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The current valid version of ISO 9001 from 2015 provides a few changes, including change planning, identifying all stakeholders, the term high level structure (HLS) and risk management based on Risk-based Thinking (RBT). Even if there are already many papers which describe the concept of the last version, there are still questions about following some of the “new” requirements from the standard. Especially today, when Industry 4.0 as a concept introduces a new perception about Safety and Security, it is necessary to understand the purpose of the standard requirements linked directly with the risks and their perception. Nowadays, at a time of system integration, it is not possible to elevate the system’s requirements over standard elements of the current Industrial Revolution referred to as Industry 4.0. RBT in management system integration does not have a strictly defined structure. Each organisation applies its own procedures and tools to evaluate and manage business risks, which present some limitations resulting from the overall culture and aims of the organisation. In an effort to integrate management systems, a production system applying Industry 4.0 requirements can involve many new limitations resulting from past ideas about integration and also the opportunities associated with knowledge management.

The paper is based on a survey made in different manufacturing organisations with the aim to analyse the level of Industry 4.0 implementation. Detailed research was focused on analysing current trends of RBT implementation in industrial enterprises (engineering, metallurgy, and automotive industry), comparing new requirements of ISO 9001 with the level of application in their processes. At the same time, the utilisation of Industry 4.0 in the management of these processes and its impact on Safety and Security were evaluated.