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Auditor Qualification Examination practice questions

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Question 1Quality Management System (ISO 9001) Auditor

Under ISO 9001:2015, which clause requires the organization to determine the scope of its quality management system, considering external and internal issues and the needs of interested parties?

  1. Clause 5.2
  2. Clause 7.5
  3. Clause 4.3 Correct answer.
  4. Clause 9.3

Explanation

Clause 4.3 requires the organization to determine the boundaries and applicability of the QMS to establish its scope, taking into account the issues from 4.1, the requirements of relevant interested parties from 4.2, and the products and services covered. Clause 5.2 addresses quality policy communication, 7.5 documented information, and 9.3 management review.

Question 2Quality Management System (ISO 9001) Auditor

An auditor is reviewing how an organization handles changes to its QMS. Which clause is the primary reference for planning changes and considering their purpose and potential consequences?

  1. Clause 7.1.6
  2. Clause 8.5.6
  3. Clause 10.2
  4. Clause 6.3 Correct answer.

Explanation

Clause 6.3 requires that changes to the QMS be carried out in a planned manner, considering purpose, potential consequences, QMS integrity, resource availability, and allocation of responsibilities. Clause 8.5.6 concerns control of changes in production and service provision, a narrower operational topic.

Question 3Quality Management System (ISO 9001) Auditor

During an audit, a process owner states that a documented procedure for internal audits was retired because ISO 9001:2015 no longer mandates it. Which auditor conclusion is most defensible?

  1. The organization is nonconforming because all QMS procedures must be documented information
  2. The organization is conforming only if the retired procedure is retained as a record
  3. The organization may justify this, since the standard requires internal audits to be conducted but does not require a documented procedure for them Correct answer.
  4. The organization is nonconforming because clause 9.2 explicitly requires a documented internal audit procedure

Explanation

ISO 9001:2015 uses the term documented information selectively and does not require a documented procedure for internal audit; it requires the audit programme to be planned and maintained as documented information. An auditor should verify that the process is still effectively planned and implemented rather than demand a procedure the standard does not require.

Question 4Quality Management System (ISO 9001) Auditor

An organization's quality policy is displayed on the intranet but staff cannot explain how it relates to their work. Which requirement is most directly at risk?

  1. The policy must be signed by each employee
  2. The policy must be reviewed at every internal audit
  3. The policy must be communicated, understood and applied within the organization Correct answer.
  4. The policy must be registered with a certification body

Explanation

Clause 5.2.2 requires the quality policy to be available and maintained as documented information, communicated, understood, and applied within the organization. Mere publication without understanding or application does not satisfy the communication requirement.

Question 5Quality Management System (ISO 9001) Auditor

Which set of items must be included in the management review inputs under clause 9.3.2?

  1. Only audit results and financial performance
  2. Status of actions from previous reviews, customer satisfaction and feedback, extent of nonconformities and corrective actions, audit results Correct answer.
  3. Only customer complaints and internal audit findings
  4. Supplier profit margins, marketing strategy, employee turnover, and competitor pricing

Explanation

Clause 9.3.2 lists inputs including the status of actions from previous management reviews, changes in external and internal issues, customer satisfaction and feedback, extent to which quality objectives have been met, process performance and product conformity, nonconformities and corrective actions, audit results, and performance of external providers.

Question 6Quality Management System (ISO 9001) Auditor

An auditor finds that calibration records for a measuring device used to verify product acceptance are missing for the last six months. Which clause is most relevant?

  1. Clause 8.4 on control of externally provided processes
  2. Clause 7.2 on competence
  3. Clause 7.1.5.2 on measurement traceability Correct answer.
  4. Clause 8.2 on requirements for products and services

Explanation

Clause 7.1.5.2 requires measuring equipment to be calibrated or verified at specified intervals, identified to enable determination of status, and safeguarded, with documented information retained as evidence of fitness. Missing calibration records indicate a breakdown in measurement traceability controls.

Question 7Quality Management System (ISO 9001) Auditor

A production supervisor tells an auditor that a new employee was allowed to operate a press because the team was short-staffed, though the employee had not completed the required training. Which clause is most directly violated?

