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Critical non-conformities

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Guest user Created:   Apr 07, 2021 Last commented:   Apr 09, 2021

Critical non-conformities

What can I do if critical nonconformities have been detected and my boss wants to continue the production without taking corrective actions?

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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.

Expert
Kristina Zvonar Brkić Apr 09, 2021

Nonconformance is not necessarily a bad thing because each non-conformance is an opportunity for improvement. ISO 13485 in sections 8.3 Control of non-conforming products and 8.5.2 Corrective action include clear and in-depth guidance on how to respond to any nonconformity discovered through your processes, connected with customer complaints, or conducted audits (both external and internal). 

The potential impact of non-conformity on your organization depends on the size and type of the nonconformance. When critical issues are discovered in the production process this may lead to the product of an unsafe medical device. Un-safe medical devices present both risks for the patient/end-user, but also for your company because your company’s rating can be compromised. 

If Top management needs to be involved in solving critical non-conformities by ensuring certain resources (financial, infrastructure, or human), they must be aware of the consequences that may have not solving non-conformities.

So, prepare a full explanation of what the consequences are if you do not resolve the nonconformity and provide that evidence Top management. If Top management has no ear for this, you can always contact the Board of Directors, the owner, or some other entity that is above your boss.

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Apr 07, 2021

Apr 09, 2021