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

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Question # 33

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:

According to Scenario 7, one of the auditors requested permission from Sean to audit the department in which he worked on a daily basis. Should Sean grant the auditor permission?

No, internal auditors should be independent of the processes being audited

Yes, Sean should grant the auditor permission

Yes, but Sean himself must be present in every audit activity

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Question # 34

You are carrying out an annual surveillance audit at an organisation that has been certificated to ISO 9001 for two years. The organisation offers home cleaning services. The scope of the quality management system covers planning the weekly activities, providing cleaning materials, cleaning the whole property (including outdoor space) alarm installation, alarm servicing, alarm monitoring and response. The business operates from a single office and employs subcontract cleaners across the whole city.

You have just completed the opening meeting. You are interviewing the Managing Director (MD).

You: I would like to gain an understanding of how the quality management system has been supporting your business and its strategic direction.

MD: We are continuing to face difficult times. The market is extremely competitive, and customers typically look for the least expensive option when choosing home cleaning services. We have not yet seen any business benefit from our quality management system.

You: Tell me how you determine external and internal issues.

MD: We use PESTLE analysis (Political, economic, social, technological, legal, environmental).

You: Why did you not use the SWOT model (Strengths, Weaknesses, Opportunities, Threats)?

MD: I had used PESTLE in my previous job.

You: How have the outputs from your PESTLE been used?

Select two audit trails which would lead to a determination of how the PESTLE analysis would affect the planning of a QMS to ISO 9001.

Has the PESTLE analysis been reviewed by the operations manager?

How many external interested parties were consulted?

What actions have been taken to address the risks and opportunities from the PESTLE analysis?

What, if any, training has been given in SWOT analysis?

How has the PESTLE analysis contributed to the improvement of the QMS?

How does the organisation share information with external interested parties?

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Answer:

Explanation:

ISO 9001:2015 requires organisations to understand their context and to use this understanding as an input to planning the quality management system. Tools such as PESTLE are acceptable methods, but auditors must verify how the outputs are used, not simply that the analysis exists.

Relevant ISO 9001 requirements:

Clause 4.1 â€“ Understanding the organisation and its contextThe organisation shall determine external and internal issues that are relevant to its purpose and strategic direction and that affect its ability to achieve the intended results of the QMS.

Clause 6.1 â€“ Actions to address risks and opportunitiesThe organisation shall plan actions to address risks and opportunities identified from context analysis and integrate these actions into the QMS processes.

Explanation of the correct audit trails:

C. What actions have been taken to address the risks and opportunities from the PESTLE analysis?

This audit trail directly links PESTLE outputs to Clause 6.1. It allows the auditor to determine whether the organisation has translated identified political, economic, social, technological, legal, and environmental issues into concrete actions within planning, operational control, or resource allocation. Without actions, the PESTLE analysis has no impact on QMS planning.

E. How has the PESTLE analysis contributed to the improvement of the QMS?

ISO 9001 requires context analysis to support improvement and strategic alignment of the QMS. This audit trail confirms whether PESTLE outputs are used as inputs to improvement activities, management review, or changes to processes, supporting Clauses 4.1, 6.1, and 10.3.

Explanation of why the other options are not selected:

A: Review by a specific manager is not a requirement of ISO 9001 and does not demonstrate impact on QMS planning.

B: PESTLE does not require consultation with external interested parties; that relates to Clause 4.2, not planning impact.

D: Training in SWOT is irrelevant, as ISO 9001 does not mandate any specific analysis tool.

F: Sharing information with external interested parties relates to communication, not to how PESTLE affects QMS planning.

ISO-aligned conclusion:

To determine how PESTLE analysis affects planning of a QMS, the auditor must follow audit trails that demonstrate:

Conversion of identified issues into risk-based actions, and

Use of those outputs to improve and adapt the QMS.

Therefore, the correct answers are C and E.

Question # 35

An audit team leader arrives at a printing organisation to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer

manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001

certificate to cover the new contract.

Which one of the options is the correct response by the auditor?

Do you realise that this involves an extension to the scope of the audit and will require an application process?

How can we audit this area when we do not have an IT specialist in the team?

Would you like a separate certificate for the IT packages to show your new client?

Would you mind writing to my programme manager with this request?

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Question # 36

Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer

complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry. The Quality

Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn

that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.

On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.

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Question # 37

Select the phrase that best describes the purpose of a quality management system to ISO 9001 in relation to the performance of an organization.

