Prepare ISO-9001-Lead-Auditor Exam Questions [2025] Recently Updated Questions [Q43-Q65]

Topic	Details
Topic 1	Managing an ISO 9001 audit program: This topic evaluates your abilities to establishing and managing a QMS audit program.
Topic 2	Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
Topic 3	Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.
Topic 4	Fundamental principles and concepts of a quality management system: The main objective of this domain is to evaluate your skills of explaining and applying ISO 9001 principles and concepts.

NEW QUESTION 43
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).

Explanation:
Quality management principles:
Customer focus = Increased revenue and market share
Engagement of people = Enhanced trust and collaboration throughout the organisation Improvement = Enhanced drive for innovation Evidence-based decision-making = Increased ability to demonstrate effectiveness of past actions According to the Quality management principles document published by ISO, each quality management principle has a statement, a rationale, key benefits, and actions you can take to apply it. Based on these descriptions, the potential benefits can be matched to the corresponding principles as follows:
Customer focus: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. The key benefits of this principle include increased customer value, customer satisfaction, customer loyalty, repeat business, reputation, customer base, revenue and market share.
Engagement of people: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value. The key benefits of this principle include improved understanding of the organization’s objectives and values, increased involvement in improvement activities, enhanced personal development, increased motivation and empowerment, enhanced trust and collaboration, and increased recognition and rewards.
Improvement: Successful organizations have an ongoing focus on improvement. The key benefits of this principle include improved organizational capabilities, alignment of improvement activities at all levels, increased ability to anticipate and react to opportunities and threats, enhanced drive for innovation, and increased levels of satisfaction.
Evidence-based decision-making: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. The key benefits of this principle include improved decision-making processes, increased ability to demonstrate the effectiveness of past decisions, increased ability to review, challenge and change opinions and decisions, and increased ability to improve performance.

NEW QUESTION 44
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management. 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. He asks for your opinion on whether this is the correct method of setting objectives.
How would you respond with the following options? Select three.

Suggest asking the certification body for guidance on this matter.

Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organisation’s requirements.

Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly.

Inform the Quality Manager that you will comment on the subject in your audit report.

Indicate that ISO 9001 requires a minimum of two quality objectives.

Suggest that all employees undertake a training course on ISO 9001.

Advise the Quality Manager that, as an auditor, you cannot provide advice to the organisation on how it should operate its QMS.

Suggest that the Quality Manager obtains external consultancy on the use of quality objectives.

According to the ISO 9001:2015 standard, clause 6.2.1 requires organizations to establish quality objectives at relevant functions, levels, and processes needed for the quality management system. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The quality objectives must also be measurable, monitored, communicated, and updated as appropriate.
In this scenario, the Quality Manager of XYZ Corporation has set quality objectives for every employee in the organization except top management. This has created a lot of resistance to the QMS, and the Chief Executive is asking questions about the cost and the method of setting objectives. The Quality Manager asks for your opinion as an auditor on whether this is the correct method of setting objectives.
As an auditor, you cannot provide advice to the organization on how it should operate its QMS. Your role is to assess the conformity and effectiveness of the QMS against the requirements of the standard and the organization’s own policies and objectives. Therefore, you should respond with the following options:
B: Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organization’s requirements: You can suggest that the Quality Manager should familiarize himself with the requirements of clause 6.2.1 and understand how they apply to his organization. He should also consider the context and the needs and expectations of interested parties when setting quality objectives. He should ensure that the quality objectives are aligned with the quality policy and the strategic direction of the organization.
C: Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly: You can inform the Quality Manager that you will evaluate the quality objectives during the audit and check whether they meet the requirements of clause 6.2.1. If you find any gaps or weaknesses in the quality objectives, you will raise an opportunity for improvement to help the organization improve its QMS. You will also verify whether the quality objectives are monitored, communicated, and updated as appropriate.
D: Inform the Quality Manager that you will comment on the subject in your audit report: You can inform the Quality Manager that you will document your findings and observations on the quality objectives in your audit report. You will also provide a summary of the audit results and any recommendations for improvement.
You will also indicate the level of conformity and effectiveness of the QMS.
These three options would help you to maintain your impartiality and professionalism as an auditor and to provide constructive feedback to the organization

