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A proposed approach to the revision of IEC 80001-1 following annex SL

MacMahon, Silvana Togneri orcid logoORCID: 0000-0003-0179-2436, Cooper, Todd and McCaffery, Fergal orcid logoORCID: 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

Abstract
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
Subjects:Computer Science > Information technology
DCU Faculties and Centres:DCU Faculties and Schools > Faculty of Engineering and Computing > School of Computing
Research Initiatives and Centres > Lero: The Irish Software Engineering Research Centre
Published in: Software Process Improvement and Capability Determination. Communications in Computer and Information Science (CCIS) 770. Springer. ISBN 978-3-319-67382-0
Publisher:Springer
Official URL:https://doi.org/10.1007/978-3-319-67383-7_22
Copyright Information:© 2017 Springer
Funders:Lero Science Foundation Ireland Research Centre for Software
ID Code:28397
Deposited On:02 Jun 2023 14:27 by Silvana Macmahon . Last Modified 02 Jun 2023 14:27
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