How does an organization address risks and opportunities in ISO 9001

In ISO 9001:2015, addressing risks and opportunities is a fundamental part of the quality management system (QMS), aiming to increase the effectiveness of the QMS, achieve improved results, and prevent negative effects. The standard requires an organization to integrate a risk-based thinking approach into its overall processes. Here's how an organization can address risks and opportunities according to ISO 9001:

1. Understanding the Context: The organization needs to understand its internal and external context, including any factors that can impact its QMS objectives. This understanding helps in identifying potential risks and opportunities.

2. Planning: Once the risks and opportunities are identified, the organization should plan actions to address these. This includes deciding how to:

   • Mitigate or eliminate the risks.
   • Enhance opportunities to achieve the intended outcomes of the QMS.

3. Integration into the QMS Processes: The actions to address risks and opportunities are integrated into the organization's QMS processes. This integration ensures that risk-based thinking is embedded in the planning and execution of all QMS processes.

4. Evaluation of Effectiveness: The organization must evaluate the effectiveness of these actions. This involves monitoring, measurement, analysis, and evaluation of the actions taken to address risks and opportunities.

5. Documentation: ISO 9001:2015 does not explicitly require documented procedures for risk management. However, the organization needs to maintain documented information to the extent necessary to have confidence that the processes have been carried out as planned.

6. Continual Improvement: Addressing risks and opportunities is a continuous process. The organization should regularly review and analyze the risks and opportunities and take corrective actions to continually improve the QMS.

7. Leadership and Commitment: Top management must demonstrate leadership and commitment to the risk management process. They should ensure that the resources needed for risk management are available and that its importance is communicated throughout the organization.

By following these steps, an organization can effectively manage risks and opportunities, leading to the enhancement of customer satisfaction and continuous improvement of its quality management system.