Free PECB ISO-9001 Lead Auditor Practice Exams - Page 2 of 6

Question #11

During an internal audit, it was discovered that the calibration of a spectrometer used daily for production had expired, causing a nonconformance under Clause 7.1.5.2 of ISO 9001:2015. The root cause was the organization not considering the risk of the calibration provider leaving the country.

Which corrective action is the best one?

A . We will select one sample, which we will send to an external laboratory and will use it as our internal standard.
B . We will look for a local company to provide this service.
C . We will have the results on one out of ten of our routine production samples double-checked by an external local laboratory.
D . We will add this to our external issue register, assess its associated risk, and plan action to address that risk.

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Question #12

DRAG DROP

In the context of a third-party audit, match the activity with the party responsible in relation to the audit process.

To complete the table, click on the blank section you want to compete so that it is highlighted in red, and then did on the applicable text from the options below. Alternatively, drag and drop each option to the appropriate blank section.

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Correct Answer:

Explanation:

In the context of a third-party audit, the activities and the parties responsible can be matched as follows:

Review the organization’s processes:

This is typically the responsibility of the audit team. They examine the processes to ensure they comply with the specified standards1.

Review the audit results: The audit team leader usually reviews the audit findings to ensure accuracy and completeness before they are finalized1.

Issue the certificate: The certification body is responsible for issuing the certificate if the audit is successful and the organization meets the required standards1.

Select the audit team: The individual(s) managing the audit programme are responsible for selecting the audit team. This ensures that the team has the appropriate skills and knowledge for the audit1. These roles are essential to maintain the integrity and effectiveness of the audit process. The audit team conducts the actual audit, the team leader oversees the audit process, the certification body grants the certification, and the management of the audit program ensures that the right team is in place to conduct the audit1.

Based on the description of the image you’ve provided, here’s how the activities match with the responsible parties in the context of a third-party audit:

Review the organization’s processes: This activity is typically the responsibility of the Audit Team. They are tasked with examining the processes to ensure they meet the requirements of the standard being audited.

Review the audit results: The Audit Team Leader is usually responsible for this activity. They oversee the audit process and are in charge of reviewing the findings and ensuring that the audit objectives

are met.

Issue the certificate: The Certification Body is responsible for issuing the certificate if the organization’s management system is found to be in compliance with the standard.

Select the audit team: The Individual(s) managing the audit programme are responsible for selecting the audit team. They ensure that the team has the appropriate competence and resources to effectively conduct the audit.

These roles are defined within the framework of ISO 9001:2015 and are essential for the proper conduct of a third-party audit. The audit team and its leader play a critical role in the operational aspects of the audit, while the certification body and those managing the audit programme have overarching responsibilities for the audit’s governance and integrity.

Question #13

ABC is a service organisation that cleans and irons bed and table linen for four large hospitals in the city centre. It claims to meet ISO 9001:2015 requirements. During an internal audit, an auditor observes that machine No. 4 is being operated with the three variables outside the limits established in the applicable documented procedure SP-701. The auditor has decided to raise a nonconformity.

Which six elements should be included in the nonconformity report?

A . Condition of the table linens upon receipt from the hospital
B . Applicable procedure: SP-701
C . Competence record of the machine operator
D . Identification number of the washing machine
E . Manufacturer of the washing machine
F . Name of the Quality Manager
G . Number of the production order
H . The concentration of the cleaning liquid used vs the concentration fixed in SP-701
I . The planned duration of the process vs the minimum time required in SP-701
J . Weight of linen being washed vs the maximum weight required in SP-701

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Question #14

A small deaning services organisation is about to start work on a hospital dleaning contract for the local Health Trust. You, as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract requires that a cleaning plan is produced. You: "How was the cleaning plan for the contract developed?" Service Manager: "We have a basic template that covers the materials, labour requirements and cleaning methods to be employed. Some of that is specified by the customer." You: "How does the plan deal with locations like the intensive care wards and the operating theatres, which are included in the contract?" Service Manager: "The basic plan covers general wards, but we will do more frequent cleaning in those areas if the hospital requests it." You: "Are you aware of the regulatory requirements for cleaning standards in hospitals?" Service Manager: "No. We depend on the hospital to look after that side of things in the contract." You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001. You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was substituted to that specified in the contract. At the follow- up audit, the corrective action proposed was to "obtain a concession from the Health Trust for use of the new chemical."

Which one of the following options is the reason why you did not accept this action taken?

A . The substitute chemical has not been used before in the Health Trust.
B . The action assumes that the Health Trust will agree to the change.
C . Staff have not been trained in the use of the new chemical.
D . The process for making changes to the contract has not been addressed.
E . The substitute chemical may not be as effective as the original.

