ISO 13485 internal audit: entrust it to a truly independent auditor.
Your annual internal audit required by clause 8.2.4, run from planning to action plan by an auditor from outside your organisation, with the platform as the engine of the document analysis.
Initial scoping is free, with no commitment. Fixed price, single-site scope.
What you get
- Audit plan
- Audit execution
- Audit report
- Action plan
Good to know
- Scope: one site
Ideal if: you have no independent auditor in-house, or the annual audit is coming up and the team has no time to run it properly.
What ISO 13485 clause 8.2.4 requires
The standard requires internal audits at planned intervals, to determine whether the quality management system conforms to planned arrangements, to the requirements of ISO 13485 and to applicable regulatory requirements, and whether it is effectively implemented and maintained.
Two points are regularly underestimated.
Auditors must not audit their own work
The standard requires auditors to be selected so as to ensure the objectivity and impartiality of the audit process. In a team of three people who have all contributed to the system, that condition is structurally hard to meet.
The audit must cover regulatory requirements
An internal audit that simply works through the chapters of ISO 13485 without testing the system against MDR obligations misses part of its purpose.
The independence problem
In a medical device SME, the quality manager has usually written the procedures, trained the teams and built the records. Asking them to audit that system means asking them to find their own blind spots.
Notified Bodies know this. An internal audit report that finds nothing, or only minor formal findings, is a warning sign, not a cause for satisfaction.
An external auditor brings three things an internal one cannot: no personal stake in the system being audited, a comparison with dozens of other organisations, and the freedom to ask the uncomfortable questions.
Exhaustive coverage, not a sample
A traditional internal audit works by sampling. The auditor has two or three days, picks a sample of files, batches and records, and extrapolates. It is the accepted method, and that is also its limit: whatever is not in the sample goes unseen.
The platform analyses your entire document base before the audit. The auditor therefore arrives already knowing where the inconsistencies are, which documents are out of date and which cross-references do not match.
They can then spend their time on site on what calls for human judgement: understanding why a gap exists, assessing its real criticality, and checking with the teams what the documents do not say.
Frequently asked questions
Yes. Clause 8.2.4 requires auditors to be selected so as to ensure the objectivity and impartiality of the audit process, and states that auditors must not audit their own work. An auditor from outside your organisation meets this requirement structurally, whereas an internal appointment means you have to demonstrate the absence of any conflict.
The standard refers to planned intervals without setting a frequency. Established practice, and what Notified Bodies expect, is full coverage of the system over an annual cycle. Planning must take into account the importance of the processes and the results of previous audits.
An internal audit meets the clause 8.2.4 obligation and covers your quality management system. A mock audit simulates the real conditions of a certification or Notified Body audit, to uncover gaps before the external auditor does. The two are often combined in the year leading up to certification.
No, and that is deliberate. A rehearsed internal audit loses its value. We need access to your documents as they really are and the availability of process owners for interviews. Nothing else.
They appear in the report, graded as such, with proposed corrective actions and their priority. That is precisely the point of the exercise: to uncover major non-conformities while you can still address them, rather than in front of the Notified Body.
Is your annual audit coming up?
Tell us about your scope and your deadline. Scoping is free.