The Countdown Is On
The holidays are near, but so is February 2, 2026—the day QMSR becomes law. Before the year ends, take a few hours to run a quick, structured self-check of your system. A small investment now can save major audit stress later.
The Seven-Point Readiness Checklist
- Documentation & Structure – Do you have a Quality Manual and Medical Device Files aligned with ISO 13485?
- Risk Integration – Is risk explicitly addressed in your SOPs and records?
- Supplier Oversight – Are agreements signed, risk-tiered, and performance trended?
- CAPA Effectiveness – Have you verified that actions worked?
- Training & Competence – Do records show understanding, not just attendance?
- Internal Audit – Have you audited against QMSR requirements and closed findings?
- Management Review – Has leadership reviewed readiness and allocated resources?
End-of-Year Tips
- Archive obsolete procedures and train on new ones.
- Update supplier performance reports for the year.
- Validate data trending tools and CAPA dashboards.
- Schedule for January refresher training.
Celebrate Progress and Plan Ahead
Even if some tasks remain open, acknowledge what you’ve accomplished. QMSR is a journey — not a panic button. Set clear January targets and keep momentum through the final stretch.
Need a quick readiness audit before year-end? Compliance Insight can run a half-day mini-assessment and deliver a prioritized action plan. Contact us today!
