Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

“Audit-Proof” Your Labeling

Posted by crimsonlanguage on 2012/11/20

Labeling and labeling translation processes are getting more and more attention these days. In fact, most auditors don’t actually examine the translated labeling itself (though some might) – rather, following the “process model” they will look at your translation process and the basis of approval for your translation suppliers.

On more than one occasion, clients have contacted us to request copies of our ISO certificates for an in-process audit. In these situations, we typically send our ISO 9001, ISO 13485, ISO 14971 certificates along with our Notified Body endorsements and, more recently, a copy of the cover page for our labeling translation risk management patent (U.S. Pat No. 8,140,322 B2).

Did that provide the proof that the auditor was looking for? You bet!


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