Regulation (EC) No 216/2008 of the European Parliament and of the Council (repealed)Show full title

ANNEX V Criteria for qualified entities referred to in Article 13

1. The entity, its Director and the staff responsible for carrying out the checks, may not become involved, either directly or as authorised representatives, in the design, manufacture, marketing or maintenance of the products, parts, appliances, constituents or systems or in their operations, service provision or use. This does not exclude the possibility of an exchange of technical information between the involved organisations and the qualified entity.

2. The entity and the staff responsible for the certification tasks must carry out their duties with the greatest possible professional integrity and the greatest possible technical competence and must be free of any pressure and incentive, in particular of a financial type, which could affect their judgment or the results of their investigations, in particular from persons or groups of persons affected by the results of the certification tasks.

3. The entity must employ staff and possess the means required to perform adequately the technical and administrative tasks linked with the certification process; it should also have access to the equipment needed for exceptional checks.

4. The staff responsible for investigation must have:

• sound technical and vocational training,

• satisfactory knowledge of the requirements of the certification tasks they carry out and adequate experience of such processes,

• the ability required to draw up the declarations, records and reports to demonstrate that the investigations have been carried out.

5. The impartiality of the investigation staff must be guaranteed. Their remuneration must not depend on the number of investigations carried out or on the results of such investigations.

6. The entity must take out liability insurance unless its liability is assumed by one Member State in accordance with its national law.

7. The staff of the entity must observe professional secrecy with regard to all information acquired in carrying out their tasks under this Regulation.