Q
Hello,
My company is currently implementing ISO 13485 and I am attempting to do a GAP analysis. I just needed some clarifications as to what is required of the quality manual in the last paragraph of section 4.2.2 Quality Manual.
"The quality manual shall outline the structure of the documentation used in the quality management system"
Does this mean I have to do a chart mapping of all of our documents in the QAM?
If yes, can I just include those procedures which are required by ISO 13485?
Does anyone have any examples of what they did for their company?

Any help would be greatly appreciated!
My company is currently implementing ISO 13485 and I am attempting to do a GAP analysis. I just needed some clarifications as to what is required of the quality manual in the last paragraph of section 4.2.2 Quality Manual.
"The quality manual shall outline the structure of the documentation used in the quality management system"
Does this mean I have to do a chart mapping of all of our documents in the QAM?
If yes, can I just include those procedures which are required by ISO 13485?
Does anyone have any examples of what they did for their company?
Any help would be greatly appreciated!
. That makes sense and is much simpler than what I was thinking.