Railway Safety Directive 2004/49/EC & Role of European Railway Agency (ERA)

Railway Safety Directive 2004/49/EC & Role of European Railway Agency (ERA) Dragan JOVICIC Safety Assessment Sector (Safety Unit) Slide n 1

Content of the presentation 1. Role of European Railway Agency (ERA); 2. Railway Safety Directive 2004/49/EC; 3. Requirements in Directive 2004/49/EC for National Safety Authorities (NSA); 4. SMS Safety Certification: a) RU and IM Safety Management System; b) Safety Certification of Railway Undertakings; c) Safety Authorisations of Infrastructure Managers Slide n 2

Role of the European Railway Agency (ERA) Slide n 3

1 Role of the European Railway Agency EU Transport Policy Revitalising the railways EU rail transport policy and legislation are based on: opening up of rail transport and rail supply market to competition technical harmonisation interoperability maintaining at least, and increasing when reasonably practicable, existing level of safety by developing a common approach to safety transparency publication of rules and regulation by public bodies Slide n 4

1 Role of the European Railway Agency Core Objectives and Role of the Agency to contribute, on technical matters, to the implementation of the EU legislation (Article 1 of the Agency Regulation 881/2004) and to oversee the processes related to safety and interoperability and to provide greater impetus to the processes Slide n 5

The Agency s tasks and, hence, its organisational structure are based on mainly three components Regulation (EC) N 881/2004 (Agency Regulation) 1 Role of the European Railway Agency Legal basis for the Agency s work European Directives European Directives (Railway European Safety Directives Directive, (Railway Safety Directive, (Railway Interoperability Safety Directives, ) Directive, Interoperability Directives, ) Interoperability Directives, ) ERA Work Programme (annually adopted by the Administrative Board) Slide n 6

1 Role of the European Railway Agency Organisation Chart of the Agency Slide n 7

1 Role of the European Railway Agency Agency Tasks Agency is System Authority Steering ERTMS activities, seeking for operational harmonisation, ensuring change control management Technical Specifications for Interoperability (TSIs) Operational Interoperability (TSI OPE, Vocational Competences, 1520-System, etc.) Economic Studies for European funded infrastructure projects Impact Analyses for the operational Units Equivalence of national rules with basic parameters in TSIs Processes of placing vehicles into service and their alignment with the Interoperability Directive Slide n 8

1 Role of the European Railway Agency Agency Tasks Safety Regulation Validation and registration of the notifications of national safety rules, including an analysis of their mode of publication Technical advice on new national safety rules and on safetyrelated aspects Safety Reporting Elaboration of common safety indicators as well as monitoring and analysis of the development of safety on Europe s railways, including dissemination of information Common methods and approaches to accident investigation Safety Certification Common Safety Method for Conformity Assessment Development of a migration strategy towards a single Community certificate Certification Scheme for the Entity in Charge of Maintenance Slide n 9

1 Role of the European Railway Agency Agency Tasks Safety Assessment Common framework for risk assessment Methodology for calculating and assessing the achievement of safety targets for EU Member States Definition, for each Member State, of their respective safety targets including their assessment Horizontal Activities Support to the national safety authorities and investigating bodies to facilitate their exchange of information and harmonisation of decision making criteria by setting up networks and task forces Public databases of safety related documents such as safety certificates, licences, national safety rules, investigation reports and indicators Slide n 10

The Agency is controlled by an Administrative Board and has some binding principles for its work The Administrative Board 1 Role of the European Railway Agency Governance and Control 1 representative per Member State 4 Commission representatives 6 representatives of sector organisations (railway undertakings, infrastructure managers, railway industry, trade unions, passengers, freight customers) no voting rights Norway and Iceland no voting rights The Working Principles Budgetary and financial control with regular evaluation of all work Transparency and public access to documents Neutrality and impartiality Slide n 11

