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QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

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Question 1

Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.

Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled. The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean ' s requirements.

The top management, in cooperation with Sean, assigned 10 more employees to the audit team. Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.

Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting

The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.

Based on the scenario above, answer the following question:

Scenario 7 states that Sean planned audit activities on his own. Is this acceptable?

Options:

No, audit activities should be planned by top management

Yes, it is the responsibility of the audit team leader to plan audit activities

No, the audit team leader should always cooperate with the other members of the team to plan audit activities

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Question 2

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

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 3

ISO 9001 is based on quality management principles. Match each of the following quality management principles to the related activity.

Options:

Answer:

Explanation:

Related Activity

Correct Quality Management Principle

Communicate client needs and expectations throughout the organisation.

Customer focus

Encourage an organisation-wide commitment to quality.

Leadership

Empower staff to determine constraints to performance and to take the initiative without fear.

Engagement of people

Establish authority, responsibility, and accountability for managing processes.

Process approach

Continuously educate and train people at all levels on how to apply basic tools and methodologies to achieve objectives.

Improvement

Determine, measure, and monitor key indicators to demonstrate the organisation’s performance.

Evidence-based decision making

Determine relevant interested parties (such as providers, partners, customers, investors, employees, or society as a whole) and their connection with the organisation.

Relationship management

1. Customer focus

ISO 9001 states that organizations must understand and consistently meet customer needs and expectations.

➡ Communicating client needs throughout the organization ensures alignment and customer satisfaction.

[Reference: Clause 0.2; Clause 5.1.2 (Customer focus), , 2. Leadership, Leadership establishes unity of purpose and direction and promotes a culture of quality across the organization.➡ Encouraging organization-wide commitment to quality is a core leadership responsibility.Reference: Clause 0.2; Clause 5.1 (Leadership and commitment), , 3. Engagement of people, ISO emphasizes that competent, empowered, and engaged people at all levels enhance organizational capability.➡ Empowering staff to identify constraints and act without fear reflects true engagement.Reference: Clause 0.2; Clause 7.3 (Awareness), , 4. Process approach, The process approach requires clear definition of responsibilities, authorities, inputs, outputs, and controls.➡ Establishing authority, responsibility, and accountability for processes is fundamental to this principle.Reference: Clause 0.2; Clause 4.4 (QMS and its processes), , 5. Improvement, Organizations must continually improve products, services, and system effectiveness.➡ Ongoing education and training enable improvement through better tools and methods.Reference: Clause 0.2; Clause 10.3 (Continual improvement), , 6. Evidence-based decision making, Effective decisions are based on the analysis of data and information.➡ Measuring and monitoring KPIs directly supports evidence-based decisions.Reference: Clause 0.2; Clause 9.1 (Monitoring, measurement, analysis, and evaluation), , 7. Relationship management, Sustained success depends on managing relationships with relevant interested parties.➡ Identifying interested parties and understanding their connection to the organization reflects this principle.Reference: Clause 0.2; Clause 4.2 (Interested parties), , , , ]

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