ANNEX I

Supervision process as referred to in Article 3

1.   GENERAL

The national safety authority shall develop a structured and auditable process for the complete activity which takes into account the elements below. This ensures that the supervision process is iterative and takes into account the need to continually improve, as shown in the diagram below in the Appendix.

2.   SETTING UP THE SUPERVISION STRATEGY AND PLAN(S)

The national safety authority shall:

(a)

collect and analyse data/information from a variety of sources as an input to the strategy and the plan or plans. Sources could include information gathered during the assessment of safety management systems, outcomes of previous supervision activities, information from authorisations of subsystems or vehicles, national investigation bodies accident reports/recommendations, other accident/incident reports or data, railway undertakings' or infrastructure managers' annual safety reports to the national safety authority, annual maintenance reports from entities in charge of maintenance, complaints from members of the public and other relevant sources;

(b)	identify in the supervision strategy risk areas for targeted supervision activities, including those emerging from the integration and management of human and organisational factors, where relevant;

(c)	develop a supervision plan or plans showing how it will give effect to the supervision strategy during the lifecycle of valid single safety certificates and safety authorisations;

(d)	produce an initial estimate of resources required to give effect to the plan or plans, based on the target areas identified;

(e)	allocate resources to give effect to the plan or plans;

(f)	address in the supervision strategy and plan(s) any matters relating to cross-border operations or infrastructure(s) through coordination with other national safety authority (or authorities).

3.   COMMUNICATING THE SUPERVISION STRATEGY AND PLAN(S)

The national safety authority shall:

(a)	communicate the overall objectives of the supervision strategy and overall explanation of the plan or plans to relevant railway undertakings or infrastructure managers and, where appropriate, more widely to other stakeholders;

(b)	provide relevant railway undertakings or infrastructure managers with an overall explanation on how the supervision plan or plans will be undertaken.

4.   DELIVERING THE SUPERVISION ACTIVITIES

The national safety authority shall:

(a)	give effect to the plan or plans;

(b)	take proportionate action(s) to deal with failure of a railway undertaking or an infrastructure manager to comply with its legal obligations, including issuing any urgent safety alerts and applying temporary safety measures when necessary;

(c)	evaluate how adequately a railway undertaking or an infrastructure manager has developed and implemented an action plan or plans to remedy any non-compliance or residual concern within a specified time period;

(d)	document the results of its supervision activities.

5.   OUTCOMES OF SUPERVISION ACTIVITIES

The national safety authority shall:

(a)	share results of its supervision activities with the relevant railway undertaking or infrastructure manager, including identifying areas of non-compliance on the part of the railway undertaking or infrastructure manager and any areas of good practice to support safety improvement;

(b)	have an overview of the safety performance of the individual railway undertakings or infrastructure managers operating in its Member State;

(c)	publish and communicate to relevant stakeholders its views on the overall safety performance in the Member State;

(d)	publish and communicate to relevant stakeholders its views on the effectiveness of the safety regulatory framework;

(e)

use and when relevant, share information on the performance of the safety management system gathered during the supervision of railway undertakings or infrastructure managers, prior to reassessing the application for a renewal or an update of the single safety certificate or the safety authorisation, with the Agency acting as safety certification body or the relevant national safety authority, in the case of cross-border infrastructure;

(f)

where appropriate, take any enforcement actions, identify whether there is a case for restricting or revoking the single safety certificate or safety authorisation and in cases where it is not responsible for issuing the single safety certificate or safety authorisation, inform the competent authority accordingly.

6.   REVIEWING SUPERVISION ACTIVITIES

On the basis of information gathered and experience gained during supervision activities and the safety performance both at individual level and at Member State level, the national safety authority shall at regular intervals:

(a)	conduct a review of the supervision strategy and plan(s) to check that the original targeted activity, use of data/information from a variety of sources, supervision outcomes and resource allocation are appropriate, changing priorities as necessary;

(b)	revise the plan or plans if needed and consider the impact of the changes on the supervision strategy;

(c)	contribute when necessary with its views and any proposals to its Member State to overcome any deficiencies in the safety regulatory framework.

ANNEX II

Framework for coordinated and joint supervision as referred to in Article 8(2)

The relevant national safety authorities shall develop arrangements based on the following principles and specific elements:

1.	Agree which railway undertakings and infrastructure managers are operating in such a manner as to require coordinated or joint supervision.

2.	Agree on common language(s) and the level of confidentiality of the information to be used for the purposes of their coordination arrangements.

3.

Agree what information to exchange and a timetable for the exchange: (a) exchange relevant information on railway undertakings and infrastructure managers identified under point 1 and share results from their assessment activities; (b) provide copies of safety authorisations where appropriate; (c) share results from related supervision activities, including enforcement decisions and actions, where relevant; (d) share information on the safety performance of railway undertakings and infrastructure managers identified under point 1 in each Member State.

4.

Share decision-making criteria: (a) share information on how each national safety authority targets its activities for each railway undertaking and infrastructure manager concerned as part of the supervision plan; (b) establish a dialogue between relevant national safety authorities on the proposed response to dealing with major compliance gaps.

5.

Manage coordination: (a) share existing supervision strategies and plans; (b) establish common points of interest and/or common issues; (c) plan efficiently individual, coordinated or joint initiatives without causing unnecessary inconvenience to the railway undertakings and infrastructure managers and by avoiding overlaps in the scope of these initiatives.

6.	Agree on which national safety authority (or authorities) should follow up actions aimed to address residual concerns which have been deferred for supervision where appropriate.

7.

Agree what areas to target in a coordinated or joint manner: (a) identify key risks for the relevant railway undertakings and infrastructure managers to be addressed in a coordinated or joint manner by national safety authorities; (b) agree which national safety authority will lead activities on what issues, where relevant, on the basis of well-established criteria; (c) agree what types of joint supervision activities to undertake, where relevant; (d) agree how railway undertakings and infrastructure managers should be made aware of the arrangements and agreements national safety authorities are reaching.

8.

Share good practice: (a) develop arrangements to review and coordinate on a regular basis the supervision activities for the relevant railway undertakings and infrastructure managers; (b) develop arrangements to evaluate the effectiveness of the coordination and cooperation between national safety authorities, including the Agency as appropriate.

ANNEX I

Safety management system requirements related to railway undertakings

1.   CONTEXT OF THE ORGANISATION

1.1.    The organisation shall:

(a)	describe the type, extent and area of its operations;

(b)	identify the serious risks for safety posed by its railway operations whether they are carried out by the organisation itself, or by contractors, partners or suppliers under its control;

(c)	identify interested parties (e.g. regulatory bodies, authorities, infrastructure managers, contractors, suppliers, partners), including those parties external to the railway system, that are relevant to the safety management system;

(d)	identify and maintain legal and other requirements related to safety from the interested parties referred to in point (c);

(e)	ensure that the requirements referred to in point (d) are taken into account in developing, implementing and maintaining the safety management system;

(f)	describe the scope of the safety management system, indicating which part of the business is included or not in its scope and taking into account the requirements referred to in point (d).

2.   LEADERSHIP

2.1.   Leadership and commitment

2.1.1.   Top management shall demonstrate leadership and commitment to the development, implementation, maintenance and continual improvement of the safety management system by:

(a)	taking overall accountability and responsibility for safety;

(b)	ensuring commitment to safety by management at different levels within the organisation through their activities and in their relationships with staff and contractors;

(c)	ensuring that the safety policy and safety objectives are established, understood and are compatible with the strategic direction of the organisation;

(d)	ensuring the integration of the safety management system requirements into the organisation's business processes;

(e)	ensuring that the resources needed for the safety management system are available;

(f)	ensuring that the safety management system is effective in controlling the safety risks posed by the organisation;

(g)	encouraging staff to support compliance with the safety management system requirements;

(h)	promoting continual improvement of the safety management system;

(i)	ensuring that safety is considered when identifying and managing the organisation's business risks and explaining how conflict between safety and other business goals will be recognised and resolved;

(j)	promoting a positive safety culture.

2.2.   Safety policy

2.2.1.   A document describing the organisation's safety policy is established by the top management and is:

(a)	appropriate to the organisation's type and extent of railway operations;

(b)	approved by the organisation's chief executive (or a representative(s) of the top-management);

(c)	actively implemented, communicated and made available to all staff.

2.2.2.   The safety policy shall:

(a)	include a commitment to conform with all legal and other requirements related to safety;

(b)	provide a framework for setting safety objectives and evaluating the organisation's safety performance against these objectives;

(c)	include a commitment to control safety risks which arise both from its own activities and those caused by others;

(d)	include a commitment to continual improvement of the safety management system;

(e)	be maintained in accordance with the business strategy and the evaluation of the safety performance of the organisation.

