To determine if your quality system meets ISO 9001 section 6.1 requirements for addressing risks and opportunities, you need to look closely at how your organization identifies, plans, and integrates actions for managing risks and pursuing opportunities. Here’s what you should assess in your current system to identify compliance gaps.

1. Consideration of Relevant Issues (6.1.1):

Start by reviewing if your organization has assessed both internal and external issues as outlined in sections 4.1 and 4.2. You should have a clear understanding of factors that impact your ability to meet quality objectives—such as customer requirements, market trends, or regulatory changes. Confirm whether there is documentation or evidence (e.g., risk assessments, strategic planning notes) that shows these factors have been evaluated. If this assessment hasn’t been done, or if it’s informal, it may be an area to address.

2. Identifying and Addressing Risks and Opportunities (6.1.1a-d):

Verify that you have a structured approach to identify both risks (potential negative impacts) and opportunities (potential positive impacts) for your QMS. Ask yourself if there is a documented list or register of risks and opportunities, as well as an outline of actions taken to enhance positive outcomes, prevent negative ones, and support continuous improvement. If these risks and opportunities aren’t documented, or if actions aren’t defined, this could indicate a gap in compliance.

3. Planning Actions to Address Risks and Opportunities (6.1.2a):

You should check if there is a clear plan that outlines how your organization will address each identified risk and opportunity. Actions should be proportionate to the potential impact on product and service quality, meaning critical risks should have robust actions to mitigate them. This might include contingency plans, new initiatives, or quality checks. Look for evidence, like documented plans or meeting notes, that actions are carefully considered based on the importance of each risk or opportunity.

4. Integration and Evaluation of Actions (6.1.2b):

Assess how well these planned actions are integrated into your quality management processes. For example, confirm if actions are embedded in your operational workflows, procedures, or work instructions, and check if roles and responsibilities are assigned for implementation. Also, look at how you measure the effectiveness of these actions—do you have metrics or reviews in place to evaluate if the actions are achieving the intended results? If there is no follow-up or performance tracking, this could be a compliance gap.

5. Proportionality of Actions:

Lastly, review if the actions taken are appropriate to the potential impact of each risk or opportunity. Ensure that more significant risks receive greater focus and that opportunities are realistically pursued without overwhelming resources.

By examining these areas, you can gauge if your current system aligns with section 6.1 requirements. Identifying any gaps will help you make targeted adjustments to improve your QMS’s capacity to handle risks and capitalize on opportunities effectively.