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THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on Safety on the Community’s railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive)(1), and in particular Article 6(1) thereof,
Having regard to Recommendation ERA/REC/SAF/09-2009 from the European Railway Agency, delivered to the Commission on 18 September 2009, on a common safety method for conformity assessment.
Whereas:
(1) Directive 2004/49/EC provides a framework for equal conditions for all railway undertakings, through the application of the same safety certification requirements across the Union. The purpose of the common safety method (CSM) is to provide a framework for national safety authorities to harmonise their decision-making criteria across the Union, in accordance with Article 17(4) of Directive 2004/49/EC.
(2) It is necessary to provide for a method for national safety authorities to assess the adequacy of processes developed by railway undertakings to meet the harmonised requirements for obtaining Part A safety certificates issued in accordance with Article 10(2)(a) and Part B safety certificates issued in accordance with Article 10(2)(b) of Directive 2004/49/EC. The criteria by which assessment by national safety authorities shall be carried out should be defined and the procedures to be followed should be established.
(3) Regarding conformity with the safety requirement according to which responsibility for railway vehicle maintenance should be clearly defined, a railway undertaking which is not the entity in charge of maintenance for all vehicles used in its operation, should through appropriate contractual arrangements, such as the General Contract of Use (GCU), ensure that every vehicle has an entity in charge of maintenance to take responsibility for vehicle maintenance in accordance with Article 14a of Directive 2004/49/EC. The contract between the parties should specify the exchange of information between both undertakings needed to guarantee the safe operation of vehicles.
(4) In assessing conformity with safety requirements of products or services provided by contractors or suppliers of railway undertakings, such as provision of services by training centres recognised in accordance with Directive 2007/59/EC of the European Parliament and of the Council of 23 October 2007 on the certification of train drivers operating locomotives and trains on the railway system in the Community(2), authorisations or certificates granted in accordance with relevant Union law to contractors or suppliers may be considered valid evidence. Certification of entities in charge of maintenance in accordance with Article 14a of Directive 2004/49/EC may also be regarded valid evidence. Until the European certification system enters into force, certificates delivered on the basis of the Memorandum of Understanding establishing the basic principles of a common system of certification of entities in charge of maintenance for freight wagons(3) signed on 14 May 2009 may be considered valid evidence when assessing conformity with relevant safety requirements.
(5) National safety authorities assess a railway undertaking’s ability to comply with all the requirements required to operate in general and on the specific network for which it is seeking a certificate by assessing its safety management system at global level.
(6) Each national safety authority should put in place arrangements to examine whether the results outlined in the application for a safety certificate are being delivered in operation after the award of the certificate and whether all the necessary requirements are complied with on a continuous basis, as required by Article 16(2)(f) and Article 17(2) of Directive 2004/49/EC. This therefore requires the development of a post-award supervision regime based on key fundamental principles in order to ensure a harmonised approach by national safety authorities in each Member State.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 27(1) of Directive 2004/49/EC,
HAS ADOPTED THIS REGULATION:
This Regulation establishes a common safety method (CSM) for assessing conformity with requirements for obtaining safety certificates as referred to in Article 6(3)(b) of Directive 2004/49/EC.
The CSM includes:
a procedure and criteria for assessing applications by railway undertakings for safety certificates as referred to in Article 10(2) of Directive 2004/49/EC, as set out in Annexes I, II and III to this Regulation;
principles for supervising compliance with the requirements of Directive 2004/49/EC after the national safety authority has granted the certificate, as set out in Annex IV to this Regulation.
For the purposes of this Regulation, the following definition shall apply: ‘supervision’ means the arrangements put in place by the national safety authority to oversee safety performance after it has granted a safety certificate.
1.When examining applications for both Part A and Part B safety certificates submitted after the entry into force of this Regulation, national safety authorities shall apply the procedure set out in Annex I to this Regulation for assessing their conformity with requirements in Directive 2004/49/EC. National safety authorities shall use the assessment criteria set out in Annex II to this Regulation for safety certificates issued in accordance with Article 10(3) of Directive 2004/49/EC and those contained in Annex III to this Regulation for safety certificates issued in accordance with Article 10(4) of Directive 2004/49/EC. These criteria shall also be used in case of renewal of safety certificates in accordance with Article 10(5) of Directive 2004/49/EC.
2.During assessment, national safety authorities may accept commitments by applicants that they will manage risks through the use of contracts with third parties. The contracts shall also specify the exchange of information needed to ensure the safe operation of vehicles, especially in the areas relating to managing maintenance.
3.Products or services provided by contractors or suppliers to railway undertakings shall be presumed to conform to safety requirements if the contractors, suppliers or products are certified in accordance with relevant certification schemes established under Union legislation, for the provision of such products and services.
After granting a safety certificate, national safety authorities shall, for both Part A and Part B safety certificates, supervise railway undertakings’ continued application of their safety management system and shall apply the principles for supervision set out in Annex IV.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 December 2010.
For the Commission
The President
José Manuel Barroso
National safety authorities shall develop structured and auditable processes to be undertaken by suitably competent persons. They shall scrutinise applications against the assessment criteria for safety management systems set out in Annex II and III. They shall record and give reasons for all decisions. The national safety authority’s overall assessment process shall be periodically internally reviewed and continuously improved to secure its continued effectiveness and efficiency.
National safety authorities shall monitor the quality of their own performance at key stages in the processing of applications for safety certificates.
The assessment shall be at management-system level and process-driven. Where scrutiny reveals shortcomings, the national safety authority may exercise discretion and, depending on the nature and seriousness of the non-conformity, shall outline the points which need to be enhanced. Ultimately, the national safety authority shall exercise its power to reject an application.
