ASSESSMENT BODY (ASBO)
what is an asbo mission ?
In accordance with the (EU) 2016/796 Directive, the Regulation No. 402/2013 on the Common Safety Methods for risk evaluation and assessment (CSM-RA) and the Regulation No. 2015/1136/EU set a common framework for safety assessment and demonstration.
These regulations impose to the applicant applying common safety methods as soon as a system is subject to significant changes that can be technical, operational or organizational.
With the 4th Railway Package, the applicant has the responsability to integrate a requirements capture in order to ensure that all relevant Union law, national requirements (in line with the area of use requested) have been defined and met as well as all risks are properly covered and traced to a relevant mitigation measure.
The proposer can be a Railway Undertaking, an Infrastructure Manager, an Entity in Charge of Maintenance, a Contracting Entity or a Manufacturer.
AS CERTIFER GROUP, all our European entities have been aknowledged as AsBo by:
- Agencia Estatal de Seguridad Ferroviaria in Spain
- Agenzia Nazionale per la Sicurezza delle Ferrovie - ANSF in Italy
In Europe, the compliance with Regulation 402/2013 is mandatory when a significant change with an influence on safety is carried out. The significance of a change is defined by the proposer on the basis of six criteria. For these changes, the proposer has to demonstrate the compliance throughout the following stages:
By highlighting the importance of the risk-based approach in order to ensure the assessment and the demonstration of the safe integration, the CSM-RA imposes in the case of significant changes an independent assessment by a third-party to give confidence that the system under assessment can safely fulfil the intended objectives.
In some particular cases, application of the CSM-RA may be included in a requirement of a TSI. In such a case, same assessment procedure shall be applied considering as scope requirement of the TSI instead of significant change.
What is the role of the ASBO ?
On the basis of CSM application and demonstration that all risks are controlled, the AsBo assesses the correct application of risk management process and suitability of its results.
The AsBo gives its judgement on system definition, requirement capture, hazard identification and risk analysis, risk evaluation and risk acceptance and on the demonstration of compliance with safety requirements. Nevertheless, the AsBo cannot intervene in the prepation of the risk analysis and in the definition of significance of changes.
In case of compliance of risk assessment and risk management with CSM- RA requirements and appropriateness to fulfil safely intended objectives, the AsBo delivers a safety assessment report. The latter is requested as a mandatory evidence for EU and OTIF member National Safety Authorities.