ISO-9001-Lead-Auditor QMS ISO 9001:2015 Lead Auditor Exam Question and Answers

Understanding Clause 6.2 of ISO 9001:2015:Clause 6.2 (Quality Objectives and Planning to Achieve Them) specifies that organizations must:

Establish measurable and relevant quality objectives consistent with the quality policy (Clause 6.2.1).

Include objectives applicable to product/service conformity and customer satisfaction.

Document these objectives and their planning as documented information (Clause 6.2.1 & 6.2.2).

Plan how to achieve the objectives, including defining actions, resources, responsibilities, timelines, and methods for evaluation.

Analysis of Options:

A. Quality objectives are not being implemented by the organisation's personnel:Incorrect. While implementation is critical, this relates more to operational aspects rather than the direct requirements of Clause 6.2. Implementation issues would typically raise concerns under Clause 9.1 (Performance Evaluation).

B. The consultant has not interpreted ISO 9001 correctly:Incorrect. The consultant's interpretation of ISO 9001 is irrelevant in terms of Clause 6.2 compliance. The focus is on whether the organization aligns with the requirements, not the consultant's role.

C. Establishing quality objectives did not include top management:Incorrect. While top management involvement is vital for QMS effectiveness (Clause 5.1), this is not a direct requirement of Clause 6.2. Top management alignment is implied but not explicitly mandated for establishing quality objectives.

D. Quality objectives were not established in alignment with the organisation's quality policy:Correct. Clause 6.2.1 requires that quality objectives be consistent with the organization’s quality policy, ensuring they reflect its purpose, strategic direction, and commitment to continual improvement. Misalignment would constitute a nonconformity.

E. The organisation cannot afford to undertake quality objectives all at once:Incorrect. Financial constraints are not directly addressed in Clause 6.2. The clause focuses on planning to achieve objectives, which includes defining the necessary resources but does not demand achieving all objectives simultaneously.

F. Quality objectives are not maintained as documented information:Correct. Clause 6.2.1 specifically requires that quality objectives be maintained as documented information. Failure to document the objectives is a direct violation of this clause.

Why Options D and F Are Correct:

D: Misalignment between the quality objectives and the quality policy directly violates Clause 6.2.1, which mandates that objectives support the strategic direction of the organization.

F: Lack of documentation for quality objectives breaches the requirement to maintain them as documented information under Clause 6.2.1.

Relevant References:

Clause 6.2.1: Establishing quality objectives aligned with the quality policy.

Clause 6.2.2: Maintaining documented information for quality objectives and planning to achieve them.

Clause 5.1.1: Top management's responsibility to ensure alignment between the QMS and strategic direction.

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.

Comprehensive and Detailed In-Depth Explanation:

One of the seven quality management principles in ISO 9001:2015 is Improvement, which emphasizes continual enhancement of processes, products, and services.

Clause 10.3 (Continual Improvement) states that organizations must continuously assess risks, consequences, and impacts to improve their QMS.

Risk-based thinking (Clause 0.3.3) supports improvement by identifying and mitigating risks before they affect performance.

Clause 6.1 (Actions to Address Risks and Opportunities) requires organizations to take a proactive approach, ensuring long-term success.

Other options do not fully align with the question:

Process approach (A) focuses on managing interrelated activities.

Leadership (B) ensures commitment but does not directly address risk assessment.

Relationship management (D) deals with interested parties, not risk mitigation.

ï‚· Understanding "Context of the Organization":

The term "context of the organization" is defined in ISO 9001:2015 Clause 4.1, which states:

"The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system."

The definition emphasizes identifying both internal and external issues that influence the organization's approach to developing and achieving its objectives.

ï‚· Option Analysis:

Option A:Correct. This option aligns with the standard definition as it explicitly mentions the combination of internal and external issues that affect the organization’s approach to achieving its objectives, which is the essence of Clause 4.1.

Option B:Incorrect. The term "comparison of internal and external issues" does not reflect the ISO 9001 requirements. The standard does not require a comparison but rather an understanding of these issues.

Option C:Incorrect. Although it mentions "complexity," the focus of ISO 9001:2015 is on identifying relevant issues rather than the complexity of those issues.

Option D:Incorrect. This option mentions "coordination" and focuses only on the positive or negative effects. ISO 9001 requires identifying issues but does not emphasize coordination.

ï‚· Clause Reference and Relevance:

ISO 9001:2015 requires organizations to understand their context because internal and external factors can influence the Quality Management System's effectiveness. Understanding this context helps in:

Addressing risks and opportunities (Clause 6.1).

Aligning the QMS with the organization’s strategic direction.

ï‚· Why A is Correct:

"Combination of internal and external issues" captures the essence of Clause 4.1, making it the accurate definition of the context of the organization.

Comprehensive and Detailed In-Depth Explanation:

Auditors must focus on key processes that impact QMS effectiveness to ensure audit risks are minimized.

Clause References:

ISO 19011:2018, Clause 6.3 – Managing Audit Risk: Auditors should prioritize critical processes to obtain reasonable assurance.

Why is the Correct Answer A?

Some processes are critical (e.g., production quality, customer complaints handling).

If these material processes fail, the QMS could collapse.

Why are the Other Options Incorrect?

B (Needs of internal parties) → Important, but not the primary focus for reducing audit risk.

C (Previous audit results) → Useful for improvement but does not directly reduce current audit risks.

D (Financial risks) → ISO 9001 focuses on quality risks, not financial risks.

