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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Fundamental principles and concepts of a quality management system (QMS) | 12.5% | - Advantages of implementing a QMS based on ISO 9001 - Connection between ISO 9001 and other standards (ISO 9001, ISO/TS 9002, ISO 9004) - Applicability and scope of ISO 9001 |
| Managing an ISO 9001 audit program | 12.5% | - Audit program management - Audit program monitoring and improvement |
| Closing an ISO 9001 audit | 13.75% | - Audit completion and follow-up - Management of audit records - Audit report preparation |
| Preparing an ISO 9001 audit | 12.5% | - Steps and activities to prepare a QMS audit - Audit feasibility - Evidence types and their characteristics - Roles and responsibilities of the audit team leader and members |
| Quality management system (QMS) and ISO 9001 requirements | 13.75% | - Risks and opportunities - Leadership and commitment, quality policy, roles and responsibilities (clause 5) - Context of the organization, interested parties, and QMS scope (clause 4) - Structure of the standard |
| Fundamental audit concepts and principles | 12.5% | - Personal attributes and behaviors of a professional auditor - Audit concepts and principles - Management of combined audits |
| Conducting an ISO 9001 audit | 22.5% | - Audit techniques and evidence collection - Audit conducting process - Audit findings and conclusions |
PECB ISO-9001-Lead-Auditor Exam: Full-Scale Answers
None (Recommended: Training course and experience in Quality Management) Eligibility rules change over time, so verify the current requirements on the official page (official ISO-9001-Lead-Auditor exam page) before registering.
The PECB QMS ISO 9001:2015 Lead Auditor is PECB's certification exam for ISO 9001, at the Lead Auditor level. Related credentials include PECB Certified ISO 9001 Lead Implementer, PECB Master in Quality Management. Start simply: free demo first, full set when convinced.
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The PECB QMS ISO 9001:2015 Lead Auditor blueprint spans 7 domains — including Quality management system (QMS) and ISO 9001 requirements (13.75%), Fundamental audit concepts and principles (12.5%), Fundamental principles and concepts of a quality management system (QMS) (12.5%). Our material keeps close to this syllabus; the complete outline above lists every subtopic.
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PECB QMS ISO 9001:2015 Lead Auditor Sample Questions:
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).
Correct Answer:
Explanation:
Quality management principles:
Customer focus = Increased revenue and market share
Engagement of people = Enhanced trust and collaboration throughout the organisation Improvement = Enhanced drive for innovation Evidence-based decision-making = Increased ability to demonstrate effectiveness of past actions According to the Quality management principles document published by ISO, each quality management principle has a statement, a rationale, key benefits, and actions you can take to apply it. Based on these descriptions, the potential benefits can be matched to the corresponding principles as follows:
Customer focus: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. The key benefits of this principle include increased customer value, customer satisfaction, customer loyalty, repeat business, reputation, customer base, revenue and market share.
Engagement of people: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value. The key benefits of this principle include improved understanding of the organization's objectives and values, increased involvement in improvement activities, enhanced personal development, increased motivation and empowerment, enhanced trust and collaboration, and increased recognition and rewards.
Improvement: Successful organizations have an ongoing focus on improvement. The key benefits of this principle include improved organizational capabilities, alignment of improvement activities at all levels, increased ability to anticipate and react to opportunities and threats, enhanced drive for innovation, and increased levels of satisfaction.
Evidence-based decision-making: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. The key benefits of this principle include improved decision-making processes, increased ability to demonstrate the effectiveness of past decisions, increased ability to review, challenge and change opinions and decisions, and increased ability to improve performance.
In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.
- A. Number of sites to be audited
- B. Expectations of the organisation ' s management
- C. Scope of the audit
- D. Risk to achieving audit objectives
Correct Answer: B 🗳️
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(In the context of a second-party quality management system audit , select the two correct statements from the following:)
- A. The audit team cannot include auditors-in-training.
- B. A guide is a person appointed by the audit team leader to assist the audit team in performing the audit.
- C. A technical expert is part of the audit team.
- D. An auditor is a person who conducts an audit.
- E. An observer is a person appointed by the auditee who provides information about the organisation to the audit team.
- F. When needed, a translator appointed by the auditee.
Correct Answer: D,F 🗳️
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An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:
" The reject rate of ' finished ' product of 9.7% needs improvement as it doesn ' t meet the stated objective of top management of 5%. " Just before the Closing meeting of a third-party audit, the audit team leader is invited to a meeting with the Quality Manager. He tells the audit team leader that a member of the audit team was seen taking photographs of the factory on his phone during the day and wants him suspended from the Closing meeting with any nonconformities raised by him rescinded. The issue of photographs was not discussed during the opening meeting.
Select the three options for how the audit team leader might deal with this situation.
- A. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered
- B. Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting
- C. State that the auditor will take no further part in the audit and all his photographs will be deleted
- D. Delay the Closing meeting until the audit team leader has consulted his audit programme manager at Head Office
- E. Advise the Quality Manager that the auditor will be reported to Head Office
- F. Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to the Quality Manager once this is done
Correct Answer: A,D,F 🗳️
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You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers.
You are interviewing the Quality Systems Manager (QSM).
You: " What risks and opportunities have the business identified? "
QSM: " I ' 1l show you. This was discussed with the Managing Director at the latest management review. " Narrative: The QSM shows you the latest management review record and points to the following table:
You: " How is the business planning to address these risks and opportunities? " QSM: " The MD said that they already knew about them so it was not necessary. "
Correct Answer:
Explanation:
Non-Conformity Report:
ISO 9001 Clause Number
Nature of Problem
ISO 9001 Requirement That Has Not Been Fulfilled
6.1.1
Several risks and opportunities have not been determined.
" The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed. "
6.1.2 (a)
Actions to address risks and opportunities not planned.
" The organization shall plan actions to address risks and opportunities. " Step-by-Step Reasoning:
Clause 6.1.1 - Determining Risks and Opportunities:
Requirement: The organization must determine risks and opportunities that are relevant to its Quality Management System (QMS). This ensures that the QMS achieves intended results and prevents undesired effects.
Problem Identified: While some risks and opportunities were discussed, the organization did not perform a systematic evaluation of all risks (e.g., health and safety legislation changes, retiring trainers).
Clause 6.1.2 (a) - Planning Actions for Risks and Opportunities:
Requirement: The organization must plan actions to address identified risks and opportunities. These actions should be integrated into the QMS processes to ensure continuous improvement.
Problem Identified: The Quality Systems Manager confirmed that no plans were made to address the risks and opportunities because the Managing Director deemed it unnecessary. This violates the requirement to plan actions.
Correct Options Selected:
Clause 6.1.1 with the nature of the problem as: " Several risks and opportunities have not been determined. " Clause 6.1.2 (a) with the nature of the problem as: " Actions to address risks and opportunities not planned. " ISO 9001 Requirements Not Fulfilled:
For 6.1.1: " The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed. " For 6.1.2 (a): " The organization shall plan actions to address risks and opportunities. "
