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

TopicDetails
Topic 1
  • Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.
Topic 2
  • Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.
Topic 3
  • Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
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.

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

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PECB QMS ISO 9001:2015 Lead Auditor Sample Questions:

A small cleaning services organisation is about to start work on a hospital cleaning contract for the local Health Trust. You, as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract requires that a cleaning plan is produced.
You: " How was the cleaning plan for the contract developed? "
Service Manager: " We have a basic template that covers the materials, labour requirements and cleaning methods to be employed. Some of that is specified by the customer. " You: " How does the plan deal with locations like the intensive care wards and the operating theatres, which are included in the contract? " Service Manager: " The basic plan covers general wards, but we will do more frequent cleaning in those areas if the hospital requests it. " You: " Are you aware of the regulatory requirements for cleaning standards in hospitals? " Service Manager: " No. We depend on the hospital to look after that side of things in the contract. " You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001.
You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was substituted to that specified in the contract. At the follow-up audit, the corrective action proposed was to
" obtain a concession from the Health Trust for use of the new chemical. " Which one of the following options is the reason why you did not accept this action taken?

  • A. The process for making changes to the contract has not been addressed.
  • B. The action assumes that the Health Trust will agree to the change.
  • C. The substitute chemical has not been used before in the Health Trust.
  • D. The substitute chemical may not be as effective as the original.
  • E. Staff have not been trained in the use of the new chemical.
Reveal Solution  Discussion  0

Correct Answer: A  🗳️

Which one of the following options is the definition of the context of an organisation?

  • A. Comparison of internal and external issues that can have an effect on an organisation ' s desire to achieve its objectives.
  • B. Complexity of internal and external issues that can have an effect on an organisation ' s approach to developing and achieving its purpose.
  • C. Combination of internal and external issues that can have an effect on an organisation ' s approach to developing and achieving its objectives.
  • D. Coordination of internal and external issues that can have a positive or negative effect on an organisation ' s success.
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

Explanation: Only visible for Fast2test members. You can sign-up / login (it's free).

XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you conduct a certification audit at Stage 1. When reviewing the quality management system (QMS), you find that the objectives have been defined by an external consultant using those of a competitor, but nothing is documented. The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost.
Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?

  • A. Quality objectives were not established in alignment with the organisation ' s quality policy.
  • B. The organisation cannot afford to undertake quality objectives all at once.
  • C. The consultant has not interpreted ISO 9001 correctly.
  • D. Establishing quality objectives did not include top management.
  • E. Quality objectives are not being implemented by the organisations ' personnel.
  • F. Quality objectives are not maintained as documented information.
Reveal Solution  Discussion  0

Correct Answer: A,F  🗳️

Explanation: Only visible for Fast2test members. You can sign-up / login (it's free).

What must the auditor consider in order to mitigate audit risks and obtain reasonable assurance?

  • A. The financial risks associated with QMS implementation.
  • B. The needs and expectations of internal interested parties.
  • C. The processes deemed material to the auditee.
  • D. The previous audit results.
Reveal Solution  Discussion  0

Correct Answer: C  🗳️

Explanation: Only visible for Fast2test members. You can sign-up / login (it's free).

You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.
You: " How do you tell when the billet is ready for the rolling stage? " Operator: " I ' ve done this job for 20 years. I can tell by the bright red colour. " You: " What happens if the colour is wrong? " Operator: " The billet goes back into the furnace. " You: " Is the pyrometer ever used? " Operator: " Only in borderline cases. " You continue to interview the operator and find that around 25% of the billets are sent back to the furnace.
This includes 80% of the borderline cases.
Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.

  • A. Periodic analysis of the results of temperature checks.
  • B. Annual review records for furnace operators.
  • C. A quality objective to achieve lower recycle rates for billets.
  • D. Certification of conformance to national standards from the manufacture of the pyrometer.
  • E. Planning for monitoring and measuring the billet temperature.
  • F. A procedure that provides instruction in taking billet temperature.
  • G. Maintenance plan for the furnace.
  • H. An increase in the use of the pyrometer by operators.
Reveal Solution  Discussion  0

Correct Answer: A,E,F  🗳️

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