PECB ISO-9001-Lead-Auditor Dumps

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:

ISO 9001:2015, Clause 5.1.2 (Customer Focus) states that top management must ensure customer satisfaction by monitoring customer perceptions.

In scenario 2, top management initiated customer surveys, demonstrating their commitment to customer focus as required by Clause 5.1.2.

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

Here is the correct matching of the ISO 9001 Clause 8 extracts to the audit evidence:

Audit evidence: Three subcontract trainers who had delivered training were not approved as defined in procedure SA1 Supplier Approval revision 3.ISO 9001 Clause 8 extract: 8.4.1 ...shall apply criteria for ... external providers...(This clause requires the organization to control external providers, including ensuring their approval and competence.)

Audit evidence: A training programme for a customer was not documented as required in procedure TD 2 Training revision 2.ISO 9001 Clause 8 extract: 8.3.5 ...shall retain documented information on design and development outputs.(This clause addresses the need to retain documented information related to design and development outputs, such as a training programme.)

Audit evidence: One trainer had not recorded the damage to a customer’s training room wall caused by using sticky tape to hang training aids, as required in procedure TD 2 Training revision 2.ISO 9001 Clause 8 extract: 8.5.3 ...shall retain documented information on what has occurred.(This clause relates to retaining documented information on activities and outcomes, including records of damage or issues encountered.)

Audit evidence: Five sales orders had no record of having been reviewed to verify the ability to provide these courses.ISO 9001 Clause 8 extract: 8.2.3.1 ...shall conduct a review before committing...(This clause specifies the requirement to review and verify the organization's ability to meet customer requirements before accepting sales orders.)

These mappings reflect the specific requirements of ISO 9001:2015 for managing external providers, retaining documented information, and reviewing contracts.

According to clause 8.3 of ISO 9001:2015, the organization should establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. The design and development process should include the following activities:

•Determining the requirements for the products and services to be designed and developed, considering the intended use, the statutory and regulatory requirements, the customer and other relevant interested parties’ needs and expectations, and the potential risks and opportunities.

•Defining the design and development objectives, stages, responsibilities, and authorities, and ensuring the availability of adequate resources and competence.

•Implementing design and development controls, such as reviews, verification, and validation, to ensure that the design and development outputs meet the design and development inputs, and to identify and resolve any problems or errors.

•Maintaining documented information on the design and development inputs, outputs, reviews, verification, validation, and changes, and ensuring the traceability and conformity of the products and services to the requirements.

•Managing the design and development changes, by identifying, reviewing, and controlling them, and evaluating their effects on the products and services and the QMS.

In this case, the evidence statements that provide a meaningful audit trail for the design and development process are B, E, and F, because they relate to the design and development controls, the documented information, and the verification activities that are required by the standard. These options can help the auditor to assess the effectiveness and conformity of the design and development process, and to identify any nonconformities or opportunities for improvement. The other options are not directly related to clause 8.3, although they may be relevant for other aspects of the QMS, such as clause 7.2 on competence, clause 7.3 on awareness, clause 7.4 on communication, clause 8.2 on requirements for products and services, clause 8.4 on externally provided processes, products, and services, and clause 8.7 on control of nonconforming outputs. References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Design and Development, ISO 9001 Clause 8.3 Design and development of products and services

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires organizations to identify and control nonconforming outputs to prevent unintended use or delivery.

Clause References:

Clause 8.7 (Control of Nonconforming Outputs): Organizations must ensure that nonconforming outputs are identified and controlled to prevent unintended use or delivery.

Clause 10.2 (Nonconformity and Corrective Action): Requires organizations to take appropriate actions when nonconformities are found, including during or after service provision.

Why is the Correct Answer C?

If nonconforming products or services are identified after delivery or during service, organizations must take corrective actions to protect customers and stakeholders.

Actions may include recalls, rework, customer notifications, compensation, or process improvements.

