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Document 52013SC0035
COMMISSION STAFF WORKING DOCUMENT Accompanying the report from the Commission to the European Parliament, the Council and the European economic and social Committee on the implementation of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 Guidance papers on accreditation
COMMISSION STAFF WORKING DOCUMENT Accompanying the report from the Commission to the European Parliament, the Council and the European economic and social Committee on the implementation of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 Guidance papers on accreditation
COMMISSION STAFF WORKING DOCUMENT Accompanying the report from the Commission to the European Parliament, the Council and the European economic and social Committee on the implementation of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 Guidance papers on accreditation
/* SWD/2013/035 final */
COMMISSION STAFF WORKING DOCUMENT Accompanying the report from the Commission to the European Parliament, the Council and the European economic and social Committee on the implementation of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 Guidance papers on accreditation /* SWD/2013/035 final */
COMMISSION STAFF WORKING DOCUMENT Accompanying the report from the Commission to
the European Parliament, the Council and the European economic and social
Committee
on the implementation of
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9
July 2008 setting out the requirements for accreditation and market
surveillance relating to the marketing of products and repealing
Regulation (EEC) No 339/93
Guidance papers on accreditation 1. Introduction This Commission staff working document gives an
overview of the so-called 'CERTIF' documents which were discussed with the
Senior Officials for Standardisation and Conformity Assessment Policy Group
('SOGS') and which, following the discussions, represent a consensus between
the Commission and Member States representatives on how to approach certain
matters concerning the implementation of Chapter II on accreditation of
Regulation (EC) No 765/2008. The objective of these 'CERTIF documents' is to
provide informal guidance on question raised by national authorities and
accreditation bodies throughout the Union[1]. This staff working document therefore contains
all the documents on which a consensus was reached between 2008 (the year of
the adoption of the Regulation) and autumn 2012. 2. Impact
of the EU accreditation framework at international level (CERTIF 2008-03) The new Regulation (EC)
No 765/2008[2] embodies the European accreditation policy in relation to
conformity assessment. It introduces for the first time a common legal base for
accreditation by providing for a horizontal framework for accreditation which
lays down at European level the principles for its operation and organisation.
This framework covers accreditation linked to conformity assessment
independently whether the conformity assessment is performed in the mandatory
or voluntary sphere. Moreover it applies beyond the New Approach legislation
covering conformity assessment activities carried out in industrial sectors not
covered by the New Approach as well as in other areas such as environment,
health and agriculture. This document attempts to explain the impact of
the new accreditation framework at international level. This includes outlining
the main features and specific principles of the European accreditation policy,
the effects on the international cooperation between accreditation bodies and
its significance for the Community’s external trade policy in the field of
conformity assessment. 2.1. Background
Accreditation as an impartial means of
assessing and conveying formal demonstration of the technical competence,
impartiality and professional integrity of conformity assessment bodies is an
effective quality infrastructure tool used worldwide. At international level, cooperation between
accreditation bodies takes place within two organizations: namely within the
International Accreditation Forum (IAF) between accreditation bodies
accrediting certification and inspection bodies and within the International
Laboratory Accreditation Cooperation (ILAC) between accreditation bodies
accrediting laboratories and inspection bodies. Both entities provide for
multilateral mutual recognition arrangements between its accreditation body
members. IAF manages a Multilateral Recognition Arrangement (MLA), while ILAC
operates a Mutual Recognition Arrangement (MRA). Although the names of the
arrangements changes, both organizations have the aim through these
arrangements to establish confidence concerning the equivalence of the
operation of the signatories to the agreement and that the results of
accredited conformity assessment bodies issued under accreditation of the
signatories are equally reliable. These multilateral
mutual recognition arrangements/agreements of competence at technical level
between accreditation bodies have the ultimate aim to allow products and
services accompanied by accredited conformity attestations to enter foreign
markets without a re-testing or re-certification in the import country. The
objective of such recognition arrangement/agreements between accreditation
bodies is therefore to contribute to reinforce the acceptance of conformity
assessment certificates. At the regional level, cooperation
organizations between accreditation bodies have been established in[3]: ·
Europe: European
co-operation for accreditation (EA) ·
America: Inter America Accreditation Cooperation
(IAAC) ·
Asia – Pacific: Asia Pacific Laboratory
Accreditation Cooperation (APLAC) and Pacific Accreditation Cooperation (PAC) ·
Africa: Southern African
Development Community Accreditation (SADCA) Except for SADCA which is
currently developing its regional mutual recognition arrangement, the above
listed cooperation organisations have agreements/arrangements in place within
their region on which the ILAC/IAF arrangements build upon. By granting special
recognition IAF accepts the mutual recognition arrangements established within
EA and PAC: accreditation bodies being member of IAF and signatories to the EA
Multilateral agreement (EA MLA) or the PAC Multilateral Recognition Arrangement
(PAC MLA) are automatically accepted into the IAF MLA[4]. ILAC accepts the mutual recognition arrangements and
underlying evaluation procedures of EA, APLAC, and IAAC. Accreditation bodies
which are not affiliated to any recognised regional cooperation entity may
apply directly to ILAC and/or IAF for evaluation and recognition.[5] 2.2. The
New Legal Environment Regulation (EC) No 765/2008 provides for a
comprehensive horizontal legal framework for the operation and organisation of
accreditation in the European Economic Area (EEA)[6] applicable
as from 1 January 2010. It imposes obligations and requirements on European
national accreditation bodies, Member States and the European Commission and
sets out the respective responsibilities as well as the co-ordinating role of
the European co-operation for Accreditation (EA). Under Regulation (EC) No