  1. Clause 7.1.3 on infrastructure
  2. Clause 9.1.2 on customer satisfaction
  3. Clause 8.5.1 on control of production
  4. Clause 7.2 on competence Correct answer.

Explanation

Clause 7.2 requires the organization to determine the necessary competence of persons doing work affecting quality, ensure they are competent, and take actions to acquire needed competence. Allowing an untrained employee to perform quality-affecting work without demonstrated competence breaches this requirement.

Question 8Quality Management System (ISO 9001) Auditor

When an organization outsources a process that affects product conformity, what does ISO 9001:2015 require?

  1. The external provider becomes solely responsible for conformity of the outsourced process
  2. The outsourced process must be excluded from the QMS scope
  3. The organization must retain responsibility for conformity and apply controls to the outsourced process Correct answer.
  4. The organization must obtain certification of the external provider

Explanation

Clause 8.4 requires the organization to ensure that externally provided processes, products, and services conform to requirements, and clause 8.4.1 notes that the organization retains responsibility for conformity even when processes are outsourced. Controls must be applied based on the potential impact of the outsourced process.

Question 9Quality Management System (ISO 9001) Auditor

What is the primary purpose of the context of the organization clause (4.1) in an ISO 9001 audit?

  1. To record customer complaints received in the last year
  2. To list every competitor in the market
  3. To understand external and internal issues relevant to the organization's purpose and strategic direction that affect QMS results Correct answer.
  4. To document all legal regulations the organization must follow

Explanation

Clause 4.1 requires the organization to determine external and internal issues relevant to its purpose and strategic direction and that affect its ability to achieve the intended results of the QMS. Auditors use this to assess whether the QMS is appropriately tailored to the organization's reality.

Question 10Quality Management System (ISO 9001) Auditor

An organization identifies a risk that a key supplier may fail to deliver on time. Which clause most directly requires planning actions to address this risk?

  1. Clause 7.4 on communication
  2. Clause 6.1 on actions to address risks and opportunities Correct answer.
  3. Clause 10.3 on continual improvement
  4. Clause 8.7 on control of nonconforming outputs

Explanation

Clause 6.1 requires the organization to determine risks and opportunities that need to be addressed to give assurance that the QMS can achieve its intended results, and to plan actions to address them and evaluate their effectiveness. Supplier failure risk falls squarely within this planning requirement.

Question 11Quality Management System (ISO 9001) Auditor

An auditor notes that the organization's quality objectives are stated as 'improve quality' with no measurable target or timeframe. Which requirement is most directly unmet?

  1. Quality objectives must be identical to the quality policy
  2. Quality objectives must be approved by the certification body
  3. Quality objectives must be reviewed only at management review
  4. Quality objectives must be measurable, monitored, communicated, and updated as appropriate Correct answer.

Explanation

Clause 6.2.1 requires quality objectives to be consistent with the quality policy, measurable, take into account applicable requirements, be relevant to conformity and enhancement of customer satisfaction, be monitored, communicated, and updated as appropriate. A vague statement without measurability fails this requirement.

Question 12Quality Management System (ISO 9001) Auditor

An organization receives a customer complaint about a late delivery. The organization apologizes but takes no further action and records the complaint as closed. Which clause is most relevant to the auditor's concern?

  1. Clause 10.2 on nonconformity and corrective action Correct answer.
  2. Clause 9.1.3 on analysis and evaluation
  3. Clause 7.1.4 on environment for the operation of processes
  4. Clause 8.3 on design and development

Explanation

A complaint indicating failure to meet a requirement is a nonconformity, and clause 10.2 requires the organization to react, evaluate the need for action to eliminate the cause, implement action, review effectiveness, and retain documented information. Closing without corrective action leaves the requirement unmet.

Question 13Quality Management System (ISO 9001) Auditor

Which activity best demonstrates that an organization is meeting the requirement for monitoring customer satisfaction under clause 9.1.2?

