1.CONTEXT OF THE ORGANISATION 1.1.The organisation shall: 2.LEADERSHIP 2.1.Leadership and commitment 2.1.1.Top management shall demonstrate leadership and commitment to the development,...2.2.Safety policy 2.2.1.A document describing the organisation's safety policy is established by...2.2.2.The safety policy shall: 2.3.Organisational roles, responsibilities, accountabilities and authorities 2.3.1.The responsibilities, accountabilities and authorities of staff having a role...2.3.2.The organisation shall ensure that staff with delegated responsibilities for...2.3.3.Delegation of responsibility for safety-related tasks shall be documented and...2.3.4.The organisation shall describe the allocation of roles referred to...2.4.Consultation of staff and other parties 2.4.1.Staff, their representatives and external interested parties, as appropriate and...2.4.2.The organisation shall facilitate the consultation of staff by providing...3.PLANNING 3.1.Actions to address risks 3.1.1.Risk assessment 3.1.1.1.The organisation shall: 3.1.1.2.When assessing risk, an organisation shall take into account the...3.1.2.Planning for change 3.1.2.1.The organisation shall identify potential safety risks and appropriate safety...3.2.Safety objectives and planning 3.2.1.The organisation shall establish safety objectives for relevant functions at...3.2.2.The safety objectives shall: 3.2.3.The organisation shall have plan(s) to describe how it will...3.2.4.The organisation shall describe the strategy and plan(s) used to...4.SUPPORT 4.1.Resources 4.1.1.The organisation shall provide the resources, including competent staff and...4.2.Competence 4.2.1.The organisation's competence management system shall ensure that staff having...4.2.2.The organisation shall provide a training programme, as referred to...4.2.3.Back to work arrangements shall be in place for staff...4.3.Awareness 4.3.1.Top management shall ensure that they and their staff having...4.4.Information and communication 4.4.1.The organisation shall define adequate communication channels to ensure that...4.4.2.To ensure that safety-related information reaches those making judgements and...4.4.3.The organisation shall ensure that safety-related information is: 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:...4.5.1.2.The organisation shall ensure that an annual safety report is...4.5.2.Creating and updating 4.5.2.1.The organisation shall ensure that when creating and updating documented...4.5.3.Control of documented information 4.5.3.1.The organisation shall control documented information related to the safety...4.6.Integration of human and organisational factors 4.6.1.The organisation shall demonstrate a systematic approach to integrating human...5.OPERATION 5.1.Operational planning and control 5.1.1.When planning, developing, implementing and reviewing its operational processes, the...5.1.2.The organisation shall ensure that its operational arrangements conform to...5.1.3.To control risks where relevant for the safety of operational...5.1.4.To control the allocation of responsibilities where relevant for the...5.1.5.To control information and communication where relevant for the safety...5.1.6.To control competence where relevant for the safety of operational...5.2.Asset management 5.2.1.The organisation shall manage the safety risks associated with physical...5.2.2.The organisation shall: 5.2.3.The organisation shall ensure that its asset management arrangements, where...5.2.4.To control risks where relevant for the supply of maintenance...5.2.5.To control information and communication where relevant for the safe...5.3.Contractors, partners and suppliers 5.3.1.The organisation shall identify and control safety risks arising from...5.3.2.To control the safety risks referred to in paragraph 5.3.1,...5.3.3.In accordance with the process set out in Article 3...5.4.Management of change 5.4.1.The organisation shall implement and control changes to the safety...5.5.Emergency management 5.5.1.The organisation shall identify the emergency situations and associated timely...5.5.2.The organisation shall ensure that, for each identified type of...5.5.3.The organisation shall identify and document the roles and responsibilities...5.5.4.The organisation shall have plans for action, alerts and information...5.5.5.The organisation shall describe how resources and means for emergency...5.5.6.The emergency arrangements are regularly tested in cooperation with other...5.5.7.The organisation shall ensure that competent staff in charge, with...5.5.8.The organisation shall have a procedure to contact the entity...6.PERFORMANCE EVALUATION 6.1.Monitoring 6.1.1.The organisation shall perform monitoring in accordance with Regulation (EU)...6.1.2.The organisation shall regularly monitor at all levels within the...6.2.Internal auditing 6.2.1.The organisation shall conduct internal audits in an independent, impartial...6.3.Management review 6.3.1.Top management shall regularly review the continuing adequacy and effectiveness...6.3.2.Based on the outputs of its management review, the top...7.IMPROVEMENT 7.1.Learning from accidents and incidents 7.1.1.Accidents and incidents related to the organisation's railway operations shall...7.1.2.The organisation shall ensure that: 7.1.3.The organisation shall use information relating to the investigation to...7.2.Continual improvement 7.2.1.The organisation shall continually improve the adequacy and effectiveness of...7.2.2.The organisation shall provide means to motivating staff and other...7.2.3.The organisation shall provide a strategy to continually improve its...1.CONTEXT OF THE ORGANISATION 1.1.The organisation shall: 1.2.For the purpose of this Annex the following definitions are...2.LEADERSHIP 2.1.Leadership and commitment 2.1.1.Top management shall demonstrate leadership and commitment to the development,...2.2.Safety policy 2.2.1.A document describing the organisation's safety policy is established by...2.2.2.The safety policy shall: 2.3.Organisational