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PECB ISO-9001-Lead-Auditor Exam
QMS ISO 9001:2015 Lead Auditor (Page 4 )

Updated On: 7-Feb-2026
Page 4 of 28
PDF with 131 Questions

Which two of the following statements related to Stage 1 of an initial certification audit against ISO

9001:2015 are true?

  1. During the Stage 1 audit, the audit team:
  2. Verifies the degrees of customer satisfaction
  3. Evaluates the conditions of all sites
  4. Reviews the client's management system documented information
  5. Evaluates the results of the last management review
  6. Verifies the compliance with legal requirements
  7. Reviews the processes with high level of risk

Answer(s): D,G

Explanation:

·
Reviews the client's management system documented information: This activity involves checking the documentation of the quality management system, such as the quality policy, the quality objectives, the scope, the processes, and the procedures, to ensure that they meet the requirements of ISO 9001:2015123. The audit team also evaluates the client's understanding and implementation of the standard, and identifies any gaps or nonconformities that need to be addressed before the Stage 2 audit123.
·Reviews the processes with high level of risk: This activity involves assessing the processes that have a significant impact on the quality of the products or services, or that pose a high risk of nonconformity or customer dissatisfaction123. The audit team also verifies the client's risk management approach, and evaluates the effectiveness of the controls and actions taken to mitigate the risks123.
The other options are not statements that are true for the Stage 1 audit, according to the web search results from my internal tool. They may be related to other stages or types of audits, but they are not the focus of the Stage 1 audit.
Therefore, the correct answer is D and G.


Reference:

1: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified 2: Stage 1 of your Audit | NQA Blog 3: Getting Certified to ISO 9001 - the Stage 1 Audit



Which two of the following are included in the objectives of the 'Stage 1 initial certification audit'?

  1. To evaluate the performance of monitoring and reviewing activities.
  2. To evaluate the preparedness of the organisation for a Stage 2 audit.
  3. To evaluate the internal audit and management review processes.
  4. To review the quality manual.
  5. To make a decision on certification to ISO 9001:2015.
  6. To evaluate the operational processes of the organisation.

Answer(s): B,D

Explanation:

·To evaluate the preparedness of the organisation for a Stage 2 audit: This objective involves assessing the readiness of the organisation to undergo the Stage 2 audit, where the conformity and effectiveness of the quality management system will be verified123. The audit team will check the level of implementation and understanding of the quality management system, identify any major gaps or nonconformities, and confirm the audit scope, criteria, and plan123. ·To review the quality manual: This objective involves reviewing the documented information of the quality management system, such as the quality policy, the quality objectives, the scope, the processes, and the procedures, to ensure that they meet the requirements of ISO 9001:2015123. The audit team will also evaluate the organisation's understanding and application of the standard, and identify any areas of improvement or concern123.
The other options are not included in the objectives of the Stage 1 initial certification audit, according to the web search results from my internal tool. They may be related to other stages or types of audits, but they are not the focus of the Stage 1 audit.
Therefore, the correct answer is B and D.


Reference:

1: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified 2: Stage 1 of your Audit | NQA Blog 3: Getting Certified to ISO 9001 - the Stage 1 Audit



You are conducting a third-party Stage 1 audit at ABC Ltd, a single-site organisation that manufactures wooden furniture. You interview the Technical Director to learn more about the organisation. The Technical Director explains that they have had a successful year and that obtaining ISO 9001 certification will support the further growth of the business. You ask for an overview of the organisation's structure and its interrelationships with external interested parties.

The Technical Director shows you a document detailing all business processes and interrelationships. You notice in this document that another organisation called Teak Ltd manufactures wooden furniture on behalf of ABC Ltd. The Technical Director confirms this capability has been accounted for in the scope of the quality management system. You learn that the furniture manufactured by Teak Ltd has accounted for 40% of the sales revenue over the previous 12 months.

Which two of the following options best describe how you would plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd?

  1. Verify Teak Ltd supply arrangements as described in the ABC Ltd quality management system
  2. Verify if Teak Ltd are certified to ISO 9001
  3. Verify the controls concerning customer property implemented by Teak Ltd
  4. Verify how ABC Ltd evaluates the performance of Teak Ltd
  5. Verify the quality management system at Teak Ltd by conducting an audit at their site
  6. Verify whether the design processes of Teak Ltd comply with ISO 9001

Answer(s): A,D

Explanation:

According to ISO 9001:2015, clause 8.4, an organization is required to control the processes, products and services provided by external providers, including those that affect the quality of the organization's own products and services. This includes determining the controls to be applied to the external provision of processes, products and services, as well as the information to be communicated to the external providers. The organization is also required to monitor, measure, and evaluate the performance of the external providers and retain documented information of these activities.
Therefore, in the scenario given, ABC Ltd is responsible for controlling the processes, products and services provided by Teak Ltd, as they affect the quality of ABC Ltd's own products and services. This means that ABC Ltd should have established criteria and methods for evaluating the performance of Teak Ltd, as well as documented information of the results of such evaluation. ABC Ltd should also have defined the supply arrangements with Teak Ltd, including the specifications, requirements, and verification activities related to the products and services provided by Teak Ltd. Hence, the best options to describe how to plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd are A and D, as they are aligned with the requirements of ISO 9001:2015, clause 8.4. The other options are either irrelevant or beyond the scope of the audit, as they do not pertain to the control of external provision by ABC Ltd.


Reference:

ISO 9001:2015(en), Quality management systems -- Requirements, clause 8.4 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.1 and 6.4.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6



Which two of the following should be included in an audit plan?

  1. List of findings from the last audit
  2. Name of the auditee general manager
  3. Signature of Certification Body Technical Reviewer
  4. Sequence and timings of audit activities
  5. Date of next audit
  6. Name of auditees and auditors

Answer(s): D,F

Explanation:

According to ISO 19011:2018, clause 6.3.2, an audit plan should include the following information:
The audit objectives, scope, and criteria
The audit team members and their roles and responsibilities

The audit schedule, including the sequence and timings of audit activities, such as opening meeting, document review, interviews, observations, closing meeting, etc. The expected time and duration of each audit activity and location The name and contact details of the auditee's representative and other relevant parties The allocation of appropriate resources to support the audit activities The audit methods and techniques to be used, such as interviews, observations, sampling, etc. The audit documents and records to be prepared and retained The audit language and communication methods
The audit risks and opportunities and how to address them The audit follow-up arrangements, if applicable
Therefore, the correct answer is D and F, as they are essential elements of an audit plan. The other options are either irrelevant or optional for an audit plan.


Reference:

ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.2 ISO 19011: Guidelines for Auditing Management Systems | ASQ, section "Making audit arrangements"
ISO 19011 Management Systems Audit Checklist | Process Street, task 6.3.2



DRAG DROP
The following are stages of an audit, put them in the order they would be conducted.

  1. See Explanation for the Answer.

Answer(s): A

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.


Reference:

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 ...



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