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Most Recent PECB ISO-9001-Lead-Auditor Exam Questions & Answers
Prepare for the PECB QMS ISO 9001:2015 Lead Auditor exam with our extensive collection of questions and answers. These practice Q&A are updated according to the latest syllabus, providing you with the tools needed to review and test your knowledge.
QA4Exam focus on the latest syllabus and exam objectives, our practice Q&A are designed to help you identify key topics and solidify your understanding. By focusing on the core curriculum, These Questions & Answers helps you cover all the essential topics, ensuring you're well-prepared for every section of the exam. Each question comes with a detailed explanation, offering valuable insights and helping you to learn from your mistakes. Whether you're looking to assess your progress or dive deeper into complex topics, our updated Q&A will provide the support you need to confidently approach the PECB ISO-9001-Lead-Auditor exam and achieve success.
The questions for ISO-9001-Lead-Auditor were last updated on Dec 24, 2024.
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Which two of the following aspects of a quality management system must the organisation continually improve?
Question no: 5 Verified Answer: = C. Effectiveness and D. Efficiency
1: ISO 9000:2015 - Quality management systems --- Fundamentals and vocabulary
2: ISO 9001:2015 - Quality management systems --- Requirements
3: ISO 9001 Explained: A Comprehensive Guide to Quality Management Systems - ISMS.online
4: The 7 Principles of ISO 9001 | ISO Standards Explained
5: Key Elements of an ISO 9001:2015 Quality Management System
Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.
According to the ISO 9000:2015 - Quality management systems --- Fundamentals and vocabulary, correction is defined as ''action to eliminate a detected nonconformity''. A nonconformity is defined as ''non-fulfilment of a requirement''. Therefore, the process of modifying a non-conforming product to bring it within acceptance criteria is a correction, as it eliminates the non-fulfilment of the product specification. The other options are not correct, as they have different definitions and purposes:
* Concession: permission to release or use a nonconforming product, service or process
* Corrective action: action to eliminate the cause of a nonconformity and to prevent recurrence
* Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable potential situation
TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important
customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit
team discussed and agreed both nonconformities with TIX's quality manager. The Closing meeting was planned for 6pm with the general manager,
quality manager and service manager at the meeting room.
At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the
warehouse supervisor. Neither have participated in the audit.
The dialogue among them is as follows:
Audit team leader: "Good evening, could you please inform the three managers that we are ready to start with the Closing meeting?"
Health and Safety supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and
the other two managers have had to leave urgently to attend the emergency."
Warehouse supervisor: "They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message
from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed."
Which one of the following options would be your preferred response to the final comment made by the warehouse manager?
Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit processes.
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.
* 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
'XYZ' has already sent to you a list with all documented procedures and work instructions related to the services provided to 'ABC' (a quality manual is not included in the list).
To complete the audit planning which additional information would you ask to XYZ to submit? Select four.
The ISO 9001 Lead Auditor exam requires the auditor to have a thorough understanding of the ISO 9001:2015 standard and its requirements, as well as the organization's context, processes, risks, opportunities, and performance. Therefore, the auditor needs to ask for additional information that can help them verify these aspects during the audit planning stage. Some of the information that can be useful are:
A description of responsibilities and authorities of the key roles of XYZ: This can help the auditor to identify who is accountable for what in the organization and how they communicate with each other.
The number of personnel involved in activities related to the quality management system: This can help the auditor to assess if there are enough resources and competencies to support the QMS implementation and operation.
Information to understand XYZ's operations: This can help the auditor to understand how XYZ produces or delivers its products or services and what are its main processes and inputs.
The results of XYZ's last internal audit: This can help the auditor to evaluate if XYZ has implemented corrective actions based on previous audit findings and if it has maintained its QMS effectiveness.
The results of the last two management reviews: This can help the auditor to determine if XYZ has monitored its QMS performance against its objectives and if it has identified any significant changes or opportunities for improvement.
The quality manual (B) is not a required document for ISO 9001 certification, but it may be useful for internal reference or training purposes. It is not necessary for audit planning.
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