765/2008 EA is recognised as the official European infrastructure for
cooperation in the field of accreditation responsible for the management of the
European peer evaluation which ascertain the competence of the European
accreditation bodies[7]. The stabilization of accreditation as
authoritative and therefore last level of control of conformity assessment
activities from a technical competence point of view is at the core of the
European accreditation policy. In this respect Regulation (EC) No. 765/2008
formalizes a set of requirements in particular for accreditation bodies. These
requirements are in line with the globally accepted requirements laid down in
the relevant ISO/IEC international standards, although some of them can be
perceived as being more rigorous, going beyond the requirements set out in the
applicable standards. In particular ·
Accreditation is carried out by one single
national accreditation body appointed by its Member State (Art 4.1) ·
Accreditation is performed as a public authority
activity (Art 4.5) ·
National accreditation bodies operates free from
commercial motivations (Art 8.1) and on a not-for- profit basis (Art 4.7) ·
National accreditation bodies do not compete
with conformity assessment bodies and among each other (Art 6.1 and Art 6.2) Cross frontier accreditation is carried out
only under certain limited circumstances (Art 7): European conformity
assessment bodies are required to request accreditation by the national
accreditation body of the Member State in which they are established. The
possibility of a conformity assessment body to request accreditation in another
Member States is limited to the cases where in its Member State there is no
national accreditation body, where the national accreditation body does not
offer the requested accreditation service or where the national accreditation
body has not received a positive result in the peer evaluation in relation to
the conformity assessment activity for which accreditation is requested By laying down these specific “supplemental”
requirements, Regulation (EC) No 765/2008 protects accreditation in Europe against the risk to become an additional layer of commercial certification which would jeopardize its reliability, neutrality and credibility. Accreditation would in this case not only entail added and
unjustified cost without added value but would also be unable to provide the necessary confidence to the market creating the
need for an extra layer for supervision. 2.3. The
Impact on the Relation between EA and ILAC and IAF According to Regulation (EC) No 765/2008
European national accreditation bodies fulfilling the requirements of the
Regulation are member of EA (Article 4.10). Different from European national
accreditation bodies, accreditation bodies not members of EA may not
necessarily meet all the above outlined EU requirements as these do not apply
outside the EEA and are not addressed to third country accreditation bodies.
Although Regulation (EC) No 765/2008 does not provide for rules regarding the
relationship between EA and international co operations between accreditation
bodies, the question arises on the impact for the co-operation between European
and third countries accreditors at international level taking place within ILAC
and IAF and within their respective global Mutual
Recognition Arrangement and Multilateral Agreement to which EA belongs as a
Region. If EA would recognise the equivalence among
accreditation bodies and the equal reliability of accredited conformity
assessment bodies’ only by accreditation bodies meeting the same requirements,
EA would undermine the international multilateral mutual recognition
arrangement/agreements and isolate itself. As this is in no way the intention
of Regulation (EC) No 765/2008, EA recognizes that attestations of conformity
issued in accordance with the requirements of ISO/IEC 17011 under accreditation
bodies signatories to the ILAC MRA and IAF MLA but not signatories to the EA
MLA or BLAs[8] and not complying with all the requirements of the EU regulation
are considered to be equally reliable from a technical point of view to those
issued within the EA MLA and BLAs.[9] 2.4. The
impact on trade relations in the field of conformity assessment between the EU
and Third Countries The international mutual recognition between
accreditation bodies allow certificates and reports accompanying exported goods
and services to be more readily accepted on the international and the European
market, but the ultimate acceptance in the EU of conformity assessment
attestations issued under accreditation by non-European bodies not necessarily
complying with the new European requirements does not depend on the cooperation
and mutual recognition of accreditation bodies. The ultimate acceptance of conformity
assessment attestations is decided by the public authorities and, from an
economic point of view, by industry users and consumers. The voluntary
multilateral mutual recognition agreements between accreditation bodies taking
place at technical level support, further develop and enhance intergovernmental
trade agreements. The requirements set out above affect the acceptance of non-European certificates and test results
accredited by non-European Accreditation bodies not complying with the new EU requirements
but signatories to the ILAC/IAF MRA/MLA in the following way: 2.4.1. Conformity
assessment delivered in the voluntary sphere It will be up to the non-European conformity
assessment body operating on the European market to decide if and where to get
accredited. In order to boost the acceptance of its conformity assessment
attestations by the European market (industry as purchasers of conformity
assessment attestations and ultimately consumers) the non-European conformity
assessment body opting for accreditation may choose whether to resort to the
service of a third country accreditation body not necessarily conforming to the
new European requirements but signatory to the ILAC/IAF MRA/MLA or rather to
that of a European accreditation body. Unchanged compared to the present
situation, non-European Conformity assessment attestations issued under accreditation
by non-European Accreditation bodies not fulfilling the new European
requirements, can continue to be used on the European Market. 2.4.2. Conformity
assessment delivered in the mandatory sphere Where conformity assessment is legally
regulated, national authorities of European Member States may refuse to accept
attestations of conformity issued under accreditation by non-European
accreditation bodies not complying with the new European requirements but
signatories to the ILAC/IAF MRA/MLA. However this refusal cannot be based on
the sole argument of the non-fulfilment by the third country accreditation body
as such. The conformance to the EU requirements by the third country
accreditation body is not a condition for recognition, but non-conformance
could reinforce doubt as to the quality and value of the accreditation and
therefore as to the quality and confidence in the accredited certificates or reports.
