A Study of Quality Assurance and Unit Verification Methods in Safety Critical Environment

In the present case study we examined the development and testing methods of systems that contain safety-critical elements in different industrial fields. Consequentially, we observed the classical object-oriented development and testing environment, as both medical technology and automobile industry approaches the development of safety critical elements that way. Subsequently, we examined model-based development. We introduce the quality parameters that define development and testing. While taking modern agile methodology (scrum) into consideration, we examined whether and to what extent the methodologies we found fit into this environment.

• Miklos Taliga

• Safety-critical elements
• quality management
• unit verification
• model base testing
• agile methods
• scrum
• metamodel
• object-oriented programming
• field specific modelling
• sprint
• user story
• UML Standard.

[1] MATLAB – Simulink http://www.mathworks.com/products/simulink/
[2] ISO/IEC 12207:2008. Systems and software engineering -- Software life cycle processes.
[3] IEC 62304:2006. Medical device software -- Software life cycle processes.
[4] IEC 60601-1 Medical Electrical Equipment Package, 2009.
[5] IEC 61508-3 Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems.
[6] ISO 14971:2007. Medical devices -- Application of risk management to medical devices. ISO13485:2003: Medical devices -- Quality management systems -- Requirements for regulatory purposes.
[7] Model-based test generation - http://www.cis.upenn.edu/~rtg/testgen/
[8] Paul E. Ammann, Paul E. Black, and William Majurski, Using Model Checking to Generate Tests from Specifications, Proceedings of ICFEM'98, Brisbane, Australia (December 1998)
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[10] UML 2.x component diagram (an Agile introduction) - http://agilemodeling.com/artifacts/componentDiagram.htm
[11] Medical device software standard IEC 62304 et al: http://www.chemgineering.com/en/Scientific%20Articles/$/Medical-device-software-standard-IEC-62304-et-al./22