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UNIDOWAITRO WORKSHOP

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ASSESORS' CONCLAVE TO HARMONISE THEIR WORKING IS A REGULAR ACTIVITY ... ASSESORS' CONCLAVE TO HARMONISE THEIR WORKING. NABL PARTICIPATS IN ILAC AS WELL AS IN APLAC ... – PowerPoint PPT presentation

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Title: UNIDOWAITRO WORKSHOP


1
  • UNIDO/WAITRO WORKSHOP
  • 18-22, APRIL MALAYSIA

2
CASE STUDY NABL
  • -Devi Saran
    Tewari

3
BACK-GROUND
  • 1989-SEPT, LAUNCH OF THE INDIAN LABORATORY
    ACCREDITATION PROGRAM
  • NATIONAL COORDINATION OF TESTING AND
    CALIBRATION FACILITIES (NCTCF)
  • BY 1992,NCTCF GAVE ACCREDITATION TO 175 TESTING
    /CALIBRATION LABS.
  • 100, GOVT FUNDED. NO APPLICATION FEE NO
    ASSESSMENT CHARGES

4
  • FORMULATION OF NCTCF ACCREDITATION CRITERIA AND
    OTHER DOCUMENT STARTED

5
  • 1989-SEPT LAUNCH OF NCTCF
  • RELEASE DOCUMENTS

6
LAUNCH OF NCTCF PROGRAM

7
RELEASE OF NCTCF CRITERIA
8
  • BY FEB. -1992 175 LABRATORIES GOT NCTCF
    ACCREDITATION .
  • COMPENDIUM OF ACCREDITED LABORATORIES
  • ACCREDITATION CERTIFICATE

9
VISIT OF EUROPEAN EXPERT
GROUP(EEG)- 1992
10
  • EEG-RECOMMENDATIONS
  • 1.TO ESTABLISH NATIONAL CONFORMITY ASSESSMENT
    INFRA-STRUCTURE
  • 2.TO ALIGN THE NCTCF PROGRAM AS PER EN-45001, 2
    3
  • CHARGE THE LABS FOR ACCREDITATION SERVICES

11
1992 GOVT DIRECTS TO.
  • ALIGN THE LAB. ACCREDITATION PROGRAM AS PER
    ISO/IEC ILAC.
  • RENAME THE PROGRAM TO NABL
  • CHARGE THE LABORATORIES FOR
  • - APPLICATION FEE
  • - ASSESSMENT EXPENDITURE
  • - ANNUAL MEMBERSHIP FEE

12
STEPS TAKEN BY NABL
  • ADOPTS ISO/IEC GUIDE 25 AS ITS CRITERIA.
  • PREPARES DOCUMENTS REQUIRED FOR
  • LABORATORIES
  • ASSESSORS
  • FOR ITS OWN WORKING
  • DECIDES TO CHARGE FOR APPLICATION, ASSESSMENT
    MEMBERSHIP FEE.
  • NABL- BOARD APPROVES ACCREDITATION ACTIVITIES AS
    PER ISO/IEC GUIDES, IN 1993.
  • NABL COMMENCES ASSESSMENT ACTIVITIES.

13
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14
  • NABL COMMENCED ASSESSMENT ACTIVITIES BY USING
    NCTCF ASSESSORS

15
  • ASSESSORS CRISIS MANAGEMENT
  • TO IMPANEL LEAD ASSESSORS NABL DESIGNED
    CONDUCTED 2-DAYS COURSE.
  • THE CRITERIA FOR SELECTION OF EXPERTS FOR THE
    COURSE WERE
  • i.  SHOULD BE WORKING SCIENTIST IN LABS.
  • ii. SHOULD HAVE COMPLETED LEAD AUDITORS
    COURSE FOR ISO-9000 SYSTEM.
  • FIRST 2- DAYS ASSESSORS COURSE IN 1994-
    Oct.
  • TWO SUCH COURSES WERE CONDUCTED AND NABL LISTED
    40 LEAD ASSESSORS.

16
NABL POLICY ON ASSESSORS
  • USE ONLY THOSE EXPERTS AS TECHNICAL ASSESSORS
    WHO WORK IN LABORATORIES.
  • TO AVOID CONFLICT OF INTEREST ENSURE
    CONFIDENTIALITY, ASSESSORS ARE REQUIRED TO SIGN A
    CONTRACT WITH NABL.
  • USE THE EXPERTS ONLY FOR THEIR FIELD OF WORK AND
    AFTER TRAINING.
  • ASSESSORS TRAINING TO FOLLOW EA/APLAC NORMS
  • TO BE LEAD ASSESSOR FIVE ASSESSMENTS ARE REQUIRED

17
  • 5-DAYS ASSESSORS COURSE
  • EAL-G7, WAS TAKEN AS THE BASE DOCUMENT FOR
    DESIGNING 5-DAYS ASSESSORS CORSE
  • FIRST 5-DAYS COURSE WAS CONDUCTED IN NOV. 1994.
  • APLAC APPROVED COURSE ADOPTED IN 2000.
  • IT BECAME A REGULAR ACTIVITY
  • NABL HAS ABOUT 700 ASSESSORS

