| Date post: | 05-Apr-2018 |
| Category: |
Documents |
| Upload: | jason-hardin |
| View: | 221 times |
| Download: | 0 times |
of 30
8/2/2019 Dr V
1/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 11
STEPS TO NABL MedicalSTEPS TO NABL MedicalLaboratory AccreditationLaboratory Accreditation
in Indiain IndiaDr Thuppil Venkateshr Thuppil VenkateshLead Assessor & TC memberead Assessor & TC [email protected]@gmail.com
mailto:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
2/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 2
Quality & CompetenceQuality & Competence
in Medical Testing Laboratoriesin Medical Testing Laboratories
ISO 15189:2003 and NABL 112ISO 15189:2003 and NABL 112requirementrequirement
a stepwise approacha stepwise approach
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
3/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 3
Indian ScenarioIndian Scenario
Over 100,000 medical testing laboratoriesOver 100,000 medical testing laboratories
provide diagnostic servicesprovide diagnostic services
Over 80% are small, 18% medium and lessOver 80% are small, 18% medium and less
than 2% are large in numberthan 2% are large in number
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
4/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 4
Lab size in IndiaLab size in India
0%
10%
20%
30%
40%
50%
60%
70%
80%
small
medium
large
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
5/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 5
Accreditation status of large andAccreditation status of large and
medium labs :- as theymedium labs :- as they
can afford to meet the accreditation costcan afford to meet the accreditation cost
are able to maintain quality requirementare able to maintain quality requirement
are under the supervision of seniorare under the supervision of seniorconsultantsconsultants
are having state of art technology withare having state of art technology with
themthemare able to get external contractsare able to get external contracts
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
6/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 6
Future of small labsFuture of small labs
Do not have adequate financial or the manpowerDo not have adequate financial or the manpower
Eventually will become part of medium/large labsEventually will become part of medium/large labs
Get converted in to collection centersGet converted in to collection centers
Might close down if not accreditedMight close down if not accredited
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
7/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 7
Medical labs need to get accreditedMedical labs need to get accredited
By whom?By whom?
How?How?When?When?
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
8/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 8
Ten steps towards accreditationTen steps towards accreditation
STEP 1STEP 1
Get a copy of the IS/ISO 15189Get a copy of the IS/ISO 15189Indian StandardIndian Standard
MEDICAL LABORATORIES PARTICULAR REQUIREMENTS FOREDICAL LABORATORIES PARTICULAR REQUIREMENTS FORQUALITY AND COMPETENCEUALITY AND COMPETENCEDetai ls can be obtained frometai ls can be obtained from Bureau of Indian Standardsureau of Indian StandardsManak Bhavan, 9 Bahadur Shah Zafar Marg New delhi 110002anak Bhavan, 9 Bahadur Shah Zafar Marg New delhi 110002Telephones 2323 0131, 2323 3375, 2323 9402 website :elephones 2323 0131, 2323 3375, 2323 9402 website :www.bis.org.inww.bis.org.in
Do not use Xerox copieso not use Xerox copies
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
9/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 9
Ten steps towards accreditationTen steps towards accreditation
STEP 2STEP 2
Download a copy of the NABL documentDownload a copy of the NABL documentNABL-112ABL-112from the NABL websitefrom the NABL website
www.nabl-india.orgwww.nabl-india.org
This is free of costThis is free of cost
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
10/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 10
Ten steps towards accreditationTen steps towards accreditation
STEP 3STEP 3
FromFrom Google.comoogle.com download SAMPLEdownload SAMPLEmodel quality manual ISO 15189 of amodel quality manual ISO 15189 of a
sectionsection
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
11/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 11
Ten steps towards accreditationTen steps towards accreditation
STEP 4STEP 4
Understand terms and definitions underUnderstand terms and definitions undersection 3 on page 1 of IS/ISO 15189section 3 on page 1 of IS/ISO 15189
