Conformity assessment body in the railroad sector; application for recognition as notified body

If your company is active in the railroad sector and would like to work as a so-called conformity assessment body, it requires the corresponding recognition as a Notified Body by the Federal Railway Authority (EBA).

Description

You want to operate as a conformity assessment body in the railroad sector? Then you must have yourself recognized by the Federal Railway Authority (EBA) as a Notified Body (NB). In your application, you can also limit yourself to a selection of the fields of activity and expertise listed below.

NBs are conformity assessment bodies. For example, upon request, these bodies test products and processes to determine whether they meet the legal requirements for interoperability and suitability for use. Interoperability means that all components of a railroad system are designed in such a way that safe and continuous train traffic is guaranteed in Germany and in Europe.

Notified body (NB)

Notified bodies are conformity assessment bodies designated by the state. These bodies check compliance with the European Technical Specifications for Interoperability (TSI) and issue EC certificates of verification.
The tasks of a conformity assessment include testing, inspection, assessment and certification decision. The tests concern, among other things, components and groups of components on which the interoperability of the railroad system depends and which are necessary, for example, in the following areas:

Infrastructure:

  • Tracks, for example,
  • switches,
  • level crossings,
  • bridges,
  • tunnels,
  • railroad stations,
  • Safety and protective equipment

Energy:

  • For example, railroad power supply, catenary systems such as overhead lines, and power consumption metering and charging equipment.
  • train control, train protection, signaling:
  • Trackside and on-board control or command and signalling equipment

Rolling stock:

  • For example, car body structure,
  • current collection devices,
  • Traction and power conversion equipment,
  • braking systems,
  • couplings,
  • bogies,
  • axles,
  • doors.

Recognition as BS

The recognition as a BS is valid for a maximum of 5 years. You can extend it for another 5 years. The EBA reports this to the European Commission for publication in the NANDO database as a basis for the BS to operate throughout the EU.

The EBA monitors recognized BSs on a regular basis.

Prerequisites

  • To be recognized as a BS, you must
  • have your registered office in the Federal Republic of Germany
  • have the number of employees with technical knowledge and sufficient relevant experience as specified in European law.
  • have the relevant descriptions of procedures according to which conformity assessment is carried out in order to ensure transparency and the possibility of applying these procedures.
  • have appropriate policies and procedures that distinguish between the tasks you perform as a conformity assessment body and other activities.
  • have appropriate procedures for carrying out your activities; take the procedures into account:
    • the size of your organization,
    • the industry in which you operate
    • your company structure, and
    • the degree of complexity of the product technology in question.
  • Have the necessary resources to adequately perform the technical and administrative tasks associated with conformity assessment. In addition, you must have access to any required equipment or facilities.
  • have liability insurance for personal injury, property damage, and financial loss, with a minimum insured amount of EUR 2.5 million for each insured event, and at least 2 times the coverage for the entire year
  • be impartial, which means
    • you must not have any connection with the organization or the manufacturer of the product you are evaluating
    • if you and the organization or the manufacturer belong to the same trade or professional association:
      • there must be no conflict of interest,
    • for BS the requirements for independence according to DIN EN ISO/IEC 17065 chap. 4.2.
      are valid.

Procedure

You can apply for recognition as a BS online. Prior to submitting your application, you may schedule a free informational interview with the EBA, if needed.

If you wish to apply for recognition as a BS, the following steps are required:

  • Download the application forms F09c, F09cx and F10c from the Federal Railway Authority's website and fill them out completely.
  • Access the e-Service portal of the EBA.
  • Log in with your user account.
    • If you do not yet have a user account for the e-Service portal, you must register once.
  • Select the procedure and the type of job.
  • The application wizard will guide you step by step through the required information.
  • Upload the required documents as a file and submit the application,
    • Supported file formats: PDF, DOCX, DOC, XLSX, XLS, maximum 30 megabytes per file.
  • You will receive an automated confirmation of receipt by email when the application has been received.
  • If necessary, you will receive a follow-up request for documents still to be submitted by e-mail.
  • The EBA will confirm the completeness and verifiability of your application for recognition and will put together an assessment team.
  • After completion of the content review, you will receive a list of review questions to answer.
  • Submit the answered assessment questionnaire as a subsequent submission via the e-Service.
  • The EBA will check the content of the documents you have submitted.
  • If the results of the review are not satisfactory, the EBA will conduct an on-site assessment with you.
  • After completion of the assessment, the assessment team submits an assessment report to the recognition committee and makes a proposal regarding recognition.
  • The recognition committee at the EBA decides on the recognition. If the recognition is granted, the EBA sends you the draft of the recognition certificate including the annexes with the request to submit a statement on it within 2 weeks.
  • If you do not submit an opinion or if the certificate of recognition has been agreed between the EBA and you as a result of the opinion, the EBA will finalize the notice of recognition and the certificate and send both to you by post together with the assessment report.
  • You will also receive a cost notification, which will also be sent to you by mail. Pay the fees.

Special notes

There are no clues or specifics.

Deadlines

The recognition is valid for a maximum of 5 years and can be extended for another 5 years.

Processing time

6 to 24 months

Required documents

  • Required Documents

    • eine Beschreibung
      • Ihrer Tätigkeiten im Rahmen der Konformitätsbewertung,
      • Ihrer Verfahren im Rahmen der Konformitätsbewertungsverfahren und
      • der strukturellen Bereiche (Infrastruktur, Energieversorgung, Zugsteuerung, Zugsicherung, Signalgebung, Eisenbahnfahrzeuge), die Sie abdecken.
    • ausgefülltes Formular „F10c“ - Checkliste nach EN ISO/IEC 17065 und Bewertungsschema
    • je nach Tätigkeitsfeld, für das Sie sich anerkennen lassen wollen, zusätzlich zum Antragsformular F09c:
      • Formular "F09c1" – Anhang Fachkompetenz Infrastruktur,
      • Formular "F09c2" – Anhang Fachkompetenz Energie (nur BS),
      • Formular "F09c3" – Anhang Fachkompetenz ZZS,
      • Formular "F09c4" – Anhang Fachkompetenz Eisenbahnfahrzeuge.
    • gegebenenfalls aktuelle Urkunde der Akkreditierung nach DIN EN ISO/IEC 17065.
    • gegebenenfalls aktuelle Urkunde der Zertifizierung nach ISO 9001
    • gegebenenfalls Nachweise als EBA-anerkannte sachverständige Person
    • sonstige Kompetenznachweise
       

Forms

  • Form, Bavaria-wide: Antragsformulare für Anerkennung von Benannten Stellen und Bestimmten Stellen
    Please note

    This form has to be signed and sent to the responsible authority. You can sign the form manually and send it by email/fax or sign the form electronically with your qualified electronic signature an send it by (secure) email. If the responsible authority has set up a De-Mail account, you can also send the form by De-Mail using an sender-confirmed message.

Online procedures

  • e-Service-Portal des Eisenbahn-Bundesamts

    After successful registration, the e-Service Portal of the Federal Railway Authority offers you the possibility to submit applications online. If a particular application is not yet displayed to you, you can have it activated if necessary.

Fees

  • The fees you have to pay are calculated according to the time spent processing your application:

    • hourly rate: 120.00 EUR
    • for each quarter of an hour or part thereof: 30,00 EUR.

Legal bases

Remedy

  • Objection
  • Detailed information on how to file an objection can be found in the notice.
  • Action before the Administrative Court

Links to more information

Related issues

Status:30.07.2023

Responsible for editing:Bundesministerium für Digitales und Verkehr

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