Calculate your potential savings with our ROI Calculator
ROI CalculatorRisk-based thinking is a proactive mindset and decision-making approach that incorporates risk identification, assessment, and treatment into all facets of an organization. ISO standards create an expectation for businesses to use a risk-based thinking process to look at performance, according to the ISO 9001:2015 standard document. Risk-based thinking is the overall application of an organization’s processes, where each organization has different processes and must look at their performance in assessing themselves against all its other processes.
While ISO 9001 previously included a preventive action requirement, ISO has developed a systematic approach to control and manage an organization's risk through risk-based thinking. Organizations using this approach must now develop risk-based thinking into their general planning, evaluation of performance, and regulatory compliance. Organizations will be required to demonstrate risk-based thinking that must be used throughout their processes, strategies, and objectives.
According to the 2015 standards, risks and opportunities are addressed in different ways at various levels of the organization.
Context of the Organization: When determining the context for quality objectives of an organization, it must identify risks that may impact those objectives.
Leadership: Top management must endorse a risk-based approach throughout the company. This includes ascertaining and addressing opportunities and risks that may impact product and service quality.
Planning: As part of its planning process, the organization must identify risks and opportunities and then plan, implement, and manage its processes to address those risks.
Operations: The organization must ensure that actions listed in the planning step are implemented and controlled.
Performance evaluation: The organization must monitor, track, and evaluate identified opportunities and risks.
Improvement: If there is an increase in risk, the organization must take corrective action.
To fully implement a risk-based thinking model within quality management processes, it is essential to incorporate it into your processes and not treat it as an additional process. Therefore, utilizing risk tools as part of your QMS will ensure that you will be able to identify and manage risks proactively.
While ISO 9001:2015 does not specify the tools and methods for managing risks, traditional manual procedures are time consuming and difficult to manage. The ideal way to implement your risk-based thinking strategy is to use automated solutions such as QMS software or risk and opportunity management software.
Implementing a risk-based thinking approach in your organization is more important than just having the option to grow and be profitable. Creating an atmosphere of actively managing risks can help you ensure the quality of processes and products, improve overall efficiency, and meet legal and regulatory responsibilities.