1 Role of the European Railway Agency Involvement of the Railway Sector Article 3 of Agency Regulation (EC) N 881/2004 obliges Agency to set up working groups according to tasks given in regulation and by Agency Work Programme. Sector Associations are asked to send experts to participate and contribute. Sector organisations acting at European level*: UNIFE, CER, EIM, UITP, UIP, UIRR, ERFA, ETF, ALE Railway Sector Experts Working Party Working Party Agency Network of National Safety Authorities National Safety Authorities experts Working Party Network of National Investigation Bodies * List established by Article 21 Committee on 22 February 2005 Slide n 12

1 Role of the European Railway Agency Decision Process (Commitology) No decision power for the Agency. The Agency gives recommendations to the Commission and technical opinions upon specific request! Adoption Parliament Scrutiny European Railway Agency Working Party (CER, EIM, UNIFE, NSA,...) NSA Network Internal reconcilement Commission / RISC Social Partners Passengers/ Customers Agency Recommendation Slide n 13

Railway Safety Directive 2004/49/EC Slide n 14

Content 1. Existing railway context & 1 st steps for establishing a EU railway area 2. Objectives of the European Union 3. Purpose and scope of the safety directive (SD) 4. Scope of safety directive 5. Most important definitions 6. Development and management of safety 7. IM/RU safety management system (SMS) 8. Safety certification of RU and safety authorisation of IM 9. Further development 10. Common safety methods (CSM) 11. Common safety targets (CST) 12. Common safety indicators (CSI) 13. National safety rules (NSR) 14. Other requirements in safety directive Slide n 15

1 Existing Railway Context & 1 st steps for establishing a EU railway area without frontiers MS developed until beginning 2000 their safety rules and standards based on national technical and operational concepts Differences in principles, approach and culture created technical barriers to establish international transport operations Very close links between national industries and railways over years to detriment of opening of railway transport market 1 st EU provisions (91/440/EEC 2001/12/EC, 95/18/EC 2001/13/EC and 2001/14/EC) laid foundation stone towards regulation of EU railway transport market by opening market for international rail freight Although laying down basis, provisions on interoperability of whole network and on safety insufficient (differences in safety requirements): Interoperability Directives (96/48/EC and 2001/16/EC) 2008/57/EC sets conditions to achieve interoperability in EU rail system vs. provisions SD Safety Directive 2004/49/EC 2008/110/EC complements technical legislation (ID) and establishes common regulatory framework for railway safety Slide n 16

2 The objectives of the European Union are... to open the market for rail transport services and railway supply! to make railways business oriented and competitive! to prevent the sector from using safety as a barrier to market access or an excuse to resist change! Some cornerstones in new EU law in relation to safety: Moving the railways from self-regulation to regulation by public authorities; Introducing a framework for entry into the market for railway undertakings (licensing and safety certification); Creating a basis for mutual trust through the development of common approaches to safety; Transparency of safety data, CSI, CST, CSM, etc. Slide n 17

3 Purpose of Safety Directive 2004/49/EC (SD) Amended by Directive 2008/110/EC of 16 December 2008 Safety Directive 2004/49/EC put in place to support creation of an integrated European railway area Complementary to market opening and restructuring directives of 1 st railway package (Directives 2001/12/EC, 2001/13/EC and 2001/14/EC) With its full implementation, SD will contribute to improvement of safety: by moving railways from deterministic to risk based approach by defining principles for management, regulation and supervision of safety by requiring establishment of safety management systems by setting framework for developing CST and CSM by putting in place system for independent accident investigation by harmonising regulatory structure (NSA) in each Member State by defining the responsibilities between actors With harmonised approach to safety, SD supports mutual trust and thus mutual recognition (or cross acceptance) between Member States (MS); Slide n 18

4 Scope of safety directive (Art. 2(1) of SD) Safety Directive 2004/49/EC applies to railway system in MS, broken down into subsystems for structural and operational areas (Annex II of Interoperability Directive 2008/57/EC) It covers safety requirements of system as a whole, including safe management of infrastructure and of traffic operation and interaction between RU and IM Out of scope of SD: MS may exclude in implementing safety directive metros, trams and other light rail systems; networks functionally separate from railway system and intended only for operation of local, urban or suburban passenger services; privately owned railway infrastructure used by infrastructure owner for own freight operations; heritage vehicles running on national networks provided they comply with NSR and regulations in order to ensure safe circulation of such vehicles; heritage, museum and tourist railways operating on own network, including workshops, vehicles and staff. Slide n 19

