responsibility finder
Schleswig-Holstein

Apply for recognition as a Notified Body (NB)

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6PLus)

Service Description

If your company is active in the railroad sector and would like to work as a so-called conformity assessment body, it needs to be recognized as a notified body by the Federal Railway Authority (EBA).

Do you want to operate as a conformity assessment body in the railroad sector? Then you must be 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 areas of activity and expertise listed below.

NBs are conformity assessment bodies. On application, these bodies test products and processes, for example, 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 rail traffic is guaranteed in Germany and Europe.

Notified body (BS)

Notified bodies are conformity assessment bodies that are appointed 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, evaluation and certification decisions. The tests concern, among other things, components and component groups on which the interoperability of the rail system depends and which are necessary, for example, in the following areas:

Infrastructure:

  • For example, tracks,
  • switches,
  • level crossings,
  • bridges,
  • tunnels,
  • stations,
  • Safety and protective equipment

Energy:

  • For example, railroad power supply, catenary systems such as overhead lines and power consumption measuring and charging equipment
  • Train control, train protection, signaling:
  • Trackside and on-board train control or train protection as well as signaling

Railroad vehicles:

  • For example, wagon body structure,
  • Current collection devices,
  • Traction and energy conversion equipment,
  • braking systems,
  • couplings,
  • bogies,
  • axles,
  • doors.

Recognition as a BS

Recognition as a NB is valid for a maximum of 5 years. You can extend it for a further 5 years. The EBA reports this to the European Commission for publication in the NANDO database as the basis for EU-wide NB action.

The EBA monitors recognized NBs on a regular basis.


Process flow

You can apply for recognition as a BS online. If required, you can arrange a free information meeting with the EBA before submitting your application.

If you wish to apply for recognition as a NB, the following steps are necessary:

  • Download the application forms F09c, F09cx and F10c from the website of the Federal Railway Authority and complete them in full.
  • Call up the EBA's e-Service portal.
  • 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 e-mail when the application has been received.
  • If necessary, you will receive an additional request for documents still to be submitted by e-mail.
  • The EBA will confirm the completeness and verifiability of your application for recognition and put together an assessment team.
  • Once the content has been checked, you will receive a list of assessment questions to answer.
  • Submit the answered assessment questionnaire as a follow-up submission via the e-Service.
  • The EBA will check the content of the documents you have submitted.
  • If the results of the review are insufficient, the EBA will carry out an on-site assessment with you.
  • Once the assessment has been completed, the assessment team submits an assessment report to the recognition committee and makes a proposal regarding recognition.
  • The recognition body at the EBA decides on recognition. If recognition is granted, the EBA will send you the draft certificate of recognition including the annexes with a request to submit a statement on this within 2 weeks.
  • If you do not submit a statement or if the certificate of recognition has been agreed between the EBA and you as a result of the statement, the EBA will finalize the notice of recognition and the certificate and send them 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 post. Pay the fees.
Requirements
  • To be recognized as a BS, you must
  • have your registered office in the Federal Republic of Germany
  • have the number of employees with specialist knowledge and sufficient relevant experience specified in European law.
  • have the relevant descriptions of procedures according to which conformity assessment is carried out to ensure transparency and the possibility of applying these procedures.
  • have appropriate policies and procedures in place 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 sector in which you operate,
    • your company structure and
    • the degree of complexity of the product technology in question.
  • have the necessary resources to perform the technical and administrative tasks associated with conformity assessment in an appropriate manner. In addition, you must have access to all necessary equipment or facilities.
  • have liability insurance for personal injury, property damage and financial loss with a minimum sum insured of EUR 2.5 million for each insured event and at least 2 times the cover for the entire year
  • be impartial, which means
    • You must have no connection whatsoever 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 whatsoever,
    • the requirements for independence according to DIN EN ISO/IEC 17065 Chapter 4.2 apply to NBs.
Which documents are required?
  • a description
    • your conformity assessment activities,
    • your procedures within the framework of the conformity assessment procedures and
    • the structural areas (infrastructure, energy supply, train control, train protection, signaling, railroad vehicles) that you cover.
  • Completed form "F10c" - Checklist according to EN ISO/IEC 17065 and assessment scheme
  • depending on the field of activity for which you wish to be recognized, in addition to application form F09c:
    • Form "F09c1" - Appendix Professional competence infrastructure,
    • Form "F09c2" - Appendix for professional competence in energy (BS only),
    • Form "F09c3" - Appendix on ZZS expertise,
    • Form "F09c4" - Appendix Rail vehicle expertise.
  • If applicable, current certificate of accreditation in accordance with DIN EN ISO/IEC 17065.
  • If applicable, current certificate of certification in accordance with ISO 9001
  • Proof of EBA-approved expert status, if applicable
  • Other proof of competence
What are the fees?