  1. Collecting and analyzing customer survey results and repeat-purchase data to evaluate satisfaction Correct answer.
  2. Measuring employee attendance rates
  3. Recording only the number of complaints received
  4. Reviewing internal audit findings

Explanation

Clause 9.1.2 requires the organization to monitor customers' perceptions of the degree to which their needs and expectations have been fulfilled, and to determine the methods for obtaining, monitoring, and reviewing this information. Surveys and repeat-purchase data are recognized methods of capturing customer perception.

Question 14Quality Management System (ISO 9001) Auditor

An auditor reviewing design and development finds that verification activities were performed but no records exist of the results. Which clause is most directly relevant?

  1. Clause 7.1.5.1 on monitoring and measuring resources
  2. Clause 8.3.4 on design and development controls Correct answer.
  3. Clause 8.5.2 on identification and traceability
  4. Clause 8.4.2 on type and extent of control of external providers

Explanation

Clause 8.3.4 requires design and development verification and validation activities to be performed and documented information on these activities and their results to be retained. Missing records of verification results indicate a failure to retain required documented information.

Question 15Quality Management System (ISO 9001) Auditor

What distinguishes correction from corrective action under ISO 9001:2015?

  1. Correction is always documented, while corrective action is never documented
  2. Correction eliminates the detected nonconformity, while corrective action eliminates the cause of the nonconformity Correct answer.
  3. Correction applies only to customer complaints, while corrective action applies to internal audits
  4. Correction eliminates the cause, while corrective action eliminates the detected nonconformity

Explanation

Clause 10.2 requires the organization to react to the nonconformity and, as applicable, take action to correct it (correction), and also to evaluate the need for action to eliminate the cause so the nonconformity does not recur (corrective action). The distinction is between treating the symptom and removing the root cause.

Question 16Quality Management System (ISO 9001) Auditor

An organization determines that a process is no longer needed and removes it from its QMS. What should the auditor verify first?

  1. Whether removal affects the organization's ability to ensure conformity of products and services Correct answer.
  2. Whether the process was documented in a procedure
  3. Whether the process owner agrees with the decision
  4. Whether the process was previously audited

Explanation

ISO 9001:2015 does not require every process to be retained, but the organization must ensure that outsourcing or removal of processes does not adversely affect conformity. The auditor should assess whether the decision was justified and whether remaining processes still ensure conformity and customer satisfaction.

Question 17Quality Management System (ISO 9001) Auditor

Which statement best describes the process approach required by ISO 9001:2015?

  1. The organization must document a procedure for every process it operates
  2. The organization must determine the processes needed, their sequence and interaction, and the criteria and methods for their effective operation and control Correct answer.
  3. The organization must outsource any process it cannot measure
  4. The organization must assign every process to an external provider

Explanation

Clause 4.4 requires the organization to determine the processes needed for the QMS, their inputs and outputs, sequence and interaction, criteria and methods, resources, responsibilities, risks, and improvement opportunities. The process approach focuses on managing interrelated processes as a system rather than on mandatory procedures.

Question 18Quality Management System (ISO 9001) Auditor

An auditor is examining how the organization ensures that externally provided products meet requirements. Which clause covers the verification or other activities necessary to ensure this?

  1. Clause 9.1.1
  2. Clause 8.5.4
  3. Clause 8.4.2 Correct answer.
  4. Clause 8.6

Explanation

Clause 8.4.2 requires the organization to ensure that externally provided processes, products, and services do not adversely affect its ability to consistently deliver conforming products and services, including determining and applying verification or other activities. Clause 8.6 covers release of products and services, which is a different stage.

Question 19Quality Management System (ISO 9001) Auditor

An organization's internal audit schedule shows that the same department has been audited every year, while the logistics process has never been audited. Which requirement is most directly at risk?

  1. The audit programme must be approved by the certification body
  2. The audit programme must cover every employee at least once a year
  3. The audit programme must use only external auditors
  4. The audit programme must be planned considering the importance of processes and previous audit results Correct answer.

Explanation

Clause 9.2.2 requires the organization to plan, establish, implement, and maintain an audit programme, considering the importance of the processes concerned, changes affecting the organization, and the results of previous audits. A programme that never audits a significant process is not risk-based.

