Risks in quality management systems: What does ISO 9001:2015 intend?

This paper deals with the concept of risks introduced in the 2015 version of ISO 9001 standard, which substitutes a single preventive actions clause for a comprehensive approach throughout the Quality Management System, called risk-based thinking. It is based on decades of experience of the authors in Quality Management Systems for several organizations and the participation in standardization in ISO/TC176/SC2, ISO/TC176/SC3 and ABNT/CB25 (Brazil).
A major challenge in the management of companies is to improve their results continually and consistently. Classic management systems based on the Plan-Do-Check-Act (PDCA) cycle contain the incremental improvement when, at each cycle, correct the causes of the difference between what has been planned and the actual processes. The proactivity happens when, with risk-based thinking instilled in the culture of the organization, situations that could potentially put at risk the achievement of the goals at any level (strategic, tactical and operational) are prevented. The situations, in which advantages of opportunities for improvement, not necessarily related to situations of risk, are also considered.

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Risks. Quality Management. Opportunities for improvement.