This approach aligns with ISO 9001:2015, ensuring that products/services consistently meet requirements.

Why are the Other Options Incorrect?

A (Retaining documentation only) → While documentation is required, it alone does not ensure proper handling of nonconforming outputs.

B (Verifying conformity before correction) → While verification is good practice, ISO 9001 prioritizes corrective action over mere verification.

D (Allowing employees to handle nonconformities without structure) → ISO 9001 requires documented procedures for handling nonconformities (Clause 8.7).

The activities that are specifically required by ISO 17021-1 as part of third-party (Certification Body) surveillance audit processes are:

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

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

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

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

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

•Option I: Handling of customer complaints since last visit. This option is correct because ISO 17021-1:2015 clause 9.6.2.2 requires the certification body to review the client’s handling of customer complaints related to the certified activities since the last audit.

The following options are not correct:

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

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

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

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

Comprehensive and Detailed In-Depth Explanation:

A horizontal audit examines one process across multiple departments to assess consistency.

Thus, A is the correct answer.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 emphasizes risk-based thinking, which helps organizations identify factors that could prevent achieving planned results and take preventive action. Clause 6.1 (Actions to Address Risks and Opportunities) requires organizations to determine risks and opportunities and implement actions to mitigate potential negative impacts.

In the scenario, AL-TAX identified potential risks and implemented preventive actions, aligning with risk-based thinking. ISO 9001:2015 integrates risk management throughout the standard, ensuring processes are designed to minimize uncertainties.

B. Control of externally provided processes, products, and services: This is relevant because the organization has outsourced the manufacture of its own brand products to a supplier. According to ISO 9001, the organization must ensure that externally provided processes remain within the control of its quality management system.

C. Design and development of products and services: Even though the organization no longer manufactures in-house, it still needs to control the design and development of its products, especially since they are now being produced by an external provider.

F. Organisation roles and responsibilities: The change in strategy has led to a significant reduction in staff, which would have an impact on the roles and responsibilities within the organization. It is important to audit how these changes have been managed and communicated within the organization to ensure continued effectiveness of the quality management system.

These audit trails are aligned with the requirements of ISO 9001:2015, which emphasizes the importance of controlling externally provided processes and products, managing design and development, and clearly defining roles and responsibilities within the quality management system.

In the context of ISO 9001:2015 audits, it is the audit team leader who holds the responsibility for assigning work to the audit team. According to ISO 19011:2018 (Guidelines for auditing management systems, which complements ISO 9001:2015), the audit team leader is responsible for the organization and direction of the audit, including assigning specific roles and responsibilities to audit team members. This includes preparation of the audit plan, leading the audit, and ensuring that each team member understands their tasks.

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.

According to the ISO 9001:2015 standard, clause 8.4.1 requires organizations to ensure that externally provided processes, products and services conform to requirements. Controls must be applied to externally provided processes, products and services when:

The products and services are intended for incorporation into the organization’s own products and services.

They are provided directly to customers by the external provider on behalf of the organization.

A process, or part of a process, is provided by an external provider as a result of a decision by the organization.

In this scenario, the auditee has chosen a supplier to manufacture their own brand products based on their design drawings, supplier questionnaire and trial batches. This means that the supplier is providing a process (manufacturing) as a result of a decision by the organization (the auditee). Therefore, clause 8.4.1 applies to this situation.

•

Reviews the client’s management system documented information: This activity involves checking the documentation 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 also evaluates the client’s understanding and implementation of the standard, and identifies any gaps or nonconformities that need to be addressed before the Stage 2 audit123.

•Reviews the processes with high level of risk: This activity involves assessing the processes that have a significant impact on the quality of the products or services, or that pose a high risk of nonconformity or customer dissatisfaction123. The audit team also verifies the client’s risk management approach, and evaluates the effectiveness of the controls and actions taken to mitigate the risks123.

The other options are not statements that are true for the Stage 1 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 D and G.

