A proposed approach to the revision of IEC 80001-1 following annex SL
MacMahon, Silvana TogneriORCID: 0000-0003-0179-2436, Cooper, Todd and McCaffery, FergalORCID: 0000-0002-0839-8362
(2017)
A proposed approach to the revision of IEC 80001-1 following annex SL.
In: Software Process Improvement and Capability Determination 17th International Conference, SPICE 2017,, October 4–5, 2017, Palma de Mallorca, Spain,.
ISBN 978-3-319-67382-0
IEC 80001-1 was published in 2010 and is now undergoing revision.
Feedback gathered on the adoption of the standard has revealed a number of
barriers that have impacted its adoption. The standard provides requirements
related to the roles, responsibilities and activities that need to be performed for
the risk management of medical IT networks. One reported barrier is a lack of
drivers to motivate Top Management to implement the standard. In addition,
there is a lack of alignment between IT and biomedical engineering departments
within hopitals. Finally, the IEC 80001-1 standard was considered to be too
complicated and complex to implement. This paper presents the barriers
identified in the feedback and presents an approach to the revision of the
standard as a process based management system standard in accordance with
ISO/IEC Directives Annex SL as a means to overcome these barriers.
Metadata
Item Type:
Conference or Workshop Item (Paper)
Event Type:
Conference
Refereed:
Yes
Uncontrolled Keywords:
IEC 80001-1; Annex SL; Management System Standard; Process
Assessment; ISO 15224
Software Process Improvement and Capability Determination. Communications in Computer and Information Science (CCIS)
770.
Springer. ISBN 978-3-319-67382-0