ISO-9001-Lead-Auditor Exam Dumps : QMS ISO 9001:2015 Lead Auditor Exam

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).

Relevant ISO 9001 Requirement

Clause 7.3 – Awareness states that persons doing work under the organisation’s control shall be aware of:

The quality policy;

Relevant quality objectives;

Their contribution to the effectiveness of the QMS;

The implications of not conforming with QMS requirements.

A critical point is that ISO 9001 uses the phrase:

“persons doing work under the organisation ' s control”

This includes:

Employees,

Temporary personnel,

Agency personnel,

Subcontractors performing work on behalf of the organisation.

Why Option B is Correct

In the scenario:

The refrigeration engineers performing the actual maintenance and repair services are all subcontractors.

The Managing Director states that these subcontractors have not been informed of:

the Quality Policy,

quality objectives,

plans to address risks and opportunities.

The justification given is that the subcontractors themselves have ISO 9001-certified management systems.

However, ISO 9001 certification of a subcontractor does not remove the organisation ' s responsibility to ensure persons working under its control are aware of the organisation ' s own QMS requirements.

Therefore, the organisation has failed to demonstrate compliance with Clause 7.3 Awareness .

Why the Other Options Are Incorrect

A. Clause 7.4 – Communication

The scenario does not primarily indicate a failure of communication processes.

The issue is not whether communication methods exist, but whether the subcontractors have the required awareness.

C. Clause 7.2 – Competence

The Managing Director explicitly states that competence requirements are applied to both full-time staff and subcontractors.

No evidence is presented that competence has not been determined or evaluated.

Therefore, a competence failure is not the strongest conclusion.

D. Clause 7.5 – Documented Information

The scenario indicates documented information exists and was reviewed by the auditor.

No evidence suggests documented information is missing, uncontrolled, or unavailable.

Therefore, Clause 7.5 is not the most likely issue.

ISO-Aligned Conclusion

The organisation relies entirely on subcontracted refrigeration engineers to deliver its certified services. Because these personnel perform work under the organisation ' s control, ISO 9001 requires them to be aware of the organisation ' s quality policy, objectives, and relevant QMS requirements.

The evidence shows this awareness has not been established.

Answer: B. 7.3 Awareness

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