Analyzing Each Statement:

A.Incorrect. The audit team leader must communicate concerns as they arise, not just during the closing meeting. Per ISO 19011:2018 Clause 6.4.9, significant concerns should be shared promptly with the auditee and audit client during the audit process to allow for immediate understanding and potential resolution.

B.Incorrect. The auditor or team leader is not specifically required to inform the general manager about uncontrolled documents. Instead, the issue is communicated within the framework of the audit findings to the audit client or auditee, as appropriate.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires collaboration between the auditee (TD Advertising), the certification body, and the audit leader when making changes to audit scope.

Clause References:

ISO/IEC 17021-1:2015, Clause 9.2.3 – Conducting the Audit: Any change in audit scope must be agreed upon by all parties before proceeding.

Why is the Correct Answer C?

TD cannot unilaterally change the scope without agreement from the certification body and audit leader.

The certification body must ensure the scope remains relevant and that resources are allocated properly.

Why are the Other Options Incorrect?

A (Anne cannot withdraw) → Incorrect, Anne CAN withdraw if the changes make the audit unfeasible, but she must consult with the certification body first.

B (TD cannot change the scope) → Incorrect, scope changes are allowed but must be formally approved.

D (Anne has full authority to reject scope changes) → Incorrect, scope changes require mutual agreement among all parties.

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.

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 …”

 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.

 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.

 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.

 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.

Top management is responsible for establishing, implementing, and maintaining the quality policy. The quality policy provides a framework for setting quality objectives and must be compatible with the context of the organization and support its strategic direction. It should also provide a commitment to satisfy applicable requirements and to continuous improvement.

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:

ISO 9001:2015, Clause 4.3 (Determining the Scope of the Quality Management System) states that when determining the QMS scope, an organization must consider:

External and internal issues (Clause 4.1)

The needs and expectations of interested parties (Clause 4.2)

The products and services provided by the organization

In the scenario, Bell only considered top management's input, which fails to address Clause 4.2 (interested parties' expectations)—such as customers, suppliers, and regulatory authorities.

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 the context of a third-party audit, the activities and the parties responsible can be matched as follows:

Review the organization’s processes: This is typically the responsibility of the audit team. They examine the processes to ensure they comply with the specified standards1.

Review the audit results: The audit team leader usually reviews the audit findings to ensure accuracy and completeness before they are finalized1.

Issue the certificate: The certification body is responsible for issuing the certificate if the audit is successful and the organization meets the required standards1.

Select the audit team: The individual(s) managing the audit programme are responsible for selecting the audit team. This ensures that the team has the appropriate skills and knowledge for the audit1.

These roles are essential to maintain the integrity and effectiveness of the audit process. The audit team conducts the actual audit, the team leader oversees the audit process, the certification body grants the certification, and the management of the audit program ensures that the right team is in place to conduct the audit1.

Based on the description of the image you’ve provided, here’s how the activities match with the responsible parties in the context of a third-party audit:

Review the organization’s processes: This activity is typically the responsibility of the Audit Team. They are tasked with examining the processes to ensure they meet the requirements of the standard being audited.

Review the audit results: The Audit Team Leader is usually responsible for this activity. They oversee the audit process and are in charge of reviewing the findings and ensuring that the audit objectives are met.

Issue the certificate: The Certification Body is responsible for issuing the certificate if the organization’s management system is found to be in compliance with the standard.

Select the audit team: The Individual(s) managing the audit programme are responsible for selecting the audit team. They ensure that the team has the appropriate competence and resources to effectively conduct the audit.

These roles are defined within the framework of ISO 9001:2015 and are essential for the proper conduct of a third-party audit. The audit team and its leader play a critical role in the operational aspects of the audit, while the certification body and those managing the audit programme have overarching responsibilities for the audit’s governance and integrity.

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.

