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.’

Demands for

facilitating trade

Trade

Organizations

& Authorities

Product/

service

Suppliers

Purchasers

Regulators

Conforming

product/service

Requirements

Market

Certification

Body

Inspection

Body

Test

Lab

Cal

Lab

Conformity assessment bodies

Conformity Assessment Service

Certification

Body

Inspection

Body

Test

Lab

Cal

Lab

Conformity assessment bodies

Conformity Assessment Service

Demands for

competent

conformity

assessment

Accreditation Bodies

Accreditation service

Accreditation to Support the Market

4

Accredited Conformity Assessment

purchaser, regulator, the public ILAC

&

IAF

Accreditation

Body

Laboratory,

Inspection Body,

Certification

Body

Product

Service

Can we rely

on the AB? Can we rely

on the lab,

IB or CB?

Is it OK if

we buy it?

We check

conformance

on behalf of

you !

We assure you

of the

competence of

the Lab, IB or

CB !

We evaluate whether or not

the AB is competent !

ACCREDITATION

CONFORMITY ASSESSMENT

BODIES

PRODUCT & SERVICE PROVIDERS

Peer

Evaluation

International Standards

Standards / Regulatory requirements

/ Scheme criteria

GOVERNMENT CONSUMERS PURCHASERS

CONFIDENCE TRUST ASSURANCE

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

1977 – ILAC

established

1996 – ILAC MOU

2000 ILAC MRA

Testing &

Calibration

2001 1st

Joint IAF-ILAC General

Assembly

1993 – IAF

established

1998

IAF MLA for

QMS

IAF Bylaws

IAF

Incorporated

2004 – IAF MLAs for

EMS and Product

2003 - ILAC

Incorporated

2012 ILAC MRA

Inspection

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.

Asia Pacific

Laboratory

Accreditation

Cooperation

(APLAC)

European

Cooperation

for

Accreditation

(EA)

Inter-American

Accreditation

Cooperation

(IAAC)

Pacific

Accreditation

Cooperation

(PAC)

Southern African

Development

Community

Accreditation

(SADCA)

• The IAF MLA recognizes EA, PAC, IAAC

• The ILAC MRA recognizes EA, APLAC, IAAC

African

Accreditation

Cooperation

(AFRAC)

Arab

Accreditation

Cooperation

ILAC MRA Signatories

ILAC Associate Members

ILAC Affiliate Members

Coverage of the ILAC MRA (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

IAF MLA Signatories

IAF Members not yet Signatories

Coverage of the IAF MLA (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 The ILAC Secretariat

Elva Nilsen PO Box 7507

28 Chemin Old Chelsea Silverwater

Box 1811 NSW 2128

Chelsea, Quebec Australia

Canada J9B 1A0

Phone: +1 (613) 454 8159 Phone: +612 9736 8374

Email: iaf@iaf.nu Email: ilac@nata.com.au

www.iaf.nu www.ilac.org