ISO 9001: 2015 introduction of explicit risk-based thinking - benefit or limitation?

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This paper presents the results of a research study which aimed to evaluate the impact the revised quality management standard ISO9001: 2015 has had, through the introduction of the explicit riskbased thinking approach. Using semi structured interviews four key themes were identified; Impact, Benefits and Limitations, Training and Change Management. The results from this small scale
introductory research study have provided an early insight into the impact the revised standard has had on both organisation and customer to date from a quality professional perspective. The results have shown that ISO9001:2015's introduction of explicit risk-based thinking will have a negligibly beneficial effect on the organisation and customer. The study has also identified that the introduction of the revised quality management standard has been considered as low impact /previously established either implicitly through the standards previous edition or as part of research participants pre-existing quality management systems and processes. This paper provides early additional knowledge relating to a risk-based thinking approach and the revised ISO9001:2015 quality
management standard. It also points to the need for further review after the revised standard has become fully embedded and the 2008 equivalent has been made fully obsolete. Organisational value is also considered, for organisations looking to introduce an ISO based quality management system or modify existing quality management system to be capable of meeting the revised requirements.
Original languageEnglish
Pages (from-to)29-40
Number of pages12
JournalAsigurarea Calitatii - Quality Assurance
Issue number94
Publication statusPublished - Jun 2018


  • quality
  • quality management
  • ISO
  • ISO9001:2015
  • risk-based thinking
  • auditing
  • impact


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