Reducing Risk Through The Use of Accreditation

Mike Peet

CEO

 

South African National Accreditation System

mikep@sanas.co.za

Introduction

Ade’s law

Anybody can win – unless there happens to be a second entry

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.

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.

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.

The Role of Standards

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

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

Accreditation Bodies

CertificationBody

InspectionBody

Test Lab

Cal Lab

Product/service

Suppliers

PurchasersRegulators

Trade Organizationsand Authorities

Conformity assessment bodies

Conforming product/service

Requirements

Demands for competent conformity assessment

Demands for facilitating trade

Conformity Assessment Service

Accreditation service

Market

Supervision in the Market

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.

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.

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.

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.

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 2:1996

Key words: “competent”“specific tasks”

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.

Isn’t 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 body’s 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

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 .......)

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.

The International Picture

ILAC

EA APLACIAAC

ILAC International Laboratory Accreditation Cooperation

EA European co-operation for AccreditationAPLAC Asia Pacific Laboratory Accreditation Cooperation

IAAC Inter-American Accreditation Cooperation

SADCA

SADCA Southern African Development Cooperation for Accreditation

International Recognition Through MLAs

Mutual Evaluation

Comparable Data

- Proficiency Testing

Harmonised Operationof Accreditation Programs- ISO/IEC 17011

Accreditation Criteria(Defined Scope, ISO/IEC 17025 or ISO/IEC

17020)

The Building Blocks of Confidence

ILAC’s 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.

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

Primary Objective of the ILAC Arrangement

Eliminate testing and/or

inspection as a Technical Barrier

through

Recognition of Competence

between

Accreditation Bodies

ILAC MRA Signatories from APLAC MRA

Australia: NATACanada: SCCChina: CNALHong Kong: HKASIndia: NABLIndonesia: KANJapan: JAB, IAJapan, VLACKorea: KOLAS Malaysia: DSM

Mexico: emaNew Zealand: IANZPhilippines: BPSLASSingapore: SACTaiwan: TAF Thailand: TLAS, DMScUSA: A2LA, IAS, NVLAPVietnam: BoA

ILAC MRA Signatories from EA MLA

Belgium: BELTEST/ BKO/OBEBulgaria: BAS Czech Republic: CAIDenmark: DANAKEstonia: EAKFinland: FINASFrance: COFRACGermany: DAP, DKD, DACH, DATech, DASMINGreece: ESYDIreland: NABItaly: SINALLatvia: LATAKLithuania: LA

Netherlands: RvANorway: NAPoland: PCAPortugal: IPACRomania: RENARSlovakia: SNASSlovenia: SASpain: ENACSweden: SWEDACSwitzerland: SAS Turkey: TurkakUnited Kingdom: UKAS

ILAC MRA Signatories from Unaffiliated Economies

South Africa: SANAS Brazil: INMETRO

Israel: ISRAC

Egypt: NAB

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?

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.

Conclusion

Any Questions?