Since the basis for an ISO9001-based QMS is the process approach to managing organizations as a system of interrelated processes, we need to start with identifying the organization's core processes. Examples include the Sales Order Process, Order Fulfill Process, Purchasing Process, Project Management Process, Quality Planning Process, etc. Once identified, we need to assign ownership for these processes. Everyone in the organization works in one or more of these processes and has a role to play.
No longer does the burden for the QMS fall on just a couple dedicated employees. The managers who were not previously engaged in the QMS are now process owners. Process owners are responsible to establish, document, and maintain their respective processes and work to continually improve its effectiveness and interaction with other processes.
This is where we begin. Then to sustain these changes we audit. We audit the process to ensure each has an approach that is deployed where needed, delivers intended results, and is continually improved. We also audit process results to ensure the process has key performance indicators, tracked levels of performance, and positive trends.
This is where we begin when we must start from scratch. Then once the leadership fully embraces and masters the process approach by managing the organization as a system of interrelated processes the rest of the QMS requirements are relatively easy to deploy.