QMS standards are based on the process approach. Any activity that is receives input and converts it to output can be considered as a process. In order to company function effectively, it should identify and manage linked processes (nonconformity reporting, CAPA, audit management, etc.).
It’s all connected
Systems consist of processes, and processes are made up of tasks. When scheming and implementing a QMS, this hierarchy of systems, processes, and tasks is important to help deploy an effective and compliant QMS.
When thinking about a system, processes, and tasks as related to QMS documentation, the system relates to the quality manual, the processes bind to procedures, and tasks associate to work instructions.
It can be a bit hard to build and maintain the process approach having a paper-based QMS. So, having QMS managed by the software is a better alternative.
Built to support
qmsWrapper is built to support the processes approach. It comes with already included processes that address QMS requirements. Processes are defined through the flowcharts as the sequence of tasks that are assigned to specific users, depending on the process.
We like to say that processes implement SOPs through a series of tasks and decisions in a sequence where one triggers another assuring nothing is left behind.
Once the processes are created, the ISO compliance then becomes easier as you only have to start them in a project. The QMS Process will automatically create and assign subsequent tasks. It’s intuitive as the QMS processes predetermine all the essential QMS tasks so none is forgotten. Of course, you still have to perform and update the task-related work, maintaining conformity with ISO throughout.
The implementation of processes ensures that every step is tracked, documented, validated, and approved.
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What is MTQ?
We call this approach the Management Through Quality (MTQ). The Management Through Quality compliance is different because the focus is not on quality as the end game, but rather on quality as the process to achieve compliance. MTQ means as your team members complete their tasks, they trigger QMS events that get automatically reported to the QMS system where managers can oversee the progress in qmsWrapper.
The team is working on their task not knowing it is a compliance matter, without adding another layer of management and bureaucracy to their daily work.
Such a processes-oriented system enables users to become more efficiently involved in QMS. The quality becomes everyone’s business! This ultimately leads to compliance which is not limited only to “reporting” or tracking of reports.