5 Most important definitions (Art. 3 of SD) For purpose of SD, definitions for following terms are provided: railway system infrastructure manager railway undertaking safety authority national safety rules investigator-in-charge accident serious accident incident investigation causes safety management systems common safety targets (CSTs) common safety methods (CSMs) common safety indicators (CSIs) Agency (European Railway Agency) technical specification for interoperability (TSI) notified bodies interoperability constituents 'safety management system means the organisation and arrangements established by an infrastructure manager or a railway undertaking to ensure the safe management of its operations Slide n 20

6 Development and Management of Safety (Art. 4 in SD) SD acknowledges safety levels in EU rail system generally high: important safety at least maintained during restructuring phase separating functions of previously integrated railway companies and moving railway sector further from self-regulation to public regulation when reasonably practicable, safety improved vs. EU legislation, technical and scientific progress considering competitiveness of rail transport mode safety processes to harmonise based on existing methods in EU MS shall ensure priority given to prevention of serious accidents MS ensure safety rules laid-down, applied and enforced in open and non-discriminatory manner supporting development of single EU rail transport system MS ensure measures to develop and improve railway safety take account need of system based approach as TSIs define minimum safety levels and requirements of sub-systems Slide n 21

6 Development and Management of Safety (Art. 4 in SD) SD sets up responsibility for safe operation of railway system and control of risks associated with upon those operating railway system (IM & RU), each for its part of system IM/RU have to identify and implement risk control measures, where appropriate in cooperation with each other, to apply national safety rules and standards and to establish Safety Management System (SMS) in compliance SD Other actors (manufacturers, maintenance suppliers, wagon keepers, service providers and procurement entities) bear responsibility for their products or services NSA does not have any immediate responsibility for safety. It provides national regulatory framework + supervision of operator's performance Slide n 22

7 IM/RU Safety Management System (SMS) (Art. 9 in SD) SMS backbone process enabling IM/RU : to ensure safe management of railway operation and control of all risks associated linked to IM/RU activity, including supply of maintenance and material and use of contractors to deliver general requirements in Art. 4 of SD, where general concept of continuous improvement of railway safety, a system-based approach and allocation of responsibilities within IM/RU organisation are introduced SMS process-orientated management system, built around harmonised principles. Shall contain for IM/RU description of safety related processes and procedures, all of which shall be capable of internal audits SMS principles in Art. 9 & detailed requirements in Annex III of SD IM/RU SMS submitted to safety certification/authorisation by safety authority (NSA) according to Art. 10 & 11 of SD Slide n 23

Developing Techniques, Planning, Measuring, Reviewing Organisation Development Policy Development 7 IM/RU Safety Management System (SMS) Key Elements Key elements of cyclical/ iterative SMS process: planning of preventative/ corrective actions implementation on an adequate scale assessment/monitoring/ verification of effectiveness enforcement, review and revision IM/RU submit NSA Annual Safety Report achievement safety targets development national safety indicators and CSI (Ax I SD) results internal safety audits found deficiencies Audit Policy Organising Planning & Implementing Measuring Performance Reviewing Performance Slide n 24

8 Safety Certification of RU (Art. 10 in SD) Safety Authorisation of IM (Art. 11 in SD) Grant access to infrastructure RU Safety Certificate from NSA: Part A : NSA acceptance of RU SMS vs. Art. 9 & Annex III SD Standard & valid throughout whole Community (X-Acceptance) Part B: additional requirements specific to network NSA of other MS Renewed at intervals not exceeding 5 years or updated wholly/partially type or extent of operation substantially altered Revoked by NSA if conditions for certification no longer satisfied Manage and operate infrastructure IM Safety Authorisation from NSA Part A : NSA acceptance of IMSMS vs. Art. 9 & Annex III SD Part B: provisions for specific requirements (design, mainten., oper. infra) Renewed at intervals not exceeding 5 years or updated wholly/partially whenever substantial changes to infrastructure Revoked by NSA if IM no longer satisfies conditions for safety authorisation NSA keep ERA informed issued, renewed, amended, revoked SC/SA Slide n 25