2.3.   Organisational roles, responsibilities, accountabilities and authorities

2.3.1.   The responsibilities, accountabilities and authorities of staff having a role that affects safety (including management and other staff involved in safety-related tasks) shall be defined at all levels within the organisation, documented, assigned and communicated to them.

2.3.2.   The organisation shall ensure that staff with delegated responsibilities for safety-related tasks shall have the authority, competence and appropriate resources to perform their tasks without being adversely affected by the activities of other business functions.

2.3.3.   Delegation of responsibility for safety-related tasks shall be documented and communicated to the relevant staff, accepted and understood.

2.3.4.   The organisation shall describe the allocation of roles referred to in paragraph 2.3.1. to business functions within and where relevant, outside the organisation (see 5.3. Contractors, partners and suppliers).

2.4.   Consultation of staff and other parties

2.4.1.   Staff, their representatives and external interested parties, as appropriate and where relevant, shall be consulted in developing, maintaining and improving the safety management system in the relevant parts they are responsible for, including the safety aspects of operational procedures.

2.4.2.   The organisation shall facilitate the consultation of staff by providing the methods and means for involving staff, recording staff's opinion and providing feedback on staff's opinion.

3.   PLANNING

3.1.   Actions to address risks

3.1.1.   Risk assessment

3.1.1.1.   The organisation shall:

(a)

identify and analyse all operational, organisational and technical risks relevant to the type, extent and area of operations carried out by the organisation. Such risks shall include those arising from human and organisational factors such as workload, job design, fatigue or suitability of procedures, and the activities of other interested parties (see 1. Context of the organisation);

(b)	evaluate the risks referred to in point (a) by applying appropriate risk assessment methods;

(c)	develop and put in place safety measures, with identification of associated responsibilities (see 2.3. Organisational roles, responsibilities, accountabilities and authorities);

(d)	develop a system to monitor the effectiveness of safety measures (see 6.1. Monitoring);

(e)

recognise the need to collaborate with other interested parties (such as railway undertakings, infrastructure managers, manufacturer, maintenance supplier, entity in charge of maintenance, railway vehicle keeper, service provider and procurement entity), where appropriate, on shared risks and the putting in place of adequate safety measures;

(f)	communicate risks to staff and involved external parties (see 4.4. Information and communication).

3.1.1.2.   When assessing risk, an organisation shall take into account the need to determine, provide and sustain a safe working environment which conforms to applicable legislation, in particular Directive 89/391/EEC.

3.1.2.   Planning for change

3.1.2.1.   The organisation shall identify potential safety risks and appropriate safety measures (see 3.1.1. Risk assessment) before the implementation of a change (see 5.4. Management of change) in accordance with the risk management process set out in the Regulation (EU) No 402/2013 (1), including consideration of the safety risks from the change process itself.

3.2.   Safety objectives and planning

3.2.1.   The organisation shall establish safety objectives for relevant functions at relevant levels to maintain and, where reasonably practicable, improve its safety performance.

3.2.2.   The safety objectives shall:

(a)	be consistent with the safety policy and the organisation's strategic objectives (where applicable);

(b)	be linked to the priority risks that influence the safety performance of the organisation;

(c)	be measurable;

(d)	take into account applicable legal and other requirements;

(e)	be reviewed as regards their achievements and revised as appropriate;

(f)	be communicated.

3.2.3.   The organisation shall have plan(s) to describe how it will achieve its safety objectives.

3.2.4.   The organisation shall describe the strategy and plan(s) used to monitor the achievement of the safety objectives (see 6.1. Monitoring).

4.   SUPPORT

4.1.   Resources

4.1.1.   The organisation shall provide the resources, including competent staff and effective and useable equipment, needed for the establishment, implementation, maintenance and continual improvement of the safety management system.

4.2.   Competence

4.2.1.   The organisation's competence management system shall ensure that staff having a role that affects safety are competent in the safety-related tasks for which they are responsible (see 2.3. Organisational roles, responsibilities, accountabilities and authorities), including at least:

(a)	identification of the competencies (including knowledge, skills, non-technical behaviours and attitudes) required for safety-related tasks;

(b)	selection principles (basic educational level, psychological and physical fitness required);

(c)	initial training, experience and qualification;

(d)	ongoing training and periodic update of existing competencies;

(e)	periodic assessment of competence and checks of psychological and physical fitness to ensure that qualifications and skills are maintained over time;

(f)	specific training in relevant parts of the safety management system in order to deliver their safety-related tasks.

4.2.2.   The organisation shall provide a training programme, as referred to in points (c), (d) and (f) of paragraph 4.2.1, for staff performing safety-related tasks which ensures that:

(a)	the training programme is delivered according to the identified competency requirements and individual needs of the staff;

(b)	where applicable, the training ensures that staff can operate under all operating conditions (normal, degraded and emergency);

(c)	the duration of the training and the frequency of the refresher training are appropriate for the training objectives;

(d)	records are kept for all staff (see 4.5.3. Control of documented information);

(e)	the training programme is regularly reviewed and audited (see 6.2. Internal auditing) and changes made when necessary (see 5.4. Management of change).

4.2.3.   Back to work arrangements shall be in place for staff following accidents/incidents or long absences from work, including providing additional training where such a need is identified.

4.3.   Awareness

4.3.1.   Top management shall ensure that they and their staff having a role that affects safety are aware of the relevance, importance and consequences of their activities and how they contribute to the correct application and the effectiveness of the safety management system, including the achievement of safety objectives (see 3.2. Safety objectives and planning).

4.4.   Information and communication

4.4.1.   The organisation shall define adequate communication channels to ensure that safety-related information is exchanged among the different levels of the organisation and with external interested parties including contractors, partners and suppliers.

4.4.2.   To ensure that safety-related information reaches those making judgements and decisions, the organisation shall manage the identification, receipt, processing, generation and dissemination of safety-related information.

4.4.3.   The organisation shall ensure that safety-related information is:

(a)	relevant, complete and understandable for the intended users;

(b)

valid;

(c)

accurate;

(d)	consistent;

(e)	controlled (see 4.5.3. Control of documented information);

(f)	communicated before it takes effect;

(g)	received and understood.

4.5.   Documented information

4.5.1.   Safety management system documentation

4.5.1.1.   There is a description of the safety management system including:

(a)	the identification and description of the processes and activities related to safety of rail operations, including safety-related tasks and associated responsibilities (see 2.3. Organisational roles, responsibilities, accountabilities and authorities);

(b)	the interaction of these processes;

(c)	the procedures or other documents describing how these processes are implemented;

(d)	the identification of contractors, partners and suppliers with a description of the type and extent of services delivered;

(e)	the identification of contractual arrangements and other business agreements, concluded between the organisation and other parties identified under (d), necessary to control the safety risks of the organisation and those related to the use of contractors;

(f)	reference to documented information required by this Regulation.

4.5.1.2.   The organisation shall ensure that an annual safety report is submitted to the relevant national safety authority (or authorities) in accordance with Article 9(6) of Directive (EU) 2016/798, including:

(a)	a synthesis of the decisions on the level of significance of the safety-related changes, including an overview of significant changes, in accordance with Article 18(1) of Regulation (EU) No 402/2013;

(b)	the organisation's safety objectives for the following year(s) and how serious risks for safety influence the setting of these safety objectives;

(c)	the results of internal accident/incident investigation (see 7.1. Learning from accidents and incidents) and other monitoring activities (see 6.1. Monitoring, 6.2. Internal auditing and 6.3. Management review), in accordance with Article 5(1) of Regulation (EU) No 1078/2012 (2);

(d)	details of progress on addressing outstanding recommendations from the national investigation bodies (see 7.1. Learning from accidents and incidents);

(e)	the organisation's safety indicators set out to evaluate the organisation's safety performance (see 6.1. Monitoring);

(f)	where applicable, the conclusions of the annual report of the safety advisor, as referred to in RID (3), on the activities of the organisation relating to the transport of dangerous goods (4).

4.5.2.   Creating and updating

4.5.2.1.   The organisation shall ensure that when creating and updating documented information related to the safety management system adequate formats and media are used.

4.5.3.   Control of documented information

4.5.3.1.   The organisation shall control documented information related to the safety management system, in particular its storage, distribution and the control of changes, to ensure its availability, suitability and protection where appropriate.

