The International Laboratory Accreditation Cooperation (ILAC

advertisement
The International Laboratory
Accreditation Cooperation (ILAC) &
The International Accreditation Forum
(IAF)
The Role of ILAC & IAF in the International
Recognition of Conformity Assessment Results of
Products that are Subject to Technical Regulations
Peter Unger, ILAC Chair
First International Congress on Market Surveillance in Technical Regulations
Medellin, Colombia
May 14, 2015
Accreditation in the TBT
Agreement
“6.1.1 adequate and enduring technical competence of
the relevant conformity assessment bodies in the
exporting Member, so that confidence in the continued
reliability of their conformity assessment results can
exist; in this regard, verified compliance, for instance
through accreditation, with relevant guides or
recommendations issued by international standardizing
bodies shall be taken into account as an indication of
adequate technical competence;”
What is accreditation?
‘Independent evaluation of conformity assessment bodies
against recognized standards to ensure their impartiality
and competence to carry out specific activities, such as
tests, calibrations, inspections and certifications.’
Accreditation to Support the Market
Accreditation Bodies
Accreditation service
Conformity assessment bodies
Certification Inspection
Body
Body
Test
Lab
Cal
Lab
Conformity Assessment Service
Market
Product/
service
Suppliers
Conforming
product/service
Requirements
Purchasers
Regulators
Trade
Organizations
& Authorities
Demands for
competent
conformity
assessment
Demands for
facilitating trade
4
Accredited Conformity Assessment
purchaser, regulator, the public
Is it OK if
we buy it?
Product
Service
Can we rely
on the lab,
IB or CB?
Laboratory,
Inspection Body,
Certification
Body
We check
conformance
on behalf of
you !
We assure you
of the
competence of
the Lab, IB or
CB !
Can we rely
on the AB?
ILAC
&
IAF
Accreditation
Body
We evaluate
whether or not
the AB is
competent !
Peer
Evaluation
ACCREDITATION
International Standards
CONFORMITY ASSESSMENT
BODIES
Standards / Regulatory requirements
/ Scheme criteria
PRODUCT & SERVICE PROVIDERS
CONFIDENCE
GOVERNMENT
TRUST
CONSUMERS
ASSURANCE
PURCHASERS
IAF and ILAC – an Introduction
ILAC and IAF are global networks of accreditation bodies
and organisations involved in conformity assessment
activities.
– Recognition of competent conformity assessment
activities through Global Arrangements
– Development and harmonization of accreditation
practices
– Promotion of accreditation as an effective mechanism for
providing confidence in goods and services
IAF and ILAC Objectives
– Maintain the Arrangements, and expand coverage into
new economies
– Increase cooperation with all relevant stakeholders
– Act as a central ‘hub’ to harmonise conformity
assessment best practice
– Provide appropriate support to new accreditation
activities in developing countries
Global Vision
To support world trade by eliminating technical barriers,
realizing the free-trade goal of ‘tested, inspected or certified
once and accepted everywhere' .
ILAC – The Membership
• ILAC is the oversight body for laboratory and
inspection body accreditation.
Full Members
Associate Members
Affiliates
Regional Cooperation Bodies
Stakeholders
IAF– The Membership
• IAF is the oversight body in the fields of the
certification of management systems, personnel and
products.
Accreditation Bodies
Certification Body Associations
Regional Cooperation Bodies
Industry Associations
Stakeholders and Scheme Owners
IAF / ILAC timeline
2001 1st Joint IAF-ILAC General
Assembly
2000 ILAC MRA
Testing &
2012 ILAC MRA
Calibration
Inspection
1977 – ILAC
established
1996 – ILAC MOU
1993 – IAF
established
1998
IAF MLA for
QMS
IAF Bylaws
IAF
Incorporated
2003 - ILAC
Incorporated
2004 – IAF MLAs for
EMS and Product
The ILAC and IAF Arrangements
– Accreditation bodies deemed competent through peer
evaluation:
– ISO/IEC 17011
– IAF-ILAC A series documents
– Signatories recognize certificates, reports, and results
issued by organizations accredited by other Signatories
– Provides business with assurance that overseas bodies
operate to the same standard.
– Removes technical barriers to trade by eliminating redundant
conformity assessment
Regional Cooperation Bodies
• The IAF and ILAC Arrangements are structured to build on
existing and developing regional MLAs/MRAs established
around the world.
