ISO9001 requires a Quality System to adopt a process approach which is summed up by the phrase;
Plan – Do – Check – Act
Which means what?
Plan – how to meet the requirements of customers and ISO9001. Planning includes the preparation of Policies, Objectives, defining Processes, deciding how to control processes and on suitable process measurements.
Do – implement the plans using training, suitable equipment, suitable environment, procedures, work instructions, statistical techniques, presentations, more training, in fact whatever is appropriate to provide control.
Check – monitor and measure what has been implemented, report results, analyse data.
Act – take action using the information generated by the Quality System to make business decisions to improve processes. This in turn requires further planning, doing, checking and acting.
And so the process goes on and on. The result of this is continual improvement, resulting in increased customer satisfaction, which is the ultimate goal of ISO9001.
Within the planning phase Top Management need to set Quality Objectives.
Control of processes
There is a common misconception that to meet the requirements of ISO9001 requires loads and loads of procedures. Not so. ISO9001: 2008 requires only 6 documented procedures. However, as part of planning management have to decide how to control other processes to ensure that they achieve what is required of them.
ISO9001 requires suitable measurement of the processes to be adopted to demonstrate that the process is working as planned.
ISO9001 also requires one of the measurements to be regarding customer satisfaction.