1. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Staff (human) in the ECM regulation 445/2011/EU By Ing. Francis PARMENTIER Technical Manager ECM & Safety Assessment

2. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Content Maintenance System as a part of the Safety Management System Requirements concerning Staff Changes in Staffing CSM-RA – internal or external CSM AB

3. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Maintenance System as a part of the Safety Maintenance System

4. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Maintenance System as a part of the Safety Maintenance System

5. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» 445/2011/EU art. 4 - Maintenance functions Indicates that the maintenance system shall be composed of the following functions : I - The management function (MF) II - The maintenance development function (MDV) III - The fleet maintenance management function (FMM) IV - The Maintenance delivery function (MDL) Maintenance System as a part of the Safety Maintenance System

6. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Maintenance System as a part of the Safety Maintenance System

7. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Annex III - I.h. : Leadership –The organisation must have a procedure for 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. Annex III – I.5.3 : Structure and responsibility –The organisation must procedures to ensure that staff with delegated responsibilities within the organisation have the authority, competence, appropriate resources to perform their functions. Responsibility and competence should be coherent and compatible with the given role, and delegation must be in writing. Requirements concerning Staff

8. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Annex III – I.6.1.c : Competence management –The organisation must set up a competence management system (Annex III - 6.2.) providing for the allocation of staff with the appropriate competence to relevant tasks Annex III – I.7.3.g – I.7.3.h: Information –The organisation must procedures to ensure that the key operational information is made known to staff before it is applied easily accessible to staff, with copies provided to them where required Requirements concerning Staff

9. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Annex III – IV.1.c - IV.1.d –The organisation must have procedures to ensure : that all the relevant maintenance specifications in the maintenance orders are available to all involved staff (e.g. they are contained internal working instructions) 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 internal working instructions) Requirements concerning Staff

10. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Annex III – IV.3.a – IV.3.b –The organisation must have procedures to determine, identify, provide, record and keep available suitable and adequate facilities, equipment and tools to enable it to deliver the maintenance services in accordance with maintenance orders and other applicable specifications ensuring : 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 and diagnostics equipment. Requirements concerning Staff

11. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Annex III – I.2.3 : Risk assessment –The organisation must have risk assessment procedures to manage changes in equipment, procedures, organisation, staffing or interfaces, and to apply CSM-RA (352/2009/EU repealed by 402/2013/EU) Changes in staffing

12. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» 402/2013/EU annex II - Criteria for accreditation or recognition of the assessment body –ISO 17020:2012 –Different areas of competence by analogy to 2008/57/EC, e.g. : Rolling stock Freight wagon Maintenance –Competence Organisation Methodology Technical aspects CSM-RA – internal or external CSM AB

13. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Accreditation is granted by NAB (BELAC, COFRAC, …) Recognition could be granted according to 402/2013/EU art. 9 (b) Recognition by the NSA (e.g. SSICF, EPSF, …) … throught the assessment and supervision of the SMS of an RU or IM; (d) Recognition by a recognition body designated by the Member State (e.g. Belgorail, …) of the ability of an ECM, an organisation or a part of it or an individual to conduct independent assessment. Validity of the recognition of an ECM according to 402/2013/EU art 10 –Statement in field 5 ‘Additional Information’ of ECM/ECMF certificate –Validity limited to the validity of ECM/ECMF certificate CSM-RA – internal or external CSM AB

14. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Thanks for your attention.

15. www.belgorail.be info@belgorail.be © 2015 BELGORAIL 27/04/2015 – BEWAG « Staff (human) in the ECM regulation 445/20111/EU» Regulation 445/2011/EU Regulation 402/2013/EU Dissemination of the SMS guidance, Commission Regulations of Common Safety Method (CSM) for Conformity Assessment and on certification of ECMs (ERA- 14/11/2012) Workshop - Regulation 445/2011/EU (Belgorail & EU DG TAIEX – 21/11/2014) Sources