Question 20Quality Management System (ISO 9001) Auditor

During an audit, the auditee asks the auditor to suggest a specific software tool to fix a documentation problem. What is the most appropriate auditor response?

  1. Refuse to discuss the finding at all
  2. Decline to prescribe solutions and instead report the finding objectively against the requirement Correct answer.
  3. Provide the name of the tool the auditor used at another client
  4. Report the auditee for asking the question

Explanation

Auditors should remain objective and report findings against requirements rather than acting as consultants who prescribe solutions, which can compromise impartiality. The finding should describe the evidence and the requirement, leaving the corrective action design to the organization.

Question 21Quality Management System (ISO 9001) Auditor

Which of the following is a valid audit finding statement under ISO 19011 good practice?

  1. Finding: The organization should buy new gauges
  2. Finding: Calibration is generally a good idea
  3. Finding: Clause 7.1.5.2 not fully implemented; two of five gauges used for final inspection had no calibration record for the current period Correct answer.
  4. Finding: The quality manager is careless

Explanation

A well-formed finding states the requirement, the objective evidence, and the gap, allowing the organization to understand and address it. It avoids judgmental language and avoids prescribing a specific solution.

Question 22Quality Management System (ISO 9001) Auditor

An organization has no documented information describing how it controls monitoring and measuring resources, but the auditor observes that calibration is performed and records are kept. How should the auditor evaluate this?

  1. Ignore the situation because records exist
  2. Require the organization to create a procedure before continuing the audit
  3. Issue a nonconformity solely because no procedure exists
  4. Determine whether the process is effectively implemented and whether documented information required by the standard is retained, since a procedure is not always mandatory Correct answer.

Explanation

ISO 9001:2015 requires documented information to the extent necessary to support operation and retain evidence of results, but does not mandate a procedure for every activity. The auditor should verify effective implementation and the required records rather than demand a document the standard does not require.

Question 23Quality Management System (ISO 9001) Auditor

An auditor finds that a nonconformity was raised six months ago, a correction was made, but no root cause analysis or effectiveness review was performed. Which clause requirement is unmet?

  1. Clause 10.2 requires evaluating the need for action to eliminate the cause and reviewing the effectiveness of corrective action Correct answer.
  2. Clause 8.7 requires the organization to retain nonconforming outputs
  3. Clause 9.1.3 requires analysis of customer satisfaction data only
  4. Clause 7.5 requires all corrective actions to be documented as procedures

Explanation

Clause 10.2 requires the organization to evaluate the need for action to eliminate the causes of nonconformity, implement the action, review its effectiveness, and update risks and opportunities as necessary. Performing only a correction leaves the cause unaddressed.

Question 24Quality Management System (ISO 9001) Auditor

An organization claims conformity to ISO 9001:2015 but has excluded clause 8.3 (design and development) from its scope. Under what condition is this exclusion acceptable?

  1. The organization must still perform design verification even if it does not design
  2. The organization can justify that design and development requirements are not applicable to its products and services Correct answer.
  3. The exclusion is never acceptable under ISO 9001:2015
  4. The organization must obtain written permission from its customers

Explanation

ISO 9001:2015 allows requirements to be determined as not applicable when they do not affect the organization's ability to ensure conformity, and such determinations must be justified and documented. Design and development may be excluded when the organization does not design its products or services.

Question 25Quality Management System (ISO 9001) Auditor

An auditor observes that top management delegates all QMS responsibilities to a consultant and does not participate in management review. Which clause requirement is most directly at risk?

  1. Clause 7.1.2 people
  2. Clause 5.1 leadership and commitment Correct answer.
  3. Clause 9.2 internal audit
  4. Clause 8.4 control of external providers

Explanation

Clause 5.1 requires top management to demonstrate leadership and commitment by taking accountability for the effectiveness of the QMS, ensuring integration of QMS requirements into business processes, and participating in management review. Delegating all responsibility to a consultant undermines this accountability.

Question 26Quality Management System (ISO 9001) Auditor

Under ISO 9001:2015, which clause requires the organization to determine the boundaries and applicability of the quality management system to establish its scope?