9 Further Development Ensure high level of safety maintained in Community rail system and, when and where necessary and reasonably practicable, improved in non-discriminatory way important to: harmonise methods describing how assess safety levels and compliance with safety requirements (Common Safety Methods CSM) harmonise methods for defining safety targets and describing how assess achievement of safety targets (Common Safety Targets CST) harmonise safety indicators used for monitoring railway safety performance in MS (Common Safety Indicators CSI) harmonise safety rules and use common standards requires during transition period collection and analysis of national safety rules for identifying differences between MS (National Safety Rule) European Railway Agency (ERA) set up to provide recommendations on CSM/CST/CSI, further harmonisation measures towards "a common approach to railway safety" and to monitor railway safety development in Community (Regulation (EC) N 881/2004) Slide n 26

10 Common Safety Methods (CSM) (Art. 6 in SD) What kinds of CSMs in Directive 2004/49/EC? Article 6(3): "The CSMs shall describe how the safety level, and the achievement of safety targets and compliance with other safety requirements, are assessed by elaborating and defining:" a) risk evaluation and assessment methods b) methods for assessing conformity with requirements in Safety Certificates and Safety Authorisations issued in accordance with Art. 10 and 11, and c) as far as they are not yet covered by TSIs, methods to check that the structural subsystems of the railway system are operated and maintained in accordance with the relevant essential requirements Art. 6(3)(a) addresses requirement in Annex III(2)(d): IM/RU SMS has "procedures and methods for carrying out risk evaluation and implementing risk control measures whenever a change of the operating conditions or new material imposes new risks on the infrastructure or on operations" CSM based on examination of existing methods in MS. Revised at regular intervals, taking into account experience gained from their application and global development of railway safety and obligations on MS as laid down in Art. 4(1) (i.e. maintain safety + improve where reasonably practicable) Slide n 27

INDEPENDENT ASSESSMENT HAZARD MANAGEMENT [Ax III(2)(g) of SD] 10 Common Safety Methods (CSM) (Art. 6 in SD) CSM on Risk Assessment (Art. 6(3)(a) in SD) CSM Regulation adopted by RISC in November 2008 Basically CSM made of 3 steps: (a) (b) (c) Hazard identification Risk analysis and risk evaluation based on exiting risk acceptance principles Demonstration of the system compliance with the identified safety requirements Additional requirements: (a) (b) Hazard Management Independent Assessment (Assessment Body) Preliminary System Definition Codes of Practice Significant Change? SYSTEM DEFINITION HAZARD IDENTIFICATION AND CLASSIFICATION Similar Reference Systems RISK ASSESSMENT RISK ANALYSIS Explicit Risk Estimation RISK EVALUATION (vs. Risk Acceptance Criteria) Safety Requirements (i.e. safety measures to be implemented) Demonstration of Compliance with Safety Requirements Slide n 28

11 Common Safety Targets (CST) (Art. 7 in SD) CSTs define safety levels at least be reached by different parts of railway system and system as whole in each MS, expressed in RAC for: (a) (b) individual risks relating to passengers, staff, level crossing users and others, and, without prejudice to existing national and international liability rules, individual risks relating to unauthorised persons on railway premises; societal risks. Two steps approach: 1 st set CSTs: examine existing targets and safety performance in MS. Ensure current safety performance of rail system not reduced in any MS (NRV) 2 nd set CSTs: based on experience gained from 1 st set CSTs and their implementation, reflect any priority areas where safety needs to be further improved (what risks and which MS) Definition of CST based on economic evaluation of estimated cost and benefits (for operators and societal acceptance of risk) CST revised at regular intervals, taking into account global development of railway safety and obligations MS amend national safety rules to achieve at least CST and revised CST Slide n 29

