Application for recognition as a DeBo or a NoBo - procedure

Changed

17/04/2023

Conformity assessment bodies that want to submit an application for recognition as a designated body (DeBo) or notified body (NoBo) are requested to submit a file to the notifying body in accordance with the instructions below.

Content of the file

The application shall include the documents and the documentary evidence demonstrating that the conformity assessment body fulfils all the requirements and conditions set out below.

For all conformity assessment bodies (DeBo and NoBo):

The documentary evidence covering the following requirements:

Conformity assessment bodies shall be established under the national law of a Member State of the European Union in which they are established, and shall have legal personality.
Conformity assessment bodies shall be capable of carrying out all the conformity assessment tasks assigned to them by the relevant TSI or by the Railway Code, and for which they apply to be notified or designated, whether those tasks are carried out by the conformity assessment bodies themselves or on their behalf and under their responsibility.
At all times and for each conformity assessment procedure and each kind or category of product in relation to which they apply to be notified or designated, conformity assessment bodies shall have at their disposal:
1. the necessary personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks in accordance with point 8 below;
2. the relevant descriptions of procedures in accordance with which conformity assessment is to be carried out, ensuring the transparency and the ability to apply those procedures. The bodies shall have in place appropriate policies and procedures that distinguish between the tasks they carry out as a notified or designated conformity assessment body and the other activities;
3. the proper procedures for the performance of their activities which take due account of the size of undertakings, the sector in which they operate, their structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.
They shall have the means necessary to perform in an appropriate manner the technical and administrative tasks connected with the conformity assessment activities and shall have access to all necessary equipment or facilities.
Conformity assessment bodies shall take out liability insurance.
Conformity assessment bodies shall have arrangements to ensure that their personnel are bound to observe professional secrecy with regard to all information obtained in carrying out their tasks, except in relation to the notifying body.
Conformity assessment bodies shall have procedures in place which protect the proprietary rights.
The personnel responsible for carrying out the conformity assessments shall have the following skills:
1. sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified or designated;
2. satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
3. appropriate knowledge and understanding of the essential requirements, of the applicable harmonised standards and of the relevant provisions of Union law, the Railway Code or its implementing decrees;
4. the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
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.
Conformity assessment bodies shall be third-party bodies independent of the organisation or of the manufacturer of the product they assess.
A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered to be such a body.
The impartiality of the conformity assessment bodies, of their top-level management and of the assessment personnel shall be guaranteed.
Conformity assessment bodies, their 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 the products which they assess, or the authorised representative of any of those parties. This shall not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.
Conformity assessment bodies, their 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, marketing, installation, use or maintenance of those 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 or designated. This prohibition shall apply, in particular, to consultancy services.
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.
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.

Only for notified bodies (NoBo only):

This application shall be accompanied by:

1. a description of the conformity assessment activities, the conformity assessment module or modules and the product or products for which the body claims to be competent;

2. an accreditation certificate, valid at the time of submission of the application and at any time subsequent to this submission, issued by a national accreditation body in accordance with the provisions of Regulation (EC) No 765/2008, attesting that the conformity assessment body complies with harmonised standards as laid down in Article 2(10) of that Regulation and the 15 requirements referred to above;

3. evidence demonstrating that they participate in the relevant standardisation activities and the activities of the notified conformity assessment bodies' coordination group established under the relevant Union law, and that they ensure that their assessment personnel are informed of those activities and that they apply as general guidance the administrative decisions and documents produced as a result of that group.

4. For conformity assessment bodies that are notified for trackside and/or on-board control-command and signalling subsystems evidence demonstrating that they participate in the activities of the ERTMS group referred to in Article 29 of Regulation (EU) 2016/796, and that they ensure that their assessment personnel are informed of these activities. They shall apply the guidelines produced as a result of the work of this group. In the event that they consider it inappropriate or impossible to apply them, the conformity assessment bodies concerned shall submit their observations for discussion to the ERTMS group for the continuous improvement of the guidelines.

5. Where specific tasks connected with conformity assessment are subcontracted or where a subsidiary is used, evidence demonstrating that the conformity assessment body ensures that the subcontractor or the subsidiary meets the same requirements:

a. The notified body shall inform the notifying body of the use of a subcontractor or a subsidiary.

b. The notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

c. The notified bodies may subcontract their activities or have them carried out by a subsidiary only with the agreement of the client.

d. The notified bodies shall keep at the disposal of the notifying body the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under the relevant TSI.

Where a notified 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 points 1, 2 and 3 above and with the conditions set out in the 15 points referred to above, in so far as the applicable harmonised standards cover those requirements.

Only for designated bodies (DeBo only):

This application should be accompanied by:

1. a description of the conformity assessment activities, the conformity assessment module or modules and the product or products for which the body claims to be competent;

2. evidence demonstrating that they comply with the 15 requirements referred to above.

4. an accreditation certificate, valid at the time of submission of the application and at any time subsequent to this submission, issued by a national accreditation body in accordance with the provisions of Regulation (EC) No 765/2008, attesting that the conformity assessment body complies with the requirements set out in points 2 and 3 above.

5. Where a designated 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 same requirements:

a. The designated body shall inform the notifying body of the use of a subcontractor or a subsidiary.

b. The designated bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

c. The designated bodies may subcontract their activities or have them carried out by a subsidiary only with the agreement of the client.

d. The designated bodies shall keep at the disposal of the notifying body the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under the relevant TSI, unless the designated body is in possession of documents relating to work carried out by subsidiaries or subcontractors in accordance with the relevant national rules.

Where a designated 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 points 2 and 3 above and with the conditions set out in the 15 points referred to above, in so far as the applicable harmonised standards cover those requirements.

Procedure for the submission of the file

The application for recognition as a designated body (DeBo) or notified body (NoBo ) must be sent to the notifying body by registered and signed mail, either by post or electronically in accordance with the applicable regulations (i.e. by an electronic service recognised by Regulation (EU) No 910/2014).

Postal address:

FPS Mobility and Transport
Valérie Verzele
Director-General
Directorate-General Sustainable Mobility and Rail Policy
Vooruitgangstraat 56 Rue du Progrès
1210 Brussels
Belgium

Email address: valerie.verzele@mobilit.fgov.be

Questions concerning the designation or notification procedure can be sent to the following email address: debo-nobo@mobilit.fgov.be