We are planning to add IS013485 to our AS9100 QMS. I know we are required to have a management review before certification. The way our draft schedule is, a normally scheduled management review (every 3 months) does not fall after implementing the ISO 13485 system and before the stage 1 audit.
While we could do an extra management review, but we would prefer not to. Can we plan the first ISO 13485 management review after stage 1 but before stage 2, with the updated management review agenda ready before stage 1?
I am finding conflicting information if management review needs to be done before the stage 1 audit or can be between stage 1 and stage 2?
While we could do an extra management review, but we would prefer not to. Can we plan the first ISO 13485 management review after stage 1 but before stage 2, with the updated management review agenda ready before stage 1?
I am finding conflicting information if management review needs to be done before the stage 1 audit or can be between stage 1 and stage 2?