New in the latest version of ISO 13485 is to divide actions taken in response to nonconforming product detected before delivery versus actions taken in response to nonconforming product detected after delivery of the product.

This is a really good change to how the standard addresses these two different scenarios.

Evaluated

Every non-conformance needs to be evaluated for the extent of its occurrence.

For every non-conformance we need to evaluate does it impact one device, an entire lot of devices, or is it over a time period and could impact several lots of devices and where are those devices.

If a non-conformance is limited to devices which have not been delivered, then we can fairly easily quarantine them and prevent them from use until we’ve identified, evaluated and mitigated the non-conformance.

ISO 13485

It should be noted that ISO 13485 refers to responses detected before “delivery” of the product.

This is an important stipulation, because often product may have been shipped to different business partners, but the product has not yet been delivered to the end-user.

In any case, product that is still within the control of the organization may be handled in one of three ways depending on the nonconformity and the risk profile.

The three possible dispositions are typically:

• Eliminate the detected nonconformity.
• Disposition the material for a different use other than its original intended use or application.
• Use the material as is (also known as acceptance under concession).

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