Abstract Legal requirements on safety culture and human factors has been part of the regulations in high hazard industries such as nuclear and aviation for several years and will now be a part of the European railway safety legislation. In 2016, the concepts of safety culture and human factors was introduced in the re-cast European railway safety legislation (Directive EU 2016/798). The new railway safety regulations on Common Safety Method (CSM) for Safety management systems (SMS) 1169/2010 and 1158/2010 will include requirements on integration of human and organizational factors and safety culture within the railway license holders´ safety management system. Guidance on implementation will be published by the European Agency for Railways (ERA). The new regulations must be applied by the EU members states from 16 June 2019. The concept of human and organizational factors is used to emphasize the broad range of factors influencing human performance, the interaction of such factors as well as a systemic safety view. The use of a new definition will reflect the systemic safety perspective where the interaction between humans, technology and organizations is explicitly considered. A new definition of the concept of safety culture is introduced. This paper will give an overview of the definitions and requirements related to safety culture and the interaction between humans, technology and organization in the re-cast railway safety legislation.


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