ISO AssistantISO 13485 software for practical quality-system control
ISO Assistant helps medical-device-related suppliers and SMEs keep quality-system records under control, including document control, training, NCRs, traceable records, calibration, maintenance and audit readiness.
Training evidence can stay linked to the controlled record that triggered it.
ISO Assistant workspace
Practical fit
Control the quality records that need traceability
ISO 13485 environments need disciplined records, current instructions and clear follow-up. ISO Assistant supports practical quality-system maintenance where your process needs controlled documents, training evidence and operational registers.
Audit readiness
Support quality-system control
- SOPs, work instructions and revision history
- Training records linked to current procedures
- NCRs, incidents, corrective actions and follow-up
- Calibration, maintenance and audit evidence
Standards note
Useful ISO software depends on your process, not certification promises.
ISO Assistant does not imply regulatory approval or certification. It helps manage records and workflows that may support an ISO 13485 quality system, depending on your organisation's requirements.