The ISO 9001 Lead Auditor exam requires the auditor to have a thorough understanding of the ISO 9001:2015 standard and its requirements, as well as the organization’s context, processes, risks, opportunities, and performance. Therefore, the auditor needs to ask for additional information that can help them verify these aspects during the audit planning stage. Some of the information that can be useful are:

A description of responsibilities and authorities of the key roles of XYZ: This can help the auditor to identify who is accountable for what in the organization and how they communicate with each other.

The number of personnel involved in activities related to the quality management system: This can help the auditor to assess if there are enough resources and competencies to support the QMS implementation and operation.

Information to understand XYZ’s operations: This can help the auditor to understand how XYZ produces or delivers its products or services and what are its main processes and inputs.

The results of XYZ’s last internal audit: This can help the auditor to evaluate if XYZ has implemented corrective actions based on previous audit findings and if it has maintained its QMS effectiveness.

The results of the last two management reviews: This can help the auditor to determine if XYZ has monitored its QMS performance against its objectives and if it has identified any significant changes or opportunities for improvement.

The quality manual (B) is not a required document for ISO 9001 certification, but it may be useful for internal reference or training purposes. It is not necessary for audit planning.

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.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 is based on seven quality management principles, one of which is Relationship Management. This principle emphasizes the importance of maintaining open communication and collaboration with interested parties, including suppliers and customers.

Clause 7.4 (Communication) requires organizations to determine what, when, with whom, and how communication should take place. Since AL-TAX failed to ensure clear communication channels, it did not adhere to this principle. Effective relationship management helps improve supply chain performance, customer satisfaction, and overall QMS effectiveness.

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.

Identifying the source of information

Sampling available data

Gathering audit evidence

Verifying objective evidence

Evaluating evidence against the audit criteria

Making audit conclusions

Evaluating against the audit criteria

According to ISO 19011:2018, clause 6.4, the process of collecting and verifying information during an audit involves the following steps1:

Identifying the source of information: The audit team should identify the sources of information that are relevant to the audit objectives, scope and criteria. These sources may include documents, records, personnel, processes, activities, facilities, equipment, etc. The audit team should also determine the methods and tools for accessing and collecting the information, such as interviews, observations, document review, sampling, etc.

Sampling available data: The audit team should select a representative sample of the available data to verify the conformity and effectiveness of the management system. The sample size and selection method should be based on the audit objectives, scope and criteria, as well as the level of confidence and risk. The audit team should also consider the validity, reliability, relevance and sufficiency of the data.

Gathering audit evidence: The audit team should use the methods and tools identified in the previous step to collect audit evidence, which is the records, statements of fact or other information that are relevant to the audit criteria and verifiable. The audit team should record the audit evidence in a clear, concise and objective manner, using notes, checklists, photographs, audio or video recordings, etc.

Verifying objective evidence: The audit team should verify the accuracy, completeness and authenticity of the audit evidence collected. This may involve cross-checking different sources of information, confirming the identity and authority of the persons providing the information, examining the original documents or records, etc. The audit team should also identify any discrepancies, inconsistencies or gaps in the audit evidence.

Evaluating evidence against the audit criteria: The audit team should compare the audit evidence with the audit criteria to determine the extent of conformity and nonconformity. The audit team should also identify any opportunities for improvement, best practices, positive aspects or potential risks. The audit team should use professional judgement and apply the principles of auditing when evaluating the audit evidence.

Making audit conclusions: The audit team should consolidate the audit findings and evaluate the overall performance and effectiveness of the management system. The audit team should also consider the audit objectives, scope and criteria, as well as the context and expectations of the auditee and other interested parties. The audit team should provide a clear, concise and objective statement of the audit conclusions, which may include the degree of conformity, the achievement of the intended outcomes, the need for corrective actions, the suitability for certification, etc.

Evaluating against the audit criteria: The audit team should review the audit conclusions and ensure that they are consistent with the audit criteria and supported by sufficient and appropriate audit evidence. The audit team should also ensure that the audit conclusions are communicated to the auditee and other relevant parties in a timely and effective manner, using the agreed audit report format and distribution method.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 emphasizes continual improvement as a fundamental requirement of an effective Quality Management System (QMS).

Clause Reference:

Clause 4.4.1 (Quality Management System and Its Processes) states that organizations must:

Determine processes needed for the QMS

Establish criteria and methods for process effectiveness

Ensure continual improvement of the system

Why is the Correct Answer C?

Continual improvement is a core principle of ISO 9001.

Organizations must regularly assess and enhance their QMS to adapt to new challenges and maintain effectiveness.

Why are the Other Options Incorrect?

A (To change the QMS quarterly) → ISO 9001 does not mandate a specific frequency for system changes.

B (To review the QMS annually) → QMS reviews must be conducted as needed, not strictly annually.

D (To conduct a QMS gap analysis every two years) → Gap analysis is useful but is not a mandatory requirement under Clause 4.4.

Comprehensive and Detailed In-Depth Explanation:

As per ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action), all identified nonconformities, including minor ones, must be documented and communicated to the auditee.

Minor nonconformities can lead to major issues if left unaddressed. The auditor must inform the organization before moving to the next audit phase so that corrective actions can be taken. Clause 9.2.2 (Internal Audit) states that audit findings should be reported without undue delay.

Since Li Na did not report the minor nonconformities immediately, her decision was incorrect. Minor nonconformities should always be documented and communicated before proceeding to the next phase.

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B. Applicable procedure: SP-701

D. Identification number of the washing machine

H. The concentration of the cleaning liquid used vs the concentration fixed in SP-701

I. The planned duration of the process vs the minimum time required in SP-701

J. Weight of linen being washed vs the maximum weight required in SP-701

C. Competence record of the machine operator

Comprehensive and Detailed In-Depth Explanation:

Clause References:

ISO 19011:2018 (Guidelines for Auditing Management Systems), Clause 5.3 – Establishing the Audit Objectives

ISO/IEC 17021-1:2015, Clause 9.1.2 – Audit Planning

Why is the Correct Answer C?

