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    1.global Perspective of Accreditation-190707

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    Laboratory accreditation provides several important benefits: it ensures technical validity and comparability of test results, allows for reliable decision making, and provides national and international acceptance of laboratories. Accreditation is evaluated based on adherence to standards like ISO/IEC 17025 and involves on-site assessments of laboratories' management systems, personnel competence, and technical capabilities. Accredited laboratories benefit from recognition of their technical quality which supports regulatory compliance and trade.

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    1.global Perspective of Accreditation-190707

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    zilangamba_s4535
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    Laboratory accreditation provides several important benefits: it ensures technical validity and comparability of test results, allows for reliable decision making, and provides national and international acceptance of laboratories. Accreditation is evaluated based on adherence to standards like ISO/IEC 17025 and involves on-site assessments of laboratories' management systems, personnel competence, and technical capabilities. Accredited laboratories benefit from recognition of their technical quality which supports regulatory compliance and trade.

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    1.Global Perspective of Accreditation-190707

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    Laboratory accreditation provides several important benefits: it ensures technical validity and comparability of test results, allows for reliable decision making, and provides national and international acceptance of laboratories. Accreditation is evaluated based on adherence to standards like ISO/IEC 17025 and involves on-site assessments of laboratories' management systems, personnel competence, and technical capabilities. Accredited laboratories benefit from recognition of their technical quality which supports regulatory compliance and trade.

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    694 views24 pages

    1.global Perspective of Accreditation-190707

    Uploaded by

    zilangamba_s4535
    Laboratory accreditation provides several important benefits: it ensures technical validity and comparability of test results, allows for reliable decision making, and provides national and international acceptance of laboratories. Accreditation is evaluated based on adherence to standards like ISO/IEC 17025 and involves on-site assessments of laboratories' management systems, personnel competence, and technical capabilities. Accredited laboratories benefit from recognition of their technical quality which supports regulatory compliance and trade.

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    of 24

    Global Perspective of Accreditation

    Importance of Laboratory Accreditation

    Importance of Output Data from Lab


    INPUT
    LABORATORY DATA DECISION HEALTH, SAFETY ENVIRONMENT COMMERCE

    Comparability in Measurements
    Measurement traceability Reference Material Test Methods Proficiency Testing Uncertainty of measurement

    COMPETENCE OF A LABORATORY
    In evaluating the competence of a laboratory, the following methods are used: On-the-spot assessment of the laboratory by the experts. By evaluating the results of a particular test/measurement in a proficiency testing programme.

    International Standards and Guides applicable to laboratories


    ISO/IEC 17000 : Conformity assessment Vocabulary and general principles

    ISO/IEC 17025: General Requirements for the Competence of Testing & Calibration Laboratories ISO 15189 : Medical Laboratories Particular Requirements for Quality and Competence 6

    International Standards and Guides applicable to laboratories


    ISO/IEC Guide 43: Proficiency Testing by inter laboratory comparisons Part I & Part II ISO/IEC 17011: General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies

    Types of Certification
    First Party Certification Second Party Certification
    : Laboratory belongs to user, who is

    satisfied and uses for his own jobs


    : Laboratory does not belong to

    user but user using his own means certifies the laboratory, and uses for his own requirements .
    : Certifying/Accreditation body for

    Third Party Certification

    laboratories , is neither the owner of the laboratory nor is the user.


    8

    The Roles of the International Laboratory Accreditation Cooperation (ILAC)


    To develop the principles and the practice of laboratory accreditation To harmonize procedures and criteria for accreditation To assist in the development of new programmes To facilitate mutual recognition of members programme To reduce technical barriers in trade To improve International acceptability of test results
    9

    Bilateral Mechanism MRA


    A C E B D G F

    10

    ILAC
    EAL
    C C
    Lab Lab

    APLAC
    C C C C C C C C C

    11

    Development of Laboratory Accreditation


    War time test house scheme Australia NATA Australia Telarc New Zealand STP Denmark NVLAP USA ILAC International Conference A2LA USA ISO/IEC Guide 25 - Requirements for Competence RNE France CSCP Canada NCTCF India NABL India NAMAS UK HOKLAS Hong Kong EA - European Co-operation APLAC - Asia Pacific Co-operation 1943 1946 1973 1973 1976 1977 1978 1978 1979 1980 1981 1992 1981 1985 1987 1992

