EA-2/11 - EA Policy for Conformity Assessment Schemes

Publication
Reference EA-02/11

EA Policy For
Conformity Assessment
Schemes

(Sector schemes)

PURPOSE
EA recognises that the market sometimes requires accreditation of Conformity
Assessment Bodies (CABs) to conform to special requirements set out in sector
schemes: this is the policy for EA to develop and maintain co-operation with
such sector schemes and mutual confidence.

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Authorship
The publication has been prepared by the EA Executive 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 EA secretariat: [email protected].

Please check our website for up-to-date information http://www.european-

accreditation.org/

Date of endorsement: 17 November 2005

Date of implementation: 1 rst July 2006

Category: 2 MLA support documents

Revision of the document

Changes are marked in bold

1- All references to “ISO” have been replaced by ISO/IEC where relevant.

2- Chapter 3 section3.1.2, 2nd paragraph

The requirements established by the SO for the CABs must necessarily include the compliance
with all the provisions of the relevant standards that are formally accepted by EA currently:
ISO/IEC 17025 ISO 15189, ISO/IEC 17020, EN 45011(or its equivalent ISO), EN 45012 (or its
equivalent ISO), ISO/IEC 17024, and the relevant guidance established by EA.

3- Chapter 3 section 3.3

EA will not participate if the CAS has been produced without demonstrated market demand.

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Contents

1 PURPOSE 4

2 DEFINITIONS 4

3 EA PREREQUISITES FOR THE ESTABLISHMENT OF

RELATIONS WITH SCHEME OWNERS 5

4. CONFORMITY ASSESSMENT SCHEMES (CAS) COVERED

BY THE EA-MLA 6

5 SCHEME OWNERS AND EA RELATIONSHIPS 8

6. IMPLEMENTATION 10

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1 Purpose
This document has the following four objectives:

1) To lay down the policy established by EA regarding the conditions under

which EA can establish formal relationships with Scheme Owners
(Clause 3)
2) To set out the principles by which schemes can be considered as
“covered by the MLA”. (Clause 4)
3) To set out the nature of the relationships between EA and the Scheme
Owner (Clause 5).
4) To describe the decision-taking process followed by EA in these issues.

It is neither the aim of this document nor the competence of EA to determine

in which conformity assessment schemes each signatory can or cannot
operate at national level as long as that activity is not presented as covered
by the MLA.

2 Definitions
2.1 Activity covered by the MLA: Conformity assessment activity to which,
once accredited by a signatory to the MLA, the commitments agreed in
the MLA apply and whose correct accreditation is assessed as part of the
peer evaluation process.

2.2 Conformity assessment scheme (CAS): In this document, conformity

assessment scheme is understood as the set of documents that
establish:

I) The requirements / reference documents that must be used by the

Conformity Assessment Bodies (CABs) (i.e. test procedures, regulatory
documents against which the certification or inspection is going to be
performed, etc.)
II) The requirements applicable to the CABs that specify criteria
regarding their organization, mode of operation, staff, equipment, reports,
etc.
III) The requirements applicable to the organizations that perform
assessments of CABs (accreditation bodies or other organizations
performing assessments of CABs).

2.3 Scheme owner (SO): Organization that has established a CAS. The
following are examples of SOs:

• Standardization bodies
• Conformity Assessment Bodies
• Public administration bodies
• Organizations that use services provided by CABs

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• Organizations that buy or sell products subject to conformity

assessment activities

2.4 SO Recognition (of the CAB): Recognition means that the SO is

authorizing the CABs to carry out activities within the remit of the scheme
provided that they have accreditation. The SO, through such a
recognition process, may authorize the CAB to, for example:

• Perform conformity assessment activities in the regulatory field

• Perform conformity assessment activities so that these can be
recognized by certain organizations that make use of the reports
or certificates (COI, IWTO, WADA, EFI, etc).
• Perform conformity assessment activities on products or systems
so that such activities can be taken into account in their buying
decisions (EUREPGAP, BRC, AECMA, GFSI, Bluetooth)

Note: Not all the CAS include recognition

2.5 Scheme Specific Requirements (for Accreditation Bodies): Specific

applications of any ISO/IEC 17011 requirement for a particular scheme
established by the SO.

2.6 Scheme Specific Requirements (for the CAB): Requirements laid

down by the SO at the CAB level these requirements may go beyond but
must not contradict, nor exclude, any of the requirements included in the
standards used for accreditation (ISO/IEC 17025, ISO/IEC 17020, etc).

2.7 End User (of a CAS): The party in the market that uses the information
issued by a CAB (report, certificate, mark, etc) within its decision making
process. Typically, End Users are the public authorities in the regulatory
field, or buyers/specifiers of tested, certified or inspected goods

3 EA prerequisites for the establishment of relations with

Scheme Owners

3.1 EA will cooperate with SO only if:

3.1.1 The SO can demonstrate a clear market support for the scheme. This
has to include evidence of support for the scheme coming from all
interested parties. The number and nature of the “interested parties” will
be different for different CAS nevertheless the acceptance of the scheme
by the end user (see definitions) will always be needed.

