Free Questions for ISO-9001-Lead-Auditor

Shared by Bowers on 04-10-2024

For More Free Questions and Preparation Resources

Check the Links on Last Page

Question 1
Question Type: MultipleChoice

During a second-party audit of a dairy farm (by a potential customer) complying with ISO 9001:2015, the auditor verifies that there is
large variability in the daily production of the milking yard. The current agreement with their only customer is to provide 2,000 litres per
day. However, in the last two years, they have noticed an increasing variability in daily production.

If they produce less than 2,000 litres, they are penalised with a fine of 1.5 pesos for every litre that they do not provide. If they produce
more than 2,000 litres, they use the extra milk to feed the pigs.

This process has been in operation for decades. The dairy farm was founded by the grandfather of the current owners, who did not want
to alter the established practices.

The auditor raises a nonconformity on the basis that the process is not under control (Clause 8.1).

If you had been the auditor, which one of the following actions would you have accepted?

Options:
A- Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and make an agreement with a
second customer.

B- Apply the existing process of addressing the risks and opportunities of milk production.
C- Retain the current contract and try to sell the occasional surplus milk to a second customer.

D- Analyse the daily dispatch of milk for 7 days to determine its variability.

Answer:
B

Explanation:
The action that the auditor would have accepted is:

* Option B: Apply the existing process of addressing the risks and opportunities of milk production. This option is correct because ISO
9001:2015 clause 8.1 requires the organization to plan, implement and control the processes needed to meet the requirements for the
provision of products and services, and to implement actions determined in clause 6.1, which refers to the actions to address risks and
opportunities. The organization should apply the existing process of addressing the risks and opportunities of milk production, which may
include identifying the sources of variability, assessing the potential impacts and consequences, determining and implementing
appropriate actions to reduce or eliminate the variability, monitoring and measuring the effectiveness of the actions, and reviewing and
updating the actions as necessary.

The following options are not correct:

* Option A: Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and make an agreement
with a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of
the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not
demonstrate the organization's commitment to meet the customer and applicable statutory and regulatory requirements, as required by
ISO 9001:2015 clause 8.2.2.

* Option C: Retain the current contract and try to sell the occasional surplus milk to a second customer. This option is not correct
because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and
consistency of the products and services provided by the organization. It also does not demonstrate the organization's commitment to
meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.

* Option D: Analyse the daily dispatch of milk for 7 days to determine its variability. This option is not correct because it does not address
the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products
and services provided by the organization. It also does not demonstrate the organization's commitment to implement actions to address
risks and opportunities, as required by ISO 9001:2015 clause 8.1.

* ISO 9001:2015 Quality management systems - Requirements, Clause 8: Operation, Subclause 8.1: Operational planning and control,
Subclause 8.2: Requirements for products and services

* ISO 9001 Lead Auditor Course Material, Module 4: ISO 9001:2015 Requirements, Slide 23: Clause 8 - Operation

* ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 4.2: ISO 9001:2015 Requirements, Subsection 4.2.8: Clause 8 -
Operation

* Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 -
Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection 3.2.3: Section 3 - Audit Process, Subsection 3.2.4:
Section 4 - Audit Competencies
Question 2
Question Type: MultipleChoice

A Health Trust has contracted with Servitup, a catering services organisation which has been certified to ISO 9001 for 1 year. It provides
services to ten, small rural

hospitals in remote locations involving purchase and storage of dry goods and fresh produce, preparing meals and loading heated
trolleys for ward service by hospital

staff. An auditor is conducting the first sole surveillance audit at one site with the Deputy Catering Manager (DCM).

At the closing meeting attended solely by the DCM, the auditor informs him that he has found numerous gaps in the QMS processes
which lead him to consider

recommending suspension of the organisation's certification. He is particularly concerned with the evidence that patient health is being
adversely affected by produce

stored beyond its safe consumption date, poor kitchen hygiene and undercooked meals. The DCM says that he cannot make any
decisions about these issues in the

absence of the Catering Manager due to illness but will write everything down and report to the Catering Manager.

Which two actions should you take in the context of the audit?
Options:
A- Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit.

B- Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to
protect the integrity of the Certification Body.

C- Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due
course.

D- Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work.

E- Recommend that all personnel should be given urgent in-depth training in the QMS.

