Quality Systems

The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. Quality Systems includes all activities which contribute to quality, directly or indirectly.

Product quality depends on many variables, such as the caliber of the components or materials used; type of equipment used in design, production, handling, installation, testing and shipping; the equipment calibration and maintenance procedures employed; the training and experience of production and supervisory personnel; the level of "workmanship;” and sometimes the environmental conditions (temperature, humidity, level of dust particles) in the area where the product is produced. The process, organizational structure, procedures, and resources that manufacturers and suppliers use to control these variables to produce a product of consistent quality which meets defined specifications is called a quality system. The standards that are being adopted globally for quality systems are the ISO 9000 standards.

Quality Systems registration or approval (sometimes misnamed "Quality Systems certification") involve the assessment and periodic audit of the adequacy of a supplier's Quality Systems by a third party, known as a Quality Systems registrar. When a supplier's system conforms to the registrar's interpretation of an ISO 9000 standard, the registrar issues the supplier a "certificate of registration." Interpretations of an ISO 9000 standard may not be consistent from one registrar to another.

Note that the supplier's Quality Systems are registered, not an individual product. Consequently, Quality Systems registration does not imply product conformity to any given set of requirements. Registration programs can be conducted in conjunction with or independently from a certification program. Registrars may or may not concurrently operate a product certification program for Quality Systems.

A manufacturer may choose to evaluate his own Quality Systems. Such self-audits are usually major components of the Quality Systems itself. Such self-audits can increase the confidence of management in its production system and demonstrate to its personnel that the firm is committed to quality management.

In Quality Systems “Second party" evaluations are also common. In these cases, it is usually the buyer who requires and conducts Quality Systems evaluations of his suppliers. These evaluations are mandatory only for companies wishing to become suppliers to that buyer.

"Third party" Quality Systems evaluations and registrations may be voluntary or mandatory and are conducted by persons or organizations independent of both the supplier and the buyer. According to a recent ISO survey, 31 countries reported the existence of one or more third party registration schemes in their countries.