Classifying Minor & Major Nonconformities

Before we can classify a nonconformity as a minor or major, we must have a clear understanding of their definitions.

ISO/IEC 17021-1 clause 3.13, Minor nonconformity
nonconformity that does not affectthe capability of the management system to achievethe intended results.

In other words, a nonconformity that is NOT likely to result in the delivery of a nonconforming product or service. Examples of minor nonconformities may include: administrative errors in non-deliverable records or procedures, a lapse in following a procedure that did not impact the deliverable product or service, etc.

ISO/IEC 17021-1 clause 3.12, Major nonconformity
nonconformity that affects the capability of the management system to achieve the intended results.

Note 1 to entry: Nonconformities could be classified as major in the following circumstances:
• if there is a significant doubt that effective process control is in place, or that products or services will meet specified requirements;
• a number of minor nonconformities associated with the same requirement or issue could demonstrate a systemic failure and thus constitute a major nonconformity.

For greater clarity, a major nonconformity exists in the following situations:

• a nonconformity where the effect is judged to be detrimental to the integrity of the product or service;
• the absence of or total breakdown of a system to meet an ISO 9001 or 9100-series standard requirement, a customer QMS requirement, or a requirement defined by the organization;
• any nonconformity that can result in the probable delivery of a nonconforming product or service