—

appropriate to the risks, character and extent of operations of the applicant;

—

based on judgments of the railway undertaking’s overall ability to operate safely as described in its safety management system.

(a)

refer accurately to the relevant criteria and ensure that the applicant has understood clearly the identified areas of non-compliance;

(b)

identify the relevant part of related regulations, rules, and standards;

(c)

state why the assessment criterion is not met;

(d)

agree on further commitments, information and any supporting evidence to be provided, as required by the level of detail of the criterion, and specify both the action required by the applicant to rectify the deficiency and the timeframe for compliance;

(e)

specify areas which could be subject to further scrutiny through supervision after the award of the certificate.

A.1

There are procedures put in place to identify risks associated with railway operations, including those directly arising from work activities, job design or workload and the activities of other organisations/persons.

A.2

There are procedures in place to develop and put in place risk control measures.

A.3

There are procedures in place to monitor the effectiveness of risk control arrangements and to implement changes when required.

A.4

There are procedures in place to recognise the need to work together with other entities (such as the infrastructure manager, railway undertakings, the manufacturer, the maintenance supplier, the entity in charge of maintenance, the railway vehicle keeper, the service provider and the procurement entity), where appropriate, on issues where they have shared interfaces that are likely to affect the putting in place of adequate risk control measures in accordance with Article 4(3) of Directive 2004/49/EC.

A.5

There are procedures for agreed documentation and communication with the relevant entities including the identification of roles and responsibilities of each participating organisation and the specifications for information exchanges.

A.6

There are procedures to monitor the effectiveness of these arrangements and to implement changes when required.

B.1

There are procedures to derive maintenance requirements/standards/processes from safety data and from the assignment of rolling stock.

B.2

There are procedures to adapt maintenance intervals according to the type and extent of service performed and/or data from rolling stock.

B.3

There are procedures to ensure that the responsibility for maintenance is clearly defined, to identify the competencies required for maintenance posts and to allocate appropriate levels of responsibility.

B.4

There are procedures to collect information on malfunctions and defects arising from day-to-day operation and to report them to those responsible for maintenance.

B.5

There are procedures to identify and report risks arising from defects and construction non-conformities or malfunctions throughout the lifecycle to interested parties.

B.6

There are procedures to verify and control the performance and results of maintenance to ensure that they comply with corporate standards.

C.1

There are procedures to verify the competence of contractors (including subcontractors) and suppliers.

C.2

There are procedures to verify and control the safety performance and results of all contracted services and products supplied either by the contractor or supplier to ensure that they comply with the requirements set out in the contract.

C.3

Responsibilities and tasks relating to railway safety issues are clearly defined, known and allocated between the contracting partners and among all other interested parties.

C.4

There are procedures to ensure traceability of safety-related documents and contracts.

C.5

There are procedures to ensure that safety tasks, including the exchange of safety-related information, are performed by the contractors or the supplier according to relevant requirements set out in the contract.

D.1

There are procedures to identify potential risks from parties external to the railway system where appropriate and reasonable.

D.2

There are procedures to establish control measures to mitigate the risks identified under D1 insofar as the responsibilities of the applicant are concerned.

D.3

There are procedures to monitor the effectiveness of the measures identified under D2 and implement changes where appropriate.

E.1

There is a description of the activity that makes clear the type, extent and risk of operation.

E.2

There is a description of the structure of the safety management system, including the allocation of roles and responsibilities.

E.3

There is a description of safety management system procedures required by Article 9 and Annex III of Directive 2004/49/EC consistent with the type and extent of services operated.

E.4

Safety-critical processes and tasks relevant to the type of activity/service are listed and briefly described.

F.1

There is a description of how coordination of safety management system activities across the organisation is ensured, based on proven knowledge and lead responsibility at management level.

F.2

There are procedures to ensure that staff with delegated responsibilities within the organisation have the authority, competence and appropriate resources to fulfil their duty.

F.3

Safety-related areas of responsibility, and the distribution of responsibilities to specific functions associated with them, together with their interfaces, are clearly defined.

