ISO $9001$:$2015$

Can you provide some auditing questions and answers to below process Medical devices alerts

The Trust Medical Engineering Manager will evaluate the Medical Device Alerts to establish whether this alert is applicable to the department.

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$$ If applicable to the Medical Engineering Department it must be determined whether the information applies to any of the equipment on the Trust Equipment Inventory Database.

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$$ If not applicable the Trust Medical Engineering Manager will update the Trust Risk Management Datix System.

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If action is required, the Trust Medical Engineering Manager emails out to the relevant Team Manager$($s$)$ the Medical Device Alerts and the definitive list of equipment for them to action.$$ The Trust Medical Engineering Manager or Team Manager adds the alert to e$-$Quip and jobs are created to carry out actions required.

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It is the responsibility of the Team Manager$($s$)$ to take responsibility to action the Medical Device Alerts. The Team Manager$($s$)$ shall respond back by email to the Trust Medical Engineering Manager that action has been taken within the specified time period. The Team Manager shall save any Medical Device Alerts emails communications in their allocated Medical Device Alerts email folder.

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It is the responsibility of the Trust Medical Engineering Manager to ensure that all Medical Device Alerts are actioned and monitored through to closure.

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The Trust Medical Engineering Manager will update the Trust Risk Management $$Datix$$ System with the action taken and save the actioned Medical Device Alerts in the allocated file in the Common Folder.

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