2025 100% Free ISO-9001-Lead-Auditor–Perfect 100% Free Pass Guide | QMS ISO 9001:2015 Lead Auditor Exam Learning Mode
2025 100% Free ISO-9001-Lead-Auditor–Perfect 100% Free Pass Guide | QMS ISO 9001:2015 Lead Auditor Exam Learning Mode
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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q195-Q200):
NEW QUESTION # 195
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements.
The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.
You are interviewing the Training Manager (TM).
You: "What quality objectives apply to the training process?"
TM: "One of the quality objectives we aim for is a 90% minimum exam pass rate for all open training courses." You: "How do you measure this objective?" The Training Manager shows you a record on her computer and you see the following:
Which two of the following statements are true?
- A. You would raise a nonconformity as a requirement in clause 8.7 has not been fulfilled.
- B. You would raise a nonconformity as a requirement in clause 10.2 has not been fulfilled.
- C. You would determine how the exam pass rate figures were analysed.
- D. You would check the training of personnel.
- E. You would determine what corrective action was being taken to address the low pass rates.
- F. You would determine the relative difficulty of each training course by reviewing them.
Answer: C,E
Explanation:
In this scenario, the organization has set a quality objective of achieving a 90% minimum exam pass rate for all courses. The auditor's task is to assess whether this objective is being monitored effectively and if appropriate actions are taken when the objective is not met.
B: You would determine how the exam pass rate figures were analysed: ISO 9001:2015, particularly Clause
9.1 (Monitoring, measurement, analysis, and evaluation), requires organizations to evaluate performance data.
The auditor should verify how the organization analyses the pass rate data to ensure trends are identified, and corrective actions are planned based on this analysis.
D: You would determine what corrective action was being taken to address the low pass rates: When performance falls short of the objective, as seen with Course 4 (where the pass rate is below 90% in all months), Clause 10.2 (Nonconformity and corrective action) requires organizations to take corrective actions to address issues. The auditor would need to check if corrective actions have been initiated to address consistently low pass rates.
Statements A, C, E, and F do not directly address the monitoring and corrective action required under ISO
9001:2015 in this context.
NEW QUESTION # 196
Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?
- A. Audit Plan
- B. Procedures
- C. Audit Report
- D. Risk Matrices
- E. Findings
- F. Checklist / Prompts
Answer: A,F
Explanation:
According to ISO 19011:2018, clause 6.3, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the information listed in my previous response, such as the audit objectives, scope, criteria, schedule, team, methods, report, etc. The audit plan should be prepared and completed prior to the on-site audit, and should be communicated to the audit team and the auditee1.
According to ISO 19011:2018, clause 6.4.3, the checklist / prompts are documents that list the questions or topics that need to be covered during an audit. The checklist / prompts can help the auditor to collect and verify information relevant to the audit criteria, and to ensure the consistency and completeness of the audit.
The checklist / prompts should be prepared and completed prior to the on-site audit, and should be based on the audit plan and the audit scope and objectives1.
Therefore, the two documents that an auditor needs to prepare and complete prior to the on-site audit are B and D, as they are essential for planning and conducting the audit. The other options are not correct, as they are either prepared or completed after the on-site audit, or not required by the standard:
*A. Audit Report: The audit report is a document that provides a complete, accurate, concise, and clear record of the audit. The audit report should include the information listed in my previous response, such as the audit objectives, scope, criteria, findings, conclusions, etc. The audit report should be prepared and completed after the on-site audit, and should be distributed to the audit client and the auditee1.
*C. Procedures: Procedures are documents that specify the way activities are to be performed. Procedures may be part of the audit criteria, if they are part of the organization's management system, or part of the audit programme, if they are part of the certification body's or registrar's requirements. Procedures are not prepared or completed by the auditor prior to the on-site audit, but rather reviewed or followed by the auditor during the audit1.
