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

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015, Clause 5.2.1 (Establishing the Quality Policy) states that top management must establish, implement, and maintain a quality policy.

In the scenario, the quality manager (Leslie) created the policy, but top management did not establish it themselves, which violates Clause 5.2.1. While the policy can be drafted by a team, top management must take full ownership of its development and approval.

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 is typically performed by an organization (often a customer) on an external provider (supplier) to evaluate their capability and performance—i.e., to determine whether they can consistently meet requirements.

ISO 9001:2015 supports this purpose through its requirements for control of externally provided processes, products and services , where the organization must evaluate and monitor external providers :

ISO 9001 requires the organization to “ determine and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers based on their ability to provide processes or products and services in accordance with requirements.” ➜ This aligns directly with Option B (evaluate an external provider’s management system) , because evaluating a provider’s system/process controls is a primary way to confirm their ability to meet requirements.

ISO 9001 also requires analysis/evaluation of data including “ the performance of external providers .” ➜ This reinforces that ISO 9001 expects organizations to evaluate suppliers , which is the practical purpose of a second-party audit.

Why the other options are not correct under ISO 9001 context:

A (certify) is not the purpose of a second-party audit; certification is done by an independent third-party certification body , not by a customer/supplier relationship.

C (inspect products) can be one control activity, but ISO 9001’s requirement is broader— evaluate/monitor/re-evaluate the provider’s capability and performance, not only inspect output.

D (approve processes) may occur as a result of evaluation, but ISO 9001 explicitly emphasizes evaluation and monitoring , making B the best definition.