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Commission Regulation (EU) No 1169/2010 of 10 December 2010 on a common safety method for assessing conformity with the requirements for obtaining a railway safety authorisation (Text with EEA relevance)
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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 (CSM) for conformity assessment,
Whereas:
(1) The purpose of the common safety method (CSM) to be established 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. It should enable national safety authorities to assess conformity with requirements in a uniform manner.
(2) The CSM should include all the harmonised requirements and assessment methods to enable national safety authorities to issue an infrastructure manager with a safety authorisation covering the adequacy of the safety management system in general and any network-specific authorisation. Furthermore, it is likely that the infrastructure manager will apply for the network-specific part of the authorisation at the same time as it applies for a general authorisation based on its safety management system.
(3) National safety authorities assess the ability of an infrastructure manager to comply with all the requirements required to operate in general and on the specific network for which it is seeking an authorisation by assessing its safety management system at global level.
(4) Each national safety authority needs to put in place arrangements to examine whether the results outlined in the application for a safety authorisation are being delivered in operation after the award of the authorisation 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.
(5) 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 authorisation as referred to in Article 6(3)(b) of Directive 2004/49/EC.
The CSM includes:
a procedure and criteria for assessing applications by infrastructure managers for safety authorisations as referred to in Article 11(1)(a) and (b) of Directive 2004/49/EC, as set out in Annex I and II to this Regulation;
principles for supervising compliance with the requirements of Directive 2004/49/EC after the national safety authority has granted the authorisation, as set out in Annex III 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 authorisation.
1.When examining applications for safety authorisations 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. The national safety authorities shall also use the assessment criteria set out in Annex II to this Regulation.
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 areas relating to managing maintenance.
3.Products or services provided by contractors or suppliers to infrastructure managers 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 authorisation, national safety authorities shall supervise infrastructure managers’ continued application of their safety management system and shall apply the principles for supervision set out in Annex III.
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, 10 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. 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 authorisations.
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 infrastructure manager's overall ability to operate safely as described in its safety management system.
National safety authorities shall complete the assessment within the time 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 infrastructure managers 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 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 authorisation.
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 action 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 periodic 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.
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).
Article 11(1)(b) of Directive 2004/49/EC.
Article 11(1)(b) of Directive 2004/49/EC.
Article 11(1)(b) of Directive 2004/49/EC.
Article 11(1)(b) of Directive 2004/49/EC.
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