ISO 9001:2015 places a great deal of emphasis on using risk to drive processes and make decisions. The old mindset of using corrective and preventive actions to deal with adverse events has been replaced with the risk-driven approach, aiming to prevent it from happening rather than recovering once it happens. For those that are new to Risk Management, however, this can be a challenging shift. Not only do business leaders need to understand the latest standard, they need to understand the role of risk and the tools available to them to help manage risk.
This white paper will overview the major shifts that ISO 9001:2015 presents within the context of risk, mainly focusing on building your quality management system around risk. Next, it will outline the key features of risk and the process of Risk Management, while applying that to the new standard. Finally, it will give examples of common tools for leveraging Risk Management in your organization: The Decision Tree, Risk Matrix, Failure Modes and Effects Analysis, Bowtie Matrix and Risk Register.