Audit Software for ISO 13485
In quality management for medical devices, evidence is what counts: notified bodies and authorities expect a documented audit procedure, objective auditors and corrective actions that are tracked without gaps. IMS-Audit Cloud documents your internal audits to ISO 13485 in an audit-proof way — with field-level change tracking and reports that the notified body’s auditor can follow directly.
Internal audits under ISO 13485
In clause 8.2.4, ISO 13485 requires internal audits as evidence that the quality management system conforms to the planned and documented arrangements, the requirements of the standard and the applicable regulatory requirements, and is effectively implemented:
- Conduct internal audits at planned intervals
- Maintain a documented procedure for planning and conducting audits
- Define and record the audit criteria, scope, frequency and methods
- Select auditors so as to ensure objectivity and impartiality — nobody audits their own work
- Take into account the importance of the processes and the results of previous audits when planning the programme
- Corrections and corrective actions without undue delay — with verification of their effectiveness
- Retain records of the audits and their results
Note: this overview summarises key requirements and does not replace the text of the standard.
From requirement to practice — with IMS-Audit Cloud
Documented audit process
From the audit programme through criteria and audit team to the report — every step is held centrally on the audit and retained as evidence.
Go to feature →CAPA with effectiveness checks
Corrective and preventive actions with root cause analysis, deadlines, automatic escalation — and the documented effectiveness check that the standard explicitly requires.
Go to feature →Audit-proof evidence
Field-level change tracking: who changed what, and when? The history answers the notified body’s questions at a click.
Go to feature →Catalogues & checklists
Ready-made ISO 13485 standard catalogue sold separately; you import your own checklists on regulatory requirements via Excel.
Go to feature →Audit programme & deadlines
The audit programme as an annual overview; deadlines from action management flow into the calendar automatically.
Go to feature →Reports for third-party audits
Audit reports as PDFs in your corporate design, reproducible at any time from the recorded data — ready to print for the management review and certification audit.
Go to feature →ISO 13485 and internal audits
What does ISO 13485 require for internal audits beyond ISO 9001?
ISO 13485 places particular emphasis on documentation: a documented audit procedure; recorded criteria, scope, frequency and methods; and the explicit verification of the effectiveness of corrective actions. On top of that, the applicable regulatory requirements serve as a benchmark for the audit.
Does IMS-Audit support providing evidence to the notified body?
Yes. All audit data, findings, actions and their effectiveness checks are held centrally and in an audit-proof way with a field-level change history — you generate reports as PDFs directly from the recorded data.
Is there a ready-made question catalogue for ISO 13485?
Yes. The ISO 13485 standard catalogue is one of the ready-made standard catalogues available from us separately — just get in touch. You create your own catalogues at any time or import them via Excel.
Can I combine ISO 13485 with ISO 9001?
Yes. Many medical device manufacturers run both systems in parallel — in IMS-Audit Cloud you audit them in one system, with a shared audit programme and one action cockpit.
More answers — on pricing, hosting and contract terms — in the FAQ.
Also part of the integrated management system
Audit Software for ISO 9001
audit programme, question catalogues, corrective actions and reports — with IMS-Audit Cloud.
Learn more →Audit Software for ISO 27001
audit programme, risk assessment, actions with escalation and audit-proof evidence — with IMS-Audit Cloud.
Learn more →Audit Software for ISO 45001
audit programme, site inspections on a tablet, actions with escalation and reports — with IMS-Audit Cloud in the browser.
Learn more →Internal audits under ISO 13485 — see it for yourself.
All modules included, no set-up fee — in a personal meeting we show you the cloud using your own topics.