To effectively determine and address risks and opportunities in an ISO 9001 QMS, an organization can follow these steps:

- Determine potential risks and opportunities that could impact the QMS and its objectives using tools like SWOT analysis and Failure Mode and Effects Analysis (FMEA).

- Evaluate the significance of each risk and opportunity regarding their potential impact on processes, product or service quality, customer satisfaction, and the organization's ability to meet its goals, considering both internal and external factors.

- Develop strategies to address and mitigate risks while harnessing opportunities. Create action plans, allocate resources, and set measurable objectives.

- Put the plans into action, ensuring that all relevant personnel know their roles and responsibilities.

- Continuously monitor and review the effectiveness of the risk and opportunity management processes, adjusting them as needed to maintain QMS performance.

Integration into the QMS involves documenting these risks and opportunities, incorporating them into decision-making processes, and regularly reviewing them for changes. This approach should be complemented by involving employees at all levels, ensuring risk management is a continuous, organization-wide effort aligned with quality objectives and strategies.