4.6.   Integration of human and organisational factors

4.6.1.   The organisation shall demonstrate a systematic approach to integrating human and organisational factors within the safety management system. This approach shall:

(a)	include the development of a strategy and the use of expertise and recognised methods from the field of human and organisational factors;

(b)	address risks associated with the design and use of equipment, tasks, working conditions and organisational arrangements, taking into account human capabilities as well as limitations, and the influences on human performance.

5.   OPERATION

5.1.   Operational planning and control

5.1.1.   When planning, developing, implementing and reviewing its operational processes, the organisation shall ensure that during operation:

(a)	risk acceptance criteria and safety measures are applied (see 3.1.1. Risk assessment);

(b)	plan(s) to achieve the safety objectives are delivered (see 3.2. Safety objectives and planning);

(c)	information is collected to measure the correct application and effectiveness of the operational arrangements (see 6.1. Monitoring).

5.1.2.   The organisation shall ensure that its operational arrangements conform to the safety-related requirements of applicable Technical Specifications for Interoperability and relevant national rules and any other relevant requirements (see 1. Context of the organisation).

5.1.3.   To control risks where relevant for the safety of operational activities (see 3.1.1. Risk assessment), at least the following shall be taken into account:

(a)

planning of existing or new train routes and new train services, including the introduction of new types of vehicles, the need to lease vehicles and/or to hire staff from external parties and the exchange of information on the maintenance for operational purposes with entities in charge of maintenance;

(b)	development and implementation of train timetables;

(c)	preparation of trains or vehicles before movement, including pre-departure checks and train composition;

(d)	running trains or movement of vehicles in the different operating conditions (normal, degraded and emergency);

(e)	adaptation of the operation to requests for removal from operation and notification of return to operation issued by entities in charge of maintenance;

(f)	authorisations for movements of vehicles;

(g)	usability of interfaces in train driving cabs and train control centres and with equipment used by maintenance staff.

5.1.4.   To control the allocation of responsibilities where relevant for the safety of operational activities, the organisation shall identify responsibilities for coordinating and managing the safe running of trains and movements of vehicles and define how relevant tasks affecting the safe delivery of all services are allocated to competent staff within the organisation (see 2.3. Organisational roles, responsibilities, accountabilities and authorities) and to other external qualified parties when appropriate (see 5.3. Contractors, partners and suppliers).

5.1.5.   To control information and communication where relevant for the safety of operational activities (see 4.4. Information and communication), relevant staff (e.g. train crews) shall be advised of the details of any specified conditions of travel, including relevant changes which may result in a hazard, temporary or permanent operational restrictions (e.g. due to specific type of vehicles or to specific routes) and conditions for exceptional consignments, where applicable.

5.1.6.   To control competence where relevant for the safety of operational activities (see 4.2. Competence), the organisation shall ensure, in accordance with applicable legislation (see 1. Context of the organisation), for its staff:

(a)	compliance with their training and work instructions, and corrective actions are taken where required;

(b)	specific training in case of anticipated changes affecting the running of operations or their task assignment;

(c)	adoption of adequate measures following accidents and incidents.

5.2.   Asset management

5.2.1.   The organisation shall manage the safety risks associated with physical assets throughout their life cycle (see 3.1.1. Risk assessment), from design to disposal, and fulfil the human factors requirements in all phases of the life cycle.

5.2.2.   The organisation shall:

(a)	ensure that the assets are used for the purpose intended while maintaining their safe operational state, in accordance with Article 14(2) of Directive (EU) 2016/798 where relevant, and their expected level of performance;

(b)	manage the assets in normal and degraded operations;

(c)	detect as soon as reasonably practicable instances of non-compliance with operating requirements before or during the operation of the asset, including the application of restrictions of use as appropriate to ensure a safe operational state of the asset (see 6.1. Monitoring).

5.2.3.   The organisation shall ensure that its asset management arrangements, where applicable, conform to all essential requirements as set out in the relevant Technical Specifications for Interoperability and any other relevant requirements (see 1. Context of the organisation).

5.2.4.   To control risks where relevant for the supply of maintenance (see 3.1.1. Risk assessment), at least the following shall be taken into account:

(a)	the identification of the need for maintenance to keep the asset in a safe operational state, based on the planned and real use of the asset and its design characteristics;

(b)	the management of the removal of the asset from operation for maintenance, when defects have been identified or when asset condition degrades outside the limits of a safe operational state as referred to in point (a);

(c)	the management of the return to operation of the asset with eventual restrictions of use after maintenance has been delivered to ensure it is in a safe operational state;

(d)	the management of monitoring and measurement equipment to ensure that it is fit for its intended purpose.

5.2.5.   To control information and communication where relevant for the safe management of assets (see 4.4. Information and communication), the organisation shall take into account:

(a)	the exchange of relevant information within the organisation or with external entities responsible for maintenance (see 5.3. Contractors, partners and suppliers), in particular on safety-related malfunctions, accidents, incidents as well as on eventual restrictions of use of the asset;

(b)	the traceability of all necessary information including the information related to point (a) (see 4.4. Information and communication and 4.5.3. Control of documented information);

(c)	the establishment and maintenance of records including the management of changes affecting the safety of assets (see 5.4. Management of change).

5.3.   Contractors, partners and suppliers

5.3.1.   The organisation shall identify and control safety risks arising from outsourced activities, including operations or cooperation with contractors, partners and suppliers.

5.3.2.   To control the safety risks referred to in paragraph 5.3.1, the organisation shall define the criteria for the selection of the contractors, partners and suppliers and the contract requirements they have to meet, including:

(a)	the legal and other requirements related to safety (see 1. Context of the organisation);

(b)	the level of competence required to deliver the tasks set out in the contract (see 4.2. Competence);

(c)	the responsibilities for the tasks to be performed;

(d)	the expected safety performance to be maintained during the contract;

(e)	the obligations relating to the exchange of safety-related information (see 4.4. Information and communication);

(f)	the traceability of safety-related documents (see 4.5. Documented information).

5.3.3.   In accordance with the process set out in Article 3 of Regulation (EU) No 1078/2012, the organisation shall monitor:

(a)	the safety performance of all activities and operations of contractors, partners and suppliers to ensure that they comply with the requirements set out in the contract;

(b)	the awareness of contractors, partners and suppliers of safety risks they entail to the organisation's operations.

5.4.   Management of change

5.4.1.   The organisation shall implement and control changes to the safety management system to maintain or improve the safety performance. This shall include decisions at the different stages of the change management and the subsequent review of safety risks (see 3.1.1. Risk assessment).

5.5.   Emergency management

5.5.1.   The organisation shall identify the emergency situations and associated timely measures to be taken to manage them (see 3.1.1. Risk assessment) and to re-establish normal operating conditions in accordance with Regulation (EU) 2015/995 (5).

5.5.2.   The organisation shall ensure that, for each identified type of emergency:

(a)	the emergency services can be promptly contacted;

(b)	the emergency services are provided with all relevant information both in advance, to prepare their emergency response, and at the time of an emergency;

(c)	first aid is provided internally.

5.5.3.   The organisation shall identify and document the roles and responsibilities of all parties in accordance with Regulation (EU) 2015/995.

5.5.4.   The organisation shall have plans for action, alerts and information in case of emergency including arrangements to:

(a)	alert all staff with responsibility for emergency management;

(b)	communicate information to all parties (e.g. infrastructure manager, contractors, authorities, emergency services), including emergency instructions for passengers;

(c)	take any decisions required in accordance with the type of emergency.

5.5.5.   The organisation shall describe how resources and means for emergency management have been allocated (see 4.1. Resources) and how training requirements have been identified (see 4.2. Competence).

5.5.6.   The emergency arrangements are regularly tested in cooperation with other interested parties and updated when appropriate.

5.5.7.   The organisation shall ensure that competent staff in charge, with adequate language skills, can be contacted easily and without delay by the infrastructure manager and provide the latter with the right level of information.

5.5.8.   The organisation shall have a procedure to contact the entity in charge of maintenance or the railway vehicle keeper in the event of an emergency.

6.   PERFORMANCE EVALUATION

6.1.   Monitoring

6.1.1.   The organisation shall perform monitoring in accordance with Regulation (EU) No 1078/2012:

(a)	to check the correct application and the effectiveness of all the processes and procedures in the safety management system, including the operational, organisational and technical safety measures;

(b)	to check the correct application of the safety management system as a whole, and if it achieves the expected outcomes;

(c)	to investigate whether the safety management system conforms to the requirements in this Regulation;

(d)	to identify, implement and evaluate the effectiveness of the corrective measures (see 7.2. Continual improvement), as appropriate, if any relevant instance of non-compliance to points (a), (b) and (c) is detected.

