S.L. 427.99 Art. 14Conformity assessment bodies. S.L. 427.45.

(1) The procedures for assessment and notification of conformity assessment bodies, and the monitoring of notified bodies shall be those prescribed in the Method for Designating Conformity Assessment bodies Regulations. In addition, a conformity assessment body shall meet the requirements laid down in these regulations.

(2) The Technical Regulations Division shall notify the bodies responsible for carrying out the procedure for the assessment of conformity referred to in sub-regulation (1), to the Commission and the other Member States using the electronic notification tool developed and managed by the Commission and in accordance with the provisions of Article 37 of Directive (EU) 2016/797.

(3) A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by the relevant TSI and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

At all times and for each conformity assessment procedure and each kind or category of product in relation to which it has been notified, a conformity assessment body shall have at its disposal:

(a) the necessary personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

(b) the relevant descriptions of procedures in accordance with which conformity assessment is to be carried out, ensuring the transparency and the ability to apply those procedures. It shall have in place appropriate policies and procedures that distinguish between tasks it carries out as a notified conformity assessment body and other activities;

(c) the proper procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

It shall have the means necessary to perform in an appropriate manner the technical and administrative tasks concerned with the conformity assessment activities and shall have access to all necessary equipment or facilities.

(4) Conformity assessment bodies shall participate in, or ensure that their assessment personnel are informed of, the relevant standardisation activities and the activities of the notified conformity bodies ‘coordination group established under the relevant Union Law, and shall apply as a general guidance the administrative decisions and documents produced as a result of the work of that group.

(5) Conformity assessment bodies that are notified for track-side and/or on-board control-command and signalling subsystems shall participate in, or shall ensure that their assessment personnel are informed of, the activities of the ERTMS group referred to in Article 29 of Regulation (EU) 2016/796. They shall follow the guidelines produced as a result of the work of that group. In the event that they consider it inappropriate or impossible to apply them, the conformity assessment bodies concerned shall submit their observations for discussion to the ERTMS group for the continuous improvement of the guidelines.

(6) Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Articles 30 to 32 of Directive (EU) 2016/797 and shall inform the Technical Regulations Division accordingly.

(7) Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established. Activities of notified bodies may be subcontracted or carried out by a subsidiary only with the agreement of the client.

(8) Notified bodies shall keep at the disposal of the Technical Regulations Division the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under the relevant TSI.

(9) A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products which they assess, or the authorised representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purpose.

(10) A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacturer or construction, marketing, installation, use or maintenance of those products, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgment or integrity in relation to conformity assessment activities for which they are notified. This prohibition shall apply, in particular, to consultancy services.

(11) Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.