EA-1/06  EA Multilateral Agreement. Criteria for signing.

Policy and procedures for development

Publication
Reference EA-1/06 A-AB:2022

EA Multilateral Agreement.

Criteria for signing.

Policy and procedures for

development.

PURPOSE
This document sets out the terms of the EA Multilateral Agreement, under which the signatories
recognise the equivalence of each other’s accreditation systems, defines the activities which are
covered by the agreement, and describes the expansion of the agreement to new scopes.

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 EA-1/06  EA Multilateral Agreement. Criteria for signing. Policy and procedures for development.

Authorship
This document has been prepared by the Horizontal Harmonization Committee.

Official language
The text may be translated into other languages as required. The English language version
remains the definitive version.

Copyright
The copyright of this text is held by EA. The text may not be copied for resale.

Further information
For further information about this publication, contact your national member of EA or the
Secretariat: secretariat@european-accreditation.org.

For up-to-date information, please check our web site at http://www.european-

accreditation.org

Category : Governance and Policy Documents

Date of endorsement : 5th April 2022

Date of implementation : Immediate

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 EA-1/06  EA Multilateral Agreement. Criteria for signing. Policy and procedures for development.

CONTENTS

1 INTRODUCTION .............................................................................................4

2 THE EA MLA ..................................................................................................5

3 PURPOSE OF THE EA MLA ............................................................................5

4 OPERATION AND MANAGEMENT OF THE EA MLA........................................5

5 REQUIREMENTS FOR SIGNING THE EA MLA ................................................6

6 RIGHTS OF EA MLA SIGNATORIES ...............................................................7

7 SCOPE AND STRUCTURE OF THE EA MLA ...................................................7

7.1 GENERAL ......................................................................................................7

7.2 COVERAGE OF THE EA MLA .........................................................................9

7.3 EXPANSION OF THE SCOPE OF THE EA MLA ...............................................9

8 APPENDIX 1 – EA MLA SIGNATURE TEMPLATE .......................................... 12

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 EA-1/06  EA Multilateral Agreement. Criteria for signing. Policy and procedures for development.

1 INTRODUCTION

The European co-operation for Accreditation (EA) is the association of National Accreditation
Bodies (NABs), which conduct and administer accreditation of Conformity Assessment Bodies
(CABs).
The role of EA and the individual National Accreditation Bodies of the EU/EEA member states
is defined in the Regulation (EC) No 765/2008 setting out the requirements for accreditation1.
In the EU accreditation system - as described in the aforementioned Regulation - EA has been
assigned the prime role for defining, harmonising and building consistency in accreditation as a
service to European trade, industry and society.
Furthermore, EA incorporates in its MLA other National Accreditation Bodies of countries not
being members of the EU and EFTA, but members of the Council of Europe and of the EU
neighbourhood policy.
EA has established a Multilateral Agreement (EA MLA), under which the signatories recognise
the equivalence of each other’s accreditation system.
An on-going programme of cooperation has been set up which is aimed at developing and
maintaining the EA MLA among all members.
The principal elements of the programme to establish mutual confidence are:
• Participation in the EA peer evaluation program;
• Exchange of information on the development and operation of accreditation systems;
• Participation in the work and decision making of the EA General Assembly (EA GA),
Committees, EA MLA Council (EA MAC) and working groups, where applicable;
• Cooperate in efforts to set up assessment teams and in the exchange of persons to
participate in assessments of accredited CABs;
• Cooperation with parties interested in European accreditation system including the
European Commission, stakeholders and international organisations like IAF and ILAC.
This document sets out the terms of the EA MLA, defining:
• The EA MLA, its purpose and consequences;
• The criteria to sign the EA MLA and the rights of signatories; and
• The structure and scope of the EA MLA, including the procedures to expand its scope.

For the purpose of this document the following definitions apply:

• Accreditation Field: The unique combination of a conformity assessment field (EA MLA
Level 2) and a standard containing requirements for CABs performing that activity (EA
MLA Level 3), e.g.: Testing / EN ISO/IEC 17025;
• Scope of the EA MLA: Accreditation activities endorsed by the EA GA;
• Scope of Recognition (of an EA MLA signatory): Accreditation Field(s) of a NAB for
which the EA MAC decided positively the signatory status.
1 EA is the body designated by the European Commission pursuant to Article 14 of the Regulation
(EC) No 765/2008 to operate the peer evaluation of NABs in the Member States.

