Conformity Assessment Body in the Railway Sector; Application for Recognition as a Specified 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 Specified 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 Specified Body (BSt). In your application, you can also limit yourself to a selection of the areas of activity and expertise listed below.

BSt are conformity assessment bodies. These bodies check, for example, on request, products and processes to see whether they meet the requirements contained in the notified national regulations. All components of a railroad system must be designed in such a way as to ensure safe train operations in Germany. In addition, vehicles must be compatible with the line on which they operate.

Designated body (BSt)

Designated bodies are conformity assessment bodies designated by the state. They check compliance with the notified national regulations that apply in addition to the European Technical Specifications for Interoperability (TSIs). The result of this examination is a test certificate according to the notified national technical regulations (NNTV).

The tasks of a conformity assessment include testing, inspection, evaluation 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 in the following areas, for example:

  • Infrastructure,
    • for example, tracks, switches, level crossings, bridges, tunnels, stations, safety and protective equipment.
  • trackside and on-board control or command and signalling.
  • rolling stock,
    • for example, car body structure, current collection equipment, traction and power conversion equipment, braking systems, couplings, bogies, axles, doors.

Recognition as BSt

Recognition as a BSt is valid for a maximum of 5 years. It can be extended for a further 5 years and is published by the EBA both on the EBA website and via the European Railway Agency (ERA) in the reference document database (RDD).

Recognized BSts are regularly monitored by the EBA.

Prerequisites

In order to be recognized as a BSt, you must

  • have your registered office in the Federal Republic of Germany
  • have the number of staff members 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; the procedures take 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 that amount 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, or
    • you and the organization or the manufacturer belong to the same trade or professional association:
      • there must be no conflict of interest whatsoever,
  • for BSt the requirements for independence according to DIN EN ISO/IEC 17065 chap. 4.2. apply.

Procedure

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

If you wish to apply for recognition as a BSt, 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 eService 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 confirms the completeness and verifiability of your application for recognition and puts 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 eService.
  • 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 review 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 will send 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 notification of costs, which will also be sent to you by mail. Pay the fees.

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 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 "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.

    Method of payment: SEPA bank transfer

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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