12 Common Safety Indicators (CSI) (Art. 5 in SD) Information on safety of railway system rare and not generally publicly available necessary to establish CSIs: to assess harmonised way achievement of CST by railway system coordination between CSI and CST developments, and to facilitate monitoring of railway safety performance (transparency) National definitions related to CSIs may apply during transitional period List of CSI + associated units given in Annex I of SD, e.g. number of train collisions number of train derailments number of accidents at level crossings etc. European Railway Agency proposing harmonised definitions of safety indicators between MS. Some economic indicator definitions added vs. Annex I MS collect information about CSI and included in NSA Annual Report Slide n 30

13 National Safety Rules (NSR) (Art. 8 in SD) Current situation where national safety rules continue to play a role regarded as transitional stage leading ultimately to situation in which European harmonised rules will apply To harmonise those rules (market opening & X-acceptance), MS establish binding NSR & ensure published & made available to all IM, RU and applicants for SC/SA (clear language & understandable) Applicable NSR notified to EC vs. Annex II of SD ERA centralises (data base) and analyses NSR, looking at: establishment of binding NSR? publication of rules? availability of rules? rules in clear language can be understood? body or organisation responsible for publication Appropriate recommendations to EC to make relevant information more easily accessible Slide n 31

13 National Safety Rules (NSR) Notification of new NSR - (Art. 8 in SD) To keep at minimum new specific national rules, not based on common standards, to prevent further barriers being created and to harmonise gradually safety rules, EC monitor introduction of new rules by MS New rules shall be in line with Community legislation and facilitate migration towards a common approach to railway safety. All interested parties shall be consulted before a MS adopts a NSR requiring a higher safety level than CSTs New draft rule, with justification of reasons for its introduction, shall be submitted to Commission for examination If it appears draft safety rule not in conformity with Community legislation or constitutes a means of arbitrary discrimination or a disguised restriction on rail transport operation between MS. Concerned MS suspend adoption, entry into force or implementation of rule until decision adopted (Committee procedure) Slide n 32

14 Other Requirements in Safety Directive Each MS shall establish an independent safety authority (NSA) NSA to exchange views and experience to harmonise their decision-making criteria across EU and to get mutual-trust (Chapter IV - Art.16,17 & 18) Each MS shall establish an independent accident and incident investigation body (NIB) NIB conduct active exchange of views and experience to develop common investigation methods and draw up common principles for follow up of recommendations (Chapter V) Slide n 33

National Safety Authority (NSA) (Requirements) Slide n 34

Content 1. Establishment of a National Safety Authority (NSA) 2. NSA Responsibility 3. Decision-making principles by NSA 4. NSA Network & Role of European Railway Agency 5. Structure of the approach to RU/IM Safety Certification and authorisation 6. Annual Report Slide n 35

1 Establishment of a National Safety Authority (Art. 16(1) of SD) Each MS shall establish a safety authority, which may be the Ministry responsible for transport matters NSA shall be independent in its organisation, legal structure and decision making from any RU, IM, applicant and procurement entity NSA does not have any immediate responsibility for safety. It provides national regulatory framework, authorises placing in service, issues certificates and supervises operator's performance Safety Directive 2004/49/EC sets up responsibility for safe operation of railway system and control of risks associated with upon those operating railway system (IM & RU), each for its part of system Other actors (manufacturers, maintenance suppliers, wagon keepers, service providers and procurement entities) bear responsibility for their products or services Slide n 36

2 NSA Responsibility (Art. 16(2) in SD) Issue, renew, amend and revoke relevant parts of safety certificates and of safety authorisations granted vs. Art. 10 and 11 of SD Authorise placing in service of structural subsystems vs. Article 15 of Directive 2008/57 (on interoperability) Check that structural subsystems are operated and maintained vs. relevant essential requirements Supervise that interoperability constituents are in compliance with essential requirements Authorise placing in service of new and substantially altered rolling stock not yet covered by a TSI Slide n 37