18
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19
FACTS ABOUTAPPLICANT LABORATORIES
  • .
  • APPLICATIONS RECEIVED USED TO BE INCOMPLETE IN
    MANY CASES.
  • QUALITY MANUALS RECEIVED USED TO BE
    UNSATISFACTORY IN MANY CASES.
  • ON SITE ASSESSMENT REVEALED THAT MANY OF THE LABS
    WERE NOT AWARE ABOUT THE NABLs CRITERIA,
    REQUIREMENTS AND CONTENTS OF QUALITY MANUAL

20
NABLs CORRECTIVE THREE STEPS
  • DEVELOPED A GUIDE FOR PREPARING QUALITY MANUAL.
  • INTRODUCTION OF PRE-EVALUATION
  • STARTED THREE DAYS COURSE ON ISO/IEC GUIDE 25
    AND SWITCHED TO 4-DAYS ON ISO/IEC 17025.

21
  • COURSE CONTENTS FOR THE LABORAORY PERSONEL
  •    ELEMENTS OF ISO/IEC 17025
  •    IIDIVIDUAL AND GROUPEXERCISES AND WORKSHOPS
    BASED ON 17025.   
  • CLASSIFYING NCs
  •   HOW TO WRITEF QUALITY MANUAL..
  •   CONDUCTING INTERNAL AUDIT.
  •   METHODOLOGY OF WORKING OF NABL
  •   LINKAGES WITH ILAC/APLAC/EA etc.

22
NABL TRAINING COURSES
23
NABLs OTHER REGULAR ACTIVITIES
  • THE FIRST NABL NEWS WAS PUBLISHED IN JULY 1995,
    AND IT IS A QUARTERLY ISSUE.
  • NABL CONDUCTED ASSESORS ORIENTATION COURSES ON
    ISO/IEC 17025
  • ASSESORS CONCLAVE TO HARMONISE THEIR WORKING IS
    A REGULAR ACTIVITY
  • NABL PARTICIPATES CONTRIBUTES IN ILAC AS WELL
    AS IN APLAC CONFERENCES
  • APLAC-1999 MEET HELD AT NEW-DELHI

24
  • THE FIRST NABL NEWS WAS PUBLISHED IN JULY 1995,

25
  • NABL CONDUCTED ASSESORS ORIENTATION COURSES ON
    ISO/IEC 17025

26
  • ASSESORS CONCLAVE TO HARMONISE THEIR WORKING

27
NABL PARTICIPATS IN ILAC AS
WELL AS IN APLAC CONFERENCES
  • .

28
  • APLAC-1999 MEET AT NEWDELHI
  • .

29
SOURCES OF NABLs
REVENUE APPLICATION AND ANNUAL MEMBER FEE
  • Testing Calibration Laboratories (per
    field)Rs. 10,000
  • Clinical Laboratories (covering all fields)
  • Small Laboratories (up to 100 patients/ day) Rs.
    10,000
  • Medium Laboratories (101-500 patients/ day) Rs.
    20,000
  • Large Laboratories (above 500 patients/ day) Rs.
    50,000 
  • Forensic Laboratories (covering all fields) Rs.
    20,000 
  • Assessment Charges / Travel, Boarding and Lodging
    expenditure
  •   ON actual BASIS.
  • NABL CHARGES ITS LABORATORIES FOR PT PROGRAMS
    THEY PARTICIPATE
  • NABL STILL RECEIVES GOVT. GRANT.
  • NABL IS COMMITTED TO BE FINANCIALLY SELF RELIANT

30
ORGANIZATIONAL STRUCTURE
BOARD
DIRECTOR
TRAINING
P.T.
ACCREDITATION ACTIVITIES
ADMINISTRATION / FINANCE
QUALITY ASSURANCE
31
INTERNATIONAL LINKAGES
  • NABL IS COMMITTED TO MAINTAIN ITS WORKING AS PER
    THE CUURENT ILAC/APLAC THEIR APPROVED
    DOCUMENTS.
  • ISO/IEC 17025
  • ISO 15189
  • ISO 17011
  • ISO/IEC GUIDE 43
  • APLAC MR001,
  • AND OTHER ILAC/APLAC DOCUMENTS.

32
NABL IS APLAC MRA PARTNER
  • NABL BECAME A SIGNATORY TO APLAC MUTUAL
    RECOGNITION ARRANGEMENT ON 26TH Oct.-2000.
  • SCOPE OF RECOGNITION Testing/Calibration
  • NABL HAS ACCREDITED ABOUT 900 TESTING
    CALIBRATION LABORATORIES
  • APLAC RE-EVALUATION OF NABL WAS COMPLETED
    IN JULY 2004.

33
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34
THANKS
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