PECB ISO-9001-Lead-Auditor : QMS ISO 9001:2015 Lead Auditor Exam
- Exam Code: ISO-9001-Lead-Auditor
- Exam Name: QMS ISO 9001:2015 Lead Auditor Exam
- Updated: Oct 09, 2026
- Q & A: 268 Questions and Answers
About PECB ISO-9001-Lead-Auditor Exam
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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:
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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:
You are preparing for interviews with two members of top management. Based on the information that you gathered about the organization, you conclude that it is the top management who takes all the important decisions and closely supervises and controls employees. Based on this, which management style is practiced in the organization?
- A. Centralized
- B. Laissez-faire
- C. Autocratic
Correct Answer: C 🗳️
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During a third-party audit of a pharmaceutical company (CD9000) having seven COVID-19 vaccination stations in various terminals at a major international airport, you, as audit team leader, interview the CD9000' s Supervisor in Terminal 2.
You: "I see that the temperature of the freezer where you keep the vaccines reads -17.2 °C. I understood that the upper limit for storing vaccines was < -18.0 °C." Supervisor: "Yes, I know this. But do not worry, the people who calibrated the temperature sensors said that they have an uncertainty of +/- 1 °C. So, we ensure that the reading remains between -17 °C and -19 °C." From the following, select two options that would form your next step.
- A. Immediately halt the vaccination process due to the risk to patients.
- B. Considering that the difference of less than 1 degree is insignificant, accept the comment and proceed with the audit.
- C. Ask to see the competence records of the supervisors of all terminals.
- D. Ask to see the documented test method to determine if there is additional information on the limits for storage temperature.
- E. Ask to see the calibration report for the measuring equipment.
- F. Raise a non-conformance for storing vaccine at a temperature higher than the maximum value established in the test specification.
Correct Answer: D,E 🗳️
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What is a horizontal audit?
- A. In-depth investigation of all the processes in a specific department or organizational unit
- B. In-depth investigation of one process across various departments in the organization
- C. In-depth investigation of all the processes in major functional areas of the organization
Correct Answer: B 🗳️
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The following are stages of an audit, put them in the order they would be conducted.
Correct Answer:
Explanation:
Establishing the audit programme objectives
Determining and evaluating the audit programme risks and opportunities
Establishing the audit programme
Initiating the audit
Preparing all audit activity
Conducting the audit activities
To complete the sequence, you can drag and drop the options to the appropriate blank section.
Here is a brief explanation of each stage:
Establishing the audit programme objectives: This is the first stage of the audit process, where the purpose, scope, and criteria of the audit programme are defined. The audit programme objectives should be aligned with the strategic direction and policies of the organization, and should address the needs and expectations of the interested parties12.
Determining and evaluating the audit programme risks and opportunities: This is the second stage of the audit process, where the factors that can affect the achievement of the audit programme objectives are identified and assessed. The audit programme risks and opportunities should consider the internal and external issues, the requirements and changes of the interested parties, and the results and feedback from previous audits12.
Establishing the audit programme: This is the third stage of the audit process, where the audit programme is designed and implemented. The audit programme should include the audit programme procedures, the audit programme resources, the audit methods and techniques, the audit frequency and schedule, and the audit programme performance indicators12.
Initiating the audit: This is the fourth stage of the audit process, where the audit is prepared and planned. The audit initiation involves selecting the audit team, establishing the contact with the auditee, defining the audit objectives, scope, and criteria, developing the audit plan, and conducting the document review123.
Preparing all audit activity: This is the fifth stage of the audit process, where the audit activities are organized and coordinated. The audit preparation involves assigning the audit tasks, communicating with the auditee and the audit team, arranging the logistics, preparing the working documents, and conducting the opening meeting123.
Conducting the audit activities: This is the sixth and final stage of the audit process, where the audit evidence is collected and evaluated. The audit conduct involves performing the audit activities, such as interviews, observations, document reviews, and tests, documenting the audit findings, preparing the audit conclusions, and conducting the closing meeting123.
I hope this helps you with your ISO 9001 Lead Auditor objectives and content. If you have any further questions, please feel free to ask. # References: 1: ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Process | Flowchart | Summary - Accountinguide 3: What are the Stages of the Auditing Process & Why it is Important ...
State the correct sequence of events in the certification process for an organisation to obtain third-party accredited certification to ISO 9001.
Correct Answer:
Reference: ISO 9001:2015 Clause 9.2 emphasizes the planning of audits and their scheduling to achieve desired results.
Step 2: Conduct Certification Audit StagesThe certification process includes a two-stage audit.
Stage 1 Audit: Review of documentation to verify readiness and understanding of the Quality Management System (QMS).
Stage 2 Audit: A detailed evaluation of the implementation and effectiveness of the QMS against ISO 9001 requirements.Reference: Clause 8.1 of ISO 9001:2015 discusses operational planning and control, which includes the preparation for audit activities.
Step 3: Award ISO 9001 CertificateAfter successfully completing the certification audits and resolving any identified non-conformities, the certification body awards the ISO 9001 certificate. This certificate demonstrates that the organization ' s QMS meets the ISO 9001 standard.Reference: Clause 10 of ISO 9001:
2015 focuses on continual improvement and conformity, which leads to the certification issuance.
Step 4: Accredit Certification BodyCertification bodies must be accredited to ensure they meet international standards for certification. Accreditation is conducted by bodies like UKAS (United Kingdom Accreditation Service) or ANAB (ANSI National Accreditation Board), ensuring the credibility and global acceptance of the certification process.Reference: Clause 7.1.5 of ISO 9001 covers resource monitoring, which supports the integrity of the certification process.
By following these steps, organizations can ensure an effective and compliant certification process, achieving ISO 9001 certification.
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