ISO AssistantKeep ISO 13485 quality records under control
Bring controlled documents, supplier NCRs, training and audit evidence into one workspace. Keep responsibilities clear and follow-up connected for your medical device quality system.
From everyday tasks to audit-ready evidence
Take a 1:49 tour of ISO Assistant: records, reminders, audits, management reviews and document approvals.
1:49 demo · Captions included
Illustrative NCR entry: a missing lot identifier on medical device components.
ISO Assistant workspace
Connect supplier non-conformances to competence evidence
For medical device suppliers, incoming-material checks, controlled instructions and staff competence need clear records. Capture a lot-identification issue in an NCR, then document the instruction changes and training needed to strengthen receiving checks.
- Document supplier non-conformances, affected materials and containment in an NCR.
- Keep receiving and inspection instructions under revision and approval control.
- Reference the relevant instruction in training records and record attendance and effectiveness.
- Maintain calibration, maintenance and audit evidence alongside the quality records.
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.
Explore it yourself or get a guided walkthrough
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