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 EA-1/06  EA Multilateral Agreement. Criteria for signing. Policy and procedures for development.

2 THE EA MLA

The EA Multilateral Agreement (EA MLA) is a multilateral arrangement between EA

members2 whereby the signatories recognise and accept:
(a) The equivalence of the accreditation systems operated by the signatories;
(b) The reliability of the conformity assessment results (e.g. a report or certificate)
provided by CABs accredited by the signatories for the relevant scope.
EA is the body designated by the European Commission pursuant to Article 14 of the
Regulation (EC) No 765/2008 to operate the peer evaluation of NABs in the Member States.
Thus, a NAB being a signatory to the EA MLA means that the NAB had successfully
undergone a peer evaluation as referred by Articles 10 and 11 of the Regulation.

3 PURPOSE OF THE EA MLA

The EA MLA main purpose is to provide confidence to all interested parties in conformity
assessment results (e.g. reports and certificates) provided by CABs accredited by EA MLA
signatories.
Acceptance in the marketplace of the EA MLA and thereby of conformity assessment results
provided by CABs accredited by EA MLA signatories is of major importance for the
development of the internal market in Europe in facilitating cross border trade as well as in
demonstration of compliance with the European legislation for products and services
contributing to protect the health, safety and environment.
NABs are expected to apply for every MLA Accreditation Field where they are active.

4 OPERATION AND MANAGEMENT OF THE EA MLA

The EA MLA is managed by the EA MAC, which is responsible for conducting peer
evaluations of NABs according to the procedures defined in EA-2/02 (EA Procedure for the
evaluation of a National Accreditation Body) and considering the requirements described in
clause 5 of the present document.
The outcomes of peer evaluations are the basis for the decision-making process of the EA
MAC and the acceptance of signatories to the EA MLA.
The acceptance of signatories is associated to a Scope of Recognition. A NAB can be
signatory to a part or to all the accreditation activities included in the scope of the EA MLA
(see EA MLA Signature Template – Appendix 1). The scope and structure of the EA MLA is
detailed in clause 7 of this document.
A list of signatories, identifying the Scope of Recognition for each one, of the EA MLA is
maintained on the EA website as well as in document EA-INF/03 (Signatories to the EA
Multilateral Agreement).

2Admission to the EA MLA is restricted to EA members. NABs that are not eligible to be an EA member, as defined in the EA Articles of
Association may, under certain circumstances, be invited to enter into a cooperation agreement with EA. Some of these cooperation
agreements (COA) may be extended into cooperation agreements for mutual recognition (COAMR).

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EA-2/02 also defines procedures to deal with EA MAC decisions on suspensions and
withdrawals of the signatory status.

5 REQUIREMENTS FOR SIGNING THE EA MLA

Each NAB signatory or applicant to the EA MLA agrees to abide by its terms and conditions
and shall:
(a) Maintain conformity with the relevant requirements defined in the Articles of
Association, the obligations defined in the Rules of Procedure (EA-1/17) and with the
specific membership criteria defined in EA-1/17-S1;
(b) Fulfil the requirements in EN ISO/IEC 17011;
(c) Fulfil the relevant requirements in the Regulation (EC) No 765/2008;
(d) Fulfil supplementary requirements defined in EA mandatory documents and in IAF and
ILAC documents approved by EA as mandatory;
(e) Be fully operational, having demonstrated experience in operating an accreditation
body, access to technical expertise in all aspects of its accreditation activities, and
granted at least one accreditation that is valid at the time of the peer evaluation in each
scope of recognition (see 7.1) for which it signed or applied;
(f) Ensure that all accredited CABs comply with the relevant standard defining
requirements for CABs (Level 3 and Level 4, where applicable) and the supplementary
requirements defined in European legal provisions, EA mandatory documents and in
IAF and/or ILAC documents approved by EA as mandatory;
(g) Bring those supplementary requirements to the attention of accredited and applicant
CABs;
(h) Inform accredited and applicant CABs that only conformity assessment results (e.g.
reports or certificates) that refers to the relevant accreditation are considered to be
under the EA MLA;
(i) Only subcontract assessment activities to accreditation bodies having signed the EA
MLA, or the IAF MLA, or the ILAC MRA for that particular scope;
(j) Cover the costs of the peer evaluations including travel, accommodation and expenses
of the evaluation teams and provide sufficient translators;
(k) Report any significant changes in its status and/or its operating practices without delay
to the EA Secretariat. Significant changes are those that could affect issues such as
competence, impartiality and operational ability and include, but are not limited to,
those related to legal status, relationship with government, senior personnel, contact
persons, and offices addresses. The NAB shall provide an impact analysis related to
the reported changes;
(l) Accept accreditation systems operated by other EA MLA signatories as equivalent to
its own accreditation system;
(m) Promote the international acceptance of the conformity assessment results (e.g.
reports or certificates) issued by CABs accredited by accreditation bodies that are

