Equipment Qualification vs. Process Qualification and Process Validation

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.