Transcript No Slide Title

Reducing Risk Through
The Use of Accreditation
Mike Peet
CEO
South African National Accreditation System
[email protected]
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
Supervision in the Market
Accreditation Bodies
Accreditation service
Conformity assessment bodies
Certification
Body
Inspection
Body
Test
Lab
Cal
Lab
Conformity Assessment Service
Market
Product/
service
Suppliers
Conforming
product/service
Requirements
Purchasers
Regulators
Trade
Organizations
and Authorities
Demands for
competent
conformity
assessment
Demands for
facilitating
trade
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
APLAC
IAAC
SADCA
EA
APLAC
ILAC
IAAC
SADCA
European co-operation for Accreditation
Asia Pacific Laboratory Accreditation Cooperation
International Laboratory Accreditation Cooperation
Inter-American Accreditation Cooperation
Southern African Development Cooperation for Accreditation
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)
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: 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
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
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?