6.6 国境を越える認定

According to Article 7(1) of Regulation (EC) No 765/2008, conformity assessment bodies, whether third-party or first-party/ in-house, are required when requesting accreditation to do so with the national accreditation body 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 national accreditation body in another Member State is limited to cases where

—there is no national accreditation body in its own Member State and no other national accreditation body to which recourse is had [Article 7(1)(a)],

—the national accreditation body does not offer the requested accreditation service [Article 7(1)(b)],

—the national accreditation body has not received a positive outcome in the peer evaluation in relation to the conformity assessment activity for which accreditation is requested i.e. the national accreditation body is not a signatory to the EA Multilateral Agreement for the accreditation of the conformity assessment activity concerned [Article 7(1)(c)].

Article 7(1) of the Regulation is closely linked to and is a logical consequence of the non-competition principle.

The cross-border provision laid down in Article 7 is perceived to be very stringent and unnecessarily burdensome for multi- nationally active conformity assessment bodies having their head office in one Member State with local entities/sites established in other Member States and 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 organisations is feared. In case of a strict legal interpretation of Article 7, due to their structures, multinational conformity assessment bodies may not benefit from the advantage of one accreditation certificate sufficient for the whole territory of the EU, although avoiding multiple accreditations is one of the objectives of the Regulation.

The duplication of unnecessary assessments and burdens on multinational conformity assessment bodies should be avoided while ensuring adequate control of local entities of conformity assessment bodies. There has to be an exchange of information and effective cooperation between national accreditation bodies for assessment, re-assessment and surveillance of local sites of multinational conformity assessment bodies where 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.

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 are to be provided by the local national accreditation body to the national authorities of the other Member State. National authorities of the Member States in which the local national accreditation body is established should be kept informed thereof.

The conformity assessment bodies 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 conformity assessment body is therefore allowed to request accreditation with the national accreditation body of the head office whose scope can also cover the activities performed by the local site, including those located in another Member State.

In cases of accreditation for notification, the supervision of multi-site accredited bodies is done under the cross-border cooperation among the national accreditation bodies; however, the responsibility remains with the national accreditation body of the Member State in which the conformity assessment body is established. The conformity assessment body as the main entity to be accredited and notified must have itself the means and the competence to carry out the tasks required for the accreditation. While it may have recourse to subsidiaries/subcontracting, it should not rely for all tests and evaluations on subsidiaries/subcontractors.

The notified accredited conformity assessment body may subcontract specific tasks connected with the conformity assessment, has to ensure that the subcontractor meets the same requirements that are applicable to the notified accredited body itself and may subcontract specific activities only with the agreement of the client (274).Thus, structures where the head office of the candidate-accredited body in the Member State of notification consists of very few staff performing only commercial tasks but none of the conformity assessment tasks for which the body is (to be) notified would be carried out in that Member State cannot be accepted. The multi-site accreditation is however only permitted under the Regulation if the accredited conformity assessment body 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 national accreditation body 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 conformity assessment body, 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, then the accreditation certificate (in its annexes) has to 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 conformity assessment body. 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 has to 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 conformity assessment bodies, 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 conformity assessment body cannot 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 national accreditation body. 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 national accreditation body and the national accreditation body of the head office taking the accreditation decision, while surveillance must be carried out in cooperation with or by the local national accreditation body. The multinational conformity assessment body must fully cooperate with the national accreditation bodies involved. Local entities cannot reject the participation of the local national accreditation body in the assessment, reassessments and surveillance process. Harmonised rules for co-operation between national accreditation bodies exist in the form of the EA cross frontier policy. Multi-site accreditation has to be managed under the EA cross frontier policy in order to guarantee the involvement of the local national accreditation body.

The multi-site accreditation does not supersede sub-contracting, which remains a viable solution in case a conformity assessment body 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 conformity assessment body. In this case, the subcontractor is not covered by the accreditation of the conformity assessment body. The accredited conformity assessment body may subcontract specific parts of its conformity assessment activities to a different legal entity according to the applicable conformity assessment body standard to which it is accredited and only to the extent allowed in this standard. The conformity assessment body must be able to demonstrate to the national accreditation body that the subcontracted activities are carried out in a competent and reliable manner consistent with the applicable requirements for the activities in question. The accredited conformity assessment attestation must be issued exclusively under the name and responsibility of the accredited conformity assessment body, i.e. the legal entity holding the accreditation. The contractual relationship with the client remains with the accredited conformity assessment body.