2 NSA Responsibility (Art. 16(2) in SD) Check that conditions and requirements laid down in safety certificates/ authorisations are met and that IM/RU are operating under requirements of Community or national law Monitor, promote, and, where appropriate, enforce and develop safety regulatory framework including the system of national safety rules Supervise that vehicles are duly registered in the national vehicle register (NVR) and that safety-related information in NVR is accurate and kept up-to-date Issue train driving licences and complementary certificates (Art. 6(1) of Directive 2007/59/EC) Slide n 38

3 Decision-making principles by NSA (Art. 17 in SD) Work in open, non-discriminatory and transparent way, justifying its decisions and allowing all parties to be heard Respond to requests within 4 months after requested information is provided May not transfer or subcontract his tasks to any IM, RU or procurement entity. It can request their technical assistance or that of other qualified bodies Consult all persons involved and interested parties, including IM, RU, staff representatives, etc. for elaboration of national regulatory framework Free to carry out all inspections and investigations. It shall be granted access to documents, premises, installations and equipment of IM/RU Judicial review against NSA decisions shall be possible Slide n 39

4 NSA Network & Role of European Railway Agency In order to harmonise decision-making criteria across the Community and create mutual trust, NSA shall exchange views and experience Cooperation between NSAs to facilitate and coordinate safety certification of RU granted with international train paths NSA Network meetings organised by the European Railway Agency. The Agency is facilitator for exchange of information and experience Regular peer reviews between NSA for exchanging best practices, identifying weaknesses and improving decision-making process One NSA presents way of working - Other NSA explain how they are solving similar problems Slide n 40

5 Structure of the approach to RU/IM Safety Certification RU's SMS Guidelines (published by Agency) Network specific guidelines (published by network or MS) CSM for Risk Assessment CSM for Monitoring IM's Support Have to be applied Art. 9 & Ax III in SD Implementation of an SMS and network-specific provisions Deliverance of safe operation and maintenance IM's RU's RU&IM follow provisions in their SMS IM's RU's Certification Bodies NSA [home country] Part A + B High-level initial assessment and granting of certificate Post-award supervision of delivery IM's RU's Certification Bodies NSA [foreign country] Part B Has to be applied CSM for Conformity Assessment Legally binding Criteria and Procedures for Conformity Assessment by NSA + General Principles for IM's post-award supervision RU's CSM for Monitoring Support (still under discussion) Up to NSA to set up and organise Slide n 41

6 Annual Report (Art. 18 in SD) Each year the safety authority shall publish an Annual Report on activities in preceding year and send it to European Railway Agency The report shall include information on: development of railway safety, including an aggregation at Member State level of the common safety indicators laid down in Annex I important changes in legislation and regulation concerning railway safety development of safety certification and safety authorisation results of and experience relating to supervision of IM and RU from next year: experience of the application of common safety methods (CSM) Slide n 42

Overview of Safety Management Systems A key element for Safety Certification of RU's and Safety Authorisation of IM's Slide n 43

Railway certification in the Directives... RU Maintenance Workshops IM Maintenance Workshops Certification under discussion Training Centres SMS ECM SMS ECM ECM Maintenance Workshops Mandatory After 2012 Mandatory but within RU/IM Certificate NSA's: SMS assessment against the "CSM for Conformity Assessment"/ ECM MoU or system in place later Voluntary MoU until 2012 then mandatory Certification Bodies: For ECMs or as support to NSAs against a standard (to be developed) Voluntary Sidings Perhaps to be considered in a standard Suppliers Slide n 44

... and the harmonised sector-wide approach to safety certification Given by legal texts Given by legal texts Harmonised basic Elements / Requirements Harmonised Assessment Criteria Harmonised Assessment Procedures Need to fulfil ECM's/... IM's RU's Find help in Guidelines for setting up Have to apply Find help in NSA Certification Bodies Need a standard to audit and certify against Guidelines on Assessment Criteria and Procedures Given e.g. by Agency s Technical Documents Given by Agency s Technical Documents Slide n 45

Advantages of a common approach Integration of all certification regimes in the railway sector into two schemes mandatory assessment and presumption of conformity by the NSAs according to the "Common Safety Method for Conformity Assessment" voluntary assessment and presumption of conformity by accredited bodies according to pertinent standards This should help to ensure that: companies with different services/areas of operation can be certified in only one procedure; the bureaucratic burden on both, companies and authorities, will be likewise minimised; the certification systems are transparent, and; mutual trust will be strengthened; Slide n 46