The fees you have to pay are based on the time required to process your application:

  • Hourly rate: EUR 120.00
  • for every quarter of an hour or part thereof: EUR 30.00.
Legal basis
Appeal
  • Objection
  • Detailed information on how to lodge an objection can be found in the notification.
  • Appeal to the administrative court
Applications / forms

Forms available: Yes
Written form required: No
Informal application possible: No
Personal appearance required: No
Online services available: Yes

What else should I know?

There are no indications or special features.

Author

Federal Railway Authority (EBA)


Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

Technically approved by

Federal Ministry for Digital and Transport Affairs (BMDV)

Professionally released on

05.07.2023

Teaser

If your company is active in the railroad sector and would like to work as a so-called conformity assessment body, it needs to be recognized as a notified body by the Federal Railway Authority (EBA).

Process flow

You can apply for recognition as a BS online. If required, you can arrange a free information meeting with the EBA before submitting your application.

If you wish to apply for recognition as a NB, the following steps are necessary:

  • Download the application forms F09c, F09cx and F10c from the website of the Federal Railway Authority and complete them in full.
  • Call up the EBA's e-Service portal.
  • 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 e-mail when the application has been received.
  • If necessary, you will receive an additional request for documents still to be submitted by e-mail.
  • The EBA will confirm the completeness and verifiability of your application for recognition and put together an assessment team.
  • Once the content has been checked, you will receive a list of assessment questions to answer.
  • Submit the answered assessment questionnaire as a follow-up submission via the e-Service.
  • The EBA will check the content of the documents you have submitted.
  • If the results of the review are insufficient, the EBA will carry out an on-site assessment with you.
  • Once the assessment has been completed, the assessment team submits an assessment report to the recognition committee and makes a proposal regarding recognition.
  • The recognition body at the EBA decides on recognition. If recognition is granted, the EBA will send you the draft certificate of recognition including the annexes with a request to submit a statement on this within 2 weeks.
  • If you do not submit a statement or if the certificate of recognition has been agreed between the EBA and you as a result of the statement, the EBA will finalize the notice of recognition and the certificate and send them 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 post. Pay the fees.

Requirements

  • To be recognized as a BS, you must
  • have your registered office in the Federal Republic of Germany
  • have the number of employees with specialist knowledge and sufficient relevant experience specified in European law.
  • have the relevant descriptions of procedures according to which conformity assessment is carried out to ensure transparency and the possibility of applying these procedures.
  • have appropriate policies and procedures in place 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 sector in which you operate,
    • your company structure and
    • the degree of complexity of the product technology in question.
  • have the necessary resources to perform the technical and administrative tasks associated with conformity assessment in an appropriate manner. In addition, you must have access to all necessary equipment or facilities.
  • have liability insurance for personal injury, property damage and financial loss with a minimum sum insured of EUR 2.5 million for each insured event and at least 2 times the cover for the entire year
  • be impartial, which means
    • You must have no connection whatsoever 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 whatsoever,
    • the requirements for independence according to DIN EN ISO/IEC 17065 Chapter 4.2 apply to NBs.

Which documents are required?

  • a description
    • your conformity assessment activities,
    • your procedures within the framework of the conformity assessment procedures and
    • the structural areas (infrastructure, energy supply, train control, train protection, signaling, railroad vehicles) that you cover.
  • Completed form "F10c" - Checklist according to EN ISO/IEC 17065 and assessment scheme
  • depending on the field of activity for which you wish to be recognized, in addition to application form F09c:
    • Form "F09c1" - Appendix Professional competence infrastructure,
    • Form "F09c2" - Appendix for professional competence in energy (BS only),
    • Form "F09c3" - Appendix on ZZS expertise,
    • Form "F09c4" - Appendix Rail vehicle expertise.
  • If applicable, current certificate of accreditation in accordance with DIN EN ISO/IEC 17065.
  • If applicable, current certificate of certification in accordance with ISO 9001
  • Proof of EBA-approved expert status, if applicable
  • Other proof of competence

What are the fees?

The fees you have to pay are based on the time required to process your application:

  • Hourly rate: EUR 120.00
  • for every quarter of an hour or part thereof: EUR 30.00.

Legal basis

Appeal

  • Objection
  • Detailed information on how to lodge an objection can be found in the notification.
  • Appeal to the administrative court

Applications / forms

Forms available: Yes
Written form required: No
Informal application possible: No
Personal appearance required: No
Online services available: Yes

What else should I know?

There are no indications or special features.

Author

Federal Railway Authority (EBA)


Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

Technically approved by

Federal Ministry for Digital and Transport Affairs (BMDV)

Professionally released on

05.07.2023

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