Audit objectives must be clearly defined in the audit offer to ensure that the scope, criteria, and purpose are agreed upon in advance.

ISO/IEC 17021-1:2015 (which governs certification bodies) requires that audit objectives be established before the audit begins to ensure transparency and effectiveness.

Sending audit objectives after an agreement has been reached could lead to misalignment between the auditee’s expectations and the audit’s purpose.

Why are the Other Options Incorrect?

A (Audit objectives should be known only after agreement) → Incorrect because objectives must be pre-defined in the audit offer.

B (Only the auditee should know the objectives) → Incorrect because both the auditor and auditee must align on objectives.

D (Approval from the lead auditor is sufficient) → Incorrect because audit planning follows formal procedures defined by ISO/IEC 17021-1.

According to ISO 19011:2018, clause 6.3.2, an audit plan should include the following information:

The audit objectives, scope, and criteria

The audit team members and their roles and responsibilities

The audit schedule, including the sequence and timings of audit activities, such as opening meeting, document review, interviews, observations, closing meeting, etc.

The expected time and duration of each audit activity and location

The name and contact details of the auditee’s representative and other relevant parties

The allocation of appropriate resources to support the audit activities

The audit methods and techniques to be used, such as interviews, observations, sampling, etc.

The audit documents and records to be prepared and retained

The audit language and communication methods

The audit risks and opportunities and how to address them

The audit follow-up arrangements, if applicable

Therefore, the correct answer is D and F, as they are essential elements of an audit plan. The other options are either irrelevant or optional for an audit plan. References:

ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.2

ISO 19011: Guidelines for Auditing Management Systems | ASQ, section “Making audit arrangements”

ISO 19011 Management Systems Audit Checklist | Process Street, task 6.3.2

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

Comprehensive and Detailed In-Depth Explanation:

According to ISO 17021-1:2015, Clause 9.6.2 (Surveillance Activities):

The certification body is responsible for planning and conducting surveillance audits to ensure continued compliance.

The auditee’s top management (A) does not develop surveillance activities, but they must participate.

The audit team leader (C) conducts the surveillance audit, but they do not develop the program.

Thus, B is the correct answer.

Comprehensive and Detailed In-Depth Explanation:

Minor nonconformities are isolated issues that do not significantly impact the QMS but still require correction.

Failure to close nonconformities on time (Answer A) is a procedural issue and is considered minor unless it leads to repeated failures.

Major nonconformities include:

Lack of top management commitment (Answer B), which affects leadership and strategic direction.

Failure to take corrective actions for recurrent issues (Answer C), which indicates systemic failure.

A first-party audit is an internal audit conducted by auditors who are employed by the organization being audited but who have no vested interest in the audit results of the area being audited1. The purpose of a first-party audit is to assess the conformity of the organization’s quality management system to the requirements of ISO 9001 and to identify opportunities for improvement2. Therefore, the two auditors who would not participate in a first-party audit are:

•A. An auditor employed by an external consultancy organization: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit (if the external consultancy organization is a customer or supplier of the organization being audited) or a third-party audit (if the external consultancy organization is a certification body or registrar).

•F. An auditor from a customer: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit, as a customer is an interested party that has specific requirements for the organization being audited.

The other options are not correct, as they could participate in a first-party audit, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited:

•B. An auditor from an interested party: This auditor could be a first-party auditor, as long as the interested party is within the organization being audited. For example, an auditor from the finance department could audit the production department, as long as they are not involved in the production process or affected by its outcomes.

•C. An auditor trained in-house: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The source of the auditor’s training is not relevant for determining the type of audit, as long as the auditor is competent and qualified to perform the audit.

•D. An auditor trained in the IRCA scheme: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The IRCA scheme is a professional certification scheme for auditors of management systems, which provides recognition of the auditor’s competence and credibility3. However, being trained in the IRCA scheme does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.

•E. An auditor certified by IRCA: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. Being certified by IRCA means that the auditor has met the requirements of the IRCA scheme and has demonstrated their competence and credibility as an auditor of management systems3. However, being certified by IRCA does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 19011:2018, Clause 6.4.6 (Conducting Interviews), group interviews should be conducted with at least two auditors to ensure objectivity and accuracy.

This prevents bias or misinterpretation of responses.

It allows for cross-validation of information.

It ensures that the audit results remain objective and impartial.

Since Li Na conducted the group interviews alone, she did not follow audit best practices. The correct approach would have been to have another auditor present during the interviews.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting):

The certification body retains ownership of the audit report as it is responsible for the certification decision.

The auditee may receive a copy, but it does not own the report.

The audit team leader compiles the report but does not own it.

Thus, C is the correct answer.

In this scenario, the audit team leader must balance maintaining the integrity of the audit plan while considering the auditee’s request. The two best responses allow for flexibility without compromising the audit's rigor:

A. I could audit the other laboratories virtually at the end of this audit: Virtual audits can be a valid option, especially in multi-site audits. ISO 9001:2015 does not prohibit virtual audits, and in certain situations, they are practical for reviewing documentation or observing operations remotely.

C. I could try to revise the audit programme to see if I can audit all laboratories: Revising the audit programme to accommodate additional site visits is a reasonable compromise. ISO 9001:2015 audits are based on risk and sampling, but the audit team leader has the flexibility to adjust the audit scope if it fits within the audit duration and resources.