6.1.2.   The organisation shall regularly monitor at all levels within the organisation the performance of safety-related tasks and intervene if these tasks are not being properly performed.

6.2.   Internal auditing

6.2.1.   The organisation shall conduct internal audits in an independent, impartial and transparent way to collect and analyse information for the purposes of its monitoring activities (see 6.1. Monitoring), including:

(a)	A schedule of planned internal audits which can be revised depending on the results of previous audits and monitoring of performance;

(b)	The identification and selection of competent auditors (see 4.2. Competence);

(c)	The analysis and evaluation of the results of the audits;

(d)	The identification of the need for corrective or improvement measures;

(e)	The verification of the completion and effectiveness of these measures;

(f)	The documentation pertaining to the execution and results of audits;

(g)	The communication of the results of audits to the top management.

6.3.   Management review

6.3.1.   Top management shall regularly review the continuing adequacy and effectiveness of the safety management system including at least consideration of:

(a)	details of progress on addressing outstanding actions from previous management reviews;

(b)	changing internal and external circumstances (see 1. Context of the organisation);

(c)

the organisation's safety performance related to: (i) the achievement of its safety objectives; (ii) the results from its monitoring activities, including the internal audit findings, and internal accident/incident investigations and status of their respective actions; (iii) the relevant outputs from supervisory activities conducted by the national safety authority;

(d)	recommendations for improvement.

6.3.2.   Based on the outputs of its management review, the top management shall take overall responsibility for the planning and implementation of needed changes to the safety management system.

7.   IMPROVEMENT

7.1.   Learning from accidents and incidents

7.1.1.   Accidents and incidents related to the organisation's railway operations shall be:

(a)	reported, logged, investigated and analysed to determine their causes;

(b)	reported to national bodies as appropriate.

7.1.2.   The organisation shall ensure that:

(a)	recommendations from the national safety authority, the national investigating body and industry/internal investigations are evaluated and implemented if appropriate or mandated;

(b)	relevant reports/information from other interested parties such as railway undertakings, infrastructure managers, entities in charge of maintenance and railway vehicle keepers are considered and taken into account.

7.1.3.   The organisation shall use information relating to the investigation to review the risk assessment (see 3.1.1. Risk assessment), to learn with the aim of improving safety and, where applicable, to adopt corrective and/or improvement measures (see 5.4. Management of change).

7.2.   Continual improvement

7.2.1.   The organisation shall continually improve the adequacy and effectiveness of its safety management system, taking into account the framework set out in Regulation (EU) No 1078/2012 and at least the outputs of the following activities:

(a)	monitoring (see 6.1. Monitoring);

(b)	internal auditing (see 6.2. Internal auditing);

(c)	management review (see 6.3. Management review);

(d)	learning from accidents and incidents (see 7.1. Learning from accidents and incidents).

7.2.2.   The organisation shall provide means to motivating staff and other interested parties to be active in improving safety as part of its organisational learning.

7.2.3.   The organisation shall provide a strategy to continually improve its safety culture, relying on the use of expertise and recognised methods to identify behavioural issues affecting the different parts of the safety management system and to put in place measures to address these.

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(1)  Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 (OJ L 121, 3.5.2013, p. 8).

(2)  Commission Regulation (EU) No 1078/2012 of 16 November 2012 on a common safety method for monitoring to be applied by railway undertakings, infrastructure managers after receiving a safety certificate or safety authorisation and by entities in charge of maintenance (OJ L 320, 17.11.2012, p. 8).

(3)  Point 2.1. of the Appendix to Annex I to Directive (EU) 2016/798.

(4)  Point 2.2. of the Appendix to Annex I to Directive (EU) 2016/798.

(5)  Commission Regulation (EU) 2015/995 of 8 June 2015 amending Decision 2012/757/EU concerning the technical specification for interoperability relating to the ‘operation and traffic management’ subsystem of the rail system in the European Union (OJ L 165, 30.6.2015, p. 1).

ANNEX II

Safety management system requirements related to infrastructure managers

1.   CONTEXT OF THE ORGANISATION

1.1.    The organisation shall:

(a)	describe the character and extent of its operations;

(b)	identify the serious risks for safety posed by its railway operations whether they are carried out by the organisation itself, or by contractors, partners or suppliers under its control;

(c)	identify interested parties (e.g. regulatory bodies, authorities, railway undertakings, infrastructure managers, contractors, suppliers, partners), including those parties external to the railway system, that are relevant to the safety management system;

(d)	identify and maintain legal and other requirements related to safety from the interested parties referred to in point (c);

(e)	ensure that the requirements referred to in point (d) are taken into account in developing, implementing and maintaining the safety management system;

(f)	describe the scope of the safety management system, indicating which part of the business is included or not in its scope and taking into account the requirements referred to in point (d).

1.2.    For the purpose of this Annex the following definitions are applied:

(a)

‘character’ in relation to railway operations carried out by infrastructure managers means the characterisation of operation by its scope, including infrastructure design and construction, infrastructure maintenance, traffic planning, traffic management and control, and by the use of the railway infrastructure, including conventional and/or high speed lines, transport of passengers and/or goods;

(b)	‘extent’ in relation to railway operations carried out by infrastructure managers means the extent characterised by the length of railway track and the estimated size of the infrastructure manager in terms of number of employees working in the railway sector.

2.   LEADERSHIP

2.1.   Leadership and commitment

2.1.1.   Top management shall demonstrate leadership and commitment to the development, implementation, maintenance and continual improvement of the safety management system by:

(a)	taking overall accountability and responsibility for safety;

(b)	ensuring commitment to safety by management at different levels within the organisation through their activities and in their relationships with staff and contractors;

(c)	ensuring that the safety policy and safety objectives are established, understood and are compatible with the strategic direction of the organisation;

(d)	ensuring the integration of the safety management system requirements into the organisation's business processes;

(e)	ensuring that the resources needed for the safety management system are available;

(f)	ensuring that the safety management system is effective in controlling the safety risks posed by the organisation;

(g)	encouraging staff to support compliance with the safety management system requirements;

(h)	promoting continual improvement of the safety management system;

(i)	ensuring that safety is considered when identifying and managing the organisation's business risks and explaining how conflict between safety and other business goals will be recognised and resolved;

(j)	promoting a positive safety culture.

2.2.   Safety policy

2.2.1.   A document describing the organisation's safety policy is established by the top management and is:

(a)	appropriate to the organisation's character and extent of railway operations;

(b)	approved by the organisation's chief executive (or a representative(s) of the top-management);

(c)	actively implemented, communicated and made available to all staff.

2.2.2.   The safety policy shall:

(a)	include a commitment to conform with all legal and other requirements related to safety;

(b)	provide a framework for setting safety objectives and evaluating the organisation's safety performance against these objectives;

(c)	include a commitment to control safety risks which arise both from its own activities and those caused by others;

(d)	include a commitment to continual improvement of the safety management system;

(e)	be maintained in accordance with the business strategy and the evaluation of the safety performance of the organisation.

2.3.   Organisational roles, responsibilities, accountabilities and authorities

2.3.1.   The responsibilities, accountabilities and authorities of staff having a role that affects safety (including management and other staff involved in safety-related tasks) shall be defined at all levels within the organisation, documented, assigned and communicated to them.

2.3.2.   The organisation shall ensure that staff with delegated responsibilities for safety-related tasks shall have the authority, competence and appropriate resources to perform their tasks without being adversely affected by the activities of other business functions.

2.3.3.   Delegation of responsibility for safety-related tasks shall be documented and communicated to the relevant staff, accepted and understood.

2.3.4.   The organisation shall describe the allocation of roles referred to in paragraph 2.3.1. to business functions within and where relevant, outside the organisation (see 5.3. Contractors, partners and suppliers).

2.4.   Consultation of staff and other parties

2.4.1.   Staff, their representatives and external interested parties, as appropriate and where relevant, shall be consulted in developing, maintaining and improving the safety management system in the relevant parts they are responsible for, including the safety aspects of operational procedures.

2.4.2.   The organisation shall facilitate the consultation of staff by providing the methods and means for involving staff, recording staff's opinion and providing feedback on staff's opinion.