NEW QUESTION 45
You are carrying out an annual audit at an organisation that has been certificated to ISO 9001 for two years.
The organisation offers home security
services. The scope of the quality management system covers alarm installation, alarm servicing, alarm monitoring and response. The business operates from a single office and employs subcontract installers and service technicians across the country.
You have just completed the opening meeting. You are interviewing the Managing Director (MD).
You: “I would like to gain an understanding of how the quality management system has been supporting your business and its strategic direction.” MD: “We are continuing to face difficult times. The market is extremely competitive, and customers typically look for the least expensive option when choosing home security services. We have not yet seen any business benefit from our quality management system.” You: “Tell me how you determine external and internal issues.” MD: “We use SWOT analysis (Strengths Weaknesses, Opportunities, Threats).” You: “How have the outputs from your SWOT been used?” Select two of the following audit trails would you take to explore the extent to which the SWOT analysis and the outputs from this have been used to enable the business to achieve the intended results(s) of its quality management system according to ISO 9001.

Establish how many interested parties need to be consulted

Establish how the organisation reviews information about external and internal issues

Establish how the organisation shares information with external interested parties

Establish what actions were taken to improve the QMS

Establish whether the SWOT analysis has been reviewed by the procurement manager

Establish whether the SWOT analysis is focussed solely on the QMS

According to ISO 9001:2015, clause 4.1, the organisation must determine the external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended results of its quality management system. The organisation must also monitor and review the information about these issues. SWOT analysis is a tool that can help the organisation to identify its strengths, weaknesses, opportunities, and threats. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to review the information periodically and update it as necessary. Therefore, one audit trail would be to establish how the organisation reviews information about external and internal issues, such as how often, by whom, using what criteria, and with what results. 123 According to ISO 9001:2015, clause 10.3, the organisation must continually improve the suitability, adequacy, and effectiveness of the quality management system. The organisation must also consider the results of analysis and evaluation, and the outputs from management review, to determine if there are any needs or opportunities for improvement. SWOT analysis can help the organisation to identify the areas where improvement is needed or possible, such as addressing the weaknesses and threats, or exploiting the strengths and opportunities. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to take actions to implement the improvement, such as setting objectives, allocating resources, assigning responsibilities, and evaluating the effectiveness. Therefore, another audit trail would be to establish what actions were taken to improve the QMS, such as what, when, by whom, how, and with what results. 124 References:
1: ISO 9001:2015 – Quality management systems – Requirements
2: Advisera, “Context of the organization in ISO 9001:2015 explained”, https://advisera.com/9001academy
/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
3: ISO Templates, “ISO 9001 – Clause 4: Context of the organisation explained”, https://resources.iso- templates.com/blog/iso-9001-clause-4-context-of-the-organisation-explained
4: Advisera, “How to implement continual improvement in ISO 9001”, https://advisera.com/9001academy
/knowledgebase/how-to-implement-continual-improvement-in-iso-9001/

NEW QUESTION 46
In the context of a third-party audit, match the activity with the party responsible in relation to the audit process.

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.

NEW QUESTION 47
Put the following steps of a third-party audit into the correct sequence in which they happen.

