4.4.2 To the extent necessary, the organization shall:
a. maintain documented information to support the operation of its processes;
b. retain documented information to have confidence that the processes are being carried out as planned.
The organization shall establish and maintain documented information that includes:
—— a general description of relevant interested parties (see 4.2 a);
—— the scope of the quality management system, including boundaries and applicability (see 4.3);
—— a description of the processes needed for the quality management system and their application throughout the
——the sequence and interaction of these processes; assignment of the responsibilities and authorities for these processes.
NOTE: The above description of the quality management system can be compiled into a single source of documented information and referred to as a quality manual.