TAKE ISO 9001 ISO-9001-Lead-Auditor PRACTICE QUESTIONS FOR AMAZING RESULTS [Q10-Q33]

TAKE ISO 9001 ISO-9001-Lead-Auditor PRACTICE QUESTIONS FOR AMAZING RESULTS

 PECB ISO-9001-Lead-Auditor Exam Dumps Are Essential To Get Good Marks

NEW QUESTION # 10
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. A quality objective to achieve lower recycle rates for billets.
• B. Periodic analysis of the results of temperature checks.
• C. Annual review records for furnace operators.
• D. A procedure that provides instruction in taking billet temperature.
• E. Certification of conformance to national standards from the manufacture of the pyrometer.
• F. Planning for monitoring and measuring the billet temperature.
• G. An increase in the use of the pyrometer by operators.
• H. Maintenance plan for the furnace.

Answer: B,D,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

NEW QUESTION # 11
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 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. Interview the A2 plant manager, now working in Plant A1
• 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. Visit Plant A2 to interview personnel of company B

Answer: A

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.
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 ...

NEW QUESTION # 12
Match the process descriptions below to the process names:

Answer:

Explanation:

Explanation:
Match the process descriptions below to the process names:
The process by which the accuracy of test equipment is checked against a known standard. = Calibration The process by which a product or service is visually examined to determine conformity to requirements. = Evaluation The process by which data is examined in detail to reach a specific answer or answers. = Analysis The process by which a parameter of a product or service is examined to determine a specific value. = Measurement According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, the definitions of the process names are as follows:
Calibration: operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.
Evaluation: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.
Analysis: detailed examination of the elements or structure of something.
Measurement: process to experimentally obtain one or more quantity values that can reasonably be attributed to a quantity.
Therefore, the process descriptions can be matched to the process names based on these definitions.
References:
ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary

NEW QUESTION # 13
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization manufactures cosmetics for major retailers.
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." Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.

Answer:

Explanation:

Explanation:
Nonconformity report
ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met." Evidence: 40 cleaning records are available for 63 batches.

NEW QUESTION # 14
You are conducting a third-party Stage 1 audit at ABC Ltd, a single-site organisation that manufactures wooden furniture. You interview the Technical Director to learn more about the organisation. The Technical Director explains that they have had a successful year and that obtaining ISO 9001 certification will support the further growth of the business. You ask for an overview of the organisation's structure and its interrelationships with external interested parties.
The Technical Director shows you a document detailing all business processes and interrelationships. You notice in this document that another organisation called Teak Ltd manufactures wooden furniture on behalf of ABC Ltd. The Technical Director confirms this capability has been accounted for in the scope of the quality management system. You learn that the furniture manufactured by Teak Ltd has accounted for 40% of the sales revenue over the previous 12 months.
Which two of the following options best describe how you would plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd?

• A. Verify the quality management system at Teak Ltd by conducting an audit at their site
• B. Verify if Teak Ltd are certified to ISO 9001
• C. Verify Teak Ltd supply arrangements as described in the ABC Ltd quality management system
• D. Verify whether the design processes of Teak Ltd comply with ISO 9001
• E. Verify the controls concerning customer property implemented by Teak Ltd
• F. Verify how ABC Ltd evaluates the performance of Teak Ltd

Answer: C,F

Explanation:
According to ISO 9001:2015, clause 8.4, an organization is required to control the processes, products and services provided by external providers, including those that affect the quality of the organization's own products and services. This includes determining the controls to be applied to the external provision of processes, products and services, as well as the information to be communicated to the external providers. The organization is also required to monitor, measure, and evaluate the performance of the external providers and retain documented information of these activities.
Therefore, in the scenario given, ABC Ltd is responsible for controlling the processes, products and services provided by Teak Ltd, as they affect the quality of ABC Ltd's own products and services. This means that ABC Ltd should have established criteria and methods for evaluating the performance of Teak Ltd, as well as documented information of the results of such evaluation. ABC Ltd should also have defined the supply arrangements with Teak Ltd, including the specifications, requirements, and verification activities related to the products and services provided by Teak Ltd.
Hence, the best options to describe how to plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd are A and D, as they are aligned with the requirements of ISO 9001:2015, clause 8.4.
The other options are either irrelevant or beyond the scope of the audit, as they do not pertain to the control of external provision by ABC Ltd.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 8.4 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.1 and 6.4.2 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

NEW QUESTION # 15
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."