F- Thank the DCM for his time and express an expectation that improvements will be made in the QMS.

Answer:
B, C

Explanation:
The actions that should be taken in the context of the audit are:

* Option B: Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of
certification to protect the integrity of the Certification Body. This option is correct because the auditor has found serious and significant
gaps in the QMS processes that affect the health and safety of the patients, which is a major nonconformity that may warrant suspension
of certification. The auditor should inform the individual(s) managing the audit programme of the situation and the audit findings, and
recommend immediate suspension of certification to protect the integrity of the Certification Body and the credibility of the certification
scheme. The auditor should also follow the Certification Body's procedures and rules for suspension of certification and communicate
the decision and the consequences to the auditee.

* Option C: Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit
report in due course. This option is correct because the auditor should not terminate or postpone the closing meeting due to the absence
of the Catering Manager, as the DCM is the auditee's nominated representative for the audit. The auditor should continue with the
meeting, present the audit conclusions and the audit findings, and inform the DCM that the organisation will receive the audit report in
due course. The auditor should also explain the audit outcome recommendation and the suspension of certification, and request the
DCM to acknowledge the receipt and understanding of the audit results.

The following options are not correct:

* Option A: Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next
surveillance visit. This option is not correct because the auditor should not close the meeting without presenting the audit conclusions
and the audit findings, as this would violate the audit principles of fairness and transparency. The auditor should also not advise that the
issues will be addressed at the next surveillance visit, as this would imply that the auditor is accepting the auditee's delay and inaction,
and that the auditor is not taking the major nonconformity seriously.

* Option D: Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work. This
option is not correct because the auditor should not conclude the meeting early or reschedule it due to the absence of the Catering
Manager, as this would disrupt the audit process and the audit schedule. The auditor should also not wait for the Catering Manager to
return to work, as this would delay the communication and resolution of the major nonconformity, and potentially compromise the health
and safety of the patients.

* Option E: Recommend that all personnel should be given urgent in-depth training in the QMS. This option is not correct because the
auditor should not recommend or prescribe specific corrective actions to the auditee, as this would violate the audit principles of
 independence and objectivity. The auditor should only report the audit findings and the audit outcome recommendation, and leave the
responsibility and authority for determining and implementing the corrective actions to the auditee.

* Option F: Thank the DCM for his time and express an expectation that improvements will be made in the QMS. This option is not
correct because the auditor should not thank the DCM for his time and express an expectation that improvements will be made in the
QMS, as this would imply that the auditor is satisfied and optimistic with the auditee's performance and response, and that the auditor is
not taking the major nonconformity seriously. The auditor should instead express the concern and dissatisfaction with the auditee's QMS
processes and the impact on the health and safety of the patients, and communicate the suspension of certification and the need for
urgent and effective corrective actions.

* ISO 19011:2018 Guidelines for auditing management systems, Clause 6.4.2: Conducting audit activities, Subclause k) and l)

* ISO 9001 Lead Auditor Course Material, Module 5: Conducting an Audit, Slide 20: Closing Meeting

* ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 5.5: Closing Meeting

* Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 -
Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection 3.2.3: Section 3 - Audit Process, Subsection 3.2.4:
Section 4 - Audit Competencies

Question 3
Question Type: MultipleChoice
Select six tasks you would expect to be completed at the audit team meeting of a third-party audit team leader and his audit team in
preparation for a Closing meeting for a four-day initial certification audit.

Options:
A- Audit team leader informs the individual(s) managing the audit programme that the closing meeting is ready to be held.

B- Hold daily audit team meeting to review any timetable issues and potential findings and their impact on the audit for other team
members.

C- Final audit team meeting to agree findings and categories including clarification of any uncertainties.

D- Agree the roles of each audit team member for the closing meeting.

E- Audit team review any points raised by the auditee nominated representative.

F- Audit team agree final audit outcome recommendation.

G- Audit team leader completes final report, including individual findings and certification recommendation.

H- Audit team complete final version of their individual findings.

I- Re-audit corrective actions taken to correct findings found during the audit.

J- Write the audit finding report out when detected and obtain signature of the auditee.