Explanation:
Sequence:
Stage 1 Audit
Stage 2 Opening Meeting
Interviews
Stage 2 Closing Meeting
Close-out of Stage 2 Audit Findings
Issue Certificate
Surveillance Audit
Follow-up Audit
To complete the sequence, you can drag and drop the options to the appropriate blank section.
Here is a brief explanation of each step:
Stage 1 Audit: This is the initial audit that aims to assess the readiness of the organization for the stage 2 audit. It involves reviewing the documentation of the quality management system, evaluating the scope and objectives of the audit, and identifying any major gaps or nonconformities34.
Stage 2 Opening Meeting: This is the meeting that marks the start of the stage 2 audit. It involves confirming the audit plan, the audit criteria, the audit scope, and the audit team. It also provides an opportunity for the auditee to ask any questions or raise any concerns34.
Interviews: This is the main activity of the stage 2 audit, where the audit team collects evidence by interviewing the personnel involved in the quality management system, observing the processes and activities, and examining the records and documents. The audit team uses various techniques, such as sampling, measurement, analysis, and evaluation, to verify the conformity and effectiveness of the quality management system345.
Stage 2 Closing Meeting: This is the meeting that marks the end of the stage 2 audit. It involves presenting the audit findings, the audit conclusions, and the audit report to the auditee. It also provides an opportunity for the auditee to provide feedback, ask questions, or dispute any findings34.
Close-out of Stage 2 Audit Findings: This is the process of verifying that the auditee has taken appropriate corrective actions to address any nonconformities or opportunities for improvement identified during the stage 2 audit. The audit team may request evidence or conduct a follow-up visit to confirm the effectiveness of the corrective actions34.
Issue Certificate: This is the process of issuing a certificate of conformity to the auditee, if the audit team is satisfied that the quality management system meets the requirements of the standard and that there are no major nonconformities or unresolved issues. The certificate is valid for a specified period, usually three years, and is subject to periodic surveillance audits34.
Surveillance Audit: This is the process of conducting periodic audits, usually once a year, to monitor the continued conformity and effectiveness of the quality management system. It involves reviewing the changes, improvements, and performance of the quality management system, and identifying any new nonconformities or opportunities for improvement34.
Follow-up Audit: This is the process of conducting an additional audit, usually in response to a significant change, a complaint, or a major nonconformity, to verify the impact and the corrective actions taken by the auditee. It may result in the suspension, withdrawal, or renewal of the certificate, depending on the outcome of the audit34.

NEW QUESTION 48
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.

NEW QUESTION 49
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements.
The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.
You are interviewing the Training Manager (TM).
You: “What quality objectives apply to the training process?”
TM: “One of the quality objectives we aim for is a 90% minimum exam pass rate for all open training courses.” You: “How do you measure this objective?” The Training Manager shows you a record on her computer and you see the following:

Which two of the following statements are true?

You would check the training of personnel.

You would determine how the exam pass rate figures were analysed.

You would determine the relative difficulty of each training course by reviewing them.

You would determine what corrective action was being taken to address the low pass rates.

You would raise a nonconformity as a requirement in clause 10.2 has not been fulfilled.

You would raise a nonconformity as a requirement in clause 8.7 has not been fulfilled.

NEW QUESTION 50
An organisation wants to certify their ISO 9001:2015-based QMS for the first time. Arrange the activities in the correct sequence from 2 to 5.
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.

NEW QUESTION 51
You are conducting 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 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.

NEW QUESTION 52
In a third-party audit to ISO 9001, select two options of when the organisation is required to act in response to reported findings.

A recommendation is given in the report.

A finding of good practice is reported.

An opportunity for improvement is raised.

A major non-conformity is raised.

A finding of conformity is reported.

A minor non-conformity is raised.

According to ISO 19011:2018, clause 6.6.2, a nonconformity is the non-fulfilment of a requirement. A nonconformity can be classified as either major or minor, depending on the nature and extent of the deviation from the audit criteria. A major nonconformity is a nonconformity that affects the ability or the integrity of the organization’s management system to achieve the intended results. A minor nonconformity is a nonconformity that does not affect the ability or the integrity of the organization’s management system to achieve the intended results, but is a deviation from the audit criteria1.
According to ISO/IEC 17021-1:2015, clause 9.4.9, the organization is required to analyze the cause and describe the specific correction and corrective actions taken, or planned to be taken, to eliminate detected nonconformities, within a defined time. The organization is also required to provide the certification body with records and evidence of the implementation and effectiveness of the correction and corrective actions taken.
The certification body will then verify the correction and corrective actions taken by the organization and decide on the certification status2.
Therefore, the two options of when the organization is required to act in response to reported findings are D and F, as they indicate the presence of nonconformities that need to be corrected and prevented from recurring.
The other options are not correct, as they do not require the organization to act in response to reported findings:
*A. A recommendation is given in the report: A recommendation is a suggestion for improvement that is not related to a nonconformity. A recommendation is not binding for the organization and does not affect the certification status. The organization may choose to accept or reject the recommendation, but it is not required to act on it.
*B. A finding of good practice is reported: A finding of good practice is a positive observation that indicates a strength or a best practice of the organization’s management system. A finding of good practice is not related to a nonconformity and does not affect the certification status. The organization may choose to acknowledge or share the finding of good practice, but it is not required to act on it.
*C. An opportunity for improvement is raised: An opportunity for improvement is a potential area where the organization’s management system can be enhanced or optimized. An opportunity for improvement is not related to a nonconformity and does not affect the certification status. The organization may choose to pursue or ignore the opportunity for improvement, but it is not required to act on it.
*E. A finding of conformity is reported: A finding of conformity is a confirmation that the organization’s management system fulfils the audit criteria. A finding of conformity is not related to a nonconformity and does not affect the certification status. The organization may choose to celebrate or communicate the finding of conformity, but it is not required to act on it.
References: ISO 19011:2018(en), Guidelines for auditing management systems, ISO/IEC 17021-1:2015(en), Conformity assessment – Requirements for bodies providing audit and certification of management systems
– Part 1: Requirements

