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Authors: Julieth Patricia Castellanos-Ardila and Barbara Gallina

Affiliation: IDT, Mälardalen University, Västerås, Sweden

Keyword(s): Process Recertification, Systematic Reuse, Automated Compliance Checking, ISO 14971.

Abstract: Revisions of safety-related standards lead to the release of new versions. Consequently, products and processes need to be recertified. To support that need, product line-oriented best practices have been adopted to systematize reuse at various levels, including the engineering process itself. As a result, Safety-oriented Process Line Engineering (SoPLE) is introduced to systematize reuse of safety-oriented process-related artifacts. To systematize reuse of artifacts during automated process compliance checking, SoPLE was conceptually combined with a logic-based framework. However, no integrated and tool-supported solution was provided. In this paper, we focus on process recertification (interpreted as the need to show process plan adherence with the new version of the standard) and propose a concrete technical and tool-supported methodological framework for reusing (safety-oriented) compliance artifacts while recertifying. We illustrate the benefits of our methodological framework b y considering ISO 14971 versions, and measuring the enabled reuse. (More)

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Paper citation in several formats:
Castellanos-Ardila, J. and Gallina, B. (2021). Reusing (Safety-oriented) Compliance Artifacts while Recertifying. In Proceedings of the 9th International Conference on Model-Driven Engineering and Software Development - MODELSWARD; ISBN 978-989-758-487-9; ISSN 2184-4348, SciTePress, pages 53-64. DOI: 10.5220/0010224900530064

@conference{modelsward21,
author={Julieth Patricia Castellanos{-}Ardila. and Barbara Gallina.},
title={Reusing (Safety-oriented) Compliance Artifacts while Recertifying},
booktitle={Proceedings of the 9th International Conference on Model-Driven Engineering and Software Development - MODELSWARD},
year={2021},
pages={53-64},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0010224900530064},
isbn={978-989-758-487-9},
issn={2184-4348},
}

TY - CONF

JO - Proceedings of the 9th International Conference on Model-Driven Engineering and Software Development - MODELSWARD
TI - Reusing (Safety-oriented) Compliance Artifacts while Recertifying
SN - 978-989-758-487-9
IS - 2184-4348
AU - Castellanos-Ardila, J.
AU - Gallina, B.
PY - 2021
SP - 53
EP - 64
DO - 10.5220/0010224900530064
PB - SciTePress