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  • Lab Accreditation System

    Naveen Jangra, NABL info@nabl-india.org

    naveenhr.nabl@gmail.com

  • About NABL

    Established with objective to provide Govt. and Industry with a scheme for third-party assessment of laboratories.

    NCTCF Program started in 1981 in DST.

    GoI adopted a new policy on economic liberalization in 1991.

    Renamed as NABL & aligned to International Std. in 1993.

    Cabinet Decision to registered as an Autonomous Body under the Societies Act.

    Registered as Society in August 12, 1998.

  • NABL Operations

    Accreditation program in accordance with requirements of ISO/IEC 17011: 2004.

    Testing and Calibration accredited by NABL, complies with ISO/IEC 17025: 2005.

    Medical Laboratories accredited by NABL, complies with ISO 15189: 20012.

    Proficiency Testing Provider accredited by NABL, complies with ISO/IEC 17043: 2010.

    Reference Material Producers (RMP) accreditation as per ISO Guide 34: 2009.

  • Global Scenario

    Results issued by NABL Accredited Lab are acceptable amongst 87 economies (signatories to ILAC MRA). NABL Accredited Laboratories are members of Global family of more than 40,000 accredited laboratories.

    NABL has emerged as the second largest laboratory Accreditation Body (after China).

  • MRA Signatory Status

    Signatory to Mutual Recognition Arrangement (MRA) since the year 2000: Asia Pacific Laboratory Accreditation Cooperation (APLAC) International Laboratory Accreditation Cooperation (ILAC)

    Reevaluated in 2004, 2008 and 2012, signatory status was reaffirmed.

    Next re-evaluation of NABL is due in 2016.

  • Peer Evaluation Process (ISO/IEC 17040: 2005)

    Accreditation Body in country A (ISO/IEC 17011: 2004)

    Accreditation Body in country B (ISO/IEC 17011: 2004)

    Recognition

    Laboratory in country A (ISO/IEC 17025: 2005)

    Test/Calibration Result Recognition of

    Equivalence

    Laboratory in Country B (ISO/IEC 17025: 2005)

    Test /Calibration Result

  • Acceptance of Results (issued by NABL Accredited Labs) by Govt. & Regulators CGHS and Government Hospital Laboratories Bureau of Energy Efficiency (BEE) Food Safety & Standards Authority of India (FSSAI) State Electricity Boards (SEBs) Agricultural & Processed Food Products Export Dev. Authority Telecom Engineering Centre (TEC) Central Pollution Control Boards (CPCB) Export Inspection Agency (EIA) Tea Board, Coffee Board, Spices Board etc. Judiciary relies on Accredited Forensic Labs

    Contd..

  • Central Public Work Department (CPWD) Ministry of Defence (MoD) Delhi Metro Railway Corporation (DMRC) Police Department Ministry of Agriculture Department of Weights & Measures (Legal Metrology) Ministry of Drinking Water and Sanitation (MDWS) Insurance companies rely on reports of Medical Labs

    And many more..

  • Metrology & Accreditation Metrology is often divided into 3 sub fields Scientific & Fundamental Metrology Applied & Industrial Metrology Legal Metrology

    BIPM, OIML, ILAC & ISO endorse following recommendations in order to rely on global acceptability of calibration to be performed: 1. In NMI which shall be normally signatory to CIPM-MRA & CMC

    published in the relevant areas of the KCDB Or 2. In NABL accredited lab (signatory to APLAC/ILAC arangement)

    NMI works with AB to determine the requirements for the best practice for a broad range of measurement laboratories. Experience of NMIs own laboratories to share for practical understanding of the process involved. NMI has leadership role in reliable measurement which meets requirements of public policy expressed in regulations.

  • Metrology & Accreditation

    Measurement uncertainty reported with certificate shall follow the principles established in GUM/ISO Guide 98

    Results of measurement made in accredited laboratory

    shall be traceable to SI units of measurement The above principle should be used wherever there is a

    need to demonstrate the metrological traceability for the purpose of international acceptability.

