Exam ISO-9001-Lead-Auditor Topic 2 Question 32 Discussion

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).