thu thp thng tin vnh gi chng kin:

Thu thp thng tin: on nh githu 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 khngnh h thng qun l cht lng caPTN ph hp chun mc cng nhn.

nh gichng kin: Chuyn giak thut, chuyn gia t vn k thuts chng kin cc php th/hiuchun trong phm vi lnh vc ngk cng nhn do cc th nghim vintin hnh (s lng cc php th/hiuchun ngh quan st do onchuyn gia nh gi xc nh v lachn theo nguyn tc qui nh trongAG 22 Hng dn cho chuyn giak thut nh gi PTN m bokt qu nh gi l in hnh chonng lc ng k cng nhn ca

PTN). nh gi chng kin c ththc hin ti PTN hoc hin trngtu thuc phm vi thc hin phpth/hiu chun ca PTN.

on nh gi phi m bo tin nhgi theo chng trnh nh.

Hp kt thc nh gi: Kt qu nh gic cp y trong bo co nh gi

AFL 01.08 v c thng bo vi PTN ticuc hp kt thc nh gi. Bo co nh

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.

Assessment: The assessment includes 2

stages: Collect information and witness

assessment

Collect in formation:Assessment team

collects information through staff

interview, documents and record

review, the laboratorys activityobservation in order to collect theobjective 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 laboratoryof technical assessors) for ensure thatthe 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.

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 closingmeeting. Assessment report proposes BoA


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gi ngh ln VPCNCL mt trong 3 hnhthc sau:

Khng ngh cng nhn PTN; ngh cng nhn vi iu kin c

nh gi b sung (follow up) tiPTN;

ngh cng nhn; ngh cngnhn sau khi khc phc cc iukhng ph hp.

Bo co nh gi phi baogm: nhn xtchung, nhng im khng ph hp vkhuyn ngh c pht hin trong qu trnh

nh gi, ngh ln VPCNCL gm: phmvi ngh cng nhn bao gm s lngphp th/hiu chun ngh, lnh vc,phm vi, ngi c thm quyn k.

Cc im khng ph hp c phn loithnh loinng (1) hoc loinh (2) v yucu PTN thc hin hnh ng khc phc.

Cc im khuyn ngh khng yu cu btbuc PTN phi c hnh ng khc phc.

PTN phi thc hin hnh ng khc phcv gi km bng chng cho VPCNCLtrong thi hn tho thun vi on chuyngia nh gi, ti a khng qu 3 thng kt ngy nh gi cng nhni vi trnghp nh gi ln u. Trng hp nh gili v nh gi gim st, nh gi m rng

thi hn thc hin hnh ng khc phc tia khng qu 2 thng.

Sau thi hn ti a qui nh thc hinkhc phc nu trnnu PTN khng gi hs hnh ng khc phc ti VPCNCL thh s qu trnh nh gi khng cn hiulc ngh cng nhn.Trng hp PTN phi nh gi b sung th

thi gian nh gi b sung ti PTN ctho thun vi on CGG nhng cng

one of three mode:

Not suggest to accredit;

Suggest to accredit on condition that

conduct a follow up assessment inlaboratory;

Suggest accrediting; suggest

accrediting after the corrective action

taken of nonconformity.

Assessment report has to include:

conclusion, non-conformities and

observations are found in the assessment

process that proposed BoA includes: thenumber of testing/calibration, scope, field of

testing/calibration, approved signatories.

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.

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.

After time for corrective action taken as

above, if laboratory doesnt send correctiveaction 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 upassessment but not exceeds 3 months.


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khng qu 3 thng k t ngy nh gi.

4.3.7. Thm xt, ra quyt nh Cngnhn

Sau khi thm xt hnh ng khc phc tyu cu on CGG tp hp ton b h snh gi, lp ngh cng nhn v chuynh s ln Ban thm xt.

Trong qu trnh thm xt, cc thnh vinBan thm xt c th yu cu on nh gicng nhn gii thch hoc cung cp thmthng tin lm r vn no .Thnh vin Ban thm xt c quyn t chi ngh cng nhn nu xt thy qu trnhnh gi cng nhn khng tun th ngcc qui nh chung v cng nhn.

Cn c theo ngh ca Ban thm xt vh s qu trnh nh gi cng nhn, Gimc Vn phng cng nhn s ra quyt nhcng nhn.

Thi gian thm xt, ra quyt nh cngnhn khng qu 15 ngy lm vic.

