Annex XI of machinery directive 2006/42/EC - Minimum criteria for the notification of bodies

The text in RED color is the amended or added text in comparison with the former 98/37/EC machinery directive.


ANNEX XI : Minimum criteria to be taken into account by Member States for the notification of bodies

1. The body, its director and the staff responsible for carrying out the verification tests shall not be the designer, manufacturer, supplier or installer of machines which they inspect, nor the authorised representative of any of these parties. They shall not become involved, either directly or as authorised representatives, in the design, construction, marketing or maintenance of the machines. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.

2. The body and its staff shall carry out the verification tests with the highest degree of professional integrity and technical competence and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of the inspection, especially from persons or groups of persons with an interest in the result of verifications.

3. For each category of machinery for which it is notified, the body must possess personnel with technical knowledge and sufficient and appropriate experience to perform a conformity assessment. It must have the means necessary to complete the technical and administrative tasks connected with implementation of the checks in an appropriate manner; it must also have access to the equipment necessary for the exceptional checks.

4. The staff responsible for inspection shall have:

- sound technical and vocational training,

- satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests,

- the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.

5. The impartiality of inspection staff shall be guaranteed. Their remuneration shall not depend on the number of tests carried out or on the results of such tests.

6. The body shall take out liability insurance unless its liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the tests.

7. The staff of the body shall be bound to observe professional secrecy with regard to all information obtained in carrying out its tasks (except vis-à-vis the competent administrative authorities of the State in which its activities are carried out) under this Directive or any provision of national law giving effect to it.

8. Notified bodies shall participate in coordination activities. They shall also take part directly or be represented in European standardisation, or ensure that they know the situation in respect of relevant standards.

9. Member States may take all necessary measures they regard as necessary in order to ensure that, in the event of cessation of the activities of a notified body, the files of its customers are sent to another body or are made available to the Member State which has notified it.

Comment : A XI-1

Requirements 1 to 7 are mostly defined in the test standards (IEC 17025), inspection standards (EN 17020) or certification standards (EN 45011, ISO / IEC 17065:2012).

Original Comment : A XI-1

Les exigences 1 à 7 sont pour la plupart définies dans les référentiels d’essais (CEI 17025) les référentiels d’inspection (EN 17020) ou les référentiels de certification (EN 45011, ISO/CEI 17065:2012).