Auditing process

First of all, you can start with checking the procedure, is there a procedure in place, who is responsible to carry out the procedure, to whom non-compliances products should be reported. Then you can check when the last time was reported non-conforming product and how it was resolved. Have any corrective actions been taken, what records are there about that? Review the evidence that the corrective action taken is effective.

For more detail on this topic, you can see the following articles:

• ISO 13485:2016 nonconforming product – How to approach the post-delivery actions https://advisera.com/13485academy/blog/2017/04/11/iso-134852016-nonconforming-product-how-to-approach-the-post-delivery-actions/
• What are the consequences of noncompliance with ISO 13485 for manufacturers of medical devices? https://advisera.com/13485academy/blog/2017/11/02/what-are-the-consequences-of-noncompliance-with-iso-13485-for-manufacturers-of-medical-devices/
• Five steps for ISO 9001 non-conforming products https://advisera.com/9001academy/blog/2014/01/13/five-steps-iso-9001-nonconforming-products/

You can see how we prepared the form for the non-conforming product so, maybe it will give you an idea about the additional questions:

• Non-Conforming Product Record https://advisera.com/13485academy/documentation/non-conforming-product-record-iso-13485-2016/
• Registry of Non-Conformities https://advisera.com/13485academy/documentation/registry-of-non-conformities-iso-13485-2016/