第25条 ノーティファイドボディに関する要件

1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

2. A conformity assessment body shall be established under the national law of a Member State and shall have legal personality.

3. A conformity assessment body shall be a third-party body independent from business and as regards the batteries it assesses, in particular from battery manufacturers, the battery manufacturers’ trade partners, shareholding investors on the battery manufacturers’ plants and from other notified bodies and the notified bodies’ business associations, parent companies or subsidiaries.

4. 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, importer, distributor, installer, purchaser, owner, user or maintainer of the batteries which they assess, nor the representative of any of those parties. That prohibition shall not preclude the use of assessed batteries that are necessary for the operations of the conformity assessment body or the use of such batteries for personal purposes.

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, marketing, importation, distribution, installation, use or maintenance of those batteries, or represent the parties engaged in those activities. They shall not engage in any activity that could conflict with their independence of judgement or their integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

A conformity assessment body shall ensure that the activities of its parent or sister companies, subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities.

5. A conformity assessment body and its 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 conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it in Annex VIII, periodical audits in accordance with Article 48(2) and third-party verification in accordance with Article 51 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 set out in Annex VIII, for periodical audits in accordance with Article 48(2) and third-party verification in accordance with Article 51, and for each category of batteries 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 necessary descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency of those procedures and their ability to be reproduced;

(c)appropriate policies and procedures to distinguish between activities that it carries out as a notified body and other tasks;

(d)the necessary procedures for the performance of conformity assessment tasks which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the battery technology in question and the mass or serial nature of the production process.

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks related to its conformity assessment activities in an appropriate manner and shall have access to all necessary information, testing equipment or facilities. This shall include establishment and the supervision of internal procedures, general policies, codes of conduct or other internal rules, the assignment of personnel to specific tasks, and conformity assessment decisions, without delegating them to a subcontractor or a subsidiary.

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 requirements and obligations laid down in Articles 6 to 10 and Articles 12, 13 and 14 and in Articles 48 to 52, of the applicable harmonised standards referred to in Article 15 and common specifications referred to in Article 16 and of the relevant provisions of Union harmonisation legislation and of national law;

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

8. The impartiality of a conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top-level management and the personnel responsible for carrying out the conformity assessments tasks shall not depend on the number of conformity assessments carried out or on the results of those assessments.

9. A conformity assessment body shall take out liability insurance unless liability is assumed by the state in accordance with national law in the notifying Member State, 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 the conformity assessment tasks in accordance with Annex VIII, periodical audits in accordance with Article 48(2), or third-party verification in accordance with Article 51, except in relation to the notifying authority and national authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

11. A conformity assessment body shall participate in, or ensure that its personnel responsible for carrying out the conformity assessment tasks is informed of, the relevant standardisation activities and the activities of the sectoral coordination group of notified bodies established pursuant to Article 37 and shall apply as general guidance the administrative decisions and documents produced by that group.