New Release ISO-9001-Lead-Auditor ISO 9001 Questions

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.

Comprehensive and Detailed Explanation From ISO 9001 / ISO 19011 Guidance:

ISO 9001:2015 requires audits to be planned and conducted objectively, but it refers auditors to ISO 19011 for detailed guidance on audit activities, including audit team meetings and preparation for closing meetings.

ISO 19011:2018 describes the purpose of the audit team meeting before the closing meeting as ensuring alignment, consistency, and clarity of audit conclusions and messages to the auditee.

Explanation of the selected tasks:

C. The audit team review any points raised by the auditee-nominated representative during the audit.

ISO 19011 requires the audit team to consider and evaluate information and concerns raised by the auditee to ensure audit findings are accurate, fair, and evidence-based before the closing meeting.

E. The audit team agrees on the audit opportunities for improvement to be presented to the supplier.

Before the closing meeting, the audit team must align on opportunities for improvement so that these are presented consistently and clearly, without contradiction between auditors.

F. The audit team agrees on the roles of each audit team member for the closing meeting.

ISO 19011 requires clear allocation of responsibilities within the audit team. Agreeing who will present findings, nonconformities, or conclusions is a normal and expected preparation activity.

G. The audit team leader writes all audit finding reports, taking into account the inputs provided by each auditor.

The audit team leader is responsible for consolidating audit inputs and ensuring consistency of reporting, even though individual auditors contribute evidence and findings.

H. Each audit team member completes the report of their individual findings.

ISO 19011 expects each auditor to document their findings and provide them to the audit team leader for consolidation into the final audit report.

J. The audit team agrees on the conformities and non-conformities to be included in the final audit report.

Before the closing meeting, the audit team must reach consensus on audit conclusions to ensure findings are clear, justified, and consistently communicated.

Explanation of why the other options are not selected:

A: Daily meetings with the auditee’s Quality Manager are not part of an internal audit team meeting and may compromise independence.

B: The final audit report is not completed and signed during the audit team meeting prior to the closing meeting.

D: Refusing to review corrective actions is inappropriate; however, corrective actions are normally reviewed after the audit, not during preparation for the closing meeting.

I: Informing the Procurement Manager is an administrative action, not a task of the audit team meeting.

ISO-aligned conclusion:

An audit team meeting prior to the closing meeting focuses on alignment, consolidation of findings, agreement on conclusions, and preparation for clear communication. The six correct tasks are therefore C, E, F, G, H, and J.

According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:

•Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently.

•Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed.

•Select the external providers that have demonstrated their competence and conformity to the requirements. The selection should be based on the evaluation results and the organization’s needs. The selection should be documented and approved.

•Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely.

•Monitor the performance and conformity of the external provider, using the established criteria and methods. The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed.

In this case, the evidence statements that demonstrate a nonconformity with clause 8.4 are A and C, because they show that the organization did not retain documented information of the selection and evaluation of the external provider, and the monitoring of the external provider’s performance. These are requirements of the standard and essential for ensuring the quality of the externally provided processes, products, and services. The other options are not directly related to clause 8.4, although they may indicate other nonconformities or weaknesses in the organization’s QMS. For example, option B may relate to clause 7.1.3 on contingency planning, option D may relate to clause 8.2.3 on review of requirements, option E may relate to clause 8.6 on release of products and services, and option F may relate to clause 5.1.1 on leadership and commitment. References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems