Classifying Minor & Major Nonconformities

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

Nonconformity classifications are defined in ISO/IEC 17021-1 for both ISO 9001 & AS9100 audits. AS9101 expands these definitions for AS9100 series audits. However, IMO, AS9101 merely clarifies the vague definitions contained in ISO/IEC 17021-1.

Due to the ambiguous/vague nature of many “requirements” contained in ISO 9001 & AS9100, the auditor must be able to justify each nonconformity (which the auditee may appeal to the CB). Due to the auditor's bias toward a particular interpretation of the standard, far too many auditors “imagine” nonconformities where none exist.

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

And

AS9101F, sec. 3.4 Minor Nonconformity
The requirements of ISO/IEC 17021-1 clause 3.13 apply.
In addition a minor nonconformity can be a single system failure or lapse in conformity to meet a 9100-series standard requirement, customer QMS requirement, or documented information defined by the organization.

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.

And

AS9101F, sec. 3.3 Major Nonconformity
The requirements of ISO/IEC 17021-1 clause 3.12 apply.
In addition, a major nonconformity can be one or more of 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 a 9100-series standard requirement, a customer QMS requirement, or documented information defined by the organization;
• any nonconformity that can result in the probable delivery of nonconforming product or service; and
• a condition that can result in the failure or reduce the usability of the product or service and its intended purpose.

As you can see, the threshold for a Major Nonconformance is actually quite low. Consequently, many CBs ask their auditors to provide justification for identifying minor nonconformities that could be interpreted as major nonconformities. This justification should identify any factors mitigating the nonconformity from a major to a minor.