ISO-9001 Lead Auditor Exam Dumps Questions

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Full version: ISO-9001 Lead Auditor Exam Dumps Questions
1.DRAG DROP
You are carrying out an annual audit at an organisation that offers home security services. You are
interviewing the Quality Manager (QM)
You: "Would you tell me about your management review process?"
QM: "The senior management team plans to review the management system every six months. The
review follows a set agenda and records are maintained."
You: "May I see the records from the last two management reviews?"
Narrative: The Quality Manager gives you the latest record, which shows the last management review
took place nine months ago.
The Quality Manager then gives you the previous management review record, which took place one
year before the latest review.
You: "Are there any other review reports in the last two years?
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QM: "No, these are the only ones."
You decide to raise a nonconformity.
To complete the nonconformity report click on the blank section you want to complete 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.
Answer:
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2.Which one of the following options best describes the purpose of a Stage 1 third-party audit?
A. To determine the auditees understanding of ISO 9001.
B. To get to know the organisation's customers.
C. To learn about the organisation's procurement processes.
D. To introduce the audit team to the client.
Answer: A
Explanation:
The purpose of a Stage 1 third-party audit is to determine an organization’s readiness for their Stage
2 Certification Audit. During the Stage 1, the auditor will review the organization’s management
system documented information, evaluate the site-specific conditions, and have discussions with
personnel. The objective is to assess the alignment of the organization’s design with ISO 9001
requirements and to identify any areas of concern that could be classified as a nonconformance
during the Stage 2 Audit. The auditor will also use the Stage 1 Audit to complete Stage 2 Audit
planning, including a review of the allocation of resources and details for the next phase of the audit.
Therefore, the option that best describes the purpose of a Stage 1 third-party audit is A, to determine
the auditees understanding of ISO 9001.
The other options are not correct, as they are not the main focus of a Stage 1 audit:
• B. To get to know the organization’s customers: This is not the purpose of a Stage 1 audit, as the
auditor is not interested in the specific details of the organization’s customers, but rather in the
organization’s ability to meet customer and applicable statutory and regulatory requirements.
• C. To learn about the organization’s procurement processes: This is not the purpose of a Stage 1
audit, as the auditor is not interested in the specific details of the organization’s procurement
processes, but rather in the organization’s ability to control externally provided processes, products
and services.
• D. To introduce the audit team to the client: This is not the purpose of a Stage 1 audit, as the auditor
is not there to make introductions, but rather to conduct a preliminary examination of the
organization’s compliance with ISO 9001 standards.
Reference: What is the difference between Stage 1 and Stage 2 Audits? - ISO Update, The ISO 9001
Audit Process Explained | ISO Explained, What is an ISO Stage 2 Audit? ? RiskOptics - Reciprocity
3.Which of the following two documents does an auditor need to prepare and complete prior to the on-
site audit?
A. Audit Report
B. Audit Plan
C. Procedures
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D. Checklist / Prompts
E. Risk Matrices
F. Findings
Answer: BD
Explanation:
According to ISO 19011:2018, clause 6.3, the audit plan is a document that provides the basis for
agreement regarding the conduct of the audit. The audit plan should include the information listed in
my previous response, such as the audit objectives, scope, criteria, schedule, team, methods, report,
etc. The audit plan should be prepared and completed prior to the on-site audit, and should be
communicated to the audit team and the auditee1.
According to ISO 19011:2018, clause 6.4.3, the checklist / prompts are documents that list the
questions or topics that need to be covered during an audit. The checklist / prompts can help the
auditor to collect and verify information relevant to the audit criteria, and to ensure the consistency
and completeness of the audit. The checklist / prompts should be prepared and completed prior to the
on-site audit, and should be based on the audit plan and the audit scope and objectives1. Therefore,
the two documents that an auditor needs to prepare and complete prior to the on-site audit are B and
D, as they are essential for planning and conducting the audit. The other options are not correct, as
they are either prepared or completed after the on-site audit, or not required by the standard:
• A. Audit Report: The audit report is a document that provides a complete, accurate, concise, and
clear record of the audit. The audit report should include the information listed in my previous
response, such as the audit objectives, scope, criteria, findings, conclusions, etc. The audit report
should be prepared and completed after the on-site audit, and should be distributed to the audit client
and the auditee1.