Answer:

Explanation:

Explanation:
A screenshot of a computer Description automatically generated

NEW QUESTION # 16
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.

• A. Re-audit corrective actions taken to correct findings found during the audit.
• B. Audit team complete final version of their individual findings.
• C. Audit team leader completes final report, including individual findings and certification recommendation.
• D. Agree the roles of each audit team member for the closing meeting.
• E. Hold daily audit team meeting to review any timetable issues and potential findings and their impact on the audit for other team members.
• F. Audit team agree final audit outcome recommendation.
• G. Audit team leader informs the individual(s) managing the audit programme that the closing meeting is ready to be held.
• H. Write the audit finding report out when detected and obtain signature of the auditee.
• I. Audit team review any points raised by the auditee nominated representative.
• J. Final audit team meeting to agree findings and categories including clarification of any uncertainties.

Answer: A,B,D,F,I,J

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.
References:
*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

NEW QUESTION # 17
Who would be defined as a witness during a witness audit?
Choose two of the following options:

• A. An auditor
• B. An existing member of the audit team
• C. Someone with a qualification from the certification body
• D. An assessor for the accreditation body

Answer: A,D

Explanation:
Comprehensive and Detailed Explanation: = According to the web search results from my internal tool, a witness audit is a technique used during an accreditation audit, where the accreditation body observes the performance and competence of the certification body auditors in conducting an audit12. A witness audit can also be used by a certification body to monitor and evaluate its own auditors3. During a witness audit, the following roles can be defined:
*An auditor: This is the person who is being witnessed by the accreditation body or the certification body. The auditor is responsible for conducting the audit according to the audit plan, criteria, and standards, and for providing audit evidence and findings123.
*An assessor for the accreditation body: This is the person who witnesses the auditor on behalf of the accreditation body. The assessor is responsible for evaluating the auditor's performance and competence, and for providing feedback and recommendations to the accreditation body123.
The other options are not defined as witnesses during a witness audit, according to the web search results from my internal tool. They are:
*Someone with a qualification from the certification body: This is not a specific role in a witness audit, as anyone who is involved in the audit process should have a qualification from the certification body. Moreover, having a qualification does not necessarily mean that the person is a witness or an auditor4.
*An existing member of the audit team: This is not a specific role in a witness audit, as the audit team consists of the auditors who are conducting the audit, not the ones who are witnessing it. The witness audit is a separate activity from the audit itself, and the witness should not interfere with the audit process or influence the audit outcome123.
Therefore, the correct answer is B and D.
References: 1: DQS Inc. | Witness Audits | Auditor Training 2: Have you ever been involved with a witness audit? - IFSQN 3: Certac - Witness Audit of Certification Bodies 4: ISO 19011:2018 - Guidelines for auditing management systems

NEW QUESTION # 18
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?

• A. Recommend that all personnel should be given urgent in-depth training in the QMS.
• B. Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course.
• C. 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.
• D. Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work.
• E. Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit.
• 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.
References:
*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

NEW QUESTION # 19
An audit team leader arrives at a printing company to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. The Quality Manager wants the ISO
9001 certificate to cover the new contract.
During the audit, a team member found that some print jobs had been rejected by several clients over some months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract.
The auditor finds that the responsibility for checking spelling errors is placed on the printer that sets up the print run.
In line with the policy of the certification body, the audit team raise improvement opportunities in the audit report. Which three of the following options would represent acceptable opportunities for improvement in the report?

