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Safety critical software development – extending quality management system practices to achieve compliance with regulatory requirements

Bujok, Andrzej Beniamin, MacMahon, Silvana Togneri orcid logoORCID: 0000-0003-0179-2436, McCaffery, Fergal, Whelan, Dick, Mulcahy, Bernard and Rickard, William J. (2016) Safety critical software development – extending quality management system practices to achieve compliance with regulatory requirements. In: Software Process Improvement and Capability Determination 16th International Conference, SPICE 2016, 9-10 June 2016, Dublin, Ireland. ISBN 978-3-319-38980-6

Abstract
Software is increasingly being used to provide functionality in safety critical domains. The complexity involved in the development of software for these domains can bring challenges concerned with safety and security. International standards are published, providing information on practices which must be implemented in order to satisfy the regulations. This paper details an investigation of the relevant standards that companies need to implement in order to satisfy the regulatory requirements. A literature review was conducted which examines the relevant Quality management system, Risk Management and Software development standards across the safety critical domains. To examine the challenges in implementing these standards, interviews were conducted with a medical device software development company having a Quality management system in place and beginning to implement the relevant Software development standards. In addition, an interview was conducted with a consultancy company who have experience in the implementation and maintenance of Quality management systems in small and medium enterprises. Future work will focus on the integration of practices which need to be implemented by companies developing safety critical software.
Metadata
Item Type:Conference or Workshop Item (Paper)
Event Type:Conference
Refereed:Yes
Uncontrolled Keywords:Quality management system; Risk Management; Software development; Standards; Safety critical software development; Regulatory requirements; Integrated use of standards; Small and medium enterprises.
Subjects:Computer Science > Information technology
Medical Sciences > Health
DCU Faculties and Centres:DCU Faculties and Schools > Faculty of Engineering and Computing > School of Computing
Research Institutes and Centres > Lero: The Irish Software Engineering Research Centre
Published in: Clarke, Paul and O'Connor, Rory, (eds.) SPICE 2016: Software Process Improvement and Capability Determination, Proceedings. Communications in Computer and Information Science (CCIS) 609. Springer. ISBN 978-3-319-38980-6
Publisher:Springer
Official URL:https://doi.org/10.1007/978-3-319-38980-6_2
Copyright Information:© 2016 Springer
Funders:Science Foundation Ireland Principal Investigator Programme, grant number 08/IN.1/I2030 (co-funded by the Irish Government and European Regional Development Fund)(, Lero - the Irish Software Research Centre grant 10/CE/I1855 & 13/RC/20194
ID Code:28412
Deposited On:22 Jun 2023 12:11 by Silvana Macmahon . Last Modified 09 Oct 2023 09:43
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