  1. Clause 9.2
  2. Clause 4.3 Correct answer.
  3. Clause 7.5
  4. Clause 5.2

Explanation

Clause 4.3 requires the organization to determine the boundaries and applicability of the QMS in order to establish its scope, and to consider external and internal issues, requirements of relevant interested parties, and the organization's products and services. The scope must be maintained as documented information and must state the justification for any requirement of the standard that the organization determines is not applicable.

Question 27Quality Management System (ISO 9001) Auditor

Which clause of ISO 9001:2015 requires top management to demonstrate leadership and commitment by taking accountability for the effectiveness of the quality management system?

  1. Clause 5.1 Correct answer.
  2. Clause 8.1
  3. Clause 6.1
  4. Clause 4.4

Explanation

Clause 5.1 requires top management to demonstrate leadership and commitment with respect to the QMS, and it explicitly states that top management is accountable for the effectiveness of the QMS. The clause lists supporting behaviours, such as ensuring the integration of QMS requirements into business processes and promoting improvement.

Question 28Quality Management System (ISO 9001) Auditor

When an auditor verifies that quality objectives meet ISO 9001:2015 requirements, which characteristic must the objectives exhibit in addition to being consistent with the quality policy?

  1. They must be approved by an external certification body
  2. They must be published on the organization's website
  3. They must be measurable and monitored Correct answer.
  4. They must be reviewed only at management review

Explanation

Clause 6.2 requires quality objectives to be consistent with the quality policy, measurable, monitored, communicated, and updated as appropriate. Measurability is what allows the organization to determine whether the objectives are being achieved.

Question 29Quality Management System (ISO 9001) Auditor

An auditor is checking whether the organization has identified the knowledge necessary for the operation of its processes and to achieve conformity of products and services. Which clause is most directly relevant?

  1. Clause 7.1.6 Correct answer.
  2. Clause 8.5.1
  3. Clause 7.4
  4. Clause 9.3

Explanation

Clause 7.1.6 addresses organizational knowledge, requiring the organization to determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. It also requires that this knowledge be maintained and made available to the extent necessary.

Question 30Quality Management System (ISO 9001) Auditor

Which requirement applies to documented information that the organization determines is necessary for the effectiveness of its quality management system?

  1. It must be retained for a minimum of five years
  2. It must be stored only in electronic form
  3. It must be approved by the certification body
  4. It must be controlled to ensure it is available and protected Correct answer.

Explanation

Clause 7.5.3 requires documented information required by the QMS and by ISO 9001 to be controlled to ensure it is available and suitable for use where and when it is needed, and protected from loss of integrity, improper use, or loss of confidentiality. Control activities include distribution, access, retrieval and use, storage and preservation, and change control.

Question 31Quality Management System (ISO 9001) Auditor

During an audit of clause 8.4, the auditor finds that the organization has a list of approved suppliers but no records of how suppliers were evaluated and selected. What is the most appropriate finding?

  1. A nonconformity because records of supplier evaluation and selection are not retained Correct answer.
  2. No finding because supplier evaluation is not required by ISO 9001
  3. An observation because supplier lists are sufficient evidence of control
  4. A nonconformity because the organization must use a formal scoring model

Explanation

Clause 8.4.1 requires the organization to apply criteria for the evaluation and selection of external providers, and clause 7.5 requires documented information determined as necessary to be retained as evidence. Without records of evaluation and selection, the auditor cannot verify that the criteria were applied, so a nonconformity is appropriate.

Question 32Quality Management System (ISO 9001) Auditor

Which of the following best describes the purpose of the management review required by clause 9.3?

  1. To calculate the cost of poor quality for the finance department
  2. To approve the annual internal audit schedule
  3. To ensure the continuing suitability, adequacy, effectiveness and alignment of the QMS with strategic direction Correct answer.
  4. To verify that individual products meet acceptance criteria

Explanation

Clause 9.3 requires top management to review the organization's QMS at planned intervals to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization. The review considers specified inputs and results in decisions and actions related to improvement and resource needs.

