It will happen to you too.

Maybe not today or tomorrow, but it will happen, an unannounced audit from your Notified Body.

Unannounced audits by the Notified Body (NB) are performed without any prior notice or schedule. The auditor can show up at any time and expect to have access to your premises and documentation related to your medical devices, including IVD devices. A Notified Body also has the right to visit your suppliers or subcontractors to check their compliance with applicable requirements and the status of the Quality Management System (QMS). In some cases, the auditor can also take product samples for further examination and analysis.

Unannounced audits can be very stressful and disruptive for your company, but there are ways to make them less stressful and chaotic.

  1. First and foremost, keep your compliance high at all times.
    The best way to avoid any problems during an unannounced audit is to always maintain a high level of compliance with your quality management system and relevant regulations and standards.
  1. Organize your documentation.
    This is of course a part of the above, but your documentation and records are essential for proving your compliance. You should therefore keep them continuously organized and accessible since you won’t have any time for “housekeeping” before the audit.
  1. Have a plan or even better a SOP or instruction for unannounced audits.
    Before the audit happens, you should have a clear plan on how to handle an unannounced audit. The SOP should include how to greet the auditor and confirm their identity. Confirming that the unknown person at your door is who they claim they are is extremely important. So, make sure you outline who is responsible for what, how to communicate with the auditor, and how to escalate any issues if they occur. And don´t forget to assign back-ups for people who might not be available on that particular day.
  1. Train your staff.
    Your staff should be aware of the possibility and the purpose of unannounced audits, and they should know how to act professionally and cooperatively with the auditor. This does of course not differ from any other audit, but the lack of preparation time can cause high stress among staff.
  1. Monitor your critical suppliers and include unannounced audits by NB in your contracts.
    Your suppliers and subcontractors are also part of your quality management system, and they may be subject to unannounced audits by the notified body as well. You must therefore be able to show that you monitor their performance and compliance regularly. You also need to inform your critical suppliers about the potential of unannounced audits by the notified body and agree on how to handle them.

The above tips will help you to demonstrate your commitment to quality and safety in case of an unannounced audit. But it will also increase your confidence and reduce the stress that always comes with an audit, but even more when it comes unannounced.

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