This module is the tool for designing the overall architecture of the software to suit your particular business needs. Initially the system administrator will take the first steps and involve others in the running and administration of the software. This is where he/she will assign responsibility for the major functions of the software, usually to managers of functions such as Quality, Human Resources, Calibration, Maintenance, and others. Such responsible people are called “Module Managers” in QISS. Module managers will later manage the particular modules, again by first designing the architecture of the module by assigning authorities and responsibilities to different people.

“The responsibilities and authorities are defined and communicated within the organization.”

ISO 9001:2008 / ISO 9001:2015 Quality management systems – Requirements, Clause 5.5.1

“The organization shall determine, collect and analyses appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the Quality Management System can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.”

ISO 9001:2008 / ISO 9001:2015 Quality management systems – Requirements, Clause 8.4


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