Trng hp t chc ng k nhiu aim hoc nhiu PTN th PTN hoc aim no hon thnh h s trc s nhnc quyt nh cng nhn trc v m

bo ton b cc v tr v cc PTN u ccng s hiu

H s cng nhn gi PTN bao gm: quytnh cng nhn km ph lc cng nhnbaogm phm vi c cng nhn, ngi cthm quyn k v cc iu kin c thkhc, chng ch cng nhn, du VILAS cm s ring ca PTN.

4.3.8. Gim st sau cng nhn

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

4.3.7. Review, accreditation decision

After reviewing and closing all thecorrective actions, the team leader will

propose all the records of assessment to

Review Panel

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

Based on the proposal of the Review Panel

and the assessment records, Director of BoA

will make the decision on accreditation.

Duration for record review and accreditationdecision is not exceeding 15 working days.

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.

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. SurveillanceBoA conducts periodically surveillance

assessment at the accredited organizations


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gim st PTN m bo rng PTN ccng nhn vn duy tr s ph hp vichun mc cng nhn v cc qui nh caVPCNCL.

Trc cuc nh gi gim st PTN phinp h s theo di chng trnh thnghim thnh tho/so snh lin phngtrong nm theo mu AFL 01.01 n Vn

phng Cng nhn Cht lng.

VP CNCL cng c th tin hnh nh git 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 ngca t chc trong phm vi c cngnhn;

nh gi t xut (do khiu ni, doyu cu ca c quan qun l, do yucu ca cc t chc Quc t v cngnhn m VPCNCL l thnh vin);

nh gi o lng i vi cc phnghiu chun.

Trng hp nh gi gim st hoc txut nu on CGG pht hin nhng iukhng ph hp nghim trng, nh hngti cht lng, khch quan, trung thc,mc tin cy trong phm vi cng nhn thon CGG c th ngh nh ch cngnhnPTN hoc nh ch phm vi c th.

Nhng iu khng ph hp pht hin trongqu trnh nh gi gim st phi c PTNkhc phc ngay v thi hn hon thnhc tha thun vi on CGG nhngkhng qu 2 thng k t ngy tin hnhnh gi gim st.

Nu qu 2 thng m PTN khng thc hinxong hnh ng khc phccc iu khng

ph hp, VPCNCL s ra thng bo tmthi nh ch hiu lc cng nhn PTN v

khong thi gian tm thi nh ch hiu lccng nhn t nht l 6 thng. Sau thi gian

once a year in order to ensure that the

laboratory always maintain in conformity

with accreditation standard and BoA

regulation.

Before surveillance, the laboratory mustsend to BoA the PT list in this year

following the form AFL 01.01.

BoA can conduct unforeseen assessment in

case of:

Organization changes that effect to

capabilities of accredited scope oflaboratory;

Unforeseen assessment due to

(complaints, authorized organization

and international organization

requirement that BoA is a member);

Measurement audit for calibration

laboratory.

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.

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


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nh ch nu PTN khng cung cp choVPCNCL bng chng v hnh ng khc

phc, VPCNCL s quyt nh hy b hiulc cng nhn.

n thi hn nh gi gim st, v l dochnh ng, PTN phi gi vn bn nghhon lch gim st. Thi gian hon ti akhng qu 2thng.

Trng hp qu 2 thng m PTN vnkhng th b tr tin hnh nh gi gimst hoc ht thi hn tm thi nh ch(trng hp PTN khng thc hin trong

vng 2 thng hnh ng khc phc saucucnh gi gim st) th VPCNCL s raquyt nh hy b hiu lc cng nhn.Trong mt s trng hp c th, gim cVPCNCL quyt nh.

4.3.9. M rng phm vi cng nhnKhi PTN c nhu cu m rng phm vicng nhn nh m rng php th/hiuchun, thm quyn k, lnh vc, v tr, PTNlm nng kcng nhn theo mu giti VP CNCL ngh nh gi m rng.

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

Trng hp m rng thm quyn k, cp

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

4.3.10.Thu hp phm vicng nhnPTN c th ch ng gi cng vn thng

bo ti BoA ngh thu hp phm vi

c cng nhn. BoA sra quyt nh thuhp hoc thu hi quyt nh cng nhn tu

provide BoA the evidence of taken

corrective actions, BoA will decide to

withdraw the laboratorys validity ofaccreditation.

Laboratory can change the time ofsurveillance due to the adequate reason.

Laboratory must send a formal writing to

BoA for the surveillance delay. Delay period

is not exceeded2months.

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 willwithdraw the validity of accreditation. In

special case, BoA director will make the

final decision.

4.3.9. Extend scopeWhen laboratory needs to expend the

accreditation scope such as test/calibration,

field of accreditation, signatories, locationlaboratory should apply the accreditation

application to BoA for expanding the scope.

