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

TopicDetails
Topic 1
  • 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 2
  • Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.
Topic 3
  • Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
Topic 4
  • Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
Topic 5
  • Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.
Topic 6
  • 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.

Reference: https://pecb.com/en/education-and-certification-for-individuals/iso-9001/iso-9001-lead-auditor

PECB QMS ISO 9001:2015 Lead Auditor Sample Questions:

Question #1

You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: " I ' d like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months? " Auditee: " We have made some strategic changes, the main one being that we no longer manufacture our own products in house. " You: " That sounds like quite a significant change. What has been the impact of that? " Auditee: " We now mainly sell other manufacturers ' products, under their brand names, and have outsourced manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging time. " You: " I ' m sure. What were the reasons for making the change? " Auditee: " Our manufacturing section was a small operation, and we struggled to cope with fluctuations in demand. During busy periods, we found it hard to meet lead times, and in quiet periods we had staff with little to do. This was having an impact on customer satisfaction and meant we had to charge premium prices that made our product uncompetitive. " You: " How did you go about the change? " In relation to the auditor ' s question about how the change was managed, the auditee mentions the steps listed below. Match the ISO 9001 clauses to the steps.
To complete the table, click on the blank section you want to complete so it is highlighted in red and then click on the ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show which step the requirement applies to.

Reveal Solution  Discussion  0

Correct Answer:


Explanation:

Here is the correct matching of ISO 9001:2015 clauses to the steps mentioned in the change management process:
We identified risks and opportunities and fed these into our risk management processes.
Clause 6.1 (Actions to address risks and opportunities)
We found a suitable supplier.
Clause 8.4 (Control of externally provided processes, products, and services) We monitored customer feedback and noticed an increase in negative feedback about lead times.
Clause 9.1.2 (Customer satisfaction)
We put together a plan for implementation.
Clause 6.2.2 (Planning to achieve quality objectives)
We monitored the performance of the new supplier.
Clause 8.4.2 (Type and extent of control of external providers)
We noticed that productivity targets were being missed.
Clause 9.1.1 (Monitoring, measurement, analysis, and evaluation)
We communicated the plan internally.
Clause 7.4 (Communication)
We looked at the data at the management review and decided we needed to do something different.
Clause 9.3.2 (Management review inputs)
We reorganised the staffing and implemented redundancies.
Clause 7.1.2 (People)
We set an objective to effectively implement the transition and outsource manufacturing.
Clause 6.2.1 (Quality objectives and planning to achieve them)
This aligns the steps of the change process with relevant ISO 9001:2015 clauses related to risk, planning, communication, and monitoring.

Question #2

You work for an organisation, ' ABC ' , which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit an external provider, ' XYZ ' , which provides packaging materials to your organisation. It is
4 pm, and the audit is dlose to an end;
you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled for 5 pm.
' XYZ ' has two manufacturing lines: M1 is a clean room for primary packaging materials (i.e. will be in direct contact with the food), and M2 is for secondary materials (i.e. will not be in direct contact with food).
Auditor 1 audited the two manufacturing lines.
You: " What findings would you report? "
Auditor 1: " I have one issue. Earlier today in the morning I saw some secondary material stocked in the clean room. I would propose raising a nonconformity. " You: " How would you write the nonconformity? " Auditor 1: " In the clean room, there was a pallet with secondary materials. " What additional information would you add to this text to complete the nonconformity report? Select six.

  • A. Description of the ISO 9001:2015 requirement not being complied with and the clause number
  • B. The type of nonconformity (major or minor)
  • C. Evidence that the secondary material was approved ready to be used
  • D. Description of the secondary material
  • E. The date on which the evidence was identified
  • F. Name of the forklift driver that was moving the pallet
  • G. Description of any primary material close to this pallet
  • H. The signature of the clean room ' s supervisor accepting the nonconformity
  • I. Batch number of the secondary material
  • J. More information in the place within the clean room where secondary material was found
Reveal Solution  Discussion  0

Correct Answer: A,B,D,E,G,I  🗳️

Question #3

According to ISO 9000, what is quality?

  • A. A set of conditions under which work is performed
  • B. The degree to which a set of inherent characteristics of an object fulfills requirements
  • C. The ability of an object to realize an output that will fulfill the requirements for that output
  • D. The efficiency with which resources are utilized in achieving objectives
Reveal Solution  Discussion  0

Correct Answer: B  🗳️

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Question #4

State the correct sequence of events in the certification process for an organisation to obtain third-party accredited certification to ISO 9001.