Question 33Quality Management System (ISO 9001) Auditor

An auditor is reviewing how the organization handles changes to the quality management system. Which clause requires the organization to consider the purpose of the changes and their potential consequences?

  1. Clause 10.1
  2. Clause 8.5.6
  3. Clause 4.2
  4. Clause 6.3 Correct answer.

Explanation

Clause 6.3 requires the organization to plan changes to the QMS, and to carry them out in a planned and systematic manner that considers the purpose of the changes and their potential consequences, the integrity of the QMS, the availability of resources, and the allocation or reallocation of responsibilities and authorities.

Question 34Quality Management System (ISO 9001) Auditor

An auditor finds that a calibration record for a torque wrench used in final inspection shows the calibration was performed six months after the due date, but the organization has no record of evaluating the validity of prior measurement results. What requirement has most likely not been met?

  1. Clause 7.2 competence
  2. Clause 8.4 control of external providers
  3. Clause 8.6 release of products and services
  4. Clause 7.1.5.2 measurement traceability Correct answer.

Explanation

Clause 7.1.5.2 requires that when measuring equipment is found unfit for its intended use, the organization determine whether the validity of previous measurement results has been adversely affected and take appropriate action as necessary. The overdue calibration is evidence that the equipment may not have been fit for use, and the absence of any evaluation of prior results is the gap.

Question 35Quality Management System (ISO 9001) Auditor

Which statement correctly describes how ISO 9001:2015 treats the concept of risk-based thinking?

  1. It requires a documented risk register for every process
  2. It requires the organization to plan actions to address risks and opportunities and evaluate their effectiveness Correct answer.
  3. It requires a formal risk management process certified to ISO 31000
  4. It requires risk assessment only for design and development activities

Explanation

Clause 6.1 requires the organization to determine the risks and opportunities that need to be addressed, plan actions to address them, and evaluate the effectiveness of those actions. ISO 9001 does not mandate a specific risk methodology or a formal risk register; the organization may use whatever approach suits its context.

Question 36Quality Management System (ISO 9001) Auditor

An organization's process for handling customer complaints shows that complaints are logged and resolved, but there is no evidence that the effectiveness of the actions taken is reviewed. Which clause requirement is most directly relevant?

  1. Clause 7.1.2
  2. Clause 9.1.2
  3. Clause 10.2.1 Correct answer.
  4. Clause 8.2.1

Explanation

Clause 10.2.1 requires the organization to react to nonconformities, evaluate the need for action to eliminate the cause, implement the action, review the effectiveness of any corrective action taken, and update risks and opportunities determined during planning. The missing review of effectiveness is a gap against this clause.

Question 37Quality Management System (ISO 9001) Auditor

Which of the following is the most appropriate way for an auditor to verify that clause 7.2 competence requirements are met for a welding operator?

  1. Confirm that the operator's job description lists welding duties
  2. Ask the operator to sign a statement confirming competence
  3. Examine evidence of the operator's qualification and evaluate the effectiveness of the actions taken to acquire competence Correct answer.
  4. Confirm that the operator has attended a training course

Explanation

Clause 7.2 requires the organization to determine the necessary competence of persons doing work under its control, ensure they are competent, and evaluate the effectiveness of actions taken to acquire competence. Training attendance alone does not demonstrate competence; the auditor needs evidence of qualification and evaluation of effectiveness, such as performance records or practical assessment.

Question 38Quality Management System (ISO 9001) Auditor

An auditor is examining how the organization ensures that monitoring and measuring resources are suitable for the specific monitoring and measurement activities undertaken. Which clause contains the requirement to determine the validity of previous measurement results when equipment is found unfit for use?

  1. Clause 9.1.1
  2. Clause 8.6
  3. Clause 7.1.5.1
  4. Clause 7.1.5.2 Correct answer.

Explanation

Clause 7.1.5.2 addresses measurement traceability and requires the organization to determine whether the validity of previous measurement results has been adversely affected when measuring equipment is found unfit for its intended use, and to take appropriate action. Clause 7.1.5.1 addresses the general provision of monitoring and measuring resources.

