The International Laboratory Accreditation
Cooperation (ILAC)
&
The International Accreditation Forum (IAF)
Benefits of the ILAC & IAF Multilateral Mutual
Recognition Arrangements
ITU Regional Consultation on Conformance Assessment &
Interoperability, September 2010
What is ILAC ?
International Laboratory Accreditation Cooperation
• Established in 1977 to promote communication among
laboratory accreditation bodies around the world
• Formalized as a cooperation in 1996 with 44 bodies signing a
Memorandum of Understanding (MOU)
• On 2 November 2000, a mutual recognition arrangement was
signed, among the 36 accreditation body members from 28
economies, which had successfully completed a peer evaluation
• ILAC was incorporated in the Netherlands on 20 January 2003.
• Approx. 33,000 laboratories & over 6,000 inspection bodies
have now been accredited by the 67 ILAC Full Members.
ILAC’s Global Role
Principal international forum for:
• Recognition of competent test and calibration labs world-wide
through its Mutual Recognition Arrangement (MRA)
• Development and appropriate harmonization of laboratory
accreditation practice across the globe
• Promotion of laboratory accreditation as an effective mechanism for
providing confidence in measurement results, which is essential for
global trade facilitation and socio-economic issues
• Assisting with the development of laboratory accreditation systems
ILAC Goals
• Strengthen/deepen the existing ILAC MRA, promote the use
of accredited labs & appropriately link this activity to intergovernmental trade activity
• Continually promote the clear distinction between
certification & accreditation to help reduce the confusion in
the marketplace
• Provide assistance to developing countries by providing
appropriate pre-MRA support to new accreditation systems
• Increase cooperation with all relevant stakeholders, i.e. labs,
regulators, industry groups, standard writing bodies and
governments
ILAC Membership Categories
• MEMBERSHIP CATEGORIES: • CURRENTLY: (as of 3 Sept 2010)
–
–
–
–
–
Full Members (Signatories);
Associates;
Affiliates;
Stakeholders;
Regional Cooperation Bodies.
– 67 Full Members from 55
economies;
– 20 Associates from 20
economies;
– 20 Affiliates from 19 economies;
– 4 Regional Cooperation Bodies;
– 25 Stakeholders.
• Full Members & Associates have voting rights for all matters except
admission of new Full Members, where voting is restricted to the Full
Members only. There are currently 137 member organisations
representing 89 economies.
ILAC Organisation Chart
General Assembly
Arrangement Council
Advisory Committees
Executive Committee
Proficiency Testing
Consultative Group
Secretariat
Arrangement
Management
Committee
Laboratory
Committee
Financial
Audit
Committee
Arrangement Committee
Accreditation Committee
Marketing &
Communications
Committee
Joint Development Support
Committee
Joint Inspection Group
MRAs Between Accreditation
Bodies
The Fundamental Purpose of the ILAC
Mutual Recognition Arrangement is to
demonstrate that:
A laboratory accredited by one signatory has
equivalent competence to a Laboratory accredited
by the other signatories.
The ILAC Vision
Accredited once Accepted Everywhere
Governments can take advantage of the ILAC Arrangement
to further develop or enhance trade agreements. The ultimate
aim is increased use and acceptance by industry as well as
government of the results from accredited laboratories,
including results from laboratories in other countries.
In this way, the free-trade goal of 'product tested once and
accepted everywhere' can be realised.
How does the ILAC
Arrangement (MRA) Work?
• The ILAC Arrangement is based on the results of an
intensive evaluation of each accreditation body carried out
by peers and in accordance with the relevant rules and
procedures contained in several ILAC publications (P-Series
or A-Series Documents).
– Procedural Series (P Series) - Procedural and policy
publications for the operation of the ILAC Arrangement,
and which form part of the criteria for
ILAC Arrangement evaluations.
– ILAC-IAF Joint Publications (A Series) - Joint IAF
and ILAC documents used for the evaluation of regions,
unaffiliated bodies and inspection bodies.
How does the ILAC
Arrangement (MRA) Work?
