The Quality Management Development based on Risk-based Thinking Approach according to ISO 9001

Uncertainty always surrounds enterprises and could be the source of events that can have a negative and positive impact on it. The success of a modern enterprise increasingly depends on its ability to recognize such events in a timely manner and to implement the corresponding response actions before their onset. The management of risks and opportunities is aimed to improve the stability of the enterprise in modern dynamic market conditions. The standard ISO 9001:2015 does not require the introduction of risk management, confining itself to risk-oriented thinking approach. But in fact the new ISO 9001:2015 requirements can be realized with the introduction of a systematic approach to the risk management. The article analyzes the requirements of ISO 9001:2015 regarding risks and opportunities. The content of risks and opportunities is investigated. The review of terminology in the field of risk management is carried out. The risk management mechanisms presented in international risk management standards have been studied: ISO 31000, ISO 31010, the OGC's guidance for the management of risk, the PMI's practice standard for risk management. The authors give explanations on the development, updating, application, registration and preservation of documented information in the field of risks. The experience of enterprises introducing risk management has been analyzed, difficulties encountered with them have been revealed. Under research authors present recommendations on the application in practice of the requirements of ISO 9001:2015 in the field of risks. The research presents the conceptual model of risk management, reflecting the place of risk management of the quality management system in the general management system. Also the research identifies the main processes of risk management in quality management with indication of inputs and outputs. The presented approach is based on the requirements of ISO 9001:2015 Standard and can be adaptively implied in practice.