3.   PLANNING

3.1.   Actions to address risks

3.1.1.   Risk assessment

3.1.1.1.   The organisation shall:

(a)

identify and analyse all operational, organisational and technical risks relevant to the character and extent of operations carried out by the organisation. Such risks shall include those arising from human and organisational factors such as workload, job design, fatigue or suitability of procedures, and the activities of other interested parties (see 1. Context of the organisation);

(b)	evaluate the risks referred to in point (a) by applying appropriate risk assessment methods;

(c)	develop and put in place safety measures, with identification of associated responsibilities (see 2.3. Organisational roles, responsibilities, accountabilities and authorities);

(d)	develop a system to monitor the effectiveness of safety measures (see 6.1. Monitoring);

(e)

recognise the need to collaborate with other interested parties (such as railway undertakings, infrastructure managers, manufacturer, maintenance supplier, entity in charge of maintenance, railway vehicle keeper, service provider and procurement entity), where appropriate, on shared risks and the putting in place of adequate safety measures;

(f)	communicate risks to staff and involved external parties (see 4.4. Information and communication).

3.1.1.2.   When assessing risk, an organisation shall take into account the need to determine, provide and sustain a safe working environment which conforms to applicable legislation, in particular Directive 89/391/EEC.

3.1.2.   Planning for change

3.1.2.1.   The organisation shall identify potential safety risks and appropriate safety measures (see 3.1.1. Risk assessment) before the implementation of a change (see 5.4. Management of change) in accordance with the risk management process set out in Regulation (EU) No 402/2013, including consideration of the safety risks from the change process itself.

3.2.   Safety objectives and planning

3.2.1.   The organisation shall establish safety objectives for relevant functions at relevant levels to maintain and, where reasonably practicable, improve its safety performance.

3.2.2.   The safety objectives shall:

(a)	be consistent with the safety policy and the organisation's strategic objectives (where applicable);

(b)	be linked to the priority risks that influence the safety performance of the organisation;

(c)	be measurable;

(d)	take into account applicable legal and other requirements;

(e)	be reviewed as regards their achievements and revised as appropriate;

(f)	be communicated.

3.2.3.   The organisation shall have plan(s) to describe how it will achieve its safety objectives.

3.2.4.   The organisation shall describe the strategy and plan(s) used to monitor the achievement of the safety objectives (see 6.1. Monitoring).

4.   SUPPORT

4.1.   Resources

4.1.1.   The organisation shall provide the resources, including competent staff and effective and useable equipment, needed for the establishment, implementation, maintenance and continual improvement of the safety management system.

4.2.   Competence

4.2.1.   The organisation's competence management system shall ensure that staff having a role that affects safety are competent in the safety-related tasks for which they are responsible (see 2.3. Organisational roles, responsibilities, accountabilities and authorities), including at least:

(a)	identification of the competencies (including knowledge, skills, non-technical behaviours and attitudes) required for safety-related tasks;

(b)	selection principles (basic educational level, psychological and physical fitness required);

(c)	initial training, experience and qualification;

(d)	ongoing training and periodic update of existing competencies;

(e)	periodic assessment of competence and checks of psychological and physical fitness to ensure that qualifications and skills are maintained over time;

(f)	specific training in relevant parts of the safety management system in order to deliver their safety-related tasks.

4.2.2.   The organisation shall provide a training programme, as referred to in points (c), (d) and (f) of paragraph 4.2.1, for staff performing safety-related tasks which ensures that:

(a)	the training programme is delivered according to the identified competency requirements and individual needs of the staff;

(b)	where applicable, the training ensures that staff can operate under all operating conditions (normal, degraded and emergency);

(c)	the duration of the training and the frequency of the refresher training are appropriate for the training objectives;

(d)	records are kept for all staff (see 4.5.3. Control of documented information);

(e)	the training programme is regularly reviewed and audited (see 6.2. Internal auditing) and changes made when necessary (see 5.4. Management of change).

4.2.3.   Back to work arrangements shall be in place for staff following accidents/incidents or long absences from work, including providing additional training where such a need is identified.

4.3.   Awareness

4.3.1.   Top management shall ensure that they and their staff having a role that affects safety are aware of the relevance, importance and consequences of their activities and how they contribute to the correct application and the effectiveness of the safety management system, including the achievement of safety objectives (see 3.2. Safety objectives and planning).

4.4.   Information and communication

4.4.1.   The organisation shall define adequate communication channels to ensure that safety-related information is exchanged among the different levels of the organisation and with external interested parties including contractors, partners and suppliers.

4.4.2.   To ensure that safety-related information reaches those making judgements and decisions, the organisation shall manage the identification, receipt, processing, generation and dissemination of safety-related information.

4.4.3.   The organisation shall ensure that safety-related information is:

(a)	relevant, complete and understandable for the intended users;

(b)

valid;

(c)

accurate;

(d)	consistent;

(e)	controlled (see 4.5.3. Control of documented information);

(f)	communicated before it takes effect;

(g)	received and understood.

4.5.   Documented information

4.5.1.   Safety management system documentation

4.5.1.1.   There is a description of the safety management system including:

(a)	the identification and description of the processes and activities related to safety of rail operations, including safety-related tasks and associated responsibilities (see 2.3. Organisational roles, responsibilities, accountabilities and authorities);

(b)	the interaction of these processes;

(c)	the procedures or other documents describing how these processes are implemented;

(d)	the identification of contractors, partners and suppliers with a description of the type and extent of services delivered;

(e)	the identification of contractual arrangements and other business agreements, concluded between the organisation and other parties identified under (d), necessary to control the safety risks of the organisation and those related to the use of contractors;

(f)	reference to documented information required by this Regulation.

4.5.1.2.   The organisation shall ensure that an annual safety report is submitted to the relevant national safety authority (or authorities) in accordance with Article 9(6) of Directive (EU) 2016/798, including:

(a)	a synthesis of the decisions on the level of significance of the safety-related changes, including an overview of significant changes, in accordance with Article 18(1) of Regulation (EU) No 402/2013;

(b)	the organisation's safety objectives for the following year(s) and how serious risks for safety influence the setting of these safety objectives;

(c)	the results of internal accident/incident investigation (see 7.1. Learning from accidents and incidents) and other monitoring activities (see 6.1. Monitoring, 6.2. Internal auditing and 6.3. Management review), in accordance with Article 5(1) of Regulation (EU) No 1078/2012;

(d)	details of progress on addressing outstanding recommendations from the national investigation bodies (see 7.1. Learning from accidents and incidents);

(e)	the organisation's safety indicators set out to evaluate the organisation's safety performance (see 6.1. Monitoring);

(f)	where applicable, the conclusions of the annual report of the safety advisor, as referred to in RID (1), on the activities of the organisation relating to the transport of dangerous goods (2).

4.5.2.   Creating and updating

4.5.2.1.   The organisation shall ensure that when creating and updating documented information related to the safety management system adequate formats and media are used.

4.5.3.   Control of documented information

4.5.3.1.   The organisation shall control documented information related to the safety management system, in particular its storage, distribution and the control of changes, to ensure its availability, suitability and protection where appropriate.

4.6.   Integration of human and organisational factors

4.6.1.   The organisation shall demonstrate a systematic approach to integrating human and organisational factors within the safety management system. This approach shall:

(a)	include the development of a strategy and the use of expertise and recognised methods from the field of human and organisational factors;

(b)	address risks associated with the design and use of equipment, tasks, working conditions and organisational arrangements, taking into account human capabilities as well as limitations, and the influences on human performance.

5.   OPERATION

5.1.   Operational planning and control

5.1.1.   When planning, developing, implementing and reviewing its operational processes, the organisation shall ensure that during operation:

(a)	risk acceptance criteria and safety measures are applied (see 3.1.1. Risk assessment);

(b)	plan(s) to achieve the safety objectives are delivered (see 3.2. Safety objectives and planning);

(c)	information is collected to measure the correct application and effectiveness of the operational arrangements (see 6.1. Monitoring).

5.1.2.   The organisation shall ensure that its operational arrangements conform to the safety-related requirements of applicable Technical Specifications for Interoperability and relevant national rules and any other relevant requirements (see 1. Context of the organisation).

5.1.3.   To control risks where relevant for the safety of operational activities (see 3.1.1. Risk assessment), at least the following shall be taken into account:

(a)	identification of the safe boundaries of transport for traffic planning and control based on the design characteristics of the infrastructure;

(b)	traffic planning, including timetable and train path allocation;

(c)	real-time traffic management in normal mode and in degraded modes with the application of traffic restrictions of use and the management of traffic disruptions;

(d)	setting of conditions for running exceptional consignments.