• Each accreditation body signatory to the Arrangement agrees to
abide by its terms and conditions and by the ILAC evaluation
procedures and shall:
– Maintain conformance with the current version of ISO/IEC
17011, related ILAC guidance documents, and a few, but
important, supplementary requirements, and
– Ensure that all accredited laboratories comply with ISO/IEC
17025 or ISO 15189 (for medical testing laboratories) and
related ILAC policy and guidance documents.
How does the ILAC
Arrangement (MRA) Work?
• ISO Standards:
– ISO/IEC 17011:2004 - Conformity assessment -- General
requirements for accreditation bodies accrediting conformity
assessment bodies
– ISO/IEC 17025:2005 - General requirements for the
competence of testing and calibration laboratories
– ISO 15189:2007- Medical laboratories -- Particular
requirements for quality and competence
The International Picture
ILAC
APLAC
EA
IAAC
SADCA
ILAC
International Laboratory Accreditation Cooperation
EA
European Cooperation for Accreditation
APLAC
Asia Pacific Laboratory Accreditation Cooperation
IAAC
Inter-American Accreditation Cooperation
SADCA
Unaffiliated Bodies
Southern African Development Community Accreditation
Peer evaluated ABs who are not geographically located in one of the
established regions
Status & Operation of the
ILAC MRA
• As of 3 September 2010, 67 Full Members representing 55 economies
are signatories to the ILAC Arrangement (MRA).
• The MRAs of the recognised regions underpin the ILAC Arrangement
(MRA).
• Currently, the MRAs of 3 of the 4 Regional Cooperation Body
members in ILAC are recognised by ILAC (EA, APLAC and IAAC).
• Recognition of a region is achieved after successful peer evaluation by
ILAC.
• Each recognised region undergoes a re-evaluation by ILAC every 4
years.
• Signatories to the EA, APLAC and IAAC MRAs, who are also
members of ILAC, are entitled to become signatories (Full Members)
to the ILAC Arrangement.
Status & Operation of the
ILAC MRA (cont’d)
• Unaffiliated bodies are ABs who do not have a Regional Cooperation
body in their geographical region.
• ILAC relies on the evaluations undertaken by the recognised regions to
grant and maintain ILAC signatory status for the ILAC members in
their respective regions.
• ILAC itself undertakes the evaluations of the regions, the unaffiliated
bodies (those ABs who do not have a region in their geographical area)
and those ABs who are part of a developing region, that has not yet
obtained recognition (eg SADCA).
• ILAC draws its peer evaluators from the regions and unaffiliated
bodies.
Benefits of ILAC
• The development of the MRA underpins cross border trade through
the acceptance of accredited test results. “Tested once, accepted
everywhere”.
• A support structure to lead the co-ordination of a consistent approach
and the harmonisation of best practice.
• The provision of a platform to exchange information and enable
knowledge transfer.
• Support to developing and emerging economies.
• Links with other international organisations such as IAF, ISO &
ISO/CASCO, BIPM, IEC, OIML, WADA, IFCC, WHO and trade
organisations.
In Summary:
Primary Objective of the ILAC Arrangement
• Eliminate testing as a Technical Barrier to
Trade
through
• Recognition of Competence
between
• Accreditation Bodies
ILAC-MRA Mark
ILAC-MRA Mark (cont’d)
• 47 ILAC Full Members have signed Licensing Agreements with
ILAC, for the use of the Combined MRA Mark.
• The Combined MRA Mark, is the ILAC-MRA Mark used in
combination with the accreditation body’s own mark.
• Once licensed, accreditation bodies can enter into a Sub-Licensing
Agreement with their accredited laboratories for the use of the ILAC
Laboratory Combined MRA Mark.
• The ILAC Laboratory Combined MRA Mark is the ILAC-MRA Mark
used in combination with the mark which an accredited lab is entitled
to use.
