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ISO 13485 planning related query

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Guest user Created:   Feb 27, 2020 Last commented:   Feb 28, 2020

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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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 Feb 28, 2020

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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Feb 27, 2020

Feb 28, 2020