The other options, such as extending the audit duration (B, F) or strictly adhering to the original plan (D, E), may not be practical or necessary. Revising the plan to audit all laboratories or using virtual auditing ensures that the audit remains efficient while addressing the organization's concerns​.

•To evaluate the preparedness of the organisation for a Stage 2 audit: This objective involves assessing the readiness of the organisation to undergo the Stage 2 audit, where the conformity and effectiveness of the quality management system will be verified123. The audit team will check the level of implementation and understanding of the quality management system, identify any major gaps or nonconformities, and confirm the audit scope, criteria, and plan123.

•To review the quality manual: This objective involves reviewing the documented information of the quality management system, such as the quality policy, the quality objectives, the scope, the processes, and the procedures, to ensure that they meet the requirements of ISO 9001:2015123. The audit team will also evaluate the organisation’s understanding and application of the standard, and identify any areas of improvement or concern123.

The other options are not included in the objectives of the Stage 1 initial certification audit, according to the web search results from my internal tool. They may be related to other stages or types of audits, but they are not the focus of the Stage 1 audit.

Therefore, the correct answer is B and D.

D. I would look for evidence that the actions resulting from the risk assessment had been taken.

According to ISO 9001:2015, Clause 6.1.2 requires the organization to plan actions to address risks and opportunities. The organization must integrate and implement these actions into its quality management system and evaluate their effectiveness. The auditor should seek evidence that the organization has assessed the risks and taken appropriate actions.

B. I would ask to audit the Technical Manager by phone.

As the Technical Manager is responsible for this process and is absent due to illness, it is reasonable to attempt to contact him to obtain accurate information. This ensures that the audit process is not unduly delayed and that the information is obtained from the appropriate person.

A. I would not accept the legal compliance expert answering the question.

While the legal compliance expert might not be the best source for technical details, outright rejecting their input is not appropriate. It is better to first verify if the expert can provide relevant information.

C. I would delay the audit until the return of the Technical Manager.

This would be an inefficient approach. Contacting the Technical Manager by phone is a more practical and reasonable option.

E. I would ask for a different guide instead of the legal compliance expert.

The guide's role is not necessarily to answer technical questions but to facilitate the audit. Since Jack is already familiar with the situation, replacing him may not add value.

F. I would ask the consultant to leave the meeting since he is not an employee of the organization.

This is inappropriate and could disrupt the audit process. There is no rule in ISO 9001 preventing a consultant from assisting in the audit if authorized by the organization.

Why Not the Other Options:

According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:

•Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently.

•Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed.

•Select the external providers that have demonstrated their competence and conformity to the requirements. The selection should be based on the evaluation results and the organization’s needs. The selection should be documented and approved.

•Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely.

•Monitor the performance and conformity of the external provider, using the established criteria and methods. The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed.

In this case, the evidence statements that demonstrate a nonconformity with clause 8.4 are A and C, because they show that the organization did not retain documented information of the selection and evaluation of the external provider, and the monitoring of the external provider’s performance. These are requirements of the standard and essential for ensuring the quality of the externally provided processes, products, and services. The other options are not directly related to clause 8.4, although they may indicate other nonconformities or weaknesses in the organization’s QMS. For example, option B may relate to clause 7.1.3 on contingency planning, option D may relate to clause 8.2.3 on review of requirements, option E may relate to clause 8.6 on release of products and services, and option F may relate to clause 5.1.1 on leadership and commitment. References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems

Understanding Clause 7.1.5.2 – Measurement Traceability:ISO 9001:2015 requires organizations to ensure that measuring equipment (e.g., spectrometers) is calibrated and traceable to recognized standards. The failure to maintain calibration within valid dates directly violates this clause and raises concerns about the reliability of the measurement results.

Root Cause of the Nonconformity:The organization failed to plan for the possibility that the calibration service provider (X-TECH) might become unavailable, leading to expired calibration. This indicates inadequate risk-based thinking, which is required under Clause 6.1 of ISO 9001:2015.

Option Analysis:

A. Select one sample for external lab analysis to use as an internal standard:Incorrect. While using an internal standard could provide short-term verification of results, this action does not address the root cause (failure to consider risks associated with external providers).

B. Look for a local company to provide this service:Incorrect. While finding a new local service provider resolves the immediate calibration issue, it does not address the risk of future provider unavailability.

C. Double-check one out of ten samples externally:Incorrect. This corrective action ensures some quality assurance for batch release but does not resolve the nonconformance related to expired calibration.

D. Add this issue to the external issue register, assess its associated risk, and plan action to address that risk:Correct. This approach directly addresses the root cause (failure to anticipate the calibration provider leaving) and ensures proper risk management. ISO 9001:2015 emphasizes risk-based thinking under Clause 6.1, requiring organizations to identify risks and opportunities and implement plans to mitigate them.

Why D is the Best Option:

By adding the issue to the external issue register, the organization ensures it is monitored and tracked.

Assessing the risk ensures proactive measures are in place for similar issues in the future.

Planning actions to address the risk ensures a sustainable solution is implemented, such as identifying multiple service providers or ensuring backup plans for calibration services.

ISO 9001 References:

Clause 6.1 (Actions to Address Risks and Opportunities): Requires organizations to consider risks and opportunities that could affect the intended results of the QMS.

Clause 7.1.5.2 (Measurement Traceability): Mandates that measuring equipment must be calibrated and traceable to ensure valid results.

Clause 10.2 (Nonconformity and Corrective Action): Requires organizations to determine the root cause of nonconformities and take actions to ensure they do not recur.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 9000:2015, which provides definitions for terms used in ISO 9001:2015, a management system is defined as a set of interrelated or interacting elements of an organization to establish policies, objectives, and processes to achieve those objectives.

