EA successfully fulfilled its cooperation role with the European Railway Agency (ERA) to improve the consistent assessment of Conformity Assessment Bodies regarding the Interoperability Directive.
Picture: Susana Huerta Vela (ENAC), one of EA Representatives for the EA-ERA project.
In March 2014, the European Commission (EC) Directorate-General for Mobility and Transport (DG MOVE) asked ERA to provide a formal advice, in collaboration with EA, on an accreditation scheme for notified bodies (NoBos) under the Interoperability Directive 2008/57/EC (IOD). The ultimate aim was to improve the quality of work performed by the notified bodies in the railway sector.
A preliminary ERA-EA meeting was held in August 2014 to share information about the ERA accreditation scheme project while identifying how EA can support this project. The project work progressed through an ad hoc task force group (TFG) gathering ERA’s internal project team, EA, EU railway NoBos and the Intergovernmental Organisation for International Carriage by Rail (OTIF). Invited to provide two experts for this TFG, EA nominated Susana Huerta Vela (ENAC) and Martins Ozolins (LATAK) as EA representatives, as well as Inge-Lise Clausen (DANAK) and Curt-Peter Askolin (SWEDAC) as their deputies. The whole TFG met four times until December 2015 when the project was finalized and the final report was made available. The ERA advice to the EC was given in early January
Let us give the technical floor to Susana Huerta Vela who kindly accepted to answer a few questions.
What were the objectives of the EA-ERA cooperation project? Who should benefit from the accreditation scheme at the end?
The main objective was to develop a detailed set of requirements, in particular the technical requirements, needed to be fulfilled by notified bodies in order to rise and harmonize the general level of performance of EU notified bodies under Directive 2008/57/EC and to increase trust in the work performed by notified bodies.
– To provide confidence to Member State’s notifying authorities that Conformity Assessment Bodies (CABs) have the correct procedures and competence to perform NoBo activities as described in the EU railway legal framework.
– To increase the mutual trust amongst the relevant stakeholders in the EC certification process.
– To provide sectorial requirements to apply when accrediting CABs for the purpose of notification under the IOD.
The beneficiaries should be stakeholders, such as:
– national Safety Authorities, in granting authorization for placing in service of subsystems, network projects or vehicles
– manufacturers or applicants intending to prepare EC declarations based on EC certificates
– RUs and/or Infrastructure Managers intending to operate the certified products
– ECMs intending to maintain the certified products
– owners and keepers of the certified products
– CABs to be notified
What is the project outcome? ERA set out the principles of the accreditation scheme for NoBos under the IOD. Could you shortly explain what the content of the accreditation scheme is and why ISO/IEC 17065:2012 has been identified as the best suitable standard?
The following four principles have been applied in identifying the baseline standard.
1) The accreditation to one international standard shall be considered sufficient to ensure the competence of the CAB to perform NoBo activities.
2) The suitable standard shall cover all the activities which a NoBo may be demanded to perform
in relation to the assigned modules described in the relevant TSI(s).
3) In addition to the suitable baseline standard, the accreditation scheme shall define as little
additional requirements as possible.
4) The analysis regarding the International standards and Modules provided in the EA guide EA-2/17 INF: 2014 has been taken into account by ERA.
The standard ISO/IEC 17065:2012 meets these requirements; therefore:
– The baseline standard EN ISO/IEC 17065:2012 applies in all its clauses
– The sectorial accreditation scheme does not contradict or exclude any of the requirements of the EN ISO/IEC 17065:2012, and
– The sectorial accreditation scheme provides railway interoperability specific amplified criteria to the baseline standard, as required by the EN ISO/IEC 17065:2012 standard in its introduction (The requirements contained in this International Standard are written, above all, to be considered as general criteria for certification bodies operating product, process or service certification schemes; they may have to be amplified when specific industrial or other sectors make use of them, or when particular requirements such as health and safety have to be taken into account. Annex A contains principles relating to certification bodies and certification activities that they provide.).
The accreditation scheme developed is divided into two parts:
PART I, which provides general references and information as, Legal requirements for Notified Bodies, Scheme owner, NAB assessment team, Accreditation information…etc.
PART II, which provides sectorial requirements to apply when accrediting CABs for the purpose of notification under the IOD as.
– This part describes amplified criteria specific to railways to be applied in addition to the general criteria described in the EN ISO/IEC 17065:2012.
– The amplified criteria to the general requirements are detailing specific aspects of the railway domain.
– The amplified criteria set out in this document do not contradict nor exclude any of the requirements set out in the baseline standard.
What is the next step now?
The proposal for the accreditation scheme has been sent to European Commission in January by ERA. The EC should analyse and decide on its implementation.
As far as the EA-ERA project cooperation was concerned, what were the keys to success?
In my personal opinion, the keys to success were:
– From EA side: the human team with all EA representatives willing to cooperate in an open work frame and, of course, the technical competence and knowledge about railway sector and the standards.
– From ERA side: having a clear understanding of what an accreditation scheme is and which are the competences and skills of each partner and a smooth and transparent project management.
Finally let us give the conclusive word to Andreas Steinhorst who, as the EA Executive Secretary, is responsible for EA’s cooperation projects with the EC and its agencies.
Can EA build upon this new success story for future cooperation projects?
EA appreciated very much the quality of the work accomplished by the TFG, which has successfully elaborated the draft accreditation scheme for notified bodies under the IOD. Therefore many thanks in particular to the EA representatives for the excellent work. This successful outcome is a very good example of good cooperation between EA and the European Commission and its agencies. This IOD-related project was very well managed in accordance with the initial plans and timeframe. In that regard, I would like to thank Luca Trinca from ERA (Interoperability Unit, Project Manager) for the very good and trustful cooperation.
The project meets all EA’s and hopefully ERA’s expectations and could be used as a good example for future cooperation projects with the European Commission and its DGs/agencies.