Free PECB ISO-9001 Lead Auditor Practice Exams

Question #1

Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

A . Consistently provide products that meet customers’ requirements
B . Decreased number of management system nonconformities
C . Decreased number of warranty claims
D . Decreased number of nonconforming products in all stages of the manufacturing cycle
E . Enhanced customer satisfaction
F . Increased profits

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Question #2

An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oll and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality

Manager explains that the Managing Director authorised release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.

Which of the following options for the best description of the nonconformity?

A . A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager.
B . Release of the product without acceptable test results has been accepted by the customer for Project DK.
C . Products for Project DK have been released before product approval through the quality control process.
D . The untested product was not recalled until the galvanic efficiency of the anodes was verified.

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Question #3

DRAG DROP

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

time. The organisation 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 #4

You work for an organisation, ‘A’, which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, ‘B’, which provides packaging materials to your organisation. It is 4 p.m. and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled for 5 p.m.

You, as audit team leader, audited top management, the laboratory, and the storage of raw materials.

Auditor 1 audited the two manufacturing lines and dispatch areas.

You to Auditor 1: "What findings would you report?"

Auditor 1: "When reviewing the Dispatch records, I noticed that during the morning two different trucks (Number 011 and 025) delivered the same

batch number of the product (Batch 33555). Truck 011 left the plant at 9.15 am and Truck 025 left the plant at 11.30 am. Procedure P-02 Rev.3 says

that trucks should carry a complete batch. The batch number, once on the truck, is captured using a QR device."

You: "OK, what do you think?"

Auditor 2: "I think that this is a nonconformity."

You: "OK.

How would you describe the evidence on which the nonconformity will be based"?

Identify which one of the following statements best describes the identified nonconformity.

A . Dispatch personnel are not fully aware of the need to conform to written procedures.
B . Dispatch personnel do not always carry out its activities in conformance with Procedure P-02 rev 3.
C . The batch 33555 was delivered split in two different trucks (011 and 025).
D . A product delivered to the client was not identified as required in P-02 Rev 3.

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Question #5

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 #6

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 bank section you want to complete so it is highlighted in red and then click on the applicable text from the options below.

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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

According to ISO 19011:2018, clause 5, the audit programme is a set of one or more audits planned for a specific time frame and directed towards a specific purpose. The audit programme includes all activities necessary to plan, organize, and conduct the audits. The audit programme management involves the following steps1:

Establishing the audit programme objectives: The audit programme objectives define the intended outcomes of the audit programme, such as verifying conformity, evaluating performance, identifying improvement opportunities, etc. The audit programme objectives should be aligned with the strategic direction and policies of the organization and the needs and expectations of the interested parties.

Determining and evaluating the audit programme risks and opportunities: The audit programme

risks and opportunities are the factors that can affect the achievement of the audit programme objectives, such as changes in the internal or external context, availability of resources, competence of auditors, etc. The audit programme risks and opportunities should be identified, analyzed, and evaluated to determine the appropriate actions to address them.

Establishing the audit programme: The audit programme is established by defining the audit programme scope, criteria, methods, and resources. The audit programme scope defines the extent and boundaries of the audit programme, such as the processes, functions, sites, activities, etc. that will be audited. The audit programme criteria are the set of policies, procedures, or requirements used as a reference for the audits. The audit programme methods are the techniques used to conduct the audits, such as interviews, observations, document review, sampling, etc. The audit programme resources are the human, technical, and financial resources needed to implement the audit programme.

Initiating the audit: The audit initiation is the process of formally establishing the arrangements for an individual audit within the audit programme. The audit initiation involves contacting the auditee and the audit client, confirming the audit objectives, scope, and criteria, and obtaining the necessary information and access for the audit.

Preparing all audit activity: The audit preparation is the process of developing the audit plan and the audit work documents for an individual audit. The audit plan is a document that provides the basis for agreement regarding the conduct of the audit, such as the audit schedule, the audit team, the audit methods, the audit language, the audit report, etc. The audit work documents are the records that provide evidence of the audit activities, such as the audit checklist, the audit notes, the audit findings, etc.

Conducting the audit activities: The audit activities are the processes of collecting and verifying audit evidence and evaluating it against the audit criteria to make the audit conclusions. The audit activities include the opening meeting, the communication during the audit, the roles and responsibilities of the audit team and the auditee, the audit evidence collection and verification, the audit findings generation and recording, the closing meeting, and the audit report preparation and distribution.

