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Equipment Qualification vs. Process Qualification and Process Validation

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Guest user Created:   Oct 20, 2022 Last commented:   Oct 20, 2022

Equipment Qualification vs. Process Qualification and Process Validation

I am trying to get a better understanding about the guidance on Equipment Qualification vs. Process Qualification and Process Validation. Can you refer me to the sections of the standard that speak about those topics?

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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.

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Kristina Zvonar Brkić Oct 20, 2022

There are no specific direct requirements regarding the process and/or equipment qualifications. There is a requirement in the ISO 13485:2016 6.3 Infrastructure states that the organization will document requirements for the maintenance activities, control of the work environment, and monitoring and measurement. 
 
Further on, in requirement 7.5.6 Validation of processes for production and service provision is stated that the manufacturer must validate any process where the resulting output is not apparent. In this requirement is stated which elements must be covered for the validation.  

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Oct 20, 2022

Oct 20, 2022

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