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| 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 |
- Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
|
| Topic 3 |
- Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.
|
| Topic 4 |
- 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 5 |
- Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
|
| Topic 6 |
- 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.
|
PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q145-Q150):
NEW QUESTION # 145
In the context of a third-party certification audit, it is very important to have effective communication. Which is not the responsibility of the audit team leader?
- A. Confirming formal communication channels between the audit team and the auditee during the opening meeting.
- B. Communicating the progress, any significant findings and any concerns to the auditee and audit client, as appropriate.
- C. Planning formal communication arrangements, so an auditee can communicate with the auditor any time during the audit.
- D. If audit objectives are unattainable, reporting the reasons to the accreditation body.
Answer: D
Explanation:
Responsibilities of the Audit Team Leader:
ISO 19011:2018 (guidelines for auditing management systems), which supports the principles in ISO 9001:
2015, specifies the responsibilities of an audit team leader. These responsibilities include:
* Planning the audit and establishing effective communication between the audit team and auditee.
* Ensuring that formal communication channels are agreed upon and followed.
* Reporting the audit progress, significant findings, and any concerns to the auditee or audit client as necessary.
* Managing the audit team and ensuring adherence to the defined objectives and scope.
Analysis of Options:
* A. Reporting unattainable audit objectives to the accreditation body:Incorrect. This is not the responsibility of the audit team leader. The accreditation body oversees the certification body and is not directly involved in specific audits. If objectives are unattainable, the audit team leader would report them to the audit client (the certification body), not the accreditation body.
* B. Planning formal communication arrangements:Correct. This is one of the responsibilities of the audit team leader. They ensure auditees can communicate with auditors as needed during the audit process.
* C. Confirming communication channels during the opening meeting:Correct. During the opening meeting, the audit team leader must establish clear communication protocols to ensure effective information exchange between the audit team and auditee.
* D. Communicating progress, findings, and concerns:Correct. Keeping the auditee and audit client informed about progress and significant findings is a critical responsibility of the audit team leader to maintain transparency and ensure the audit objectives are met.
Why Option A is Correct:
The audit team leader does not have any obligation to report unattainable objectives to the accreditation body
. Instead, they are responsible for communicating issues to the audit client (typically the certification body).
The accreditation body operates at a higher level and is concerned with overseeing certification bodies, not individual audits.
Relevant References:
* ISO 19011:2018, Clause 6.4 (Conducting the Audit): Emphasizes the responsibilities of the audit team leader, including communication with the auditee and client.
* ISO 9001:2015, Clause 9.2 (Internal Audit): Highlights the importance of planning and communication during audits, which is reflected in third-party audits as well.
NEW QUESTION # 146
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.
When reviewing the customer complaint file, you find that the organisation is facing a legal dispute with a customer over damage to an expensive cashmere coat.
Select the best option for how this should be handled by the Quality Management System.
- A. Make an offer to replace the coat with a new one.
- B. Settle the court case by negotiation with the customer.
- C. Report the situation to the customer with suggested remedial action.
- D. Give an explanation to the customer of what went wrong.
Answer: C
Explanation:
According to the ISO 9001:2015 standard, clause 10.2 requires organizations to review nonconformities, including any arising from customer complaints, and to take appropriate actions to determine the cause, implement corrections and preventive actions, and verify their effectiveness. The organization must also monitor the effectiveness of the actions taken and make changes if necessary.
In this scenario, the auditee is facing a legal dispute with a customer over damage to an expensive cashmere coat. This is a nonconformity that arises from customer complaint and has a significant impact on customer satisfaction and reputation. Therefore, clause 10.2 applies to this situation.
The best option for how this should be handled by the Quality Management System is B.
B means that the organization should report the situation to the customer with suggested remedial action. This option follows the principle of transparency and accountability, as well as respecting the customer's rights and expectations. The organization should also investigate the root cause of the damage and prevent it from happening again in other shops or products.
The other options are not appropriate because:
A means that the organization should settle the court case by negotiation with the customer. This option may not be feasible or satisfactory for both parties, especially if there is a large amount of compensation involved or if there are legal implications for other customers.
C means that the organization should make an offer to replace the coat with a new one. This option may not be sufficient or acceptable for both parties, especially if there is evidence of negligence or poor quality on behalf of the organization.
D means that the organization should give an explanation to the customer of what went wrong. This option may not be enough or convincing for both parties, especially if there is no evidence of negligence or poor quality on behalf of the organization.
NEW QUESTION # 147
Which two of the following roles do not contribute to the audit outcomes?
- A. Guide
- B. Individual(s) managing the audit programme
- C. Technical expert
- D. Observer
- E. Auditee
- F. Consultant
Answer: B,E
Explanation:
The individual(s) managing the audit programme and the auditee are both roles that contribute to the audit outcomes. The individual(s) managing the audit programme are responsible for planning, conducting, and reporting on the audit activities, as well as ensuring that they are aligned with the organization's quality objectives and risk management processes1. The auditee is the person or entity that is subject to an audit, and their participation, cooperation, and feedback are essential for achieving a successful audit outcome2. References:
ISO 9001 Lead Auditor Reference Materials
ISO 9001 Lead Auditor Candidate Handbook
ISO 9001 Lead Auditor Course Material
ISO 9001 Lead Auditor Training Course IRCA Certified
NEW QUESTION # 148
A Health Trust has contracted with Servitup, a catering services company that has been certified to ISO
9001 for one year. It provides services to 10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager (DCM).
DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are really short of staff." You: "I see. It really shouldn't affect the QMS so the audit can progress as normal." DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is." You: "OK, let's start with the Quality Policy. What are the main issues for the QMS here?" DCM: Give me a minute. I need to look at the Quality Policy on the noticeboard in his office.
You find that two internal audits have been carried out in the first year by the Catering Manager. One of them indicates that complaints from patients are increasing in number, mainly due to food being served too cold. The DCM comments that the trolley thermometer is often unreliable.
Which two of the following actions would be "correction" in dealing with the complaints?
- A. Request ward staff to test the temperature of the food on the plates before serving to patients.
- B. Monitor and record the temperature of food on the trolleys against defined standards before release to the wards.
- C. Purchase a new thermometer to replace the unreliable one used for the ward trolleys.
- D. Plug trolleys into ward electricity sockets to heat food to the correct temperature after a patient complains.
- E. Calibrate thermometers more frequently to ensure accuracy of readings for food temperature on the trolleys.
- F. Keep a spare thermometer in case of a thermometer malfunction.
Answer: C,E
NEW QUESTION # 149
Match the process descriptions below to the process names:

Answer:
Explanation:

Explanation:
A white background with black text Description automatically generated

NEW QUESTION # 150
......
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