Reference: ISO 19011:2018(en), Guidelines for auditing management systems

Question #7

Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?

A . Audit Report
B . Audit Plan
C . Procedures
D . Checklist / Prompts
E . Risk Matrices
F . Findings

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Correct Answer: B,D
B,D

Explanation:

According to ISO 19011:2018, clause 6.3, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the information listed in my previous response, such as the audit objectives, scope, criteria, schedule, team, methods, report, etc. The audit plan should be prepared and completed prior to the on-site audit, and should be communicated to the audit team and the auditee1.

According to ISO 19011:2018, clause 6.4.3, the checklist / prompts are documents that list the questions or topics that need to be covered during an audit. The checklist / prompts can help the auditor to collect and verify information relevant to the audit criteria, and to ensure the consistency and completeness of the audit. The checklist / prompts should be prepared and completed prior to the on-site audit, and should be based on the audit plan and the audit scope and objectives1. Therefore, the two documents that an auditor needs to prepare and complete prior to the on-site audit are B and D, as they are essential for planning and conducting the audit. The other options are not correct, as they are either prepared or completed after the on-site audit, or not required by the standard:

• A. Audit Report: The audit report is a document that provides a complete, accurate, concise, and clear record of the audit. The audit report should include the information listed in my previous response, such as the audit objectives, scope, criteria, findings, conclusions, etc. The audit report should be prepared and completed after the on-site audit, and should be distributed to the audit client and the auditee1.

• C. Procedures: Procedures are documents that specify the way activities are to be performed. Procedures may be part of the audit criteria, if they are part of the organization’s management system, or part of the audit programme, if they are part of the certification body’s or registrar’s requirements. Procedures are not prepared or completed by the auditor prior to the on-site audit, but rather reviewed or followed by the auditor during the audit1.

• E. Risk Matrices: Risk matrices are tools that help to assess and prioritize the risks and opportunities associated with the audit programme or the audit. Risk matrices may be part of the audit programme management, if they are used to determine and evaluate the audit programme risks and opportunities, or part of the audit preparation, if they are used to determine and evaluate the audit risks and opportunities. Risk matrices are not prepared or completed by the auditor prior to the on-site audit, but rather used or updated by the auditor during the audit programme management or the audit preparation1.

• F. Findings: Findings are the results of the evaluation of the collected audit evidence against the audit criteria. Findings can indicate either conformity or nonconformity, as well as positive aspects or opportunities for improvement. Findings are not prepared or completed by the auditor prior to the on-site audit, but rather generated and recorded by the auditor during the audit activities1.

Reference: ISO 19011:2018(en), Guidelines for auditing management systems

Question #8

Select which one of the following statements is true.

A . The team leader shall be an auditor that is qualified in the scheme.
B . An audit team can include non-qualified auditors.
C . A technical expert can replace a qualified auditor on an audit team.
D . Audits leading to auditor qualification are undertaken annually.

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Question #9

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation 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. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.

You are nearing the end of the audit and you are reviewing your audit notes.

You notice a recurring trend concerning the SWIFT database as shown below:

You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).

You: "Good afternoon."

OD: "Good afternoon."

You: "What responsibility do you have concerning the SWIFT database?"

OD: "I maintain it. If anyone wishes to propose an update to the database, they send me an email with details of their proposal. I then either process the database update myself, or I send the request to the consultant who designed the database 20 years ago. The necessary software changes are made, and the amended software is immediately released to users."

You: "Would you explain how the software amendments are controlled?"

OD: "Of course. I personally update every computer myself."

You: "Do you inform the database users of the changes?"

OD: "No I don’t. They find out for themselves by using the software, or they come to see me if they have any questions."

You: "How do you ensure that the database users use the latest version?"

OD: "That’s easy, I update every computer myself."

You: "During the audit, I noted there were several versions of SWIFT in use (you refer to your audit notes)."

OD: "I know. That’s because some versions work better than others, and depending on user needs and experiences, we allow users to revert to using an earlier version if they find it works better for them."

Based on the scenario, which two of the following statements are true? There is evidence of nonconformity with a requirement defined in …

A . clause 7.1.3 Infrastructure
B . … clause 7.1.4 Environment for the operation of processes
C . clause 7.5.1 Documented information – General
D . … clause 7.5.2 Documented information – Creating and updating
E . … clause 7.5.3 Control of documented information

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Question #10

Which one of the following documents addresses audit time calculation for third-party certification audits?

A . ISO 17021-1
B . ISO 19011
C . ISO 9000
D . ISO 9001

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