Answer:
C, D, E, F, H, I
Explanation:
The tasks that are expected to be completed at the audit team meeting of a third-party audit team leader and his audit team in
preparation for a Closing meeting for a four-day initial certification audit are:

* Option C: Final audit team meeting to agree findings and categories including clarification of any uncertainties. This option is correct
because the audit team meeting is an opportunity for the audit team leader and the audit team members to review and consolidate the
audit findings, to ensure that they are clear, accurate, objective, and supported by sufficient audit evidence. The audit team should also
agree on the categories of the findings, such as nonconformity, observation, or opportunity for improvement, and resolve any
uncertainties or disagreements among the audit team members.

* Option D: Agree the roles of each audit team member for the closing meeting. This option is correct because the audit team meeting is
an opportunity for the audit team leader to assign the roles and responsibilities of each audit team member for the closing meeting, such
as presenting the audit findings, answering questions, or taking notes. The audit team leader should also ensure that the audit team
members are prepared and confident to perform their roles and to communicate effectively with the auditee.

* Option E: Audit team review any points raised by the auditee nominated representative. This option is correct because the audit team
meeting is an opportunity for the audit team to review any points raised by the auditee nominated representative during the audit, such
as requests for clarification, feedback, or complaints. The audit team should consider the validity and relevance of the points raised and
decide how to address them in the closing meeting or in the audit report.

* Option F: Audit team agree final audit outcome recommendation. This option is correct because the audit team meeting is an
opportunity for the audit team to agree on the final audit outcome recommendation, based on the audit findings and the audit criteria.
The audit team should also consider the implications and consequences of the audit outcome recommendation for the auditee and the
certification body, and ensure that the recommendation is consistent and justified.
* Option H: Audit team complete final version of their individual findings. This option is correct because the audit team meeting is an
opportunity for the audit team to complete the final version of their individual findings, based on the agreement and feedback from the
audit team meeting. The audit team should ensure that their individual findings are written in a clear, concise, and factual manner, and
that they include the audit criteria, the audit evidence, and the audit conclusion. The audit team should also submit their individual
findings to the audit team leader for review and approval.

* Option I: Re-audit corrective actions taken to correct findings found during the audit. This option is correct because the audit team
meeting is an opportunity for the audit team to re-audit the corrective actions taken by the auditee to correct the findings found during the
audit, if applicable and feasible. The audit team should verify the effectiveness and adequacy of the corrective actions and update the
audit findings accordingly. The audit team should also document the results of the re-audit and communicate them to the auditee.

The following options are not correct:

* Option A: Audit team leader informs the individual(s) managing the audit programme that the closing meeting is ready to be held. This
option is not correct because this task is not part of the audit team meeting, but part of the communication between the audit team leader
and the individual(s) managing the audit programme. The audit team leader should inform the individual(s) managing the audit
programme that the closing meeting is ready to be held after the audit team meeting, when the audit team has completed all the tasks
and is ready to present the audit results to the auditee.

* Option B: Hold daily audit team meeting to review any timetable issues and potential findings and their impact on the audit for other
team members. This option is not correct because this task is not part of the final audit team meeting, but part of the daily audit team
meetings that are held during the audit. The daily audit team meetings are opportunities for the audit team to review the progress and
performance of the audit, to identify and resolve any issues or problems, and to coordinate and adjust the audit plan and activities as
needed.
 * Option G: Audit team leader completes final report, including individual findings and certification recommendation. This option is not
correct because this task is not part of the audit team meeting, but part of the audit reporting process. The audit team leader should
complete the final report, including the individual findings and the certification recommendation, after the closing meeting, when the audit
team has received and considered the feedback and comments from the auditee. The audit team leader should also ensure that the final
report is reviewed and approved by the appropriate authorities before issuing it to the auditee and the certification body.

* Option J: Write the audit finding report out when detected and obtain signature of the auditee. This option is not correct because this
task is not part of the audit team meeting, but part of the audit evidence collection and documentation process. The audit team should
write the audit finding report out when detected and obtain the signature of the auditee during the audit, when the audit team has
observed and verified the audit evidence and has communicated the audit finding to the auditee. The signature of the auditee does not
indicate acceptance or agreement with the audit finding, but only acknowledgement of receipt.

