Dealing with a medical device company. I am wondering whether environmental deviations beyond action limits should be handled (i.e. assessment on the affect to product as well as remedial actions to bring area back into compliance) within the environmental monitoring system or whether each environmental deviation should be idnetified as a product noncofnromance and handled via nonconforming product controls. In the latter example the excusion would trigger a noncofroming product report and the assoicated product assessment and remedial actions would be determined and documented via the MRB council (there is an environmental subject matter expert that sits on this panel) What are your thoughts? Is there anywhere in the standards that this is clearly addressed?

Thanks

Can anyone help with info on this?

Welcome to the Cove.

You post in the ISO 14001 forum so I guess you have an EMS. Any environmental deviations should be documented as provided for in your environmental management system - be it an NC or CA and the root cause traced and identified. If it has something to do with product non conformance, addressed it.

It seems you are confused by a similar provision in your Quality management system. One addressed quality issues and the other environmental.