4.4.1、The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.
The organization’s quality management system shall also address customer and applicable statutory and regulatory quality management system requirements.
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:
a. determine the inputs required and the outputs expected from these processes;
b. determine the sequence and interaction of these processes;
c. determine and apply the criteria and methods (including monitoring, measurements and related performance indicators. needed to ensure the effective operation and control of these processes;
d. determine the resources needed for these processes and ensure their availability;
e. assign the responsibilities and authorities for these processes;
f. address the risks and opportunities as determined in accordance with the requirements of 6.1;
g. evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h. improve the processes and the quality management system.