1.Global Perspective of Accreditation-190707
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7/28/2019 1.Global Perspective of Accreditation-190707
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Global Perspective ofGlobal Perspective of
AccreditationAccreditation
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ImportanceImportance
ofofLaboratory AccreditationLaboratory Accreditation
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Importance of Output Data from Lab
INPUT
LABORATORY
DATA
DECISION
HEALTH, SAFETY
ENVIRONMENT
COMMERCE
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Comparability in MeasurementsComparability in Measurements
Measurement traceability
Reference Material
Test Methods
Proficiency Testing
Uncertainty of measurement
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COMPETENCE OF A LABORATORYCOMPETENCE OF A LABORATORY
In evaluating the competence of a laboratory, the
following methods are used:
On-the-spot assessment of the laboratory by theexperts.
By evaluating the results of a particular
test/measurement in a proficiency testingprogramme.
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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
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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 AccreditingConformity Assessment Bodies
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Types of Certification
First Party : Laboratory belongs to user, who is
Certification satisfied and uses for his own jobs
Second Party : Laboratory does not belong to
Certification user but user using his own meanscertifies the laboratory, and usesfor his own requirements .
Third Party : Certifying/Accreditation body for
Certification laboratories , is neither the ownerof the laboratory nor is the user.
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The Roles of the International Laboratory
Accreditation Cooperation (ILAC)
To develop the principles and the practice oflaboratory accreditation
To harmonize procedures and criteria for
accreditation To assist in the development of new programmes
To facilitate mutual recognition of membersprogramme
To reduce technical barriers in trade
To improve International acceptability of testresults
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Bilateral Mechanism MRA
A C F
B D G
E
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ILAC
EAL APLAC
C C C C C C C
C C
C
C
C
Lab
Lab
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Development of Laboratory Accreditation
War time test house scheme Australia 1943
NATA Australia 1946
Telarc New Zealand 1973
STP Denmark 1973
NVLAP USA 1976
ILAC International Conference 1977
A2LA USA 1978ISO/IEC Guide 25 - Requirements for Competence 1978
RNE France 1979
CSCP Canada 1980
NCTCF India 1981NABL India 1992
NAMAS UK 1981
HOKLAS Hong Kong 1985
EA - European Co-operation 1987
APLAC - Asia Pacific Co-operation 1992
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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
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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
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MRA EvaluationsOn-site evaluation (five days):
Review of records Training and competence of assessors
Assessments properly conducted and up-to-date
Appropriate committees and grantingarrangements
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
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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
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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
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NABL Accredits For:
Biological
ChemicalElectricalElectronicsFluid-Flow
MechanicalNon-Destructive
Testing etc.Clinical
Forensic
Electro-Technical
Mechanical
Radiological
Thermal & Optical
Fluid-Flow etc
TestingTesting
LaboratoriesLaboratories CalibrationCalibration
LaboratoriesLaboratories
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Certification
Procedure by which a third-party (certification body)
gives a written assurance that a product, process orservice (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 managementsystem
Does not confer technical credibility of the test result
Certification is not appropriate for laboratories or
inspection bodies
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Accreditation
Procedure by which an authoritative body (NABL)
gives formal recognition that a body (laboratory) orperson (signatory) is competent to carry out specifictasks (scope)
Criteria - ISO/IEC 17025 (includes all those
requirements of ISO 9001 relevant to the scope oflaboratories)
Assures the client that the procedures and test resultsare technically valid
Recognizes the technical competence of laboratorystaff
Endorses the the laboratory operates the themanagement system effectively
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BENEFITS OFBENEFITS OF
ACCREDITATIONACCREDITATIONNational 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 legalchallenge
Saves money by getting it right at first time.
C f it A t St tConformit Assessment Str ct re
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Conformity Assessment StructureConformity Assessment StructureInternational
Mutual Recognition
(ILAC )
GOVERNMENTGOVERNMENT
Recognizes Accreditation BodiesRecognizes Accreditation Bodies
International
Mutual recognition
( IAF )
Regional
Mutual Recognition
( APLAC )
Regional
Mutual recognition
( PAC )
Laboratories
Test items/
Materials
or Calibrate
Equipment.
ISO/IES 17025
InspectionBodies
Inspect designs,
Processes,
Products,
Services, Plant
ISO/IEC 17020
ProductCertifier
License
Products to use
a Cert. MarkISO/IEC -Guide 65
QMS Certifiers
Certify Quality
Management
systems
ISO/IEC
Guide 62
EMS CertifiersCertify
Environmental
Management
SystemsISO/IEC Guide 66
Personnel
Certify
Personnel as
Competent
ISO/IEC
17024
Generates
technically
valid test
results /
calibration
data
Design,processes
Products
Services ,Plant
are certified(Standard/
Specifications)
An Item or
Material is
Certified
(Standards/
Specifications)
Companies are
certified
ISO 9001: 2000
Companies are
Certified
ISO 14001
Personnel
Are Certified
To Check
Against
Requirements
Accreditation Bodies
Accredited laboratories , Inspection Bodies, Certification Bodies
(ISO/IEC 17011)
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Spectrum of Laboratory Accreditation
PROCEDURES RULESEXAMINATION
OF QM
ASSESSMENT SURVEILLANCE
LABORATORY
ACCREDITATION
ACTIVITIES
ACCREDITATIN
CERTIFICATE SCOPE
T
C
NABL
NABL NEWS
NABL Website
ASSESSORS
TRAINING
MONITORING
NATA
A2LA
SCC
IAS
PROFICIENCY
TESTING
PROGRAMME
ILAC
APLAC
INTERNATIONAL
LINKAGES
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