ISO9001 GAP Analysis Question 7 How to verify 4.4.1 g regarding changes to processes

To verify compliance with ISO 9001:2015 section 4.4.1 part (g), you need to evaluate whether the processes within your quality management system (QMS) are achieving their intended results and if changes are effectively implemented when necessary. Start by reviewing your documented objectives for each process. These objectives should be clear, measurable, and aligned with both your business goals and the requirements of the ISO standard.

Check if there is a consistent system for assessing process performance against these objectives. This involves examining performance data, including any key performance indicators (KPIs) or metrics that have been established. Analyze whether these metrics are being met consistently or if there are any deviations. For processes that do not meet intended results, ensure there's a documented procedure for reviewing and analyzing areas of shortfall. This should include conducting root cause analysis to understand underlying issues.

Next, verify that there are mechanisms in place for implementing changes and improvements. Look for records of changes made to processes in response to performance evaluations. This includes any modifications to processes, resources, or training that have been implemented to address issues or enhance performance. Check if these changes are formally documented and communicated to all relevant personnel. It's important that your team understands the changes and their roles in sustaining improvements.

Finally, ensure there is evidence of monitoring the impact of these changes. This involves reviewing follow-up data to confirm that changes have led to the desired improvement in process performance. There should be a proactive approach to continuous improvement, with regular management reviews assessing the effectiveness of changes and determining further opportunities for enhancement. By examining these aspects of your QMS, you can ensure compliance with part (e) of the standard, demonstrating an ability to adapt and optimize processes to consistently meet quality objectives.