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signatories to the EA MLA, to the ILAC Mutual Recognition Arrangement (ILAC MRA)
and to the IAF Multilateral Recognition Arrangement (IAF MLA);
(n) Declare, when requested, conformity assessment results (e.g. reports or certificates)
issued by CABs accredited by accreditation bodies that are signatories for the relevant
scope to the EA MLA, to the ILAC Mutual Recognition Arrangement (ILAC MRA) and to
the IAF Multilateral Recognition Arrangement (IAF MLA) as reliable as those issued by
CABs accredited by themselves3;
(o) Promote the EA, ILAC and IAF arrangements to stakeholders;
(p) Make publicly accessible information about the Level 4 Sector standards, sectorial
schemes and activities based on EU legislations (Directives, Regulations) included in
the accreditation services offered by the NAB;
(q) Notify, in writing and not later than three months in advance, other EA MLA signatories
of any voluntary withdrawal or reduction of the scope of recognition;
(r) Upon changes to requirements of this agreement, ensure conformity with the new
requirements within the period specified by EA.

6 RIGHTS OF EA MLA SIGNATORIES

An EA MLA signatory may refer at any time to its status as a signatory to the EA MLA,
according to EA rules (EA-3/01: EA Conditions for the use of accreditation symbols, logos
and other claims of accreditation and reference to the EA MLA signatory status).

7 SCOPE AND STRUCTURE OF THE EA MLA

7.1 General

The scope of the EA MLA is described in a five levels structure, according to Table 1, two of
which (Levels 2 and 3) are used to define the Scope of Recognition of the signatories.
Table 1 presents the hierarchy of conformity assessment activities, standards and schemes
with possible combinations.

3 The activity is only deemed to be accredited if the corresponding certificate or report refers to the relevant accreditation.

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Table 1 – EA MLA Structure

EA MLA LEVEL
STANDARDS, ACTIVITIES AND EXPLANATIONS
LEVEL DEFINITION
1 Requirements for accreditation bodies The requirements in EN ISO/IEC 17011, in Regulation (EC) No
765/2008 and, when applicable, the supplementary
requirements defined in EA mandatory documents and in
IAF and/or ILAC documents endorsed by EA as mandatory
2 Conformity assessment activities of (a) Calibration
conformity assessment bodies to which (b) Testing (including Medical examinations)
accreditation bodies grants accreditation (c) Inspection
against standards included in Level 3 (d) Product certification
(hereafter conformity assessment (e) Management system certification
activities) (f) Certification of persons
(g) Validation and Verification
(h) Proficiency testing providers
(i) Reference material producers
(J) Biobanking
3 Harmonized Standards (or other normative (a) EN ISO/IEC 17025
documents) containing general (b)1 EN ISO/IEC 17025
requirements for conformity assessment (b)2 EN ISO 15189
bodies performing conformity assessment (c) EN ISO/IEC 17020
activities included in Level 2 (hereafter (d) EN ISO/IEC 17065
conformity assessment standards) (e) EN ISO/IEC 17021-1
(f) EN ISO/IEC 17024
(g)1 EN ISO/IEC 17029
(g)2 EN ISO 140654
(h) EN ISO/IEC 17043
(i) EN ISO 17034
(j) EN ISO 20387
4 Documents containing criteria - Examples of Sector standards:
supplementary to those contained in ISO 15195 (a); ISO 22870 (b)2; ISO/TS 22003 (e); ISO/IEC
Level 3 standards. Such documents are: 27006 (e)
(i) Sector specific standards or other
recognisable normative documents - Examples of Sectoral schemes:
(hereafter Sector standards); (g)2 Implementing Regulation (EU) 2018/2067 on the
(ii) Sectoral schemes as specified in verification of data and on the accreditation of verifiers,
Regulation (EC) No 765/2008 Articles (d)Directive 2014/90/EU on marine equipment
2(10) and 13;
(iii) Conformity assessment schemes
according to EA-1/22 (hereafter Schemes)

Note:
Level 4 is only applicable where
documents supplementing Level 3
standards exist (meaning that a Level 5 is
often directly connected to a Level 3
standard).
5 Scope of accreditation: standards or other Note:
normative documents used by the - Can include, for example, specific testing methods and
accredited conformity assessment body to specific management system requirements (e.g.: ISO 9001
deliver an accredited conformity and ISO 14001).
assessment field.