BoA will review record and conduct an

extend assessment on laboratory. Procedure

for extend scope same as initial assessment.

In case extend for signatories, update

methods, extend scope (range, LOD,

CMC)of accredited test/calibration, BoAcould review and decide base on capabilities

of laboratory record.

4.3.10.Reduce accreditation scopePTN could initiative send a letter to BoA for

reduction of accredited scope. BoA will

review and send to laboratory reduce scopeor withdraw accreditation decision base on


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vo phm vi ngh ca PTN.

BoA s ch ng thu hp phm vi cngnhn ca PTN trong trng hp thng qua

nh gi gim st, nh gi t xut, ktqu tham gia PT ca PTN khng p ngyu cu duy tr cng nhn.

4.3.11.nh gi liKhi ht hn hiu lc cng nhn (3 nm)nu PTN mun tip tc duy tr cng nhnth PTN np n ng k cng nhn li choVPCNCL. Thi gian np n v tin hnh

nh gi cng nhn li l 2 thng trc khiht hiu lc cng nhn.

Trng hp sau khi ht hn hiu lc cngnhn m PTN khng np n ng k cngnhn li th sau 3 thng Vn phng CNCLs thng bo cho cc bn c lin quan vcng b trn website ca VP CNCL v vicht hiu lc cng nhn ca PTN.

Vic nh gi cng nhn li c tin hnhnh nh gi ln u. H s ng k cngnhn khng cn np phiu hi. PTN khngcn np cc ti liu m PTN khng c thayi so vi ln nh gi u. Nu c ccthng tin thay i th Phng th nghim cncp nht thng tin thay i vo mu phlc D.

Nhng iu khng ph hp pht hin trongqu trnh nh gi li/nh gi m rng

phi c PTN khc phc ngay v thi hnhon thnh c tha thun vi onCGG nhng khng qu 2 thng k tngy tin hnh nh gi.

Sau 2 thng nu PTN khng gi h s hnh

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

suggest of laboratory.

BoA couldinitiative reduce accredited scope

base on surveillance, unforeseen assessment,

laboratory PT results are not satisfy ofaccreditation requirement.

4.3.11.ReassessmentWhen 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 re-assessment during 2 months before the

validity of accreditation comes to an end.

In case the accreditation expires, after 3

months, if laboratory doesnt submit anapplication, the suspension shall be

informed by the BoA to the related bodies

and posted to Boaswebsite.

The accreditation reassessment shall be

carried out as initial assessment. Lab

Application record dont need to sendquestionnaire. Laboratory doesnt need tosend any document that has not any change

with last assessment. If laboratory have any

change that laboratory shall fill in form

annex D

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.

After 2 months, if laboratory could not send

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


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ngh cng nhn.

4.4. Thi hn hiu lc cng nhn

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

V d: ngy k quyt nh cng nhn l3/4/2007 th thi hn hiu lc cng nhn l3/4/2007 n 3/4/2010v ngy cng nhnln u l 3/4/2007

Trng hp nh gi m rng: thi hnhiu lc ca quyt nh cng nhn m rngs trng vi thi hn hiu lc cng nhnca quyt nh cng nhn ban u hoccng nhn li gn nht.V d: ngy k quyt nh cng nhn lnu l 3/4/2007 th thi hn hiu lc cngnhn l 3/4/2007 n 3/4/2010. Ngy kquyt nh m rng l 5/7/2008 th thihn hiu lc cng nhn ca quyt nhcng nhn m rng l 5/7/2008 n3/4/2010

Trng hp nh gi li: thi hn hiulc ca quyt nh cng nhn li c chialm 2 trng hp Trng hp PTN thc hin nh gi

li ng thi hn qui nh caVPCNCL tnh hiu lc cng nhn l

3 nm nhng ly mc l ngy cngnhn ln u

V d: ngy k quyt nh cng nhn lnu l 5/7/2005 th thi hn hiu lc cngnhn l 5/7/2005 n 5/7/2008. Ngy kquyt nh li l bt c ngy no t5/5/2008 n 5/10/2008 th thi hn hiulc cng nhn ca quyt nh cng nhnli 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

4.4. Accreditation validity

The first assessment for accreditation: theaccreditation 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

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 validityperiod 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


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


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li khng theo thi hn qui nh caVPCNCL th thi hn hiu lc cngnhn l 3 nm k t ngy k quytnh cng nhn li v ngy cng

nhn ln u l ngy k quyt nhcng nhn.