roles, responsibilities, accountabilities and authorities 2.3.1.The responsibilities, accountabilities and authorities of staff having a role...2.3.2.The organisation shall ensure that staff with delegated responsibilities for...2.3.3.Delegation of responsibility for safety-related tasks shall be documented and...2.3.4.The organisation shall describe the allocation of roles referred to...2.4.Consultation of staff and other parties 2.4.1.Staff, their representatives and external interested parties, as appropriate and...2.4.2.The organisation shall facilitate the consultation of staff by providing...3.PLANNING 3.1.Actions to address risks 3.1.1.Risk assessment 3.1.1.1.The organisation shall: 3.1.1.2.When assessing risk, an organisation shall take into account the...3.1.2.Planning for change 3.1.2.1.The organisation shall identify potential safety risks and appropriate safety...3.2.Safety objectives and planning 3.2.1.The organisation shall establish safety objectives for relevant functions at...3.2.2.The safety objectives shall: 3.2.3.The organisation shall have plan(s) to describe how it will...3.2.4.The organisation shall describe the strategy and plan(s) used to...4.SUPPORT 4.1.Resources 4.1.1.The organisation shall provide the resources, including competent staff and...4.2.Competence 4.2.1.The organisation's competence management system shall ensure that staff having...4.2.2.The organisation shall provide a training programme, as referred to...4.2.3.Back to work arrangements shall be in place for staff...4.3.Awareness 4.3.1.Top management shall ensure that they and their staff having...4.4.Information and communication 4.4.1.The organisation shall define adequate communication channels to ensure that...4.4.2.To ensure that safety-related information reaches those making judgements and...4.4.3.The organisation shall ensure that safety-related information is: 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:...4.5.1.2.The organisation shall ensure that an annual safety report is...4.5.2.Creating and updating 4.5.2.1.The organisation shall ensure that when creating and updating documented...4.5.3.Control of documented information 4.5.3.1.The organisation shall control documented information related to the safety...4.6.Integration of human and organisational factors 4.6.1.The organisation shall demonstrate a systematic approach to integrating human...5.OPERATION 5.1.Operational planning and control 5.1.1.When planning, developing, implementing and reviewing its operational processes, the...5.1.2.The organisation shall ensure that its operational arrangements conform to...5.1.3.To control risks where relevant for the safety of operational...5.1.4.To control the allocation of responsibilities where relevant for the...5.1.5.To control information and communication where relevant for the safety...5.1.6.To control competence where relevant for the safety of operational...5.2.Asset management 5.2.1.The organisation shall manage the safety risks associated with physical...5.2.2.The organisation shall: 5.2.3.The organisation shall ensure that its asset management arrangements, where...5.2.4.To control risks where relevant for the supply of maintenance...5.2.5.To control information and communication where relevant for the safe...5.3.Contractors, partners and suppliers 5.3.1.The organisation shall identify and control safety risks arising from...5.3.2.To control the safety risks referred to in paragraph 5.3.1,...5.3.3.In accordance with the process set out in Article 3...5.4.Management of change 5.4.1.The organisation shall implement and control changes to the safety...5.5.Emergency management 5.5.1.The organisation shall identify the emergency situations and associated timely...5.5.2.The organisation shall ensure that, for each identified type of...5.5.3.The organisation shall identify and document the roles and responsibilities...5.5.4.The organisation shall have plans for action, alerts and information...5.5.5.The organisation shall describe how resources and means for emergency...5.5.6.The emergency arrangements are regularly tested in cooperation with other...5.5.7.The organisation shall coordinate emergency plans with all railway undertakings...5.5.8.The organisation shall have arrangements to halt operations and railway...5.5.9.For cross-border infrastructure, the cooperation between the relevant infrastructure managers...6.PERFORMANCE EVALUATION 6.1.Monitoring 6.1.1.The organisation shall perform monitoring in accordance with Regulation (EU)...6.1.2.The organisation shall regularly monitor at all levels within the...6.2.Internal auditing 6.2.1.The organisation shall conduct internal audits in an independent, impartial...6.3.Management review 6.3.1.Top management shall regularly review the continuing adequacy and effectiveness...6.3.2.Based on the outputs of its management review, the top...7.IMPROVEMENT 7.1.Learning from accidents and incidents 7.1.1.Accidents and incidents related to the organisation's railway operations shall...7.1.2.The organisation shall ensure that: 7.1.3.The organisation shall use information relating to the investigation to...7.2.Continual improvement 7.2.1.The organisation shall continually improve the adequacy and effectiveness of...7.2.2.The organisation shall provide means to motivating staff and other...7.2.3.The organisation shall provide a strategy to continually improve its...

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)

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 safety1, 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 20162, 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 1158/20103, (EU) No 1169/20104 and (EU) No 1077/20125. 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 Structure6 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/EEC7 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 Council8.

(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 Council9, 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: