How does ISO 9000 work?
 

WHAT DOES ISO 9000 ASK THE LEADERSHIP AND THE PEOPLE TO DO?

ISO 9000 standard opens by requiring each of the organizations activities or "processes" to be described clearly so that everyone in the organization knows how to carry out their job. (4.1) This is done by writing procedures which people can follow if ever they are in doubt about how a task is done.(4.2) The numbers shown here in brackets are the paragraph numbers in ISO 9001 standard which the description refers to.

The policies and procedures within the system need to be kept up to date so people can be sure of using a current version of a procedure, and any records which people create need to be maintained in a safe condition.
  LEADERSHIP (MANAGEMENT RESPONSIBILITY)

The standard gives the leadership of an organization clear responsibility to define its objectives in delivering quality and meeting its customer's requirements (5.1). The customer's requirements must be first identified and then agreed (5.2). This commitment to the customer must be written in the form of a policy statement (5.3). Once these customer objectives are set they must then be achieved in a planned manner.

To do this, the organization must define its functional objectives and then the achievement of those objectives must be planned by the leadership (5.4). The people in the organization must know their own responsibilities in fulfilling the plan (5.5).

The organization needs to have a champion for this system and this person is the management representative. Their job is to first manage the development of the quality system prior to ISO 9000 registration and then later to report on the performance of the system to the leadership.

The people in the organization must also be made aware of the performance of the organization in meeting its objectives.

The leadership has a key role in ensuring the quality system is effective. They achieve this through a regular management review of the quality system performance in which they identify the need for change and allocate the resources to make change happen. The review process is very similar to the financial review of the business (5.6).

RESOURCES MANAGEMENT

The resources which the leadership allocate in this review may be people, skill development or changes to equipment and facilities (6.1, 6.2, 6.3, 6.4).

The processes which will be used to first identify customer requirements and then later to deliver the product or service required by the customer must then planned in a way that ensures the customer receives what they were promised (7.1).

OPERATIONS (PRODUCT AND SERVICE REALIZATION)

First the customer's requirements must be clearly specified and agreed. Then the organization must ensure it has the capability to meet any order before it is accepted from the customer. During the ensuing customer relationship the organization must maintain communication and any product or information given to the company by the customer must be protected (7.2).

If the customer requires a unique product or service to be designed for them the design must be properly planned. Controls have to be in place to ensure meeting all the customer's requirements in what is finally delivered to them (7.3).

Next the products and services that are purchased externally to enable the customer's product or service to be delivered, must be managed to ensure they are delivered into the organization at the right time and the correct requirements (7.4).

The core operations of the business which add value for the customer then need to be operated so they deliver right the first time and this is done by giving clear instructions and keeping equipment in good condition. The processes themselves, then need to be monitored to ensure they perform as expected (7.5) and activities must be tracked at all stages to ensure there is no process failure. Wherever instruments are used for the monitoring of either process or product they must be calibrated to ensure the results the instruments give are reliable (7.6).

  MEASURING TO IMPROVE

Finally, the quality system as well as the business processes must be monitored and measured to ensure that they perform as planned (8.1).

The monitoring, whether at a system or process level, is to be used to drive continual improvement (8.1).

The ultimate measure of whether the quality system is effective is the satisfaction level of the customer but preventive measurement will be achieved by internally auditing the processes within the quality system. The independent internal audit which the standard requires needs to be supported by continuous monitoring of individual processes and products whenever they are critical to the final delivery to the customer (8.2).

If at any point requirements are not met the product or service must be isolated and a decision taken on whether to rework (8.3) .

To achieve this the data that is collected from the measurement activity must be analyzed and the results of the analysis used to drive improvement in both the quality system and individual process (8.4).

The changes required to a process are then identified through a defined Corrective Action process and this develops with time into Preventive Action where problems are eliminated on a proactive, not reactive basis. This causes continuous improvement in both the business processes and the quality system of the business (8.5).