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

Comprehensive and Detailed In-Depth Explanation:

According to ISO 19011:2018, Clause 6.4.3 (Roles and Responsibilities of Guides and Observers):

The auditee assigns a guide to assist the audit team.

The guide provides logistical support, helps with navigation, and arranges access to necessary personnel and records.

The audit team leader does not assign the guide, but they may request one.

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.

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. ????

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:

Toning down (or de-escalation) is a conflict resolution technique where:

Common agreements are emphasized to reduce tension.

Disagreements are addressed with a rational and constructive approach.

Option A describes compromise, and Option B describes authoritative resolution, which are different conflict resolution techniques.

 Clause: 8.5.4

 Nature of Problem: Cleaning and sanitising records are not available for every batch.

 Unfulfilled Requirement: "The organization shall implement production provision under controlled conditions."

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.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires organizations to ensure competence of personnel whose work affects quality performance.

Clause References:

Clause 7.2 – Competence: Organizations must determine, provide, and evaluate competence of employees performing work under the QMS.

ISO 19011:2018, Clause 6.4.6 – Audit Evidence: Auditors should use a combination of document review, interviews, and observation to verify competence.

Why is the Correct Answer C?

The organizational chart shows reporting structures and helps verify roles and responsibilities.

Job descriptions outline required qualifications, skills, and competencies for each role.

These documents provide objective audit evidence that personnel meet the required competencies for their positions.

Why are the Other Options Incorrect?

A (Sufficient evidence) → Partially correct, but competence verification often requires multiple sources of evidence, including training records, certifications, and observations.

B (Not relevant) → Incorrect because verifying competence is crucial for ensuring effective QMS implementation.

D (Direct observation only) → Observation alone is insufficient; documentation and interviews are also required to confirm competence.

According to the ISO - Management system standards page, the key benefits of an effective management system include improved operational effectiveness and efficiency, improved risk management and protection of people and the environment, and enhanced drive for innovation. The Integrated Use of Management System Standards (IUMSS) handbook also states that the purpose and objectives of management system standards are to help organizations improve their performance by specifying repeatable steps that organizations consciously implement to achieve their goals and objectives.

Therefore, the complete sentence is:

“The purpose of a management system standard is to improve the performance of an organisation.”

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.

The following table shows the possible matching of the records to the requirements of clause 8.4:

Table

Requirements

Records

Define product requirements

Product specification

Criteria for selection

List of requirements to be met by the external provider

Evaluation of potential external provider

External provider questionnaire

External provider selection

Approved external provider list

Communicate requirements

Purchase order

Monitoring of performance

External provider delivery times and quality issues

Comprehensive and Detailed Explanation: = 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:

Define the product requirements that are relevant for the external provision, such as specifications, drawings, standards, codes, etc. These should be documented and communicated to the external provider. A record of the product specification can be used as evidence of this requirement.

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. A record of the list of requirements to be met by the external provider can be used as evidence of this requirement.

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. A record of the external provider questionnaire can be used as evidence of this requirement.

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. A record of the approved external provider list can be used as evidence of this requirement.

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. A record of the purchase order can be used as evidence of this requirement.

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. A record of the external provider delivery times and quality issues can be used as evidence of this requirement.

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

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 emphasizes the importance of communication as part of an effective Quality Management System (QMS).

Clause References:

Clause 7.4 (Communication): This requires organizations to establish what, when, with whom, and how communication should take place to ensure effectiveness.

Quality Management Principle – Engagement of People: Effective communication allows stakeholders (employees, suppliers, customers) to fully participate and contribute to quality objectives.

Why is the Correct Answer A?

Appropriate communication means ensuring that messages are clear, relevant, and accessible to the intended audience.

Different stakeholders (employees, customers, regulatory bodies, suppliers) may require different formats, languages, or media to ensure they fully understand and engage.

This aligns with ISO 9001:2015, which emphasizes that communication must be tailored to the needs of the recipient for maximum effectiveness.

Why are the Other Options Incorrect?

