S.L. 427.37 Art. 21Requirements for notified bodies. S.L. 427.45.

(1) For the purposes of notification under these regulations, a conformity assessment body shall meet the requirements laid down in sub-regulations (2) to (16) and in the Method for Designating Conformity Assessment Bodies Regulations.

(2) A conformity assessment body shall be established under Maltese law and have legal personality.

(3) A conformity assessment body shall be a third-party body independent of the organisation or the lift or the safety component for lifts it assesses. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of lifts or safety components for lifts which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body. (4)) (a) 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 lifts or safety components for lifts which they assess nor representative of any of those parties. This shall not preclude the use of assessed lifts or safety components for lifts that are necessary for the operations of the conformity assessment body or the use of lifts or safety components for lifts for personal purposes. This does not preclude the possibility of exchange of technical information between the manufacturer or the installer and the body.

(b) 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, manufacture or construction, the marketing, installation, use or maintenance of those lifts or safety components for lifts, 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.

(c) 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.

(5) Conformity assessment bodies and their personnel shall 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 their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

(6) (a) A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Schedule IV to XII 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.

(b) At all times and for each conformity assessment procedure and each kind or category of lifts or safety components for lifts in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:

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

(ii) 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;

(iii) 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.

(c) A conformity assessment body shall 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.

(7) The personnel responsible for carrying out conformity assessment tasks shall have the following:

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

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

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

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

(8) The impartiality of conformity assessment bodies, their top level management and assessment personnel shall be ensured. The remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

(9) Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.

(10) The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Schedule IV to XII or any provision of national law giving effect to it, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

(11) Conformity assessment bodies shall 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 Union harmonisation legislation and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

(12) Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in these regulations insofar as the applicable harmonised standards cover those requirements.

(13) 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 these regulations, and shall inform the Technical Regulations Division accordingly.

(14) Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries, wherever these are established.

(15) Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

(16) 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 Schedules IV to XII.