However, where government-to-government Mutual
recognition agreements (MRAs) between the Community and a third country in
relation to conformity assessment are in place[10],
national authorities of European Member States will accept the test reports and
certificates issued by bodies that the foreign party has designated under the
MRA for assessing conformity in the categories of products or sectors covered
by the MRA. The products accompanied by such conformity
attestations can be exported and placed on the other party’s market without
undergoing additional conformity assessment procedures.
Each importing party agrees, by the terms of the MRA,
to recognize the conformity assessment attestations issued by agreed conformity
assessment bodies of the exporting party, independently of whether
accreditation has been used to back up the designation process of the
conformity assessment bodies under the MRA or not, and independently of, in
case accreditation is used by the non-European Party, the fulfillment by the
third Party accreditation body of the EU requirements. Accreditation contributes to a quality driven
and reliable conformity assessment infrastructure. It provides for confidence
which is of great importance for Regulators, purchasers of conformity assessment
services and consumers and facilitates cross-border trade of goods and
services. By providing mutual confidence in the competence of CABs and
attestation issued by them, accreditation technically underpins trade by
promoting mutual recognition and the global acceptance of conformity assessment
results within the Internal Market and in relation to third countries. The
“additional” requirements for accreditation bodies set out in Regulation
765/2008 designed to consolidate the added value of accreditation do not create
a technical barrier impeding trade. The level of acceptance of conformity
attestations issued under accreditation of accreditation bodies not meeting the
EU requirements in the European Union will continue to be accepted or refused
in the same way as they are today. 3. Cross Border
Accreditation Activities (CERTIF 2009-06 Rev 6) 3.1. Introduction
This document concerns the interpretation of
the cross border accreditation provisions of Article 7 of Regulation (EC)
765/2008 (“the Regulation”) in relation to multinational conformity assessment
bodies. Bearing in mind that the ultimate say on matters of EU law rests with
the European Court of Justice, this draft paper contains a proposal for a
common understanding and pragmatic solution on the implementation of the
cross-border accreditation regime which is the result of the discussions held
between all interested parties involved (public authorities, EA and its
members, conformity assessment bodies and the Industry). The application of Article 7 of the Regulation
must be done in the light of the Single market principles such as the freedom
of establishment and the freedom to provide services and account must be taken
of other pieces of legislation such as Directive 123/2006/EC on Services in the
Internal Market (the "Services Directive"), whilst guaranteeing the
full respect and application of the fundamental principles and objectives of
the European accreditation policy. This is valid in particular for the
non-competition principle, which is a necessary condition for accreditation to
be the last level of control of the adequacy of conformity assessment services. 3.2. Background According to Article 7.1 of the Regulation,
conformity assessment bodies (CABs), whether third-party or first-party/in-house
bodies, are required when requesting accreditation to do so with the
national accreditation body (NAB) of the Member State in which they are
established. This general rule allows for exceptions:
the possibility of a conformity assessment body to request accreditation with a
NAB in another Member State is limited to cases where ·
there is no NAB in its own Member State [Article 7.1(a)], ·
the NAB does not offer the requested
accreditation service [Article 7.1(b)] ·
the NAB has not received a positive outcome in
the peer evaluation in relation to the conformity assessment activity for which
accreditation is requested [Article 7.1(c)]. Article 7.1 of the Regulation is closely linked
to and is a logical consequence of the non-competition principle embodied in
Article 6 of the same Regulation. It is important to prevent conformity
assessment bodies from shopping around for accreditation certificates, thus
creating a “market for accreditation” leading to the commercialisation of
accreditation which jeopardizes the added value and role of accreditation as a
public authority activity and last level of control of the conformity
assessment chain. 3.3. Problem
Definition Against this background, the issue to be
tackled concerns multinationally active CABs, i.e. CABs having their head
office in one Member State and which exercise their activity in another or
several Member States. This activity can be carried out in another Member State on a temporary basis (free provision of services)[11] or on
a permanent basis by means of one or more local entities such as subsidiaries,
branches or agencies (freedom of establishment)[12]. CABs may provide their services to clients in
other Member States on the basis of free provision of services without having
to be established there. The accredited conformity assessment results given on
the basis of free provision of service will be recognised by the public
authorities and accepted on the basis of the mutual recognition principle set
out in Article 11(2) of the Regulation. Indeed, under this provision, "National
authorities shall recognise the equivalence of the services delivered by those
accreditation bodies which have successfully undergone peer evaluation under
Article 10, and thereby accept, on the basis of the presumption referred to in
paragraph 1 of this Article, the accreditation certificates of those bodies and
the attestations issued by the conformity assessment bodies accredited by them."
Business operators are free to organise and
structure themselves in the way they think is best to serve their clients, for
example to get established in various Member States and to operate via local
entities. In this case the question arises for the need
for an accreditation for the multinational organisation as a whole or of parts
of that organization in the locations where they are established and operate:
can the operations of the local entity be covered by the accreditation of the
head office issued by the NAB where the head office is established or shall the
local entity be accredited by the local NAB? The cross-border provision
laid down in Article 7 is perceived to be very stringent and unnecessarily
burdensome for multinational CABs with local entities/sites established in
other Member States working under the supervision of the head office and under
the same quality system and management, as implying costly duplications of
assessments. The risk of suffering
a competitive disadvantage compared to third-country organizations is feared.