5.1.4.   To control the allocation of responsibilities where relevant for the safety of operational activities, the organisation shall identify responsibilities for planning and operating the rail network and define how relevant tasks affecting the safe delivery of all services are allocated to competent staff within the organisation (see 2.3. Organisational roles, responsibilities, accountabilities and authorities) and to other external qualified parties when appropriate (see 5.3. Contractors, partners and suppliers).

5.1.5.   To control information and communication where relevant for the safety of operational activities (see 4.4. Information and communication), relevant staff (e.g. signallers) shall be informed about specific routing requirements for trains and movements of vehicles including relevant changes which may result in a hazard, temporary or permanent operational restrictions (e.g. due to track maintenance) and conditions for exceptional consignments where applicable.

5.1.6.   To control competence where relevant for the safety of operational activities (see 4.2. Competence), the organisation shall ensure, in accordance with applicable legislation (see 1. Context of the organisation), for its staff:

(a)	compliance with their training and work instructions, and corrective actions are taken where required;

(b)	specific training in case of anticipated changes affecting the running of operations or their task assignment;

(c)	adoption of adequate measures following accidents and incidents.

5.2.   Asset management

5.2.1.   The organisation shall manage the safety risks associated with physical assets throughout their lifecycle (see 3.1.1. Risk assessment), from design to disposal, and fulfil the human factors requirements in all phases of the life cycle.

5.2.2.   The organisation shall:

(a)	ensure that the assets are used for the purpose intended while maintaining their safe operational state and their expected level of performance;

(b)	manage the assets in normal and degraded operations;

(c)	detect as soon as reasonably practicable instances of non-compliance with operating requirements before or during the operation of the asset, including the application of restrictions of use as appropriate to ensure a safe operational state of the asset (see 6.1. Monitoring).

5.2.3.   The organisation shall ensure that its asset management arrangements, where applicable, conform to all essential requirements as set out in the relevant Technical Specifications for Interoperability and any other relevant requirements (see 1. Context of the organisation).

5.2.4.   To control risks where relevant for the supply of maintenance (see 3.1.1. Risk assessment), at least the following shall be taken into account:

(a)	the identification of the need for maintenance to keep the infrastructure in a safe operational state, based on the planned and real use of the infrastructure and its design characteristics;

(b)	the management of the removal of the asset from operation for maintenance, when defects have been identified or when asset condition degrades outside the limits of a safe operational state as referred to in point (a);

(c)	the management of the return to operation of the asset with eventual restrictions of use after maintenance has been delivered to ensure it is in a safe operational state;

(d)	the management of monitoring and measurement equipment to ensure that it is fit for its intended purpose.

5.2.5.   To control information and communication where relevant for the safe management of assets (see 4.4. Information and communication), the organisation shall take into account:

(a)	the exchange of relevant information within the organisation or with external entities responsible for maintenance (see 5.3. Contractors, partners and suppliers), in particular on safety-related malfunctions, accidents, incidents as well as on eventual restrictions of use of the asset;

(b)	the traceability of all necessary information including the information related to point (a) (see 4.4. Information and communication and 4.5.3. Control of documented information);

(c)	the establishment and maintenance of records including the management of changes affecting the safety of assets (see 5.4. Management of change).

5.3.   Contractors, partners and suppliers

5.3.1.   The organisation shall identify and control safety risks arising from outsourced activities, including operations or cooperation with contractors, partners and suppliers.

5.3.2.   To control the safety risks referred to in paragraph 5.3.1, the organisation shall define the criteria for the selection of the contractors, partners and suppliers and the contract requirements they have to meet, including:

(a)	the legal and other requirements related to safety (see 1. Context of the organisation);

(b)	the level of competence required to deliver the tasks set out in the contract (see 4.2. Competence);

(c)	the responsibilities for the tasks to be performed;

(d)	the expected safety performance to be maintained during the contract;

(e)	the obligations relating to the exchange of safety-related information (see 4.4. Information and communication);

(f)	the traceability of safety-related documents (see 4.5. Documented information).

5.3.3.   In accordance with the process set out in Article 3 of Regulation (EU) No 1078/2012, the organisation shall monitor:

(a)	the safety performance of all activities and operations of contractors, partners and suppliers to ensure that they comply with the requirements set out in the contract;

(b)	the awareness of contractors, partners and suppliers of safety risks they entail to the organisation's operations.

5.4.   Management of change

5.4.1.   The organisation shall implement and control changes to the safety management system to maintain or improve the safety performance. This shall include decisions at the different stages of the change management and the subsequent review of safety risks (see 3.1.1. Risk assessment).

5.5.   Emergency management

5.5.1.   The organisation shall identify the emergency situations and associated timely measures to be taken to manage them (see 3.1.1. Risk assessment) and to re-establish normal operating conditions in accordance with Regulation (EU) 2015/995.

5.5.2.   The organisation shall ensure that, for each identified type of emergency:

(a)	the emergency services can be promptly contacted;

(b)	the emergency services are provided with all relevant information both in advance, to prepare their emergency response, and at the time of an emergency;

(c)	first aid is provided internally.

5.5.3.   The organisation shall identify and document the roles and responsibilities of all parties in accordance with Regulation (EU) 2015/995.

5.5.4.   The organisation shall have plans for action, alerts and information in case of emergency, including arrangements to:

(a)	alert all staff with responsibility for emergency management;

(b)	communicate information to all parties (e.g. railway undertakings, contractors, authorities, emergency services), including emergency instructions for passengers;

(c)	take any decisions required in accordance with the type of emergency.

5.5.5.   The organisation shall describe how resources and means for emergency management have been allocated (see 4.1. Resources) and how training requirements have been identified (see 4.2. Competence).

5.5.6.   The emergency arrangements are regularly tested in cooperation with other interested parties and updated when appropriate.

5.5.7.   The organisation shall coordinate emergency plans with all railway undertakings that operate on the organisation's infrastructure, with the emergency services, so as to facilitate their rapid intervention, and with any other party that could be involved in an emergency situation.

5.5.8.   The organisation shall have arrangements to halt operations and railway traffic promptly, if necessary, and to inform all interested parties of the action taken.

5.5.9.   For cross-border infrastructure, the cooperation between the relevant infrastructure managers shall facilitate the necessary coordination and preparedness of the competent emergency services on both sides of the border.

6.   PERFORMANCE EVALUATION

6.1.   Monitoring

6.1.1.   The organisation shall perform monitoring in accordance with Regulation (EU) No 1078/2012:

(a)	to check the correct application and the effectiveness of all the processes and procedures in the safety management system, including the operational, organisational and technical safety measures;

(b)	to check the correct application of the safety management system as a whole, and if it achieves the expected outcomes;

(c)	to investigate whether the safety management system conforms to the requirements in this Regulation;

(d)	to identify, implement and evaluate the effectiveness of the corrective measures (see 7.2. Continual improvement), as appropriate, if any relevant instance of non-compliance to points (a), (b) and (c) is detected.

6.1.2.   The organisation shall regularly monitor at all levels within the organisation the performance of safety-related tasks and intervene if these tasks are not being properly performed.

6.2.   Internal auditing

6.2.1.   The organisation shall conduct internal audits in an independent, impartial and transparent way to collect and analyse information for the purposes of its monitoring activities (see 6.1. Monitoring), including:

(a)	A schedule of planned internal audits which can be revised depending on the results of previous audits and monitoring of performance;

(b)	The identification and selection of competent auditors (see 4.2. Competence);

(c)	The analysis and evaluation of the results of the audits;

(d)	The identification of the need for corrective or improvement measures;

(e)	The verification of the completion and effectiveness of these measures;

(f)	The documentation pertaining to the execution and results of audits;

(g)	The communication of the results of audits to the top management.

6.3.   Management review

6.3.1.   Top management shall regularly review the continuing adequacy and effectiveness of the safety management system including at least consideration of:

(a)	details of progress on addressing outstanding actions from previous management reviews;

(b)	changing internal and external circumstances (see 1. Context of the organisation);

(c)

the organisation's safety performance related to: (i) the achievement of its safety objectives; (ii) the results from its monitoring activities, including the internal audit findings, and internal accident/incident investigations and status of their respective actions; (iii) the relevant outputs from supervisory activities conducted by the national safety authority;

(d)	recommendations for improvement.

6.3.2.   Based on the outputs of its management review, the top management shall take overall responsibility for the planning and implementation of needed changes to the safety management system.

7.   IMPROVEMENT

7.1.   Learning from accidents and incidents

7.1.1.   Accidents and incidents related to the organisation's railway operations shall be:

(a)	reported, logged, investigated and analysed to determine their causes;

(b)	reported to national bodies as appropriate.

