A68M24AT APL 01 Thu Tuc Cong Nhan Phong Thi Nghiem

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

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

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. 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. 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.

4. Ni dung 4.1. nh ngha v Cc ch vit tt

1. Purpose To define the responsibility and content of accreditation assessment process for laboratory of Bureau of Accreditation VILAS. 2. Scope This procedure is applied for Bureau of Accreditation VILAS, applicants and accredited laboratories 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. Content 4.1. Definition and Abbreviation



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 ph hp nng

Major non-conformity

L nhng iu khng ph hp do khng p ng mt yu cu c th theo chun mc cng nhn, mang tnh h thng v tc ng trc tip n 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 ph hp nh

Minor non-conformity

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

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

Observation

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.



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

Xem xt ti liu

Quyt nh thnh 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



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

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



4.3. Trnh t tin hnh nh gi cng nhn 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.

Chun mc cng nhn phng xt nghim l ISO 15189:2007, yu cu ring v cc hng dn c lin quan ca APLAC, ILAC

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.

PTN c cung cp b ti liu lin

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 05;

+ 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;

4.3. Accreditation assessment process 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

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 fields AGL

09; + Accreditation assessment

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

+ Regulation for using of accreditation logo and symbol AG 01;

+ Complaints procedure - AP 02; + Appeals procedure - AP 03;



+ 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; Phng th nghim cn nghin cu k cc ti liu 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 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. 4.3.3. Np n ng k cng nhn 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 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);

+ Regulation of Confidentiality; + Accreditation fees - AGL10; + Questionnaire AFL 01.02; + Application form AF 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 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. 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 of accreditation. The application form (AF 11.01) need to submit to BoA these following documents: Quality Manual; Questionnaire (AFL 01.02);



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);

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.

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).

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 . 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. 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.

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 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)

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. BoA can 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 application and give a code for applicant.



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

BoA will make the assessment contract to the laboratory according to Procedure Laboratory accreditation assessment fee regulation AGL 10. The duration from accepting information of applicant up to assessment announcement is about 30 days (based on laboratory preparation). 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 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. Assignment of Assessment team and preparation for assessment schedule Assignment of Assessment team: Based on the assessment requirement and regularly assessment schedule, scheduling personnel will propose an assessment team for



trnh Lnh o VPCNCL duyt. 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. 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 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. 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. 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

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

submitting the approval of BoAs management. 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. Document Review The assessment team will review the adequacy of the applicants documents following 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 for 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 having proper reason. For example: the assessor is



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)

S ngy nh gi ti ch s ty thuc vo phm vi ng k cng nhn ca PTN. 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 4.3.6. 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). PTN c th thu hp hoc xin m rng thm phm 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, 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)

The number of on-site assessment days depend on the scope of applicant 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. 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...) Laboratory can limit or expand the scope of accreditation at the opening meeting,



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. Thc hin nh gi: Vic nh gi PTN gm 2 hnh thc sau : Thu thp thng tin v nh gi chng kin: 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

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 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.

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



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.

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. 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. 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. 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

one of three mode: 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.

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. 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 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.



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. 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. 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. Thi gian thm xt, ra quyt nh cng nhn khng qu 15 ngy lm vic. 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 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. 4.3.8. Gim st sau cng nhn Trong thi gian hiu lc cng nhn, nh k 12 thng, VPCNCL tin hnh nh gi

4.3.7. Review, accreditation decision After reviewing and closing all the corrective 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 accreditation decision 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. Surveillance BoA conducts periodically surveillance assessment at the accredited organizations



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. 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.

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. 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

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. BoA can conduct unforeseen assessment in case of: Organization changes that effect to

capabilities of accredited scope of laboratory;

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



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. 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. 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 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. 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

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. 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. 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, BoA could review and decide base on capabilities of laboratory record. 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



vo phm vi ngh ca PTN. 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. 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. 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. 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. 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. 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

suggest of laboratory. BoA could initiative reduce accredited scope base on surveillance, unforeseen assessment, laboratory PT results are not satisfy of accreditation requirement. 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 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 an application, the suspension shall be informed by the BoA to the related bodies and posted to Boas website. 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 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, the assessment records will no longer validate.



ngh cng nhn. 4.4. Thi hn hiu lc cng nhn 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. 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

4.4. Accreditation validity 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 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



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. 4.5. Phn nn, yu cu xem xt li 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. Cc phn nn c gii quyt theo Th tc gii quyt phn nn AP 02. 4.6. Chnh sch v s dng dch v hiu chun 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 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. 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 Complaints AP 02. 4.6. Policy of equipment calibration services



cp trong APL 02 4.7. Chnh sch v th nghim thnh tho/ so snh lin phng 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 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

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



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 hin

AFL 01.08 Bo co nh gi

AFL 01.09 Danh mc php th c cng nhn

AFL 01.10 Danh mc php hiu chun c cng nhn

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 sinh-Huyet 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

AFL 01.06 Witnessing 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/Immunology

AFLM 01.04

Medical Technical Assessor Assessment checklist/Discipline: Microbiology

AFLM 01.05 Assessment report

AFLM 01.06 Accredited Medical Tests

Documents

A68M24AT APL 01 Thu Tuc Cong Nhan Phong Thi Nghiem