A Quality Management System (QMS) is a type of management system that ensures organizations meet customer and regulatory requirements while improving performance.

Clause 3.5.3 of ISO 9000:2015 clearly defines "management system" and aligns with this question. The other options do not fit the definition:

Standard refers to an established norm or requirement.

Organization scope defines the boundaries of a QMS but is not a system itself.

Quality manual is a document (optional under ISO 9001:2015) that describes a QMS but is not the system itself.

Comprehensive and Detailed In-Depth Explanation:

Completeness ensures that all necessary audit evidence, observations, and findings are properly documented, which is critical for traceability and accountability in an audit.

While transparency and fair presentation are principles of auditing, completeness is specifically related to maintaining audit work documents, as required in ISO 19011:2018, Clause 6.5.4 (Preparing Audit Work Documents).

According to the ISO 9001:2015 standard, clause 8.7 requires that an organization identify and control any nonconforming outputs that do not conform to the requirements of the customer or other relevant requirements. Nonconforming outputs are any outputs from the process, product or service that do not meet the specified quality criteria. Nonconforming outputs must be dealt with in one or more of the following ways:

Correction of the nonconformity

Segregation, containment, return or suspension of provision of products and services

Informing the customer

Authorisation for acceptance under concession

The organization must also retain documented information on the description of the nonconformity, the actions taken, any concessions obtained, and the identification of the authority deciding the action to resolve the nonconformity.

In this scenario, you have interviewed a line supervisor who is responsible for managing a manual picking line where operators are removing contaminant materials from incoming products. The supervisor has explained that these plastic items are rejected at this stage because they do not meet their processing standards and they can damage their machinery and compromise their quality standards. The supervisor has also mentioned that some of these rejected items are melted down in another process later on and some are disposed of as waste products that cannot be recycled.

Based on this information, you can investigate further by taking two actions:

A. Check the process for handling nonconforming items: You can verify whether there is a documented procedure for identifying, segregating, containing, returning or suspending provision of nonconforming items at this stage. You can also check whether there is a system for informing customers about any nonconforming items that may affect their satisfaction or expectations.

D. Determine what happens to the waste products: You can verify whether there is a documented procedure for disposing of waste products that cannot be recycled as per environmental regulations and customer requirements.

These two actions would help you to determine whether there are any nonconforming outputs at this stage and how they are controlled by the organization.

According to the ISO 19011:2018 document, the audit plan should provide the basis for agreement regarding the conduct and scheduling of the audit activities. The amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives1. The scope of the audit refers to the extent and boundaries of the audit, such as the audit criteria, the audit objectives, the organizational and functional units, and the processes to be audited1. The complexity of the audit refers to the degree of difficulty or intricacy of the audit, such as the number and diversity of the auditees, the audit criteria, the audit methods, and the audit team composition2. The risk of not achieving the audit objectives refers to the possibility that the audit may fail to provide reliable and sufficient audit evidence to support the audit conclusions and report1.

Therefore, the complete sentence is:

In the context of a third-party audit, the amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives.

According to ISO 9001:2015, clause 7.2, an auditor shall have the competence to:

Understand the requirements of ISO 9001 and how they relate to the audit

Understand the organization’s quality management system and its processes

Understand the applicable legal, regulatory, contractual and other requirements that affect the audit

Understand the needs and expectations of interested parties other than customers

Plan and conduct audits in accordance with ISO 19011

Evaluate audit evidence and draw appropriate conclusions

Communicate audit findings effectively1

Therefore, knowledge of ISO 9001 requirements and ISO 19011 audit principles are essential for every member of an audit team auditing an ISO 9001 quality management system.

ï‚· Responsibilities of the Audit Team Leader:

ISO 19011:2018 (guidelines for auditing management systems), which supports the principles in ISO 9001:2015, specifies the responsibilities of an audit team leader. These responsibilities include:

Planning the audit and establishing effective communication between the audit team and auditee.

Ensuring that formal communication channels are agreed upon and followed.

Reporting the audit progress, significant findings, and any concerns to the auditee or audit client as necessary.

Managing the audit team and ensuring adherence to the defined objectives and scope.

ï‚· Analysis of Options:

A. Reporting unattainable audit objectives to the accreditation body:Incorrect. This is not the responsibility of the audit team leader. The accreditation body oversees the certification body and is not directly involved in specific audits. If objectives are unattainable, the audit team leader would report them to the audit client (the certification body), not the accreditation body.

B. Planning formal communication arrangements:Correct. This is one of the responsibilities of the audit team leader. They ensure auditees can communicate with auditors as needed during the audit process.

C. Confirming communication channels during the opening meeting:Correct. During the opening meeting, the audit team leader must establish clear communication protocols to ensure effective information exchange between the audit team and auditee.

D. Communicating progress, findings, and concerns:Correct. Keeping the auditee and audit client informed about progress and significant findings is a critical responsibility of the audit team leader to maintain transparency and ensure the audit objectives are met.

ï‚· Why Option A is Correct:

The audit team leader does not have any obligation to report unattainable objectives to the accreditation body. Instead, they are responsible for communicating issues to the audit client (typically the certification body). The accreditation body operates at a higher level and is concerned with overseeing certification bodies, not individual audits.

ï‚· Relevant References:

ISO 19011:2018, Clause 6.4 (Conducting the Audit): Emphasizes the responsibilities of the audit team leader, including communication with the auditee and client.

ISO 9001:2015, Clause 9.2 (Internal Audit): Highlights the importance of planning and communication during audits, which is reflected in third-party audits as well.

