The organisation shall have procedures for:
establishing a maintenance policy appropriate to the organisation's type and extent of service and approved by the organisation's chief executive or his or her representative;
ensuring that safety targets are established, in line with the legal framework and consistent with an organisation's type, extent and relevant risks;
assessing its overall safety performance in relation to its corporate safety targets;
developing plans and procedures for reaching its safety targets;
ensuring that the resources needed to perform all processes are available to comply with the requirements of this Annex;
identifying and managing the impact of other management activities on the maintenance system;
ensuring that senior management is aware of the results of performance monitoring and audits and takes overall responsibility for the implementation of changes to the maintenance system;
ensuring that staff and staff representatives are adequately represented and consulted in defining, developing, monitoring and reviewing the safety aspects of all related processes that may involve staff.
the performance of relevant processes;
the results of processes (including all contracted services and products);
the effectiveness of risk control arrangements;
information on experience, malfunctions, defects and repairs arising from day-to-day operation and maintenance.
develop an internal audit plan, which may be revised depending on the results of previous audits and monitoring of performance;
analyse and evaluate the results of the audits;
propose and implement specific corrective measures or actions;
verify the effectiveness of previous measures or actions.
The organisation shall have procedures to ensure that:
identified shortcomings are rectified;
new safety developments are implemented;
internal audit findings are used to bring about improvement in the system;
preventive or corrective actions are implemented, when needed, to ensure compliance of the railway system with standards and other requirements throughout the lifecycle of equipment and operations;
relevant information relating to the investigation and causes of accidents, incidents, near-misses and other dangerous occurrences is used to learn and, where necessary, to adopt measures in order to improve the level of safety;
relevant recommendations from the national safety authority, from the national investigation body and from industry or internal investigations are evaluated and implemented if appropriate;
relevant reports or information from railway undertakings/infrastructure managers, keepers or other relevant sources are considered and taken into account.
the identification of posts with responsibility for performing within the system all the processes necessary for compliance with the requirements of this Annex;
the identification of posts involving safety tasks;
the allocation of staff with the appropriate competence to relevant tasks.
identification of the knowledge, skills and experience required for safety-related tasks as appropriate for the responsibilities;
selection principles, including basic educational level, mental aptitude and physical fitness;
initial training and qualification or certification of acquired competence and skills;
assurance that all staff are aware of the relevance and importance of their activities and how they contribute to the achievement of safety objectives;
ongoing training and periodical updating of existing knowledge and skills;
periodic checks of competence, mental aptitude and physical fitness where appropriate;
special measures in the case of accidents/incidents or long absences from work, as required.
the receipt and processing of specific information;
the identification, generation and dissemination of specific information;
making available reliable and up-to-date information.
relevant and valid;
accurate;
complete;
appropriately updated;
verified;
consistent and easy to understand (including the language used);
made known to staff in accordance with their responsibilities, before it is applied;
easily accessible to staff, with copies provided to them where required.
checks of the accuracy and completeness of national vehicle registers regarding the identification (including means) and registration of the vehicles maintained by the organisation;
maintenance documentation;
information on support provided to keepers and, where appropriate, to other parties, including railway undertakings/infrastructure managers;
information on the qualification of staff and subsequent supervision during maintenance development;
information on operations (including mileage, type and extent of activities, incidents or accidents) and requests of railway undertakings, keepers and infrastructure managers;
records of maintenance performed, including information on deficiencies detected during inspections and corrective actions taken by railway undertakings or by infrastructure managers such as inspections and monitoring undertaken before the departure of the train or en route;
release to service and return to operation;
maintenance orders;
technical information to be provided to railway undertakings/infrastructure managers and keepers for maintenance instructions;
emergency information concerning situations where the safe state of running is impaired, which may consist of:
the imposition of restrictions of use or specific operating conditions for the vehicles maintained by the organisation or other vehicles of the same series even if maintained by other entities in charge of maintenance, whereby this information shall also be shared with all involved parties;
urgent information on safety-related issues identified during maintenance, such as deficiencies detected in a component common to several categories or series of vehicles;
all relevant information or data needed to submit the annual maintenance report to the certification body and to the relevant customers (including keepers), whereby this report shall also be made available upon request to national safety authorities.
regularly monitor and update all relevant documentation;
format, generate, distribute and verify changes to all relevant documentation;
receive, collect and archive all relevant documentation.
contractors, subcontractors and suppliers are competent;
contractors, subcontractors and suppliers have a maintenance and management system that is adequate and documented.
responsibilities and tasks relating to railway safety issues;
obligations relating to the transfer of relevant information between both parties;
the traceability of safety-related documents.
all maintenance activities affecting safety;
all safety-critical components.
ensuring compliance with the specifications related to the basic parameters for interoperability as set out in the relevant technical specifications for interoperability (TSIs);
verifying in all circumstances the consistency of the maintenance file with the authorisation related to the vehicle (including any national safety requirements), including the conformity to the technical file and the type of records as in the European Register of Authorised Types of Vehicles (ERATV);
managing any substitution in the framework of maintenance;
identifying the need for risk assessment of the potential impact of the change in question on the safety of the railway system, by application of the common safety methods related to the risk evaluation and assessment methods as adopted pursuant to point (a) of Article 6(1) of Directive (EU) 2016/798;
managing the configuration of all technical changes affecting the system integrity of the vehicle.
