What elements need to exist for an auditor to raise a nonconformity?

For an auditor to raise a nonconformity, the presence of proof is essential. Proof refers to objective evidence that a requirement of the quality management system has not been met. This evidence can include documented information, results from observations, or other findings that highlight discrepancies between the identified requirements and actual practices.

The existence of proof helps to establish a clear connection between the nonconformity and any specific criteria defined in the ISO 9001 standards. An auditor relies on proof to substantiate their findings, ensuring that the nonconformity is valid and grounded in observable facts rather than assumptions or subjective interpretations.

While observations and records are important aspects of the audit process, as they contribute to the gather of proof, they alone do not constitute the basis for raising a nonconformity without the presence of clear evidence. Proof serves as the foundation on which the auditor's conclusion rests and is crucial in maintaining the integrity and credibility of the audit findings.