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Hello,
First off, I am new to Quality Management so please be patient with me. We are a small medical device company and starting to build our Quality System. Along the line, I see that there is a need for a 'Master Item File'. To me, it sounds like it's a record of all the item we use in the production of our product.
Is this true? Does such file have to be made for every product or can it be a universal file for all the products we manufacture? Is it even a requirement by the FDA?
How would you define the master item file?
Thanks.
First off, I am new to Quality Management so please be patient with me. We are a small medical device company and starting to build our Quality System. Along the line, I see that there is a need for a 'Master Item File'. To me, it sounds like it's a record of all the item we use in the production of our product.
Is this true? Does such file have to be made for every product or can it be a universal file for all the products we manufacture? Is it even a requirement by the FDA?
How would you define the master item file?
Thanks.
I see this is your first post!