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

B. Control of externally provided processes, products, and services: This is relevant because the organization has outsourced the manufacture of its own brand products to a supplier. According to ISO 9001, the organization must ensure that externally provided processes remain within the control of its quality management system.

C. Design and development of products and services: Even though the organization no longer manufactures in-house, it still needs to control the design and development of its products, especially since they are now being produced by an external provider.

F. Organisation roles and responsibilities: The change in strategy has led to a significant reduction in staff, which would have an impact on the roles and responsibilities within the organization. It is important to audit how these changes have been managed and communicated within the organization to ensure continued effectiveness of the quality management system.

These audit trails are aligned with the requirements of ISO 9001:2015, which emphasizes the importance of controlling externally provided processes and products, managing design and development, and clearly defining roles and responsibilities within the quality management system.

ISO 9001 audits (including second-party audits) must be conducted in line with audit principles of fairness, objectivity, and impartiality, with guidance provided by ISO 19011:2018 for audit activities, including closing meetings.

Relevant ISO guidance

ISO 19011 – Closing meeting guidance states that the purpose of the closing meeting is to:

present audit findings and conclusions,

ensure the auditee understands the non-conformities,

explain the next steps, including reporting and follow-up.

Auditors must not:

prescribe solutions,

analyse or design corrective actions,

make commercial or approval decisions on behalf of the audited organisation.

Explanation of the correct option:

C. Present the non-conformities and inform them that the report will be sent within ten working days, close the meeting and leave the site.

This option correctly reflects the auditor’s role:

The non-conformities are presented clearly and transparently in the closing meeting.

The auditee is informed of the reporting process and timeline.

The auditor does not analyse solutions, recommend actions, or influence supplier approval decisions.

The meeting is closed professionally and objectively, in line with ISO 19011.

Explanation of why the other options are incorrect:

A: Closing meetings must be conducted with the agreed auditee representatives; hiding findings undermines transparency and audit integrity.

B: Analysing how to overcome the situation constitutes consulting, which compromises auditor impartiality.

D: Recommending removal from an approved supplier list exceeds the auditor’s authority and violates audit independence.

ISO-aligned conclusion:

The auditor’s responsibility at the closing meeting is limited to presenting findings and explaining next steps, not advising, consulting, or making business decisions. Therefore, the correct and ISO-compliant option is C.