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

TopicDetails
Topic 1
  • Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.
Topic 2
  • 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 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.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q227-Q232):

NEW QUESTION # 227
During an ISO 9001 audit of an electric cable manufacturer, you are reviewing the customer file for XYZ Construction in the Sales Department. This contract specifies that the installation configuration of the cable runs should meet national fire safety standards for Category A.
You discover that the customer later agreed to the approval of a less stringent Category B configuration instead.
The organization has the following quality policy document displayed in the reception area.
"This organization is committed to providing electric cables to customers' requirements, in accordance with statutory regulations for their use. Continual improvement is a permanent objective of the organization. This policy shall be communicated to all employees and, where required, to all interested parties." Referring to the scenario, select the two options for which the organization is meeting its policy commitments.

Answer: B,E


NEW QUESTION # 228
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 the manufacture of our own brand products to one of our suppliers." You: "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. The steps represent different elements of the Plan/Do/Check/Act cycle.
Select three steps which apply to the 'check' element of the cycle.

Answer: A,C,D

Explanation:
The "Check" stage of the PDCA cycle is about monitoring, measuring, analysing and evaluating performance against objectives, requirements and planned activities.
B is correct because reviewing data at management review is part of evaluating QMS performance.
C is correct because monitoring customer feedback is checking whether customer needs and expectations are being met.
D is correct because monitoring supplier performance checks whether the outsourced manufacturing process is effective.
A, E, F and H are mainly "Plan/Do" activities. G may be a monitoring result, but the strongest three "Check" activities are B, C and D because they directly involve review, monitoring and evaluation of QMS performance.


NEW QUESTION # 229
(When raising a non-conformity during an audit, which two of the following items should you include in the non-conformity statement?)

Answer: A,F

Explanation:
ISO 9001:2015 requires that nonconformities be objective, evidence-based, and referenced against defined requirements, not personal, prescriptive, or solution-driven.
When a nonconformity is raised, it must clearly show what requirement was not met and what objective evidence demonstrates this failure.
# Why D (Audit criteria) is required
* A nonconformity must reference the requirement that was not fulfilled (e.g., ISO 9001 clause, procedure, contract, or legal requirement).
* ISO 9001 defines nonconformity as "non-fulfilment of a requirement".
* Without audit criteria, there is no basis for declaring a nonconformity.
# Supported by:
* Clause 9.2.2 - Internal audits must determine whether the QMS conforms to requirements
* Clause 10.2.2 - Documented information shall describe the nature of the nonconformity
# Why E (Relevant audit evidence) is required
* ISO 9001 requires decisions and conclusions (including audit findings) to be based on evidence.
* Audit evidence ensures objectivity and prevents subjective or opinion-based findings.
# Supported by:
* Clause 9.1.3 - Analysis and evaluation shall be based on data and information
* Clause 9.2.2 - Audit results must demonstrate conformity or nonconformity based on evidence
# Why the other options are NOT correct
* A (Name of person responsible)ISO 9001 focuses on system and process failures, not blaming individuals.
* B (Target time for corrective action)This is part of corrective action planning, not the nonconformity statement itself (Clause 10.2).
* C (Name of technical expert)ISO 9001 does not require identifying auditors or experts in the nonconformity statement.
* F (Action to eliminate the nonconformity)Auditors must not prescribe solutions. The auditee determines corrective actions (Clause 10.2).


NEW QUESTION # 230
What is reliability in the context of service quality?

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:Reliability in service quality refers to the consistent and dependable delivery of promised services.
ISO 9001:2015 emphasizes reliability through:
* Clause 8.2.1 (Customer Communication) - Ensuring clarity in service commitments.
* Clause 8.5.1 (Control of Service Provision) - Ensuring processes meet requirements consistently.
Other options do not fully define reliability:
* Option A (Safe services) relates to safety, not reliability.
* Option B (Readiness and goodwill) relates to responsiveness, not reliability.
* Option D (Low cost) focuses on pricing, not quality.


NEW QUESTION # 231
In the context of a third-party management system certification audit, which two of the following statements are correct?

Answer: A,D


NEW QUESTION # 232
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