• A. A business consultant can be recommended for advice on improving operations.
• B. Operational planning activities may benefit from a clearer risk-based approach.
• C. An intensive training plan that involves all production personnel.
• D. A plan to determine why the errors occur and to prevent them.
• E. The organisation needs to delay its certification to gain more experience of the QMS.
• F. More process time needs to be allocated to the new employees.
• G. The responsibility for checking printing needs to be independent of the operators.
• H. The recruitment process to include spelling tests to filter out unsuitable candidates.

Answer: B,D,G

Explanation:
According to the ISO 9001 Auditing Practices Group Guidance on Improvement Opportunities1, an improvement opportunity is a suggestion made by the auditor for the auditee to consider that, if implemented, may enhance the performance of the QMS. Improvement opportunities are not mandatory, but they should be based on objective evidence and aligned with the audit criteria and objectives. Improvement opportunities should also be realistic, feasible, and beneficial for the auditee. In this case, the evidence statements that represent acceptable improvement opportunities in the report are A, C, and E, because they address the potential causes and effects of the spelling errors in the print run, and propose possible actions that may improve the quality of the products and services, and the effectiveness of the QMS. These options are consistent with the requirements and principles of ISO 9001, such as clause 6.1 on actions to address risks and opportunities, clause 8.1 on operational planning and control, clause 8.5.1 on control of production and service provision, and clause 10.2 on nonconformity and corrective action. The other options are not appropriate improvement opportunities, because they are either irrelevant, unrealistic, or unhelpful for the auditee. For example, option B may contradict the audit objective and scope, option D may imply a lack of auditor competence or impartiality, option F may not address the root cause of the problem, option G may not be applicable or effective, and option H may not be feasible or justified. References: ISO 9001 Auditing Practices Group Guidance on Improvement Opportunities, ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Audit Evidence

NEW QUESTION # 20
In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.

• A. Number of sites to be audited
• B. Scope of the audit
• C. Expectations of the organisation's management
• D. Risk to achieving audit objectives

Answer: C

Explanation:
According to ISO 19011:2018, clause 6.3.2, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the following information1:
*the audit objectives, scope and criteria
*the audit team members and their roles and responsibilities
*the audit schedule, including the date, time and location of each audit activity
*the expected time and duration of meetings and interviews
*the allocation of appropriate resources to critical areas of the audit
*the identification of the audit client and the auditee
*the identification of the guides and observers, if any
*the documents and records to be reviewed before and during the audit
*the audit methods and tools to be used
*the audit language and terminology
*the audit report content, format, distribution and expected completion date
*the risk to achieving audit objectives and the contingency plan, if any Therefore, the issue which is not expected to be included in the audit plan is C, expectations of the organisation's management. This issue is not relevant to the conduct of the audit, as the audit is based on the audit criteria, not on the management's expectations. The management's expectations may be considered during the audit initiation or the audit programme management, but they are not part of the audit plan.
References: ISO 19011:2018(en), Guidelines for auditing management systems, How to create an ISO 9001 internal audit plan - Advisera

NEW QUESTION # 21
Match the process descriptions below to the process names:

Answer:

Explanation:

Explanation:
A white background with black text Description automatically generated

NEW QUESTION # 22
You work as an external quality consultant for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, 'B', to ISO
9001 which provides packaging materials to your organisation. It is 4 pm and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled at 5 pm.
You, as Audit Team Leader, audited top management. You explain to the audit team that you identified two nonconformities:
a. There is no documented information on Top Management Reviews, as required in clause 9.3 of ISO
9001:2015.
b. There is no evidence of Top Management Commitment as required in clause 5.1 of ISO 9001:2015. (e.g., not ensuring the availability of resources to operate the QMS, not ensuring the establishment of objectives, no promotion of improvement, no promotion of the process approach).
All agreed to present these two nonconformities. They went to meet the Top Management of 'B' and noticed that the General Manager and three other managers (Production, Human Resources, and Sales) were present in the meeting room.
Considering the seriousness of the two nonconformities to Top Management, as audit team leader, from the following select the best option:

