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Supporting compliance with safety standards by trust case templates

Abstrakt

Standard Compliance (SC) Framework presented in this paper encompasses methods and tools which provide support for application of standards. The framework is based on trust case methodology. A trust case is a data structure which represents a justification that an object (a system, an infrastructure, an organization) exhibits certain properties. It contains an argument and related evidence which support claimed properties. A trust case which argues the compliance with a standard is built, according to the framework, on the basis of a trust case template. Such a template is derived from the standard and is represented in a reusable format. The article describes SC Framework in more detail and presents a case study of its application. The case study demonstrates an example trust case template derived from Medical devices - Application of risk management to medical devices (ISO 14971:2000) standard. Some details of the web-based software tool supporting the presented approach are also given.

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Kategoria:
Aktywność konferencyjna
Typ:
publikacja w wydawnictwie zbiorowym recenzowanym (także w materiałach konferencyjnych)
Tytuł wydania:
Risk, Reliability and Societal Safety : Proceedings of the European Safety and Reliability Conference 2007 (ESREL 2007), Stavanger, Norway, 25-27 June 2007. Vol. 2, Thematic Topics strony 1367 - 1374
Język:
angielski
Rok wydania:
2007
Opis bibliograficzny:
Cyra Ł., Górski J.: Supporting compliance with safety standards by trust case templates// Risk, Reliability and Societal Safety : Proceedings of the European Safety and Reliability Conference 2007 (ESREL 2007), Stavanger, Norway, 25-27 June 2007. Vol. 2, Thematic Topics/ ed. ed. Terje Aven, Jan Erik Vinnem ; Department of Industral Economics, Rish Management and Planning, University of Stavanger, Norway. London: Taylor and Francis, 2007, s.1367-1374
Weryfikacja:
Politechnika Gdańska

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