
Article 1 

1. This Regulation establishes a common safety method (CSM) for monitoring, enabling the effective management of safety in the railway system during its operation and maintenance activities and, where appropriate, improving the management system.
2. This Regulation shall be used for the following:
(a) to check the correct application and the effectiveness of all the processes and procedures in the management system, including the technical, operational and organisational risk control measures. In case of railway undertakings and infrastructure managers, checking will include the technical, operational and organisational elements that are necessary for the issue of the certification/authorisation specified in Article 10(2)(a) and 11(1)(a) and the provisions adopted to obtain the certification/authorisation specified in Article 10(2)(b) and 11(1)(b) of Directive 2004/49/EC;
(b) to check the correct application of the management system as a whole, and if the management system achieves the expected outcomes; and
(c) to identify and implement appropriate preventive, corrective or both types of measures if any relevant instance of non-compliance to points (a) and (b) is detected.
3. This Regulation shall apply to railway undertakings, infrastructure managers after receiving a safety certificate or safety authorisation and entities in charge of maintenance.
Article 2 
For the purposes of this Regulation the definitions of Article 3 of Directive 2004/49/EC shall apply.
In addition, the following definitions shall apply:

((a)) ‘management system’ means either the safety management systems of railway undertakings and infrastructure managers, as defined in Article 3(i) of Directive 2004/49/EC and complying with requirements laid down in Article 9 and Annex III of that Directive, or the system of maintenance of entities in charge of maintenance complying with requirements laid down in Article 14a(3) of that Directive;
((b)) ‘monitoring’ means the arrangements put in place by railway undertakings, infrastructure managers or entities in charge of maintenance to check their management system is correctly applied and effective;
((c)) ‘interfaces’ means interfaces as defined in Article 3(7) of Commission Regulation (EC) No 352/2009.
Article 3 

1. Each railway undertaking, infrastructure manager and entity in charge of maintenance:
(a) shall be responsible for conducting the monitoring process set out in the Annex;
(b) shall ensure that risk control measures implemented by their contractors are also monitored in compliance with this Regulation. To this end, they shall apply the monitoring process set out in the Annex or require their contractors to apply this process through contractual arrangements.
2. The monitoring process shall contain the following activities:
(a) the definition of a strategy, priorities and plan(s) for monitoring;
(b) the collection and analysis of information;
(c) the drawing up of an action plan for instances of unacceptable non-compliance with requirements laid down in the management system;
(d) the implementation of the action plan, if such a plan is drawn up;
(e) the evaluation of the effectiveness of action plan measures, if such a plan is drawn up.
Article 4 

1. Railway undertakings, infrastructure managers and entities in charge of maintenance, including their contractors, shall ensure through contractual arrangements that any relevant safety-related information resulting from applying the monitoring process set out in the Annex is exchanged between them, to enable the other party to take any necessary corrective actions to ensure continuous achievement of the safety performance of the railway system.
2. If, through the application of the monitoring process, railway undertakings, infrastructure managers and entities in charge of maintenance identify any relevant safety risk as regards defects and construction non-conformities or malfunctions of technical equipment, including those of structural sub-systems, they shall report those risks to the other parties involved to enable them to take any necessary corrective actions to ensure continuous achievement of the safety performance of the railway system.
Article 5 

1. The infrastructure managers and railway undertakings shall report to the national safety authority on the application of this Regulation through their annual safety reports in accordance with Article 9(4) of Directive 2004/49/EC.
2. The national safety authority shall report on the application of this Regulation by the railway undertakings, infrastructure managers, and as far as it is aware of it, by the entities in charge of maintenance in accordance with Article 18 of Directive 2004/49/EC.
3. The annual maintenance report of entities in charge of maintenance of freight wagons set out in point I.7.4(k) of Annex III to Regulation (EU) No 445/2011, shall include information about the experience of entities in charge of maintenance in applying this Regulation. The Agency shall gather this information in coordination with the respective certification bodies.
4. The other entities in charge of maintenance that do not fall under the scope of Regulation (EU) No 445/2011 shall also share their experience with the Agency on the application of this Regulation. The Agency shall coordinate the sharing of experience with these entities in charge of maintenance.
5. The Agency shall collect all information on the experience of the application of this Regulation and, when necessary, shall make recommendations to the Commission with a view to improving this Regulation.
6. The national safety authorities shall support the Agency in collecting such information from railway undertakings and infrastructure managers.
7. The Agency shall submit to the Commission not later than three years after the entry into force of this Regulation a report analysing the effectiveness of the method and of the experience of railway undertakings, infrastructure managers and entities in charge of maintenance in applying this Regulation.
Article 6 
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 apply from 7 June 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 16 November 2012.
For the Commission
The President
José Manuel BARROSO
ANNEX
1.  1.1. The inputs to the monitoring process shall be all the processes and procedures contained in the management system, including technical, operational and organisational risk control measures.
 1.2. The activities referred in Article 3(2) of the monitoring process are described in Sections 2 to 6.
 1.3. This monitoring process is repetitive and iterative, as shown in the diagram below in the Appendix.

