Conducting your 1st internal audit for ISO 13485:2016 certification

You are applying for ISO 13485:2016 certification, and during the application process you learn that you are required to complete a full quality system audit prior to the Stage 1 certification audit. Does anyone in your company have the qualifications to conduct an internal audit?

In most start-up MedTech companies the only person qualified to conduct an internal audit is the Quality Manager, and they can't audit their own work. Therefore, you need to hire a consultant to conduct your first internal audit. You need to know what to expect during the Stage 1 and Stage 2 certification audits, you need to know if a preassessment has any value to you, and you need to know what tasks need to be complete before you are ready to conduct your first internal audit.

Rob Packard is a former certification body auditor for BSI, and Vanessa Lucien is a quality and regulatory consultant located outside Montreal that helps Medical Device Academy conduct internal audits of MedTech start-ups.