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Commission Delegated Regulation (EU) 2018/762 of 8 March 2018 establishing common safety methods on safety management system requirements pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council and repealing Commission Regulations (EU) No 1158/2010 and (EU) No 1169/2010 (Text with EEA relevance)
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THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety(1), and in particular Article 6(6) thereof,
Having regard to Recommendation ERA-REC-115-REC from the European Union Agency for Railways delivered to the Commission on 9 March 2017, on the revision of the common safety methods for conformity assessment and the common safety methods for supervision,
Whereas:
(1) The common safety methods (CSMs) describe how the safety levels and the achievement of safety targets and compliance with other safety requirements are assessed.
(2) In accordance with Article 6(5) of Directive (EU) 2016/798, the CSMs are to be revised at regular intervals, taking into account the experience gained from their application and the global development of railway safety and with the objective of generally maintaining and, where reasonably practicable, continuously improving safety.
(3) By its Implementing Decision of 1 September 2016(2), the Commission issued a mandate to the European Union Agency for Railways (the ‘Agency’) in accordance with Article 6(2) of Directive (EU) 2016/798 to revise Commission Regulations (EU) No 1158/2010(3), (EU) No 1169/2010(4) and (EU) No 1077/2012(5). On 9 March 2017, the Agency issued its recommendation, enclosing a report on the results of the consultation of national safety authorities, social partners and users and a report assessing the impact of the amended CSMs to be adopted, to address the mandate of the Commission. The Commission examined the recommendation issued by the Agency to verify that the mandate was fulfilled as referred to in Article 6(4) of Directive (EU) 2016/798.
(4) The purpose of the safety management system is to ensure that the railway undertakings and infrastructure managers achieve their business objectives in a safe manner. The safety management system is often integrated with other management systems to increase the overall performance of the organisation and reduce costs while mutualising the efforts at all levels of the organisation. To this end, the common framework of the ISO High Level Structure(6) is used to functionally cluster the requirements of the safety management system, as referred to in Article 9 of Directive (EU) 2016/798. This framework also facilitates the understanding and application of a process approach by the railway undertakings and infrastructure managers when developing, implementing, maintaining and continually improving their safety management system.
(5) Once issued with a single safety certificate or with a safety authorisation, the applicant should continue to use its safety management system as referred to in Article 9 of Directive (EU) 2016/798.
(6) The human behaviour plays a central role in the safe and efficient operation of the railway. Where that behaviour is considered to have contributed to an accident or incident, it may be that organisational factors, such as workload or job design, had an influence on that behaviour, and thus led to a lesser performance and aggravation of the consequences of that accident or incident. Therefore, it is essential that the railway undertakings and infrastructure managers take a systematic approach to supporting human performance and managing human and organisational factors within the safety management system.
(7) The way safety is perceived, valued and prioritised in an organisation reflects the real commitment to safety at all levels in the organisation. Therefore, it is also important for railway undertakings and infrastructure managers to identify the actions and behaviours that can shape a positive safety culture and to promote through their safety management system this culture of mutual trust, confidence and learning in which staff are encouraged to contribute to the development of safety by reporting dangerous occurrences and providing safety-related information.
(8) The safety management system should take into account the fact that Council Directive 89/391/EEC(7) and its relevant individual directives are fully applicable to the protection of the health and safety of workers engaged in railway construction, operation and maintenance. It does not create any additional responsibilities or tasks for the issuing authority other than to check if health and safety risks have been taken into account by the applicant for a single safety certificate or for a safety authorisation. Responsibility for checking the compliance with Directive 89/391/EEC may still be allocated on other competent authorities appointed by the Member States.
(9) The safety management system should where relevant take into consideration the potential additional risks generated by transporting dangerous goods by rail and thereby, should also take account of Directive 2008/68/EC of the European Parliament and of the Council(8).
(10) Regulations (EU) No 1158/2010 and (EU) No 1169/2010 will become obsolete and should therefore be replaced by this Regulation.
(11) As regards safety certificates, it follows from Article 10(15) of Directive (EU) 2016/798 that the national safety authority may require that the safety certificates be revised following substantial changes to the safety regulatory framework. The changes brought about by Article 9 of Directive (EU) 2016/798 and by this Regulation, even though relevant and important, are not substantial. Therefore, Regulation (EU) No 1158/2010 should apply to safety certificates issued in accordance with Directive 2004/49/EC of the European Parliament and of the Council(9), until their expiry date. For the same reason, it is also necessary to postpone the repeal of Regulation (EU) No 1158/2010 until the end of the last day of the period during which it may still be applied by national safety authorities for the purposes of supervision. Moreover, in accordance with Directive (EU) 2016/798, existing safety certificates continue to be subject to Directive 2004/49/EC, on which Regulation (EU) No 1158/2010 was based.
