SOP for Control of Nonconforming Product/Proces

According to the ISO 13485:2016, there is a requirement for the SOP for the Control of nonconforming product (requirement 8.3.1 General).

Return merchandise authorization is covered in the requirement 8.3.3 Actions in the response to non-conforming product detected after delivery. Usually, this requirement is covered in the same SOP for the Control of non-conforming products. Organizations must take actions appropriate to the effect that non-conforming products can be issued.

For more details, please see the following article:

• 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/
• Understanding dispositions for ISO 9001 nonconforming product https://advisera.com/9001academy/blog/2014/11/18/understanding-dispositions-iso-9001-nonconforming-product/

On the following link you can see how our procedure and template for the non-conforming product look like in ISO 13485:2016 Documentation toolkit:

• Procedure for Control of Non-Conforming Products https://advisera.com/13485academy/documentation/procedure-for-control-of-non-conforming-products-iso-13485-2016/
• Non-Conforming Product Record https://advisera.com/13485academy/documentation/non-conforming-product-record-iso-13485-2016/