Reducing Risk Through The Use of Accreditation

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Reducing Risk Through The Use of Accreditation

• Mike Peet
• CEO
•  
• South African National Accreditation System
• mikep_at_sanas.co.za

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Introduction

• Ades law
• Anybody can win unless there happens to be a
  second entry

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Globalisation

• The World Trade Organisation encourages members
  to use tariffs (fees paid at the border) to
  manage market access rather than non-tariff
  measures.
• Tariffs are transparent and can be lowered as
  the market opens. Lower tariffs are exposing
  other access restrictions, such as technical
  requirements.

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Globalisation

• This is a laudable objective but pre-supposes
  that a very technically sophisticated
  infrastructure is available to local
  manufacturers / service providers to enable them
  to objectively demonstrate the compliance of
  their products and/or manufacturing / service
  delivery processes to relevant ISO/IEC and other
  appropriate regional and international standards.

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The Role of Standards

• Standards play an increasingly important role in
  improving the operations of the marketplace and
  promoting growth and trade.
• Many factors have contributed to this mass
  production a growing demand for interchangeable
  parts globalization manufacturers concerns
  about product liability litigation demands for
  cheaper goods public demand for product safety
  and concerns about technical compatibility
  between products and demands for precision in
  product measurement.

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The Role of Standards

• What happens after the Standards and Guides
  have been created and harmonized at the
  international level?

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The Role of Conformity Assessment

• Conformity Assessment is the internationally
  recognised term used to refer to the procedures
  to determine, directly or indirectly, that
  relevant requirements in technical regulations or
  standards are fulfilled.
• These procedures may include sampling, testing,
  inspection, evaluation, verification, and
  assurance of conformity, registration,
  accreditation and approval as well as their
  combinations

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Supervision in the Market
Accreditation Bodies
Accreditation service
Conformity assessment bodies
Certification Body
Inspection Body
Test Lab
Cal Lab
Conformity Assessment Service
Market
Demands for competent conformity assessment
Conforming product/service
Product/ service
Purchasers Regulators
Requirements
Suppliers
Trade Organizations and Authorities
Demands for facilitating trade
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Important Factors When Selecting a Conformity
Assessment Body

• A conformity assessment body must be able to
  supply accurate and reliable testing, calibration
  or measurement results.
• Factors contributing to the technical competence
  of a conformity assessment body include
• Qualifications, training and experience of the
  staff
• Correct equipment properly calibrated and
  maintained
• Adequate quality assurance procedures
• Proper sampling practices
• Appropriate and valid testing procedures and
  methods
• Traceability of measurement to national
  standards
• Accurate recording and reporting procedures
• Suitable testing / inspection facilities.

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Why is Technical Competence so Critical?

• Minimise Risk
• Throughout the world today, customers seek
  reassurance that the products, materials or
  services they produce or purchase meet their
  expectations or conform to specific requirements.
  
• This often means that the product is sent to a
  conformity assessment body to determine its
  characteristics against a standard or a
  specification.
• For the manufacturer or supplier, choosing a
  technically competent conformity assessment body
  minimises the risk of producing or supplying a
  faulty product.

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Why is Technical Competence so Critical?

• Avoid Expensive Retesting
• Testing and/or inspection of products and
  materials can be expensive and time consuming,
  even when they are done correctly the first time.
  
• If not done correctly, then the cost and time
  involved in re-testing and/or inspection can be
  even higher if the product has failed to meet
  specifications or expectations.
• Not only costs go up, but your reputation as a
  supplier or manufacturer can go down.
• You can also be held liable for any failure of
  your product, particularly if it involves public
  safety or financial loss to a client.

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How Can We be Sure That a Conformity Assessment
Body is Technically Competent?

• Throughout the world, many countries now rely on
  Accreditation as a means of determining technical
  competence.
• Accreditation uses transparent and impartial
  criteria and procedures specifically developed to
  determine technical competence.
• Specialist technical assessors conduct a thorough
  evaluation of all factors in a conformity
  assessment body that affect the production of
  test, calibration and/or inspection data.
• The criteria are based on international standards
  ISO/IEC 17025 and ISO/IEC 17020 which are used
  for evaluating laboratories and inspection bodies
  throughout the world.

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Accreditation
Procedure by which an authoritative body gives
formal recognition that a body or person is
competent to carry out specific tasks
ISO/IEC Guide 21996 Key
words competent specific tasks
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Independent Recognition

• Accreditation provides formal and independent
  recognition to competent conformity assessment
  bodies, thus providing a ready means for
  customers to identify and select reliable
  testing, measurement and calibration services.
• To maintain this recognition, conformity
  assessment bodies are re-evaluated periodically
  by the accreditation body to
• ensure their continued compliance with
  requirements and
• check that their standard of operation is being
  maintained.
• The conformity assessment body may also be
  required to participate in relevant proficiency
  testing programs between reassessments, as a
  further demonstration of technical competence.

