CONFORMITY ASSESSMENT ACTIVITY CARRIED OUT AS A NOTIFIED BODY (NOBO)
The activity performed by the Directorate of Certification includes – pursuant to Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 (hereinafter referred to as Directive) – as follows:
- A procedure for the issuance of a CE conformity or eligibility statement for system components of the European railway, allowing for interoperability (Article 9)
- CE certification procedure for subsystems of the European railway system (Annex IV).
The Directorate of Certification will check, examine and certify – during a CE conformity or eligibility procedure – the specific system component allowing for interoperability, for conformity to or eligibility for use as defined in relevant Technical Specifications for Interoperability (hereinafter referred as TSIs), and evaluates the construction and manufacture of a system component allowing for interoperability, and issues a CE Conformity or Eligibility Certificate according to the applied assessment module, to the applicant.
The Directorate of Certification will check, examine and certify – during a CE verification procedure – the specific subsystem for compliance with the Directive and other specifications under the Contract, and that it can be put into operation. It evaluates the construction and manufacture of subsystem and issues a CE Control Certificate to the applicant.
Each Technical Specifications for Interoperability relevant to the conformity assessment activity performed by the Directorate of Certification is set out as follows:
TECHNICAL SPECIFICATIONS FOR INTEROPERABILITY – TSIs
Infrastructure
- Commission Resolution No. 1299/2014/EU (November 18, 2007) on Technical Specifications for Interoperability concerning the Infrastructure subsystem of the European Union railway system
- Commission Implementing Regulation (EU) 2019/776 of 16 May 2019 amending Commission Regulations (EU) No 321/2013, (EU) No 1299/2014, (EU) No 1301/2014, (EU) No 1302/2014, (EU) No 1303/2014 and (EU) 2016/919 and Commission Implementing Decision 2011/665/EU as regards the alignment with Directive (EU) 2016/797 of the European Parliament and of the Council and the implementation of specific objectives set out in Commission Delegated Decision (EU) 2017/1474
Energy
- Commission Resolution No. 1301/2014/EU (November 18, 2014) on Technical Specifications for Interoperability concerning the energy subsystem of the European Union railway system
- Commission Implementing Regulation (EU) (2018/868 of 13 June 2018) amending Regulation (EU) No 1301/2014 and Regulation (EU) No 1302/2014 as regards provisions on energy measuring system and data collecting system
- Commission Implementing Regulation (EU) 2019/776 of 16 May 2019 amending Commission Regulations (EU) No 321/2013, (EU) No 1299/2014, (EU) No 1301/2014, (EU) No 1302/2014, (EU) No 1303/2014 and (EU) 2016/919 and Commission Implementing Decision 2011/665/EU as regards the alignment with Directive (EU) 2016/797 of the European Parliament and of the Council and the implementation of specific objectives set out in Commission Delegated Decision (EU) 2017/1474
Control-command and signalling
- Commission Regulation (EU) 2016/919 of 27 May 2016 on the technical specification for interoperability relating to the ‘control-command and signalling’ subsystems of the rail system in the European Union
- Commission Implementing Regulation (EU) 2019/776 of 16 May 2019 amending Commission Regulations (EU) No 321/2013, (EU) No 1299/2014, (EU) No 1301/2014, (EU) No 1302/2014, (EU) No 1303/2014 and (EU) 2016/919 and Commission Implementing Decision 2011/665/EU as regards the alignment with Directive (EU) 2016/797 of the European Parliament and of the Council and the implementation of specific objectives set out in Commission Delegated Decision (EU) 2017/1474
Disabled and handicapped accessibility
- Commission Order No. 1300/2014/EU (November 18, 2014) on Technical Specifications for Interoperability concerning the Disabled and handicapped accessibility for the European Union railway system
- Commisson Implementing Regulation (EU) 2019/772 of 16 May 2019 amending Regulation (EU) No 1300/2014 as regards inventory of assets with a view to identifying barriers to accessibility, providing information to users and monitoring and evaluating progress on accessibility
Tunnel safety
- Commission Order No. 1303/2014/EU (November 18, 2014) on Technical Specifications for Interoperability concerning safety of railway tunnels belonging to the European Union railway system
- Commission Regulation (EU) 2016/912 of 9 June 2016 correcting Regulation (EU) No 1303/2014 concerning the technical specification for interoperability relating to ‘safety in railway tunnels’ of the rail system of the European Union