*E. Risk Matrices: Risk matrices are tools that help to assess and prioritize the risks and opportunities associated with the audit programme or the audit. Risk matrices may be part of the audit programme management, if they are used to determine and evaluate the audit programme risks and opportunities, or part of the audit preparation, if they are used to determine and evaluate the audit risks and opportunities. Risk matrices are not prepared or completed by the auditor prior to the on-site audit, but rather used or updated by the auditor during the audit programme management or the audit preparation1.
*F. Findings: Findings are the results of the evaluation of the collected audit evidence against the audit criteria. Findings can indicate either conformity or nonconformity, as well as positive aspects or opportunities for improvement. Findings are not prepared or completed by the auditor prior to the on-site audit, but rather generated and recorded by the auditor during the audit activities1.
References: ISO 19011:2018(en), Guidelines for auditing management systems
NEW QUESTION # 197
Scenario 3:
Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.
To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.
The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.
The audit team began by gathering information about Fin-Pro's understanding of ISO 9001 requirements.
While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.
The team also reviewed the organizational chart and job descriptions to confirm employee competence.
They observed the company's working environment (social, psychological, and physical conditions).
The audit team analyzed the evidence and prepared an audit report with findings and conclusions.
What type of evidence has been collected by the ACB's audit team, as presented in scenario 3?
- A. Documentary, confirmative, verbal.
- B. Verbal, documentary, physical.
- C. Observational, secondary, qualitative.
- D. Physical, verbal, analytical.
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Audit evidence includes information collected through different methods to assess compliance with ISO
9001:2015 requirements.
Clause References:
* ISO 19011:2018, Clause 6.4.6 - Audit Evidence: Audit evidence must be objective, verifiable, and based on facts.
* ISO 9001:2015, Clause 9.1.1 - Monitoring, Measurement, Analysis, and Evaluation: Requires organizations to collect and analyze data from multiple sources to verify effectiveness.
Types of Audit Evidence Collected in Scenario 3:
* Verbal Evidence - Employee interviews regarding training and awareness sessions.
* Documentary Evidence - Organizational charts, job descriptions, training records.
* Physical Evidence - Workplace observations to assess working conditions.
Why is the Correct Answer B?
* The audit team used a combination of verbal (interviews), documentary (records), and physical (site observations) evidence.
* This triangulation approach enhances audit reliability and ensures compliance verification.
Why are the Other Options Incorrect?
* A (Confirmative evidence) # Not a formal audit term in ISO 9001 or ISO 19011.
* C (Analytical evidence) # Incorrect, as analysis was not a primary method used.
* D (Qualitative evidence only) # Incorrect because the audit involved both qualitative (interviews) and quantitative (documents, physical) evidence.
Reference:
ISO 19011:2018, Clause 6.4.6 - Audit Evidence
ISO 9001:2015, Clause 9.1.1 - Monitoring, Measurement, Analysis, and Evaluation
NEW QUESTION # 198
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?
- A. Yes, but Sean himself must be present in every audit activity
- B. Yes, Sean should grant the auditor permission
- C. No, internal auditors should be independent of the processes being audited
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 19011:2018, Clause 5.1 (Impartiality) states that:
* Internal auditors must be independent of the processes they audit to ensure objectivity.
* Auditing one's own department introduces bias and is not permitted.
Thus, Sean must not allow the auditor to audit their own department.
NEW QUESTION # 199
"A set of interrelated or interlacing elements of an organization to establish policies and objectives, and processes to achieve those objectives" is the definition of a/an:
- A. Management system
- B. Standard
- C. Organization scope
- D. Quality manual
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 9000:2015, which provides definitions for terms used in ISO 9001:2015, a management system is defined as a set of interrelated or interacting elements of an organization to establish policies, objectives, and processes to achieve those objectives.
A Quality Management System (QMS) is a type of management system that ensures organizations meet customer and regulatory requirements while improving performance.
Clause 3.5.3 of ISO 9000:2015 clearly defines "management system" and aligns with this question. The other options do not fit the definition:
* Standard refers to an established norm or requirement.
* Organization scope defines the boundaries of a QMS but is not a system itself.
* Quality manual is a document (optional under ISO 9001:2015) that describes a QMS but is not the system itself.
NEW QUESTION # 200
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