  • Process for Accreditation

    not one to be taken lightly or without forethought

    Requirements

    knowledge resources

    commitment planning

  • Calibration

    Electro-technical Mechanical Radiological Thermal Optical Fluid-Flow

    Scope of NABL Accreditation - Labs Testing

    Biological Chemical Electrical Electronics Fluid-Flow Mechanical NDT Optical &

    Photometry Radiological Thermal Forensic

    Medical Clinical Biochemistry Clinical Pathology Cytogenetics Cytopathology Haematology &

    Immuno-haematology Histopathology Microbiological &

    Serology Nuclear Medicine (in-vitro)

  • 684

    827 847

    1039

    1180

    1359

    1643

    1891

    2154

    2359

    500

    700

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    Mar 2006 Mar 2007 Mar 2008 Mar 2009 Mar 2010 Mar 2011 Mar 2012 Mar 2013 Mar 2014 March 2015

    Growth of Accredited Labs N

    o. o

    f Acc

    redi

    ted

    labo

    rato

    ries

    As on 15th January 2016 is 3275

  • 0

    100

    200

    300

    400

    500

    600

    2005-06 2006-07 2007-08 2008-09 2009-10 2010-11 2011-12

    2012-13 2013-14 2014-15

    156 183

    268 236

    418

    369

    431 472

    549 594

    Incoming Applications N

    o. o

    f Lab

    orat

    orie

    s

    Since April 2015 till 20th January 2016 NABL has received 531 applications

  • 0

    100

    200

    300

    400

    500

    600

    Mar 2006

    Mar 2007

    Mar 2008

    Mar 2009

    Mar 2010

    Mar 2011

    Mar 2012

    Mar 2013

    Mar 2014

    Mar 2015

    166 143 151

    195 212

    288 318

    433 472

    561

    Grant of Fresh Accreditation (FY Wise) N

    o. o

    f Acc

    redi

    ted

    Labo

    rato

    ries

    Financial Year Since April 2015 till 15th January 2016 NABL has granted 410 fresh Accreditation

  • Proficiency Testing Programs

    NABL-NPL Proficiency Testing (PT) Programs NPL has conducted 48 PT programs in calibration as per

    MoU signed between NABL and NPL. For another MoU, discussion is underway.

    APLAC Proficiency Testing Programs

    APLAC offers PT programs to its MRA signatory partners. Each member can nominate max. 4 labs in each program. NABL has participated in most of the (98) PT programs.

  • PT Provider Accreditation (ISO/IEC 17043: 2010)

    2011 Program launched 19 Applications received

    11 PTP accredited 03 Assessors Training Course organised 63 Assessors Trained.

  • New Areas of Accreditations Reference Material Producer (RMP) Accreditation-ISO Guide 34 Program initiated in collaboration with PTB Germany 2014 Program launched

    05 application received

    02 RMP accredited

    02 Assessors Training Course organised

    40 Assessors Trained

  • Awareness Program & Conclave on Accreditation

    More 150 awareness programs across the country Collaborating partners: CII, FICCI, CMAI, State Govt.

    Departments, Scientific Institutions etc. World Accreditation Day (WAD) on every 9th June

    partnering with QCI Lab Conclaves with CII (Delhi, Bangalore, Pune) Assessors Conclave & Calibration Lab Awareness

    Programmes in 4 regions across the country Assessors Conclave for Medical and Testing fields

    happening now.

  • Participation in International Activities & Relations

    SAARC Region Cooperation with support of PTB, Germany

    Supports the accreditation activities of SAARC region particularly for Nepal, Bangladesh, Sri Lanka and Bhutan. Accredited 15 Laboratories 6 Assessor Training Programs for Nepal, Bangladesh & Sri Lanka MoU with Bhutan and MoU with NBSM (Nepal) Participation in SAARC Activity Meets

  • Cross-Frontier Accreditation

    Other Accreditation Bodies (ABs) of World have accredited labs in India (PJLA, UKAS, COFRAC, A2LA, IAS, SAS)

    International Workshops / Conferences / Evaluations NABL officers widely participates in APLAC, SAARC, ILAC,

    WADA, EURACHEM and ISO/CASCO meetings/conferences

    7 NABL officers are APLAC Evaluators and have participated in evaluations of other Accreditation Bodies across the globe

  • > Measurement Traceability > Competency & Training > Measurement Uncertainty > Regulators & Regulations > Data Acquisition System > Device Certification

    Challenges in CEMS Accreditation

  • Accreditation does not guarantee success, its only one step along the quality journey

    CONTINUAL IMPROVEMENT

    QUALITY MANAGEMENT

    CUSTOMER SATISFACTION

    ACCREDITATION

    ERROR REDUCTION

  • THANK YOU

    We are available at info@nabl-india.org

    Slide Number 1About NABL NABL OperationsGlobal ScenarioMRA Signatory StatusSlide Number 6Acceptance of Results (issued by NABL Accredited Labs) by Govt. & RegulatorsMetrology & AccreditationMetrology & AccreditationProcess for AccreditationScope of NABL Accreditation - LabsSlide Number 14Slide Number 15Slide Number 16Proficiency Testing ProgramsSlide Number 18New Areas of AccreditationsAwareness Program & Conclave on AccreditationParticipation in International Activities & Relations> Measurement Traceab

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