The ISO 9001 model is based on a specific management philosophy. This philosophy determines the structure, planning and implementation of the standard. It is the single most important element which is embedded within the standard. It’s called the Shewhart/Deming Cycle. It is a simple but powerful concept. This cycle contains four elements:

Plan > Do > Check > Act

where as an organization,

• You plan the elements of the QMS in order to meet customer requirements and enhance their satisfaction;
• You implement the QMS as per the plan;
• You monitor, measure and analyze the performance of the QMS against the plan; and
• You take actions to continually improve the QMS.

You will also need to apply the same philosophy when managing the processes that make up the QMS, where

• You establish the objectives to be achieved for a given process and determine the necessary activities, resources and methods of operation and control to achieve those objectives;
• You implement the plan;
• You monitor, measure and analyze the performance of the process against the plan; and
• You take actions to continually improve the process.

Therefore, the PDCA philosophy is applied at both the system and process levels. And where necessary, it can also be applied further down at the activity level. This is the master key to the understanding, planning and implementation of the ISO 9001 model. This approach enables you to explore the QMS down to its very last detail.

The Shewhart/Deming approach provides you with a consistent method for the management of the QMS, both at the macro and micro levels. It is also very useful when planning the documentation of the QMS. You will have to determine the purpose of a certain documentation and the objectives it is supposed to achieve. Then implement and monitor its usage and consequently identify areas or opportunities for continual improvement. In order to ensure the effective application of this approach, you will need to establish an effective QMS organization that thrives on communication.

For example, top management is responsible for ensuring that quality objectives are established at the relevant functions and levels of the organization. How would you go about doing this? Simply apply:

PLAN: What is the objective of this task?

DO: Define the resources and methods of achieving this task?

CHECK: Define how the quality objectives are to be monitored, measured and analyzed?

ACT: Define the improvement processes of the quality objectives?

There are various inputs to be considered at the planning stage. Top management has to be clear on the corporate objectives in order to ensure that the quality objectives are well-aligned to them.

Quality Management Principles

The ISO 9001 model is based on the Eight Quality Management Principles. From these principles, tangible benefits are derived. These principles are known as the Eight Quality Management Principles. It is crucial that the QMS that you establish and implement demonstrate these principles in action.

One key to better understanding of the requirements of ISO 9001 is to understand these underlying principles, and inn the operation of the quality management system, these principles must be adhered to, without fail:

• Customer focus ~ Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.
• Leadership ~ Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives. Involvement of people ~ People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
• Process approach ~ A desired result is achieved more efficiently when activities and related resources are managed as a process.
• Systems approach to management ~ Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
• Continual improvement ~ Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
• Factual approach to decision making ~ Effective decisions are based on the analysis of data and information.
• Mutually beneficial supplier relationships ~ An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

ISO 9001 Quality Management System
The purpose of the ISO 9001 international standard is to provide a quality management system model that is focused towards the enhancement of customer satisfaction on a continual basis. This is achieved by enhancing your organization’s ability to meet all of your obligations towards your customers. And the method by which this ability is enhanced is prescribed concisely by the ISO 9001 standard. ISO 9001 uses the systems approach in its quality management system model. The effectiveness of the quality management system is continually improved through the application of the process approach, where a process is managed via its inputs, activities and outputs.