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Select six of the activities that are specifically required by ISO 17021-1 as part third-party(Certification Body) surveillance audit processes.
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.
Answer: A,B,C,F,H,I
Explanation: The activities that are specifically required by ISO 17021-1 as part of thirdparty
•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.
References:
•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
During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals ata major international airport, you interview the CD 9000's General Manager (GM), who wasaccompanied by Jack, the legal complianceexpert. Jack is acting as the guide in the absence of the Technical Manager due to himcontracting COVID-19.You: "What external and internal issues have been identified that could affect CD9000 andits quality management system?"GM: "Jack guided us on this. We identified issues like probable competition of anotherlaboratory organisation in the airport, legalrequirements on COVID-19 continuously changing, the shortage of competent laboratoryanalysists, the epidemic declining soon,shortage of chemicals for the analysis. It was quite a good experience."You: "Did you document these issues?"GM: "No. Jack said that ISO 9001 does not require us to document these issues."You: "How did you determine the risks associated with the issues and did you plan actionsto address them?"GM: "I am not sure. The Technical Manager is responsible for this process. Jack may beable to answer this question in his absence."Select two options for how you would respond to the General Manager's suggestion:
A. I would not accept the legal compliance expert answering the question. B. I would ask to audit the Technical Manager by phone. C. I would delay the audit until the return of the technical manager D. I would look for evidence that the actions resulting from the risk assessment had been taken. E. I would ask for a different guide instead of the legal compliance expert. F. I would ask the consultant to leave the meeting since he is not an employee of the organisation.
Answer: A,D
Explanation: According to clause 4.1 of ISO 9001:2015, the organization should determine
external and internal issues that are relevant to its purpose and its strategic direction and
that affect its ability to achieve the intended results of its quality management system. The
organization should monitor and review these issues and update them as necessary.
Although the standard does not explicitly require documented information of these issues, it
does require documented information as evidence of the implementation of the actions
taken to address risks and opportunities, as per clause 6.1. The organization should also
retain documented information as evidence of the results of the monitoring, measurement,
analysis and evaluation of its QMS, as per clause 9.1. Therefore, the auditor should not
accept the legal compliance expert answering the question, as he is not the person
responsible for the process and may not have the necessary competence or knowledge of
the QMS. The auditor should also look for evidence that the actions resulting from the risk
assessment had been taken, as this is a requirement of the standard and a way to verify
the effectiveness of the QMS. The other options are not appropriate courses of action for
the auditor, because they do not address the audit objective or criteria, or they may
compromise the audit integrity or impartiality. For example, option B may not be feasible or
reliable, as the Technical Manager may not be available or able to provide the necessary
evidence by phone. Option C may cause unnecessary delay and inconvenience for the
audit process and the auditee. Option E may not solve the problem, as the guide is not the
main source of evidence or information for the audit. Option F may be disrespectful or
unprofessional, as the consultant may have a legitimate role or interest in the audit.
References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Context of
the Organization, ISO 9001 Auditing Practices Group Guidance on Audit Evidence
Question # 3
An internal auditor of a manufacturer of polystyrene packaging products for the electronicsindustry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. Thenonconformity (NC 3) stated:"The reject rate of the finished product of 9.7% needs improvement as it doesn't meet thestated objective of top management of 5%."As the third-party auditor reviewing the internal audit process, you come across thenonconformity. For corrective action, the Quality Manager conducted an investigation intothe reject rates. He reported that the collection baskets for products ejecting from themoulding machines were not large enough. About 6% of products fell onto the wet and dirtyfactory floor. Management stated that replacing the baskets was too costly and ordered theMaintenance 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.
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.
References:
•ISO 9001:2015 Quality management systems - Requirements
Noitol is an organisation specialising in the design and production of e-learning trainingmaterials for the insurance market. During an ISO 9001 audit of the developmentdepartment, the auditor asks the Head of Development about the process used forvalidation of the final course design. She states that they usually ask customers to validatethe product with volunteers. She says that the feedback received often leads to keyimprovements.The auditor samples the design records for a recently completed course for the 247Insurance organisation. Design verification was carried out but there was no validationreport. The Head of Development advises that this customer required the product on anurgent basis, so the validation stage was omitted. When asked, the Head estimates thatthis occurs about 50% of the time. She confirms that they always ask for feedback andoften make changes. There is no record of feedback in the design file for the course.The auditor decides to review the training course design process in more depth.Select three options that provide a meaningful audit trail for this process.
