ANNEX IISupplementary provisions
ANNEX II CRITERIA FOR ACCREDITATION OR RECOGNITION OF THE ASSESSMENT BODY 1. The assessment body shall fulfil all requirements of the ISO/IEC 17020:2012 standard and of its subsequent amendments. The assessment body shall exercise professional judgement in performing the inspection work defined in that standard. The assessment body shall fulfil both the general criteria concerning competence and independence in that standard and the following specific competence criteria: (a) competence in risk management: knowledge and experience of the standard safety analysis techniques and of the relevant standards; (b) all relevant competences for assessing the parts of the railway system affected by the change; (c) competence in the correct application of safety and quality management systems or in auditing management systems. 2. By analogy to Article 28 of Directive 2008/57/EC concerning the notification of notified bodies, the assessment body shall be accredited or recognised for the different areas of competence within the railway system, or parts of it for which an essential safety requirement exists, including the area of competence involving the operation and maintenance of the railway system. 3. The assessment body shall be accredited or recognised for assessing the overall consistency of the risk management and the safe integration of the system under assessment into the railway system as a whole. This shall include competence of the assessment body in checking the following: (a) organisation, that is the arrangements necessary to ensure a coordinated approach to achieving system safety through a uniform understanding and application of risk control measures for subsystems; (b) methodology, that is evaluation of the methods and resources deployed by various stakeholders to support safety at subsystem and system level; and (c) the technical aspects necessary for assessing the relevance and completeness of risk assessments and the level of safety for the system as a whole. 4. The assessment body may be accredited or recognised for one, several or all of the areas of competence listed in points 2 and 3.