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SOP for Control of Nonconforming Product/Proces

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Guest user Created:   Nov 23, 2020 Last commented:   Nov 25, 2020

SOP for Control of Nonconforming Product/Proces

We currently have no process for RMAs, but we do have an SOP for Control of Nonconforming Product/Proces. Typically, do you see these as separate SOPs, or are they usually combined? I'm relatively new to ISO 13485 and 9001 and am not really sure how to go about writing the procedure for this.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Nov 25, 2020

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:

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:

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Nov 23, 2020

Nov 25, 2020