Mock audit: find your gaps before the auditor does.
A simulation of a certification or Notified Body audit, run under real conditions, with a gap report and prioritised remediation.
Initial scoping is free, with no commitment. Schedule it several weeks before the real audit.
What you get
- Audit under real conditions
- Findings report
- Prioritised remediations
Good to know
- ISO 13485 certification or Notified Body audit
Ideal if: your certification or Notified Body audit is scheduled and you want to find the gaps before the auditor does.
Three audits, three different purposes
Confusing an internal audit, a mock audit and audit preparation is costly, because it often leads you to do the wrong one of the three.
The internal audit meets an obligation
ISO 13485 clause 8.2.4 requires it at planned intervals. It covers your QMS, following a formal audit plan. Its purpose is compliance, not a dress rehearsal.
The mock audit rehearses the event
It reproduces the real conditions of the upcoming audit: the same scope, the same pace, the same demands for evidence, with an auditor who behaves like the Notified Body's. Its purpose is to reveal what would happen on the day.
Audit preparation trains the people
It comes later, a few weeks before, and focuses on how to answer. Its subject is no longer the system but the teams.
What the simulation brings to light
A system can be compliant on paper and still hold up poorly in an audit. Certification audits rarely fail because procedures are missing.
It is almost always a matter of demonstration: evidence that exists but that nobody can find in the time allowed, a record that does not carry the revision of the document it applies, a management review whose decisions are recorded nowhere, a process described in a procedure that the teams have been applying differently for two years.
These gaps only show under real conditions, when someone asks for the evidence and watches what happens next. That is exactly what the mock audit reproduces.
When to schedule it
The right time depends on how long you will need to fix what the mock audit reveals.
Too late, and you get a list of gaps you will not have time to address, and the simulation only adds anxiety. Too early, and the system keeps changing, so the findings lose their relevance.
In practice, two to three months before the real audit leaves time to remediate major gaps and rework the supporting evidence. If your deadline is closer, audit preparation is often the best use of the time left, and we will tell you so.
Frequently asked questions
No. The internal audit meets the requirement of ISO 13485 clause 8.2.4 and must be conducted according to a formal audit plan. The mock audit is a simulation and carries no weight towards that obligation. The two are often combined in the year before a certification, but one does not exempt you from the other.
The one for the audit you are preparing: ISO 13485 certification, a Notified Body audit under the MDR or IVDR, or a surveillance audit. Scope and standard are set at scoping, based on the audit notification or audit programme you have received.
Two to three months is a good benchmark: early enough to fix major gaps, late enough for the findings to remain valid. If your audit is only a few weeks away, external audit preparation is usually more useful than a simulation.
That is the whole point. The auditor asks for evidence in the same terms, applies the same time limits and grades findings against the same criteria. A lenient mock audit is useless: its value lies precisely in being uncomfortable before it counts.
Findings graded as a Notified Body would grade them, distinguishing major from minor non-conformities, and remediation priorities that take into account the time left before the real audit. The aim is an actionable plan, not an inventory.
Is your certification audit scheduled?
Tell us the date and the standard. We will tell you whether a mock audit is still the right use of the time you have left.