V d: ngy k quyt nh cng nhn lnu l 5/7/2005 th thi hn hiu lc cngnhn l 5/7/2005 n 5/7/2008. Ngy kquyt nh li l bt c ngy no t sau5/10/2008 th thi hn hiu lc cng nhnca quyt nh cng nhn li l 3 nm kt ngy k quyt nh v ngy cng nhn

ln u cng l ngy k quyt nh nh kquyt nh ngy 8/11/2008 th thi hnhiu lc l 8/11/2008 n 8/11/1010 vngy cng nhn ln u l 8/11/2008.

4.5. Phn nn, yu cu xem xt li

Cc t chc c cng nhn; cc t chcng k cng nhn; cc t chc v c nhns dng dch v ca cc t chc c cngnhn hoc xin cng nhn; cc c quan qunl v cc c nhn c quan tm u cquyn phn nn v chnh sch, th tc, ccquy nh v cc hot ng c th ca cquan cng nhn. PTN c cng nhn hocang ng k cng nhn c quyn yu cuxem xt licc 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 cVPCNCL gii quyt theo Th tc giiquyt yu cu xem xt li AP 03.

Cc phn nn c gii quyt theo Thtc gii quyt phn nn AP 02.

4.6.

Chnh sch v s dng dch v hiuchun thit b

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 re-accreditation.

For example: the first accreditation is



to grant re-accreditation is any date from


period is 3 years from the date to grant

reaccreditations and the first accreditation

is the date to grant reaccreditations; thedate 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. Complaints, Appeals

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.

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.

The complaints are related to procedure

The ComplaintsAP 02.

4.6.

Policy of equipment calibrationservices


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cp trong APL 02

4.7. Chnh sch v th nghim thnhtho/ so snh lin phng

cp trong APL 03

Vi cc PTN c cng nhn, nu kt quthc hin chng trnh TNTT/SSLP nmngoi gii hn cho php v khng c hnhng khc phc ph hp th Gim cVPCNCL s quyt nh thnh lp onnh gi t xut xem xt cc hot ng

c cng nhn v c th a ra ccquyt nh nh ch hoc hu b hiu lccng nhn ca PTN .Cc PTN tham gia chng trnhTNTT/SSLP phi c ngha v thc hiny cc yu cu ca chng trnh.Cc PTN c cng nhn phi c trchnhim v ngha v tham gia cc chngtrnh TNTT/SSLP c lin quan n lnhvc c cng nhn do VILAS lm umi hoc t chc trng hp PTN khngtham gia TNTT/SSLP th PTN c th bnh ch hoc hu b hiu lc cng nhnty thuc h s qu trnh tham giaTNTT/SSLP.

PTN phi c chnh sch, k hoch, nidung c th i vi hot ng TNTT/SSLPv lp h s y v kt qu hot ngny thng bo cho VPCNCL.Nu cc PTN

khng tham gia cc chng trnhTNTT/SSLP

4.8. Cc biu mu:

AF11.01Mu n ng k cngnhn

AFL 01.01 Phiu theo di PT

AFL 01.02 Phiu hi PTN

AFL 01.03 Yu cu xem xt ban u

Mention in APL 02

4.7. Policy of Inter-laboratorycomparison/Proficiency testing

programmersMention in APL 02

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

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


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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 Bo co quan st k nng

AFL 01.07 Bo co nhng pht hinAFL 01.08 Bo co nh gi

AFL 01.09Danh mc php th ccng nhn

AFL 01.10Danh mc php hiuchun c cng nhn

AFLM 01.01 Phieu hoi

Ph lc GPh lc ca n ng kcng nhn cho PXN

AFLM 01.02 Bo co Pht hin

AFLM 01.03

Bo co quan st k nngdnh cho chuyn gia kthut/lnh vc: Ha sinh-Huyet hoc-Min dch

AFLM 01.04

Bo co quan st k nngdnh cho chuyn gia kthut/lnh vc: Vi sinh

AFLM 01.05 Bo co nh gi

AFLM 01.06Danh mc ch tiu xtnghim c cng nhn

AFL 01.06Witnessing the tests/calibration

report

AFL 01.07 Finding report

AFL 01.08 Assessment report

AFL 01.09 Accredited tests

AFL 01.10 Accredited calibrations

AFLM 01.01 Questionnaire for laboratory

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 Assessor

Assessment

checklist/Discipline:

Microbiology

AFLM 01.05 Assessment report

AFLM 01.06 Accredited Medical Tests

a69ujfgl_apl 01 Cong Nhan Ptn 11 2011

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