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

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires specific roles and responsibilities for audit leaders and certification bodies.

Clause References:

ISO 19011:2018, Clause 5.5 – Conducting the Audit: Defines audit team leader responsibilities.

ISO/IEC 17021-1:2015, Clause 9.1.2 – Audit Planning: Defines certification body responsibilities, including the certification agreement.

Why is the Correct Answer D?

The certification agreement is signed between the certification body and the auditee (TD Advertising).

Anne (audit team leader) does NOT have authority to sign the agreement—that is the responsibility of the certification body’s management.

Why are the Other Options Incorrect?

A (Establishing audit criteria and objectives) → Correct responsibility of the audit leader as per ISO 19011.

B (Determining audit feasibility) → Audit leaders assess feasibility but do not sign agreements.

C (Assigning responsibilities for the audit team) → This is part of the audit leader’s role in planning audits.

According to ISO 19011:2018, clause 6.6.2, a nonconformity is the non-fulfilment of a requirement. A nonconformity can be classified as either major or minor, depending on the nature and extent of the deviation from the audit criteria. A major nonconformity is a nonconformity that affects the ability or the integrity of the organization’s management system to achieve the intended results. A minor nonconformity is a nonconformity that does not affect the ability or the integrity of the organization’s management system to achieve the intended results, but is a deviation from the audit criteria1.

According to ISO/IEC 17021-1:2015, clause 9.4.9, the organization is required to analyze the cause and describe the specific correction and corrective actions taken, or planned to be taken, to eliminate detected nonconformities, within a defined time. The organization is also required to provide the certification body with records and evidence of the implementation and effectiveness of the correction and corrective actions taken. The certification body will then verify the correction and corrective actions taken by the organization and decide on the certification status2.

Therefore, the two options of when the organization is required to act in response to reported findings are D and F, as they indicate the presence of nonconformities that need to be corrected and prevented from recurring. The other options are not correct, as they do not require the organization to act in response to reported findings:

•A. A recommendation is given in the report: A recommendation is a suggestion for improvement that is not related to a nonconformity. A recommendation is not binding for the organization and does not affect the certification status. The organization may choose to accept or reject the recommendation, but it is not required to act on it.

•B. A finding of good practice is reported: A finding of good practice is a positive observation that indicates a strength or a best practice of the organization’s management system. A finding of good practice is not related to a nonconformity and does not affect the certification status. The organization may choose to acknowledge or share the finding of good practice, but it is not required to act on it.

•C. An opportunity for improvement is raised: An opportunity for improvement is a potential area where the organization’s management system can be enhanced or optimized. An opportunity for improvement is not related to a nonconformity and does not affect the certification status. The organization may choose to pursue or ignore the opportunity for improvement, but it is not required to act on it.

•E. A finding of conformity is reported: A finding of conformity is a confirmation that the organization’s management system fulfils the audit criteria. A finding of conformity is not related to a nonconformity and does not affect the certification status. The organization may choose to celebrate or communicate the finding of conformity, but it is not required to act on it.

Comprehensive and Detailed In-Depth Explanation:

Once a Stage 2 certification audit has commenced, certain logistical or planning-related elements may still be adjusted, while others are fixed by prior agreement and cannot be changed.

✅ C. Audit Plan:

The audit plan is a document that outlines the scope, objectives, criteria, and logistics of the audit. According to ISO/IEC 17021-1:2015 (the standard for bodies providing audit and certification of management systems), clause 9.2.3.3 allows for modification of the audit plan based on real-time conditions during the audit — such as availability of auditees or changes in process access.

✅ F. Increase of Audit Duration:

Audit duration is generally determined during audit planning based on factors like employee count, risk, complexity, etc. However, if during Stage 2 it is found that more time is needed (e.g., due to additional processes, scope not fully covered, or significant findings), auditors are permitted to extend the audit. This ensures full coverage of all required areas as per ISO/IEC 17021-1 clause 9.1.4 and IAF MD 5.

