ERA guide for application of the Common Safety Methods ... - Europa

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European Railway AgencyGuide for the application of the CSM Regulation [G 2] Article 6 (1) allows the proposer to appoint any assessment body, who fulfils the criteria inAnnex II, to check the correct application of the CSM process for the system underassessment. This is without prejudice to contractual obligations or to any relevant legalrequirements in the Member State. In order to reduce duplication of checks and costs, if heso wishes, the proposer may decide to ask the NSA whether they would agree to act as theindependent assessment body. This would be in addition to their tasks under Article 6 (3) ofthe CSM. The NSA is free to accept or refuse the task to act as an assessment body, unlessit is required by Community or national legislation. If they refuse, the proposer will have toappoint another independent assessment body. The NSA will remain responsible for thetasks required under the Railway Safety Directive and Railway Interoperability DirectiveArticle 6 (4)Where the significant changes concern a structural subsystem that needs an authorisation forplacing in service as referred to in Article 15(1) or Article 20 of Directive 2008/57/EC, the safetyauthority may act as the assessment body unless the proposer already gave that task to anotified body in accordance with Article 18(2) of that Directive.[G 1] In addition to the authorisation required for placing in service structural sub-systems, theNSA may also perform the checking of the correct application of the CSM process to thestructural sub-system. By analogy with Article 6 (3) above, the same kind of explanation asthe one already provided in that article are also valid for Article 6 (4).Article 7. Safety assessment reportsArticle 7 (1)The assessment body shall provide the proposer with a safety assessment report.[G 1] The purpose of the safety assessment report is to support the proposer in the acceptance ofthe significant change. Without prejudice to the legal requirements in the Member State, theproposer remains nevertheless responsible for the acceptance of the change within thesystem under assessment.Article 7 (2)In the case referred to in point (a) of Article 5(1), the safety assessment report shall be taken intoaccount by the national safety authority in its decision to authorise the placing in service ofsubsystems and vehicles.[G 1] Additional explanation is not judged necessary.Article 7 (3)In the case referred to in point (b) of Article 5(1), the independent assessment shall be part of thetask of the notified body, unless otherwise prescribed by the TSI.If the independent assessment is not part of the task of the notified body, the safety assessmentreport shall be taken into account by the notified body in charge of delivering the conformitycertificate or by the contracting entity in charge of drawing up the EC declaration of verification. Reference: ERA/GUI/01-2008/SAF Version: 1.1 Page 20 of 54File Name: Guide_for_Application_of_CSM_V1.1.docEuropean Railway Agency ● Boulevard Harpignies, 160 ● BP 20392 ● F-59307 Valenciennes Cedex ● France ● Tel. +33 (0)3 27 09 65 00 ● Fax +33 (0)3 27 33 40 65 ● http://www.era.europa.eu
European Railway AgencyGuide for the application of the CSM Regulation [G 1] By virtue of Article 5 (1), TSI may request risk assessments to be performed. The notifiedbodies have the responsibility to assess the conformity of the system under assessment tothe requirements of the applicable TSI. If notified bodies do not fulfil the criteria in Annex IIof the CSM Regulation for performing the independent assessment of the correct applicationof the CSM, they could subcontract the assessment work to another assessment body whomeets those criteria. In this case:(a) the notified bodies will have to check that the tasks of that other assessment body areduly performed;(b) the assessment body who performs the assessment work has to deliver its conclusionsto the notified body or to the contracting entity within an independent safety assessmentreport. That report will support the notified body to provide its conclusions on thecompliance with the considered TSI.[G 2] By virtue of Article 6 (2), independently on whether the notified body will perform the workhimself or whether he will subcontract it to an assessment body, duplication of work shall beavoided.Article 7 (4)When a system or part of a system has already been accepted following the risk managementprocess specified in this Regulation, the resulting safety assessment report shall not be calledinto question by any other assessment body in charge of performing a new assessment for thesame system. The recognition shall be conditional on demonstration that the system will be usedunder the same functional, operational and environmental conditions as the already acceptedsystem, and that equivalent risk acceptance criteria have been applied.[G 1] Member States and assessment bodies have to apply the principle of mutual recognition onthe risk assessments that are evaluated in compliance with the CSM. Such a mutualrecognition is to be based on the harmonised evidences that are produced during the riskmanagement and risk assessment activities covered by the CSM.[G 2] If for a railway system the following is done in a Member State:(a) the risk assessment of the system is compliant with the CSM;(b) the application of the CSM is assessed by an assessment body, and;(c) the system is accepted by the proposer (see Article 7 (1));assessment bodies in other Member States have to apply the principle of mutual recognitionto this risk assessment. The system can therefore be used in other Member States withoutadditional risk assessments and checks provided the related proposer demonstrates that:(d) the system will be used under the same functional, operational and environmentalconditions as the already accepted system in the original Member State, and;(e) the same risk acceptance criteria are applied for controlling the identified hazard(s) asthe ones that are applied in the concerned Member State for controlling the samehazard(s), or are considered as acceptable in that Member State.[G 3] If a condition is not fulfilled in point [G 2] of Article 7 (4), the mutual recognition principlecannot be applied automatically; additional assessments by the proposer are thereforenecessary. The difference needs to be considered as a deviation with respect to the systemalready accepted. If the application of Article 4 (2) shows that this deviation can beconsidered as a significant change when compared to the accepted system, the deviationshall be assessed in compliance with the CSM. Reference: ERA/GUI/01-2008/SAF Version: 1.1 Page 21 of 54File Name: Guide_for_Application_of_CSM_V1.1.docEuropean Railway Agency ● Boulevard Harpignies, 160 ● BP 20392 ● F-59307 Valenciennes Cedex ● France ● Tel. +33 (0)3 27 09 65 00 ● Fax +33 (0)3 27 33 40 65 ● http://www.era.europa.eu
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