B (Timely responses) → Important but does not specifically refer to appropriateness in communication.

C (Communicating processes and assumptions to all interested parties) → Communication should be relevant; sharing all details might not be necessary or appropriate.

D (Only top management handling external communication) → Communication must be distributed across relevant functions, not restricted to leadership.

In this scenario, the time allocated by the audit team leader for the Human Resources audit is fixed, and as an auditor, you must work within that constraint. Although the sampling criteria suggests reviewing 25 personnel files, it is acceptable to adjust the sample size based on time and resource limitations. ISO 9001:2015 emphasizes risk-based thinking and practical resource management (Clause 7.1), so it is reasonable to review a smaller sample if the time is insufficient.

Option B is a pragmatic approach, allowing you to focus on quality over quantity by reviewing as many cases as time allows without compromising the audit schedule.

Options like extending the audit (A, C, D) are impractical in a structured audit environment, especially for second-party audits where maintaining the agreed schedule is important​​.

Questions no: 16 Verified Answer: = C. 7.4 Communication Comprehensive But Short Explanation: = Clause 7.4 of ISO 9001:2015 requires the organization to determine the internal and external communications relevant to the quality management system, including what will be communicated, when, with whom, and how. The scenario indicates a potential gap in communication with subcontractors regarding the Quality Policy, objectives, and plans to address risks and opportunities, which is a requirement even if the subcontractors have their own ISO 9001 certified systems123. References: = This response is based on the general requirements of ISO 9001:2015 related to communication with external parties, such as subcontractors, as outlined in various resources discussing Clause 7.4123.

Comprehensive and Detailed In-Depth Explanation:

Auditors must report findings truthfully and accurately to ensure an unbiased assessment of the QMS.

Clause References:

ISO 19011:2018, Clause 4 – Principles of Auditing:

Fair Presentation → Requires auditors to report truthfully and accurately, without bias or omission.

Integrity → Ensures auditors adhere to ethical conduct.

Why is the Correct Answer A?

The audit team reported findings truthfully, based on collected evidence.

Fair presentation ensures that both positive and negative findings are included in the audit report.

Objective evidence was gathered through interviews, document reviews, and observations.

Why are the Other Options Incorrect?

B (Integrity) → Related to ethics and professional conduct, but not specifically about presenting findings.

C (Confidentiality) → Important, but does not apply to the principle of reporting findings accurately.

D (Objectivity) → Ensures impartiality, but "fair presentation" directly addresses accurate reporting of findings.

Understanding the Purpose of a Quality Management System (QMS):The primary objective of ISO 9001:2015 is to improve the overall performance of the organization by:

Ensuring consistent delivery of products and services that meet customer and regulatory requirements.

Focusing on enhancing customer satisfaction.

Promoting continual improvement of the organization’s processes and practices.

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:

Comprehensive and Detailed In-Depth Explanation:

Stratified sampling is the best method when the population consists of different groups or categories. In this case:

ME has two areas of operations (electrical and mechanical services).

Complaints were collected separately for each area.

By choosing representative samples from each category (electrical & mechanical complaints), Li Na ensured a balanced approach.

Systematic sampling selects samples at fixed intervals, which does not ensure proportional representation of both groups.

Block selection sampling is used when focusing on a specific time period or section, which does not apply here.

Thus, stratified sampling (B) is the correct answer.

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.

Comprehensive and Detailed In-Depth Explanation:

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

The auditor can set a reasonable deadline for corrective actions.

10 to 60 days is a best practice timeframe for the auditee to respond.

The auditee must propose corrective actions, but the audit team has the authority to set the deadline.

A 7-day deadline (A) is too short, and the audit team—not the auditee—determines the timeframe (B).

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.