The Regulation does not apply to third-country bodies which are therefore free
to request accreditation (even multiple accreditations) with the European NABs
of their own choice. In case of a strict legal interpretation of Article 7, due to their structures, multinational CABs may
not benefit from the advantage of one accreditation certificate sufficient for
the whole territory of the EU, although avoiding multiple accreditation is one
of the objectives of the Regulation[13]. Practice shows, however,
that for a long time the majority of multinational CABs have been having their
local entities accredited by local NABs, resulting in multiple accreditations
from various NABs, for reasons linked to commercial arguments more than to
necessity. Moreover, it appears that a number of these organizations are fully
prepared to continue with this practice, for the same reasons. According to the
concerned parties, such multiple accreditations are due to the demand from
local regulators and/or from the local market not recognizing the equivalence
of the accreditations issued by the different NABs signatories to the European
Co-operation for accreditation multilateral agreement (EA MLA).
In light of the mutual recognition principle provided for in Article 11.2 of
the Regulation, such statements in relation to public authorities are no longer
acceptable, as national authorities are obliged to recognize the equivalence of
the services delivered and to accept the accreditation certificates issued by
the NABs which have successfully passed the peer evaluation managed by EA and
which are as a result, signatories to the EA MLA for the relevant accreditation
activity. The acceptance by the
market place indeed remains a challenge and problem to be tackled. End users
still perceive some European NABs and related accreditation certificates and
logos to be more valuable than others. To overcome these perceptions and
resistances the EA MLA should be promoted through activities targeting the CABs
and their clients. CABs should contribute to convince the market that the
accreditation given by the EA MLA signatories are equivalent by abstaining from
promoting one or another NAB which hinders the process of acceptance of the
equivalence of services offered by the NABs and fosters the use of multiple
accreditations. Instead, the value and quality of accredited certificates,
independently of which NAB has accredited them, should be promoted. Within this
context a statement on the accreditation certificate attesting the equivalence
of the accreditations issued by EA MLA signatories and the introduction of a
single European accreditation symbol, an EA symbol, to be used by the
signatories to the EA MLA could be further considered. Such measures, in
particular the latter, may go beyond the Regulation but could possibly be an
effective tool to foster the understanding and visibility of the EA MLA and
thereby the acceptance of the equivalence of the EA MLA signatories. 3.4. Solution 3.4.1. General
terms (1)
Duplication of unnecessary assessments and
burdens on multinational CABs should be avoided. This is required by the
principle of non-duplication, which is to be inferred from the case law about Article
56 TFEU and is explicitly set out in Article 10(3) of the Services Directive. (2)
Market needs in relation to accreditation should
be met, but without compromising the fundamental principles of the European
accreditation policy. (3)
Adequate controls of local entities of
multinational CABs must be assured. (4)
Exchange of information and effective
cooperation between NABs for assessment, re-assessment and surveillance of
local sites of multinational CABs is necessary. Based on mutual recognition of
all assessments carried out by EA members, any duplication of assessments of
organisational aspects or requirements should be strictly avoided. (5)
If necessary and on reasoned request, relevant
information on carrying out accreditation against national legislative
requirements of another Member State and/or requirements set out in relevant
national sectoral schemes shall be provided by the local NAB to the national
authorities of the other Member State. National authorities of the Member Stats
in which the local NAB is established should be kept informed thereof. (6)
It should be underlined that the solution
proposed has no effect on the civil liability regimes across the European Union. 3.4.2. Multi-site
accreditation The CAB with local
sites(regardless of their legal personality), provided that the latter operate
under the same global quality system and management and
that the head office has the means to substantially influence and control their
activities, can be considered as being only one
organisation with regard to the conformity assessment activity carried out.
Such a CAB is therefore allowed to request accreditation with the NAB of the head office whose scope can also cover the activities
performed by the local site, including those located in another Member State. The multi-site accreditation is however only
permitted under the Regulation if the accredited CAB maintains the final
responsibility for the activities performed by local sites covered by the scope
of the multi-site accreditation. The accreditation certificate issued by the
NAB where the head office is established names one legal entity - the head
office - and it is this legal entity which holds the accreditation and which is
responsible for the accredited activities of the CAB, including any activity
performed by the local site that forms part of the scope of the accreditation.
Where these local sites carry out key activities (as listed in EN ISO/IEC 17011[14]), then the accreditation certificate (in its annexes) shall clearly
identify the address of these site offices. The local site is entitled to offer directly to
the local market conformity attestations under the multisite accreditation, but
only on behalf of the accredited CAB. These accredited certificates and reports
are therefore issued under the accreditation, name and address of the head
office without the logo of the local site. However this does not impede
mentioning on the conformity assessment certificate or report the contact
details of the local site issuing the certificate or report in question. The multi-site accreditation is meant for use
only by companies within the same organisation and where the head office
maintains the responsibility for the activities performed and
certificates/reports issued by the local sites. The responsibility shall be
demonstrated on the basis of contractual or equivalent legal relationships
between the head office and the local entity and internal regulations that
further specify these relationships in terms of management and
responsibilities. The solution of the multi-site accreditation
can be applied to all types of local entities (subsidiaries, branches,
agencies, offices etc), regardless of their legal personality and is in
principle valid for all types of CABs, including laboratories, inspection and
certification bodies as long as they carry out clearly identified and relevant
activities for the purpose of accreditation. The multi-site accreditation solution is
excluded when the above mentioned conditions are not fulfilled, i.e. the CAB
can not be considered as one organisation with regard to conformity assessment
and the head office does not maintain the ultimate responsibility for the
activities of the local entities. In this case the local sites being separate
legal entities should apply for their own accreditation with the local NAB. As
a consequence it can be considered that the local entity carries out the
conformity assessment service completely independently of the head office. In case of the multi-site accreditation,
initial assessment and reassessments must be carried out in close cooperation
between the respective local NAB and the NAB of the head office taking the
accreditation decision, while surveillance must be carried out in cooperation
with or by the local NAB. The multinational CAB must fully cooperate with the
NABs involved. Local entities cannot reject the participation of the local NAB
in the assessment, reassessments and surveillance process. Harmonised rules for
co-operation between NABs exist in the form of the EA cross frontier policy.
