posted on 2014-06-05, 14:43authored bySilvana Togneri MacMahon, Fergal Mc Caffery, Frank Keenan
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.
History
Publication
The 13th International SPICE Conference on Process Improvement and Capability dEtermination [Communications in Computer and Information Science];349, pp. 37-48
Publisher
Springer
Note
peer-reviewed
Other Funding information
SFI
Rights
The original publication is available at www.springerlink.com