Category Archives: Notified Bodies

Notified Bodies’ Unannounced Audits

On September 24, 2013 the European Commission published a recommendation that Notified Bodies perform unannounced audits in addition to annual and recertification audits. Unannounced audits are already being performed by Notified Bodies and will become common practice over the next couple of years. If you would like to read more about the recommendation, follow the link here: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32013H0473&from=EN.

If you are a manufacturer of medical devices and sell in the EU, than you should be preparing for these surprise visits. Auditors could show up sooner than you expect. The KAS Group has already had some experience with the new unannounced audit recommendation.

KAS Group recently had experience with one of these audits. The Notified Body representatives began by asked to see the manufacturing area. Next, they gathered a sample of lots numbers and announced that they intended to perform lot traceability all the way back to the raw materials. If the trail lead them to other departments such as inspection, quality, purchasing, etc., they would then review those processes as well — this process which is not typical of a surveillance audit. The audit consisted of 5-10 lots which were traced back to the raw materials level, and the audit lasted one day.

The auditors mentioned that their organization would be performing 450 audits this year with the intention of increasing that number to 1500 in 2015. Moreover, these audits will include subcontractors. If a subcontractor refuses an audit, it could jeopardize the certificates of the manufacturer.

If your company is not preparing for audits, it should do so immediately; an audit might be just around the corner. In addition, these audits stress the importance of external audits and communication. It is imperative that your employees and subcontractors are aware of the EU recommendation and that they are prepared. It is also important to communicate with employees and subcontractors what unannounced audits mean for them and your business.

Posted by Spencer Kimber