    12

    MRA Developments
    GATT Technical Barriers - re-test, re-inspection requirements Australia - New Zealand Laboratory MRA - 1981 Then Australia and New Zealand with UK, Sweden, Netherlands, etc. EA multilateral MRAs (include Aus, NZ, HK, Singapore, USA) APLAC multilateral MRA - 1997 ILAC World-wide multilateral MRA joining EA and APLAC and other regions - being developed
    13

    MRA Evaluations
    Based on APLAC MR 001 requirements International teams of trained evaluators Possible pre-evaluation Documentation review (two days): ISO/IEC Guide 58 compliance of management system Accreditation criteria consistent with ISO/IEC 17025 Independence and authority

    14

    MRA Evaluations
    On-site evaluation (five days): Review of records Training and competence of assessors Assessments properly conducted and up-to-date Appropriate committees and granting arrangements Traceability of measurement Reporting and close out of corrective action requests and follow-up if required Acceptance by APLAC MRA Council and signing on Ongoing surveillance evaluations
    15

    A Typical Accreditation Body


    National accreditation body is a statutory body May be established by Act of Parliament (NABL has been established by the Cabinet) User and/or government funded, not for profit organisation General third-party accreditation body Internationally recognized through MRAs
    16

    Functions of An Accreditation Body


    To promote the development and maintenance of good practice in testing and measuring To establish and maintain international recognition for its national accreditation programmes

    17

    NABL Accredits For:


    Testing Laboratories Biological Chemical Electrical Electronics Fluid-Flow Mechanical Non-Destructive Testing etc. Clinical Forensic Calibration Laboratories Electro-Technical Mechanical Radiological Thermal & Optical Fluid-Flow etc

    18

    Certification
    Procedure by which a third-party (certification body) gives a written assurance that a product, process or service (of an organisation) conforms to specified requirements Specified requirements - ISO 9001 Assures the client that the organisation has in place an effective quality or environmental management system Does not confer technical credibility of the test result

    Certification is not appropriate for laboratories or inspection bodies


    19

    Accreditation
    Procedure by which an authoritative body (NABL) gives formal recognition that a body (laboratory) or person (signatory) is competent to carry out specific tasks (scope) Criteria - ISO/IEC 17025 (includes all those requirements of ISO 9001 relevant to the scope of laboratories) Assures the client that the procedures and test results are technically valid Recognizes the technical competence of laboratory staff Endorses the the laboratory operates the the management system effectively
    20

    BENEFITS OF ACCREDITATION
    National and international recognition Public and industry acceptance Assurance to clients of good laboratory practice Provides global equivalence Provides comparability in measurements Decision makers can rely on test results Improves staff motivation Ensures better support in the event of legal challenge Saves money by getting it right at first time.
    21

    Conformity Assessment Structure


    International Mutual Recognition (ILAC ) Regional Mutual Recognition ( APLAC ) GOVERNMENT Recognizes Accreditation Bodies International Mutual recognition ( IAF ) Regional Mutual recognition ( PAC )

    Accreditation Bodies Accredited laboratories , Inspection Bodies, Certification Bodies (ISO/IEC 17011) Inspection Laboratories Bodies Test items/ Inspect designs, Materials Processes, or Calibrate Products, Equipment. Services, Plant ISO/IES 17025 ISO/IEC 17020 Generates technically valid test results / calibration data Design, processes Products Services ,Plant are certified (Standard/ Specifications) Product Certifier License Products to use a Cert. Mark ISO/IEC Guide 65 An Item or Material is Certified (Standards/ Specifications) QMS Certifiers Certify Quality Management systems ISO/IEC Guide 62 EMS Certifiers Certify Environmental Management Systems ISO/IEC Guide 66 Personnel Certify Personnel as Competent ISO/IEC 17024

    Companies are certified ISO 9001: 2000

    Personnel Companies are Are Certified Certified To Check ISO 14001 Against Requirements

    22

    Spectrum of Laboratory Accreditation


    ASSESSMENT PROCEDURES RULES EXAMINATION OF QM LABORATORY ACCREDITATION ACTIVITIES ACCREDITATIN CERTIFICATE SURVEILLANCE

    T
    SCOPE

    PROFICIENCY TESTING PROGRAMME

    C
    NABL NEWS

    NABL
    NABL Website ASSESSORS MONITORING TRAINING

    ILAC APLAC

    INTERNATIONAL LINKAGES

    NATA A2LA SCC IAS

    23

    Thanks
    24

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