Abstract
What This Chapter Is About:
-
This chapter provides information regarding the content of the quality management part of the safety case.
-
It describes to some degree how the ISO 9001 quality management system, IRIS system and the European module system for assessment of conformity are linked to this part of the safety case report.
-
It explains how an agile approach and agile practices can be included in this part of the safety case.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References and Further Reading
“Blue Guide”. Guide to the implementation of directives based on the New Approach and the Global Approach, NA, 2016
CLC/TR 50506-2:2009. Railway applications – Communication, signalling and processing systems – Application Guide for EN 50129 – Part 2: Safety assurance
COMMISSION DECISION 2010/713/EU of 9 November 2010 on modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council
COMMISSION REGULATION (EU) 2016/919 of 27 May 2016 on the technical specification for interoperability relating to the ‘control-command and signalling’ subsystems of the rail system in the European Union
DIRECTIVE 2006/66/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC
DIRECTIVE (EU) 2016/797 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 May 2016 on the interoperability of the rail system within the European Union (recast)
EN 50126-2: draft 2016. Railway applications – The specification and demonstration of Reliability, Availability, Maintainability and Safety (RAMS) – Part 2: System approach to safety
EN 50128:2011. Railway applications – Software for railway control and protections systems
Eurocae. ED-216:2012. Formal methods supplement to ED-12C and ED-109A
European ROHS directive or similar
European WEEE directive or similar
Hanssen, G.K., Haugset, B., Stålhane, T., Myklebust, T., Kulbrandstad, I.: Quality Assurance in Scrum Applied to Safety Critical Software. XP 2016, Edinburgh
IAF MD 5:2013. Duration of QMS and EMS Audits. Can be downloaded at www.iaf.nu/upFiles/IAFMD52013QMSEMS_Audit_DurationPub.pdf
IEC 61160:2005. Design review
IEC 61508-1:2010, second edition; Functional safety of electrical/electronic/programmable electronic safety-related systems – Part 1: General requirements
IEEE Std 828 – 2012: Standard for Configuration Management in Systems and Software Engineering
IEEE Std 730-2014: Standard for Software Quality Assurance Plans
IPC-A-610:2010 Acceptability of Electronics Assemblies Training and Certification Program. This document presents acceptance requirements for the manufacture of electrical and electronic assemblies
IRIS certification rules 2017. Rules for achieving and maintaining IRIS Certification recognition. Ed.3
ISO 10005:2005. Quality management systems – Guidelines for quality plans
ISO 10006:2003. Quality management systems – Guidelines for quality management in projects
ISO 17020:2012. Conformity assessment – Requirements for the operation of various types of bodies performing inspection
ISO 19011:2011. Guidelines for auditing and management systems
ISO 26262-6:2011. Road vehicles – Functional safety – Part 6: Product development: software level
ISO 9001:2008. Quality management systems – Requirements
ISO 9001:2015. Quality management systems – Requirements
ISO Std.10007, 2003-06-15: Quality management systems —Guidelines for configuration management
ISO/IEC 14598-4:1999. Software engineering – Product evaluation – Part 4: Process for acquirers
ISO/IEC 25041:2012. Systems and software engineering – Systems and software Quality Requirements and Evaluation (SQuaRE) – Evaluation guide for developers, acquirers and independent evaluators
ISO/IEC 90003:2014. Software engineering – Guidelines for the application of ISO 9001:2008 to computer software
ISO/IEC/IEEE 26515:2011. Systems and Software engineering – Developing user documentation in an agile environment. First edition.
ISO/IEC/IEEE 29148:2011. International Standard – Systems and software engineering – Lifecycle processes – Requirements engineering
ISO/IEC/IEEE 42010:2011. Systems and software engineering – Architecture description. First edition.
ISO/TS 22163:2017. Railway applications – Quality management system – Business management system requirements for rail organizations: ISO 9001:2015 and particular requirements for application in the rail sector
Managing Competence for Safety-Related Systems, IET/BCS/HSE, 2007; (Part 1: Key guidance; Part 2 Supplementary material). HSE. 2007
Myklebust, T., Stålhane, T.: Safety Stories – A New Concept in Agile Development. SafeComp 2016-09, Trondheim
Myklebust, T., Stålhane, T., Hanssen, G.K., Wien, T., Haugset, B.: Scrum, Documentation and the IEC 61508-3:2010 Software Standard. PSAM 12, Hawaii, 2014a
Myklebust, T., Stålhane, T., Hanssen, G.K., Haugset, B.: Change Impact Analysis as Required by Safety Standards, What to Do? PSAM 12, Hawaii, 2014b
Myklebust, T., Stålhane, T., Lyngby, N.: The Agile Safety Plan. PSAM13, Seoul, 2016
Myklebust, T., Hanssen, G.K., Lyngby, N.: A Survey of the Software and Safety Case Development Practice in the Railway Signalling Sector. ESREL Portoroz, Slovenia, 2017
Regarding batteries and accumulators in Europe, see e.g. http://ec.europa.eu/environment/waste/batteries/index.htm
Stålhane, T., Myklebust, T.: The Role of CM in Agile Development of Safety-Critical Software. SafeComp/SASSUR 2015, Delft, Netherlands
Stålhane, T., Myklebust, T., Hanssen, G.: The Application of Safe Scrum to IEC 61508 Certifiable Software. PSAM11/ESREL 2012, Helsinki, June 2012
Stålhane, T., Katta, V., Myklebust, T.: Change Impact Analysis in Agile Development. EHPG Røros, 2014a
Stålhane, T., Hanssen, G.K., Myklebust, T., Haugset, B.: Agile Change Impact Analysis of Safety Critical Software. SafeComp, Sassur, 2014b
Vouk, M.: Back-to-back testing. Information and Software Technology. 32(1), 34–45 (1990)
WKD-STR-006 Core elements for the approval of quality management systems to the European interoperability directive 2008/57/EC
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2018 Springer International Publishing AG
About this chapter
Cite this chapter
Myklebust, T., Stålhane, T. (2018). Safety Case: Quality Management Report. In: The Agile Safety Case. Springer, Cham. https://doi.org/10.1007/978-3-319-70265-0_7
Download citation
DOI: https://doi.org/10.1007/978-3-319-70265-0_7
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-70264-3
Online ISBN: 978-3-319-70265-0
eBook Packages: Computer ScienceComputer Science (R0)