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
Slide n° 2 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April 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
Slide n° 3 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April 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
Slide n° 4 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April 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
Slide n° 5 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April st Day: understanding of specific railway needs for Accreditation and Recognition RASBOs and Railway Notified Bodies (NOBOs) ERA presented Regulation 402/ 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
Slide n° 6 Workshop to NABs & RBs on Reg. 402/2013 and Harmonised sectorial accreditation scheme for railway NOBOs - Valenciennes, April 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
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]
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!