7.1.2.   The organisation shall ensure that:

(a)	recommendations from the national safety authority, the national investigating body and industry/internal investigations are evaluated and implemented if appropriate or mandated;

(b)	relevant reports/information from other interested parties such as railway undertakings, infrastructure managers, entities in charge of maintenance and railway vehicle keepers are considered and taken into account.

7.1.3.   The organisation shall use information relating to the investigation to review the risk assessment (see 3.1.1. Risk assessment), to learn with the aim of improving safety and, where applicable, to adopt corrective and/or improvement measures (see 5.4. Management of change).

7.2.   Continual improvement

7.2.1.   The organisation shall continually improve the adequacy and effectiveness of its safety management system, taking into account the framework set out in Regulation (EU) No 1078/2012 and at least the outputs of the following activities:

(a)	monitoring (see 6.1. Monitoring);

(b)	internal auditing (see 6.2. Internal auditing);

(c)	management review (see 6.3. Management review);

(d)	learning from accidents and incidents (see 7.1. Learning from accidents and incidents).

7.2.2.   The organisation shall provide means to motivating staff and other interested parties to be active in improving safety as part of its organisational learning.

7.2.3.   The organisation shall provide a strategy to continually improve its safety culture, relying on the use of expertise and recognised methods to identify behavioural issues affecting the different parts of the safety management system and to put in place measures to address these.

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(1)  Point 2.1. of the Appendix to Annex I to Directive (EU) 2016/798.

(2)  Point 2.2. of the Appendix to Annex I to Directive (EU) 2016/798.

ANNEX I

Content of the application for a single safety certificate

Note: all information is mandatory, including the documents annexed to the application, except where indicated with ‘O’ (optional). Where the railway undertaking needs to establish a corrective action plan referred to in point 9, the information about it is mandatory.

1.   Type of application:

1.1.   New

1.2.   Renewal

1.3.   Update

1.4.   EIN of the previous certificate (in case of renewal or update application only)

2.   Type of operation requested (select one or more) (1) :

2.1.   Passenger transport including high-speed services

2.2.   Passenger transport excluding high-speed services

2.3.   Freight transport including dangerous goods services (2)

2.4.   Freight transport excluding dangerous goods services

2.5.   Shunting only

2.6.   Other (specify)

3.   Rail transport operations:

3.1.   Expected date of starting services/operations (O)

3.2.   Member State(s) concerned with the intended area of operation

3.3.   Definition of the intended area of operation (for the concerned networks) (3)

3.4.   Station(s) in neighbouring Member State(s) (in the cases referred to in Article 3(11) of Implementing Regulation (EU) 2018/763 and Article 10(8) of Directive (EU) 2016/798)

4.   Safety certification body:

4.1.   The Agency

4.2.   The national safety authority (in the cases referred to in Article 10(8) of Directive (EU) 2016/798)

5.   Applicant's information:

5.1.   Legal denomination

5.2.   Acronym (O)

5.3.   Complete postal address

5.4.   Phone

5.5.   Fax (O)

5.6.   Email

5.7.   Website (O)

5.8.   National registration number

5.9.   VAT number (O)

5.10.   Other relevant information (O)

6.   Contact person information:

6.1.   First name

6.2.   Surname

6.3.   Title or function

6.4.   Complete postal address

6.5.   Phone

6.6.   Fax (O)

6.7.   Email

6.8.   Language or languages spoken

Documents annexed to the application

7.   Documents submitted for the safety management system part of the assessment:

7.1.   Description of the safety management system and other documents demonstrating compliance with the requirements set out in point (a) of Article 10(3) of Directive (EU) 2016/798 and showing how those requirements are met.

7.2.   Information cross-referencing the safety management system (see point 7.1) against Annex I to Delegated Regulation (EU) 2018/762, including an indication where in the safety management system documentation the relevant requirements of the applicable technical specification for interoperability relating to the operation and traffic management subsystem are met.

8.   Documents submitted for the national part (for each Member State covered by the intended area of operation) of the assessment:

8.1.   Description or other demonstration of how the safety management arrangements address the relevant national rules notified in accordance with Article 8 of Directive (EU) 2016/798.

8.2.   Information cross-referencing the safety management system (see point 7.1) against the requirements laid down in the relevant national rules (see point 8.1).

9.   Corrective action plan(s)

9.1.   The current status of the action plan or plans established by the railway undertaking to resolve any major non-compliance and any other area of concern identified during supervision activities since the previous assessment.

9.2.   The current status of the action plan or plans established by the railway undertaking to resolve residual concerns from the previous assessment.

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(1)  For each Member State concerned with the intended area of operation.

(2)   ‘Dangerous goods’ means substances and articles whose carriage is authorised only under the conditions prescribed in Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13).

(3)  For each Member State concerned with the intended area of operation.

ANNEX II

Safety assessment process

1.   GENERAL

1.1.   The safety certification body and the national safety authorities concerned with the intended area of operation shall develop a structured and auditable process for the complete activity which takes into account the elements set out in this Annex. The safety assessment process shall be iterative, as shown in the diagram below (see Figure 1 in the Appendix), that is the safety certification body and the national safety authorities concerned with the intended area of operation shall be entitled to make reasonable requests for further information or re-submission in accordance with this Regulation.

2.   RECEIPT OF APPLICATION

2.1.   After receiving the application for a single safety certificate, the safety certification body shall formally and promptly acknowledge receipt of the application.

2.2.   The safety certification body and the national safety authorities concerned with the intended area of operation shall assign competent resources to deliver the assessment process.

3.   INITIAL SCREEN

3.1.   The safety certification body in coordination with the national safety authorities concerned with the intended area of operation shall undertake promptly on receipt of the application an initial screen to check the following elements:

(a)	the applicant has provided the basic information which is either required by the legislation or needed for it to be processed effectively;

(b)

the application file contains sufficient evidence and is structured and internally cross-referenced so that it can be properly assessed against the safety management system requirements and relevant notified national rules. The safety certification body in coordination with the national safety authorities concerned with the intended area of operation shall conduct an initial review of the actual content of the evidence contained in the application to make an initial judgement on the quality, sufficiency and appropriateness of the safety management system;

(c)	if applicable, the current status of the action plan (or plans) established by the railway undertaking to resolve any major non-compliance and any other area of concern identified during supervision activities since the previous assessment is included;

(d)	if applicable, the current status of the action plan (or plans) established by the railway undertaking to resolve residual concerns from previous assessment is included.

3.2.   The national safety authorities concerned with the intended area of operation shall also check that the evidence for the type, extent and intended area of operation is clearly identified.

3.3.   Following the checks referred to in points 3.1 and 3.2, the safety certification body and the national safety authorities concerned with the intended area of operation shall decide if there are any areas in which, for their respective part, further information is necessary. Where further information is necessary, the safety certification body and the national safety authorities concerned with the intended area of operation may promptly seek the information, to the extent that they deem reasonably necessary to support their assessment.

3.4.   The safety certification body and the national safety authorities concerned with the intended area of operation shall read a sufficient sample of the application, each for their own part, to check that its content is understandable. If it is clearly not, the safety certification body and the national safety authorities concerned with the intended area of operation shall decide, each for their own part, whether it needs to be returned, with a request for an improved version.

4.   DETAILED ASSESSMENT

4.1.   After the completion of the initial screen stage, the safety certification body and the national safety authorities concerned with the intended area of operation shall proceed, each for their own part, to the detailed assessment of the application file (see Figure 2 in the Appendix), using the safety management system requirements and relevant notified national rules.

4.2.   In undertaking the detailed assessment referred to in point 4.1, in accordance with Article 18(1) of Directive (EU) 2016/798, the safety certification body and the national safety authorities concerned with the intended area of operation shall exercise professional judgment, be impartial and proportionate, and provide documented reasons for conclusions reached.

4.3.   The assessment shall determine whether the safety management system requirements and relevant notified national rules are met or whether further information shall be requested. During the assessment, the safety certification body and the national safety authorities concerned with the intended area of operation shall also seek evidence that the safety management system requirements and relevant notified national rules have been met from the outputs of the safety management system processes, using sampling methods where appropriate, to ensure that the applicant has understood and can meet the requirements according to the type and extent of the railway operations and the intended area of operation in order to ensure safe operation of the railway.

4.4.   Any type 4 issue shall be resolved to the satisfaction of the safety certification body and lead to an update of the application file where appropriate before the single safety certificate can be issued.

4.5.   Residual concerns may be deferred for consideration to supervision, or actions may be agreed upon with the applicant, based on its proposal for updating the application file, or both. In such a case formal resolution of the issue shall take place after the issue of the single safety certificate.