Legal base for harmonising assessment methods Article 6(3)(a) of Railway Safety Directive CSM on Risk Assessment Article 6(3)(b) - Common Safety Methods for assessing conformity with requirements in Safety Certificates and Safety Authorisations issued in accordance with Articles 10 and 11 (CSM for Conformity Assessment turned into a Commission Regulation) Article 6(3)(c) of Railway Safety Directive CSM on Monitoring Article 16(2)(e) of Railway Safety Directive High-level conformity Assessment The issue, renewal, amendments and revocation of relevant parts of Safety Certificates and of Safety Authorisations granted in accordance with Articles 10 and 11 and checking that conditions and requirements laid down in them are met and that Infrastructure Managers and Railway Undertakings are operating under the requirements of Community or national law. Detailed post-award supervision Slide n 47

Role of SMS according to legal base and Compliance with TSIs and other rules within SMS Article 10(1) of Railway Safety Directive The purpose of the safety certificate is to provide evidence that the railway undertaking has established its Safety Management System and can meet requirements laid down in TSIs and other relevant Community legislation and in national safety rules in order to control risks and provide transport services safety on the network. Article 10(2)(b) of Railway Safety Directive Network specific Part B certificate Certification confirming acceptance of the provisions adopted by the Railway Undertaking to meet specific requirements necessary for the safe supply of its services on the relevant network. These requirements may concern the application of the TSIs and national safety rules, including the network operating rules, acceptance of staff certificates and authorisation to operate vehicles used by Railway Undertakings. The certification shall be based on documentation submitted by the railway undertaking as described in Annex IV. Slide n 48

Responsibilities of the players (I) Member States Member State Responsibility for the general maintenance and, where reasonably practicable, continuous improvement of railway safety (Article 4(1) SD) MS take this responsibility by : enforcing and applying safety rules in an open and nondiscriminatory manner; ensuring that the responsibility for safe operation and maintenance is laid upon the RUs/IMs ; ensuring that the CSTs are reached on Member State level. Slide n 49

Responsibilities of the players (II) Railway Undertakings and Infrastructure Managers RU/IM Responsibility for the safe operation and maintenance (Article 4(3) SD) To take this responsibility, which means : to ensure the control of all risks associated with its particular activity, to contribute to the achievement of the CSTs for the whole railway system of a MS and to be in conformity with the national safety rules, the RU/IM has to establish a safety management system Slide n 50

Responsibilities of the players (III) National Safety Authorities National Safety Authorities Responsibility (among others) for granting safety certificates and authorisations and checking that conditions and requirements laid down in them are met (Article 16(2)(e) SD) NSAs take this responsibility by: applying the CSM for Conformity Assessment for granting safety certificates and authorisations to let RUs/IMs start their operation, and; carrying out post-award supervision to check whether the necessary level of safety performance is delivered on the ground Slide n 51

Legal base for RU s Safety Certification and IM's Safety Authorisation Article 10 and 11 of Railway Safety Directive Part A / Generic SMS Procedures confirmation of the NSA s acceptance with the RU s/im s implementation of the SMS procedures Part B / network specific part confirmation of the NSA s acceptance of the RU s/im s network specific provisions Article 9 and Annex III of Railway Safety Directive Description of basic elements and requirements of the SMS Slide n 52

Addressed to the Railway Undertakings [Art. 9 & Annex III in SD] + supported by Agency Guidelines on SMS setup and implementation Safety Certification for Railway Undertakings in two parts (i.e. at least two Safety Certificates) Safety Certification confirming acceptance by NSA of RUs provisions for management of a safe operation (in two parts) Part A Certificate General SMS Requirements Part B Certificate Network specific Addressed to the NSAs who will be using the CSM on Conformity Assessment Criteria and procedures once granted it is valid in all Member States without additional assessment SMS Assessment Criteria and procedures Has to be obtained and granted separately for each network Slide n 53