Multi-site accreditation needs to be managed under the EA cross frontier policy
in order to guarantee the involvement of the local NAB. EA is therefore
requested to review its existing cross frontier policy for cooperation between
EA members, so as to fully implement the multi-site accreditation, without
complicating or compromising the proper execution of the peer evaluation. 3.4.3. About
Subcontracting The multi-site accreditation does not supersede
sub-contracting, which remains a viable solution in case a CAB may wish to
sub-contract part of its activities to legal entities located and operating in
the same or other Member States, which however do not belong to the same
organisation, i.e. are not part of a multinational CAB. In this case, the
subcontractor is not covered by the accreditation of the CAB. The accredited
CAB may subcontract specific parts of its conformity assessment activities to a
different legal entity according to the applicable CAB standard to which it is
accredited and only to the extent allowed in this standard. The CAB must be
able to demonstrate to the NAB that subcontracted activities are carried out in
a competent and reliable manner consistent with relevant requirements of the
applicable normative documents for the activities in question. The accredited conformity assessment attestation must be issued
exclusively under the name and responsibility of the accredited CAB, i.e. the
legal entity holding the accreditation. The contractual relationship with the client remains with the
accredited CAB. 4. Systematic
approach to addressing accreditation issues within SOGS (Certif 2009-07 rev 1) This draft document represents a revised
version of a proposal on how accreditation should be systematically addressed
within SOGS and on how to manage the attendance and presence of the
representatives of the European Co-operation for accreditation (EA) during SOGS
meetings. The draft document, representing the views of the Commission in
accordance with the national authorities college of the EA Advisory Board
(EAAB-NAC), can be interpreted as a set of informal rules of procedures,
supplementing the existing draft terms of reference of SOGS. A diagramme has
been added explaining the relations and communication channels between the main
actors of the European accreditation policy. 4.1. Rationale SOGS is an informal a group, i.e. a forum where
Commission services and representatives from national administrations of Member
States can have an open discussion and reach a common understanding on general
policy related to standardization and conformity assessment. Accreditation
exists in relation to conformity assessment (forming the last level of control
in the conformity assessment chain ensuring conformity with the applicable
requirements) and is essential for a competent, trusted, quality-driven and
transparent conformity assessment structure, able to play its part in the
protection of public interests. As a result, accreditation issues have been
tabled for discussion within SOGS whenever the Commission felt that there has
been a need to do so. Regulation 765/2008, which enshrines the new
European accreditation policy, reinforces considerably the role of
accreditation, thereby giving to accreditation a level of significance and
recognition which it never had before. Under technical harmonisation
legislation the use of accreditation is intensified as it constitutes the
privileged technical instrument in support of notification, i.e. the decision
of national authorities by which conformity assessment bodies are authorised to
carry out specific conformity assessment in support of technical harmonisation
legislation. Accreditation must therefore be operated in such a manner as to
provide national authorities with the necessary sound technical base they can
rely on in order to back up their notification decisions. Continuous and comprehensive substantial
discussions on the needs in relation to accreditation are required. As a consequence
accreditation and related issues should not be put on the SOGS agenda
sporadically, but should instead be discussed on a regular basis, and following
a set of common rules of procedure. The creation of a special SOGS subgroup
dedicated exclusively to accreditation is not envisaged – as has been the case
with market surveillance. Instead a part of the plenary meeting should be
devoted to accreditation. It essential that the Community has a common
understanding of the interpretation, implementation and future development of
the European policy on accreditation. In the framework of this policy EA is
placed in the position of an organisation of major European interest, similar
to the European Standardisation Organisations (CEN, CENELC and ETSI) in the
field of the European standardisation policy. Pursuant to Article 14 of
Regulation 765/2008 EA is recognized as the official European Infrastructure
for Accreditation. The operation and management by EA of a robust, uniform and
transparent peer evaluation system in accordance with the Regulation and the
further developments of such a system is at the centre of the European policy
on accreditation. In light of Article 11 of Regulation 765/2008 having
successfully undergone the EA peer evaluation implies –
presumption of conformity for the evaluated
national accreditation bodies to the requirements of the Regulation –
mutual recognition by the national authorities
of accreditation certificates and accredited conformity assessment
attestations. EA is expected to fulfill its new role and
related tasks by providing Europe with the necessary reliable, effective and
trustworthy infrastructure which meets the evolving needs of the market,
regulators and society. EA shall be fully accountable for technical expertise,
impartiality, cost efficiency and cost effectiveness, capacity of response to
arising needs and challenges - also in view of the Community financing which
may be granted to EA on the basis of the Framework Partnership Agreement.[15] Particular attention should therefore be given
to the co-operation with EA, by translating into practical terms the commitment
to cooperate effectively to implement the European
policy on accreditation contained in the General Policy
Guidelines for Cooperation between the European
co-operation for Accreditation and the European Commission, the European Free
Trade Association and the competent national authorities, which have
been signed by EA, EFTA, the Commission and the vast majority of SOGS members. SOGS is deemed to be the appropriate platform
where a substantial and comprehensive exchange between the Commission, national
authorities and EA takes place in order to assure that EA serve the aims and
needs of national authorities and the Commission in particular in relation to
the operation of accreditation in support of the implementation and development
of Community harmonisation legislation. In no way does this document intend to
compromise, to replace or to put into question the existence and function of
the EAAB-NAC, which continues to guarantee the representation of the interests
of national authorities of EU and EFTA Member States within the EAAB, thereby
