We just got a message from our ISO 13485 CB, that the upgrade to ISO 9001:2015 along with the renewal of the ISO13485 will now attract a minimum 2 day upgrade audit. The two days is contingent on conducting the audit concurrently with a regularly scheduled ISO13495/9001 audit. The cycle will continue forward perhaps with an additional 1.0 to 1.5 days surveillance audit and 2.0 additional days in triennial recertification audit. These additional days will be in addition to the normally scheduled days to perform the ISO 13485 audits.
We need to give our agreement within a months time failing which it means that we are no longer interested in keeping certification to ISO9001.
We need to give our agreement within a months time failing which it means that we are no longer interested in keeping certification to ISO9001.