Safety Authorisation for Infrastructure Managers in one step (one single Safety Authorisation) Addressed to the Infrastructure Managers [Art. 9 & Annex III in SD] + supported by Agency Guidelines on SMS setup and implementation Addressed to the NSAs who will be using the CSM on Conformity Assessment Safety Authorisation confirming acceptance by NSA of IMs provisions for management of a safe operation (in one step) General Criteria and procedures SMS Requirements SMS Assessment Network specific Criteria and procedures Slide n 54

POST-AWARD SUPERVISION CERTIFICATION Common Safety Method for Conformity Assessment Safety Certification Safety Authorisation First Member State: applied in two steps Further Member States: only Part B Assessment is applied Criteria to assess fulfilment of SMS Basic Elements and Requirements [Article 9 and Annex III in SD] Part A Part B General Network specific Applied in one assessment General Network specific Part A Part B Assessment Procedures General General Network specific Network specific Slide n 55

Monitoring of Safety Performance Implementation of SMS Procedures Roles of players within Safety Certification/Authorisation Regime Monitoring of Safety Performance Implementation of SMS Procedures SMS Procedures NSA High level assessment Safety Authorisation Safety Certificate IM Co-operation RU IM RU Post award supervision of delivery Safety Performance NSA Slide n 56

Place of CSM for Conformity Assessment RU's SMS Guidelines (published by Agency) Network specific guidelines (published by network or MS) CSM for Risk Assessment CSM for Monitoring IM's Support Have to be applied Art. 9 & Ax III in SD Implementation of an SMS and network-specific provisions Deliverance of safe operation and maintenance IM's RU's RU&IM follow provisions in their SMS IM's RU's Certification Bodies NSA [home country] Part A + B High-level initial assessment and granting of certificate Post-award supervision of delivery IM's RU's Certification Bodies NSA [foreign country] Part B Has to be applied CSM for Conformity Assessment Legally binding Criteria and Procedures for Conformity Assessment by NSA + General Principles for IM's post-award supervision RU's CSM for Monitoring Support (still under discussion) Up to NSA to set up and organise Slide n 57

Part A assessment High level conformity assessment (I) Criteria to check the RU s/im s general SMS provisions against requirements from Article 9 and Annex III SD Assessment at system-level, not necessarily involving the examination of detailed risk control measures, including visits and interviews to discuss any queries about application. Part B Assessment Criteria to check RU s network specific provisions against harmonised Part B requirements (Recommendation from the Agency from December 2008) Article 10(2)(b) SD: The certification shall be based on documentation submitted by the railway undertaking as described in Annex IV. Slide n 58

Annex III 2 (c) of Railway Safety Directive Compliance with TSIs and other rules within the SMS Procedures to meet existing, new and altered technical and operational standards or other prescriptive conditions as laid down in TSIs, or in national safety rules referred to in Article 8 and Annex II, or in other relevant rules, or in authority decisions, and procedures to assure compliance with the standards and other prescriptive conditions throughout the lifecycle of equipment and operations. Slide n 59

Example of compliance with TSIs High level conformity assessment (II) Does RU/IM know that they have to apply relevant parts of TSIs? know where and how to find it? have procedures that are deemed to ensure correct application? If TSIs do not apply can they do same for national rules Using the assessment criteria under Annex III(2)(c) Same process applies for other SMS requirements Slide n 60

Monitoring of RU/IM Criteria for SMS to ensure RU/IM capable of: Detailed post-award supervision delivering exhaustive and consistent compliance with the network specific rules for operation, staff and rolling stock (including relevant parts of TSIs) using only suitably fit and competent staff (delivery of competence management system described in SMS) organising of work and distributing (safety related) tasks to deliver safe operation operating rolling stock on granted parts of network in compliance with network specific rules and technical provisions Monitoring RU s safety performance against provisions given in their SMS Delivery of safe operation and maintenance on ground (done what is written written what is done) Evidence given during conformity assessment subject to further verification and scrutiny by NSA through supervision regime Slide n 61

Many thanks for your attention! Thank you for your attention! Slide n 62