According to Point 5.2 Article (1) of „Commission regulation (EU) No 1299/2014 of 18 November 2014 on the technical specifications for interoperability relating to the ‘infrastructure’ subsystem of the rail system in the European Union” the constituents to be qualified are the following:
The modules defined in Commission Decision 2010/713/EU form the basis of the procedures for assessing conformity and applicability, furthermore EC verification. During the assessment of the constituents BME ITS Plc carries out the procedure of conformity assessment by applying the modules listed in Table no 1.
| Placed on the EU market before the relevant TSI coming into effect | Placed on the EU market after the relevant TSI coming into effect | |
| Rail | CA or CH | CB + CD or CB + CF or CH |
| Rail fastening Systems | CA or CH | |
| Track sleepers | CA or CH |
The following modules are to be used for the conformity assessment of the constituents enabling interoperability:
a) CA Module – Internal production control
Internal production control is a conformity assessment through which the manufacturer complies with the obligations set for it, and furthermore ensures as well as declares on its sole responsibility that the constituents enabling interoperability in question meet the requirements of the relevant TSI (technical specifications for interoperability).
b) CB Module – EC type examination
By using the CB module BME ITS Plc examines the technical design of the constituent enabling interoperability, and controls and certifies that the technical design of the constituent meets the requirements of the relevant TSI. The EC type examination can be carried out in any of the following ways:
c) CD module – Conformity to type based on the quality management system of the production procedure
By using the CD module BME ITS Plc, in the course of investigating the quality management system documentation forming part of the annex of the application submitted by the Customer, checks whether the operation of the quality management system ensures the compliance of the constituent with the type described in the EC type examination certificate and furthermore with the requirements of the relevant TSI.
d) CF module – Conformity to type based on product verification
By using the CF Module BME ITS Plc performs the appropriate assessments in order to check whether the interoperability constituents comply with the approved type described in the EC type examination certificate and furthermore with the requirements of the TSI. According to the preference of the manufacturer the assessments for checking the compliance of the product with the requirements of the TSI is performed either by examining all constituents (all-component examination) or by examining the constituents on a statistical basis (random sampling examination)
e) CH module – Conformity based on the full quality management system
By using the CH Module BME ITS Plc, in the course of checking the technical documentation of the constituent selected for production–forming part of the annex of the application submitted by the Customer–as well as the technical documentation of the quality management system, checks whether the operation of the quality assurance system ensures the compliance of the constituent with the requirements of the relevant TSI.
During the assessment of the subsystem BME ITS Plc carries out the conformity assessment by using the following modules:
a) SG module – EC verification based on unit verification
By using the SG Module BME ITS Plc, besides checking the technical documentation forming part of the annex of the application submitted by the Customer, performs or gets the appropriate assessments prescribed in the relevant TSIs, harmonized standards and/or technical instructions or the equivalent assessments of these performed in order to check whether the subsystem complies with the requirements of the relevant TSI(s). In the case of the non-availability of such harmonized standards and/or technical instructions the applicant and the concerned NoBo decides on the performance of the appropriate assessments.
In case the EC verification is most effectively carried out by utilizing the data collected (e.g. gained with the bodywork testing coach or any other measuring device) by the infrastructure manager, the contracting party or the involved main contractors, the NoBo takes these data into consideration during the conformity assessment.
b) SH1 Module – Conformity based on the assessment of the full quality management system and the design
By using the SH1 Module BME ITS Plc, in the course of checking the quality management system documentation and the planning documentation forming part of the annex of the application submitted by the Customer, checks whether the plan complies with the requirements of the relevant TSI(s), and furthermore whether the operation of the quality assurance system ensures the compliance of the subsystem with the requirements of the relevant TSI.
The SH1 Module is selectable only in case all the activities supporting the subsystem to be verified (design, production, assembly, installation) are regulated by the quality management system concerning the design, production and control of the end product approved and supervised by the Notified Body.