RELIABLE ISO-9001-LEAD-AUDITOR BRAINDUMPS PDF - PASS GUARANTEED QUIZ 2025 PECB FIRST-GRADE EXAM ISO-9001-LEAD-AUDITOR STUDY SOLUTIONS

Reliable ISO-9001-Lead-Auditor Braindumps Pdf - Pass Guaranteed Quiz 2025 PECB First-grade Exam ISO-9001-Lead-Auditor Study Solutions

Reliable ISO-9001-Lead-Auditor Braindumps Pdf - Pass Guaranteed Quiz 2025 PECB First-grade Exam ISO-9001-Lead-Auditor Study Solutions

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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:

TopicDetails
Topic 1
  • Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
Topic 2
  • Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
Topic 3
  • 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.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q200-Q205):

NEW QUESTION # 200
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
Based on scenario 4, conducting which of the activities below is NOT the responsibility of Anne?

  • A. Assigning responsibilities for the audit team members.
  • B. Establishing audit criteria and objectives.
  • C. Signing the certification agreement.
  • D. Determining the audit feasibility.

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires specific roles and responsibilities for audit leaders and certification bodies.
Clause References:
* ISO 19011:2018, Clause 5.5 - Conducting the Audit: Defines audit team leader responsibilities.
* ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning: Defines certification body responsibilities, including the certification agreement.
Why is the Correct Answer D?
* The certification agreement is signed between the certification body and the auditee (TD Advertising).
* Anne (audit team leader) does NOT have authority to sign the agreement-that is the responsibility of the certification body's management.
Why are the Other Options Incorrect?
* A (Establishing audit criteria and objectives) # Correct responsibility of the audit leader as per ISO 19011.
* B (Determining audit feasibility) # Audit leaders assess feasibility but do not sign agreements.
* C (Assigning responsibilities for the audit team) # This is part of the audit leader's role in planning audits.


NEW QUESTION # 201
Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit processes.

  • A. Conduct a minimum number of annual surveillance audits during the certification period.
  • B. Review changes to the QMS since last visit.
  • C. Complete a full document review of the quality management system.
  • D. Review the calibration status of the instrumentation.
  • E. Audit use of certification marks on marketing materials.
  • F. Review the status of previously raised findings and audit effectiveness of any outstanding findings.
  • G. Failing to meet financial responsibilities.
  • H. Handling of customer complaints since last visit.
  • I. Verify legal compliance.
  • J. Confirm effectiveness of internal audit and management review.

Answer: B,E,F,H,I,J

Explanation:
The activities that are specifically required by ISO 17021-1 as part of third-party (Certification Body) surveillance audit processes are:
*Option A: Audit use of certification marks on marketing materials. This option is correct because ISO 17021-
1:2015 clause 9.6.2.2 requires the certification body to audit the client's use of marks and/or any other reference to certification, as applicable, to ensure conformity with the certification requirements.
*Option B: Review changes to the QMS since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review any changes affecting the client's quality management system and its ability to continue to fulfil the requirements of the standard used for certification.
*Option C: Confirm effectiveness of internal audit and management review. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to confirm the continuing effectiveness of the client's quality management system, including the effectiveness of the internal audit and management review processes.
*Option F: Review the status of previously raised findings and audit effectiveness of any outstanding findings.
This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the status of findings and any corrective actions taken by the client in response to previous audits, and to verify the effectiveness of the implemented corrective actions.
*Option H: Verify legal compliance. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to verify the client's compliance with applicable statutory and regulatory requirements related to the scope of certification.
*Option I: Handling of customer complaints since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the client's handling of customer complaints related to the certified activities since the last audit.
The following options are not correct:
*Option D: Complete a full document review of the quality management system. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to complete a full document review of the quality management system during surveillance audits. A full document review is only required during the initial certification audit or when there are significant changes to the quality management system or the certification requirements.
*Option E: Failing to meet financial responsibilities. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to audit the client's financial responsibilities during surveillance audits. The certification body may have contractual arrangements with the client regarding the payment of fees, but this is not part of the surveillance audit process.
*Option G: Review the calibration status of the instrumentation. This option is not correct because ISO 17021-
1:2015 clause 9.6.2.2 does not require the certification body to review the calibration status of the instrumentation during surveillance audits. The certification body may audit the client's monitoring and measuring resources as part of the quality management system requirements, but this is not a specific activity required by ISO 17021-1.
*Option J: Conduct a minimum number of annual surveillance audits during the certification period. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to conduct a minimum number of annual surveillance audits during the certification period. The certification body may determine the frequency and duration of surveillance audits based on the risk and performance of the client, but this is not a specific activity required by ISO 17021-1.
References:
*ISO 17021-1:2015 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements
*ISO 9001 Lead Auditor Course Material, Module 7: Audit Follow-up and Surveillance, Slide 8: Surveillance Audit
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 7.2: Audit Follow-up and Surveillance
*Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection
3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies


NEW QUESTION # 202
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. Calibrate thermometers more frequently to ensure accuracy of readings for food temperature on the trolleys.
  • B. Plug trolleys into ward electricity sockets to heat food to the correct temperature after a patient complains.
  • C. Monitor and record the temperature of food on the trolleys against defined standards before release to the wards.
  • D. Keep a spare thermometer in case of a thermometer malfunction.
  • E. Request ward staff to test the temperature of the food on the plates before serving to patients.
  • F. Purchase a new thermometer to replace the unreliable one used for the ward trolleys.

Answer: A,F


NEW QUESTION # 203
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. Report the situation to the customer with suggested remedial action.
  • B. Make an offer to replace the coat with a new one.
  • C. Give an explanation to the customer of what went wrong.
  • D. Settle the court case by negotiation with the customer.

Answer: A

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 # 204
You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.
You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?" TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry." You: "How is their regulatory competence maintained?" TD: "They are dedicated individuals with lots of contacts in the sector." You: "How does the business enable them to maintain their understanding of current regulatory requirements?" TD: "We leave that up to them."

Answer:

Explanation:

Explanation:
A screenshot of a computer Description automatically generated


NEW QUESTION # 205
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