F.4

There is a procedure to ensure that safety tasks are clearly defined and delegated to staff with appropriate competence.

G.1

There is a description of how responsibilities are allocated for each safety-related process throughout the organisation.

G.2

There is a procedure for regular monitoring of task performance assured by the line management chain that must intervene if the tasks are not being properly performed.

G.3

There are procedures to identify and manage the impact of other management activities on the safety management system.

G.4

There are procedures to hold those with a role in the management of safety accountable for their performance.

G.5

There are procedures to allocate resources to deliver the tasks under the safety management system.

H.1

There are procedures in place to ensure that staff and staff representatives are adequately represented and consulted in defining, proposing, reviewing and developing the safety aspects of operational procedures that may involve staff.

H.2

Staff involvement and consultation arrangements are documented.

(a)

procedures for periodic reviews of the safety management system, as found to be necessary;

(b)

procedures for describing arrangements to monitor and analyse relevant safety data;

(c)

procedures for describing how identified shortcomings are rectified;

(d)

procedures for describing the implementation of new safety management rules based on development and lessons learnt;

(e)

procedures for describing how internal audit findings are used to bring about improvement in the safety management system.

(a)

communicated and made available to all staff, e.g. via the organisation’s intranet;

(b)

appropriate to the type and extent of service;

(c)

approved by the organisation’s chief executive.

K.1

There are procedures to determine relevant safety targets in line with the legal framework, and there is a document stating these targets.

K.2

There are procedures to determine relevant safety targets consistent with the type and extent of the railway operations covered and the relevant risks.

K.3

There are procedures to regularly assess overall safety performance in relation to the organisation’s corporate safety targets and to those established on member state level.

K.4

There are procedures in place to regularly monitor and review operational arrangements by:

K.5

There are procedures in place by the railway undertaking to develop plans and procedures for reaching its targets.

L.1

For safety related requirements relevant to the type and extent of operations, there are procedures for:

L.2

There are procedures in place to ensure that the right staff, procedures, specific documents, equipment and rolling stock are used for the purpose intended.

L.3

The safety management system has procedures in place to ensure that maintenance is carried out according to the relevant requirements.

M.1

There are management procedures for changes in equipment, procedures, organisation, staffing or interfaces.

M.2

There are risk assessment procedures to manage changes and to apply the common safety method on risk evaluation and assessment as set out in Commission Regulation (EC) No 352/2009 (13) when required.

M.3

The railway undertaking has procedures in place to feed the results of risk assessment into other processes within the organisation and make them visible to relevant staff.

N.1

There is a competence management system that includes at least:

N.2

There are procedures within the competence management system providing for:

O.1

There are procedures to ensure that:

O.2

There are procedures to ensure that:

O.3

There are arrangements in place for the sharing of information between railway organisations.

P.1

There are procedures to ensure that all relevant safety information is accurate, complete, consistent, easy to understand, appropriately updated, and duly documented.

P.2

There are procedures to:

P.3

There is a procedure for configuration control of vital safety information.

Q.1

There are procedures to ensure that accidents, incidents, near misses and other dangerous occurrences:

Q.2

There are procedures to ensure that:

Q.3

There are procedures for relevant information relating to the investigation and causes of accidents, incidents, near misses and other dangerous occurrences to be used to learn and, where required, to adopt preventive measures.

R.1

A document identifies all types of emergency, including degraded operations, and there are procedures in place to identify new ones.

R.2

There are procedures in place to ensure that, for each identified type of emergency:

R.3

The roles and responsibilities of all parties are identified and set out in a document.

R.4

Plans for action, alerts and information exist and include:

R.5

There is a document describing how resources and means have been allocated and how training requirements have been identified.

R.6

There are procedures in place to re-establish normal operating conditions as soon as possible.

R.7

There are procedures for testing emergency plans in cooperation with other parties to train staff, test procedures, identify weak points and verify how potential emergency situations are managed.

R.8

There are procedures to ensure that competent staff in charge (particularly relating to dangerous goods services), with adequate language skills, can be contacted easily and without delay by the infrastructure manager.

