ISO 9001 - Understanding ISO 9001 Requirements

0.2 Process Approach (Continued)
NOTE: In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows.

Plan:Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies.

Do: Implement the processes

Check:Monitor and check processes and product against policies, objectives and requirements for the product and report the results

Act:Take actions to continually improve process performance

PLAN-DO-CHECK-ACT (PDCA) - Key Explanation Points and Tips:

See Figure 3

ÞPLAN-DO-CHECK-ACT (PDCA) - is a very effective tool for business management and the ISO 9001 standard strongly recommends its use. PDCA is a dynamic cycle that can be applied to each of the organization’s processes, and also to the system of processes as a whole. It may be used to plan, implement, control and continually improve both product realization and other QMS processes.

ÞMaintenance and continual improvement of QMS processes can be achieved by applying PDCA to processes at all levels within the organization - from the executive high-level strategic processes, such as business planning or management review to operational processes such as product realization or calibration.

Þ(PLAN) - For each QMS process you must establish:

ÞProcess owner and his/her accountability

ÞProcess inputs, outputs, value adding or conversion activities and sequence/interaction of these activities (sub-processes) within the process. Many of the COP’s and SOP’s may have sub-processes.

ÞProcess policies, responsibilities and accountability.

ÞProcess objectives and performance indicators and methods to monitor and measure process performance to these objectives and indicators.

ÞResources needed (e.g. facility, equipment, labor, materials, time, etc).

ÞPreventive and detective controls needed for process activity, input, output and resources used.

ÞProcess documentation (e.g. procedures, forms, work instructions, specification, etc.)

ÞThe nature, method, frequency and timing of interaction with other processes and where this interaction will occur - input, output, use of resources, conversion activity, etc.

ÞYou must pay a lot of attention to this stage of your QMS development. Planning must also consider how you will meet customer, applicable regulatory, and your own organizational requirements, in addition to ISO 9001 requirements. We will look at QMS planning in more detail when we review clause 4.1 requirements.

Þ(DO) - Deploy and implement your QMS processes and manage and control them according to your plan as documented above.

Þ(CHECK) - Monitor and measure the effectiveness of your QMS processes against policies and objectives that you established under PLAN. Monitoring and measuring activity may focus on any or all of a process’s inputs; outputs; use of resources for conversion; and interaction with other processes.

Þ (ACT) - Collect and analyze your monitoring and measurement information and use it to determine the effectiveness of each process as well as your overall QMS in meeting requirements. Use the information to correct problems and continually improve individual processes.

ÞAs mentioned above PDCA is a dynamic cycle and so continual improvement must be an on-going process for improving your QMS and enhancing customer satisfaction.



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