ABSTRACT

This chapter deals with the very important subject of incorporating risk management principles into the quality management system (QMS). It refers to particular guidance documents on the subject that are available. It states how risk management should be addressed in the quality manual and in certain Level 2 procedures. Certain Level 2 procedures are virtually required to include risk management principles by regulations and standards. This chapter also covers the Level 3 procedures that should address risk management principles in telling employees how to handle in detail the tasks for certain key areas.