obtain access to the recommendations for maintenance of the initial documentation and to collect sufficient information on planned operations;
analyse those recommendations for maintenance of the initial documentation and to provide, by application of the common safety methods related to the risk evaluation and assessment methods as adopted pursuant to point (a) of Article 6(1) of Directive (EU) 2016/798, the first maintenance file, also taking into account the information contained in any associated guarantees;
ensure that the implementation of the first maintenance file is done accordingly.
collect at least the relevant information in relation to:
the type and extent of operations effectively performed, including, but not limited to accidents, serious accidents and incidents, as defined in Directive (EU) 2016/798;
the detected failures on components;
the type and extent of operations planned;
the maintenance effectively performed.
define the need for updates, taking into account the limit values for interoperability;
make proposals for and approve changes and their implementation, with a view to a decision based on clear criteria, taking into account the findings from risk assessment performed by application of the common safety methods related to the risk evaluation and assessment methods as adopted pursuant to point (a) of Article 6(1) of Directive (EU) 2016/798;
ensure that the implementation of changes is done accordingly;
monitor the effectiveness of the changes through a process in consistency with the methods for assessing the safety level and the safety performance of railway operators at national and Union level as adopted pursuant to point (d) of Article 6(1) of Directive (EU) 2016/798.
application of the common safety methods related to the risk evaluation and assessment methods as adopted pursuant to point (a) of Article 6(1) of Directive (EU) 2016/798 for assessment of changes of the maintenance file;
engineering disciplines required for managing the establishment and the changes of the maintenance file and the development, assessment, validation and approval of substitutions in the framework of maintenance;
maintenance activities on safety-critical components;
joining techniques (including welding and bonding);
non-destructive testing.
the documentation relating to the development, assessment, validation and approval of a substitution in the framework of maintenance;
the configuration of vehicles, including, but not limited to, safety-critical components and on-board software modifications;
records of the maintenance performed;
results of studies concerning return on experience;
all the successive versions of the maintenance file, including risk assessment;
reports on the competence and supervision of maintenance delivery and fleet maintenance management;
technical information to be provided to support keepers, railway undertakings and infrastructure managers.
applicable rules and technical specifications;
the maintenance plan for each vehicle;
a list of spare parts, including a sufficiently detailed technical description of each part to allow like-for-like replacement with the same guarantees;
a list of materials, including a sufficiently detailed description of their use and the necessary health and safety information;
a dossier that defines the specifications for activities affecting safety and contains intervention and in-use restrictions for components;
a list of components or systems subject to legal requirements and a list of those requirements (including brake reservoirs and tanks for the transport of dangerous goods);
application of the common safety methods related to the risk evaluation and assessment methods as adopted pursuant to point (a) of Article 6(1) of Directive (EU) 2016/798 for assessing changes affecting the fleet maintenance management function.
maintenance orders;
return to operation, including restrictions on use relevant to railway undertakings and infrastructure managers.
check the completeness and appropriateness of the information delivered by the fleet maintenance management function in relation to the activities ordered;
verify the use of the required, relevant maintenance documents and other standards applicable to the delivery of maintenance services in accordance with maintenance orders;
ensure that all relevant maintenance specifications, as defined in applicable regulations and specified standards contained in the maintenance orders, are available to all involved staff (e.g. they are contained in internal working instructions).
components (including spare parts) and materials are used as specified in the maintenance orders and supplier documentation;
components and materials are stored, handled and transported in a manner that prevents wear and damage and as specified in the maintenance orders and supplier documentation;
all components and materials, including those provided by the customer, comply with relevant national and international rules as well as with the requirements of relevant maintenance orders.
the safe delivery of maintenance, including the health and safety of maintenance staff;
ergonomics and health protection, also including the interfaces between users and information technology systems or diagnostic equipment.
calibrated or verified at specified intervals, or prior to use, against international, national or industrial measurement standards — where no such standards exist, the basis used for calibration or verification shall be recorded;
adjusted or re-adjusted as necessary;
identified to enable the calibration status to be determined;
safeguarded from adjustments that would invalidate the measurement result;
protected from damage and deterioration during handling, maintenance and storage.
joining techniques (including welding and bonding);
non-destructive testing;
final vehicle testing and release to service;
maintenance activities on brake systems, wheel sets and draw gear and maintenance activities on specific components of freight wagons for the transport of dangerous goods, such as tanks, valves, etc.;
maintenance activities on safety-critical components;
maintenance activities on control-command and signalisation systems;
maintenance activities on door control systems;
other identified specialist areas affecting safety.
works performed in accordance with the maintenance orders;
any possible fault or defect regarding safety which is identified by the organisation;
the release to service.
clear identification of all facilities, equipment and tools;
all maintenance works performed, including personnel, tools, equipment, spare parts and materials used and taking into account:
relevant national rules where the organisation is established;
requirements laid down in the maintenance orders, including requirements regarding records;
final testing and the decision regarding the release to service;
the control measures required by maintenance orders and the release to service;
the results of calibration and verification, whereby, for computer software used in the monitoring and measurement of specified requirements, the ability of the software to perform the desired task shall be confirmed prior to initial use and reconfirmed as necessary;
the validity of the previous measuring results when a measuring instrument is found not to conform to requirements.
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).