PECB ISO-9001-Lead-Auditor Exam With Confidence Using Practice Dumps

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).

A second-party audit of a key supplier should focus on whether the supplier’s QMS is suitable, effective, and capable of meeting requirements. ISO 19011 recommends considering context, changes, prior audit results, interested-party concerns, and effectiveness of key QMS processes.

B is relevant because outsourced processes affecting conformity may need to be audited or otherwise controlled. C and F are relevant because audit planning should consider changes since previous audits and previous audit results. D is relevant because ISO 9001 requires relevant interested parties and their requirements to be considered. I is relevant because the QMS must remain suitable and aligned with context and strategic direction. J is relevant because internal audit and management review are key mechanisms for evaluating QMS effectiveness.

A is mainly relevant to certification-body controls, not a supplier second-party audit. E is too prescriptive; ISO 9001 does not require annual audits of all external providers. G may be useful depending on scope, but the stronger required audit trails here are B, C, D, F, I, and J. H is outside ISO 9001 QMS audit scope unless directly relevant to contractual or QMS risks.

===========

In this scenario, the organization has set a quality objective of achieving a 90% minimum exam pass rate for all courses. The auditor’s task is to assess whether this objective is being monitored effectively and if appropriate actions are taken when the objective is not met.

B. You would determine how the exam pass rate figures were analysed: ISO 9001:2015, particularly Clause 9.1 (Monitoring, measurement, analysis, and evaluation), requires organizations to evaluate performance data. The auditor should verify how the organization analyses the pass rate data to ensure trends are identified, and corrective actions are planned based on this analysis.

D. You would determine what corrective action was being taken to address the low pass rates: When performance falls short of the objective, as seen with Course 4 (where the pass rate is below 90% in all months), Clause 10.2 (Nonconformity and corrective action) requires organizations to take corrective actions to address issues. The auditor would need to check if corrective actions have been initiated to address consistently low pass rates.

Statements A, C, E, and F do not directly address the monitoring and corrective action required under ISO 9001:2015 in this context​​.