There are 17 terms with foot notes provided.There are 17 terms with foot notes provided.You need to refer to and stick to theseYou need to refer to and stick to these
internationally accepted terminologies allinternationally accepted terminologies allthrough your documentationthrough your documentation
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
12/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 12
Terms and definitionsTerms and definitions
Provided on pages 1 and 3 of the IS/ISO 15189 : 2003 ofProvided on pages 1 and 3 of the IS/ISO 15189 : 2003 ofthe August 2005 issue. Total of 17 are listedthe August 2005 issue. Total of 17 are listed
ExampleExample: 3.13: 3.13 referral laboratoryreferral laboratory refers to other laboratory torefers to other laboratory towhich awhich a samplesampleis submitted for a supplementary oris submitted for a supplementary or
confirmatory examination procedure and report.confirmatory examination procedure and report.3.14 Sample3.14 Sampleis one or more parts taken from a system andis one or more parts taken from a system and
intended to provide information on the system, often tointended to provide information on the system, often toserve as a basis of decision on the system or its product.serve as a basis of decision on the system or its product. AAvolume of serum taken from a larger volume of serumvolume of serum taken from a larger volume of serum
3.11 Primary sample3.11 Primary sampleSpecimen set of one or more partsSpecimen set of one or more partsinitially taken from a systeminitially taken from a system
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
13/30
mailto:[email protected]8/2/2019 Dr V
14/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 14
Management requirementManagement requirement
(15)(15)
4.14.1 Organization and ManagementOrganization and Management (4.1 to 4.1.4 a to j)(4.1 to 4.1.4 a to j)
4.24.2 Quality Management SystemQuality Management System (4.2 to 4.2.3 a to f, 4.2.4 a to(4.2 to 4.2.3 a to f, 4.2.4 a tow & 4.2.5)w & 4.2.5)
4.34.3 Document ControlDocument Control
4.44.4 Review of ContractsReview of Contracts
4.54.5 Examination by Referral LaboratoriesExamination by Referral Laboratories
4.64.6 External services and suppliesExternal services and supplies
4.74.7 Advisory ServicesAdvisory Services
4.84.8 Resolution of ComplaintsResolution of Complaints
4.94.9 Identification and Control of Non ConformitiesIdentification and Control of Non Conformities
4.104.10 Corrective ActionCorrective Action4.114.11 Preventive ActionPreventive Action
4.124.12 Continual improvementContinual improvement
4.134.13 Quality and Technical RecordsQuality and Technical Records
4.144.14 Internal AuditInternal Audit
4.154.15 Management ReviewManagement Review
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
15/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 15
4.14.1
4.1 ORGANISATION AND MANAGEMENT4.1 ORGANISATION AND MANAGEMENT 4.1.1 Legal identity :4.1.1 Legal identity : 4.1.2 Laboratory design appropriate to meet the needs :4.1.2 Laboratory design appropriate to meet the needs : 4.1.3 Conformity with relevant requirements for permanent facilities,4.1.3 Conformity with relevant requirements for permanent facilities, Decentralized facilities :Decentralized facilities : 4.1.5a appropriate authority for all personnel, resources to carry out their duties:4.1.5a appropriate authority for all personnel, resources to carry out their duties:
4.1.4 Possible conflict of interest, financial or political considerations:4.1.4 Possible conflict of interest, financial or political considerations: 4.1.5b4.1.5b 4.1.5c Confidentiality, impartiality and operational integrity4.1.5c Confidentiality, impartiality and operational integrity 4.1.5d4.1.5d 4.1.5e Organizational structure, relation with other organizations4.1.5e Organizational structure, relation with other organizations 4.1.5f Function descriptions and interrelationships4.1.5f Function descriptions and interrelationships 4.1.5g Staff training (to be considered along with NABL-112)4.1.5g Staff training (to be considered along with NABL-112) 4.1.5h Technical management4.1.5h Technical management 4.1.5i Quality manager (authority and responsibilities)4.1.5i Quality manager (authority and responsibilities) 4.1.5j Deputies for all key functions4.1.5j Deputies for all key functions
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
16/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 16
4.24.2
4.2.1 Documentation, communication and4.2.1 Documentation, communication and
