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Risk Analysis of the external and internal environment according to ISO 9001:2015

Marieta Stefanova, Svetlana Todorova


Many biscuit manufacturers face the issue of updating quality management systems based on a risk analysis imposed by recent changes to ISO 9001:2015. It has been found that the main innovation in the standard is the determination of the analysis of the risk related to the influence of external and internal factors of the environment. The purpose of this study is to apply in practice a methodology for risk analysis of the external and internal environment of the organization using the example or the case of biscuit production. The model is based on an expert evaluation and includes the simultaneous application of FMEA (failure mode and effects analysis) and PESTLE (Political, Economic, Social, Technological, Legal and Environmental) analyses. The application of the two methods has allowed the identification of risk priorities in the internal and external environment, and their ranging has allowed the identification of activities necessary to reduce or eliminate risks. The paper is expected to be particularly useful for those organizations that are about to update their quality management systems according to ISO 9001: 2015.


risk analysis, risk priorities, FMEA, ISO 9001:2015

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