A. How are students advised about prior learning requirements? B. How is customer feedback integrated into the course? C. How is the cost of the course calculated? D. What risks and opportunities have been notified to interested parties? E. How is design documentation controlled and managed? F. How is technical content of courses verified as correct? G. How is the tutor trained to deliver the completed course? H. What are the qualifications of the administrative staff?
Answer: B,E,F
Explanation: According to clause 8.3 of ISO 9001:2015, the organization should establish,
implement, and maintain a design and development process that is appropriate to ensure
the subsequent provision of products and services. The design and development process
should include the following activities:
•Determining the requirements for the products and services to be designed and
developed, considering the intended use, the statutory and regulatory requirements, the
customer and other relevant interested parties’ needs and expectations, and the potential
risks and opportunities.
•Defining the design and development objectives, stages, responsibilities, and authorities,
and ensuring the availability of adequate resources and competence.
•Implementing design and development controls, such as reviews, verification, and
validation, to ensure that the design and development outputs meet the design and
development inputs, and to identify and resolve any problems or errors.
•Maintaining documented information on the design and development inputs, outputs, reviews, verification, validation, and changes, and ensuring the traceability and conformity
of the products and services to the requirements.
•Managing the design and development changes, by identifying, reviewing, and controlling
them, and evaluating their effects on the products and services and the QMS.
In this case, the evidence statements that provide a meaningful audit trail for the design
and development process are B, E, and F, because they relate to the design and
development controls, the documented information, and the verification activities that are
required by the standard. These options can help the auditor to assess the effectiveness
and conformity of the design and development process, and to identify any nonconformities
or opportunities for improvement. The other options are not directly related to clause 8.3,
although they may be relevant for other aspects of the QMS, such as clause 7.2 on
competence, clause 7.3 on awareness, clause 7.4 on communication, clause 8.2 on
requirements for products and services, clause 8.4 on externally provided processes,
products, and services, and clause 8.7 on control of nonconforming outputs. References:
ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Design and
Development, ISO 9001 Clause 8.3 Design and development of products and serv
Question # 5
You work for organisation A. You are asked to lead an internal audit of A's qualitymanagement system. It has a head office in Plant A1 and a second Plant A2 nearby. Dueto the COVID-19 pandemic, production in A2 was discontinued and it was rented to alogistics organisation B, not 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 internalaudit 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, 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.
References: 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 …
Question # 6
Which of the following two documents does an auditor need to prepare and complete priorto the on-site audit?
A. Audit Report B. Audit Plan C. Procedures D. Checklist / Prompts E. Risk Matrices F. Findings
Answer: B,D
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.
References: ISO 19011:2018(en), Guidelines for auditing management system
Question # 7
Select the term which best describes the quality management system process of modifyinga non-conforming product to bring it within acceptance criteria.
A. Concession B. Correction C. Corrective action D. Preventive action
Answer: B
Explanation: According to the ISO 9000:2015 - Quality management systems —
Fundamentals and vocabulary, correction is defined as “action to eliminate a detected
nonconformity”. A nonconformity is defined as “non-fulfilment of a requirement”. Therefore,
the process of modifying a non-conforming product to bring it within acceptance criteria is a
correction, as it eliminates the non-fulfilment of the product specification. The other options
are not correct, as they have different definitions and purposes:
•Concession: permission to release or use a nonconforming product, service or process
•Corrective action: action to eliminate the cause of a nonconformity and to prevent
recurrence
•Preventive action: action to eliminate the cause of a potential nonconformity or other
undesirable potential situation
References: ISO 9000:2015 - Quality management systems — Fundamentals and
vocabulary, ISO 9001 nonconforming product: How to understand dispositions - Advisera
Question # 8
You are an auditor from a construction organisation who is conducting a second party auditto ISO 9001 at a steel rolling mill producingstructural steelwork. When auditing the rolling process, you find that the operator who isunloading the furnace does not use theadjacent infrared pyrometer to measure the appropriate product temperature in readinessfor 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 backto the furnace. This includes 80% of the borderline cases.Select three options that would provide evidence of conformance with clause 9.1.1 of ISO9001.
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.
References:
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 # 9
Select six tasks you would expect to be completed at the audit team meeting of a thirdpartyaudit team leader and his audit team in preparation for a Closing meeting for a fourdayinitial certification audit.
A. Audit team leader informs the individual(s) managing the audit programme that theclosing meeting is ready to be held. B. Hold daily audit team meeting to review any timetable issues and potential findings andtheir impact on the audit for other team members. C. Final audit team meeting to agree findings and categories including clarification of anyuncertainties. 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 certificationrecommendation. H. Audit team complete final version of their individual findings. I. Re-audit corrective actions taken to correct findings found during the audit.