implementationimplementation
4.2.2 IQC and EQA4.2.2 IQC and EQA
4.2.3 Quality policy statement : content and4.2.3 Quality policy statement : content and
availabilityavailability
4.2.4 Content of the quality manual4.2.4 Content of the quality manual4.2.5 Calibration, monitoring and preventive4.2.5 Calibration, monitoring and preventive
maintenance of instrumentsmaintenance of instruments
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
17/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 17
4.34.3
4.3.1 Procedures for document4.3.1 Procedures for documentmanagementmanagement
4.3.24.3.2
4.3.3 Identification of documents4.3.3 Identification of documents4.3.2 a-d, g Availability, release, review,4.3.2 a-d, g Availability, release, review,
amendmentsamendments
4.3.2. h Changes4.3.2. h Changes4.3.2 e-f Archives and removing of invalid4.3.2 e-f Archives and removing of invalid
documentsdocuments
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
18/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 18
Ten steps towards accreditationTen steps towards accreditation
STEP 5 continuedSTEP 5 continued
Understand carefully all 8 Claus under theUnderstand carefully all 8 Claus under theTECHNICAL REQUIREMENTTECHNICAL REQUIREMENT
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
19/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 19
Technical requirement (8)Technical requirement (8)
5.15.1 PersonnelPersonnel
5.25.2Accommodation and EnvironmentalAccommodation and Environmental
ConditionsConditions
5.35.3 Examination ProceduresExamination Procedures
5.45.4 Laboratory EquipmentLaboratory Equipment
5.65.6Assuring the Quality of ExaminationAssuring the Quality of Examination
ProceduresProcedures
5.75.7 Pre-examination ProceduresPre-examination Procedures
5.85.8 Reporting of ResultsReporting of Results
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
20/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 20
5.15.1
5.1.1 Organizational plan, personnel policies, job descriptions5.1.1 Organizational plan, personnel policies, job descriptions 5.1.2 Records of education and qualification5.1.2 Records of education and qualification 5.1.3 Supervision and competency5.1.3 Supervision and competency 5.1.4 Responsibilities of the laboratory director5.1.4 Responsibilities of the laboratory director
5.1.5 Adequate staff resources5.1.5 Adequate staff resources 5.1.6 Training of personnel in quality assurance5.1.6 Training of personnel in quality assurance 5.1.7 Authorization to perform specific tasks5.1.7 Authorization to perform specific tasks 5.1.8 Use of and access to computers5.1.8 Use of and access to computers 5.1.9 Continuing education program5.1.9 Continuing education program
5.1.10 Training to prevent or contain the effects of adverse incidents5.1.10 Training to prevent or contain the effects of adverse incidents 5.1.11 Assessment of competency after training and re-evaluation5.1.11 Assessment of competency after training and re-evaluation 5.1.12 Qualification for professional judgements5.1.12 Qualification for professional judgements 5.1.13 Confidentiality of information regarding patients5.1.13 Confidentiality of information regarding patients
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
21/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 21
5.25.2
5.2 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS5.2 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS 5.2.1 Adequacy and suitability of the lab space (including other sites)5.2.1 Adequacy and suitability of the lab space (including other sites) 5.2.45.2.4 5.2.2 Risk of injury and protection from hazards5.2.2 Risk of injury and protection from hazards 5.2.3 Accommodation for sample collection5.2.3 Accommodation for sample collection
5.2.45.2.4 5.2.5 Control and registration of environmental conditions5.2.5 Control and registration of environmental conditions 5.2.6 Separation of incompatible activities5.2.6 Separation of incompatible activities 5.2.7 Access control5.2.7 Access control 5.2.8 Adequate communication system within the facilities5.2.8 Adequate communication system within the facilities
5.2.9 Storage of samples and documents assuring integrity5.2.9 Storage of samples and documents assuring integrity 5.2.10 Housekeeping5.2.10 Housekeeping
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
22/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 22
Ten steps towards accreditationTen steps towards accreditation
STEP 7STEP 7
Study in detail all clauses (scope wise)Study in detail all clauses (scope wise)referred in NABL-112referred in NABL-112