❌ A. Agreed Language of the Audit:

This is determined and agreed upon in the contract and audit planning stages. Changing it during Stage 2 would create communication and documentation issues, especially in multi-site or multi-national audits.

❌ B. Audit Scope:

The audit scope is defined in the contract and certification agreement based on clause 4.3 of ISO 9001:2015. Changing it mid-audit would invalidate planning, required competencies, and potentially even the certification basis.

❌ D. Agreed Standard for the Audit Criteria:

Changing the standard (e.g., from ISO 9001 to ISO 13485) is fundamentally altering the purpose and contractual basis of the audit and is not permissible once Stage 2 has started.

❌ E. Audit Checklist:

The checklist is a tool prepared by the auditor as part of audit preparation and is based on the audit plan and standard requirements. While it may be adapted during the audit (e.g., if new risks arise), it does not constitute a formal change like duration or scope.

Relevant References:

ISO/IEC 17021-1:2015 Clause 9.2.3.3 (Audit Plan Modification)

IAF MD 5:2019 (Duration of QMS Audits)

ISO 9001:2015 Clause 4.3 (Scope of the QMS)

ISO/IEC 17021-1:2015 Clause 9.1.4 (Audit Duration)

Comprehensive and Detailed In-Depth Explanation:

Auditors must report findings truthfully and accurately to ensure an unbiased assessment of the QMS.

Clause References:

ISO 19011:2018, Clause 4 – Principles of Auditing:

Fair Presentation → Requires auditors to report truthfully and accurately, without bias or omission.

Integrity → Ensures auditors adhere to ethical conduct.

Why is the Correct Answer A?

The audit team reported findings truthfully, based on collected evidence.

Fair presentation ensures that both positive and negative findings are included in the audit report.

Objective evidence was gathered through interviews, document reviews, and observations.

Why are the Other Options Incorrect?

B (Integrity) → Related to ethics and professional conduct, but not specifically about presenting findings.

C (Confidentiality) → Important, but does not apply to the principle of reporting findings accurately.

D (Objectivity) → Ensures impartiality, but "fair presentation" directly addresses accurate reporting of findings.

A Stage 1 audit is a preliminary assessment to evaluate the readiness of the organisation for the Stage 2 certification audit. The audit scope is defined by the audit client and the certification body based on the application and the contract. If the organisation wants to include a new work area that was not part of the original scope, the auditor should advise the Quality Manager that an extension of the scope is possible but will have to go through established procedures, such as submitting a formal request, providing relevant information, and paying additional fees. The auditor should also suggest that the Quality Manager will advise the programme manager, who is responsible for managing the audit programme, that the audit scope should be revised to include the new work area. The programme manager will then decide whether to approve or reject the request, and communicate the decision to the auditor and the Quality Manager. The auditor should not proceed with the audit of the new work area without the approval of the programme manager and the confirmation of the audit scope. 1234 References:

1: ISO 19011:2018 - Guidelines for auditing management systems

2: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified

3: What is the difference between Stage 1 and Stage 2 Audits? - ISO Update

4: Getting Certified to ISO 9001 - the Stage 1 Audit

Comprehensive and Detailed In-Depth Explanation:

Auditors must focus on key processes that impact QMS effectiveness to ensure audit risks are minimized.

Clause References:

ISO 19011:2018, Clause 6.3 – Managing Audit Risk: Auditors should prioritize critical processes to obtain reasonable assurance.

Why is the Correct Answer A?

Some processes are critical (e.g., production quality, customer complaints handling).

If these material processes fail, the QMS could collapse.

Why are the Other Options Incorrect?

B (Needs of internal parties) → Important, but not the primary focus for reducing audit risk.

C (Previous audit results) → Useful for improvement but does not directly reduce current audit risks.

D (Financial risks) → ISO 9001 focuses on quality risks, not financial risks.