• C. Procedures: Procedures are documents that specify the way activities are to be performed.
Procedures may be part of the audit criteria, if they are part of the organization’s management
system, or part of the audit programme, if they are part of the certification body’s or registrar’s
requirements. Procedures are not prepared or completed by the auditor prior to the on-site audit, but
rather reviewed or followed by the auditor during the audit1.
• E. Risk Matrices: Risk matrices are tools that help to assess and prioritize the risks and
opportunities associated with the audit programme or the audit. Risk matrices may be part of the audit
programme management, if they are used to determine and evaluate the audit programme risks and
opportunities, or part of the audit preparation, if they are used to determine and evaluate the audit
risks and opportunities. Risk matrices are not prepared or completed by the auditor prior to the on-site
audit, but rather used or updated by the auditor during the audit programme management or the audit
preparation1.
• F. Findings: Findings are the results of the evaluation of the collected audit evidence against the
audit criteria. Findings can indicate either conformity or nonconformity, as well as positive aspects or
opportunities for improvement. Findings are not prepared or completed by the auditor prior to the on-
site audit, but rather generated and recorded by the auditor during the audit activities1.
Reference: ISO 19011:2018(en), Guidelines for auditing management systems
4. Select all that apply: Which of the following are benefits of applying the process approach?
A. Enhanced ability to focus effort on process effectiveness and efficiency
B. Increased accountability through defined roles andresponsibilities
C. Improved process outputs by eliminating the need for management review
D. Continual improvement through effective use of resources
E. All of the above except C
Answer: E
5.Which two of the following aspects of a quality management system must the organisation
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continually improve?
A. Adaptability
B. Applicability
C. Effectiveness
D. Efficiency
E. Responsiveness
F. Suitability
Answer: CD
Explanation:
Question no: 5 Verified Answer = C. Effectiveness and D. Efficiency
Comprehensive and Detailed = Effectiveness and efficiency are two of the seven quality management
principles that form the basis of ISO 9001. According to ISO 9000:2015, clause 3.2.14, effectiveness
is the “extent to which planned activities are realized and planned results achieved”. According to
clause 3.2.15, efficiency is the “relationship between the result achieved and the resources used”. In
other words, effectiveness is about doing the right things, and efficiency is about doing things right.
ISO 9001:2015, clause 10.3, requires the organisation to continually improve the suitability,
adequacy, and effectiveness of the quality management system. This implies that the organisation
should also improve the efficiency of its processes, products, and services, as efficiency is a key
factor in achieving customer satisfaction, reducing costs, and increasing profitability. Some of the
ways that the organisation can improve its effectiveness and efficiency are: - Establishing SMART
(specific, measurable, achievable, relevant, and time-bound) objectives and monitoring their progress
- Implementing the Plan-Do-Check-Act (PDCA) cycle to plan, execute, evaluate, and improve its
activities - Applying the process approach to manage its interrelated processes as a coherent system
- Using evidence-based decision making to analyse data and information and take appropriate
actions - Seeking feedback from customers and other interested parties and addressing their needs
and expectations - Identifying and addressing risks and opportunities that can affect its performance
and conformity - Encouraging innovation and creativity to find new and better ways of doing things -
Benchmarking its performance against best practices and industry standards - Providing training and
development opportunities for its personnel to enhance their competence and motivation 12345
Reference:
1: ISO 9000:2015 - Quality management systems ? Fundamentals and vocabulary
2: ISO 9001:2015 - Quality management systems ? Requirements
3: ISO 9001 Explained: A Comprehensive Guide to Quality Management Systems - ISMS.online
4: The 7 Principles of ISO 9001 | ISO Standards Explained
5: Key Elements of an ISO 9001:2015 Quality Management System
6.You have been nominated audit team leader of a third-party audit.
Which of the following could be the two most relevant objectives of this audit?
A. Evaluate the satisfaction interested parties
B. Evaluate the effectiveness of the management system
C. Identify the need of resources
D. Evaluate the capability of the management system to establish and achieve objectives
E. Identify opportunities for improvement
F. Evaluate the benefits obtained since the implementation of the management system
Answer: BD
Explanation:
Evaluate the effectiveness of the management system: This objective involves verifying that the
quality management system meets the requirements of a specific standard, such as ISO 9001:2015,
and that it achieves the intended results and outcomes. The audit team will collect and analyse audit
evidence to determine the degree of conformity and performance of the quality management
system23.
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• Evaluate the capability of the management system to establish and achieve objectives: This
objective involves verifying that the quality management system supports the strategic direction and
policies of the organization, and that it addresses the needs and expectations of the interested
parties. The audit team will assess the suitability, adequacy, and alignment of the quality
management system objectives, and the effectiveness of the planning and implementation processes
to achieve them23.
The other options are not the most relevant objectives of a third-party audit, according to the web
search results from my internal tool. They may be related to other aspects or types of audits, but they
are not the focus of a third-party audit.
Therefore, the correct answer is B and D.
Reference:
1: Safeguarding Your Business: The Power of Third-Party Security Audits
2: ISO 19011:2018 - Guidelines for auditing management systems
3: Third Party Audit C QMSGurus.com
7.According to ISO 19011, what two activities take place during the conduct of a audit follow-up?
A. Verify the effectiveness of the implemented corrective actions
B. Verify corrections taken to fix the reported non-conformities
C. Verify legal compliance
D. Plan the next audit
E. Determine feasibility of the audit
F. Assign roles and responsibilities of observers
Answer: AB
Explanation:
According to ISO 19011:2018, clause 6.7, the audit follow-up is the process of verifying the
completion and effectiveness of corrective actions taken by the auditee as a result of an audit. The
audit follow-up can include two main activities:
Verifying the effectiveness of the implemented corrective actions: this means checking whether the
actions taken by the auditee have addressed the root causes of the nonconformities and prevented
their recurrence or occurrence in other areas. The verification can be done by reviewing documents,
records, data, or other evidence provided by the auditee, or by conducting a follow-up audit on site or
remotely.
Verifying corrections taken to fix the reported non-conformities: this means checking whether the
auditee has corrected the nonconformities identified during the audit and eliminated their immediate
effects. The verification can be done by reviewing documents, records, data, or other evidence
provided by the auditee, or by conducting a follow-up audit on site or remotely.
The audit follow-up can be conducted as a separate audit or as part of a subsequent audit, depending
on the audit programme, the audit objectives, the audit criteria, the audit scope, the audit risks, and
the audit findings. The audit follow-up should be planned and conducted in accordance with the same
principles and processes as the initial audit, and the results should be documented and reported
accordingly.
Reference:
ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.7
ISO 19011 Management Systems Audit Checklist | Process Street, task 6.7.1 and 6.7.2
Conducting the Audit Follow-Up: When to Verify - The Auditor, section “Conducting the audit follow-
up”
8.You work for organisation A. You are asked to lead an internal audit of A's quality management
system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19
pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not
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related to A. There are no A employees working in A2. Organisation A expects to reassume
production in A2 as soon as possible.
Which of the following actions would you consider appropriate when planning the internal audit of A's
quality management system?
A. Visit Plant A2 to interview personnel of company B
B. Visit Plant A2 to interview B's quality manager
C. Visit Plant A2 to interview A's security personnel and B's maintenance department
D. Interview the A2 plant manager, now working in Plant A1
Answer: D
Explanation:
In this scenario, the organisation A has two plants, A1 and A2, but the production in A2 was
discontinued due to the COVID-19 pandemic and the plant was rented to another organisation B.
There are no A employees working in A2, and the organisation A expects to reassume production in
A2 as soon as possible.
Therefore,the appropriate action to plan the internal audit of A’s quality management system is:
• Interview the A2 plant manager, now working in Plant A1: This action involves interviewing the
person who is responsible for the management and operation of the plant A2, and who is currently
working in the plant A1. The interview should aim to gather information about the status and condition
of the plant A2, the impact of the COVID-19 pandemic on the quality management system, the
arrangements and agreements with the organisation B, and the plans and actions to resume
production in the plant A25. This action is relevant and necessary for the internal audit, as it can help
to assess the readiness and effectiveness of the quality management system, and to identify any
gaps or nonconformities that need to be addressed.
