ISO-9001-Lead-Auditor Practice Questions

ISO 9001:2015 clearly distinguishes between management review inputs and management review outputs.

Relevant ISO 9001 requirement

Clause 9.3.2 – Management review inputsManagement review shall consider information on, among other things:

customer satisfaction and feedback from relevant interested parties;

the extent to which quality objectives have been met;

the effectiveness of actions taken to address risks and opportunities.

Explanation of the correct answers:

B.  

This represents information on risks and opportunities and the effectiveness of actions taken to address them, which is an explicit management review input under Clause 9.3.2.

C.  

Customer feedback is a direct input to management review, supporting evaluation of customer satisfaction, as required by Clause 9.3.2 and Clause 9.1.2.

D.  

This provides evidence of the extent to which quality objectives have been met, which is a mandatory management review input under Clause 9.3.2.

Explanation of why the other options are not inputs:

A.  

Revisions required to the quality system documentationThese are typically outputs of management review (decisions on changes to the QMS), not inputs.

E.  

Procurement of a laser measuring toolThis is a specific operational or resource decision, not a required management review input.

F.  

Actions for quality system improvementActions for improvement are management review outputs, covered under Clause 9.3.3, not inputs.

ISO-aligned conclusion:

Management review inputs are performance data and information used by top management to make decisions. In this scenario, the correct input audit evidence is:

updates to risks and opportunities,

customer feedback, and

performance against quality objectives.

Here is the correct matching of the ISO 9001 Clause 8 extracts to the audit evidence:

Audit evidence: Three subcontract trainers who had delivered training were not approved as defined in procedure SA1 Supplier Approval revision 3.ISO 9001 Clause 8 extract: 8.4.1 ...shall apply criteria for ... external providers...(This clause requires the organization to control external providers, including ensuring their approval and competence.)

Audit evidence: A training programme for a customer was not documented as required in procedure TD 2 Training revision 2.ISO 9001 Clause 8 extract: 8.3.5 ...shall retain documented information on design and development outputs.(This clause addresses the need to retain documented information related to design and development outputs, such as a training programme.)

Audit evidence: One trainer had not recorded the damage to a customer’s training room wall caused by using sticky tape to hang training aids, as required in procedure TD 2 Training revision 2.ISO 9001 Clause 8 extract: 8.5.3 ...shall retain documented information on what has occurred.(This clause relates to retaining documented information on activities and outcomes, including records of damage or issues encountered.)

Audit evidence: Five sales orders had no record of having been reviewed to verify the ability to provide these courses.ISO 9001 Clause 8 extract: 8.2.3.1 ...shall conduct a review before committing...(This clause specifies the requirement to review and verify the organization's ability to meet customer requirements before accepting sales orders.)

These mappings reflect the specific requirements of ISO 9001:2015 for managing external providers, retaining documented information, and reviewing contracts.

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.  

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.  

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.  

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 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.

The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.

Table

Audit evidence

ISO 9001 Clause 8 extract

Four of the 10 pallets of stock sampled in the warehouse were not labelled.

“8.5.2 … shall use suitable means to identify outputs …”

A damaged pallet of stock seen in the quarantine area was leaking liquid onto the floor.

“8.7.1 … shall ensure that outputs that do not conform to their requirements are identified and controlled …”

One of the fork-lift truck drivers had no fork-lift truck driving licence.

“8.5.1 e … shall include, as applicable … the appointment of competent persons …”

There was no pest control provision in the warehouse.

“8.5.4 … shall preserve the outputs during production and service provision …”

Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full.

“8.1 … shall plan, implement and control the processes …”

ISO 9001:2015 does not define detailed audit role terminology itself, but it explicitly refers to ISO 19011 for audit guidance. This makes ISO 19011 authoritative for defining audit roles and responsibilities within ISO 9001 audits.

ISO 9001:2015, Clause 9.2.2 – NOTE:

“See ISO 19011 for guidance.”

Therefore, the correctness of the statements is determined using ISO 19011 (Auditing management systems) principles, which are fully applicable to second-party audits.

✅

B.  

✔ Correct

ISO 19011 defines an auditor simply and clearly as “a person who conducts an audit.”

This definition applies equally to first-, second-, and third-party audits.

This statement is universally correct and fully aligned with ISO auditing terminology.

✅

F.  

✔ Correct

ISO 19011 allows the use of translators/interpreters to support communication during audits.

Translators are typically appointed by the auditee, not the audit team.

Translators are not members of the audit team and do not influence audit conclusions.

This is a valid and correct statement for second-party audits.

❌ Why the other options are incorrect

❌

A.  

In ISO 19011, a guide is appointed by the auditee, not by the audit team leader.

The guide assists with logistics and access, not audit execution.

❌ Incorrect appointment authority.

❌

C.  

ISO 19011 explicitly allows auditors-in-training to be part of the audit team under supervision.

❌ Incorrect restriction.

❌

D.  

An observer does not provide information or participate in the audit.

Observers may attend (e.g. regulators, accreditation bodies) but remain passive.

❌ Incorrect role description.

❌

E.  

A technical expert supports the audit team, but is not considered an auditor.

They provide subject-matter expertise under the direction of auditors.

❌ The statement is misleading and therefore incorrect.

In ISO 9001:2015, the responsibility for managing the audit program lies with those overseeing the entire audit process rather than the Audit Team Leader. During the planning stage, before involving the Audit Team Leader, key actions for managing the audit program include:

1. Providing the Resources Needed: According to clause 7.1 (Resources), the audit program manager must ensure that the necessary resources are in place to conduct the audit effectively. This encompasses logistical support, personnel, and other required resources for the audit to proceed smoothly.

2. Reviewing Reports of Previous Audits: As per clause 9.2.2 (Internal Audit), it is essential to consider the results of previous audits to plan effectively for the upcoming audit. This helps identify areas that require particular attention, ensuring continuity and focusing on recurring issues or improvements since the last audit.

These actions ensure that the audit is thoroughly prepared and that there is continuity and focus on any areas that might need closer inspection. The other options, such as preparing the audit plan, assigning responsibilities, preparing checklists, and selecting the audit team members, generally fall under the duties of the Audit Team Leader once they are appointed and engaged in the planning process.