R
rfoley14411
Hi! I am very familiar with ISO13485 - the version before current & knew the really old ISO9002. A few starting questions on the new ISO 9001:
-Can you still 'grandfather' the old ways - understanding you need compliant documentation, need to stake the sand by date & do it right going forward?
-Design & Development: I have no prior knowledge so am trying to get going on understanding this.
-We make our own 'standard' parts that we have been making forever, have controlled datasheet that customers order from & we control changes to them - will I need to do anything for D & D on this?
-We also make 'custom' parts that are generated from initial customer inquiry with their specs - we figure it out, spec & control on our end & get their approval before starting - is this acceptable or is something further needed?
Thank you in advance!!
-Can you still 'grandfather' the old ways - understanding you need compliant documentation, need to stake the sand by date & do it right going forward?
-Design & Development: I have no prior knowledge so am trying to get going on understanding this.
-We make our own 'standard' parts that we have been making forever, have controlled datasheet that customers order from & we control changes to them - will I need to do anything for D & D on this?
-We also make 'custom' parts that are generated from initial customer inquiry with their specs - we figure it out, spec & control on our end & get their approval before starting - is this acceptable or is something further needed?
Thank you in advance!!