Comprehensive and Detailed In-Depth Explanation:

The audit team selected 4 out of 45 customer complaints for electrical services, which is too low based on standard statistical sampling methods. According to ISO 19011:2018 (Guidelines for Auditing Management Systems), for a population size between 13 and 52, a minimum sample size should be 5 to achieve a reasonable level of confidence.

This means the selected sample (4 complaints) was insufficient and did not align with standard sampling procedures. Therefore, the correct answer is A.

Establishing the audit programme objectives

Determining and evaluating the audit programme risks and opportunities

Establishing the audit programme

Initiating the audit

Preparing all audit activity

Conducting the audit activities

To complete the sequence, you can drag and drop the options to the appropriate blank section.

Here is a brief explanation of each stage:

Establishing the audit programme objectives: This is the first stage of the audit process, where the purpose, scope, and criteria of the audit programme are defined. The audit programme objectives should be aligned with the strategic direction and policies of the organization, and should address the needs and expectations of the interested parties12.

Determining and evaluating the audit programme risks and opportunities: This is the second stage of the audit process, where the factors that can affect the achievement of the audit programme objectives are identified and assessed. The audit programme risks and opportunities should consider the internal and external issues, the requirements and changes of the interested parties, and the results and feedback from previous audits12.

Establishing the audit programme: This is the third stage of the audit process, where the audit programme is designed and implemented. The audit programme should include the audit programme procedures, the audit programme resources, the audit methods and techniques, the audit frequency and schedule, and the audit programme performance indicators12.

Initiating the audit: This is the fourth stage of the audit process, where the audit is prepared and planned. The audit initiation involves selecting the audit team, establishing the contact with the auditee, defining the audit objectives, scope, and criteria, developing the audit plan, and conducting the document review123.

Preparing all audit activity: This is the fifth stage of the audit process, where the audit activities are organized and coordinated. The audit preparation involves assigning the audit tasks, communicating with the auditee and the audit team, arranging the logistics, preparing the working documents, and conducting the opening meeting123.

Conducting the audit activities: This is the sixth and final stage of the audit process, where the audit evidence is collected and evaluated. The audit conduct involves performing the audit activities, such as interviews, observations, document reviews, and tests, documenting the audit findings, preparing the audit conclusions, and conducting the closing meeting123.

I hope this helps you with your ISO 9001 Lead Auditor objectives and content. If you have any further questions, please feel free to ask. 😊

The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.

Table

Audit evidence

ISO 9001 Clause 8 extract

Four of the 10 pallets of stock sampled in the warehouse were not labelled.

“8.5.2 … shall use suitable means to identify outputs …”

A damaged pallet of stock seen in the quarantine area was leaking liquid onto the floor.

“8.7.1 … shall ensure that outputs that do not conform to their requirements are identified and controlled …”

One of the fork-lift truck drivers had no fork-lift truck driving licence.

“8.5.1 e … shall include, as applicable … the appointment of competent persons …”

There was no pest control provision in the warehouse.

“8.5.4 … shall preserve the outputs during production and service provision …”

Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full.

“8.1 … shall plan, implement and control the processes …”

Based on the scenario and the concept of an ‘audit trail’ within the context of ISO 9001, the three statements that apply would likely be:

A. Decisions on improvement action timescales not involving departmental managers. This indicates a lack of involvement and communication with those responsible for implementing the improvements, which is a key part of an effective audit trail1.

B. Evaluation of the results of the improvement action not always documented by the Quality Manager. Proper documentation is essential for an audit trail, as it provides evidence that actions have been evaluated and are effective1.

C. Limited knowledge of the content of Quality Improvement Requests by departmental staff. An audit trail should ensure that all relevant parties are aware of and understand the actions being taken, which is not the case here1.

These points suggest issues with the communication, documentation, and involvement of relevant personnel in the quality management system processes, which are crucial for maintaining an effective audit trail and, by extension, a robust quality management system.

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Comprehensive and Detailed In-Depth Explanation:

Clause 8.3.2 e) – Internal Resource Needs:Delays due to staff shortages highlight a lack of internal resources, directly relating to this clause that requires internal resource planning for design and development.

Clause 8.3.6 – Design and Development Changes:Ongoing formulation changes due to feedback need to be documented and reviewed. This clause requires retention of documented information on changes.

Clause 8.3.5 – Design and Development Outputs:Customer approvals for formulations are outputs of the design process and must be retained as documented information, as per this clause.

Clause 8.3.4 d) – Design and Development Controls:Consumer trials are a validation activity. This clause ensures such trials are conducted to confirm that resulting products meet defined requirements.

Clause 8.3.2 e) – External Resource Needs:Shelf-life tests done by an external lab are part of the external resources needed for development and are referenced here.

Comprehensive and Detailed In-Depth Explanation:

During communication with top management, the auditor should discuss:

The quality policy (ISO 9001:2015, Clause 5.2.1), ensuring that it is established, communicated, and understood.

Internal audits (ISO 9001:2015, Clause 9.2), verifying that they are planned and effectively implemented.

These discussions help assess leadership commitment and the effectiveness of the QMS.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 19011:2018, Clause 5.2 (Audit Program Management):

The audit committee is responsible for establishing the internal audit program.

The audit schedule (A) is determined within the program, but it is not the main role of the committee.

Thus, C is the correct answer.

Quality management principles:

Customer focus = Increased revenue and market share

Engagement of people = Enhanced trust and collaboration throughout the organisation

Improvement = Enhanced drive for innovation

Evidence-based decision-making = Increased ability to demonstrate effectiveness of past actions

According to the Quality management principles document published by ISO, each quality management principle has a statement, a rationale, key benefits, and actions you can take to apply it. Based on these descriptions, the potential benefits can be matched to the corresponding principles as follows:

Customer focus: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. The key benefits of this principle include increased customer value, customer satisfaction, customer loyalty, repeat business, reputation, customer base, revenue and market share.

