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

The correct answer is:

Event

Selecting audit team = Individual(s) managing the audit programme

Conducting the audit = Audit team

Preparing the audit plan = Audit team leader

Requesting the audit = Audit client

To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below. Alternatively, drag and drop each option to the appropriate blank section. Responsibility:- Individual(s) managing the audit programme

Audit team

Audit team leader

Audit client

According to ISO 19011:2018, clause 5.3, the individual(s) managing the audit programme are responsible for selecting the audit team, taking into account the competence and availability of the auditors and any experts needed. 1

According to clause 6.2, the audit team is responsible for conducting the audit, which includes collecting and verifying audit evidence, evaluating audit findings, and preparing the audit report. 1

According to clause 6.1, the audit team leader is responsible for preparing the audit plan, which includes defining the audit objectives, scope, criteria, and duration, as well as assigning roles and responsibilities to the audit team members. 1

According to clause 5.2, the audit client is the person or organization that requests the audit, which can be the auditee (the person or organization being audited) or any other person or organization that has an interest in the audit results. 1

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)

According to ISO 9001:2015, clause 4.3, the organization is required to determine the scope of its quality management system (QMS) by considering the external and internal issues referred to in clause 4.1. Clause 4.1 requires the organization to determine the external and internal issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended results of its QMS. These issues can include positive and negative factors or conditions for consideration, such as legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local. The organization is also required to monitor and review these issues.

Therefore, the correct answer is C, as external issues of the organization’s context are one of the factors that must be considered when determining the scope of the QMS. The other options are either not directly related to the scope of the QMS, or are not explicitly mentioned in clause 4.3.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 19011:2018, Clause 6.4.6 (Conducting Interviews), group interviews should be conducted with at least two auditors to ensure objectivity and accuracy.

This prevents bias or misinterpretation of responses.

It allows for cross-validation of information.

It ensures that the audit results remain objective and impartial.

Since Li Na conducted the group interviews alone, she did not follow audit best practices. The correct approach would have been to have another auditor present during the interviews.

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.