Webinar on Best Practices for FDA and ISO 13485 Corrective Actions
This webinar will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity.
- (1888PressRelease) May 16, 2014 - Complianz World, a US based company, is a leading GRC training provider, brings a range of topics related to compliance, delivered through webinars by industry experts.
Even though ISO 13485 requirements for Corrective Actions stress finding and correcting the root cause of a non-conformity, which is the essence of Corrective Action, that is not enough. Containment and Correction must now be an integral part of your system. With FDA's increasing emphasis on enforcement, doing robust corrections and corrective actions is a must Course Objective:
For many year, early in the life of ISO 9001 and ISO 13485, it to a lot of education on the part of ISO auditors to teach companies the difference between Corrections (fixing the problem) and Corrective Actions, fixing the root cause of the problem. And companies learned that well, and generally meeting expectations of their ISO auditors. However, now, although corrections are usually being done, they are usually done under other portions of ISO 13485, such as control of nonconforming product and customer feedback and complaints. These often have little visibility in the Corrective Action system, and generally do not address at all containing or correcting quality system issues that are often a major part of a Corrective Actions system. So now ISO auditors, or at least ISO 13485 Notified Body auditors, are expecting that companies now document and provide evidence that they are doing containment or correction, and quickly as well!
Course Outline:
Overview of CAPA system for Current ISO 13485 compliance
Why Containment and Correction have been overlooked
Why this is a hot item with ISO auditors
What is really the difference between correction and corrective action
What kinds of containment can be done for Quality System nonconformities
Defining and documenting Containment actions - Quickly
Where does Preventive Action fit in
Examples of Containment actions
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