UNIDOWAITRO WORKSHOP

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

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CASE STUDY NABL

• -Devi Saran
  Tewari

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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

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• FORMULATION OF NCTCF ACCREDITATION CRITERIA AND
  OTHER DOCUMENT STARTED

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• 1989-SEPT LAUNCH OF NCTCF
• RELEASE DOCUMENTS

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LAUNCH OF NCTCF PROGRAM

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

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

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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

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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.

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• NABL COMMENCED ASSESSMENT ACTIVITIES BY USING
  NCTCF ASSESSORS

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• 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.

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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

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• 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

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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

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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.

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• 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.

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NABL TRAINING COURSES
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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

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• THE FIRST NABL NEWS WAS PUBLISHED IN JULY 1995,

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• NABL CONDUCTED ASSESORS ORIENTATION COURSES ON
  ISO/IEC 17025

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• ASSESORS CONCLAVE TO HARMONISE THEIR WORKING

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NABL PARTICIPATS IN ILAC AS
WELL AS IN APLAC CONFERENCES

• .

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• APLAC-1999 MEET AT NEWDELHI
• .

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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

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ORGANIZATIONAL STRUCTURE
BOARD
DIRECTOR
TRAINING
P.T.
ACCREDITATION ACTIVITIES
ADMINISTRATION / FINANCE
QUALITY ASSURANCE
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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.

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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.

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THANKS