4.6.   The safety certification body and the national safety authorities concerned with the intended area of operation shall be transparent on how they judge the severity of each identified issue referred to in Article 12(1).

4.7.   When identifying an issue referred to in Article 12(1), the safety certification body and the national safety authorities concerned with the intended area of operation shall be specific and help the applicant understand the level of detail expected in the response. To that end, the safety certification body and the national safety authorities concerned with the intended area of operation shall take the following steps:

(a)	refer accurately to the relevant safety management system requirements and notified national rules and help the applicant to understand the identified issues;

(b)	identify the relevant part of related regulations and rules;

(c)	state why the individual safety management system requirement or notified national rule, including any related legislation, is not met;

(d)	agree with the applicant on further commitments, documents and any other supporting information to be provided, as required by the level of detail of the safety management system requirement or the notified national rule;

(e)	specify and agree with the applicant on a timeframe for compliance, reasonable and proportionate to the difficulty of providing the information requested.

4.8.   If the applicant significantly delays providing the requested information, the safety certification body may decide to extend the timeframe for the applicant's response or to reject the application after notice.

4.9.   The timeframe for taking the decision on the issuing of the single safety certificate may only be extended, until the requested information has been submitted, upon decision of the safety certification body in coordination with the national safety authorities concerned with the intended area of operation and with the agreement of the applicant in one of the following cases:

(a)	type 1 issues referred to in Article 12(1) that, considered individually or collectively, prevent the assessment or parts of it from continuing;

(b)	type 4 issues or multiple type 3 issues referred to in Article 12(1) that, considered collectively, may raise the category to a type 4 issue, preventing the issuing of the single safety certificate.

4.10.   To be satisfactory, the applicant's written responses shall be sufficient to allay the concerns expressed and to demonstrate that its proposed arrangements will meet the relevant criteria or notified national rules.

4.11.   Where a response is considered unsatisfactory, it shall be explained precisely why, identifying the further information or demonstration required of the applicant to make it satisfactory.

4.12.   If concerns emerge that the application could be rejected, or that it will take a longer time to reach a decision than the timeframe allowed for the assessment, the safety certification body may consider possible contingency measures.

4.13.   When it is concluded that either the application meets all requirements or that further progress is unlikely in securing satisfactory responses to outstanding matters, the safety certification body and the national safety authorities concerned with the intended area of operation shall, each for their own part, complete the assessment by the following steps:

(a)	stating whether all criteria have been met or whether there are still matters outstanding;

(b)	identifying any residual concern;

(c)	identifying any restriction or condition of use to be included in the single safety certificate;

(d)	reporting on the follow-up of major non-compliances identified during supervision activities, as referred to in Article 5 of Delegated Regulation (EU) 2018/761, where appropriate;

(e)	ensuring that the safety assessment process has been correctly applied;

(f)	compiling the outcome of the assessment, including summary conclusions and where appropriate, an opinion concerning the issuing of the single safety certificate.

4.14.   The safety certification body and the national safety authorities concerned with the intended area of operation shall record and justify in writing all findings and judgments in order to facilitate both the assurance process and the decision-making process, as well as to assist with any appeal against the decision to issue or not the single safety certificate.

5.   DECISION-MAKING

5.1.   Based on the conclusions of the completed assessment, a decision shall be made on whether to issue a single safety certificate or to reject the application. Where a single safety certificate is to be issued, some residual concerns may be identified. A single safety certificate shall not be issued where any type 4 issue referred to in Article 12(1) is identified and not resolved during the assessment.

5.2.   The safety certification body may decide to restrict the scope of the single safety certificate, by identifying restrictions or conditions of use, if it is concluded in coordination with the national safety authorities concerned with the intended area of operation that such restrictions or conditions of use address any type 4 issue that would prevent the issue of the single safety certificate. The single safety certificate shall be updated on request of the applicant after all residual concerns have been addressed in its application file.

5.3.   The applicant shall be informed about the decision of the safety certification body, including the outcome of the assessment, and a single safety certificate shall be issued as appropriate.

5.4.   If the issuing of the single safety certificate is refused or if the single safety certificate contains restrictions or conditions of use other than those defined in the application, the safety certification body shall inform the applicant, giving the reasons for the decision, and notify it of the procedure to request a review of or to appeal against the decision.

6.   CLOSING ASSESSMENT

6.1.   The safety certification body shall complete the administrative closure by ensuring that all documents and records are reviewed, organised and archived. To continually improve its process, the safety certification body shall identify historic information and lessons learned for use by future assessments.

7.   SPECIFIC PROVISIONS FOR THE RENEWAL OF A SINGLE SAFETY CERTIFICATE

7.1.   A single safety certificate may be renewed upon request of the applicant before the expiry of its validity to ensure continuity of certification.

7.2.   In the case of a renewal application, the safety certification body and the national safety authorities concerned with the intended area of operation shall check details of changes to the evidence submitted in the previous application and consider the results of past supervision activities as referred to in Article 5 of Delegated Regulation (EU) 2018/761 to prioritise or target the relevant safety management system requirements and notified national rules upon which to assess the renewal application.

7.3.   The safety certification body and the national safety authorities concerned with the intended area of operation shall take a proportionate approach to re-assessment, based on the degree of changes proposed.

8.   SPECIFIC PROVISIONS FOR THE UPDATE OF A SINGLE SAFETY CERTIFICATE

8.1.   A single safety certificate shall be updated whenever there is a substantial change proposed to the type or extent of operation in accordance with Article 10(13) of Directive (EU) 2016/798, or in case of extension of the area of operation in accordance with Article 10(14) of that Directive.

8.2.   Where it intends to make any change referred to in point 8.1, the railway undertaking holding the single safety certificate shall notify the safety certification body without delay.

8.3.   Following the notification by the railway undertaking as referred to in point 8.2, the safety certification body shall:

(a)	check that the change relating to any potential application is clearly described and that potential safety risks are assessed;

(b)	discuss with the railway undertaking and the national safety authorities concerned with the intended area of operation the need for an update of the single safety certificate.

8.4.   The safety certification body in coordination with the national safety authorities concerned with the intended area of operation may make further enquiries with the applicant. Where the safety certification body agrees that the proposed change is not substantial, it shall inform the applicant in writing that an update is not required, keeping a record of the decision for the registered file.

8.5.   In the case of an update application, the safety certification body and the national safety authorities concerned with the intended area of operation shall:

(a)	check details of changes to the evidence submitted in the previous application upon which the current certificate was issued;

(b)	consider the results of past supervision activities as referred to in Article 5 of Delegated Regulation (EU) 2018/761, and in particular, issues relating to the ability of the applicant to effectively implement and monitor its change management process;

(c)	prioritise or target the relevant safety management system requirements and notified national rules in order to assess the update application.

8.6.   The safety certification body and the national safety authorities concerned with the intended area of operation shall take a proportionate approach to re-assessment, based on the degree of changes proposed.

8.7.   An application to the safety certification body to update a single safety certificate shall not lead to the extension of its validity period.

8.8.   The safety certification body shall decide at the request of the applicant whether the single safety certificate needs to be updated where the conditions under which the single safety certificate was issued are to be changed without any impact on the type, extent or area of operation.

ANNEX III

Content of the single safety certificate

The single safety certificate confirming acceptance of the railway undertaking's safety management system including the provisions adopted by the railway undertaking to meet specific requirements necessary for safe operation on the relevant network in conformity with Directive (EU) 2016/798 and applicable national legislation shall contain the following information:

1.    European Identification Number (EIN) of the single safety certificate

2.   Identification of the railway undertaking:

2.1.   Legal denomination

2.2.   National registration number

2.3.   VAT number

3.   Identification of the safety certification body:

3.1.   Organisation

3.2.   Member State (where applicable)

4.   Certificate information:

4.1.   New

4.2.   Renewal

4.3.   Update

4.4.   EIN of the previous certificate (in case of renewal or update only)

4.5.   Validity start and end dates

4.6.   Type of operation (1)

4.6.1.   Passenger transport including high-speed services

4.6.2.   Passenger transport excluding high-speed services

4.6.3.   Freight transport including dangerous goods services

4.6.4.   Freight transport excluding dangerous goods services

4.6.5.   Shunting only

4.6.6.   Other operations (1)

5.    Applicable national legislation  (1)

6.    Area of operation  (1)

7.    Restrictions and conditions of use

8.    Additional information

9.    Issuing date and authorised signatory/stamp of the authority

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(1)  For each Member State concerned with the intended area of operation.