QMSR Assessment

1 of 12 — Does your executive team demonstrate visible commitment to quality?

Yes — Leadership actively champions quality Partially — Some involvement but inconsistent No — Quality is delegated without oversight

2 of 12 — Do you have a documented QMS roadmap aligned with ISO 13485 / QMSR?

Yes — Documented and actively followed Partially — Exists but not current No — No formal roadmap

3 of 12 — Have you established a Quality Manual or equivalent top-level documentation?

Yes — Current and ISO-aligned Partially — Exists but needs updating No — No Quality Manual

4 of 12 — Are design controls in place for product development?

Yes — Full design control process Partially — Some controls, gaps exist No — No formal design controls

5 of 12 — Do you have a risk management process integrated into development?

Yes — Risk integrated throughout Partially — Risk analysis exists but isolated No — No formal risk management

6 of 12 — Is there a functioning document control system?

Yes — Controlled with approvals and versioning Partially — Some control, not comprehensive No — Documents not controlled

7 of 12 — Are quality responsibilities clearly defined and documented?

Yes — Roles documented and understood Partially — Some roles defined No — Responsibilities unclear

8 of 12 — Do you have a supplier qualification and oversight process?

Yes — Risk-based qualification and monitoring Partially — Some suppliers qualified No — No formal supplier process

9 of 12 — Is there a process for handling nonconformances and corrective actions?

Yes — CAPA system with effectiveness checks Partially — Process exists, gaps in execution No — No formal CAPA process

10 of 12 — Do you conduct internal audits or management reviews?

Yes — Regular audits and reviews Partially — Infrequent or incomplete No — No audits or reviews

11 of 12 — Is your team aware of the differences between 21 CFR 820 and QMSR?

Yes — Team trained on changes Partially — Some awareness No — Team unaware of changes

12 of 12 — Does your organization foster a quality culture where issues are reported early?

Yes — Open culture, issues escalated quickly Partially — Mixed, depends on the team No — Issues often hidden or delayed

QMSR Readiness Self-Assessment