• A. Present the nonconformities to the managers, inform them that the report will be sent within 10 days, close the meeting and leave the site.
• B. Ask the General Manager to have a private conversation in which you present the nonconformities only to him because of their sensitive nature.
• C. Present the nonconformities to the whole group and analyse with them how to overcome this situation.
• D. Present the nonconformities to the whole group and inform that you will recommend your company to remove them from the approved suppliers list.

Answer: C

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 Event.

NEW QUESTION # 23
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 introduce the audit team to the client.
• C. To learn about the organisation's procurement processes.
• D. To get to know the organisation's customers.

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.
References: 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

NEW QUESTION # 24
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

Answer:

Explanation:

NEW QUESTION # 25
Select which one of the following statements is true.

• A. An audit team can include non-qualified auditors.
• B. A technical expert can replace a qualified auditor on an audit team.
• C. The team leader shall be an auditor that is qualified in the scheme.
• D. Audits leading to auditor qualification are undertaken annually.

Answer: C

Explanation:
According to the ISO 19011:2018 standard, which provides guidelines for auditing management systems, the team leader of an audit team should be an auditor who has demonstrated the competence to manage an audit of the relevant management system scheme. This means that the team leader should have the appropriate knowledge, skills, and experience to plan, conduct, report, and follow-up an audit of the specific management system, such as ISO 9001 for quality management systems. The other options are false because: B. An audit team can include non-qualified auditors, but only as observers or trainees who do not contribute to the audit findings or conclusions. C. A technical expert can assist a qualified auditor on an audit team, but cannot replace them, as a technical expert does not have the competence to perform audits. D. Audits leading to auditor qualification are not undertaken annually, but rather as part of a certification process that involves meeting certain criteria, such as education, work experience, audit experience, and examination. References:
ISO 19011:2018, PECB Certified ISO 9001 Lead Auditor Exam Preparation Guide, ISO 9001:2015 Quality Management Systems Lead Auditor Training Course

NEW QUESTION # 26
Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.

• A. Corrective action
• B. Concession
• C. Preventive action
• D. Correction

Answer: D

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

NEW QUESTION # 27
During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.
You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?" GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, 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 actions to address them?" GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able 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 look for evidence that the actions resulting from the risk assessment had been taken.
• D. I would delay the audit until the return of the technical manager
• 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,C

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

NEW QUESTION # 28
Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.

• A. To facilitate auditing for proof of conformity to the standard.
• B. To safeguard the integrity of the quality management system.
• C. To support the operation of the processes of the quality management system.
• D. To provide confidence in the effectiveness of the quality management system.

Answer: C

Explanation:
Documented information is a means by which an organization demonstrates compliance. It communicates what we do and how we do things, it communicates what happened and what results were achieved. It is, essentially, a tool for communication. ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. The standard states that the organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned. Therefore, the purpose of retaining documented information is to support the operation of the processes of the QMS, not to facilitate auditing, provide confidence or safeguard integrity, which are secondary benefits of documented information.
References: Guidance on the requirements for Documented Information of ISO 9001:2015, ISO 9001:2015 documented information | CQI | IRCA, Documented Information Required by ISO 9001:2015 - 9000 Store

NEW QUESTION # 29
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

• A. Decreased number of management system nonconformities
• B. Increased profits
• C. Enhanced customer satisfaction
• D. Decreased number of warranty claims
• E. Decreased number of nonconforming products in all stages of the manufacturing cycle
• F. Consistently provide products that meet customers' requirements