This is the Regional /National requirementThis is the Regional /National requirement
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
23/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 23
NABL - 112NABL - 112
Provides description and type of laboratoryProvides description and type of laboratory
Covers all 23 elements from the angle ofCovers all 23 elements from the angle of
local/regional regulatory requirementlocal/regional regulatory requirement
Annexure I describes routine and specialAnnexure I describes routine and special
tests under each disciplinetests under each discipline
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
24/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 24
Ten steps towards accreditationTen steps towards accreditation
STEP 8STEP 8
Prepare your Quality System ManualPrepare your Quality System Manualcovering both requirements undercovering both requirements under
IS/ISO 15189 and NABL-112 requirementIS/ISO 15189 and NABL-112 requirement
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
25/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 25
Check and re check your systemCheck and re check your system
STEP 9STEP 9
Conduct at least one Internal Audit followedConduct at least one Internal Audit followedby the management review meeting andby the management review meeting and
document the action taken and provide thedocument the action taken and provide the
evidence for the effectiveness of the actionevidence for the effectiveness of the action
taken and document the proceedings priortaken and document the proceedings prior
to your pre assessment.to your pre assessment.
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
26/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 26
Example : under requirementsExample : under requirements
Storage and retention of samples andStorage and retention of samples and
specimensspecimens
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
27/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 27
Ten steps towards accreditationTen steps towards accreditation
STEP 9STEP 9
Now obtain application form from :Now obtain application form from :The Director NABLThe Director NABL
Fill it out carefully annex all details and submitFill it out carefully annex all details and submit
along with the prescribed feealong with the prescribed fee
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
28/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 28
Three stages ofhree stages ofNABL Accreditation ProcessABL Accreditation ProcessStage 1Stage 1 Quality System Manual adequacyQuality System Manual adequacy
study by NABL lead Assessorstudy by NABL lead Assessor
Stage IIStage II Pre-assessment visit by the LeadPre-assessment visit by the Lead
Assessor (One day)Assessor (One day)
Stage IIIStage III Final Assessment by the NABL teamFinal Assessment by the NABL team
(two days or more)(two days or more)
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
29/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 29
After final assessmentAfter final assessment
Report will reach NABL with total knowledgeReport will reach NABL with total knowledge
of the laboratoryof the laboratory
NABL technical committee will review theNABL technical committee will review the
report and recommendationsreport and recommendations
Will communicate to the laboratory aboutWill communicate to the laboratory about
the accreditation statusthe accreditation status
Accredited labs need to go in for periodicAccredited labs need to go in for periodic
surveillance with annual feesurveillance with annual fee
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]8/2/2019 Dr V
30/30
Medical Lab Accreditation in India - stepwise process QCI Bio-Rad Feb 2006 30
Take home messageTake home message
Irrespective of Laboratory size, Quality needs to be validated by ThirdIrrespective of Laboratory size, Quality needs to be validated by ThirdPartyParty
Documentation is easy under ISO 15189Documentation is easy under ISO 15189
NABL guide lines provide local/ regional requirementsNABL guide lines provide local/ regional requirements
Laboratory can be accredited by any authorized Third PartyLaboratory can be accredited by any authorized Third Party
Quality Control and PT requirements are the integral components ofQuality Control and PT requirements are the integral components ofaccreditationaccreditation
Focus should be continual improvementFocus should be continual improvement
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]