* ISO 19011:2018 Guidelines for auditing management systems, Clause 6.4.2: Conducting audit activities, Subclause i) and j)

* ISO 9001 Lead Auditor Course Material, Module 5: Conducting an Audit, Slide 19: Audit Team Meeting

* ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 5.4: Audit Team Meeting

* Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 -
Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection 3.2.3: Section 3 - Audit Process, Subsection 3.2.4:
Section 4 - Audit Competencies

Question 4
Question Type: MultipleChoice

Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit
processes.

Options:
A- Audit use of certification marks on marketing materials.

B- Review changes to the QMS since last visit.

C- Confirm effectiveness of internal audit and management review.

D- Complete a full document review of the quality management system.

E- Failing to meet financial responsibilities.

F- Review the status of previously raised findings and audit effectiveness of any outstanding findings.

G- Review the calibration status of the instrumentation.

H- Verify legal compliance.

I- Handling of customer complaints since last visit.

J- Conduct a minimum number of annual surveillance audits during the certification period.

Answer:
A, B, C, F, H, I
Explanation:
The activities that are specifically required by ISO 17021-1 as part of third-party (Certification Body) surveillance audit processes are:

* Option A: Audit use of certification marks on marketing materials. This option is correct because ISO 17021-1:2015 clause 9.6.2.2
requires the certification body to audit the client's use of marks and/or any other reference to certification, as applicable, to ensure
conformity with the certification requirements.

* Option B: Review changes to the QMS since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the
certification body to review any changes affecting the client's quality management system and its ability to continue to fulfil the
requirements of the standard used for certification.

* Option C: Confirm effectiveness of internal audit and management review. This option is correct because ISO 17021-1:2015 clause
9.6.2.2 requires the certification body to confirm the continuing effectiveness of the client's quality management system, including the
effectiveness of the internal audit and management review processes.

* Option F: Review the status of previously raised findings and audit effectiveness of any outstanding findings. This option is correct
because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the status of findings and any corrective actions taken
by the client in response to previous audits, and to verify the effectiveness of the implemented corrective actions.

* Option H: Verify legal compliance. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to
verify the client's compliance with applicable statutory and regulatory requirements related to the scope of certification.

* Option I: Handling of customer complaints since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the
certification body to review the client's handling of customer complaints related to the certified activities since the last audit.
The following options are not correct:

* Option D: Complete a full document review of the quality management system. This option is not correct because ISO 17021-1:2015
clause 9.6.2.2 does not require the certification body to complete a full document review of the quality management system during
surveillance audits. A full document review is only required during the initial certification audit or when there are significant changes to
the quality management system or the certification requirements.

* Option E: Failing to meet financial responsibilities. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2 does not require
the certification body to audit the client's financial responsibilities during surveillance audits. The certification body may have contractual
arrangements with the client regarding the payment of fees, but this is not part of the surveillance audit process.

* Option G: Review the calibration status of the instrumentation. This option is not correct because ISO 17021-1:2015 clause 9.6.2.2
does not require the certification body to review the calibration status of the instrumentation during surveillance audits. The certification
body may audit the client's monitoring and measuring resources as part of the quality management system requirements, but this is not
a specific activity required by ISO 17021-1.

* Option J: Conduct a minimum number of annual surveillance audits during the certification period. This option is not correct because
ISO 17021-1:2015 clause 9.6.2.2 does not require the certification body to conduct a minimum number of annual surveillance audits
during the certification period. The certification body may determine the frequency and duration of surveillance audits based on the risk
and performance of the client, but this is not a specific activity required by ISO 17021-1.

* ISO 17021-1:2015 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1:
Requirements

* ISO 9001 Lead Auditor Course Material, Module 7: Audit Follow-up and Surveillance, Slide 8: Surveillance Audit
 * ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 7.2: Audit Follow-up and Surveillance

* Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 -
Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection 3.2.3: Section 3 - Audit Process, Subsection 3.2.4:
Section 4 - Audit Competencies

Question 5
Question Type: MultipleChoice

An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against
section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:

"The reject rate of the finished product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%."

As the third-party auditor reviewing the internal audit process, you come across the nonconformity. For corrective action, the Quality
Manager conducted an investigation into the reject rates. He reported that the collection baskets for products ejecting from the moulding
machines were not large enough. About 6% of products fell onto the wet and dirty factory floor. Management stated that replacing the
baskets was too costly and ordered the Maintenance Manager to ensure that the floor was kept clean and dry to prevent rejects. The
auditor later checked the factory floor, which was wet and dirty in places.

