The absence or total breakdown of a system to meet the ISO 9000 requirement.
A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.
Any noncompliance that would result in the probable shipment of nonconforming product.
A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose.
A noncompliance that judgment and experience indicate is likely either to result in the failure of the quality system or to materially reduce its ability to assure controlled processes or products.
ISO 19011 - Quality and Environmental Management Systems Auditing Forum Discussions