(12) As regards safety authorisations, it follows from Article 12(2), second subparagraph of Directive (EU) 2016/798 that the national safety authority may require that the safety authorisations be revised following substantial changes to the safety regulatory framework. The changes brought about by Article 9 of Directive 2016/798/EC and by this Regulation, even though relevant and important, are not substantial. Therefore, Regulation (EU) No 1169/2010 should apply to safety authorisations issued in accordance with Directive 2004/49/EC, until their expiry date. For the same reason, it is also necessary to postpone the repeal of Regulation (EU) No 1169/2010 until the end of the last day of the period during which it may still be applied by national safety authorities for the purposes of supervision,
HAS ADOPTED THIS REGULATION:
1.This Regulation establishes common safety methods (‘CSMs’) on safety management system requirements related to railway undertakings and infrastructure managers, as referred to in point (f) of Article 6(1) of Directive (EU) 2016/798.
2.This Regulation shall apply in respect of single safety certificates and safety authorisations issued pursuant to Directive (EU) 2016/798.
For the purposes of this Regulation, ‘safety certification body’ means the body responsible for issuing a single safety certificate, either the Agency or a national safety authority.
Railway undertakings shall establish their safety management systems in accordance with the requirements set out in Annex I.
Those safety management system requirements shall apply to the single safety certificates referred to in Article 10 of Directive (EU) 2016/798, for the purposes of the assessment of applications and of supervision.
Infrastructure managers shall establish their safety management systems in accordance with the requirements set out in Annex II.
Those safety management system requirements shall apply to the safety authorisations referred to in Article 12 of Directive (EU) 2016/798, for the purposes of the assessment of applications and of supervision.
Regulations (EU) No 1158/2010 and (EU) No 1169/2010 are repealed with effect from 31 October 2025 .]
Textual Amendments
F1 Substituted by Commission Delegated Regulation (EU) 2020/782 of 12 June 2020 amending Delegated Regulations (EU) 2018/761 and (EU) 2018/762 as regards their dates of application following the extension of the transposition deadline of Directive (EU) 2016/798 of the European Parliament and of the Council (Text with EEA relevance).
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
[F1It shall apply from 16 June 2019 in the Member States that have not notified the Agency and the Commission in accordance with Article 33(2) of Directive (EU) 2016/798.
It shall apply from 16 June 2020 in the Member States that have notified the Agency and the Commission in accordance with Article 33(2) of Directive (EU) 2016/798 that they have extended the period for transposition of that Directive and that have not notified the Agency and the Commission in accordance with Article 33(2a) of Directive (EU) 2016/798 that they have further extended that transposition period.
It shall apply in all Member States from 31 October 2020 .]
Textual Amendments
F1 Substituted by Commission Delegated Regulation (EU) 2020/782 of 12 June 2020 amending Delegated Regulations (EU) 2018/761 and (EU) 2018/762 as regards their dates of application following the extension of the transposition deadline of Directive (EU) 2016/798 of the European Parliament and of the Council (Text with EEA relevance).
This Regulation shall be binding in its entirety and directly applicable in all Member States.
describe the type, extent and area of its operations;
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;
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;
identify and maintain legal and other requirements related to safety from the interested parties referred to in point (c);
ensure that the requirements referred to in point (d) are taken into account in developing, implementing and maintaining the safety management system;
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).
taking overall accountability and responsibility for safety;
ensuring commitment to safety by management at different levels within the organisation through their activities and in their relationships with staff and contractors;
ensuring that the safety policy and safety objectives are established, understood and are compatible with the strategic direction of the organisation;
ensuring the integration of the safety management system requirements into the organisation's business processes;
ensuring that the resources needed for the safety management system are available;
ensuring that the safety management system is effective in controlling the safety risks posed by the organisation;
encouraging staff to support compliance with the safety management system requirements;
promoting continual improvement of the safety management system;
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;
promoting a positive safety culture.
appropriate to the organisation's type and extent of railway operations;
approved by the organisation's chief executive (or a representative(s) of the top-management);
actively implemented, communicated and made available to all staff.
include a commitment to conform with all legal and other requirements related to safety;
provide a framework for setting safety objectives and evaluating the organisation's safety performance against these objectives;
include a commitment to control safety risks which arise both from its own activities and those caused by others;
include a commitment to continual improvement of the safety management system;
be maintained in accordance with the business strategy and the evaluation of the safety performance of the organisation.