- Commission Implementing Regulation (EU) 2019/776 of 16 May 2019 amending Commission Regulations (EU) No 321/2013, (EU) No 1299/2014, (EU) No 1301/2014, (EU) No 1302/2014, (EU) No 1303/2014 and (EU) 2016/919 and Commission Implementing Decision 2011/665/EU as regards the alignment with Directive (EU) 2016/797 of the European Parliament and of the Council and the implementation of specific objectives set out in Commission Delegated Decision (EU) 2017/1474
Vehicles – Locomotives and passenger rolling stock (LOC&PAS)
- Commission Regulation (EU) No 1302/2014 of 18 November 2014 concerning the technical specification for interoperability relating to the subsystem ‘rolling stock – locomotives and passenger rolling stock’ of the rail system of the European Union
- Commission Implementing Regulation (EU) 2020/387 of 9 March 2020 amending Regulations (EU) No 321/2013, (EU) No 1302/2014 and (EU) 2016/919 as regards the extension of the scope and transitional periods (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2019/776 of 16 May 2019 amending Commission Regulations (EU) No 321/2013, (EU) No 1299/2014, (EU) No 1301/2014, (EU) 1302/2014, (EU) No 1303/2014 and (EU) 2016/919 and Commission Implementing Decision 2011/665/EU as regards their alignment with Directive (EU) 2016/797 of the European Parliament and of the Council and implementing the specific objectives of Commission Delegated Decision (EU) 2017/1474
- Commission Implementing Regulation (EU) 2018/868 (13 June 2018) amending Regulation (EU) No 1301/2014 and Regulation (EU) No 1302/2014 as regards the provisions on the energy measuring and reporting system
Vehicles- Freight wagons (WAG)
- Commission Regulation (EU) 321/2013 of 13 March 2013 concerning the technical specification for interoperability relating to the subsystem ‘rolling stock – freight wagons’ of the rail system of the European Union and repealing Commission Decision 2006/861/EC
- Commission Implementing Regulation (EU) 2020/387 of 9 March 2020 amending Regulations (EU) No 321/2013, (EU) No 1302/2014 and (EU) 2016/919 as regards the extension of the scope and transitional periods (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2019/776 of 16 May 2019 amending Commission Regulations (EU) 321/2013, (EU) No 1299/2014, (EU) No 1301/2014, (EU) No 1302/2014, (EU) No 1303/2014 and (EU) 2016/919 and Commission Implementing Decision 2011/665/EU as regards their alignment with Directive (EU) 2016/797 of the European Parliament and of the Council and implementing the specific objectives of Commission Delegated Decision (EU) 2017/1474
- Commission Regulation (EU) 2015/924 of 8 June 2015 amending Regulation (EU) 321/2013 concerning the technical specification for interoperability relating to the subsystem ‘rolling stock – freight wagons’ of the European Union rail system
- Commission Regulation (EU) 1236/2013 of 2 December 2013 concerning the technical specification for interoperability relating to the subsystem ‘rolling stock – freight wagons’ of the rail system of the European Union and amending Regulation (EU) 321/2013
Vehicles – Noise (NOI)
- Commission Regulation (EU) 1304/2014 of 26 November 2014 concerning the technical specification for interoperability relating to the subsystem ‘rolling stock – noise’, amending Decision 2008/232/EC and repealing Decision 2011/229/EU (NOI TSI)
- Commission Implementing Regulation (EU) 2019/774 of 16 May 2019 amending Regulation (EU) 1304/2014 as regards the application of the technical specification for interoperability relating to the subsystem ‘rolling stock – noise’ to existing freight wagons
CONFORMITY ASSESSMENT ACTIVITY PERFORMED AS A DESIGNATED BODY (DEBO)
The Directorate of Certification performs its conformity assessment activity in accordance with national rules if that area is not subject to the Technical Specifications for Interoperability relevant to the European railway system:
- open issues to which national rules apply
- if a special case is valid to the Clause of Chapter 4 of TSIs
- when national rules are in force after a discrepancy, instead of a requirement set forth in TSIs
- in the case of reconstruction or upgrade, national rules are in force instead of a requirement set forth in TSIs
- fields that are not subject to Directive (EU) 2016/797 and Government Decree 413/2020:
- subways, tramways and other local railway systems
- networks that are – in a view to their function – separate from the rest of the railway system, used for local, urban and suburban passenger transport only, and railway companies operating on such networks only
- privately owned railway track network, including vehicles used on such track network, used only by the owner for his own transport operations
- track network and vehicles used strictly for local, historic or tourism purposes.
