Steps for Determining Regular Monitoring and Review of Issues (Clause 4.1)

Check for a Formal Review Schedule:

Does the business have a documented schedule for reviewing external and internal issues, such as quarterly or annually?

Are there established criteria for conducting unscheduled reviews when significant changes occur (e.g., new regulations, customer needs, market shifts)?

Look for a clear, routine process to revisit these issues periodically to ensure they are still relevant and adequately addressed by the QMS.

Assess Responsibilities for Monitoring:

Who is responsible for tracking these issues?

Does the owner or a designated employee have the authority and responsibility to identify changes and initiate reviews?

In smaller businesses, it may be a single person (often the owner or manager), but it’s important that this responsibility is defined to prevent oversight.

Review Evidence of Regular Monitoring:

Check for documentation such as meeting minutes, logs, or reports where internal and external issues were reviewed.

Confirm that there is a record of actions taken in response to changes or developments related to these issues.

Past Meeting Summaries:

Identify any records that show a history of discussions on relevant issues, including notes on adjustments made to align with strategic direction and customer expectations.

Verify Use of Performance Indicators:

What metrics or indicators are tracked regularly?

Key indicators might include customer feedback, supplier performance metrics, or production quality statistics.

These indicators should be directly linked to both internal and external issues to provide measurable evidence of ongoing monitoring.

Trends Analysis:

Review how the business tracks trends over time to help identify shifts in external or internal contexts.

Evaluate Integration with Management Review Meetings

In ISO 9001, management review meetings are a structured opportunity for examining internal and external issues. These should cover topics like customer satisfaction, operational performance, and strategic objectives.

Look for a formal structure to these meetings, which includes reviewing monitored issues and making decisions on necessary adjustments.

Confirm that meeting records reflect the ongoing monitoring of these issues and any actions taken to address significant findings.

Check for a Feedback Loop:

Does the organization gather feedback from employees, customers, or suppliers?

Engaging with stakeholders helps uncover emerging issues or confirm that current ones are still relevant.

Follow-up Processes:
Ensure there is a way to follow up on identified actions and verify their effectiveness in managing the internal and external issues.