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Oksana Zhemchugova
Reshetnev Siberian State University of Science and Technology
Russian Federation
https://orcid.org/0000-0003-4850-7874
Violetta Levshina
Reshetnev Siberian State University of Science and Technology
Russian Federation
https://orcid.org/0000-0002-2830-4298
Vol 29 No 3 (2020), Articles, pages 1-13
DOI: https://doi.org/10.15304/rge.29.3.6538
Submitted: 17-01-2020 Accepted: 08-06-2020 Published: 09-09-2020
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Abstract

The relevance of the study is associated with the problem of introducing a risk-based approach in the quality management systems (QMS) of organizations from various sectors according to the requirements of ISO 9001:2015. It hereby offers a new feature of risk classification based on their application in management systems concerning various aspects of organizations activity, in particular, risk in QMS (quality risk). The authors’ definition of the term “quality risk” is presented, and the concept of the “risk-based approach in QMS” is clarified. Methodical approaches to the choice of the complexity of the risk-based approach
depending on the QMS maturity in an organization and the factors of its environment are developed and tested in 46 organizations from various industries.

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