Corrective Actions - Current Expectation of ISO 13485 and FDA Auditors
August 27, 2015 - Fremont CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Fax:302-288-6884
Overview: This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. There will be a review of the corrective and preventive action requirements. We will cover how corrective actions should be used throughout your Quality Management System. Definitions of Correction and corrective actions, their differences and importance will be covered. Examples of each will be provided. Information will be provided to make sure your Corrective Action system including your procedures meets current FDA Quality System Regulation and ISO 13485 expectations. This includes how this leads to a robust Corrective Action system for meeting FDA Corrective Actions expectations. Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://www.compliance4all.com/control/w_product/~product_id=500406LIVE support@compliance4all.com www.compliance4all.com