The ISO 13485 covers all phases of the medical device lifecycle and one that must be covered is also the control of nonconforming products. It’s a product or a medical device that does not fulfill its specified requirements like customer or regulatory requirements. It’s important to be identified as soon as possible. Plus, ISO 13485:2016 addresses the management of non-conformity in a medical device even after its use or after its delivery.

The purpose is to separate every medical device from other conforming medical devices. When you separate it, you have to:

  1. Identify it
  2. Separate it
  3. Exclude it or not to deliver it

It’s expected from your medical device company to have a predefined procedure for cases such as nonconformity. A documented procedure that will indicate controls, authorities, and responsibilities must be set when treating non conformed medical devices.


Actions in response to nonconforming product detected before and after delivery

Communication is crucial. It’s recommended to set a person or more in each phase of development product to keep an eye on any nonconformity. The main thing is to detect them. Be aware that it can occur in raw material, components, or finished medical devices. For the whole process to be effective, you have to implement systematic controls.

After it was identified, it must be evaluated, investigated, and documented.


Documenting non-conforming product

All gathered info about non-conformity should be in a way to help you out with mapping the problem and tracking down the root cause. Bear in mind that this documentation is the first step in a process that will later lead to corrective action. When documenting the nonconformity, it is recommended that you record any characteristics of the medical device (or the service) at the time of the nonconformance. It will serve you later on when you evaluate the effects of the nonconforming product.



Corrections of nonconforming medical devices may be seen as reworking. It includes the repair, reworks, reprocessing, or any other adjustments of the medical device.

If a medical device needs to be reworked (one or more times), your company has to document the rework process in a work instruction that has undergone the same authorization and approval procedure as the original work instruction. It has to be reviewed and approved in the same process as the original work instruction before being submitted for execution. Plus, each rework instruction will refer to a specific nonconformity.

Like everything else, parameters of the rework may affect the quality. Each person involved in the design and development of the medical device will evaluate and give their professional opinion regarding the effect of the rework.







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