Division 6 Evaluation by the notified body during production

The manufacturer, or his authorised representative established in the Community, shall further involve the notified body in the production phase according to one of the following procedures to be chosen by the manufacturer or his authorised representative established within the Community:

• • the notified body shall carry out periodical checks in order to verify continuing compliance of the manufactured equipment with the technical documentation and with the requirements of this Directive; in particular the notified body shall concentrate on:

    • the correct and complete marking of the equipment according to Article 11,

    • issuing of the EC declaration of conformity according to Article 8,

    • the technical instruments applied and the results of the evaluation of the uncertainties due to production variation and their relation to the guaranteed sound power level,

• The manufacturer, or his authorised representative established in the Community, shall give the notified body free access to all the internal documentation supporting these procedures, the actual results of the internal audits and the corrective actions which have been taken, if any.

• Only if the above checks give unsatisfactory results shall the notified body carry out noise tests, which, on its own judgement and experience, may be simplified or completely carried out according to the provisions laid down in Annex III for the relevant type of equipment,

• • the notified body shall carry out or have carried out product checks at random intervals. An adequate sample of the final equipment, chosen by the notified body, must be examined and appropriate noise tests as set out in Annex III, or equivalent tests, must be carried out to check the conformity of the product with the relevant requirements of the Directive. The product checking must include the following aspects:

    • the correct and complete marking of the equipment according to Article 11,

    • issuing of the EC declaration of conformity according to Article 8.

In both procedures, the frequency of the checks shall be defined by the notified body according to the results of previous evaluations, the need to monitor corrective actions and further guidance for the frequency of the checks that may be given by the yearly production and the general reliability of the manufacturer to maintain the guaranteed values; however a check shall be carried out at least once every three years.

If there are doubts about the plausibility of the technical documentation or the adherence during production, the notified body shall inform accordingly the manufacturer, or his authorised representative established in the Community.

In those cases where equipment checked does not conform to the provisions of this Directive, the notified body must inform the notifying Member State.