4
It relates to EN ISO 14065:2013. EN ISO 14065:2020 becomes an MLA level 4 standard (g1).

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7.2 Coverage of the EA MLA

All conformity assessment results (e.g. reports and certificates) provided by CABs accredited
by a NAB signatory to an EA MLA Accreditation Field are considered to be under the EA MLA
provided that the conformity assessment results issued by the CAB contain a reference to the
relevant accreditation.

7.3 Expansion of the scope of the EA MLA

This procedure shall apply when considering the inclusion of:

i. A new conformity assessment field (Level 2) – see 7.3.1 and 7.3.2;
ii. A new conformity assessment standard (Level 3) – see 7.3.1 and 7.3.2; and
iii. New sector standards and schemes (Level 4) – see 7.3.3.
The procedure to be followed includes evaluating some general criteria and performing a
technical analysis and examination of the activity in the field, standard or scheme in question
which is normally carried out by the relevant EA technical committee.
Furthermore, analysis of the impact on the EA peer evaluation program and the need for an
EA mandatory document to ensure a harmonised application of the criteria by the NABs
should be carried out by the EA Horizontal Harmonization Committee (EA HHC) and EA
MAC.

7.3.1 General policy

Whenever a new conformity assessment standard for CABs (Level 3) performing a conformity
assessment field (Level 2) used for accreditation is introduced to the market, and a need for it
in the European market place can be clearly established, a proposal on its inclusion in the EA
MLA and by what mechanism shall be put to the EA GA for decision.
The EA GA will decide if the new conformity assessment standard shall be included in
combination with a new conformity assessment field or under an already endorsed conformity
assessment field (i.e. defining a new Level 2 and a new Level 3 in combination or just a new
Level 3). All conformity assessment activities and conformity assessment standards have to
be endorsed by the EA GA before being included in the EA MLA.
The general criteria for evaluating the suitability of a conformity assessment field, conformity
assessment standard, sector standard or scheme for inclusion under the EA MLA Levels 2, 3
or 4 are:
i. Significant relevance to the accreditation of CABs under the scope of the EA MLA
accreditation activities;
ii. Sufficient substance to contribute to the recognition of competence of CABs and/or
conformity assessment activities done by CABs;
iii. Fulfils appropriate and clearly established needs in the European market;
iv. Lack of inclusion poses threats to the European accreditation infrastructure as
serving the public interest;
v. Complementary to or supportive of any other standards currently being used;

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vi. Does not contradict, dilute the substance or have a negative impact on the outcome
of any existing Level 2 / Level 3 combination under the EA MLA; and
vii. Conformity assessment standards, sector standards and schemes must be produced
by a recognizable consensus process with involvement of relevant interested parties.
A precondition for EA expanding the EA MLA for a new conformity assessment field (Level 2)
shall be that a European or International conformity assessment standard for competence of
CABs contains requirements applicable to types of conformity assessment activities other
than those covered by the existing EA MLA.
If the new standard describes competence criteria different to those included in the standards
already included in the EA MLA for the performance of activities being under the EA MLA
and it may be used as a stand-alone document i.e. contains all criteria for accreditation of a
CAB to the standard, then the standard shall be classified as conformity assessment
standard (Level 3) in the EA MLA under the relevant activity (Level 2).
If the standard can only be used in combination with a conformity assessment standard
already included at Level 3 of the EA MLA, the new standard shall be considered as a Level
4 document (sector standard).
Whenever a new standard is introduced in the EA MLA as a Level 3 standard, it must be
further analysed to ascertain if it can be included as one of the activities already endorsed at
Level 2 of the EA MLA. If the new standard does not fit into one of the activities defined at
Level 2, a new conformity assessment field shall be introduced.