Manages the performance

Monitors the performance

Dictates the performance

Improves the performance

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Answer:

Explanation:

Understanding the Purpose of a Quality Management System (QMS):The primary objective of ISO 9001:2015 is to improve the overall performance of the organization by:

Ensuring consistent delivery of products and services that meet customer and regulatory requirements.

Focusing on enhancing customer satisfaction.

Promoting continual improvement of the organizationâ€™s processes and practices.

[Reference:Clause 0.1 (General) of ISO 9001:2015 specifies that a QMS enables organizations to achieve better performance by consistently meeting customer needs and improving their processes. It further highlights that continual improvement is a cornerstone of the standard (Clause 10.3)., Option Analysis:, A. Manages the performance:Incorrect. A QMS provides a framework to manage processes, not directly manage performance. The improvement of performance is an outcome of managing processes effectively., B. Monitors the performance:Incorrect. Monitoring is a component of performance evaluation (Clause 9.1) but does not define the overall purpose of the QMS., C. Dictates the performance:Incorrect. ISO 9001 does not "dictate" performance but allows organizations to set their own objectives and improve their operations based on their specific context and goals., D. Improves the performance:Correct. The fundamental purpose of a QMS as per ISO 9001 is continual improvement of the organizationâ€™s performance. This includes improving operational efficiency, customer satisfaction, and product/service quality., Why Option D is Correct:ISO 9001:2015 emphasizes the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking, which are designed to drive improvements in organizational performance. Continuous assessment of processes and customer feedback ensures that the organization can adapt, innovate, and improve its effectiveness over time., Relevant Clauses Supporting the Answer:, Clause 0.1: Purpose of the QMS., Clause 10.3: Continual improvement ensures that the QMS remains effective and aligned with organizational objectives., Clause 4.1: Context of the organization, which requires the QMS to align with organizational strategies and improve outcomes., , , ]

Question # 38

Select the word that best completes the sentence:

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Question # 39

Which two of the following may be changed once a Stage 2 certification audit has commenced?

Agreed language of the audit

Audit scope

Audit plan

Agreed standard for the audit criteria

Audit checklist

Increase of audit duration

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Answer:

Explanation:

Comprehensive and Detailed In-Depth Explanation:

Once a Stage 2 certification audit has commenced, certain logistical or planning-related elements may still be adjusted, while others are fixed by prior agreement and cannot be changed.

âœ… C. Audit Plan:

The audit plan is a document that outlines the scope, objectives, criteria, and logistics of the audit. According to ISO/IEC 17021-1:2015 (the standard for bodies providing audit and certification of management systems), clause 9.2.3.3 allows for modification of the audit plan based on real-time conditions during the audit â€” such as availability of auditees or changes in process access.

âœ… F. Increase of Audit Duration:

Audit duration is generally determined during audit planning based on factors like employee count, risk, complexity, etc. However, if during Stage 2 it is found that more time is needed (e.g., due to additional processes, scope not fully covered, or significant findings), auditors are permitted to extend the audit. This ensures full coverage of all required areas as per ISO/IEC 17021-1 clause 9.1.4 and IAF MD 5.

âŒ A. Agreed Language of the Audit:

This is determined and agreed upon in the contract and audit planning stages. Changing it during Stage 2 would create communication and documentation issues, especially in multi-site or multi-national audits.

âŒ B. Audit Scope:

The audit scope is defined in the contract and certification agreement based on clause 4.3 of ISO 9001:2015. Changing it mid-audit would invalidate planning, required competencies, and potentially even the certification basis.

âŒ D. Agreed Standard for the Audit Criteria:

Changing the standard (e.g., from ISO 9001 to ISO 13485) is fundamentally altering the purpose and contractual basis of the audit and is not permissible once Stage 2 has started.

âŒ E. Audit Checklist:

The checklist is a tool prepared by the auditor as part of audit preparation and is based on the audit plan and standard requirements. While it may be adapted during the audit (e.g., if new risks arise), it does not constitute a formal change like duration or scope.

Relevant References:

ISO/IEC 17021-1:2015 Clause 9.2.3.3 (Audit Plan Modification)

IAF MD 5:2019 (Duration of QMS Audits)

ISO 9001:2015 Clause 4.3 (Scope of the QMS)

ISO/IEC 17021-1:2015 Clause 9.1.4 (Audit Duration)

Question # 40

According to ISO 9000, what is quality?

The ability of an object to realize an output that will fulfill the requirements for that output

The degree to which a set of inherent characteristics of an object fulfills requirements

A set of conditions under which work is performed

The efficiency with which resources are utilized in achieving objectives

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