TÜV SÜD has carried out more than 1,000 unannounced audits at medical device manufacturers worldwide since March 2014. The surprise visits to factories follow from EU Commission Recommendation 2013/473/EU of September 24, 2013, and have since become a mandatory element in the audit program of the Notified Bodies. In spite of initial concerns, all the new audits were handled smoothly and professionally by both manufacturers and auditors. The TÜV SÜD auditors have collected the questions frequently asked by manufacturers in unannounced audits and compiled them in a clear and concise FAQ document. This free document in PDF format will prove a helpful guide and reference for all manufacturers of medical devices who wish to prepare thoroughly for unannounced audits. The latest revision of the document in English updated in May is available for download here.
All you need to know about unannounced audits – Frequently Asked Questions (FAQs) [ PDF 1158 kB ] [updated as of May 2017]
These documents may also be of interest to you:
Unannounced audits: What to expect from product testing of high-risk devices (March 2015)
Unannounced audits: First on-site visits without problems (January 2015)