Hello,
We are currently listed as a Manufacturer and Distributor on our ISO certification. However, during our 1st surveillance audit later this month Intertek wants add Design into the scope of our ISO certification and charge us an extra 0.5 days to review our design files (plus whatever extra related fees they feel like adding in). I'm having trouble understanding why it needs to be added into our scope. Yes, we control the design files (in accordance with FDA requirements) and we have no issue with the auditor reviewing the files during the allotted time of our next audit. We all know that maintaining design controls falls under the responsibility of being a Manufacturer (unless you excluded it from your QMS). So why does this activity need to be added into our certification scope if we did not apply for, or request it? We perform a lot of other activities at our facility that are not required to be listed on the scope. So why do they have to add Design? Did I miss something that lists activities that are required to be on your ISO certificate? Any feedback would be appreciated!
DJC
We are currently listed as a Manufacturer and Distributor on our ISO certification. However, during our 1st surveillance audit later this month Intertek wants add Design into the scope of our ISO certification and charge us an extra 0.5 days to review our design files (plus whatever extra related fees they feel like adding in). I'm having trouble understanding why it needs to be added into our scope. Yes, we control the design files (in accordance with FDA requirements) and we have no issue with the auditor reviewing the files during the allotted time of our next audit. We all know that maintaining design controls falls under the responsibility of being a Manufacturer (unless you excluded it from your QMS). So why does this activity need to be added into our certification scope if we did not apply for, or request it? We perform a lot of other activities at our facility that are not required to be listed on the scope. So why do they have to add Design? Did I miss something that lists activities that are required to be on your ISO certificate? Any feedback would be appreciated!
DJC
