Hello,
apologies if this is a daft question, but I'm still a bit of a newbie when it comes to QMS stuff. A recent BSI Auditor wrote the following in an NC report, can anyone explain what it actually means??
There was no evidence that assessment criteria used was according to ISO 13485:2016 and other applicable standards
Thanks in anticipation of your help.
Keith.
apologies if this is a daft question, but I'm still a bit of a newbie when it comes to QMS stuff. A recent BSI Auditor wrote the following in an NC report, can anyone explain what it actually means??
There was no evidence that assessment criteria used was according to ISO 13485:2016 and other applicable standards
Thanks in anticipation of your help.
Keith.