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Question #15

DRAG DROP

In the context of a management system audit, identify the sequence of a typical process for collecting and verifying information. The first one has 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:

Identifying the source of information

Sampling available data

Gathering audit evidence

Verifying objective evidence

Evaluating evidence against the audit criteria

Making audit conclusions

Evaluating against the audit criteria

According to ISO 19011:2018, clause 6.4, the process of collecting and verifying information during an audit involves the following steps1:

Identifying the source of information: The audit team should identify the sources of information that are relevant to the audit objectives, scope and criteria. These sources may include documents, records, personnel, processes, activities, facilities, equipment, etc. The audit team should also determine the methods and tools for accessing and collecting the information, such as interviews, observations, document review, sampling, etc. Sampling available data: The audit team should select a representative sample of the available data to verify the conformity and effectiveness of the management system. The sample size and selection method should be based on the audit objectives, scope and criteria, as well as the level of confidence and risk. The audit team should also consider the validity, reliability, relevance and sufficiency of the data.

Gathering audit evidence: The audit team should use the methods and tools identified in the previous step to collect audit evidence, which is the records, statements of fact or other information that are relevant to the audit criteria and verifiable. The audit team should record the audit evidence in a clear, concise and objective manner, using notes, checklists, photographs, audio or video recordings, etc.

Verifying objective evidence: The audit team should verify the accuracy, completeness and authenticity of the audit evidence collected. This may involve cross-checking different sources of information, confirming the identity and authority of the persons providing the information, examining the original documents or records, etc. The audit team should also identify any discrepancies, inconsistencies or gaps in the audit evidence.

Evaluating evidence against the audit criteria: The audit team should compare the audit evidence with the audit criteria to determine the extent of conformity and nonconformity. The audit team should also identify any opportunities for improvement, best practices, positive aspects or potential risks. The audit team should use professional judgement and apply the principles of auditing when evaluating the audit evidence.

Making audit conclusions: The audit team should consolidate the audit findings and evaluate the overall performance and effectiveness of the management system. The audit team should also consider the audit objectives, scope and criteria, as well as the context and expectations of the auditee and other interested parties. The audit team should provide a clear, concise and objective statement of the audit conclusions, which may include the degree of conformity, the achievement of the intended outcomes, the need for corrective actions, the suitability for certification, etc. Evaluating against the audit criteria: The audit team should review the audit conclusions and ensure that they are consistent with the audit criteria and supported by sufficient and appropriate audit evidence. The audit team should also ensure that the audit conclusions are communicated to the auditee and other relevant parties in a timely and effective manner, using the agreed audit report format and distribution method.

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

Question #16

DRAG DROP

You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM)

You: "Would you tell me about your management review process?"

QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained."

You: "May I see the records from the last two management reviews?"

Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.

The Quality Manager then gives you the previous management review record, which took place one year before the latest review.

You: "Are there any other review reports in the last two years?

QM: "No, these are the only ones."

You decide to raise a nonconformity.

To complete the nonconformity report click on the blank section you want to complete se 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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Question #17

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 . Reviews the processes with high level of risk
C . Verifies the degrees of customer satisfaction
D . Evaluates the conditions of all sites
E . Evaluates the results of the last management review
F . Reviews the client’s management system documented information
G . Verifies the compliance with legal requirements

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Question #18

XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you conduct a certification audit at Stage 1. When reviewing the quality management system (QMS), you find that the objectives have been defined by an external consultant using those of a competitor, but nothing is documented. The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost.

Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?

A . The consultant has not interpreted ISO 9001 correctly.
B . Quality objectives were not established in alignment with the organisation’s quality policy.
C . Quality objectives are not maintained as documented information.
D . Establishing quality objectives did not include top management.
E . The organisation cannot afford to undertake quality objectives all at once.
F . Quality objectives are not being implemented by the organisations’ personnel.

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Question #19

XYZ Corporation employs 100 people, and during a Stage 1 certification audit, certain issues are identified with the Quality Management System (QMS).

Which two options describe the circumstances in which you could raise a nonconformity against Clause 6.2 of ISO 9001:2015?

A . Quality objectives are not being implemented by the organisation’s personnel.
B . The consultant has not interpreted ISO 9001 correctly.
C . Establishing quality objectives did not include top management.
D . Quality objectives were not established in alignment with the organisation’s quality policy.
E . The organisation cannot afford to undertake quality objectives all at once.
F . Quality objectives are not maintained as documented information.

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Question #20

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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