providing advice to EA and input to EA policies, strategies and related
documents. 5. Notification
without accreditation - Article 5.2 of Regulation 765/2008 (CERTIF 2010-08 REV1) 5.1. Objective
of the paper The present paper provides guidance with regard
to the assessment process not based on accreditation to support the
notification of conformity assessment bodies under technical harmonisation
legislation. It describes the main elements on which such an assessment process
should be based on. It is not the aim of this paper to set up an “Article 5.2”
assessment methodology or to provide a detailed description and list of documents
to be sent in by the notifying authorities. 5.2. Background Member States notify - via the designated
notifying authorities - to the Commission and to the other Member States those
conformity assessment bodies they have decided to authorise to carry out
specific tasks pertaining to the conformity assessment procedures laid down in
the applicable piece of technical harmonisation legislation. By taking the political and legal decision
which bodies to notify, Member States take the final responsibility for the
technical competence and independence of such bodies which they must therefore
verify by the means of an adequate assessment process. According to the New Legislative Framework, the
verification of the technical competence and independence during a notification
process can be supported form a technical point of view either by an
accreditation according to the 17000 series of harmonised standards taking into
account the sector specific requirements stemming from the applicable
harmonisation legislation and other normative documents if applicable, or, if
it is decided not to use accreditation, by an alternative assessment process. While not obligatory under the New Legislative
Framework, and although accreditation and the alternative evaluation procedure
are legally equivalent, the preference of the use of accreditation to support
notification is clearly expressed in the New Legislative Framework through the
facilitated notification procedure for notification based on accreditation.
Accreditation as an independent and impartial assessment carried out by a
competent authoritative third party, i.e. the designated national accreditation
body, should be considered by the notifying authorities as the privileged
instrument for the assessment of the technical competence and impartiality of a
candidate notified body. This because –
accreditation being a standard based total,
reduces the differences in the criteria applied for notification –
accreditation provides for established
complaint and appeal procedures –
accreditation provides for the possibility to
object to an assigned assessor –
accreditation provides for established
procedures and plans for regular surveillance at close intervals to monitor the
continued fulfillment by the accredited CAB of the applicable requirements –
the existence of the EA peer evaluation system
ascertaining conformity to the requirements of Regulation 765/2008, EN ISO/IEC
17011 and other applicable requirements and therefore verifying the competence
of the national accreditation bodies to assess CABs in view of notification,
makes accreditation the most transparent assessment system in place, able to
give sufficient guarantees and confidence. To date, we do not have a comparable and
substantially equivalent alternative assessment system based on codified rules
and procedures, which entails a similar level of harmonisation and transparency
in comparison with accreditation. In particular no other assessment method
provides for a systematic, structured and widely accepted process of evaluation
of those assessing the competence of conformity assessment bodies, which
clearly represents an added value of the accreditation tool. This is why the
New Legislative Framework has considerably strengthened the role and use of
accreditation in the regulated area. 5.3. Assessment
under Article 5.2 of Regulation 765/2008 When a Member State nevertheless decides for
whatever reasons to use an alternative assessment method and not to base its
notification on accreditation, according to Article 5.2 of Regulation 765/2008
“it shall provide the Commission and the other Member States with all the
documentary evidence necessary for the verification of the competence of the
conformity assessment bodies it selects for the implementation of the Community
harmonisation legislation in question”. In order to ensure the necessary level of
confidence in the impartiality and technical competence of conformity
assessment bodies and in the issued test reports and conformity assessment
certificates issued by them, national authorities, when carrying out the
assessment without accreditation, should give detailed and comprehensive
information describing on how the candidate Notified Body has been assessed as
qualified to carry out the tasks for which it is notified and showing that it
fulfils the applicable criteria relating to Notified bodies. This information
linked to a given notification is made available through the NANDO tool to the
Commission and the other Member States. The alternative evaluation procedure should be
based at least on the following elements: –
candidate Notified Bodies should be made aware
of general conditions, their rights and obligations and requirements relating
to the assessment carried out in view of notification –
existence of a formal application procedure –
Assessment process against applicable
requirements. The assessment should consist in ·
a review of documents verifying the completeness
and appropriateness from a substantial point of view with regard to conformity to
the applicable requirements ·
an on-site assessment to check technical and
procedural aspects such as availability and appropriateness of
facilities/equipment, technical competence of staff, existence of an
appropriate management system and to check other aspects demonstrating that
conformity to requirements is properly implemented. The assessment must include
witnessing of technical activities –
production of an assessment report –
decision making process –
existence of a systematic surveillance and
related sanction mechanism providing for periodic surveillance including
on-site visits, in order to verify the continued fulfillment of requirements by
the Notified Body –
demonstration of the national authorities own
technical competence for assessing conformity assessment bodies for the purpose
of notification under technical harmonisation legislation When choosing to go down the route of the
alternative assessment process rather than of formal accreditation, national
authorities should indicate the reasons why accreditation is not chosen to back
up the notification process. Moreover, national authorities should not
outsource the assessment of conformity assessment bodies that seek to become
Notified Bodies to the national accreditation body, without asking for
accreditation. Such “light accreditation” using the service and competence of
national accreditation bodies without the recourse to accreditation is a
practice which undermines the accreditation and should therefore not be used.
