The article delves into the significance of risk-based thinking in the ISO 9001:2015 Quality Management System (QMS) standard. One of the primary concepts introduced in this standard is the systematic approach to considering and addressing risks and opportunities as an essential component of the quality management system. This approach contrasts with the previous version, ISO 9001:2008, which treated ‘prevention’ as a separate entity. The 2015 version emphasizes proactive action, making risk considerations integral to the system.
The article further elaborates that risk is inherent in all facets of the quality management system, and risk-based thinking aids in identifying, considering, and controlling these risks. Such review is not new; we do it daily, like assessing risks when crossing a road. The ISO 9001 standard has always incorporated risk-based thinking, but the latest version weaves it into the entire management system, from inception to evaluation. This approach ensures that preventive action is inherent in planning, operation, analysis, and evaluation activities.
Additionally, the article underscores the benefits of risk-based thinking. For organizations, this approach promotes a proactive culture, ensures product and service quality consistency, enhances customer confidence, and aids in regulatory compliance. The article also touches upon the relevance of internal and external issues in identifying risks, the criteria for evaluating risks, and various tools and techniques for risk identification and analysis. The emphasis is on the importance of a structured and systematic risk identification and analysis approach.
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