The other options are not appropriate actions to plan the internal audit of A’s quality management
system, according to the web search results from my internal tool.
They are:
• Visit Plant A2 to interview personnel of company B: This action involves visiting the plant A2 and
interviewing the personnel of the organisation B, who are not related to the organisation A and who
are not part of the quality management system. This action is irrelevant and unnecessary for the
internal audit, as it can not provide any evidence or information about the conformity and
improvement of the quality management system of the organisation A5.
• Visit Plant A2 to interview B’s quality manager: This action involves visiting the plant A2 and
interviewing the quality manager of the organisation B, who is not related to the organisation A and
who is not part of the quality management system. This action is irrelevant and unnecessary for the
internal audit, as it can not provide any evidence or information about the conformity and
improvement of the quality management system of the organisation A5.
• Visit Plant A2 to interview A’s security personnel and B’s maintenance department: This action
involves visiting the plant A2 and interviewing the security personnel of the organisation A and the
maintenance department of the organisation B, who are not directly involved in the quality
management system. This action is irrelevant and unnecessary for the internal audit, as it can not
provide any evidence or information about the conformity and improvement of the quality
management system of the organisation A5.
Therefore, the correct answer is D.
Reference:
1: Quality audit - Wikipedia
2: A step-by-step guide to internal quality audits
3: ISO 9001:2015 - Quality management systems ? Requirements
4: ISO 19011:2018 - Guidelines for auditing management systems
5: Audit Process | Flowchart | Summary - Accountinguide: What are the Stages of the Auditing
Process & Why it is Important …
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9.DRAG DROP
You, as auditor, are in dialogue with the quality lead and managing director of a small business that
supplies specialist laboratory equipment and furniture.
You: "I'd like to look at how you manage change in the organisation.
What changes have you made as a business, say, over the last 12 months?"
Auditee: "We have made some strategic changes, the main one being that we no longer manufacture
our
own products in house."
You: "That sounds like quite a significant change.
What has been the impact of that?"
Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have
outsourced manufacture of our own brand products to one of our suppliers. Unfortunately, we had to
make six members of our staff redundant. This represents about 20% of our workforce, so this has
been quite a challenging time."
You: "I'm sure.
What were the reasons for making the change?"
Auditee: "Our manufacturing section was a small operation, and we struggled to cope with
fluctuations in demand. During busy periods, we found it hard to meet lead times, and in quiet periods
we had staff with little to do. This was having an impact on customer satisfaction and meant we had to
charge premium prices that made our product uncompetitive."
You: "How did you go about the change?"
In relation to the auditor's question about how the change was managed, the auditee mentions the
steps listed below. Match the ISO 9001 clauses to the steps.
To complete the table, click on the blank section you want to complete so it is highlighted in red and
then click on the ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show
which step the requirement applies to.
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Answer:
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Explanation:
We identified risks and opportunities and fed these into our risk management processes. = 6.1
We found a suitable supplier. = 8.4
We monitored customer feedback and noticed an increase in negative feedback about lead times. =
9.1.2
We put together a plan for implementation. = 6.3
We monitored the performance of the new supplier. = 8.4.2
We noticed that productivity targets were being missed. = 9.1.1
We communicated the plan internally. = 7.4
We looked at the data at the management review and decided we needed to do something different.
= 9.3.2
We reorganised the staffing and implemented redundancies. = 7.1.2
We set an objective to effectively implement the transition and outsource manufacturing. = 6.2.1
10.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.
A. Outsource more processes to external providers
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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: DEG
11. Choose the correct statements about the scope of the QMS in ISO 9001:2015. (Select two)
A. It should include requirements for product services
B. It must include outsourced processes
C. It must be available as documented information
D. It should be reviewed annually
Answer: A, C
12.DRAG DROP
Select the words that best complete the sentence:
To complete the sentence with the best word(s), click on the blank section you want to complete so it
is highlighted in red and then click on the applicable text from the option(s) below. Alternatively, drag
and drop the option(s) to the appropriate blank section.