International Partnerships
• ILAC has signed a Memorandum of Understanding (MOU)
with the following organisations:
–
–
–
–
–
–
–
–
CIPM - ILAC MoU
ICSCA - ILAC MoU
IAF - ISO - ILAC MoU
UNIDO - IAF - ILAC MoU
IEC - ILAC MoU
ILAC - IAF - OIML MoU
WADA - ILAC MoU
IFCC – ILAC MoU
International Partnerships
(cont’d)
• Joint BIPM/ILAC Statement on the roles of NMIs and NABs.
• Joint Declaration of the BIPM, OIML and ILAC promoting the
existing three MRAs.
• Joint ISO-ILAC-IAF Communiqué on the alignment of ISO/IEC
17025:2005 with ISO/IEC 9001 (2008) updated January 2009.
• Joint ISO-ILAC-IAF Communiqué on the alignment of
ISO15189:2007 with ISO/IEC 9001 (2008) released September 2009.
• Agreement for Closer Cooperation was signed between ILAC and IAF
in September 2005.
The IAF Vision
To develop a single, worldwide program of conformity
assessment, which reduces risk for business, regulators
and the general public by ensuring that accredited
certification may be relied upon.
What is IAF
• The International Accreditation Forum (IAF) is a global
association of;
– Accreditation Bodies
– Certification Body Associations
– Industry associations
– Other stakeholder organisations and scheme owners
involved in conformity assessment activities in a
variety of fields including management systems,
products, services and personnel
What is IAF (cont’d)
• Established in 1993 to operate a program for the accreditation of
bodies dealing with conformity assessment.
• On 22 January 1998 the Multilateral Recognition Arrangement (MLA)
for Quality Management Systems (QMS) was signed and MLAs for
Environmental Management Systems (EMS) and Product Certification
(Product) were signed on 9 October 2004.
• Accreditation Bodies that are members of the IAF MLAs (QMS, EMS
and Product) are required to recognise the certificates issued by
certification/registration bodies accredited by all of the other
signatories to that MLA.
The objectives of IAF
• To maintain and develop a Multilateral Recognition Arrangement
(MLA) between its Accreditation Body Members to ensure recognition
of accredited certification between signatories.
• To act as a global forum to bring together accreditation bodies and
stakeholder groups to facilitate global trade.
• To develop appropriate harmonization of conformity assessment best
practice
• To promote accredited conformity assessment by working with, and
influencing, key international organisations and industry groups
IAF Membership
• MEMBERSHIP CATEGORIES:
(membership numbers as at 26 July 2010)
– 62 Accreditation Body Members;
• 46 IAF MLA Signatory Accreditation Bodies
– 18 Associate Members;
• 9 Industry/User Groups
• 9 CAB Groups
– 4 Regional Cooperation Groups
– 4 Observer Members
The IAF Structure
The IAF MLA
• The IAF MLA is a network of accreditation body members of IAF that
have been deemed competent through a stringent peer evaluation
process.
• Signatories to the IAF MLA will recognize as being equally reliable
the certificates and/or reports issued by certification/registration
bodies accredited by all other members of the IAF MLA.
• The IAF MLA provides businesses with assurance that equivalent
overseas certification/registration bodies operate to the same standard
as those in their own country.
• This acceptance removes technical barriers to international trade as
businesses will not require multiple certifications.
• This reduces time to market and well as additional cost to business.
Status of IAF MLA (cont’d)
As at 26 July 2010 the number of IAF MLA signatories to each MLA
are:
• IAF QMS MLA:
3 Regional Accreditation Groups (EA, PAC
& IAAC) and 44 Accreditation Bodies
• IAF EMS MLA:
2 Regional Accreditation Groups (EA &
PAC) and 39 Accreditation Bodies
• IAF Product MLA:
2 Regional Accreditation Groups (EA &
PAC) and 36 Accreditation Bodies
Details can be found on the IAF website at www.iaf.nu
The benefits of accredited
certification
For Government:
For business:
For Society:
•
Flexible alternative to
Legislation
•
•
•
Facilitator of trade
•
An efficient
enforcement /
monitoring tool
Greater acceptance of
products and services
opening up market
access
•
Avoid costs associated •
with multiple
certifications
•
Gain access to the
growing number of
tenders which specify
accredited certification
Public confidence in
goods and services,
despite complex global
marketplace
Minimises product
failures or recalls
The IAF MLA Mark
• The IAF MLA mark can be used by accreditation bodies that are
signatories to the MLA.
