1. Slide n° 1 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April 2016 NAB/RB Training Workshop In Valenciennes, April 2016 Training workshop to Accreditation & Recognition Bodies on Regulation 402/2013 and on Harmonised sectorial accreditation scheme for railway NOBOs Dragan JOVICIC, European Railway Agency Summary of first day presentations

2. Slide n° 2 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April 2016 1 st Day: understanding of specific railway needs for Accreditation and Recognition RASBOs and Railway Notified Bodies (NOBOs) Mr Bertrand COLLIGNON from DG MOVE (EC) presented the “EU Railway Policy: market opening & railway restructuring”  Why an EU Transport Policy?  Increasing needs for transport in EU enlargement context?  Challenges Different steps in railway market opening  Why a step wise approach to market opening  Objectives of fourth railway package  Roles of European Railway Agency ERA presented the “EU Safety and Interoperability Regulatory framework”  Roles & Responsibilities of stakeholders (RUs, IMs, ECMs, Keepers, MS, NSAs, NOBOs, CSM Assessment Bodies, etc.)  TSIs and authorisations for placing in service structural sub-systems  Concepts of SMS and CSMs

3. Slide n° 3 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April 2016 1 st Day: understanding of specific railway needs for Accreditation and Recognition RASBOs and Railway Notified Bodies (NOBOs) Mr Daniel BUNCH from DG GROW (EC) presented the principles of the “Single market & EU new approach to technical harmonisation and standardization”  Single Market Policy  Concept of Mutual Recognition  Surveillance of the market  Technical harmonisation and standardisation  Conformity Assessment  Place of accreditation  Notified Bodies and Notification Mr Maik WUTTKE from NB Rail (TüV Rheinland) presented the “EC Verification of Conformity” by a NOBO  Roles & Responsibilities of the Applicant, NOBO and other CABs  Inputs to NOBO work and Working Methods;  Results of NOBO work

4. Slide n° 4 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April 2016 1 st Day: understanding of specific railway needs for Accreditation and Recognition RASBOs and Railway Notified Bodies (NOBOs) Mr Andreas STEINHORST from EA (European Co-operation for Accreditation) presented the “harmonised use of accreditation in EU for assessing the competence of various Conformity Assessment Bodies”  What is the accreditation?  Benefits of Accreditation for Governments, Regulators and Consumers  The ISO/IEC standards applicable to accreditation  Regulation 765/2008 setting out the requirements for accreditation and market surveillance  European Accreditation Model  Role of EA in Europe – Structure – Mission  EA MLA recognition at international level by ILAC (International Laboratory Accreditation Cooperation) and IAF (International Accreditation Forum)  EA Peer Evaluation System and Process

5. Slide n° 5 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April 2016 1 st Day: understanding of specific railway needs for Accreditation and Recognition RASBOs and Railway Notified Bodies (NOBOs) ERA presented Regulation 402/2013 1.Overview of CSM RA  WHAT is it? ( Reg. 402/2013)  WHO shall apply it?  Responsibility  WHEN shall it be applied?  TOO changes  WHAT shall it be applied to?  if change is significant  WHAT controls ensure all risks are adequately controlled?  Risk Assessment method  Process or flowchart 2.Independent CSM Assessment Body  WHY is it needed?  mutual recogn.  HOW to achieve trust of its work?  HOW to become a CSM AB?  WHY are different options permitted?  GENERIC & SPECIFIC requirements  Geographical area of work - ISA report  WHEN shall ISA start & WHY?  WHAT shall be assessed & HOW?  WHAT is ISA work result?  ISA Report  Interaction with other CABs

6. Slide n° 6 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April 2016 1 st Day: understanding of specific railway needs for Accreditation and Recognition RASBOs and Railway Notified Bodies (NOBOs) Mr Clive ADAMS from Arthur D. Little presented “Independent safety assessment by a CSM Assessment Body (RASBO)”  Introduction to independent safety assessment  Timing of independent safety assessment  Planning an independent safety assessment  Conducting the independent safety assessment  Management of findings  Contents of the safety assessment report  Cross acceptance  Added value of independent safety assessment in:  identifying and correcting weaknesses in management systems  detecting systematic errors  continuously improving the management system of the company  promoting safety culture in the company

7. Slide n° 7 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April 2016 Program of 2 nd day of workshop Assessment of Competence of CSM Assessment Bodies  Example of use of recognition for assessing the competence of a CSM Assessment Body  Use of accreditation for assessing the competence of a CSM Assessment Body Latest developments for railway NoBos  Latest developments on harmonised sectorial accreditation scheme for railway notified bodies  Guided discussions on the latest development of a harmonised accreditation scheme for railway notified bodies  Any other business – Discussions Luca TRINCA [ERA] Michael SCHMITZ [EBA] [German NSA] Susana HUERTA [ENAC] [Spanish Accreditation Body]

8. Slide n° 8 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April 2016 Many thanks for your attention! E-mail: CSM.risk_assessment@era.europa.eu