To assess if your quality management system (QMS) meets the requirements of ISO 9001 section 5.1.2(a), you need to verify that you have a clear, consistent approach to understanding and meeting customer, statutory, and regulatory requirements. Here’s a guide on what to examine to determine if you are currently compliant with this requirement.

1. Identification and Documentation of Customer Requirements:

Start by reviewing how you capture and document customer requirements. This includes any specific quality, delivery, and service expectations that your customers have for your products or services. Look for evidence that you have a structured process in place, such as documented requirements from contracts, order specifications, or customer feedback. If these requirements are missing, incomplete, or inconsistently recorded, this may indicate a gap in ensuring that customer needs are fully understood and met.

2. Determination of Statutory and Regulatory Requirements:

ISO 9001 requires that you also understand and comply with relevant legal and regulatory requirements. Check if you have a list of applicable regulations, such as industry-specific standards, health and safety laws, or environmental requirements. This list should be up-to-date and relevant to your products, services, and business operations. Additionally, ensure there is a process for regularly reviewing and updating these requirements as laws and regulations change. If there’s no clear documentation of these regulatory obligations, or if updates are handled reactively rather than proactively, this could be a gap in your system.

3. Consistency in Meeting Requirements:

Meeting these requirements isn’t just about identifying them once but ensuring they are consistently applied throughout your processes. Review if you have documented procedures or quality checks in place to verify compliance at each stage of production or service delivery. Look for records such as inspection reports, audit findings, or compliance checklists that show how you consistently meet customer, statutory, and regulatory requirements. If you lack documented evidence or if compliance checks are sporadic, this may suggest that your system does not fully meet the consistency requirement in section 5.1.2(a).

4. Involvement of Top Management:

Finally, ensure that top management is actively engaged in promoting customer and regulatory focus. Evidence of this involvement might include management’s participation in regular quality reviews, customer feedback meetings, or discussions around regulatory updates. Check if leaders set objectives around customer satisfaction or compliance, and if they regularly monitor these metrics. If top management is not visibly involved in these areas, this may indicate a need for stronger leadership in customer focus.

By assessing each of these areas, you can determine if your QMS meets the requirements of section 5.1.2(a) or if further improvements are necessary to demonstrate a consistent focus on customer and regulatory requirements.