What Is Non-Conformance for ISO 9000?
Developed and published by the International Organization for Standardization, ISO 9000 is a series of standards that serve as a guide to quality products, service and management. As such, many manufacturing and service industries seek to adopt them by successfully undergoing quality audits and getting ISO 9000-certified. In certifying an organization, a non-conformance is said to occur when a policy or practice is observed that goes contrary to the requirements of documented procedures or the applicable standard.
The ISO 9000 System
Companies routinely use a quality management system, or QMS, to ensure their products or services meet quality standards. By getting ISO 9000 certified, your company establishes requirements for the QMS. Although each QMS will have specific subsystems and functions -- such as customer focus, system approach to management and supplier relationships -- ISO 9000 will have corresponding individual requirements for them. Non-conformance is an ISO 9000 audit designation indicating the QMS or a portion of it does not meet the requirements established by ISO 9000. Such a departure can be manifested in the inability to conform to a work product standard, a predefined procedure, a work product specification, a documented plan or an international standard for best practice.
A major non-conformance occurs when there is an absence or total breakdown in the system to meet the ISO 9000 requirement. Essentially, it is a deficiency that will seriously impair the effectiveness of the QMS. Typical examples of a major non-conformance include failure to take corrective or preventive action, not implementing an element of ISO 9000, not developing or implementing procedures or having many minor non-conformances.
Minor non-conformance incidences occur when an ISO 9000 requirement is not met, but without any major consequences. It is a deficiency that likely will not result in the failure of, nor seriously weaken, the QMS. The quality system will not be impacted to the extent that it reduces its ability to assure controlled processes or products. Examples include failure by one or a few individuals to correctly use a procedure, or a single observed lapse in having necessary work instruction for inspecting an equipment.
Addressing Non-Conformities for Compliance
A non-conformance indicates a problem that should be addressed with corrective action. It's a sign that something went wrong in your service, process, product, supply side or in the system itself by not meeting the specifications. It can be identified via internal audits, external audits, customer complaints, incoming material inspection or routine testing. You procedure will include immediate actions to stop further non-conformance. Assess and contain the effects of the problem by taking corrective action or placing defective items in quarantine and notifying affected customers, if necessary. Per ISO 9000 requirements, document your non-conformance procedure and keep a record of the problem and action taken.
Dr Jack Gordon, the Chief Technology Officer at Strontium Logistics, is a 20-year veteran of the engineering and marketing business who favors stiff drinks, good debates and developing innovative digital marketing strategies to help companies grow.