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Supporting compliance with safety standards by trust case templates

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)
Język
angielski
Rok wydania
2007

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