PECB ISO-9001 Lead Auditor QMS ISO 9001:2015 Lead Auditor Online Training

Question #11

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

9001:2015 are true?

A . During the Stage 1 audit, the audit team:
B . Verifies the degrees of customer satisfaction
C . Evaluates the conditions of all sites
D . Reviews the client’s management system documented information
E . Evaluates the results of the last management review
F . Verifies the compliance with legal requirements
G . Reviews the processes with high level of risk

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Question #12

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

A . To evaluate the performance of monitoring and reviewing activities.
B . To evaluate the preparedness of the organisation for a Stage 2 audit.
C . To evaluate the internal audit and management review processes.
D . To review the quality manual.
E . To make a decision on certification to ISO 9001:2015.
F . To evaluate the operational processes of the organisation.

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Question #13

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?

A . Verify Teak Ltd supply arrangements as described in the ABC Ltd quality management system
B . Verify if Teak Ltd are certified to ISO 9001
C . Verify the controls concerning customer property implemented by Teak Ltd
D . Verify how ABC Ltd evaluates the performance of Teak Ltd
E . Verify the quality management system at Teak Ltd by conducting an audit at their site
F . Verify whether the design processes of Teak Ltd comply with ISO 9001

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Question #14

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

A . List of findings from the last audit
B . Name of the auditee general manager
C . Signature of Certification Body Technical Reviewer
D . Sequence and timings of audit activities
E . Date of next audit
F . Name of auditees and auditors

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Question #15

DRAG DROP

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

The first and last stages have 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.

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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.

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 …

Question #16

You work for organisation A. You are asked to lead an internal audit of A’s quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to A. There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.

Which of the following actions would you consider appropriate when planning the internal audit of A’s quality management system?

A . Visit Plant A2 to interview personnel of company B
B . Visit Plant A2 to interview B’s quality manager
C . Visit Plant A2 to interview A’s security personnel and B’s maintenance department
D . Interview the A2 plant manager, now working in Plant A1

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Correct Answer: D
D

Explanation:

In this scenario, the organisation A has two plants, A1 and A2, but the production in A2 was discontinued due to the COVID-19 pandemic and the plant was rented to another organisation B. There are no A employees working in A2, and the organisation A expects to reassume production in A2 as soon as possible.

Therefore, the appropriate action to plan the internal audit of A’s quality management system is:

• Interview the A2 plant manager, now working in Plant A1: This action involves interviewing the person who is responsible for the management and operation of the plant A2, and who is currently working in the plant A1. The interview should aim to gather information about the status and condition of the plant A2, the impact of the COVID-19 pandemic on the quality management system, the arrangements and agreements with the organisation B, and the plans and actions to resume production in the plant A25. This action is relevant and necessary for the internal audit, as it can help to assess the readiness and effectiveness of the quality management system, and to identify any gaps or nonconformities that need to be addressed.

The other options are not appropriate actions to plan the internal audit of A’s quality management system, according to the web search results from my internal tool.

They are:

• Visit Plant A2 to interview personnel of company B: This action involves visiting the plant A2 and interviewing the personnel of the organisation B, who are not related to the organisation A and who are not part of the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5.

• Visit Plant A2 to interview B’s quality manager: This action involves visiting the plant A2 and interviewing the quality manager of the organisation B, who is not related to the organisation A and who is not part of the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5.

• Visit Plant A2 to interview A’s security personnel and B’s maintenance department: This action involves visiting the plant A2 and interviewing the security personnel of the organisation A and the maintenance department of the organisation B, who are not directly involved in the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5.

Therefore, the correct answer is D.

Reference:

1: Quality audit – Wikipedia

2: A step-by-step guide to internal quality audits

3: ISO 9001:2015 – Quality management systems ― Requirements

4: ISO 19011:2018 – Guidelines for auditing management systems

5: Audit Process | Flowchart | Summary – Accountinguide: What are the Stages of the Auditing Process & Why it is Important …

Question #17

You have been nominated audit team leader of a third-party audit.

Which of the following could be the two most relevant objectives of this audit?

A . Evaluate the satisfaction interested parties
B . Evaluate the effectiveness of the management system
C . Identify the need of resources
D . Evaluate the capability of the management system to establish and achieve objectives
E . Identify opportunities for improvement
F . Evaluate the benefits obtained since the implementation of the management system

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Question #18

Who would be defined as a witness during a witness audit? Choose two of the following options:

A . Someone with a qualification from the certification body
B . An auditor
C . An existing member of the audit team
D . An assessor for the accreditation body

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Correct Answer: B,D
B,D

Explanation:

Comprehensive and Detailed = According to the web search results from my internal tool, a witness audit is a technique used during an accreditation audit, where the accreditation body observes the performance and competence of the certification body auditors in conducting an audit12. A witness audit can also be used by a certification body to monitor and evaluate its own auditors3.

During a witness audit, the following roles can be defined:

• An auditor: This is the person who is being witnessed by the accreditation body or the certification body. The auditor is responsible for conducting the audit according to the audit plan, criteria, and standards, and for providing audit evidence and findings123.

• An assessor for the accreditation body: This is the person who witnesses the auditor on behalf of the accreditation body. The assessor is responsible for evaluating the auditor’s performance and competence, and for providing feedback and recommendations to the accreditation body123. The other options are not defined as witnesses during a witness audit, according to the web search results from my internal tool.

They are:

• Someone with a qualification from the certification body: This is not a specific role in a witness audit, as anyone who is involved in the audit process should have a qualification from the certification body. Moreover, having a qualification does not necessarily mean that the person is a witness or an auditor4.

• An existing member of the audit team: This is not a specific role in a witness audit, as the audit team consists of the auditors who are conducting the audit, not the ones who are witnessing it. The witness audit is a separate activity from the audit itself, and the witness should not interfere with the audit process or influence the audit outcome123.

Therefore, the correct answer is B and D.

Reference:

1: DQS Inc. | Witness Audits | Auditor Training

2: Have you ever been involved with a witness audit? – IFSQN

3: Certac – Witness Audit of Certification Bodies

4: ISO 19011:2018 – Guidelines for auditing management systems

Question #19

DRAG DROP

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organization 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 nonconformity.

To complete the nonconformity report 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, you may drag and drop the options to the appropriate blank section.

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Question #20

DRAG DROP

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organization manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.

You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.

You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

To complete the table click on the blank section you want to complete so it is highlighted in red and then click on the Iso 9001 cause 8.3 extracts listed below. Alternatively, drag and drop each clause to the audit evidence that applies.

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