Author: Anne Holland, CEO and Founder
Once your quality system is updated for QMSR, the next critical step is ensuring it’s not just compliant on paper, but in practice. Monitoring performance and verifying compliance through audits is how you protect your company from unexpected findings and costly corrective actions.
Training is the first line of defense. Your team should fully understand the differences and similarities between the Quality System Regulation (QS) and the QMSR. This training should go beyond reading updated procedures—it should actively compare and contrast the requirements, using real-world examples from your own processes to highlight where changes are most impactful.
After training, a well-planned internal audit is essential. An audit allows you to test the effectiveness of your updated QMS under QMSR requirements before an external auditor does. This is your opportunity to find and correct gaps proactively, strengthening your compliance.
Performing this step with the support of experienced quality professionals ensures your audit is thorough, objective, and aligned with regulatory expectations. With our expertise, we’ll help you identify risks, confirm your documentation reflects actual practices, and reinforce confidence across your organization.
Don’t let your hard work in updating your QMSR documentation go unverified. Lean into quality with medical device systems everyone can trust—and let our team conduct your internal audit to ensure you’re fully ready for what’s ahead.
