Safety critical software process assessment: how MDevSPICE® addresses the challenge of integrating compliance and capability
Clarke, Paul, Lepmets, Marion, Dorling, Alec and McCaffery, Fergal
(2015)
Safety critical software process assessment: how MDevSPICE® addresses the challenge of integrating compliance and capability.
In:
Software Process Improvement and Capability Determination.
Communications in Computer and Information Science, 526
.
Springer, pp. 13-18.
ISBN 978-3-319-19860-6
One of the primary outcomes of a software process assessment is visibility of the capability of a software process which among other things, informs us of the ability of a process to deliver consistent product quality levels. In safety critical domains, such as the medical device sector, high product quality – and particularly high product safety - is an important consideration. To address this safety concern, the medical device sector traditionally employs audits to determine compliance to software process standards and guidance. Unlike an audit which results in a pass/fail outcome, an assessment provides a process capability profile which identifies areas for improvement and enables a comparison with broader best practice. MDevSPICE® integrates the various medical device software standards and guidance within the infrastructure of a SPICE assessment model, thus encompassing aspects of compliance and capability. This paper describes some of the key enablers of this integration.
Metadata
Item Type:
Book Section
Refereed:
Yes
Uncontrolled Keywords:
Safety critical software; Medical device software; Software process improvement; Software process assessment; MDevSPICE®