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Does anyone have a checklist or some other type of aid document to help with performing a gap analysis? We are wanting to enhance our ISO 9001:2000 Quality System by adding ISO 13485:2003 and obtain a dual registration.
I have an soft copy of 13485 in MS Word there is no Annex B with it perhaps this part was omitted by the person that gave it to me. We manufacture Medical Device Components for our customers with that in mind we would like to add 13485 to our existing ISO 9001:2000 QMS so the gaps between the two standards (might) be a good place to start. Along with a hard copy of 13485 what other guidance material would you suggest?