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);
evaluate the risks referred to in point (a) by applying appropriate risk assessment methods;
develop and put in place safety measures, with identification of associated responsibilities (see 2.3. Organisational roles, responsibilities, accountabilities and authorities);
develop a system to monitor the effectiveness of safety measures (see 6.1. Monitoring);
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;
communicate risks to staff and involved external parties (see 4.4. Information and communication).
be consistent with the safety policy and the organisation's strategic objectives (where applicable);
be linked to the priority risks that influence the safety performance of the organisation;
be measurable;
take into account applicable legal and other requirements;
be reviewed as regards their achievements and revised as appropriate;
be communicated.
identification of the competencies (including knowledge, skills, non-technical behaviours and attitudes) required for safety-related tasks;
selection principles (basic educational level, psychological and physical fitness required);
initial training, experience and qualification;
ongoing training and periodic update of existing competencies;
periodic assessment of competence and checks of psychological and physical fitness to ensure that qualifications and skills are maintained over time;
specific training in relevant parts of the safety management system in order to deliver their safety-related tasks.
the training programme is delivered according to the identified competency requirements and individual needs of the staff;
where applicable, the training ensures that staff can operate under all operating conditions (normal, degraded and emergency);
the duration of the training and the frequency of the refresher training are appropriate for the training objectives;
records are kept for all staff (see 4.5.3. Control of documented information);
the training programme is regularly reviewed and audited (see 6.2. Internal auditing) and changes made when necessary (see 5.4. Management of change).
relevant, complete and understandable for the intended users;
valid;
accurate;
consistent;
controlled (see 4.5.3. Control of documented information);
communicated before it takes effect;
received and understood.
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);
the interaction of these processes;
the procedures or other documents describing how these processes are implemented;
the identification of contractors, partners and suppliers with a description of the type and extent of services delivered;
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;
reference to documented information required by this Regulation.
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;
the organisation's safety objectives for the following year(s) and how serious risks for safety influence the setting of these safety objectives;
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(11);
details of progress on addressing outstanding recommendations from the national investigation bodies (see 7.1. Learning from accidents and incidents);
the organisation's safety indicators set out to evaluate the organisation's safety performance (see 6.1. Monitoring);
include the development of a strategy and the use of expertise and recognised methods from the field of human and organisational factors;
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.
risk acceptance criteria and safety measures are applied (see 3.1.1. Risk assessment);
plan(s) to achieve the safety objectives are delivered (see 3.2. Safety objectives and planning);
information is collected to measure the correct application and effectiveness of the operational arrangements (see 6.1. Monitoring).
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;
development and implementation of train timetables;
preparation of trains or vehicles before movement, including pre-departure checks and train composition;
running trains or movement of vehicles in the different operating conditions (normal, degraded and emergency);
adaptation of the operation to requests for removal from operation and notification of return to operation issued by entities in charge of maintenance;
authorisations for movements of vehicles;
usability of interfaces in train driving cabs and train control centres and with equipment used by maintenance staff.
compliance with their training and work instructions, and corrective actions are taken where required;
specific training in case of anticipated changes affecting the running of operations or their task assignment;
adoption of adequate measures following accidents and incidents.
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;
manage the assets in normal and degraded operations;
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).
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;
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);
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;
the management of monitoring and measurement equipment to ensure that it is fit for its intended purpose.
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;
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);
the establishment and maintenance of records including the management of changes affecting the safety of assets (see 5.4. Management of change).
the legal and other requirements related to safety (see 1. Context of the organisation);
the level of competence required to deliver the tasks set out in the contract (see 4.2. Competence);
the responsibilities for the tasks to be performed;
the expected safety performance to be maintained during the contract;
the obligations relating to the exchange of safety-related information (see 4.4. Information and communication);
the traceability of safety-related documents (see 4.5. Documented information).
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;
the awareness of contractors, partners and suppliers of safety risks they entail to the organisation's operations.
the emergency services can be promptly contacted;
the emergency services are provided with all relevant information both in advance, to prepare their emergency response, and at the time of an emergency;
first aid is provided internally.
alert all staff with responsibility for emergency management;
communicate information to all parties (e.g. infrastructure manager, contractors, authorities, emergency services), including emergency instructions for passengers;
take any decisions required in accordance with the type of emergency.
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;
to check the correct application of the safety management system as a whole, and if it achieves the expected outcomes;
to investigate whether the safety management system conforms to the requirements in this Regulation;
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.