The assessment shall be:
appropriate to the risks, character and extent of operations of the applicant;
based on judgments of the railway undertaking’s overall ability to operate safely as described in its safety management system.
National safety authorities shall complete the assessment within the time period required by Article 12 of Directive 2004/49/EC whilst ensuring that the evidence provided by the applicant is sufficiently examined. The national safety authority shall inform railway undertakings of issues of major concern as early as practically possible during the assessment phase.
A decision to accept or reject an application for a safety certificate or authorisation shall be based on the evidence provided by the applicant and on whether compliance with the relevant requirements has been shown or not.
refer accurately to the relevant criteria and ensure that the applicant has understood clearly the identified areas of non-compliance;
identify the relevant part of related regulations, rules, and standards;
state why the assessment criterion is not met;
agree on further commitments, information and any supporting evidence to be provided, as required by the level of detail of the criterion, and specify both the action required by the applicant to rectify the deficiency and the timeframe for compliance;
specify areas which could be subject to further scrutiny through supervision after the award of the certificate.
There are procedures in place to ensure, where reasonably practicable, the continuous improvement of the safety management system; these shall include:
procedures for periodic reviews of the safety management system, as found to be necessary;
procedures for describing arrangements to monitor and analyse relevant safety data;
procedures for describing how identified shortcomings are rectified;
procedures for describing the implementation of new safety management rules based on development and lessons learnt;
procedures for describing how internal audit findings are used to bring about improvement in the safety management system.
A document describing the organisation’s safety policy exists and is:
communicated and made available to all staff, e.g. via the organisation’s intranet;
appropriate to the type and extent of service;
approved by the organisation’s chief executive.
collecting relevant safety data to derive trends in safety performance and assess compliance with targets;
interpreting relevant data and implementing necessary changes.
identifying these requirements and updating relevant procedures to reflect changes made to them (change control management);
implementing them;
monitoring compliance with them;
taking actions when non-compliance is identified.
identification of the knowledge and skills required for safety related tasks;
selection principles (basic educational level, mental aptitude and physical fitness required);
initial training and certification of acquired competence and skills;
ongoing training and periodical update of existing knowledge and skills;
periodic checks of competence where appropriate;
special measures in case of accidents/incidents or long absence from work, as required/where appropriate;
specific safety management system training for staff directly involved in ensuring that the safety management system works.
the identification of posts that perform safety tasks;
the identification of posts that entail responsibilities for taking operational decisions within the safety management system;
staff to have the necessary knowledge, skills and aptitude (medical and psychological) appropriate to their tasks and periodically undergo retraining;
allocating staff with the competence appropriate to relevant tasks;
monitoring how tasks are performed and implementing corrective actions where required.
staff have knowledge and understanding of the safety management system and information is easily accessible; and
appropriate documentation on the safety management system is given to relevant safety personnel.
key operational information is relevant and valid;
staff are aware of its existence before it is applied;
it is available to staff and where required copies are formally given to them.
format, generate, distribute and manage control of changes to all relevant safety documentation;
receive, collect and store all relevant documentation/information on paper or by other registration systems.
are reported, logged, investigated and analysed;
are reported, as required by relevant legislation, to national bodies.
recommendations from the national safety authority, from the national investigating body, and from industry/internal investigations are evaluated and implemented if appropriate or mandated;
relevant reports/information from other railway undertakings, infrastructure managers, entities in charge of maintenance and railway vehicle keepers are considered and taken into account.
the emergency services can be promptly contacted;
the emergency services are provided with all relevant information both in advance, to prepare their emergency response, and at the time of an emergency.
procedures to alert all staff with responsibility for emergency management;
arrangements to communicate these to all parties, including emergency instructions for passengers;
arrangements for contacting competent staff immediately so they can take any decisions required.
analyse and evaluate the results of the audits;
recommend follow-up measures;
follow up the effectiveness of measures;
document the execution of audits and the results of audits.
The service for which a Part B certificate is being sought is outlined and there is a description of how the railway undertaking’s generic procedures devised in support of its certificate issued in accordance with Article 10(2)(a) of Directive 2004/49/EC are applied to develop all the arrangements (including allocation of resources) put in place to deliver the service.
identify the categories of staff (employed or contracted) involved in providing the service and
deliver competent staff for the network concerned, especially for those staff who are asked to undertake a variety of tasks and assure certification where appropriate.
http://ec.europa.eu/transport/rail/interoperability/doc/signed_mou_on_ecm.pdf
Article 9(2) of Directive 2004/49/EC.
Article 9(2) of Directive.2004/49/EC.
Article 9(2) of Directive 2004/49/EC.
Article 9(2) of Directive 2004/49/EC.
Annex III to Directive 2004/49/EC, point 1.
Annex III to Directive 2004/49/EC, point 1.
Annex III to Directive 2004/49/EC, point 1.
Annex III to Directive 2004/49/EC, point 1.
Annex III to Directive 2004/49/EC, point 2(a).
Annex III to Directive 2004/49/EC, point 2(b).
Annex III to Directive 2004/49/EC, point 2(c).
Annex III to Directive 2004/49/EC, point 2(d).
Annex III to Directive 2004/49/EC, point 2(e).
Annex III to Directive 2004/49/EC, point 2(f).
Annex III to Directive 2004/49/EC, point 2(g).
Annex III to Directive 2004/49/EC, point 2(h).
Annex III to Directive 2004/49/EC, point 2(i).
Annex III to Directive 2004/49/EC, point 2(j).
Annex IV to Directive 2004/49/EC, first indent.
Annex IV to Directive 2004/49/EC, second indent.
Annex IV to Directive 2004/49/EC, third indent.