T
tomate
Hi,
i am new here, so please have a little patience with me.
I am a student of medical engeneering and i am working on a new internal audit schedule for a medical device company (ISO 13485 & 21 CFR 820 certified). At this time the company audits every department/process once a year. I want to create a new schedule based on status and importance.
I found many usefull informations in this cove, but i m still not shure how to understand "importance".
For the Status I will regard the findings of the previous internal and external audits and if there are any new or significantly changed processes.
But which criteria can i use to define which department/process is more or less important!? Of course the Management Review is more risky as the sales department, but how can i justify it seriously?
My last question: is it conform to audit some less important processes (sales?) only every 2 years, if there are no findings in the last internal/external Audits? There is no requirement for annual planing in 13485 or CFR 820, but it's recommended in QSIT...
Thank you for your aid!
i am new here, so please have a little patience with me.
I am a student of medical engeneering and i am working on a new internal audit schedule for a medical device company (ISO 13485 & 21 CFR 820 certified). At this time the company audits every department/process once a year. I want to create a new schedule based on status and importance.
I found many usefull informations in this cove, but i m still not shure how to understand "importance".
For the Status I will regard the findings of the previous internal and external audits and if there are any new or significantly changed processes.
But which criteria can i use to define which department/process is more or less important!? Of course the Management Review is more risky as the sales department, but how can i justify it seriously?
My last question: is it conform to audit some less important processes (sales?) only every 2 years, if there are no findings in the last internal/external Audits? There is no requirement for annual planing in 13485 or CFR 820, but it's recommended in QSIT...
Thank you for your aid!