A Stage 1 audit is a preliminary assessment to evaluate the readiness of the organisation for the Stage 2 certification audit. The audit scope is defined by the audit client and the certification body based on the application and the contract. If the organisation wants to include a new work area that was not part of the original scope, the auditor should advise the Quality Manager that an extension of the scope is possible but will have to go through established procedures, such as submitting a formal request, providing relevant information, and paying additional fees. The auditor should also suggest that the Quality Manager will advise the programme manager, who is responsible for managing the audit programme, that the audit scope should be revised to include the new work area. The programme manager will then decide whether to approve or reject the request, and communicate the decision to the auditor and the Quality Manager. The auditor should not proceed with the audit of the new work area without the approval of the programme manager and the confirmation of the audit scope. 1234 References:

1: ISO 19011:2018 - Guidelines for auditing management systems

2: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified

3: What is the difference between Stage 1 and Stage 2 Audits? - ISO Update

4: Getting Certified to ISO 9001 - the Stage 1 Audit

As the audit team leader, it is crucial to manage differing opinions constructively and ensure that the correct clause is selected for the nonconformity based on solid evidence. Here’s how the situation should be handled:

E. Invite you and the second auditor to fully explain your point of view and then decide which clause to select: This promotes collaboration and transparency, allowing both auditors to present their rationale for choosing the specific clause.

F. Review the evidence with you and the second auditor, and then decide which clause of ISO 9001 would best apply: Reviewing the evidence in relation to the specific requirements of ISO 9001 is essential for determining which clause is most appropriate.

H. Try to obtain a consensus between you and the second auditor after a discussion of the different opinions: Consensus-building is a crucial skill for an audit team leader. Achieving agreement ensures the nonconformity is addressed accurately and with full team support.

Options such as overruling immediately (D) or deferring the decision without full discussion (B) could undermine team dynamics and the audit process. Consulting the quality manager (A) or selecting an entirely different clause (G) is unnecessary, as the team should resolve the issue internally​​.

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.

Comprehensive and Detailed In-Depth Explanation:

The audit schedule provides a structured timeline of activities to be conducted during the audit.

Clause References:

ISO 19011:2018, Clause 6.4.2 – Preparing the Audit Plan:

Requires the development of an audit schedule, including the sequence and timing of activities.

ISO/IEC 17021-1:2015, Clause 9.1.3 – Audit Program:

Certification bodies must establish a schedule for conducting audits.

Why is the Correct Answer C?

The audit schedule ensures systematic execution of the audit by defining activities, responsible auditors, and timeframes.

A well-planned schedule improves efficiency and helps auditors cover all necessary areas within the given time.

Why are the Other Options Incorrect?

A (Audit objectives) → Define why the audit is conducted, not the schedule.

B (Audit criteria) → Define the standards and requirements to be evaluated, not the timeline.

D (Audit offer) → Refers to the initial proposal sent to the auditee, not the activity timeline.

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Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires organizations to ensure that auditors have the necessary competence and knowledge to conduct audits effectively.

Clause References:

ISO 19011:2018, Clause 7.2.1 – Determining Competence of Auditors: Auditors must have knowledge of applicable legal and regulatory requirements that affect the scope of the audit.

ISO/IEC 17021-1:2015, Clause 7.1.2 – Competence Requirements: Certification bodies must ensure that auditors assigned to the audit team possess relevant knowledge in areas such as legal and regulatory compliance.

Why is the Correct Answer C?

Each audit team member should have sufficient knowledge of relevant legal and regulatory requirements to ensure compliance.

This helps auditors identify gaps or nonconformities related to compliance obligations.

Having multiple team members with knowledge reduces reliance on a single expert and ensures a comprehensive assessment.

Why are the Other Options Incorrect?

A (Only one team member needs knowledge) → Incorrect because audits involve various aspects, and all auditors should have basic awareness of legal and regulatory requirements.

B (Legal knowledge is not necessary) → Incorrect because compliance is essential for QMS effectiveness.

D (Only the lead auditor needs legal knowledge) → Incorrect because ISO requires all auditors to be competent in applicable laws, not just the leader.

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.