The Decision regulates the conformity assessment procedures, the obligations of economic operators, the conformity of products, the notification of conformity assessment bodies, the requirements for notified bodies and their operation, the use of accreditation and the safeguard procedure.
Accreditation, though so far not regulated at the Community level, is operated in all Member States. The lack of common rules for that activity has resulted in different approaches throughout the Community, with the result that the degree of rigour applied in the performance of accreditation has varied between Member States. Therefore, the Regulation develops a comprehensive framework for accreditation and lays down at Community level the principles for its operation and organisation. The Regulation is a supplement to the Decision and is effective from 1 January 2010.
The Regulation shall apply to accreditations used on a compulsory or voluntary basis. According to it each Member State shall appoint a single national accreditation body, which safeguards the objectivity and impartiality of its activities, operates accreditation as a public authority and on a not for profit basis, and possesses the pertinent knowledge, competence and means for the proper performance of its tasks. The responsibilities and tasks of the accreditation bodies shall be clearly distinguished from those of other national authorities. The accreditation body shall not offer or provide any activities or services that conformity assessment bodies provide, nor shall it provide consultancy services.
The requirements for the national accreditation bodies laid down in the Regulation are the same as in the EN ISO/IEC 17011 standard for accreditation bodies accrediting conformity assessment bodies. The Regulation requires that national accreditation body be organised in such a manner as to make it independent from the conformity assessment bodies which it assesses and from commercial pressures, has an efficient management, has a sufficient number of competent personnel at its disposal, each decision relating to accreditation is taken by competent persons, safeguards the confidentiality of the information obtained, and fulfils the obligations of information.
Conformity assessment bodies should request accreditation by the national accreditation body of the Member State in which they are established. Nevertheless, the conformity assessment body has the possibility to request accreditation in another Member State in cases where in its Member State there is no national accreditation body or where such body is not competent to provide the requested accreditation services.
Each Member State shall support and monitor the proper operation of its accreditation body in order to ensure it fulfils the requirements and obligations of the Regulation. The Member State shall also ensure that the accreditation body seeks and maintains membership in the European co-operation for Accreditation (EA) and successfully undergoes the EA peer evaluation.
Each Member States shall ensure that its accreditation body has the appropriate resources, both financial and personnel, for the proper performance of its tasks. Accreditation should in principle be operated as a self-supporting activity, however, Member State shall, for instance, support the activities in European and international accreditation cooperation.
Within the EU accreditation bodies shall not compete with each other, but they may find themselves in competition on the markets of third countries, but only on condition that this has no consequemce on their activities inside the Community, nor on the cooperation and peer evaluation activities of EA. Within the EU one accreditation certificate is sufficient for the whole territory of the Union, national authorities shall recognise the equivalence of the services delivered by those accreditation bodies having undergone successfully the EA peer evaluation, and thereby accept the accreditation certificates issued by the conformity assessment bodies accredited by them.
The Hungarian legislation of accreditation is, in many respects, in accordance with the Regulation: the Hungarian Accreditation Board as the sole national accreditation body is a not for profit public body, it offers accreditation for all conformity assessment activities in an objective and impartial manner, it does not compete with conformity assessment bodies, it co-operates with other national accreditation bodies, it is self-supporting, since 1999 it has been a full member of EA, and by authorisation it attests the technical competence of designated and notified bodies. However, the European and international recognition is still missing. Its obstacle is, as it was stated in the EA peer evaluation report dated of February 2007, that several dispositions of the Law LXXVIII of 2005 on accreditation are not in conformity with the EN ISO/IEC 17011 standard for accreditation. We do hope that the forthcoming amendment of the accreditation law supports the achievement of these recognitions, and Hungary could entirely fulfil the requirement of the Regulation before its entering into force within the EU.
Dr. Rózsa Ring
Managing Director
It is necessary to ensure that products within the Community respect the protection of health, consumers and environment, and of security. The European Council acknowledged that the New Approach is an appropriate and efficient regulatory model, enhancing competitiveness of European industry but at the same time recognised the need for a clearer framework for conformity assessment, accreditation and market surveillance. Therefore, a Decision of the European Parliament and of the Council on a common framework for the marketing of products and a Regulation of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products will be soon published. On 21 February 2008 the European Parliament approved the outcome of the first reading. 
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