Pacific
European
Cooperation Accreditation
Cooperation
for
(PAC)
Accreditation
(EA)
Inter-American
Accreditation
Cooperation
(IAAC)
Asia Pacific Southern African
Development
Laboratory
Community
Accreditation
Accreditation
Cooperation
(SADCA)
(APLAC)
• The IAF MLA recognizes EA, PAC, IAAC
• The ILAC MRA recognizes EA, APLAC, IAAC
African
Accreditation
Cooperation
(AFRAC)
Arab
Accreditation
Cooperation
Coverage of the ILAC MRA
ILAC MRA Signatories
ILAC Associate Members
ILAC Affiliate Members
(May 2015)
Status of the ILAC MRA
(May 2015)
– ILAC membership includes 147 bodies from 112 different
economies (89 Full Members/MRA Signatories, 16
Associates, 13 Affiliates, 23 Stakeholders, 6 Regional
Cooperation Bodies)
– 89 ILAC MRA Signatories representing 74 economies
– ILAC MRA covers testing, calibration and inspection
– Signatories represent about 95% of Global GDP
– More than 49,000 accredited laboratories
– About 8,000 accredited inspection bodies
Coverage of the IAF MLA
IAF MLA Signatories
IAF Members not yet Signatories
(May 2015)
Status of the IAF MLA
There are 60 IAF MLA Signatories, representing 55 economies
– Main scope:
– Management systems: 53 Accreditation Bodies and EA, PAC & IAAC
– Product certification: 51 Accreditation Bodies and EA, PAC & IAAC
– Sub scope Level 4
–
Global G.A.P. IFA General Regulations: 26 Accreditation Bodies
– Sub Scope Level 5
–
ISO 9001 QMS: 53 Accreditation Bodies and EA, PAC & IAAC
–
ISO 14001 EMS: 49 Accreditation Bodies and EA, PAC & IAAC
–
Global G.A.P. CPCCs: 26 Accreditation Bodies
Accepting applications: MDMS, FSMS, ISMS, Persons, GHG, V&V
Some Specifiers of the ILAC MRA
http://ilac.org/news/category/good-news-stories/
–
WTO Technical Barriers to Trade Program
–
Canadian Department of Environment and Conservation
–
Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF)
–
US Federal Government Agencies:
–
Consumer Product Safety Commission
–
Federal Highway Administration
–
Federal Aviation Administration
–
Coast Guard
–
Department of Defense
–
Nuclear Regulatory Commission
–
Food and Drug Administration
–
Environmental Protection Agency
–
General Services Administration
Some Specifiers of the ILAC MRA
http://ilac.org/news/category/good-news-stories/
–
WTO Technical Barriers to Trade Program
–
Canadian Department of Environment and Conservation
–
Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF)
–
US Federal Government Agencies:
–
Consumer Product Safety Commission
–
Federal Highway Administration
–
Federal Aviation Administration
–
Coast Guard
–
Department of Defense
–
Nuclear Regulatory Commission
–
Food and Drug Administration
–
Environmental Protection Agency
–
General Services Administration
Federal Highway Administration
Testing of crash mitigation equipment and devices need
to be tested in accordance with FHWA specifications by
a laboratory accredited by an ILAC MRA signatory
accreditation body
Rule in effect since 2010. Statement by Nicolas Armitovich, FHWA
highway engineer:
“Even though being part of the MRA has had no impact on the
work of the agency, the overall requirement for crash tests to
be conducted by accredited laboratories has improved our
confidence in the results received.”
21
Environmental Protection Agency
• Water Sense Program requires test results from a laboratory
accredited by an ILAC MRA signatory accreditation body
• Energy Star Program requires test results from a laboratory
accredited by an ILAC MRA signatory accreditation body
• Both programs require products to be certified by an accredited
certification body accredited by an IAF MLA signatories
• Proposed rule to control formaldehyde emissions from composite
wood products requires test results from a laboratory accredited
by an ILAC MRA signatory accreditation body
22
Environmental Protection Agency
Statement by Eamon Monaghan, Program Integrity Lead,
ENERGYSTAR on the reason for using the ILAC MRA:
“We didn’t have to develop and implement our own set of rules. Any kind of
agency-specific rule creates costs or hassles for industry, and that was
something we really wanted to avoid. We currently certify products in 65
categories, many of which are certified and tested overseas. Referencing
the ILAC MRA took the EPA off the hook for developing a lot of criteria for
labs or conducting our own lab oversight. And, by working with only ILAC
signatories, we have the confidence that the labs have been appropriately
assessed. We now recognize 27 ILAC-signatory accreditation bodies
around the world.”