Answer:
Explanation:
According to the ISO 19011:2018 document, the audit plan should provide the basis for agreement
regarding the conduct and scheduling of the audit activities. The amount of detail provided in the audit
plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit
objectives1. The scope of the audit refers to the extent and boundaries of the audit, such as the audit
criteria, the audit objectives, the organizational and functional units, and the processes to be
audited1. Thecomplexity of the audit refers to the degree of difficulty or intricacy of the audit, such as
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the number and diversity of the auditees, the audit criteria, the audit methods, and the audit team
composition2. The risk of not achieving the audit objectives refers to the possibility that the audit may
fail to provide reliable and sufficient audit evidence to support the audit conclusions and report1.
Therefore, the complete sentence is:
In the context of a third-party audit, the amount of detail provided in the audit plan should reflect the
scope and complexity of the audit, as well as the risk of not achieving the audit objectives.
Reference:
1: ISO 19011:2018 - Guidelines for auditing management systems
2: Audit Complexity - an overview | ScienceDirect Topics
13.Which two of the following should be included in an audit plan?
A. List of findings from the last audit
B. Name of the auditee general manager
C. Signature of Certification Body Technical Reviewer
D. Sequence and timings of audit activities
E. Date of next audit
F. Name of auditees and auditors
Answer: DF
Explanation:
According to ISO 19011:2018, clause 6.3.2, an audit plan should include the following information:
The audit objectives, scope, and criteria
The audit team members and their roles and responsibilities
The audit schedule, including the sequence and timings of audit activities, such as opening meeting,
document review, interviews, observations, closing meeting, etc. The expected time and duration of
each audit activity and location
The name and contact details of the auditee’s representative and other relevant parties The
allocation of appropriate resources to support the audit activities
The audit methods and techniques to be used, such as interviews, observations, sampling, etc.
The audit documents and records to be prepared and retained
The audit language and communication methods
The audit risks and opportunities and how to address them
The audit follow-up arrangements, if applicable
Therefore, the correct answer is D and F, as they are essential elements of an audit plan. The other
options are either irrelevant or optional for an audit plan.
Reference:
ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.2
ISO 19011: Guidelines for Auditing Management Systems | ASQ, section “Making audit
arrangements”
ISO 19011 Management Systems Audit Checklist | Process Street, task 6.3.2
14.During a Stage 1 audit, the Quality Manager asks that the audit includes coverage of a new work
area they have expanded into since the application was made.
Which of the following two actions should the auditor take?
A. Advise the Quality Manager that an extension of the scope is possible but will have to go through
established procedures.
B. Advise the Quality Manager that the audit scope has been set and the audit will proceed as
planned.
C. Advise the Quality Manager that, within the existing scope, the new work area can be included
without any problem.
D. Determine whether the Quality Management System covers the new work area and, if so, proceed
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with the audit.
E. Suggest that she will advise the programme manager that the audit scope should be revised to
include the new work area.
Suggest that the Quality Manager cancels the audit contract and reapplies for the new situation.
Answer: AE
Explanation:
Question no: 14 Verified Answer
A) Advise the Quality Manager that an extension of the scope is possible but will have to go through
established procedures. And E. Suggest that she will advise the programme manager that the audit
scope should be revised to include the new work area. Comprehensive But Short = A Stage 1 audit is
a preliminary assessment to evaluate the readiness of the organisation for the Stage 2 certification
audit. The audit scope is defined by the audit client and the certification body based on the application
and the contract. If the organisation wants to include a new work area that was not part of the original
scope, the auditor should advise the Quality Manager that an extension of the scope is possible but
will have to go through established procedures, such as submitting a formal request, providing
relevant information, and paying additional fees. The auditor should also suggest that the Quality
Manager will advise the programme manager, who is responsible for managing the audit programme,
that the audit scope should be revised to include the new work area. The programme manager will
then decide whether to approve or reject the request, and communicate the decision to the auditor
and the Quality Manager. The auditor should not proceed with the audit of the new work area without
the approval of the programme manager and the confirmation of the audit scope.
