The risk-based approach in organization quality management systems

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.

Keywords

• ISO 9001:2015
• Risk-based thinking
• Quality managemente system
• Organizational environment
• Maturity of the quality management system
• Quality risk