A schedule of planned internal audits which can be revised depending on the results of previous audits and monitoring of performance;
The identification and selection of competent auditors (see 4.2. Competence);
The analysis and evaluation of the results of the audits;
The identification of the need for corrective or improvement measures;
The verification of the completion and effectiveness of these measures;
The documentation pertaining to the execution and results of audits;
The communication of the results of audits to the top management.
details of progress on addressing outstanding actions from previous management reviews;
changing internal and external circumstances (see 1. Context of the organisation);
the organisation's safety performance related to:
the achievement of its safety objectives;
the results from its monitoring activities, including the internal audit findings, and internal accident/incident investigations and status of their respective actions;
the relevant outputs from supervisory activities conducted by the national safety authority;
recommendations for improvement.
reported, logged, investigated and analysed to determine their causes;
reported to national bodies as appropriate.
recommendations from the national safety authority, the national investigating body and industry/internal investigations are evaluated and implemented if appropriate or mandated;
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.
monitoring (see 6.1. Monitoring);
internal auditing (see 6.2. Internal auditing);
management review (see 6.3. Management review);
learning from accidents and incidents (see 7.1. Learning from accidents and incidents).
describe the character and extent of its operations;
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;
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;
identify and maintain legal and other requirements related to safety from the interested parties referred to in point (c);
ensure that the requirements referred to in point (d) are taken into account in developing, implementing and maintaining the safety management system;
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).
‘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;
‘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.
taking overall accountability and responsibility for safety;
ensuring commitment to safety by management at different levels within the organisation through their activities and in their relationships with staff and contractors;
ensuring that the safety policy and safety objectives are established, understood and are compatible with the strategic direction of the organisation;
ensuring the integration of the safety management system requirements into the organisation's business processes;
ensuring that the resources needed for the safety management system are available;
ensuring that the safety management system is effective in controlling the safety risks posed by the organisation;
encouraging staff to support compliance with the safety management system requirements;
promoting continual improvement of the safety management system;
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;
promoting a positive safety culture.
appropriate to the organisation's character and extent of railway operations;
approved by the organisation's chief executive (or a representative(s) of the top-management);
actively implemented, communicated and made available to all staff.
include a commitment to conform with all legal and other requirements related to safety;
provide a framework for setting safety objectives and evaluating the organisation's safety performance against these objectives;
include a commitment to control safety risks which arise both from its own activities and those caused by others;
include a commitment to continual improvement of the safety management system;
be maintained in accordance with the business strategy and the evaluation of the safety performance of the organisation.
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);
evaluate the risks referred to in point (a) by applying appropriate risk assessment methods;
develop and put in place safety measures, with identification of associated responsibilities (see 2.3. Organisational roles, responsibilities, accountabilities and authorities);
develop a system to monitor the effectiveness of safety measures (see 6.1. Monitoring);
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;
communicate risks to staff and involved external parties (see 4.4. Information and communication).
be consistent with the safety policy and the organisation's strategic objectives (where applicable);
be linked to the priority risks that influence the safety performance of the organisation;
be measurable;
take into account applicable legal and other requirements;
be reviewed as regards their achievements and revised as appropriate;
be communicated.
identification of the competencies (including knowledge, skills, non-technical behaviours and attitudes) required for safety-related tasks;
selection principles (basic educational level, psychological and physical fitness required);
initial training, experience and qualification;
ongoing training and periodic update of existing competencies;
periodic assessment of competence and checks of psychological and physical fitness to ensure that qualifications and skills are maintained over time;
specific training in relevant parts of the safety management system in order to deliver their safety-related tasks.
the training programme is delivered according to the identified competency requirements and individual needs of the staff;
where applicable, the training ensures that staff can operate under all operating conditions (normal, degraded and emergency);
the duration of the training and the frequency of the refresher training are appropriate for the training objectives;
records are kept for all staff (see 4.5.3. Control of documented information);
the training programme is regularly reviewed and audited (see 6.2. Internal auditing) and changes made when necessary (see 5.4. Management of change).
relevant, complete and understandable for the intended users;
valid;
accurate;
consistent;
controlled (see 4.5.3. Control of documented information);
communicated before it takes effect;
received and understood.
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);
the interaction of these processes;
the procedures or other documents describing how these processes are implemented;
the identification of contractors, partners and suppliers with a description of the type and extent of services delivered;
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;
reference to documented information required by this Regulation.
