Surviving my first external audit in a new sector!


After 15 years of Quality Management System experience in the automotive sector, I have built quite some experience in preparing and following external IATF 16949, ISO14001 and ISO 45001 audits. I was under the impression that I had seen it all and that nothing could surprise me while undergoing and external audit…

Was I wrong there!

This year I started my new project for Quality Tracking as QMS Manager in a, for me, completely new sector: Medical Devices, at an international company in the south of Holland.

Day after King’s day, the external audit ISO 13485, Quality Management for Medical Devices, was planned on the 28th and 29th of April. Two weeks before the actual audit, the Quality department was well prepared and ready to undergo the audit.

To my surprise, only a few members of the Quality team were actively involved in the audit. To give you an impression, for this audit 3 meeting rooms were designed as below:

  • Front Room 1 (FR1) with the First Quality Head, one script and the external lead auditor.
  • Front Room 2 (FR2) with the Second Quality Head, a second script and the external co-auditor.
  • Back Room, devised in 2 teams of 3 people (Back Room 1 to support Front Room 1, Back Room 2 to support Front Room 2).

The communication between the Front Room and Back Room was done via Teams. All actions were followed through the action tracker in Teams for FR1 and FR2 to prepare documentation and to ask stakeholders to prepare their answer with Back Room before communicating their feedback to the auditor in the Front Room (an approach known from the FDA audits in USA to avoid presenting a wrong document to the auditor which can be critical for the certification of the company).

The results of this audit demonstrate the goal of this approach: no findings and two recommendations. Comparing this way of auditing with my experience of external audit in the automotive sector, I have missed a very important part of an external audit: the involvement and the ownership of each process owner, as part of the Quality Management System!

So indeed, never a dull moment while undergoing an external audit!

Marie-Dominique Sommier – QT Lead Consultant

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