ISO 8.5.3 d and 8.5.4 d state:
verifying that the action does not adversely affect the ability to meet applicable regulatory
requirements or the safety and performance of the medical device;
One NB auditor insisted that every CAPA has to be checked or approved by regulatory department. We think that is only related to the device, otherwise the standard would say so. For instance, a CAPA triggered by QA related training , which is not related to the 'medical device' does not need RA" blessing"- your opinion?
verifying that the action does not adversely affect the ability to meet applicable regulatory
requirements or the safety and performance of the medical device;
One NB auditor insisted that every CAPA has to be checked or approved by regulatory department. We think that is only related to the device, otherwise the standard would say so. For instance, a CAPA triggered by QA related training , which is not related to the 'medical device' does not need RA" blessing"- your opinion?
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