S.L. 427.41 Art. 26Requirements relating to notified bodies.

(1) For the purposes of notification, a conformity assessment body shall meet the requirements laid down in this regulation.

(2) A conformity assessment body shall:

(a) be established as stipulated in the Method for

Designating Conformity Assessment Bodies Regulations;

(b) be a third-party body independent of the organisation or the radio equipment it assesses;

(c) be capable of carrying out all the conformity assessment tasks assigned to it by Schedules III and IV 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: Provided that if a body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of radio equipment which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body;

(d) at all times and for each conformity assessment procedure and each kind or category of radio equipment in relation to which it has been notified, have at its disposal the necessary;

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

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

(g) 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 radio equipment technology in question and the mass or serial nature of the production process;

(h) have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities;

(i) ensure that the activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities;

(j) including its personnel, carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence its judgement or the results of its conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities;

(k) take out liability insurance unless liability is assumed by the State in accordance with national law;

(l) participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under the relevant European Union harmonisation legislation and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

(3) The body’s top level management and the personnel responsible for carrying out the conformity assessment tasks shall:

(a) not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the radio equipment which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed radio equipment that are necessary for the operations of the conformity assessment body or the use of such radio equipment for personal purposes;

(b) not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of those radio equipment, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

(4) The persons responsible for carrying out conformity assessment tasks shall:

(a) have sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b) have the satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c) have the appropriate knowledge and understanding of the essential requirements set out in Schedule I, of the applicable harmonised standards and of the relevant provisions of European Union harmonisation legislation and of national legislation;

(d) have the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

(5) The impartiality of a body, its top level management and of the personnel responsible for carrying out the conformity assessment tasks, shall be guaranteed and the remuneration to carry out such assessments shall not depend on the number of assessments carried out or on the results of those assessments.

(6) The personnel of a body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Schedules III and IV or any provision of national law giving effect to it, except in relation to the TRD. Proprietary rights shall be protected.