Engagement of people: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value. The key benefits of this principle include improved understanding of the organization’s objectives and values, increased involvement in improvement activities, enhanced personal development, increased motivation and empowerment, enhanced trust and collaboration, and increased recognition and rewards.

Improvement: Successful organizations have an ongoing focus on improvement. The key benefits of this principle include improved organizational capabilities, alignment of improvement activities at all levels, increased ability to anticipate and react to opportunities and threats, enhanced drive for innovation, and increased levels of satisfaction.

Evidence-based decision-making: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. The key benefits of this principle include improved decision-making processes, increased ability to demonstrate the effectiveness of past decisions, increased ability to review, challenge and change opinions and decisions, and increased ability to improve performance.

According to ISO 9001:2015, clause 9.2.2.e, the organization is required to retain documented information as evidence of the implementation of the audit programme and the audit results. This includes the records of the nonconformities identified during the internal audits and the corrective actions taken to address them. The organization is also required to verify the effectiveness of the corrective actions, as per clause 10.2.2.

Therefore, in the scenario given, the Quality Manager’s decision to automatically close any nonconformance over 3 years old without obtaining any confirmation from the relevant departments or verifying the effectiveness of the corrective actions is a clear violation of the requirements of clause 9.2.2.e. This indicates a lack of control and follow-up of the internal audit process, as well as a potential risk of recurrence or occurrence of the nonconformities in other areas. This also undermines the credibility and value of the internal audit programme, as well as the risk-based approach claimed by the Quality Manager.

Hence, the best course of action to take is D, to raise a nonconformance report against clause 9.2.2.e of ISO 9001, and to communicate the audit findings to the relevant management. The other options are either insufficient or irrelevant to address the issue, as they do not directly relate to the noncompliance with clause 9.2.2.e.

Comprehensive and Detailed In-Depth Explanation:

A technical expert is someone with specialized knowledge that helps the audit team understand specific technical aspects of the auditee’s processes.

Clause References:

ISO 19011:2018, Clause 7.3.4 – Use of Technical Experts:

Technical experts support the audit team with specialized knowledge but do not perform the audit themselves.

Why is the Correct Answer B?

A technical expert is needed when auditors lack deep expertise in specific areas, such as engineering, software, or medical devices.

They assist in interpreting complex technical requirements but do not act as auditors.

Why are the Other Options Incorrect?

A (Observer) → Observers do not contribute expertise; they only watch the audit (e.g., trainees).

C (Guide) → Guides help with logistics but do not provide technical expertise.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 9001:2015, Clause 9.2 (Internal Audit):

Internal audits are conducted by employees of the company who are trained as auditors.

External auditors are not mandatory unless required by the organization.

Thus, A is the correct answer.

Comprehensive and Detailed In-Depth Explanation:

Policies and guidelines are considered documentary evidence because they are written records that demonstrate how an organization complies with ISO 9001 requirements.

Clause References:

ISO 19011:2018, Clause 6.4.6 – Audit Evidence:

Documentary evidence includes manuals, procedures, and policies.

Why is the Correct Answer C?

Documentary evidence includes written records such as policies, procedures, and documented instructions that support QMS implementation.

Auditors review policies to verify conformance with ISO 9001.

Why are the Other Options Incorrect?

A (Confirmative evidence) → Not a recognized category in ISO auditing.

B (Technical evidence) → Technical evidence refers to measurements, test results, or product data, not policies.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions):

Minor nonconformities do not require a follow-up audit but must be corrected before the next surveillance audit.

Follow-up audits are required only for major nonconformities.

The audit team should recommend corrective actions, not enforce immediate follow-ups for minor nonconformities.

Thus, A is the correct answer.

Sequence:

Stage 1 Audit

Stage 2 Opening Meeting

Interviews

Stage 2 Closing Meeting

Close-out of Stage 2 Audit Findings

Issue Certificate

Surveillance Audit

Follow-up Audit

To complete the sequence, you can drag and drop the options to the appropriate blank section.

Here is a brief explanation of each step:

Stage 1 Audit: This is the initial audit that aims to assess the readiness of the organization for the stage 2 audit. It involves reviewing the documentation of the quality management system, evaluating the scope and objectives of the audit, and identifying any major gaps or nonconformities34.

Stage 2 Opening Meeting: This is the meeting that marks the start of the stage 2 audit. It involves confirming the audit plan, the audit criteria, the audit scope, and the audit team. It also provides an opportunity for the auditee to ask any questions or raise any concerns34.

Interviews: This is the main activity of the stage 2 audit, where the audit team collects evidence by interviewing the personnel involved in the quality management system, observing the processes and activities, and examining the records and documents. The audit team uses various techniques, such as sampling, measurement, analysis, and evaluation, to verify the conformity and effectiveness of the quality management system345.

Stage 2 Closing Meeting: This is the meeting that marks the end of the stage 2 audit. It involves presenting the audit findings, the audit conclusions, and the audit report to the auditee. It also provides an opportunity for the auditee to provide feedback, ask questions, or dispute any findings34.

Close-out of Stage 2 Audit Findings: This is the process of verifying that the auditee has taken appropriate corrective actions to address any nonconformities or opportunities for improvement identified during the stage 2 audit. The audit team may request evidence or conduct a follow-up visit to confirm the effectiveness of the corrective actions34.

Issue Certificate: This is the process of issuing a certificate of conformity to the auditee, if the audit team is satisfied that the quality management system meets the requirements of the standard and that there are no major nonconformities or unresolved issues. The certificate is valid for a specified period, usually three years, and is subject to periodic surveillance audits34.

