PECB ISO-9001-Lead-Auditor Study & Exam Dumps 2025

QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

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Question 1

An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against

section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:

" The reject rate of ' finished ' product of 9.7% needs improvement as it doesn ' t meet the stated objective of top management of 5%. "

Just before the Closing meeting of a third-party audit, the audit team leader is invited to a meeting with the Quality Manager. He tells

the audit team leader that a member of the audit team was seen taking photographs of the factory on his phone during the day and

wants him suspended from the Closing meeting with any nonconformities raised by him rescinded. The issue of photographs was not

discussed during the opening meeting.

Select the three options for how the audit team leader might deal with this situation.

Options:

Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to the Quality Manager once this is done

Advise the Quality Manager that the auditor will be reported to Head Office

Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting

Delay the Closing meeting until the audit team leader has consulted his audit programme manager at Head Office

Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered

State that the auditor will take no further part in the audit and all his photographs will be deleted

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Answer:

A, D, E

Explanation:

This option reflects a balanced and professional approach. The audit team leader should first gather information directly from the involved auditor to understand the situation before making any decisions. It demonstrates due diligence and fairness.

This ensures that the situation is properly escalated and handled in accordance with the auditing body’s procedures. Consulting the audit programme manager helps ensure consistency in handling such incidents.

The nonconformity raised is based on objective evidence, independent of the incident with the photographs. ISO 9001 audits are evidence-based, and the validity of the findings should not be compromised by unrelated issues.

1. A. Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to the Quality Manager once this is done:2. D. Delay the Closing meeting until the audit team leader has consulted his audit programme manager at Head Office:3. E. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered:

B. Advise the Quality Manager that the auditor will be reported to Head Office:

Reporting the auditor directly without first investigating the situation is premature and unprofessional. It might escalate the issue unnecessarily.

C. Apologize for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting:

Deleting evidence without proper consultation could be seen as tampering or unprofessional conduct. It’s essential to understand the context of the photographs first.

F. State that the auditor will take no further part in the audit and all his photographs will be deleted:

This is an extreme response without first investigating the situation. Taking unilateral action without gathering facts can damage the audit ' s integrity.

Why Not the Other Options:

Question 2

A small cleaning services organisation is about to start work on a hospital cleaning contract for the local Health Trust. You,

as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract

requires that a cleaning plan is produced.

You: " How was the cleaning plan for the contract developed? "

Service Manager: " We have a basic template that covers the materials, labour requirements and cleaning methods to be

employed. Some of that is specified by the customer. "

You: " How does the plan deal with locations like the intensive care wards and the operating theatres, which are included

in the contract? "

Service Manager: " The basic plan covers general wards, but we will do more frequent cleaning in those areas if the

hospital requests it. "

You: " Are you aware of the regulatory requirements for cleaning standards in hospitals? "

Service Manager: " No. We depend on the hospital to look after that side of things in the contract. "

You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001.

You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the

cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was

substituted to that specified in the contract. At the follow-up audit, the corrective action proposed was to

" obtain a concession from the Health Trust for use of the new chemical. "

Which one of the following options is the reason why you did not accept this action taken?

Options:

Staff have not been trained in the use of the new chemical.

The action assumes that the Health Trust will agree to the change.

The process for making changes to the contract has not been addressed.

The substitute chemical has not been used before in the Health Trust.

The substitute chemical may not be as effective as the original.

Question 3

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation offers warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization does not have its own transport vehicles. Stock items are not purchased by the organisation.

You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.