RECOMMENDATION FOR USE

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1 Page 1 of 6 TITLE CONTENT OF THE TECHNICAL FILE ORIGINATOR NB-RAIL STRATEGY SG SUBJECT RELATED TO Directives 2008/57/EC, 2009/131/EC, 2011/18/EU, Recommendation 2011/217/EU, Decision 2010/713/EU and all TSIs DESCRIPTION AND BACKGROUND EXPLANATION Question: How should the technical file be laid out and what should it contain? Explanation: The Notified Body (NoBo) responsible for EC Verification of subsystems must compile a technical file. The technical file is a record of information related to the subsystem in question and the EC Verification activities undertaken. It uniquely describes the subsystem undergoing EC Verification, records the assessments made and the certificates issued. An advantage of having a standardised layout is that interested stakeholders should be able to easily locate information, which is always referenced from the same place. The content of each section may vary according to the nature of the project, the subsystems involved and the assessment modules used. Ownership of the technical file is transferred to the applicant on completion of EC Verification. It must accompany the EC Declaration of Verification for reference by the National Safety Authority, when making its decision to authorise. NoBos may find it advantageous to collect the information in the format recommended here at all stages of their verification activities. The applicant shall add the national technical files and CSM assessment report and associated documentation to the EC technical file. For information: 1) Each technical file related to national rules according to Annex VI (3.3) of the Directive 2008/57/EC (as amended by 2011/18/EU) must be compiled by the relevant Designated Body (DeBo) and added to the associated NoBo technical file as a separate section. The DeBo may decide to use the NoBo technical file structure set out in this RFU. The DeBo should use country markers in the section headline to ensure that information related to national requirements is clearly separated from the EC Verification information. 2) The assessment body report (if required by the CSM regulation 2009/352/EC) and any associated documentation may also be added to the technical file as a separate section by the notified body at the applicant s request.

2 Page 2 of 6 RFU PROPOSAL See Attachment 1 DATE OF AGREEMENT AT NB RAIL PLENARY MEETING 11 October 2012 at PM 36

3 Page 3 of 6 ATTACHMENT 1 structure of EC-section of Technical File The content and format shown in this RFU are recommendations only. Requirements of the Interoperability Directives, TSIs in question and contractual obligations must be observed. The presentation and numbering of the technical file should be as follows. In the event that a certain project does not need to use any particular section, this section should be retained and marked not used or similar so as to keep section numbers identical across all technical files. Chapters specified may contain actual documents or references to them. Technical files are not always required or defined (e.g. for interoperability constituents or module SB). When a NoBo compiles technical documentation, the format defined in this RFU shall be used. 0 Technical File Title Page The following sub-headings shall provide Document control aspects. 0.1 Project name 0.2 Version Control Version Control of technical file (what has been changed per version). 0.3 List of contents 1 Actors 1.1 Notified Body(s) Identification of NoBo(s) involved in the assessment and their respective scope of assessment. 1.2 Applicant Identification of Applicant. 2 Notified Body Certificate(s) (including any ISV(s), if used) 3 Constraints on Use of the Subsystem This should contain copies of all subsystem certificates or references to certificates issued by the NoBo(s). This should refer to any constraints and limitations, and the related justification

4 Page 4 of 6 4 Project Scope and Definition The information provided under the following sub-headings should define the scope of the verification clearly, e.g. the geographic and technical scope of assessment, interfaces to other subsystems, and special considerations. This information should correspond to the information provided for the Register of Infrastructure or Register of Rolling Stock, as necessary. The information may be provided in the form of references to other documents. 4.1 General project information 4.2 Technical scope and interfaces 4.3 Project plan Overview of relevant aspects of the project history and any phasing of works. 4.4 Derogations Evidence of derogations to any TSI requirement must be provided. 4.5 List of specific cases List of those specific cases relevant to the project. 5 Project documentation The following sub-headings should contain or reference all of the technical documentation supplied to the NoBo by the applicant and used during verification activities. (It is good practice to provide the information for 5.1/ 5.2 within a combined matrix.) 5.1 Applied Standards This should contain a list of Mandatory and Voluntary Standards and any other Standards used during the assessment (relating to each TSI section).

5 Page 5 of Design evidence on subsystem This should reference drawings, parts lists, functional/technical descriptions, test procedures, test conditions, test results, etc. used during the assessment process (relating to each TSI section). It is permissible to separate the interface description(s) into a separate section. 5.3 Quality Management System / Production related evidence on subsystem 5.4 List of manufacturers and main subcontractors Information on applied QMS, to include as appropriate quality planning, relevant QM procedures, production related testing and inspection. 5.5 Provisions for operation To include the operating manual and any other documentation related to operation. 5.6 Provisions for maintenance To include the maintenance file and any other documentation related to maintenance. 5.7 Interoperability Constituents This should include declarations, certificates and supporting technical documentation. 5.8 Evidence of compliance with other regulations derived from the Treaty 5.9 Information required for register of RST/ERATV or for Register of INF/RINF 5.10 Information required for the National Vehicle Register 6 Assessment process information 6.1 Overview of NoBo assessments This should include related EC Declarations and Certificates. See also RFU-PLG013 and WKD STR 004. (Only applicable for vehicles)

6 Page 6 of Conformity Process Information, verifications and assessments made, e.g.: Top level audit trail of assessments, Audit trail records confirming witness of compliance, Design Examination Report, Surveillance plan and supporting evidence, Geographical Interfaces of the subsystem with the system into which it is incorporated. This should be limited to Notified Body reports. It should provide the audit trail through the project documentation and describe the work carried out by the Notified Body(s)