1234
Reference:
1: ISO 19011:2018 - Guidelines for auditing management systems
2: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified
3: What is the difference between Stage 1 and Stage 2 Audits? - ISO Update
4: Getting Certified to ISO 9001 - the Stage 1 Audit
15.A Health Trust has contracted with Servitup, a catering services organisation that has been
certified to ISO 9001 for one year. It provides services to 10 small rural hospitals in remote locations
involving the purchase and storage of dry goods and fresh produce, preparing meals, and loading
heated
trolleys for Ward Service by hospital staff. You, as auditor, are conducting the first surveillance audit
at one site with the Deputy Catering Manager (DCM).
DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are
really short of staff."
You: "I see. It really shouldn't affect the QMS so the audit can progress as normal."
DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is."
You: "OK, let's start with the Quality Policy.
What are the main issues for the QMS here?"
DCM: "Give me a minute. I need to look at the Quality Policy on the noticeboard in his office."
As the audit progresses, it is clear that the DCM has a very low knowledge of the QMS. He
continually has to look up the answers to your questions or ask staff members about their processes.
You decide to raise a nonconformity.
Select one of the following options that best describes the nonconformity.
A. As a member of the management team, the Deputy Catering Manager is not sufficiently aware of
the QMS.
B. The Deputy Catering Manager is not competent to manage the QMS.
C. The effectiveness of the QMS depends on the Catering Manager being present on site.
D. The Quality Policy only exists as a document in the Catering Manager's office.
Answer: A
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Explanation:
16.Which two of the following aspects of a quality management system must the organisation
continually improve?
A. Suitability
B. Adaptability
C. Effectiveness
D. Responsiveness
E. Efficiency
F. Applicability
Answer: CE
Explanation:
According to the ISO 9001:2015 document, the organisation must continually improve the suitability,
adequacy, and effectiveness of the quality management system1. However, among the six options
given, only effectiveness is directly mentioned as an aspect of the quality management system that
must be continually improved. Therefore, C is one of the correct answers.
Efficiency, on the other hand, is not explicitly stated as an aspect of the quality management system
that must be continually improved, but it is implied by the quality management principle of
improvement, which states that successful organisations have an ongoing focus on improvement2.
One of the key benefits of applying this principle is improving operational effectiveness and
efficiency2. Therefore, E is another correct answer.
Suitability, adaptability, responsiveness, and applicability are not aspects of the quality management
system that must be continually improved, according to the ISO 9001:2015document. They may be
related to the quality management system, but they are not the focus of continual improvement.
Therefore, the correct answer is C and E.
Reference: 1: ISO 9001:2015 - Quality management systems ? Requirements 2: ISO - Quality
management principles
17.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?
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
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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.
Reference:
• 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
18.An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering
organisation which manufactures sacrificial anodes for the oil and gas industry in marine
environments. These are aluminium products designed to prevent corrosion of submerged steel
structures. As one of
the auditors, you find that the organisation has shipped anodes for Project DK in the Gulf of Mexico
before the galvanic efficiency test results for the anodes have been fully analysed and reported as
required by the customer. The Quality Manager explains that the Managing Director authorised the
release of the anodes to avoid late delivery as penalties would be imposed. The customer was not
informed since the tests rarely fall below the required efficiency. You raise a nonconformity against
clause 8.6 of ISO 9001.
During the audit team meeting in preparation for the Closing meeting, the second auditor disagreed
with the clause of ISO 9001 selected for the above nonconformity. He thinks it should be clause 9.1.1.
Choose three options for how the audit team leader should best respond to the situation:
A. The audit team leader will refer to the quality manager to determine which clause they agree with.
B. Advise that he will think about the clause and announce his decision during the Closing meeting.
C. Immediately agree with the second auditor that clause 9.1.1 would be better.
D. Immediately overule the objection of the second auditor with no discussion of the clause.
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E. Invite you and the second auditor to fully explain your point of view and then decide which clause
to select.
F. Review the evidence with you and the second auditor, and then decide which clause of ISO 9001
would best apply.
G. Suggest that neither clause is accurate and instead propose clause 9.1.3 as the best one for the
nonconformity.
H. Try to obtain a consensus between you and the second auditor after a discussion of the different
opinions.
Answer: EFH
19.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.
A. Periodic analysis of the results of temperature checks.
B. Certification of conformance to national standardsfrom 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: AEF
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.
Reference:
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”
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ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6
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