It should be noted that in some cases national accreditation bodies are obliged
to carry out the assessment of candidate Notified Bodies as this is required by
existing national laws or bylaws. 6. Witnessing for new scopes
of accreditation (Certif No 2012-03) 6.1. Witnessing for new scopes This paper aims to provide a common
understanding on the interpretation of Regulation (EC) 765/2008 (“the
Regulation”) in relation to granting accreditation relating to new activities
of conformity assessment bodies. This can either relate to new conformity
assessment bodies wishing to enter the market, to existing conformity
assessment bodies wishing to extend the scope of their accreditation, or to new
regulatory requirements. According to EN-ISO 17011, accreditation cannot
be granted without a witnessing having taken place. The results of the on-site
assessment have to be taken into account in the decision-making. However, especially when it comes to new
regulatory requirements and accreditation for the purposes of notification,
this may lead to a “catch-22” situation: A conformity assessment body will not be
accredited because it has never performed a certain activity – and may
encounter difficulties finding clients as it is not accredited or may not be
able to be notified for this reason. Such a situation would effectively lead to
a closure of the conformity assessment market for new actors or activities. 6.2. Solution In order to maintain the accessibility as well
as quality of accreditation and not to create contradictory administrative
requirements, a pragmatic approach to this problem is suggested. A number of EA
members already follow this approach. It seems advisable to reach a consensus
to adopt it as a general approach across Europe and to enable EA peer
evaluation to take the solution into account. In the case of a new activity, a conditional
attestation should be granted to the conformity assessment body, if all other
conditions for accreditation are fulfilled by the conformity assessment body,
and a simulation does not present itself as a viable option. However, this
should only be granted without witnessing under the condition that, before any
accredited certificate is issued, a witnessing takes place. Furthermore, the
conformity assessment body should have procedures in place that ensure a
continued competence in areas where there is little activity. Once the witnessing has taken place an
accreditation certificate may be issued. In practice, this means that the
conformity assessment body has to ensure that a witnessing takes place, the
first time before it finalises its assessment for this specific activity. Another solution in the regulated area, where
the accreditation certificate represents the preferred means for demonstrating
the technical competence of a body, could be a temporary notification of the
new entrant conformity assessment body on the basis of the documents reviewed.
Unless the accreditation is confirmed by a witnessing within a given timeframe,
the notification is automatically withdrawn by the notifying authority. This
approach has the double benefit of being a pragmatic solution that is in line
with the relevant international standards while ensuring that accreditation is
not weakened, and maintains its role as last level of control in the conformity
assessment system. 7. Published audited annual
accounts of accreditation bodies (CERTIF 2012-05) 7.1. Objective
of the paper This paper aims to provide a common
understanding on the interpretation of Regulation (EC) 765/2008 (“the
Regulation”) in relation to its Article 8(11) that requires national accreditation
bodies to publish audited annual accounts prepared in accordance with generally
accepted accounting principles. The goal of the present paper is to clarify the
intentions of this provision, namely safeguarding the principle on
non-commerciality and demonstrating that the accreditation body has sufficient
resources to perform its tasks adequately. Both aspects are fundamental to the
correct functioning of accreditation as the last level of control in the
conformity assessment system. Thus when implementing this provision these
objectives should be borne in mind rather than a pure focus on whether the
accounts are presented in detail in compliance with accounting standards. A strict focus on financial accounting may lead
to difficulties in those Member States where the accreditation body is part of
a larger governmental structure, as such a strict reading would require a
reform of the accounts of the authority in question without contributing
proportionately to more clarity in terms of demonstrating that the aims of the
provision are met. Bearing in mind that the ultimate say on
matters of EU law rests with the European Court of Justice, this draft paper contains
a proposal for a common understanding and pragmatic solution for this question. 7.2. Background The Recital 14 of the Regulation states: “For the purposes of this Regulation,
not-for-profit operation by a national accreditation body should be understood
as an activity that is not intended to add any gain to the resources of the
body's owners or members. While national accreditation bodies do not have the
objective of maximising or distributing profits, they may provide services in
return for payment, or receive income. Any excess revenue that results from
such services may be used for investment to develop their activities further,
as long as it is in line with their main activities. It should accordingly be
emphasised that the primary objective of national accreditation bodies should
be to support or engage actively in activities that are not intended to produce
any gain.” In the same vein, Article 4(7) of the
Regulation states: “The national accreditation body shall
operate on a not-for-profit basis.” Article 4(9) of the Regulation stipulates: "Each Member State shall ensure that
its national accreditation body has the appropriate financial and personnel
resources for the proper performance of its tasks, including the fulfilment of
special tasks, such as activities for European and international accreditation
cooperation and activities that are required to support public policyand which
are not self-financing." Article 8(11) then contains the provision under
discussion, stipulating that the national accreditation body "shall publish audited annual accounts
prepared in accordance with generally accepted accounting principles." National accreditation bodies operate in
accordance with the international standard EN ISO/IEC 17011 which states: “4.5.2 The accreditation body shall have the
