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Traceability Requirements for Computer Hardware Equipment under ISO 13485

F

FongPi

#1
Hello,
After a recent TUV inspection my firm received a letter stating that the requirement for tracking assets such as laptop computers hasn’t been met. Could someone please help me understand where this is stated in ISO 13485? The only computer related requirements in ISO 13485 have to do with software, and not the actual hardware itself. Since all employee computers have unique identifiers which are recorded at the time of distribution, it seems redundant to have to address this all over again. I would like to understand where this requirement comes from and how we can demonstrate compliance with it.
Thank you in advance for sharing your wisdom!
 
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