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Cross border European accreditation in practice


05 Mar 2009

The EC Regulation n°765/2008 of 9 July 2008 sets out the general framework and requirements for European accreditation. One of the main principles under the new framework is the principle of non-competition. Therefore a stringent regime for cross-border accreditation has been set up (cf. article 7). The Regulation applies to accreditation used to support both compulsory and voluntary conformity assessment.

While strongly supporting the fundamental principles of non-competition and mutual recognition between accreditation bodies in order to reduce the need for multiple accreditations, Orgalime draws the attention to the special challenges that arise due to the very stringent cross-border provisions.
According to these provisions a conformity assessment body (CAB)1, whether third-party or first-party/in-house body, can only apply for accreditation from another Member State’s accreditation body if the accreditation which is sought is not provided for in its Member State of establishment (see details in art. 7).

Issues to be addressed
The cross-border accreditation regime implies that:
1) A CAB or other customer from a third country asking for European accreditation may have a competitive advantage compared to a European CAB/customer, as the Regulation does not apply to organisations established outside the EU and therefore third-country CABs/customers are free to contact a European accreditation body of their own choice.
2) In those cases where, in a commercial relationship, a customer requires an accreditation certificate issued by his local accreditation body and cannot be convinced of the equivalence of the accreditation issued by a foreign accreditation body signatory to the EA MLA (multi-lateral agreement), CABs and manufacturers with accredited in-house bodies established in another Member State might be put at a disadvantage in a bidding/tendering process for a contract. This would result in hampering the functioning of the Internal Market rather than supporting its efficiency, which is one of the major regulatory objectives of the Regulation.
3) In cases where CABs (including manufacturers with accredited in-house bodies) are cross-frontier organisations with sites/subsidiaries in more than one Member State, they might be forced to take out several accreditations, even for the same kind of laboratories.

The above situations must be addressed in order to avoid the creation of new technical barriers and an uneven level-playing field for CABs and manufacturers with accredited in-house laboratories.

Orgalime Recommendations

The overall objective is clear: that all accreditations issued under the EA MLA (Association for European accreditation’s multi-lateral agreement) are considered equal by both the public authorities and the market place. However, it may take some time until this is understood and functions in practice. Experience from the certification field shows that national preferences are difficult to influence, even at the level of public authorities. Therefore it will be all the more a challenge to make private customers understand and accept the new requirements in the voluntary field. It should be stressed that accreditation for example of measuring instruments might be used in court cases.

Orgalime recommends that the above challenges be addressed in the Commission guidelines that are to be elaborated under Article 38 of the Regulation.
One solution to the challenge mentioned under points 1) and 2) above would be that the EA and the signatories to the MLA be required to issue a statement which attests to the equivalence of the accreditations performed by all signatories to the MLA or, more specifically, of their local accreditation with any other accreditation issued under the MLA, whenever such a statement is requested by a customer. We also suggest that on each accreditation certificate issued by a signatory to the EA MLA a statement should be systematically inserted to say:

“This accreditation has been issued under the EA MLA and is therefore equivalent to all other accreditations issued under the EA MLA within the same accreditation scope.”

Furthermore, on a general basis the new regime and the effects of the EA MLA must be made known through efficient promotion campaigns, addressed to CABs who can then pass it on to their customers.

As for the challenge mentioned under point 3) above, such organisations with sites or subsidiaries in more than one Member State should be considered as one organisation for the purpose of accreditation. This means that the organisation concerned should be allowed to request only one accreditation, which should cover its entire structure and under which the audits/assessments of all sites and subsidiaries, carried out by auditors/assessors of the respective national accreditation body of the Member State where the site/subsidiary is established, should be coordinated and consolidated. Based on overall mutual recognition of all assessments, any duplication of assessments of organisational aspects or requirements should be strictly avoided.


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