An analysis of two new process approach-related terms in ISO 9001:2015: Risk-based thinking and context of the organization

Abstract

This paper is focused on understanding "risk-based thinking" and "context of the organization" in the process approach according to the requirements of the updated norm, ISO 9001:2015 Quality Management Systems - Requirements. These new trends should increase the ejfectivity of the quality management system, should improve company results, and should prevent negative effects of processes. This article explains how to understand the context of the organization in order to make correct strategic decisions. The author describes the integration procedure of risk-based thinking into several organizations in the Czech Republic. This article can support organizations in the implementation of the best practice of new requirements of ISO 9001:2015. This paper is focused on several production organisations from the different industrial area in the Czech Republic. This research is based on the up to date research data of world's databases. The author used the qualitative method in the form a structured interview. © 2019 University of Pardubice.