Description
Why it is useful
The purpose of the CAPA process is to prevent the recurrence and the occurrence of nonconformities.
How to use it
1. If you are recording a new CAPA use this form to record the information associated with the CAPA.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before the review of the document.
All texts that are not blue are example texts that can and should be edited by you and tailored to your situation.
Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text updated to suit your situation.
Support
If you have questions about the content of the template, you may ask questions in the support forum. The support forum is accessible on this link when you are logged into your Medical Device HQ account.
Need quality management training and a course certificate?
Should want to learn more about using the template or quality management in general, it is covered in two of our public training courses: Introduction to Quality Management for Medical Devices and ISO 13485 and Quality Management for Medical Devices and ISO 13485 blended course. Our blended courses combine a self-paced online course first followed by a live virtual classroom session.