14.4  Quality Manuals and Procedures

If any Quality Plan refers to, relies on or incorporates any quality manual or procedure, then such quality manual or procedure or the relevant parts thereof shall be submitted at the same time that such Quality Plan (or part thereof) is submitted pursuant to the Review Procedure, and the contents of such quality manual or procedure shall be taken into account in the consideration of the relevant Quality Plan (or part thereof) pursuant to the Review Procedure.