ISO 9001:2015 requires that nonconformities be objective, evidence-based, and referenced against defined requirements, not personal, prescriptive, or solution-driven.

When a nonconformity is raised, it must clearly show what requirement was not met and what objective evidence demonstrates this failure.

✅ Why D (Audit criteria) is required

A nonconformity must reference the requirement that was not fulfilled (e.g., ISO 9001 clause, procedure, contract, or legal requirement).

ISO 9001 defines nonconformity as “non-fulfilment of a requirement”.

Without audit criteria, there is no basis for declaring a nonconformity.

???? Supported by:

Clause 9.2.2 – Internal audits must determine whether the QMS conforms to requirements

Clause 10.2.2 – Documented information shall describe the nature of the nonconformity

✅ Why E (Relevant audit evidence) is required

ISO 9001 requires decisions and conclusions (including audit findings) to be based on evidence.

Audit evidence ensures objectivity and prevents subjective or opinion-based findings.

???? Supported by:

Clause 9.1.3 – Analysis and evaluation shall be based on data and information

Clause 9.2.2 – Audit results must demonstrate conformity or nonconformity based on evidence

❌ Why the other options are NOT correct

A (Name of person responsible)ISO 9001 focuses on system and process failures, not blaming individuals.

B (Target time for corrective action)This is part of corrective action planning, not the nonconformity statement itself (Clause 10.2).

C (Name of technical expert)ISO 9001 does not require identifying auditors or experts in the nonconformity statement.

F (Action to eliminate the nonconformity)Auditors must not prescribe solutions. The auditee determines corrective actions (Clause 10.2).