Reveal Solution  Discussion  0

Correct Answer:


Reference: ISO 9001:2015 Clause 9.2 emphasizes the planning of audits and their scheduling to achieve desired results.
Step 2: Conduct Certification Audit StagesThe certification process includes a two-stage audit.
Stage 1 Audit: Review of documentation to verify readiness and understanding of the Quality Management System (QMS).
Stage 2 Audit: A detailed evaluation of the implementation and effectiveness of the QMS against ISO 9001 requirements.Reference: Clause 8.1 of ISO 9001:2015 discusses operational planning and control, which includes the preparation for audit activities.
Step 3: Award ISO 9001 CertificateAfter successfully completing the certification audits and resolving any identified non-conformities, the certification body awards the ISO 9001 certificate. This certificate demonstrates that the organization ' s QMS meets the ISO 9001 standard.Reference: Clause 10 of ISO 9001:
2015 focuses on continual improvement and conformity, which leads to the certification issuance.
Step 4: Accredit Certification BodyCertification bodies must be accredited to ensure they meet international standards for certification. Accreditation is conducted by bodies like UKAS (United Kingdom Accreditation Service) or ANAB (ANSI National Accreditation Board), ensuring the credibility and global acceptance of the certification process.Reference: Clause 7.1.5 of ISO 9001 covers resource monitoring, which supports the integrity of the certification process.
By following these steps, organizations can ensure an effective and compliant certification process, achieving ISO 9001 certification.

Question #5

In the context of a management system audit, identify the sequence of a typical process for collecting and verifying information. The first one has been done for you.
To complete the sequence click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.

Reveal Solution  Discussion  0

Correct Answer:


Explanation:
Identifying the source of information
Sampling available data
Gathering audit evidence
Verifying objective evidence
Evaluating evidence against the audit criteria
Making audit conclusions
Evaluating against the audit criteria
According to ISO 19011:2018, clause 6.4, the process of collecting and verifying information during an audit involves the following steps1:
Identifying the source of information: The audit team should identify the sources of information that are relevant to the audit objectives, scope and criteria. These sources may include documents, records, personnel, processes, activities, facilities, equipment, etc. The audit team should also determine the methods and tools for accessing and collecting the information, such as interviews, observations, document review, sampling, etc.
Sampling available data: The audit team should select a representative sample of the available data to verify the conformity and effectiveness of the management system. The sample size and selection method should be based on the audit objectives, scope and criteria, as well as the level of confidence and risk. The audit team should also consider the validity, reliability, relevance and sufficiency of the data.
Gathering audit evidence: The audit team should use the methods and tools identified in the previous step to collect audit evidence, which is the records, statements of fact or other information that are relevant to the audit criteria and verifiable. The audit team should record the audit evidence in a clear, concise and objective manner, using notes, checklists, photographs, audio or video recordings, etc.
Verifying objective evidence: The audit team should verify the accuracy, completeness and authenticity of the audit evidence collected. This may involve cross-checking different sources of information, confirming the identity and authority of the persons providing the information, examining the original documents or records, etc. The audit team should also identify any discrepancies, inconsistencies or gaps in the audit evidence.
Evaluating evidence against the audit criteria: The audit team should compare the audit evidence with the audit criteria to determine the extent of conformity and nonconformity. The audit team should also identify any opportunities for improvement, best practices, positive aspects or potential risks. The audit team should use professional judgement and apply the principles of auditing when evaluating the audit evidence.
Making audit conclusions: The audit team should consolidate the audit findings and evaluate the overall performance and effectiveness of the management system. The audit team should also consider the audit objectives, scope and criteria, as well as the context and expectations of the auditee and other interested parties. The audit team should provide a clear, concise and objective statement of the audit conclusions, which may include the degree of conformity, the achievement of the intended outcomes, the need for corrective actions, the suitability for certification, etc.
Evaluating against the audit criteria: The audit team should review the audit conclusions and ensure that they are consistent with the audit criteria and supported by sufficient and appropriate audit evidence. The audit team should also ensure that the audit conclusions are communicated to the auditee and other relevant parties in a timely and effective manner, using the agreed audit report format and distribution method.
References: ISO 19011:2018(en), Guidelines for auditing management systems

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