2.  2.1. Based on their management system, each railway undertaking, infrastructure manager and entity in charge of maintenance shall be responsible for defining its strategy, priorities and plan(s) for monitoring.
 2.2. The decision on what to prioritise shall take into account information from areas that give rise to the greatest risks and, if not monitored effectively, could lead to adverse consequences for safety. An order of priority for monitoring activities shall be set, and the time, effort and resources required shall be indicated. Prioritisation shall also take into account results from previous applications of the monitoring process.
 2.3. The monitoring process shall identify as early as possible instances of non-compliance in the application of the management system that might result in accidents, incidents, near-misses or other dangerous occurrences. It shall lead to the implementation of measures to remedy such instances of non-compliance.
 2.4. 

((a)) give early warnings of any deviation from the expected outcome, or assurance that the expected outcome is achieved as planned;
((b)) give information about unwanted outcomes;
((c)) support decision making.

3.  3.1. The collection and analysis of information shall be carried out according to the strategy, priorities and plan(s) defined for the monitoring.
 3.2. 

((a)) a collection of necessary information;
((b)) an evaluation as to whether the processes, procedures, technical, operational and organisational risk control measures are correctly implemented;
((c)) a check on whether the processes, procedures, technical, operational and organisational risk control measures are effective and whether they achieve the expected outcomes;
((d)) an evaluation of whether the management system as a whole is correctly applied and whether it achieves the expected outcomes;
((e)) an analysis and evaluation of instances of identified non-compliance with points (b), (c) and (d), as well as identification of their causes.

4.  4.1. 

((a)) lead to the enforcement of correctly implemented processes, procedures, technical, operational and organisational risk control measures as specified; or
((b)) improve existing processes, procedures, technical, operational and organisational risk control measures; or
((c)) identify and implement additional risk control measures.
 4.2. 

((a)) objectives and results expected;
((b)) corrective, preventive or both types of measures required;
((c)) person responsible for implementing actions;
((d)) dates by which actions are to be implemented;
((e)) person responsible for evaluating the effectiveness of the action plan measures in accordance with Section 6;
((f)) a review of the impact of the action plan on the monitoring strategy, priorities and plan(s).
 4.3. For managing safety at interfaces the railway undertaking, infrastructure manager or entity in charge of maintenance shall decide, in agreement with the other actors involved, who shall be in charge of implementing the required action plan or parts of it.

5.  5.1. The action plan defined in Section 4 shall be implemented so as to correct identified instances of non-compliance.

6.  6.1. Correct implementation, appropriateness and effectiveness of measures identified in the action plan shall be checked using the same monitoring process as described in this Annex.
 6.2. 

((a)) verification of whether the action plan is correctly implemented and completed according to schedule;
((b)) verification of whether the expected outcome is achieved;
((c)) verification of whether in the meantime the initial conditions have changed and the risk control measures defined in the action plan are still appropriate for the given circumstances;
((d)) verification of whether other risk control measures are necessary.

7.  7.1. 

((a)) railway undertakings and infrastructure managers shall make this documentation available to the national safety authority;
((b)) entities in charge of maintenance shall make this documentation available to the certification body. If interfaces are managed through contracts, the entities in charge of maintenance shall make this documentation available to the respective railway undertakings and infrastructure managers.
 7.2. 

((a)) a description of the organisation and staff appointed to carry out the monitoring process;
((b)) the results of the different activities of the monitoring process listed in Article 3(2) and in particular the decisions made;
((c)) in the case of instances of identified non-compliance that are considered unacceptable, a list of all necessary measures to be implemented to achieve the required outcome.

Appendix