R.9

There is a procedure to contact the entity in charge of maintenance or the railway vehicle keeper in the event of an emergency.

S.1

There is an internal auditing system which is independent and impartial and which acts in a transparent way.

S.2

There is a schedule of planned internal audits which can be revised depending on the results of previous audits and monitoring of performance.

S.3

There are procedures in place to identify and select suitably competent auditors.

S.4

Procedures are in place to:

S.5

There are procedures to ensure that senior levels of the management chain are aware of the results of audits and take overall responsibility for implementation of changes to the safety management system.

S.6

There is a document showing how audits are planned in relation to routine monitoring arrangements to ensure compliance with internal procedures and standards.

A.1

There are documents containing results to show that the specific rules and specific risks associated with operating on the network for which a Part B application is being submitted have been considered and to show that the railway undertaking can comply with any network-specific rules and any exceptions to or derogations from those rules.

A.2

Network interfaces with other parties involved in railway operation on the network concerned are identified.

A.3

There are documents showing how the railway undertaking will interact with the infrastructure manager (IM) for the network and other railway undertakings operating on the network, including details on how information is shared.

A.4

There are documents showing how the railway undertaking will deal with emergency situations, including coordination with the infrastructure manager and the relevant public authorities.

A.5

There are documents identifying any specific accident/incident investigation rules and showing that the applicant can comply with them.

B.1

The documentation demonstrates that the applicant’s safety management system contains a competence management system to:

B.2

The documentation demonstrates that there are arrangements put in place to organise the day-to-day work of the staff to ensure that safety-related tasks are carried out and that staff are assigned to appropriate tasks.

B.3

The documentation demonstrates the applicant’s ability to produce documents to be used in training the relevant staff and its ability to ensure that the documents will be accurate, be kept up to date and be in a language and terminology understood by the staff who need to use them.

C.1

In the documentation, the types of rolling stock to be used on the specific network and the type of operations to be conducted are clearly indicated.

C.2

The documentation outlines how the railway undertaking complies with any operational restrictions placed on the type of rolling stock used on the network.

C.3

In the documentation, any additional maintenance requirements for the network concerned are identified and appropriate arrangements for maintenance are in place.

C.4

In the documentation, any additional requirements to manage rolling stock incidents for the network concerned are identified and appropriate arrangements are put in place.

1.

The approach of national safety authorities to supervision of railway undertakings’ compliance as referred to in Article 4(1) and 16(2)(e) of Directive 2004/49/EC shall be based on the following principles. These principles apply to the framework of supervision activities as a whole and to individual cases within that framework.

2.

National safety authorities shall apply the principle of proportionality between enforcement and risk. Action taken by a national safety authority to achieve compliance or bring railway undertakings to account for not meeting their legal obligations shall be proportionate to any risks to safety or to the potential seriousness of any non-compliance, including any actual or potential harm.

3.

National safety authorities shall apply the principle of consistency of approach to ensure that a national safety authority takes a similar approach in similar circumstances to achieve similar ends.

4.

National safety authority supervision activity shall be targeted primarily at those activities which a national safety authority believes give rise to the most serious risks or where the hazards are least well-controlled. To do so, the national safety authority shall have methods and power to assess the day-to-day performance of the railway undertaking.

5.

National safety authorities shall decide on priorities to use their resources effectively but the decision on how best to do that should rest with each individual national safety authority. Action shall be focused on those who are responsible for the risk and who are best placed to control it.

6.

National safety authorities shall apply the principle of transparency to help railway undertakings understand what is expected of them (including what they should or should not do) and what they should expect from the national safety authority.

7.

National safety authorities shall be accountable for their decisions in accordance with Article 17(3) of Directive 2004/49/EC. National safety authorities shall therefore have policies and principles by which they can be assessed. Moreover, national safety authorities shall also have a complaints procedure.

8.

National safety authorities shall develop cooperation arrangements between each other in order to share information with each other and to coordinate their response to any breaches of safety. This is particularly important for Part B safety certificates. In addition, national safety authorities shall develop cooperation arrangements with other competent authorities in order to share information and to develop unified approaches to issues that impinge on railway safety.