Integration of the Technical Product Risk Assessment within the ISO 31000 Enterprise Risk Management Concept

Throughout the 1990s, the European Union achieved, through introducing the New and Global Approach to technical harmonization and standardization, significant improvements to conformity assessment of products, by integrating safety requirements into the design process. This was achieved through preventative analysis and quantification of risk levels, with the objective of determining the scope of the required safety systems. On the other hand, we have witnessed the rapid development and implementation of holistic approaches to risk management in enterprises, collectively known as Enterprise Risk Management (ERM). Along these lines, this chapter presents the basis of the New and Global Approach, and provides a proposal for the integration of New Approach Directives risk assessment into the holistic approaches of risk management in organizations, such as ERM.