To determine if your quality management system (QMS) complies with ISO 9001:2015 section 4.4.1 part (f), you need to evaluate how effectively your organization identifies and addresses risks and opportunities related to your processes. This aligns with the requirements of section 6.1, which emphasizes proactive risk-based thinking and leveraging opportunities to enhance process effectiveness and achieve desired outcomes.

1. Identifying Risks and Opportunities

Begin by reviewing how your organization identifies risks and opportunities within your processes. This involves analyzing how comprehensively you assess internal and external factors that could impact your QMS. Look into any formal methods you use, such as SWOT analysis (Strengths, Weaknesses, Opportunities, Threats) or FMEA (Failure Modes and Effects Analysis), which can help in systematically identifying potential risks and opportunities.

Evaluate the documentation you have in place that outlines identified risks and opportunities. Ensure that there is a structured approach to capturing and assessing these factors. It’s important that this documentation is detailed and regularly updated to reflect changes in your operating environment or business objectives.

Next, assess how effectively your organization is managing these risks and opportunities. Verify that there are action plans in place to mitigate risks and capitalize on opportunities. Check if these plans include specific actions, assigned responsibilities, resources needed, and timeframes for implementation. This can be reviewed through risk registers, mitigation plans, or opportunity assessments.

Confirm that there is an ongoing process for monitoring and reviewing the effectiveness of these actions. This could involve regular meetings, audits, or performance reviews that check whether the actions taken are reducing risks or leveraging opportunities as intended. Additionally, evaluate the flexibility of your approach to adjust these actions as new risks and opportunities emerge or as circumstances change.

2. Ensuring Continual Improvement

Finally, check how this proactive management of risks and opportunities is integrated into your broader QMS framework to drive continual improvement. There should be evidence that insights gained from risk and opportunity management are fed back into your system for further refinement of processes, training, and strategic planning.

By thoroughly evaluating these aspects, you will be able to verify if your QMS meets the compliance requirements of ISO 9001:2015 regarding the management of risks and opportunities. Address any identified gaps with action plans that reinforce a culture of risk-based thinking and opportunities for enhancing process efficiency and quality outcomes.