From the following nonconformities, select three that the auditor could raise to ISO 9001.
Options:
A- 10.3 - The organisation did not continuously improve. Reject rates were unchanged.

B- 7.1.4 - The factory environment is not suitably maintained to prevent dirty products.

C- 7.1.1 - The organisation failed to provide the required resources to prevent nonconforming products.

D- 9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3).

E- 8.6 - Dirty products were released to the customer.

F- 7.3 - Staff were not aware that products were falling onto the factory floor.

G- 10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity.

H- 8.5.1 - Production operations were not properly controlled to avoid reject products.

Answer:
A, B, C

Explanation:
The auditor could raise the following nonconformities to ISO 9001 based on the scenario:

* Option A: 10.3 - The organisation did not continuously improve. Reject rates were unchanged. This option is correct because ISO
9001:2015 clause 10.3 requires the organization to improve the suitability, adequacy and effectiveness of the quality management
system. The organization did not demonstrate any improvement in reducing the reject rate of the finished product, which was a stated
objective of top management. The corrective action taken by the organization was not effective in addressing the root cause of the
problem and preventing its recurrence.

* Option B: 7.1.4 - The factory environment is not suitably maintained to prevent dirty products. This option is correct because ISO
9001:2015 clause 7.1.4 requires the organization to determine, provide and maintain the environment necessary for the operation of its
processes and to achieve conformity of products and services. The organization did not ensure that the factory floor was clean and dry,
which affected the quality of the products and increased the risk of nonconformity.

* Option C: 7.1.1 - The organization failed to provide the required resources to prevent nonconforming products. This option is correct
because ISO 9001:2015 clause 7.1.1 requires the organization to determine and provide the resources needed for the establishment,
implementation, maintenance and continual improvement of the quality management system. The organization did not provide adequate
collection baskets for the products ejecting from the moulding machines, which resulted in products falling onto the factory floor and
becoming nonconforming.

The following options are not correct:

* Option D: 9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3). This option is not correct because ISO 9001:2015
clause 9.2.2 does not specify the requirements for the wording of nonconformities in internal audit reports. The nonconformity (NC 3)
stated by the internal auditor was clear and relevant to the audit criteria and audit evidence. The issue is not with the report, but with the
corrective action taken by the organization.

* Option E: 8.6 - Dirty products were released to the customer. This option is not correct because ISO 9001:2015 clause 8.6 requires the
organization to implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been
met. The scenario does not indicate that the dirty products were released to the customer, but that they were recalled and repaired then
returned to the customers. The issue is not with the release, but with the production process and the environment.
* Option F: 7.3 - Staff were not aware that products were falling onto the factory floor. This option is not correct because ISO 9001:2015
clause 7.3 requires the organization to ensure that the persons doing work under its control are aware of the quality policy, relevant
quality objectives, their contribution to the effectiveness of the quality management system, and the implications of not conforming with
the quality management system requirements. The scenario does not indicate that the staff were not aware of these aspects, but that the
management did not provide adequate resources and environment for the staff to perform their work. The issue is not with the
awareness, but with the management responsibility and resource provision.

* Option G: 10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity. This option is not
correct because ISO 9001:2015 clause 10.2.1 requires the organization to react to the nonconformity and, as applicable, take action to
control and correct it and deal with the consequences. The scenario indicates that the Quality Manager conducted an investigation into
the reject rates and identified the cause of the nonconformity. The issue is not with the investigation, but with the corrective action taken
by the management.

* Option H: 8.5.1 - Production operations were not properly controlled to avoid reject products. This option is not correct because ISO
9001:2015 clause 8.5.1 requires the organization to implement production and service provision under controlled conditions. The
scenario indicates that the production operations were controlled by the moulding machines, which ejected the products into the
collection baskets. The issue is not with the production operations, but with the size of the collection baskets and the condition of the
factory floor.

* ISO 9001:2015 Quality management systems - Requirements

* ISO 9001 Lead Auditor Course Material, Module 6: Reporting Audit Findings, Slide 14: Writing Nonconformity Statements

* ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 6.2: Reporting Audit Findings
 * Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 -
Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection 3.2.3: Section 3 - Audit Process, Subsection 3.2.4:
Section 4 - Audit Competencies

Question 6
Question Type: MultipleChoice

An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against
section 10.3 of ISO 9001 in Report

IA202. The nonconformity (NC 3) stated:

"The reject rate of 'finished' product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%."

