Are you in Medical Devices, Pharmaceuticals, Biologics, or In-Vitro Diagnostics and wondering if your Quality System is up to par? Many companies offer very transactional internal audits that allow an organization to check that requirement off the compliance list. We perform audits that not only check all the boxes but also provide an assessment of your QMS’s effectiveness and efficacy.

 

With our audits, the organization learns much more than whether each requirement is being met; it uncovers whether the QMS meets the intent and provides value (business benefit) beyond compliance, i.e., reduced cost of poor quality, safer products, a more competitive reputation, and more.