A
Hello-
I'm an auditor for a class II MedDev 13485-certified firm. For the last couple of years (we became certified 2 years ago) I've been including every sub-system (as defined by 13485) in the audit schedule and specifically auditing each one a minimum of once per year. However, when I was recently reading over the standard I noticed that there is no specific requirement in the standard stating that this frequency of audit is necessary.
Does anyone know what ISO's expectations are in this regard? I'm considering spacing out the frequency of some of the subsystems in which my company has a better showing to once every couple of years, leaving me more time to focus on higher areas of risk - but I don't want to jeopardize our certification by not sticking to the "once per year" regimen...
thanks
I'm an auditor for a class II MedDev 13485-certified firm. For the last couple of years (we became certified 2 years ago) I've been including every sub-system (as defined by 13485) in the audit schedule and specifically auditing each one a minimum of once per year. However, when I was recently reading over the standard I noticed that there is no specific requirement in the standard stating that this frequency of audit is necessary.
Does anyone know what ISO's expectations are in this regard? I'm considering spacing out the frequency of some of the subsystems in which my company has a better showing to once every couple of years, leaving me more time to focus on higher areas of risk - but I don't want to jeopardize our certification by not sticking to the "once per year" regimen...
thanks
is not to see the audit frequency just as a number but do a Risk analysis of your QMS and see if its okay to do it once a year / twice a year.