Re: Quality Objectives - where to document them
Where is the best place to document the Quality Objectives required by ISO13485? As an appendix to the Quality Manual or in a separate independent document - is there a typical way to document them accross the medical device industry?
Thanks for any help
Alice
Hi Alice...
It is best to your convenience. Keep it prominent and visible.
Remember that it is the top management that has to establish quality objectives at relevant areas. If you are establishing it, ensure that the same has been recorded in the management review and has management decision.
As you have got to make a measure of the set objective, and see if you are meeting it., it is best to have it put up on your area notice board.
There is no typical way and what suits you best is best for you. Let it not get hidden in paper files or computer files...