6.4.1 国家認定機関

The Regulation foresees that each Member State may appoint one single national accreditation body. Only the national accreditation bodies are allowed to perform accreditation of conformity assessment bodies. No other bodies may claim to provide such services, be it according to harmonised standards or non-harmonised standards. This provision is central to the functioning of accreditation in the EU and to the framework of accreditation set up by the Regulation. Member States are not obliged to set up their own national accreditation body, should they consider it not economically viable to do so or should they not deem it useful to offer accreditation for all activities. This means that at no time more than one accreditation body may be active on the territory of a Member State for a given activity. In order to ensure transparency, Member States are therefore obliged to inform the Commission and other Member States to which national accreditation body of another Member State they are having recourse.

A list of national accreditation bodies is available online (268). National accreditation bodies have to make the activities for which they perform accreditation publicly available.

The Regulation does not prescribe the legal form a national accreditation body should take. This means that the national accreditation body may operate from within a ministry, be a governmental agency or be organised as a private company. The Regulation is, however, very clear in that accreditation is to be operated as a public authority activity and, to this effect, has to be formally recognised by the Member State.

Furthermore, the responsibilities and tasks of the national accreditation body have to be clearly distinguished from those of other national authorities. This provision aims to enhance the independence of the national accreditation body and the impartiality and objectivity of its activities. Should the national accreditation body be part of a larger public structure, such as a ministry, other departments are not allowed to influence accreditation decisions. The process of accreditation has to remain separate from other functions. It is absolutely essential to avoid a conflict of interest of the national accreditation body. This also applies to certain tasks that the national accreditation body may take on. While Decision No 768/2008/EC foresees that the national accreditation body may function as a notifying authority (269), the delegation of powers has to be clearly documented and the conditions for impartiality, namely the separation of tasks within the accreditation body ensured.

Should notification tasks be delegated to the national accreditation body, the body’s obligations under the Regulation nevertheless remain applicable. This means that its task remains the assessment of the technical competence of conformity assessment bodies according to the full accreditation process and an accreditation certificate must be issued if the technical competence of the conformity assessment body has been established. The national accreditation body may not perform any other assessments that do not meet these requirements or that meet less strict requirements which would not warrant the issuing of an accreditation certificate.

In other words, if the task of notification is to be delegated to the national accreditation body, only the notification of accredited conformity assessment bodies would be possible. The notification of conformity assessment bodies whose competence has not been assessed against the full accreditation criteria will not be possible where such a delegation has been decided on. This also means that the national accreditation body would not exercise any discretion in the notification of a body – the relevant accreditation certificate would lead to an automatic notification (270).

In addition, when providing accreditation, the national accreditation body has to fulfil a number of conditions in terms of stakeholder representation, its internal management and internal controls. Decisions on assessment have to be taken by a different person to the one who carried out the assessment of the conformity assessment body. The accreditation body has to have enough competent personnel at its disposal to ensure that it can perform its tasks. Procedures have to be in place to make sure that the personnel performs adequately and is competent to carry out its tasks. Also, adequate arrangements to ensure the confidentiality of the information obtained from conformity assessment bodies have to be in place and the accreditation body is obliged not to impose unnecessary burdens on its clients. Accreditation bodies must also have a complaint handling mechanism in place.

Furthermore, the Regulation states that the national accreditation body has to have sufficient resources to fulfil its tasks; this includes on the one hand a sufficient number of competent personnel, but also special tasks such as activities for European and international accreditation cooperation and activities that are required in support of public policy and which are not self-financing. In this respect adequate participation in EA, its committees and the peer evaluation process are of foremost importance. Member States should facilitate the participation of their national accreditation bodies in this kind of activities.

In this vein, national accreditation bodies are also obliged to publish their annual audited accounts. The intentions of this provision go beyond demonstrating sound financial management, for the purposes of peer evaluation. National accreditation bodies must therefore clearly demonstrate that the guiding principles of non-commerciality and sufficient resources for ensuring its competence in all activities are respected. Bearing in mind the overall objective of the Regulation of establishing accreditation as the last level of control in the conformity assessment system, in those cases where the accreditation body is part of a larger structure, this requirement 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 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 while safeguarding the principle of non-commerciality.

Member States have the responsibility to ensure that their national accreditation bodies meet the requirements foreseen by the Regulation on an on-going basis and to take corrective action if this should not be the case. For this reason, they are to take the utmost account of the results of the peer evaluation organised by the European accreditation infrastructure.