financial resources, demonstrated by records and/or documents, required for the
operation of its activities. The accreditation body shall have a description of
its source(s) of income.” 7.3. Problem
definition The requirement for publishing audited annual
accounts does not pose a problem for accreditation bodies that have an
independent private law status of some form. It may, however, be more
problematic for accreditation bodies that are, for example, part of a ministry
as no separate accounts for the accreditation body may exist, the budgetary and
financial management often being globalised in a overall public authority
financial statement. Thus, if the requirement to publish accounts is
approached from a purely financial perspective, a number of national
accreditation bodies will encounter difficulties in demonstrating their
compliance during peer evaluations. Considering that it is otherwise considered
to be acceptable that accreditation bodies are part of ministries as long as no
conflict of interest exists, this requirement thus needs to be applied in a way
that is meaningful for the purposes of the Regulation. Hence Article 8(11)
needs to be applied in a way that allows national accreditation bodies to
demonstrate that they are complying with the goals and provisions of the
Regulation without Member States having to substantially reform the financial
management of a ministry, which is otherwise controlled by public institution. 7.4. Solution The intentions of Article 8(11) go over and
beyond demonstrating sound financial management, for the purposes of peer evaluation
national accreditation bodies should therefore clearly demonstrate that the
guiding principles of non-commerciality and sufficient resources for competence
of the accreditation body are respected. Bearing in mind the overall objective
of the Regulation of establishing accreditation as last level of control in the
conformity assessment system, in those cases where the accreditation body is
part of a larger structure, Art. 8(11) should thus be understood to be a tool
to demonstrate compliance with these principles, rather than being used to
create unnecessary bureaucratic burdens for Member States. Thus the
accreditation bodies situated in ministerial departments must be in a position
to present at least their overall budgetary and financial figures covering
overall budgetary resources and their global and operational expenses; together
with any financial policies that apply to them in order to be able to
demonstrate that they have sufficient resources to perform their tasks
adequately whilst safeguarding the principle of non-commerciality [1] Further CERTIF documents are currently being
discussed between the Commission and Member States. A full list of CERTIF
documents, not only concerning accreditation can be found on: http://ec.europa.eu/enterprise/policies/single-market-goods/documents/certif_doc_en.htm. [2] Regulation (EC) No 765/2008 of the European
Parliament and of the Council of 9 July 2008 setting out the requirements for
accreditation and market surveillance relating to the marketing of products and
repealing Regulation (EEC) No 339/93 [3] Only the main accreditation cooperation organisations
at regional level are listed. [4] While the special recognition by IAF granted to EA
and PAC covers the IAF Product MLA, the IAF Quality Management System MLA and
the IAF Environmental Management Systems MLA, special recognition granted to IAAC is
limited to the IAF Quality Management Systems MLA. http://www.iaf.nu/ [5] For more detailed information on the IAF MLA and the
ILAC MRA and their signatories: http://www.iaf.nu/
and http://www.ilac.org/ilacarrangement.html
[6] The Agreement creating the European Economic Area
which came into force 1 January 1994 extends the Single Market to the EEA EFTA
States (Norway, Iceland, Liechtenstein) therefore covering, among others, all
the acquis relevant to the free circulation of products. [7] The peer evaluation managed by EA forms the basis for
the EA multilateral agreement (EA MLA), underpinning the ILAC MRA and IAF MRA. [8] Nationally recognized
accreditation bodies not established in one of the EU Member States or EFTA or
a candidate country to the EU, which according to the current Articles of
Association of EA may not become EA “full members”, may enter into a contract
of cooperation with EA. An accreditation body that has signed a contract of
cooperation with EA may apply to be a signatory of a Bilateral Agreement (BLA).
The BLA conveys the same benefits in relation to mutual recognition as the MLA:
recognition of the equivalence of the operation of the Bilateral Signatory
accreditation body to those of EA MLA signatories and equal reliability of
conformity assessment attestations issued by organizations accredited by the
Bilateral Signatory accreditation body. For more detailed information: http://www.european-accreditation.org/content/mla/what.htm [9] Such a statement has been
formally endorsed by the EA General Assembly the 19 November 2008. [10] Currently MRAs between the European Union and the
following countries are in place: Australia, Canada, Israel, Japan, New Zeeland, Switzerland, United States [11] This can happen in the four
following modes: a) the CAB (service provider) moves temporarily to the service
recipient's Member State to provide its services and then comes back; b) the
service recipient moves temporarily to the Member State of the CAB to receive
the service; c) neither the service recipient nor the CAB moves, whereas the
service is done from a distance (for ex. over the email and/or by phone); d)
both the CAB and the service recipient move to another (third) Member State
where the service will be provided [12] Differently from subsidiaries which have separate legal
personality, agencies or branches or offices do not need to be separate legal
entities. It follows from Art. 49 TFEU providing for the freedom of
establishment and the case law of the ECJ that the same undertaking can be
established at the same time in one or more other Member States. [13] Recital 19: “….The objective of this Regulation is to
ensure that, within the European Union, one accreditation certificate is
sufficient for the whole territory of the Union, and to avoid multiple
accreditation, which is added cost without added value….” [14] Key activities include: policy formulation, process
and/or procedure development and, as appropriate, contract review, planning
conformity assessments, review, approval and decision on the result of
conformity assessments [15] Currently under negotiation