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 reaudit
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:
Question # 10
According to ISO 19011, what two activities take place during the conduct of a audit followup?
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: A,B
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. References:
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”
Question # 11
Which two of the following are the key expected results of a quality management systemthat conforms to the requirements of ISO 9001:2015?
A. Consistently provide products that meet customers' requirements B. Decreased number of management system nonconformities C. Decreased number of warranty claims D. Decreased number of nonconforming products in all stages of the manufacturing cycle E. Enhanced customer satisfaction F. Increased profits
Answer: A,E
Explanation: The key expected results of a quality management system that conforms to
the requirements of ISO 9001:2015 are stated in clause 0.1 of the standard, which says:
“The adoption of a quality management system is a strategic decision for an organization
that can help to improve its overall performance and provide a sound basis for sustainable
development initiatives. The potential benefits to an organization of implementing a quality
management system based on this International Standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory
requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing
risks and opportunities associated with its context and objectives; d) the ability to
demonstrate conformity to specified quality management system requirements.” Therefore,
the two options that best match these benefits are A and E, as they directly relate to
providing products and services that meet customer requirements and enhancing customer
satisfaction. The other options are not explicitly mentioned as key expected results,
although they may be possible outcomes of implementing a quality management system.
References: ISO 9001:2015 - Quality management systems — Requirements, Key
Elements of an ISO 9001:2015 Quality Management System, What is ISO 9001 2015 as a
Quality Management Systems?
Question # 12
You work as an external quality consultant for an organisation, 'A', which providespackaged food to the public. You are asked to lead a team (you as the leader and twoother auditors) to audit a supplier, 'B', to ISO 9001 which provides packaging materials toyour organisation. It is 4 pm and the audit is close to an end; you are having an internalmeeting with the team to decide what will be presented to the auditee during the Closingmeeting. The Closing meeting was scheduled at 5 pm.You, as Audit Team Leader, audited top management. You explain to the audit team thatyou identified two nonconformities:a. There is no documented information on Top Management Reviews, as required inclause 9.3 of ISO 9001:2015.b. There is no evidence of Top Management Commitment as required in clause 5.1 of ISO9001:2015. (e.g., not ensuring the availability of resourcesto operate the QMS, not ensuring the establishment of objectives, no promotion ofimprovement, no promotion of the process approach).All agreed to present these two nonconformities. They went to meet the Top Managementof 'B' and noticed that the General Manager and three other managers (Production, HumanResources, and Sales) were present in the meeting room.Considering the seriousness of the two nonconformities to Top Management, as audit teamleader, from the following select the best option:
A. Present the nonconformities to the whole group and inform that you will recommendyour company to remove them from the approved suppliers list. B. Present the nonconformities to the managers, inform them that the report will be sentwithin 10 days, close the meeting and leave the site. C. Ask the General Manager to have a private conversation in which you present thenonconformities only to him because of their sensitive nature. D. Present the nonconformities to the whole group and analyse with them how to overcomethis situation.
Answer: D
Explanation: According to the guidance on conducting the audit closing meeting1, the
audit team leader should provide a summary of the audit findings and conclusions, invite
discussions, and agree on timelines for any corrective actions. The audit team leader
should also be respectful, constructive, and objective when presenting the nonconformities,
and avoid any personal or emotional comments. The audit team leader should also
consider the impact of the disruptive event (such as the Covid-19 pandemic) on the auditee’s context, interested parties, and risks2, and acknowledge any good practices or
improvements observed during the audit. Therefore, option D is the best option, as it
follows the best practices for the closing meeting and allows the auditee to understand the
nonconformities and their implications, and to participate in the analysis and resolution of
the issues. Option A is not correct, as it is not respectful, constructive, or objective, and it
does not invite any discussion or feedback from the auditee. It also assumes that the audit
team leader has the authority to recommend the removal of the supplier from the approved
list, which may not be the case. Option B is not correct, as it does not provide enough
information or explanation to the auditee, and it does not allow any discussion or feedback
from the auditee. It also does not follow the best practices for the closing meeting, such as
providing a summary of the audit, acknowledging any good practices, and agreeing on
timelines for corrective actions. Option C is not correct, as it does not involve the other
managers who are responsible for the functions or processes that were audited, and who
may have valuable input or information to share. It also does not follow the best practices
for the closing meeting, such as providing a summary of the audit, inviting discussions, and
agreeing on timelines for corrective actions. References: 1: Conducting the Audit Closing
Meeting: Sharing the Results2: Auditing ISO 9001:2015 in the Context of a Disruptive
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