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;
the organisation's safety objectives for the following year(s) and how serious risks for safety influence the setting of these safety objectives;
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;
details of progress on addressing outstanding recommendations from the national investigation bodies (see 7.1. Learning from accidents and incidents);
the organisation's safety indicators set out to evaluate the organisation's safety performance (see 6.1. Monitoring);
include the development of a strategy and the use of expertise and recognised methods from the field of human and organisational factors;
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.
risk acceptance criteria and safety measures are applied (see 3.1.1. Risk assessment);
plan(s) to achieve the safety objectives are delivered (see 3.2. Safety objectives and planning);
information is collected to measure the correct application and effectiveness of the operational arrangements (see 6.1. Monitoring).
identification of the safe boundaries of transport for traffic planning and control based on the design characteristics of the infrastructure;
traffic planning, including timetable and train path allocation;
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;
setting of conditions for running exceptional consignments.
compliance with their training and work instructions, and corrective actions are taken where required;
specific training in case of anticipated changes affecting the running of operations or their task assignment;
adoption of adequate measures following accidents and incidents.
ensure that the assets are used for the purpose intended while maintaining their safe operational state and their expected level of performance;
manage the assets in normal and degraded operations;
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).
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;
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);
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;
the management of monitoring and measurement equipment to ensure that it is fit for its intended purpose.
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;
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);
the establishment and maintenance of records including the management of changes affecting the safety of assets (see 5.4. Management of change).
the legal and other requirements related to safety (see 1. Context of the organisation);
the level of competence required to deliver the tasks set out in the contract (see 4.2. Competence);
the responsibilities for the tasks to be performed;
the expected safety performance to be maintained during the contract;
the obligations relating to the exchange of safety-related information (see 4.4. Information and communication);
the traceability of safety-related documents (see 4.5. Documented information).
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;
the awareness of contractors, partners and suppliers of safety risks they entail to the organisation's operations.
the emergency services can be promptly contacted;
the emergency services are provided with all relevant information both in advance, to prepare their emergency response, and at the time of an emergency;
first aid is provided internally.
alert all staff with responsibility for emergency management;
communicate information to all parties (e.g. railway undertakings, contractors, authorities, emergency services), including emergency instructions for passengers;
take any decisions required in accordance with the type of emergency.
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;
to check the correct application of the safety management system as a whole, and if it achieves the expected outcomes;
to investigate whether the safety management system conforms to the requirements in this Regulation;
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.
A schedule of planned internal audits which can be revised depending on the results of previous audits and monitoring of performance;
The identification and selection of competent auditors (see 4.2. Competence);
The analysis and evaluation of the results of the audits;
The identification of the need for corrective or improvement measures;
The verification of the completion and effectiveness of these measures;
The documentation pertaining to the execution and results of audits;
The communication of the results of audits to the top management.
details of progress on addressing outstanding actions from previous management reviews;
changing internal and external circumstances (see 1. Context of the organisation);
the organisation's safety performance related to:
the achievement of its safety objectives;
the results from its monitoring activities, including the internal audit findings, and internal accident/incident investigations and status of their respective actions;
the relevant outputs from supervisory activities conducted by the national safety authority;
recommendations for improvement.
reported, logged, investigated and analysed to determine their causes;
reported to national bodies as appropriate.
recommendations from the national safety authority, the national investigating body and industry/internal investigations are evaluated and implemented if appropriate or mandated;
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.
monitoring (see 6.1. Monitoring);
internal auditing (see 6.2. Internal auditing);
management review (see 6.3. Management review);
learning from accidents and incidents (see 7.1. Learning from accidents and incidents).
Commission Implementing Decision of 1 September 2016 on a mandate to the European Union Agency for Railways for the revision of the common safety methods for conformity assessment and the common safety method for supervision and repealing Implementing Decision C(2014) 1649 final (C(2016) 5504 final).
Commission Regulation (EU) No 1158/2010 of 9 December 2010 on a common safety method for assessing conformity with the requirements for obtaining railway safety certificates (OJ L 326, 10.12.2010, p. 11).
Commission Regulation (EU) No 1169/2010 of 10 December 2010 on a common safety method for assessing conformity with the requirements for obtaining a railway safety authorisation (OJ L 327, 11.12.2010, p. 13).
Commission Regulation (EU) No 1077/2012 of 16 November 2012 on a common safety method for supervision by national safety authorities after issuing a safety certificate or safety authorisation (OJ L 320, 17.11.2012, p. 3).
ISO/IEC Directives, Part 1, consolidated supplement 2016, Annex SL Appendix 2.
Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).
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).
Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community's railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive) (OJ L 164, 30.4.2004, p. 44).
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).
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).
Point 2.1. of the Appendix to Annex I to Directive (EU) 2016/798.
Point 2.2. of the Appendix to Annex I to Directive (EU) 2016/798.
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).
Point 2.1. of the Appendix to Annex I to Directive (EU) 2016/798.
Point 2.2. of the Appendix to Annex I to Directive (EU) 2016/798.
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