Question 39Quality Management System (ISO 9001) Auditor

During an audit, an auditor notices that the organization's process for handling nonconforming outputs records the disposition but not the person authorizing the concession. Which requirement is most directly affected?

  1. Clause 8.7.2 Correct answer.
  2. Clause 8.3.6
  3. Clause 8.6
  4. Clause 8.5.1

Explanation

Clause 8.7.2 requires the organization to retain documented information describing the nonconformity, the actions taken, any concessions obtained, and the identification of the authority deciding the action in respect of the nonconformity. Recording the disposition without identifying the authorizing person leaves a gap in this documented information.

Question 40Quality Management System (ISO 9001) Auditor

What is the primary purpose of the internal audit programme required by clause 9.2?

  1. To satisfy the certification body's surveillance requirements
  2. To determine whether the QMS conforms to the organization's own requirements and to ISO 9001, and is effectively implemented and maintained Correct answer.
  3. To appraise individual employee performance
  4. To verify that financial controls are operating effectively

Explanation

Clause 9.2 requires internal audits at planned intervals to determine whether the QMS conforms to the organization's own requirements for its QMS and to the requirements of ISO 9001, and whether it is effectively implemented and maintained. The programme must be planned considering the importance of processes, changes, and the results of previous audits.

Question 41Quality Management System (ISO 9001) Auditor

An auditor finds that the organization has identified a risk of power failure affecting a critical process, but no action has been planned. What is the most appropriate conclusion?

  1. A nonconformity against clause 6.1 because actions to address the risk have not been planned Correct answer.
  2. A nonconformity against clause 7.1.3 because infrastructure is inadequate
  3. No finding, because risks need only be identified
  4. An observation, because power failure is outside the organization's control

Explanation

Clause 6.1 requires the organization not only to determine the risks and opportunities that need to be addressed, but also to plan actions to address them and to evaluate the effectiveness of those actions. Identifying a risk without planning any action leaves the requirement only partially fulfilled.

Question 42Quality Management System (ISO 9001) Auditor

An auditor is evaluating whether the organization has appropriately applied the process approach. Which evidence best demonstrates this?

  1. Each department has written its own procedures independently
  2. The organization has purchased process-mining software
  3. Processes have defined inputs, outputs, sequence, interaction, and performance indicators that are monitored Correct answer.
  4. A process map exists in the quality manual

Explanation

The process approach in ISO 9001:2015 requires the organization to determine the processes needed, their inputs and outputs, sequence and interaction, criteria and methods, resources, responsibilities, and risks, and to monitor and evaluate them. Evidence of defined inputs, outputs, interactions and monitored performance indicators demonstrates the approach in practice.

Question 43Quality Management System (ISO 9001) Auditor

An auditor discovers that a supplier of critical components was added to the approved list without any evaluation, and the purchasing manager explains that the supplier was chosen because it was the cheapest. Which clause requirement has been most clearly breached?

  1. Clause 8.4.1 Correct answer.
  2. Clause 8.2.3
  3. Clause 8.5.4
  4. Clause 7.1.6

Explanation

Clause 8.4.1 requires the organization to determine and apply criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. Selecting a supplier on price alone without applying the organization's criteria is a breach of this requirement.

Question 44Quality Management System (ISO 9001) Auditor

An auditor is reviewing the organization's customer communication process. Which clause requires the organization to communicate with customers in relation to contingency actions, when relevant?

  1. Clause 8.2.1 Correct answer.
  2. Clause 8.2.4
  3. Clause 8.2.2
  4. Clause 8.2.3

Explanation

Clause 8.2.1 requires communication with customers relating to information about products and services, handling of enquiries, contracts or orders, customer feedback including complaints, handling of customer property, and establishing specific requirements for contingency actions when relevant. The contingency element was added in the 2015 revision.

Question 45Quality Management System (ISO 9001) Auditor

An auditor finds that the organization's internal audit reports consistently identify the same nonconformity in the same process year after year, with no change in the audit criteria or scope. What should the auditor conclude?