Answer: C,F

Explanation:
According to the ISO 9001:2015 document, the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015 are:
*the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
*the enhancement of customer satisfaction.
These results are derived from the quality management principles of customer focus and process approach, which are the basis of the ISO 9000 family of standards1. Customer focus means understanding and meeting customer needs and expectations, as well as exceeding them when possible1. Process approach means managing activities as interrelated processes that function as a coherent system, which leads to consistent and predictable results1.
Therefore, the correct answer is C and F.
References: 2: ISO 9001:2015 - Quality management systems - Requirements 1: ISO - Quality management principles

NEW QUESTION # 30
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you conduct a certification audit at Stage 1. When reviewing the quality management system (QMS), you find that the objectives have been defined by an external consultant using those of a competitor, but nothing is documented.
The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost.
Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?

• A. The organisation cannot afford to undertake quality objectives all at once.
• B. Quality objectives are not maintained as documented information.
• C. The consultant has not interpreted ISO 9001 correctly.
• D. Quality objectives were not established in alignment with the organisation's quality policy.
• E. Establishing quality objectives did not include top management.
• F. Quality objectives are not being implemented by the organisations' personnel.

Answer: B,D

Explanation:
According to ISO 9001:2015, clause 6.2.1, the organization is required to establish quality objectives at relevant functions, levels, and processes for the quality management system (QMS). The quality objectives must be consistent with the quality policy, measurable, monitored, communicated, and updated as appropriate.
The organization is also required to maintain documented information on the quality objectives, as per clause
7.5.1.
Therefore, in the scenario given, the quality objectives defined by the external consultant are not in alignment with the organization's quality policy, as they are based on those of a competitor, rather than the organization's own purpose, strategic direction, and customer requirements. This creates a mismatch between the organization's vision and goals, and the quality objectives that are supposed to guide and measure the QMS performance. Moreover, the quality objectives are not maintained as documented information, which makes it difficult to communicate, monitor, and update them, as well as to demonstrate evidence of their implementation and achievement.
Hence, the circumstances in which a nonconformity against clause 6.2 of ISO 9001 could be raised are B and C, as they indicate a failure to comply with the requirements of clause 6.2.1. The other options are either irrelevant or not directly related to clause 6.2, as they do not pertain to the establishment and documentation of quality objectives.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 6.2.1 and 7.5.1 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

NEW QUESTION # 31
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.

• A. Delay the Closing meeting until the audit team leader has consulted his audit programme manager at Head Office
• B. Advise the Quality Manager that the auditor will be reported to Head Office
• C. 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
• D. State that the auditor will take no further part in the audit and all his photographs will be deleted
• E. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered
• F. Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting

Answer: C,D,E

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.
References: ISO 9001:2015, ISO 19011:2018, PECB Certified ISO 9001 Lead Auditor, Common Audit Problems and How to Deal with Them, The Auditor's Guide to Conflict Resolution, Conflict Resolution in your Audit Career, How to Be a Good Auditor as a Team Leader

NEW QUESTION # 32
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.

• A. 10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity.
• B. 7.1.1 - The organisation failed to provide the required resources to prevent nonconforming products.
• C. 7.1.4 - The factory environment is not suitably maintained to prevent dirty products.
• D. 9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3).
• E. 10.3 - The organisation did not continuously improve. Reject rates were unchanged.
• F. 7.3 - Staff were not aware that products were falling onto the factory floor.
• G. 8.5.1 - Production operations were not properly controlled to avoid reject products.
• H. 8.6 - Dirty products were released to the customer.

Answer: B,C,E

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
*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

NEW QUESTION # 33
......

Latest PECB ISO-9001-Lead-Auditor Dumps with Test Engine and PDF (New Questions): https://www.examdumpsvce.com/ISO-9001-Lead-Auditor-valid-exam-dumps.html

Pass Your ISO-9001-Lead-Auditor Exam Easily - Real ISO-9001-Lead-Auditor Practice Dump Updated: https://drive.google.com/open?id=1Q7Fl0MetD3MqRalUQzI9wJw16zQXjA_n