ISO 9001:2015 – Demystifying Risk-Based Thinking for Quality Management
Understanding Risk-Based Thinking in ISO 9001:2015 IntroductionThe 2015 revision of ISO 9001 introduced a significant shift: a systematic approach to considering risk, moving beyond treating "prevention" as a separate element of a quality management system. This paper aims to clarify risk-based thinking in ISO 9001, address concerns about it replacing