7.3.2 Procedure: Level 2 and Level 3

Whenever a new conformity assessment standard to be used for accreditation of CABs is
published, the EA HHC is requested in close collaboration with the relevant technical
committee - EA Laboratory Committee (EA LC), EA Certification Committee (EA CC) or EA
Inspection Committee (EA IC) - to prepare an evaluation of the standard against:
(a) The criteria under clause 7.3.1;
(b) The compatibility with the requirements in EN ISO/IEC 17011 and in the Regulation (EC)
No 765/2008.
The analyses prepared by the EA HHC shall make a recommendation on:
(a) The suitability of the standard for the accreditation of CABs;
(b) The necessity to develop additional criteria to ensure a harmonised application of the
standard by NABs;
(c) The need to introduce, with justification, an additional conformity assessment field on
the EA MLA Level 2.
Based on the recommendation received, the EA HHC shall prepare a proposal to the EA GA.
The EA HHC shall advise the EA GA, as appropriate, of the need to develop an EA
application document and the applicable timeframe for completion.
The EA GA following a recommendation from the EA HHC, shall decide if the conformity
assessment standard shall be included under the EA MLA and any additional requirements
needed for inclusion of the standard under the EA MLA.

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Following a decision by the EA GA to include a new conformity assessment standard under

the EA MLA the relevant EA Committee shall draft application document(s), as appropriate,
and the EA MAC shall analyse and decide on the need to develop additional procedures for
the peer evaluation process.
When the conditions, as decided by the EA GA for expansion of the scope of the EA MLA,
have been fulfilled including the adoption of peer evaluation procedures as proposed by the
EA MAC, EA shall inform members that a new standard has been included under the EA
MLA and that EA members can apply to the EA MAC to join the EA MLA for the extended
scope.
The procedure proposed by the EA MAC for inclusion of a new standard under the EA MLA
may include a peer review activity e.g. peer evaluation of the NAB’s accreditation field or
document review of NAB accreditation procedures, competence, etc. This peer evaluation or
review activity shall be completed and an EA MAC decision on compliance with the
applicable requirements shall be taken before signatories to the EA MLA may claim the
activity is under the EA MLA.

7.3.3 Specific procedure: Level 4

(a) Sector standards (e.g. ISO/TS 22003, ISO/IEC 27006, ISO 22870): The application of
sector standards need approval by the EA GA after recommendation from the relevant
technical committee (EA LC, EA CC or EA IC). The full application of those sector
standards is required for the related conformity assessment activities to be considered
under the EA MLA.
Note: These Level 4 standards are published in EA-INF/01.
(b) EU legislations: The application of sector schemes, included in EU legislations, do not
need endorsement by EA (e.g. Implementing Regulation (EU) 2018/2067).
The application of other EU regulatory sector schemes, which are not published as EU
legislation, but in another type of (non-legal) document, need approval by EA.
(c) Sector schemes included in the IAF MLA or ILAC MRA scopes do not need
endorsement by EA.
(d) Schemes: EA has developed a specific procedure for evaluation of schemes by EA
members (EA-1/22). Sector schemes that have been satisfactorily evaluated according
to EA-1/22 do not need further endorsement by EA.

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8 APPENDIX 1 – EA MLA SIGNATURE TEMPLATE

MULTILATERAL AGREEMENT

The National Accreditation Body signatory to EA MLA commits itself to comply with the requirements and obligations applicable notably those defined in
document EA-1/06. The signatory status of any National Accreditation Body is subject to changes (extension, suspension and withdrawal) and can be checked
on the EA website (www.european-accreditation.org).

NATIONAL ACCREDITATION BODY

COUNTRY

SCOPE OF RECOGNITION
ACCREDITATION FIELD EA MLA Council decision date
EA MLA Level 2: Field of activity EA MLA Level 3: Standard
Calibration EN ISO/IEC 17025
Testing EN ISO/IEC 17025
(including Medical examinations) EN ISO 15189
Inspection EN ISO/IEC 17020
Product certification EN ISO/IEC 17065
Management system certification EN ISO/IEC 17021-1
Certification of persons EN ISO/IEC 17024
Validation and Verification EN ISO /IEC 17029
EN ISO 14065 (GHG)
Proficiency testing providers EN ISO/IEC 17043
Reference material producers EN ISO 17034
Biobanking EN ISO 20387

Issue date

Name Name
Position Chair of EA MLA Council
Authorised signature on behalf of Authorised signature on behalf
above National Accreditation Body of EA MLA Signatories

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