第30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 that is independent of the organisation or of the machinery or related product that it assesses.

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacture, provision, assembly, use or maintenance of machinery or related products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a conformity assessment body.

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 machinery or related products that they assess, nor shall it fulfil any of those roles in relation to partly completed machinery that has been incorporated into the assessed product or be the representative of any of those parties. This shall not preclude the use of assessed machinery or related products that are necessary for the operations of the conformity assessment body or the use of machinery or related products 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, import, distribution, manufacture, marketing, installation, use or maintenance of the machinery or related products, 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.

A conformity assessment body shall ensure that the activities of its 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 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.

6. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes VII, IX and X and in relation to which it has been notified, regardless of 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 of machinery or related products for which it has been notified, a conformity assessment body shall have at its disposal the necessary:

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

(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures;

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

(d)procedures for the performance of conformity assessment 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 machinery or related product 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 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 health and safety requirements set out in Annex III, of the applicable harmonised standards and common specifications referred to in Article 20, 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 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 assessment 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 Member 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 the conformity assessment tasks in accordance with Annexes VII, IX and X, except in relation to the competent authorities of the Member State in which its tasks are carried out. Proprietary rights, intellectual property rights and trade secrets shall be protected.

11. A conformity assessment body shall participate in, or ensure that its 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 Article 42 and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.