23
General Services Administration
• Testing of star-of-life ambulances procured
by the U.S. Government must be tested by
an ILAC MRA signatory accreditation body
• The agency still does its own inspection but
has confidence that the critical components
of the ambulance have been tested by
competent laboratories
24
Nuclear Regulatory Commission
• NRC has been using NVLAP and A2LA accreditation
for calibration laboratories
• NRC extended the accreditation recognition to ILAC
MRA signatories in Europe and the Far East
• Nuclear Energy Institute (NEI) evaluated the ILAC
MRA peer evaluation process
• NEI recommended using the ILAC MRA
• NRC recognized in early 2015 the ILAC MRA
25
U.S. Coast Guard
• Testing of equipment and devices used on
Coast Guard vessels need to be tested in
accordance with Coast Guard specifications by
a laboratory accredited by an ILAC MRA
signatory accreditation body
• Third-party certification of certain products also
required
26
U.S. Coast Guard
Statement by Kurt Heinz, chief, life saving and fire
safety, U.S. Coast Guard on the benefit of the ILAC MRA:
“Obviously, avoiding duplicative tests saves a lot of
time. A lot of the safety materials we use in ship
construction, like the fire-resistant coatings we use on
bulkheads and other areas, are manufactured in Europe
and Asia, so being able to accept and depend on test
results from labs in those countries makes sense. And,
less time spent doing routine approval work translates
into more time spent on policy and standard
development – which is a good thing.”
27
U.S. Coast Guard
• Testing of equipment and devices used on
Coast Guard vessels need to be tested in
accordance with Coast Guard specifications by
a laboratory accredited by an ILAC MRA
signatory accreditation body
• Third-party certification of certain products also
required
28
Food and Drug Administration
• Draft 2008 guidance recommends test data for imported food
should be from an ISO/IEC 17025 accredited laboratory
• Accreditation should be done by an ILAC MRA signatory
accreditation body
• Food Safety Modernization Act calls for laboratory accreditation
with FDA leaning toward using the ILAC MRA to recognize
accreditation bodies
• FDA supports state public health laboratories to get accredited by
ILAC MRA signatories by August 2017
29
Consumer Product Safety Commission
• CPSC regulations issued to protect children under the
Consumer Product Improvement Act of 2008
• Lists laboratories accredited by ILAC MRA signatory
accreditation bodies
• Standard and test methods must appear on the scope
• Many children’s products continue to be added within
the scope of this requirement for accreditation
• CPSC market surveillance activities identify less
substandard products as a result
30
Consumer Product Safety Commission
Statement by Scott Hey, program manager of the CPSC Office of
Hazard Identification and Reduction on the benefits of the ILAC
MRA:
“The MRA has had a tremendous impact on our group. With all the
products from manufacturers around the world – cribs and bunk
beds from China and the United Kingdom, bike helmets and baby
walkers from Taiwan and Italy – knowing that they have all been
through an accepted standard of testing from an accredited lab
gives us a greater level of confidence in those products. It
provides a sense of consistency in quality.”
31
The Benefits
For Government
• Facilitator of trade
• An efficient enforcement and monitoring tool
For Business
• Greater acceptance of products and services
• Avoid costs associated with repeat conformity assessment
• Informed procurement
For Consumers
• Public confidence in goods and services
• Minimises product failures or recalls
Summary
– Commitment to developing a harmonized global approach
for accreditation practices
– Maintaining the Arrangements to ensure equal reliability of
accredited services.
– Promoting greater acceptance by regulators and
businesses to remove technical barriers to trade, and
avoiding the need for duplicate certifications, testing or
inspections.
– Supporting developing economies to establish an
accreditation infrastructure.
Contact Details
For more information contact:
For more information contact:
The IAF Secretariat
Elva Nilsen
28 Chemin Old Chelsea
Box 1811
Chelsea, Quebec
Canada J9B 1A0
The ILAC Secretariat
PO Box 7507
Silverwater
NSW 2128
Australia
Phone: +1 (613) 454 8159
Email: iaf@iaf.nu
Phone: +612 9736 8374
Email: ilac@nata.com.au
www.iaf.nu
www.ilac.org
Download