Author: Anne Holland, CEO and Founder
Transitioning to QMSR compliance doesn’t have to be overwhelming—if you take a structured, practical approach. While many companies focus heavily on updating their Quality Manual, compliance runs much deeper. It’s about making sure that every layer of your quality system reflects QMSR principles.
A great starting point is creating or refining your Quality Plan. This is your roadmap for implementation, detailing timelines, responsibilities, and measurable outcomes. The plan should also account for potential resource gaps, whether in personnel training, documentation updates, or process changes.
Another critical step is updating terminology and clause references throughout all controlled documents. Many procedures, work instructions, and forms still reference “21 CFR Part 820” in ways that will soon be outdated. Every instance should be updated to reflect the QMSR framework, ensuring that your documentation speaks the same regulatory language auditors will expect.
Have you incorporated QMSR within your Quality Manual and procedures? This step is more than administrative—it builds the bridge between compliance and operational excellence. It also ensures your team members are speaking the same language when it comes to processes, responsibilities, and expectations.
Preparation is not just about avoiding findings—it’s about building confidence in your compliance posture. Let us help you get there. Lean into quality with medical device systems everyone can trust, and ensure your QMSR transition is not just completed but mastered.
