Audit the QM system

Safely navigate audits with an ISO-13485 trial audit

There is no need to be unsure about or even afraid of audits. Conduct a trial audit with our (ISO 13485 lead) auditors.

  • So you know exactly where you stand.
  • The trial audit’s specific recommendations will provide you with step-by-step instructions to quickly remedy deficits.
  • You will have already fulfilled the ISO 13485 requirement for an "internal audit" and will therefore be able to look forward to your notified body's visit with peace of mind.

Get in touch with us now for an accurate assessment of whether you will pass your next audit!

Contact us

Your five steps to a successful audit

  1. Getting in touch

    • You get in touch with us
  2. NDA

    • We sign a joint NDA
  3. QM manual review

    • You send us your QM manual and your procedure instructions. Our team studies these documents and uses them to create an audit plan. This takes a day at most.
  4. Internal audit

    • We visit you and audit your organization for a day or two. You then receive a differentiated audit report that lists all non-conformities and, if requested, contains specific suggestions for action. This adjustment takes a matter of hours.
  5. Implementation of measures

    • You implement the measures and invite your notified body to a certification audit that you will pass without any problems.

We typically need between two and three days in total. If the trial audit lasts two days, we can incorporate training elements and train you, for example, for your role as a safety officer or internal auditor. It is a regulatory requirement that you have these competencies.