  1. The process owner should be replaced
  2. The internal audit programme is effective because it consistently detects the issue
  3. The corrective action process may not be effective, and the audit programme should be reviewed for its consideration of previous results Correct answer.
  4. The nonconformity should be downgraded to an observation to reflect repeat status

Explanation

Clause 9.2.2 requires the audit programme to be planned considering the importance of processes, changes affecting the organization, and the results of previous audits. Clause 10.2 requires corrective action to eliminate the cause of nonconformities. A recurring nonconformity suggests that corrective action has not been effective and that the audit programme is not adapting to prior results.

Question 46Quality Management System (ISO 9001) Auditor

An organization's quality policy is displayed on a wall but employees in the warehouse cannot explain how their work contributes to it. Which clause requirement is most directly not fulfilled?

  1. Clause 5.2.2 Correct answer.
  2. Clause 7.4
  3. Clause 5.3
  4. Clause 9.1.1

Explanation

Clause 5.2.2 requires the quality policy to be available and maintained as documented information, communicated, and applied within the organization, and to be available to relevant interested parties as appropriate. Displaying the policy without it being understood and applied at all levels indicates a gap in communication and application.

Question 47Quality Management System (ISO 9001) Auditor

An auditor is examining the organization's control of production and service provision. The organization uses a work instruction that specifies a temperature range, but the operator records the temperature only at the start of the shift. The work instruction requires hourly recording. What is the most appropriate finding?

  1. A nonconformity because the work instruction is not controlled
  2. No finding because the operator is competent
  3. An observation because temperature monitoring is not a critical control
  4. A nonconformity because the process is not being implemented as planned Correct answer.

Explanation

Clause 8.5.1 requires the organization to implement production and service provision under controlled conditions, including the implementation of monitoring and measurement activities at specified stages. If the documented work instruction requires hourly recording and only the start-of-shift reading is taken, the process is not being implemented as planned, which is a nonconformity.

Question 48Quality Management System (ISO 9001) Auditor

An auditor is assessing whether the organization has addressed actions to address risks and opportunities effectively. Which evidence provides the strongest basis for the auditor's conclusion?

  1. A statement in the quality manual that risk-based thinking is applied
  2. A risk register listing many risks with owners assigned
  3. Records showing planned actions were implemented and their effectiveness evaluated against intended outcomes Correct answer.
  4. A management presentation describing the risk methodology used

Explanation

Clause 6.1 requires the organization to plan actions to address risks and opportunities, integrate and implement the actions into its QMS processes, and evaluate the effectiveness of these actions. Evidence of implementation and evaluation of effectiveness against intended outcomes is the strongest basis for the auditor's conclusion.

Question 49Quality Management System (ISO 9001) Auditor

An auditor is reviewing a corrective action record where the root cause was identified as 'operator error' and the action taken was to remind the operator of the procedure. What is the most significant weakness in this corrective action?

  1. The record was not retained as documented information
  2. The root cause analysis stopped at a symptom and did not address systemic causes Correct answer.
  3. The action was implemented too quickly
  4. The action was not approved by top management

Explanation

Clause 10.2.1 requires the organization to evaluate the need for action to eliminate the cause of a nonconformity so that it does not recur or occur elsewhere. Attributing the cause to 'operator error' without examining why the error occurred, such as unclear instructions, inadequate training, or process design, treats a symptom rather than a cause, so recurrence is likely.

Question 50Quality Management System (ISO 9001) Auditor

An organization's scope statement excludes clause 8.5.3 (property belonging to customers or external providers) on the grounds that it never handles customer property. During the audit, the auditor finds that the organization stores customer-supplied tooling at its site. What is the most appropriate conclusion?

  1. The exclusion is not justified because the organization does handle customer property, and the requirement should be applied Correct answer.
  2. The exclusion is acceptable if the customer has not complained
  3. The exclusion is acceptable because tooling is not a product
  4. The exclusion is acceptable because it was documented in the scope

Explanation

Clause 4.3 permits an organization to determine that a requirement is not applicable only when it does not affect the organization's ability to ensure the conformity of its products and services. Since the organization stores customer-supplied tooling, it does handle customer property, so the exclusion is not justified and clause 8.5.3 should apply.