For medical device manufacturers, the word 'audit' can trigger quite a reaction.

Start-up teams may sway between confusion and panic. Even seasoned manufacturers tense up. They know all too well what is at stake. Your processes, people, and product files are about to be examined in great detail.  The danger of a poor audit is rarely just one dramatic failure. It’s rather the death by a multiple small findings.

Key team members may be unavailable, critical documentation may be outdated, incomplete or inconsistent, and the wrong people might be sitting in front of the auditor trying to defend processes they don’t fully own.  A poorly handled audit does not just risk delaying certifications. It burdens your team with months of remediation, erodes trust and confidence, and cost you significant momentum forward.

On the flip side, well-prepared audits offer far more than just a clean report. They accelerate internal alignment, validate the quality system under real-world scrutiny, and consolidates your team. Your audit success is to a large extent decided by your preparations. As Camilla Messerli puts it, “A prepared audit team doesn’t just survive an audit - they profit from it.”

Getting to that point takes planning and practice. A successful audit begins not on the day itself, but the moment the audit date is set. Make the most of the time prior to the audit by preparing thoroughly and in a structured manner to increase your probability of passing the audit.

In this article, we will explore a structured audit preparation approach and practical insights shared by Camilla Messerli, a seasoned expert in audit situations. Her methods blend structure with adaptability, offering tangible advice that can help any team face audits with professionalism and clarity.

The audit scope may seem like a simple notification, a few lines in an email or a formal letter, but it carries essential insights for planning.

The scope defines the specific areas, processes, products, or systems that will be included in the audit. Importantly, it also (implicitly more often than explicitly) tells you what is excluded from the audit.

From the scope, you can start deducing which team members must be involved and which member need to be present during the audit. Check their schedules before confirming an audit date to make sure the necessary people have time to prepare and are available to defend their areas during the audit. There is nothing worse than having one or several of your key players not being able to attend the audit…

Closer to the actual audit date, you will receive a detailed audit plan. While the scope tells you what will be audited, the audit plan shows how and when it will happen. It includes the detailed agenda, time slots, auditor names, and often specific references to standards or processes.

Review the plan carefully to assign the right experts to the right sessions, avoid scheduling conflicts, and ensure no topic is left uncovered.

Check out the Auditor(s)

With the plan, you will also be notified about the auditor themselves. Do not forfeit the chance to take a closer look at the auditors. A quick search on LinkedIn can reveal their areas of expertise, industry background, and even personal preferences.

Knowing whether an auditor has a deep background in software, manufacturing, or regulatory affairs helps you anticipate which topics they may scrutinize more thoroughly based on their expertise. It also allows you to brief your team accordingly and prepare stronger examples in those areas.

Prepare the Team

Even though it is documents, records and physical artifacts that are most often audited, it is the people presenting them that is the key to your audit success.

Assign clear responsibilities early on to your team and follow up diligently that they conduct their individual preparation on time. Each section of the audit should have a designated process owner or subject matter expert presenting and defending it. These individuals should be involved early in the preparation and have full visibility into the audit agenda, so they can prepare their materials and anticipate potential questions.

Train your team in audit behavior. This is just as important as preparing the content. Audits have a rhythm and tone that can feel unnatural to those unfamiliar with them. Teach your team to stay calm, answer only what is asked, and avoid scrolling through unrelated documents when sharing screens. Internal audits are a powerful tool here. Use them as dry-runs to simulate real audit situations. Give your team feedback not only on the answers they give, but on their body language, clarity, and ability to find information quickly.

There are a few additional roles to consider for an audit. For example, make sure that you assign a person taking notes during the audit, including recommendations that the auditor makes, as these have a tendency not to end up in the final report. This person (or your QMR) should circulate and process these recommendations post-audit. Also make sure that you assign a “back-end” team, that is available to prepare documents outside the audit room, if required. And lastly, make sure someone is in charge of the room preparations and food/drinks. There is nothing worse, than hungry and unhappy auditors…

Clean up the content

Content preparation is where good audits are won. Start by reviewing the audit agenda and identify which processes, records, or product documentation will be discussed in each session. Ensure that all documents in these areas are up to date, completely filled out, signed, and easy to locate, both digitally and physically.

Have strong, representative examples of your work prepared and ready, and where possible, choose products or files you’ve recently reviewed or cleaned up. If you’ve deviated from a template or skipped a step in a process, be ready with a written justification.

Make sure all HR records are solid, that all trainings have been completed, that work contracts as well as evidence of competence such as education certificates are filed correctly for all employees.

Going through your Supplier Management and Quality Events is also a mandatory task for a thorough preparation.

Prepare the Room(s) for Audit Day Logistics

Since the auditor is supposed to stay in the audit room throughout the majority of the audit, a well-prepared audit room sets the tone for the entire inspection. Start by removing any unrelated documents, cleaning whiteboards, and ensuring that no sensitive or messy materials are visible (auditors notice everything).

Provide water, coffee, and light snacks to keep the atmosphere calm and focused, especially during long sessions. A word about lunch: prepare for a lunch that minimizes waiting time and is resilient to delays in the schedule. Sandwiches nearby are always a popular choice.

Always keep a printed copy of the audit agenda available for easy reference, along with enough seating and workspace for laptops and note-taking. Check power outlets in advance and provide adapters or converters, especially if the auditor is coming from abroad.

And finally, be ready to offer Wi-Fi access. If you have a guest network, have login credentials ready. If you do not have a guest network, take appropriate measures (you do not want to let the auditor in to your company network unchecked) or inform the auditor accordingly.

Plan for Post-Audit Activities

It’s a classic mistake: once the audit is over and the tension lifts, teams move on, often too quickly. But the days immediately following the audit are critical. Now is when you should debrief internally, review your notes, and assign actions not only for formal findings, but also for informal observations or weak spots your team noticed during the audit, but the auditor didn’t flag. 

These overlooked details often reveal the most valuable opportunities for improvement. Make sure to allocate time and resources for this phase in your audit plan, or risk losing insights that could strengthen your system before the next inspection.

Conclusion

Audits don’t have to be all about stress. By preparing early, understanding the scope and the auditor’s focus, and training your team to respond with clarity and professionalism, you can significantly increase your chances of not just passing the audit, but benefiting from it. Audits are not obstacles; they're opportunities. With the right mindset and structured preparation, your team can walk into any audit ready, composed, and in control.

After completing her Master's in Infection Biology at the Tropical Health Institute of Basel (University of Basel), she began working at a Swiss IVD company called BÜHLMANN Laboratories. Her work there led her to appreciate the role of Quality Managers, both in product management and in quality systems.

Following a brief temporary contract with Roche Diagnostics in Rotkreuz, she moved on to Effectum Medical AG, where she has since been working as a Senior Quality Manager and Head of Quality Management and Regulatory Affairs—both for the products for which the company acts as legal manufacturer and as a consultant for other companies.