The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by this International Standard, and
d) documents, including records, determined by the organization to be necessary to ensure the effective
planning, operation and control of its processes.
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of, and justification for, any exclusions
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.