Just before the Closing meeting of a third-party audit, the audit team leader is invited to a meeting with the Quality Manager. He tells the
audit team leader that a

member of the audit team was seen taking photographs of the factory on his phone during the day and wants him suspended from the
Closing meeting with any

nonconformities raised by him rescinded. The issue of photographs was not discussed during the opening meeting.

Select the three options for how the audit team leader might deal with this situation.
Options:
A- Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered

B- Delay the Closing meeting until the audit team leader has consulted his audit programme manager at Head Office

C- Advise the Quality Manager that the auditor will be reported to Head Office

D- State that the auditor will take no further part in the audit and all his photographs will be deleted

E- Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting

F- Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to
the Quality Manager once this is done

Answer:
A, D, F

Explanation:
The audit team leader should deal with this situation in a professional and ethical manner, while maintaining the integrity and credibility
of the audit process and the audit findings. The audit team leader should also try to resolve the conflict with the Quality Manager in a
constructive and respectful way, without compromising the audit objectives or the audit team's independence and impartiality. According
to the ISO 9001 Lead Auditor Reference Materials guides and documents, the possible actions that the audit team leader might take are:

* A. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered. This action is
consistent with the principle of evidence-based approach, which states that the audit team should collect and verify information that is
appropriate, sufficient, and reliable to support the audit findings and conclusions. The audit team leader should explain to the Quality
Manager that the nonconformities are not based solely on the photographs, but on other audit evidence that corroborates them. The
audit team leader should also remind the Quality Manager that the nonconformities are subject to review and approval by the
certification body, and that any attempt to influence or interfere with the audit results would be considered a breach of the audit
agreement and the certification rules.

* D. State that the auditor will take no further part in the audit and all his photographs will be deleted. This action is consistent with the
principle of confidentiality, which states that the audit team should exercise discretion in the use and protection of information acquired
during the audit. The audit team leader should acknowledge that the auditor's behavior was inappropriate and unprofessional, and that
he violated the audit rules and the auditee's rights. The audit team leader should apologize for the inconvenience and the discomfort
caused by the auditor, and assure the Quality Manager that the auditor will be removed from the audit team and that his photographs will
be erased from his phone and any other device or media. The audit team leader should also inform the auditor of his misconduct and the
consequences, and report the incident to the audit program manager and the certification body.

* F. Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to
the Quality Manager once this is done. This action is consistent with the principle of communication, which states that the audit team
should exchange information with the auditee in a timely, open, honest, and respectful manner. The audit team leader should express
his concern and his willingness to address the issue with the auditor, and ask for the Quality Manager's patience and cooperation. The
audit team leader should also explain that the audit process is not finished yet, and that the Closing meeting is an opportunity to present
and discuss the audit findings and conclusions, and to seek feedback and clarification from the auditee. The audit team leader should
then speak to the auditor privately, and follow the steps described in action D.

The other options are not appropriate or effective ways to deal with this situation, because they either:

* B. Delay the Closing meeting until the audit team leader has consulted his audit program manager at Head Office. This action would
disrupt the audit schedule and the audit plan, and create unnecessary delays and costs for both the audit team and the auditee. It would
 also show a lack of leadership and decision-making skills from the audit team leader, and undermine his authority and credibility. The
audit team leader should be able to handle the situation on site, and consult his audit program manager only if the situation escalates or
becomes unmanageable.

* C. Advise the Quality Manager that the auditor will be reported to Head Office. This action would escalate the conflict and create a
hostile and defensive atmosphere between the audit team and the auditee. It would also imply that the audit team leader is not capable
or willing to resolve the issue himself, and that he is threatening or punishing the auditee for raising a legitimate concern. The audit team
leader should try to defuse the tension and restore the trust and the rapport with the Quality Manager, and report the auditor to Head
Office only after the audit is completed and the audit report is submitted.

* E. Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting. This
action would not address the root cause of the problem, and would not prevent the auditor from taking more photographs or using them
for other purposes. It would also expose the audit team and the auditee to unnecessary risks and liabilities, and compromise the
confidentiality and the security of the audit information. The audit team leader should delete the photographs as soon as possible, and
not wait until the Closing meeting.

