ISO 13485 internal audit scheduling tool
Generate a structured internal audit schedule aligned with ISO 13485:2016.
Building an internal audit programme shouldn’t be guesswork.
ISO 13485 requires organisations to establish a planned audit programme that reflects the importance and risk of the processes within the quality management system.
This tool guides you through a short set of questions about your organisation and generates a structured audit schedule aligned with ISO 13485 expectations.
Build your audit schedule
Use the tool below to generate a structured internal audit programme aligned with ISO 13485.
Assess risk and coverage
The tool considers process importance and risk when structuring audit priorities.
Answer a few questions
Provide basic information about your QMS, including scope, exclusions and audit history.
Generate your
audit schedule
A structured internal audit schedule is created for review.
Built by a Lead Auditor
This tool was developed by Adam Rae, UKASwitnessed and BSI Certified Lead Auditor, based on experience conducting ISO 13485 and MDR audits.
It reflects the structured approach regulators expect when reviewing internal audit programmes.
“I’ve spent much of my career inside audits and certification reviews. When organisations prepare properly, those assessments become constructive: not something to fear.”
Adam Isaacs Rae
Founder
Need additional audit support?
Independent auditing can help ensure your programme stands up to regulatory review.