3.1.2 The CAS must be based on the internationally recognized standards

used for accreditation.

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The requirements established by the SO for the CABs must necessarily

include the compliance with all the provisions of the relevant standards
that are formally accepted by EA, currently: ISO/IEC 17025,
ISO 15189, ISO/IEC 17020, EN 45011(or its equivalent ISO), EN 45012
(or its equivalent ISO), ISO/IEC 17024, and the relevant guidance
established by EA.
Any other requirements laid down by the SO at the CAB level must not
contradict, nor exclude, any of the requirements included in the above
documents (see definition of scheme specific requirements) – process
and/or service certification schemes according to EN 45011 may define
slightly different requirements (e.g. the possibility of minor non
compliances remaining for a defined time but the certificate could be
granted).

3.2 The EA cooperation in the development of a CAS will be limited to

aspects related to assessment.

3.3 EA will not participate if the CAS has been produced without
demonstrated market demand.

4. Conformity Assessment Schemes (CAS) covered by the

EA-MLA
Schemes are covered by the EA-MLA in those cases where the SO does not:

a) establish requirements other than those established in ISO/IEC 17011 for

the AB and the different standards used by EA to establish its MLAs for
the CAB, and
b) have any role in the assessment/recognition of the CAB.

Notes: the following are the activities covered by the EA MLA at the time of
approval of this document:

Accreditation according to ISO/IEC 17025

Accreditation according to ISO/IEC 15189
Accreditation according to ISO/IEC 17020
Accreditation according to ISO/IEC 17024
Accreditation according to EN 45011
Accreditation according to EN 45012 for the certification of ISO 9001
Quality Management Systems
Accreditation according to ISO/IEC Guide 66 for the certification of ISO
14001 Environmental Management Systems

When the SO does establish scheme specific requirements for the

CAB/AB or has some role in the assessment/recognition of the CABs, the
following principles have to be fulfilled in order for the accreditation

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activities performed by a signatory to an EA-MLA to be considered as

covered by the EA-MLA for a given CAS.

4.1 First principle: the SO does not exclude any member of the relevant
MLA

4.2 Second principle: The assessment processes must fulfill all the
requirements established in ISO/IEC 17011.

Notes: Some SOs (particularly in the case of laboratories) have their own
assessment processes and seek the AB recognition of the output of such
assessment in order for it to be used by the AB in its assessment
procedure. This situation may lead to organizations outside EA benefiting
from bilateral agreements with EA MLA signatories as de facto-
signatories.

Thus, when an AB enters into an agreement with a SO for any part of the
accreditation process (including the assessment), the SO as a
subcontractor has to demonstrate the fulfillment of the subcontracting
requirements laid down in ISO/IEC 17011, and the MAC has to be
notified for the purpose of peer evaluation.

In no case can the AB (see the third principle) conclude agreements for
the recognition of the assessment processes, or base its decisions on
information supplied by organizations, that do not fulfill the paragraph
above.

This principle does not prevent the AB using assessors or experts

supplied by the SO since such activity is not considered to be
subcontracting.

4.3 Third principle: The accreditation body is the only body responsible
for the decisions taken in respect of accreditation.

Notes: By definition, accreditation bodies must take the final decision

regarding the grant or denial of accreditation, as this must be a third-
party activity.

If the SO has established a recognition process (see definitions 2.4), this

must be clearly distinct from accreditation. If the SO has laid down
scheme specific requirements for the CAB and requires the AB to assess
them, the AB will be responsible for the decisions taken regarding the
fulfillment of those requirements.

In no circumstances will it be acceptable for accreditation decisions to be

changed or influenced by any type of revision of the CAS by the SO. The
MLA will not cover activities in which the accreditation decision is not fully
taken by the signatory to the MLA.

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4.4 Fourth principle: The EA-MLA is based on signatory ABs fulfilling

the requirements of ISO/IEC 17011 and the requirements and
procedures of the MLA. Decisions regarding the maintenance of an
AB in the MLA can only be taken within EA and on the basis of such
requirements.

Notes: In order to ensure the independence and credibility of the

evaluation process, decisions regarding the maintenance of an AB in the
MLA can only be taken within EA.

Where a SO has laid down additional requirements for the AB which are
over and above but do not contravene those of ISO/IEC 17011, so long
as there is no breach of compliance with ISO/IEC 17011, a breach of the
additional requirements shall not be a reason for EA to impose sanctions
against the AB. As these additional requirements should be addressed
through a bilateral agreement between the SO and the AB, they shall not
be assessed during EA peer evaluations.