Question 7
Question Type: DragDrop

You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.
You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory
services to customers.

You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?"

TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry."

You: "How is their regulatory competence maintained?"

TD: "They are dedicated individuals with lots of contacts in the sector."

You: "How does the business enable them to maintain their understanding of current regulatory requirements?"

TD: "We leave that up to them."

Question 8
Question Type: DragDrop

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

cosmetics for major retailers.

You are interviewing the Manufacturing Manager (MM).

You: "I would like to begin by looking at the cleaning controls."

MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the

procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document
and records

the time and date alongside."

Question 9
Question Type: DragDrop

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.
The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.

Answer:
Question 10
Question Type: DragDrop

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation offers
warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport
to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization
does not have its own transport vehicles. Stock items are not purchased by the organisation.

You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.
 Answer:

Question 11
Question Type: MultipleChoice

You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing

structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the

adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.

You: "How do you tell when the billet is ready for the rolling stage?"

Operator: "I've done this job for 20 years. I can tell by the bright red colour."

You: "What happens if the colour is wrong?"

Operator: "The billet goes back into the furnace."

You: "Is the pyrometer ever used?"

Operator: "Only in borderline cases."

You continue to interview the operator and find that around 25% of the billets are sent back to the furnace. This includes 80% of the
borderline cases.

Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.

Options:
A- Periodic analysis of the results of temperature checks.

B- Certification of conformance to national standards from the manufacture of the pyrometer.

C- An increase in the use of the pyrometer by operators.

D- Maintenance plan for the furnace.

E- A procedure that provides instruction in taking billet temperature.

F- Planning for monitoring and measuring the billet temperature.

G- A quality objective to achieve lower recycle rates for billets.

H- Annual review records for furnace operators.

Answer:
A, E, F

Explanation:
 According to ISO 9001:2015, clause 9.1.1, the organization is required to determine what needs to be monitored and measured, the
methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results, and when the monitoring and
measuring shall be performed. The organization is also required to retain appropriate documented information as evidence of the results.

Therefore, in the scenario given, the organization should have planned for monitoring and measuring the billet temperature, as it is a
critical factor for the quality of the product and the process. The organization should also have established a procedure that provides
instruction in taking billet temperature, using the pyrometer or other suitable methods, to ensure consistency and accuracy. The
organization should also have performed periodic analysis of the results of temperature checks, to identify trends, problems, and
opportunities for improvement.

Hence, the options that would provide evidence of conformance with clause 9.1.1 of ISO 9001 are A, E, and F, as they are aligned with
the requirements of the clause. The other options are either irrelevant or not directly related to clause 9.1.1, as they do not pertain to the
monitoring and measurement of the billet temperature.

ISO 9001:2015(en), Quality management systems --- Requirements, clause 9.1.1

ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2

ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section ''Learning objectives''

ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6

Question 12
Question Type: MultipleChoice
Takitup is a small fabrication organisation that manufactures steel fencing, stairs and platforms for the construction sector. It has been
certified to ISO 9001 for some time and has appointed a new Quality Manager. The audit plan during a surveillance audit covers the
organisation's improvement actions and the auditor asks to see the most recent management review meeting minutes.

The auditor finds that the management review report records that none of the improvement actions set by the previous review has been
realised for a second time. A new Quality Manager has been brought in at the middle management level to rectify the situation as the
organisation is concerned that it might lose its certification.

Select three options that would provide evidence of conformance with clause 10.3 of ISO 9001.

Options:
A- Outsource more processes to external providers

B- Removing expensive external providers from the database.

C- An increase in the number of quality staff.

D- A quality objective to achieve lower reject rates by quality control.

E- Considering results from the analysis of the effectiveness of corrective actions to determine improvement opportunities.

F- The certification body auditor reporting fewer nonconformities.

G- An enhanced customer satisfaction survey score than in the previous year.

H- Automate the fabrication process to increase profitability.

Answer:
D, E, G
To Get Premium Files for ISO-9001-Lead-Auditor Visit
https://www.p2pexams.com/products/iso-9001-lead-auditor

For More Free Questions Visit

https://www.p2pexams.com/pecb/pdf/iso-9001-lead-auditor