• MLA signatories can license the MLA mark and use in conjunction
with their own accreditation body logo, for example,
Accreditation
Body Logo
QMS NO 01
The IAF MLA Mark
• Businesses seeking certification will be able to see at a glance if the
certification body issuing the certificate is accredited by an
accreditation body that is a signatory to the IAF MLA. The
certification body must include an indication as to which activity the
accreditation is related.
Accreditation
Body Logo
QMS NO 01
• As a result, businesses will benefit from having increased confidence,
signified by the presence of the IAF MLA Mark, that requirements
have actually been met.
ILAC & IAF Joint Activities
ILAC and IAF are engaged in a number of well established joint
activities the most notable of which are:
• Annual Joint General Assembly
• Joint meetings of the ILAC & IAF Executives (3/year)
• Joint peer evaluations for Regional Cooperation Bodies
• Joint Development Support Committee (JDSC)
• Joint Marketing & Communications Activities
• Joint Working Group on Maintenance of A Series documents (ie
ILAC/IAF common publications)
• World Accreditation Day - 9 June
• Tripartite MoUs with other international organisations
Network on Metrology, Accreditation and
Standardization for Developing Countries
(DCMAS network)
Building corresponding technical infrastructures to support
sustainable development and trade in developing countries and
countries in transition.
DCMAS Network Members
•
•
•
•
•
•
•
•
•
•
Bureau International des Poids et Mesures (BIPM)
International Accreditation Forum (IAF)
International Electrotechnical Commission (IEC)
International Laboratory Accreditation Co-operation (ILAC)
International Organization for Standardization (ISO)
International Trade Centre (ITC)
Telecommunication Standardization Sector of ITU (ITU-T)
International Organization of Legal Metrology (OIML)
United Nations Industrial Development Organization (UNIDO)
United Nations European Economic Commission for Europe (UNECE) Working Party on Regulatory Cooperation and Standardization Policies
(W.P.6)
Terms of reference
• Exchange information and experience
• Provide a means of pooling expertise
• Work with, and support the objectives of, global organizations, such
as the WTO as well as the UN system
• Liaise with international and local agencies to introduce MAS
programs in developing countries
• Provide information, speakers and training material for seminars and
events
Role of ILAC & IAF in
DCMAS network
• To work with other partners in an integrated manner to provide holistic
support to developing countries in metrology, accreditation and
standards development.
• Focus on the development of infrastructure in developing countries for
the accreditation of laboratories (ILAC) and certification bodies (IAF).
• This activity is channeled through the Joint ILAC/IAF Development
Support Committee (JDSC) which has close links with UNIDO and
other funding agencies.
• The ILAC and IAF Co-Chairs of the JDSC hold positions on the ILAC
and IAF Executive Committees and so have a direct voice at the
planning and operational level in each organisation.
Importance of accreditation
for developing countries
• The use of an accreditation system reduces the possibility of goods being
denied access on the basis of inadequate conformity assessment.
For developing countries
• Lack of access to recognised accreditation programmes prevents full
integration into the world trading system
• Developing an accreditation infrastructure is daunting if a government
does not have the knowledge, experience or financial resources
• For an accreditation programme to be viable it must also be sustainable in
the long term and the development of an accreditation programme in each
economy may not always be the best solution.
• Regional Accreditation Bodies are being established to service the
accreditation needs of more than one economy when it is not viable for
each economy to maintain their own AB.
World Accreditation Day
• World Accreditation Day – 9 June 2010
Global Acceptance
• World Accreditation Day – 9 June 2011
Theme to be confirmed at Annual Meetings in
Shanghai – October 2010
For more information …..
ILAC Secretariat
Email:
ilac@nata.com.au
Web:
www.ilac.org
IAF Secretariat
Email:
Secretary1@iaf.nu
Web:
www.iaf.nu