The Activity performed by the Directorate of Certification is based on the relevant national rules:
- Decree 103/2003(XII.27.) GKM on the interoperability of conventional railway systems, Annex 4 to Decree 103/2003(XII.27.) GKM – National Rules for Railways – National railways for public service and for private use (OVSZ, Volume I)
- Decree 18/1998 (VII.3.) KHVM on the issuance of National Rules for Railways, (OVSZ, Volume II)
Legislation relevant to the functional area of a Certification Body:
- Act CXXXIII. of 2009 on the Activities of Conformity Assessment Bodies
- Government Decree 315/2009. (XII. 28.) on the designation of conformity assessment bodies and the detailed rules for their activities
- NFM Decree 60/2011. (XI. 25.) on the designation of conformity assessment bodies in relation to marketing requirements within the regulatory remit of the Minister for Transport
- Directive (EU) 2016/797 (11 May, 2016) issued by the European Parliament and of the Council on the railway system interoperability within the Community (reworked text)
- Commission Decision 2010/713/EU (of 9 November 2010) on modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council
- Government Decree 413/2020 (VIII. 30.) on the interoperability of the rail system
- NFM Decree 30/2010 (XII. 23.) on the interoperability of the rail system
- Government Decree 289/2012. (X. 11.) on the detailed rules for the official approval procedures for the construction of railway structures
During a certification procedure, the Directorate of Certification checks, examines and certifies compliance of subsystems and system components with relevant requirements.
CONFORMITY ASSESSMENT ACTIVITY PERFORMED AS AN ASSESSMENT BODY (ASBO)
The main purpose of the independent evaluation related to the risk management process is to inspire confidence in all stakeholders that the control process will provide the most appropriate recommendation to participants for safe operation within the railway sector.
Stakeholders expect and require the assessment body to meet the requirements of MSZ EN ISO / IEC 17020: 2012.
MSZ EN ISO / IEC 17020: 2012 prescribes requirements, the observance of which is aimed at ensuring that the assessment body operates in a consistent and impartial manner.
The independent assessment organization of RailCert Hungary Kft. carries out an independent assessment in the different competence areas of the railway system or its parts, to which the basic safety requirements apply, within the framework of the risk management procedure for changes affecting the railway system. This includes areas of competence related to the operation, maintenance and integration of the railway system into the existing system. In practice, this applies to the various structural and functional subsystems of the EU rail system:
- Infrastructure (INF)
- Energy (ENE)
- Control-Command and Signalling (CCS)
- Traffic Operation and Management (OPE)
- Maintenance (MAI)
- Secure System Integration (SSI)
- Rolling Stock (RST)
The independent assessment body of RailCert Hungary Kft. carries out its activities on the basis of the requirements of the MSZ EN ISO/IEC 17020:2012 standard and the Commission Implementing Regulation (EU) 402/2013 of 30 April 2013 on the safety method for risk analysis and assessment.
Legislation relevant to the functional area of an Assessment Body:
- Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety
- Implementing Regulation (EU) 402/2013 on a common safety method for risk analysis and assessment and repealing Regulation (EC) No 352/2009
- Implementing Regulation (EU) 2015/1113 amending Regulation (EU) No 402/2013 on a common safety method for risk analysis and assessment
- Government Decree 390/2020. (VIII. 12.) on the designation of organizations performing risk assessment and on the detailed rules of the activities of organizations performing risk assessment
Check Designation Document (DeBo)