Inlininig procedure for CAPA

This means that, when you detect a nonconformity, first you need to eliminate it, then you need to plan how you will eliminate the cause of this nonconformity. So you need to find out what is the cause of that nonconformity and find out with what actions this cause will be eliminated. When you know your actions, then you need to plan them and document them. If the action requires a change in your documentation, then you should also need to make a change in the proper documentation. Usually, there is a form that covers all elements for properly solving the nonconformity.

Here is the link to the preview of the request form from our ISO 13485:2016 Documentation toolkit:

• Corrective/Preventive Action Request https://advisera.com/13485academy/documentation/correctivepreventive-action-request-iso-13485-2016/

For more information on how to solve corrective action, please see the following articles:

• ISO 13485 continual improvement: Seven-step process for corrective and preventive actions - https://advisera.com/13485academy/knowledgebase/iso-13485-continual-improvement-seven-step-process-for-corrective-and-preventive-actions/
• Seven Steps for Corrective and Preventive Actions to support Continual Improvement https://advisera.com/9001academy/blog/2013/10/27/seven-steps-corrective-preventive-actions-support-continual-improvement/
• How to proceed once a QMS corrective action is defined? https://advisera.com/9001academy/blog/2016/09/20/how-to-proceed-once-qms-corrective-action-is-defined/

In our ISO 13485:2016 Documentation toolkit, you can also see Procedure for corrective action:

• Procedure for Corrective and Preventive Action https://advisera.com/13485academy/documentation/procedure-for-corrective-and-preventive-action-iso-13485-2016/