ISO 13485 & EU MDR / ISO 13485 planning related query
My Query is that we don't have DQ/IQ/OQ records for most equipments since they were purchased long before we made this process. Can we make DQ/IQ/OQ records as on today?
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Yes, you can do this records now, but please implement also PQ (performance qualification).
For more detailes how to manage process validation in the medical device manufacturing industry, please read article in the following link: https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/
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