Surveillance Audit: This is the process of conducting periodic audits, usually once a year, to monitor the continued conformity and effectiveness of the quality management system. It involves reviewing the changes, improvements, and performance of the quality management system, and identifying any new nonconformities or opportunities for improvement34.

Follow-up Audit: This is the process of conducting an additional audit, usually in response to a significant change, a complaint, or a major nonconformity, to verify the impact and the corrective actions taken by the auditee. It may result in the suspension, withdrawal, or renewal of the certificate, depending on the outcome of the audit34.

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

Here is the correct matching of ISO 9001:2015 clauses to the steps mentioned in the change management process:

We identified risks and opportunities and fed these into our risk management processes.

Clause 6.1 (Actions to address risks and opportunities)

We found a suitable supplier.

Clause 8.4 (Control of externally provided processes, products, and services)

We monitored customer feedback and noticed an increase in negative feedback about lead times.

Clause 9.1.2 (Customer satisfaction)

We put together a plan for implementation.

Clause 6.2.2 (Planning to achieve quality objectives)

We monitored the performance of the new supplier.

Clause 8.4.2 (Type and extent of control of external providers)

We noticed that productivity targets were being missed.

Clause 9.1.1 (Monitoring, measurement, analysis, and evaluation)

We communicated the plan internally.

Clause 7.4 (Communication)

We looked at the data at the management review and decided we needed to do something different.

Clause 9.3.2 (Management review inputs)

We reorganised the staffing and implemented redundancies.

Clause 7.1.2 (People)

We set an objective to effectively implement the transition and outsource manufacturing.

Clause 6.2.1 (Quality objectives and planning to achieve them)

This aligns the steps of the change process with relevant ISO 9001:2015 clauses related to risk, planning, communication, and monitoring.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 Clause 5.1.1 (Leadership and Commitment) states that top management must demonstrate leadership and commitment to the QMS by actively participating in QMS implementation, integration, and effectiveness.

In scenario 2, top management refused to be directly involved in the QMS implementation team, which violates Clause 5.1.1 because leadership involvement is essential for the system’s success.

Other options do not indicate nonconformance:

Option A (Middle managers in the QMS team) is acceptable.

Option C (Leslie assigning roles) is valid if competence is ensured (Clause 5.3 – Organizational Roles, Responsibilities, and Authorities).

Option D (Team reviewing the policy before approval) aligns with best practices.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 19011:2018, Clause 5.3.2 (Access to Information), internal auditors must have unrestricted access to:

Employees and executives for interviews and observations.

Documented information to verify compliance with ISO 9001.

This ensures a transparent and objective audit process. The CEO’s approval (B) is not required unless restricted information is involved.

Questions no: 1 Verified Answer: = C, D, E Comprehensive But Short Explanation: = Potential threats to impartiality in an audit context include familiarity (having a close relationship with the auditee), intimidation (being coerced or feeling pressured), and self-audit (auditing one’s own work). These factors can compromise the auditor’s objectivity and the audit’s integrity. References: = The information is based on the ISO 9001 Auditing Practices Group documents which discuss threats to auditor impartiality and how they may compromise an auditor’s objectivity123.

According to clause 10.2.1.b of ISO 9001:2015, the organization should evaluate the need for action to eliminate the causes of nonconformities, in order to prevent their recurrence. This means that the organization should identify and address the root causes and contributing factors of the nonconformities, and implement appropriate corrective actions that are effective and proportional to the impact of the nonconformities. In this case, the evidence statement that supports the finding of nonconformance is C, because it shows that the organization did not take effective actions to prevent the recurrence of the spelling errors in the print run, which resulted in repeated customer rejections and dissatisfaction. The other options are not directly related to clause 10.2.1.b, although they may indicate other nonconformities or weaknesses in the organization’s QMS. For example, option A may relate to clause 7.2 on competence, option B may relate to clause 8.6 on release of products and services, and option D may relate to clause 7.1 on resources. References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Nonconformity and Corrective Action], ISO 9001 Clause 10. Improvement - ISO-templates.com

According to the ISO 9001:2015 standard, clause 10.2 requires organizations to review nonconformities, including any arising from customer complaints, and to take appropriate actions to determine the cause, implement corrections and preventive actions, and verify their effectiveness. The organization must also monitor the effectiveness of the actions taken and make changes if necessary.

In this scenario, the auditee is facing a legal dispute with a customer over damage to an expensive cashmere coat. This is a nonconformity that arises from customer complaint and has a significant impact on customer satisfaction and reputation. Therefore, clause 10.2 applies to this situation.

The best option for how this should be handled by the Quality Management System is B.

B means that the organization should report the situation to the customer with suggested remedial action. This option follows the principle of transparency and accountability, as well as respecting the customer’s rights and expectations. The organization should also investigate the root cause of the damage and prevent it from happening again in other shops or products.

The other options are not appropriate because:

A means that the organization should settle the court case by negotiation with the customer. This option may not be feasible or satisfactory for both parties, especially if there is a large amount of compensation involved or if there are legal implications for other customers.

C means that the organization should make an offer to replace the coat with a new one. This option may not be sufficient or acceptable for both parties, especially if there is evidence of negligence or poor quality on behalf of the organization.

D means that the organization should give an explanation to the customer of what went wrong. This option may not be enough or convincing for both parties, especially if there is no evidence of negligence or poor quality on behalf of the organization.

Comprehensive and Detailed In-Depth Explanation:

ISO 19011:2018, Clause 5.4 (Audit Records Management) states that the audit schedule must be maintained as a key record.

Thus, C is the correct answer.