The quality system shall be based on all of the following activities:

  • quality planning: establishing structures and planning integrated and consistent processes;
  • quality adherence: carrying out tasks and responsibilities in accordance with quality requirements ;
  • quality control and assurance: monitoring and evaluating how effectively the structures and processes have been established and how effectively the processes are being carried out; and
  • quality improvements: correcting and improving the structures and processes where necessary [IR Art 8(3)].