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

SectionWeightObjectives
Topic 1: Conducting an ISO 9001 audit22.5%- Audit conducting process
- Audit findings and conclusions
- Audit techniques and evidence collection
Topic 2: Fundamental audit concepts and principles12.5%- Management of combined audits
- Personal attributes and behaviors of a professional auditor
- Audit concepts and principles
Topic 3: Managing an ISO 9001 audit program12.5%- Audit program monitoring and improvement
- Audit program management
Topic 4: Fundamental principles and concepts of a quality management system (QMS)12.5%- Advantages of implementing a QMS based on ISO 9001
- Applicability and scope of ISO 9001
- Connection between ISO 9001 and other standards (ISO 9001, ISO/TS 9002, ISO 9004)
Topic 5: Quality management system (QMS) and ISO 9001 requirements13.75%- Leadership and commitment, quality policy, roles and responsibilities (clause 5)
- Risks and opportunities
- Structure of the standard
- Context of the organization, interested parties, and QMS scope (clause 4)
Topic 6: Preparing an ISO 9001 audit12.5%- Evidence types and their characteristics
- Steps and activities to prepare a QMS audit
- Audit feasibility
- Roles and responsibilities of the audit team leader and members
Topic 7: Closing an ISO 9001 audit13.75%- Audit report preparation
- Management of audit records
- Audit completion and follow-up

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q184-Q189):

NEW QUESTION # 184
In the context of a third-party certification audit, match the roles with the following responsibilities:

Answer:

Explanation:

Explanation:
In the context of a third-party certification audit, match the roles with the following responsibilities:
Responsibilities:
Conduct the audit to the assigned area.= Auditors
Assist the auditors in identifying personnel to participate in the audit.= Guide Assign each team member's responsibility for the audit.= Audit team leader Respond to questions and provide evidence to the auditor.= Auditee According to ISO 19011:2018, clause 3, the definitions of the roles are as follows1:
Auditors: persons with the competence to conduct an audit
Guide: person appointed by the auditee to assist the audit team
Auditee: organization being audited
Audit team leader: member of an audit team appointed to manage the audit or an audit team Therefore, the roles can be matched to the responsibilities based on these definitions and the description of the audit process in clause 6 of the standard1.
References: ISO 19011:2018(en), Guidelines for auditing management systems


NEW QUESTION # 185
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME ' s revenue dropped significantly. In addition, customers ' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME ' s documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME ' s representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME ' s top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME ' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
After reviewing the documented information, Li Na claimed that it was not necessary to report the minor nonconformities that were identified; instead, they would be discussed in the next audit phase. Is this acceptable?

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:
As per ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action), all identified nonconformities, including minor ones, must be documented and communicated to the auditee.
Minor nonconformities can lead to major issues if left unaddressed. The auditor must inform the organization before moving to the next audit phase so that corrective actions can be taken. Clause 9.2.2 (Internal Audit) states that audit findings should be reported without undue delay.
Since Li Na did not report the minor nonconformities immediately, her decision was incorrect. Minor nonconformities should always be documented and communicated before proceeding to the next phase.
Reference:
ISO 9001:2015, Clause 9.2.2 (Internal Audit Reporting)
ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action)


NEW QUESTION # 186
The procedures of an organisation require that all purchase orders have to be signed by the Purchasing Manager, or, in her absence, by the Production Manager. During an audit carried out in November 2020, an auditor determined that during three weeks in February 2020, the purchase orders were not signed. You raise a nonconformance under Clause 8.4.3 of ISO 9001:2015.
Which one of the following answers would you accept as a 'correction' from the Purchasing Manager?

Answer: D

Explanation:
Comprehensive and Detailed Explanation From Exact Extract:
# Correct Option D - "I will sign all the purchase orders now."
This response represents an immediate correction in accordance with ISO 9001:2015 Clause 8.4.3 - Information for external providers, which requires control over procurement documentation. The absence of required authorisation (signature) is a nonconformity in executing the organization's purchasing procedure.
Clause 8.4.3 specifically mandates that the organization:
"Shall communicate to external providers its requirements for:
a) the processes, products and services to be provided;
b) the approval of:
* products and services;
* methods, processes, and equipment;
* the release of products and services."
The purchase order process includes documented approval, which in this case was defined internally as a signature by the Purchasing or Production Manager. Signing the documents retroactively, while not ideal, is a correction to bring the documentation back into compliance and resolve the immediate issue.
# Why Other Options Are Incorrect:
* A. "No correction needed": Dismissing the nonconformity based on product performance fails to address the lack of documented control, violating Clause 8.4.3 and internal procedures.
* B. "I will ask the Production Manager to sign them now": This option shows intention but lacks immediacy and ownership. Also, backdating signatures without traceability can be ethically questionable.
* C. "I do not accept the nonconformity": This reflects noncompliance and a poor quality culture, contradicting ISO 9001's Clause 5.1.1 (Leadership commitment).
References:
ISO 9001:2015 Clause 8.4.3 - Information for external providers
ISO 9001:2015 Clause 5.1.1 - Leadership and commitment
ISO 9001:2015 Clause 10.2.1 - Correction vs. corrective action


NEW QUESTION # 187
What is the responsibility of the audit committee during an internal audit?

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.2 (Audit Program Management):
* The audit committee is responsible for establishing the internal audit program.
* The audit schedule (A) is determined within the program, but it is not the main role of the committee.
Thus, C is the correct answer.
Reference:
ISO 19011:2018, Clause 5.2 (Audit Program Management)


NEW QUESTION # 188
Match the process descriptions below to the process names:

Answer:

Explanation:

Explanation:
A white background with black text Description automatically generated


NEW QUESTION # 189
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