NEW QUESTION 53
TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit team discussed and agreed both nonconformities with TIX’s quality manager. The Closing meeting was planned for 6pm with the general manager, quality manager and service manager at the meeting room.
At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the warehouse supervisor. Neither have participated in the audit.
The dialogue among them is as follows:
Audit team leader: “Good evening, could you please inform the three managers that we are ready to start with the Closing meeting?” Health and Safety supervisor: “Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and the other two managers have had to leave urgently to attend the emergency.” Warehouse supervisor: “They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed.” Which one of the following options would be your preferred response to the final comment made by the warehouse manager?

Sorry, but we cannot proceed with the Closing meeting. So, we are leaving now, and please tell the quality manager that I will phone him tomorrow early in the morning.

We will hear what you were asked to tell us and will ask you to sign the nonconformity reports as evidence that you have accepted them. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to complete the Closing meeting.

We will hear what you were asked to tell us and will leave copies of the nonconformity reports that have been agreed with the quality manager. Please tell the managers that we will consider this as the Closing meeting and that the individual(s) managing the audit programme will send the full report in five days.

We will hear what you were asked to tell us and will then leave. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to carry out the Closing meeting.

NEW QUESTION 54
Knowledge and skills are requirements of the auditor’s competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.

Requirements of ISO 9001

ISO 19011 Audit principles

Organisation’s market sector

Organisation’s invoicing and profits of the last 5 years

Organisation’s processes

Requirements of auditee’s interested parties other than customers

NEW QUESTION 55
The following are stages of an audit, put them in the order they would be conducted.

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

NEW QUESTION 56
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.

Dispatch personnel are not fully aware of the need to conform to written procedures.

Dispatch personnel do not always carry out its activities in conformance with Procedure P-02 rev 3.

The batch 33555 was delivered split in two different trucks (011 and 025).

A product delivered to the client was not identified as required in P-02 Rev 3.

NEW QUESTION 57
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers regulatory consultancy services to manufacturers of cosmetics. The business operates from ten regional offices.
You are nearing the end of the audit and need to decide if sufficient evidence of top management leadership and commitment with respect to the quality management system has been gathered.
Which four of the following would demonstrate top management leadership and commitment with respect to the quality management system?

Approving company car budgets for the fiscal year

Briefing staff on the development of an improvement culture

Chairing management review meetings

Conducting staff disciplinary meetings

Investing time and money in corrective actions arising from nonconformities

Not attending audit closing meeting

Promoting the importance of following procedures

NEW QUESTION 58
Which one of the following options best describes the purpose of a Stage 1 third-party audit?

To determine the auditees understanding of ISO 9001.

To get to know the organisation’s customers.

To learn about the organisation’s procurement processes.

To introduce the audit team to the client.

NEW QUESTION 59
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.

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

NEW QUESTION 60
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.”

NEW QUESTION 61
Select the phrase that best describes the purpose of a quality management system to ISO 9001 in relation to the performance of an organization.

Manages the performance

Monitors the performance

Dictates the performance

Improves the performance

NEW QUESTION 62
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.”

NEW QUESTION 63
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).

NEW QUESTION 64
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).