The Approach to the Development of an Assessment Method for IEC 80001-1

Abstract

IEC 80001-1 is a risk management standard that addresses the risks associated with the incorporation of a medical device into an IT network. Our research in the area of IEC 80001-1 has to date been focused on the development of a Process Reference Model (PRM) and Process Assessment Model (PAM) for assessment against IEC 80001-1. In this paper we present the approach to the next phase of our research which focuses on the development of an assessment method which will be used to perform an assessment using the IEC 80001-1 PAM. The assessment method will ensure a standardized approach to performing an assessment while identifying key success and will contain a list of questions which will allow assessors to determine the capability level of processes within the PAM. The results of the assessment can be used as a basis for process improvement. © Springer-Verlag Berlin Heidelberg 2013.