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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:| Topic | Details | | Topic 1 | - Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.
| | Topic 2 | - Fundamental principles and concepts of a quality management system: The main objective of this domain is to evaluate your skills of explaining and applying ISO 9001 principles and concepts.
| | Topic 3 | - Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
| | Topic 4 | - Quality management system (QMS) requirements: It assesses your abilities to point out and explain different requirements for a quality management system based on ISO 9001.
| | Topic 5 | - Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q104-Q109):NEW QUESTION # 104
Match the process descriptions below to the process names:

Answer:
Explanation:

Explanation:
Match the process descriptions below to the process names:
The process by which the accuracy of test equipment is checked against a known standard. = Calibration The process by which a product or service is visually examined to determine conformity to requirements. = Evaluation The process by which data is examined in detail to reach a specific answer or answers. = Analysis The process by which a parameter of a product or service is examined to determine a specific value. = Measurement According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, the definitions of the process names are as follows:
Calibration: operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.
Evaluation: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.
Analysis: detailed examination of the elements or structure of something.
Measurement: process to experimentally obtain one or more quantity values that can reasonably be attributed to a quantity.
Therefore, the process descriptions can be matched to the process names based on these definitions.
References:
ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary
NEW QUESTION # 105
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:
Based on Scenario 7, the team worked together to draft the final audit report. Is this acceptable?
- A. Yes, audit team members should contribute to drafting one general report for the findings and conclusions
- B. No, audit team members should draft separate reports for their findings and conclusions
- C. No, it is the responsibility of the audit team leader to draft the audit report
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 6.4.9 (Audit Conclusions & Reporting):
* One consolidated audit report should be drafted based on all team members' findings.
* Each auditor does not draft separate reports (B) unless explicitly required.
Thus, A is the correct answer.
Reference:
ISO 19011:2018, Clause 6.4.9 (Audit Conclusions & Reporting)
NEW QUESTION # 106
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of
45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
After reviewing the documented information, Li Na claimed that it was not necessary to report the minor nonconformities that were identified; instead, they would be discussed in the next audit phase. Is this acceptable?
- A. Yes, during the review of documented information, only major nonconformities need to be documented if detected.
- B. No, identification of minor nonconformities or areas of concern that could become nonconformities need to be documented and communicated to the auditee before proceeding to the next audit phase.
- C. Yes, all identified nonconformities throughout the audit need to be documented and communicated at the end of the audit.
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:As per ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action), all identified nonconformities, including minor ones, must be documented and communicated to the auditee.
Minor nonconformities can lead to major issues if left unaddressed. The auditor must inform the organization before moving to the next audit phase so that corrective actions can be taken. Clause 9.2.2 (Internal Audit) states that audit findings should be reported without undue delay.
Since Li Na did not report the minor nonconformities immediately, her decision was incorrect. Minor nonconformities should always be documented and communicated before proceeding to the next phase.
NEW QUESTION # 107
Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top- notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.
In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.
Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS.
They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.
During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS.
AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.
Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.
Based on the scenario above, answer the following question:
Scenario 1 indicates that AL-TAX did not ensure clear and open communication channels with interested parties. Which quality management principle did the organization not follow in this case?
- A. Evidence-based decision making
- B. Relationship management
- C. Leadership
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015 is based on seven quality management principles, one of which is Relationship Management. This principle emphasizes the importance of maintaining open communication and collaboration with interested parties, including suppliers and customers.
Clause 7.4 (Communication) requires organizations to determine what, when, with whom, and how communication should take place. Since AL-TAX failed to ensure clear communication channels, it did not adhere to this principle. Effective relationship management helps improve supply chain performance, customer satisfaction, and overall QMS effectiveness.
NEW QUESTION # 108
What is the responsibility of the audit committee during an internal audit?
- A. To define the audit schedule
- B. To establish an internal audit program
- C. To supervise all audit functions and activities
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 5.2 (Audit Program Management):
* The audit committee is responsible for establishing the internal audit program.
* The audit schedule (A) is determined within the program, but it is not the main role of the committee.
Thus, C is the correct answer.
NEW QUESTION # 109
......
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