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

Topic	Details
Topic 1	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.
Topic 2	Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
Topic 3	Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
Topic 4	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 5	Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.

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
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation which manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. As one of the auditors, you find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
During the audit team meeting in preparation for the Closing meeting, the second auditor disagreed with the clause of ISO 9001 selected for the above nonconformity. He thinks it should be clause 9.1.1.
Choose three options for how the audit team leader should best respond to the situation:

A. Invite you and the second auditor to fully explain your point of view and then decide which clause to select.
B. Immediately overule the objection of the second auditor with no discussion of the clause.
C. Immediately agree with the second auditor that clause 9.1.1 would be better.
D. Suggest that neither clause is accurate and instead propose clause 9.1.3 as the best one for the nonconformity.
E. The audit team leader will refer to the quality manager to determine which clause they agree with.
F. Advise that he will think about the clause and announce his decision during the Closing meeting.
G. Review the evidence with you and the second auditor, and then decide which clause of ISO 9001 would best apply.
H. Try to obtain a consensus between you and the second auditor after a discussion of the different opinions.

Question #2
ISO 9001 addresses changes through several requirements, two examples of which are Clause 6.3 (Planning of Changes) and Clause 8.5.6 (Control of Changes). How do the requirements of Clause 8.5.6 differ from those of Clause 6.3?

A. Clause 8.5.6 refers to changes during the design and development of products and services.
B. Clause 8.5.6 refers to leadership and management system responsibilities.
C. Clause 8.5.6 refers to changes to legal and regulatory requirements.
D. Clause 8.5.6 refers to changes during the production and service provision.

Question #3
Among others, what does Clause 4.4 (Quality Management System and Its Processes) of ISO 9001 require from organizations?

A. To conduct a QMS gap analysis every two years
B. To change the QMS quarterly
C. To continually improve the QMS
D. To review the QMS annually

Question #4
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: " I would like to begin by looking at the cleaning controls. "
MM: " We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside.
"
Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.

You decide to raise a non-conformity.

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.