2.16.1 QUALITY PROCESSES/QUALITY PROCEDURES/WORK INSTRUCTIONS Quality processes, quality procedures, work instructions, methods, etc. are defined at an organisation level by the functional area experts, and at project and function level by the experts in those areas separately Organisation level processes act as an umbrella, whereas project and function level processes are in the purview of these top-level process definitions. Organisation level set ofprocesses may differ from the process definition for different projects and functions. It is also defined as quality planning at project level. Quality procedures must be in sync with the tone established by quality manual at an organisation level.