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Isnt ISO 9000 certification enough?

• Laboratories and/or inspection bodies can be
  checked and certified for their compliance to ISO
  9000
• This provides confidence in the conformity
  assessment bodys management system, but tells
  you nothing about its specific technical
  competence
• Evaluating technical competence requires
  additional technically focused activity
• the use of technical experts
• assessment against technical criteria
• identification of specific capabilities
• evaluation of results of PT activity

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Scopes of Accreditation (The competent tasks
recognised)

• Usually expressed in various combinations of
• Parameters (e.g. volts, ohms etc)
• Ranges (e.g. -40o to 70oC)
• Accuracy (best measurement capability or
  uncertainty of measurement)
• Type of test (electrical safety tests)
• Test specification (IEC .......)

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Why Use an Accredited Conformity Assessment
Body?

• Accreditation provides
• a means of determining competence to perform
  specific calibrations, tests and inspections
• a way for potential customers to locate competent
  and reliable testing, calibration and inspection
  services
• independent evidence of performance against
  international criteria
• customers with access to an independent complaint
  mechanism
• formal recognition and identification of
  competent laboratories and inspection bodies.

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The International Picture
ILAC
IAAC
APLAC
EA
SADCA
EA European co-operation for Accreditation
APLAC Asia Pacific Laboratory Accreditation
Cooperation
ILAC International Laboratory Accreditation
Cooperation
IAAC Inter-American Accreditation Cooperation
SADCA Southern African Development Cooperation
for Accreditation
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International Recognition Through MLAs
The Building Blocks of Confidence
Mutual Evaluation
Comparable Data - Proficiency Testing
Harmonised Operation of Accreditation Programs -
ISO/IEC 17011
Accreditation Criteria (Defined Scope, ISO/IEC
17025 or ISO/IEC 17020)
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ILACs Global Role

• ILAC is the principal international forum for
• recognition of competent test and calibration
  facilities world-wide through its Arrangement
• the development and/or appropriate harmonization
  of laboratory accreditation procedures and
  practices
• promotion of laboratory accreditation as a trade
  facilitation tool
• assistance with developing laboratory
  accreditation systems.

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The ILAC Model provides

• Harmonised approach
• Compliance with internationally agreed criteria
• Demonstrable traceability of measurement
• Resolution of differences
• An appeal process based on international best
• practice Independence of judgement and,
• as its basic purpose
• An impartial and non discriminatory mechanism
• to assist in the identification of competent
  Laboratories for specific activities

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Primary Objective of the ILAC Arrangement

• Eliminate testing and/or inspection as a
  Technical Barrier
• through
• Recognition of Competence
• between
• Accreditation Bodies

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ILAC MRA Signatories from APLAC MRA

• Australia NATA
• Canada SCC
• China CNAL
• Hong Kong HKAS
• India NABL
• Indonesia KAN
• Japan JAB, IAJapan, VLAC
• Korea KOLAS
• Malaysia DSM

• Mexico ema
• New Zealand IANZ
• Philippines BPSLAS
• Singapore SAC
• Taiwan TAF
• Thailand TLAS, DMSc
• USA A2LA, IAS,
• NVLAP
• Vietnam BoA

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ILAC MRA Signatories from EA MLA

• Belgium BELTEST/ BKO/OBE
• Bulgaria BAS
• Czech Republic CAI
• Denmark DANAK
• Estonia EAK
• Finland FINAS
• France COFRAC
• Germany DAP, DKD, DACH, DATech, DASMIN
• Greece ESYD
• Ireland NAB
• Italy SINAL
• Latvia LATAK
• Lithuania LA

• Netherlands RvA
• Norway NA
• Poland PCA
• Portugal IPAC
• Romania RENAR
• Slovakia SNAS
• Slovenia SA
• Spain ENAC
• Sweden SWEDAC
• Switzerland SAS
• Turkey Turkak
• United Kingdom
• UKAS

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ILAC MRA Signatories from Unaffiliated Economies

• South Africa SANAS Brazil INMETRO

• Israel ISRAC
• Egypt NAB

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The Importance of Decision-Making

• Accreditation Transparent and Impartial
  examination of the competence of a facility
  against a specific scope by an independent and
  competent body.
• Without Accreditation ?
• Risk based on assumption
• How much risk ?
• Three Questions Are you? By Whom? For What?

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Conclusion

• Due to the strong technological component
  associated with competent conformity assessment,
  many developed countries have an inherent
  suspicion of products coming from developing
  countries and often insist on re-testing and/or
  inspection in their own country.
• The risk to the importer of being found to be
  supplying non-conforming product can be very
  severe.
• Globalisation can therefore be expected to
  increase the need for local conformity assessment
  systems to be accepted internationally.

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Conclusion

• Any Questions?