However, EA may agree to the request from a SO to address the

fulfillment by an AB of a SO’s scheme specific requirements (for the
AB) (see definitions) during the peer evaluation process. This shall be
granted only where such scheme specific requirements are specific
applications of ISO/IEC 17011 to the scheme, for example, specific
qualification criteria for assessors, more precise content of reports, etc.
Only these can be considered as covered by the MLA; any other
activities for which the SO has laid down additional requirements for the
AB cannot be considered as covered by the MLA.

EA recognizes that SOs may seek assurance of the effectiveness of the

peer evaluation process for the particular scheme concerned. To this
end, EA will consider requests from SOs to observe the process of peer
evaluation of sector schemes on a sample basis.

4.5 Fifth principle: The information supplied to the market must

always be transparent and not create barriers to competition.

Notes: If the SO has laid down Scheme specific requirements for the
CAB, these must be clearly defined and documented by the SO and
made available to anyone that requests it. If the accreditation body has
assessed the Scheme specific requirements, reference to such
document and to the CAS will be included in the certificate or scope of
accreditation.

5 Scheme Owners and EA relationships

5.1 EA is an organization open to collaboration with any SO that operates at
the European or international level, provided the CAS fulfills the
principles set down in Clause 3 above. The depth and nature of such

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collaboration will depend on the SO and EA needs and expectations.

Nevertheless the next conditions must be respected:

5.2 When a SO fulfills the principles set down in Clauses 3 and 4 above and
wishes to control its CAS through the EA MLA, the agreements between
EA and the SO should include:

• The commitment of EA to include the SO in some of the EA

committees so as to improve the required multilateral communication
or, if appropriate, to create a specific task force for that SO.
• The possibility of receiving assistance and support (excluding
financial support) from EA in issues related to the conformity
assessment in its scheme and the possibility of nominating a single
interlocutor.
• The commitment of EA members to preferably consider the use of
assessors supplied by the SO (provided the fourth principle below is
fulfilled).
• Definition of any activities performed by the SO prior to the
accreditation that must be taken into account by the AB.

Even without an explicit agreement between SO and EA , if the SO asks

for accreditation to the CABs operating in the scheme, EA will ensure
the commitment of the ABs that operate under the scheme to:

• Evaluate the Scheme specific requirements laid down by the SO in

their assessment processes.
• Make reference to the CAS documents established by the SO in the
scope of accreditation.
• Operate accordingly to the guidelines or recommendations provided
by the SO.

In any event, the steps described in Clause 5 must be followed before

reaching this type of agreement.

5.3 In the case of CASs fulfilling only the requirements on Clause 3 but not
those in Clause 4, EA can only act as an organization that facilitates the
access of the SO to different national ABs with whom it wants to enter
agreements.

In this case, EA may reach agreements with the SO in order to, for
example:

• Create a specific task force for that SO within which scheme-related

issues can be discussed.
• Develop, if appropriate, a list of assessors recognized by the SO to be
used by the ABs in their assessments conducted under the scheme.
• Agree other commitments between the participating ABs and the SO.

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These agreements must make clear that EA will not include in its peer
evaluations the assessment of such schemes.

In any event, the steps described in Clause 6 must be followed before

reaching this type of agreement.

5.4 One of EA’s objectives is to reduce the number of assessments required

to CABs. Therefore, EA will be especially careful with those CASs in
which the SO acts or has acted de facto as an AB under its scheme. EA
will not conclude any type of agreement if the SO does not accept that
the AB may plan the assessments in such a way that, while ensuring an
appropriate technical assessment, the costs of the assessment process
are minimized, both in terms of money and time.

6. Implementation
The national ABs are responsible for analyzing if the CASs in which they
participate at the national level fulfill the requirements laid down in
Clauses 3.1 and 4.
If the CAS does not meet such requirements it is the AB’s responsibility
to make it clear to the SO, the CABs, and the general market.

Hence, the AB should have procedures to assure, both in the

accreditation certificate and in the accredited certificates/reports issued
by the CAB, differentiate between the activities covered and those not
covered by the MLA. These procedures should include the use of a
disclaimer in the accreditation certificates and in the reports/certificates
issued by the CABs in schemes not covered by the MLA stating “This
report/certificate is not covered by any EA MLA” or similar. These
procedures and their implementation must be open to assessment during
peer evaluations.

If an AB, cooperating with a SO at the national level, believes that the

CAS also has an impact on the European market, the AB should inform
EA and also recommend to the SO that it gets in touch with EA.

An SO seeking to sign an agreement with EA must contact any member

of EA or the chairman of any of its committees. The agreements must be
approved by the EA General Assembly following a proposal by the
Executive Committee, which itself should follow receipt of a favorable
opinion from the relevant EA Committee (after assessing the fulfillment of
the requirements established in this procedure and the identification of
any scheme specific requirements or additional requirements as
mentioned in 4.4).

In those cases where a CAS exists to meet the requirements of public

authorities, EA may choose to participate even if the CAS does not meet
completely the conditions defined in this document.

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