ISO 13485 Readiness Assessment

1. Quality Manual & Procedures

We maintain an up-to-date Quality Manual and controlled procedures covering all QMS processes.

0 1 2 3 4 5

Not at all Fully in place

2. Management Commitment

Executive leadership reviews QMS performance and resources at planned intervals.

0 1 2 3 4 5

Not at all Fully in place

3. Product-lifecycle Risk Management

Formal risk analyses (per ISO 14971) drive design and process decisions.

0 1 2 3 4 5

Not at all Fully in place

4. Design Controls

Design inputs, verification, validation and DHF are rigorously documented for every device family.

0 1 2 3 4 5

Not at all Fully in place

5. Supplier Qualification & Monitoring

Approved-supplier lists, scorecards and periodic re-evaluations are in place.

0 1 2 3 4 5

Not at all Fully in place

6. Traceability & UDI

We can link components to finished goods, distribution, and UDI records in seconds.

0 1 2 3 4 5

Not at all Fully in place

7. Software Validation

All QMS/production software is validated proportionate to risk (IQ/OQ/PQ and change control).

0 1 2 3 4 5

Not at all Fully in place

8. Integrated eQMS

Quality data flows seamlessly across departments with secure version control and audit trails.

0 1 2 3 4 5

Not at all Fully in place

9. Internal Audit & CAPA

We run risk-based audits, track CAPAs to closure, and verify effectiveness.

0 1 2 3 4 5

Not at all Fully in place

10. Gap-Assessment Culture

We routinely benchmark our system against ISO 13485 and regulatory updates to identify gaps.

0 1 2 3 4 5

Not at all Fully in place

ISO 13485:2016 & FDA QMSR Readiness Assessment