According to the guidance on conducting the audit closing meeting1, the audit team leader should provide a summary of the audit findings and conclusions, invite discussions, and agree on timelines for any corrective actions. The audit team leader should also be respectful, constructive, and objective when presenting the nonconformities, and avoid any personal or emotional comments. The audit team leader should also consider the impact of the disruptive event (such as the Covid-19 pandemic) on the auditee’s context, interested parties, and risks2, and acknowledge any good practices or improvements observed during the audit. Therefore, option D is the best option, as it follows the best practices for the closing meeting and allows the auditee to understand the nonconformities and their implications, and to participate in the analysis and resolution of the issues. Option A is not correct, as it is not respectful, constructive, or objective, and it does not invite any discussion or feedback from the auditee. It also assumes that the audit team leader has the authority to recommend the removal of the supplier from the approved list, which may not be the case. Option B is not correct, as it does not provide enough information or explanation to the auditee, and it does not allow any discussion or feedback from the auditee. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, acknowledging any good practices, and agreeing on timelines for corrective actions. Option C is not correct, as it does not involve the other managers who are responsible for the functions or processes that were audited, and who may have valuable input or information to share. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, inviting discussions, and agreeing on timelines for corrective actions. References: 1: Conducting the Audit Closing Meeting: Sharing the Results2: Auditing ISO 9001:2015 in the Context of a Disruptive Event.

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.

ISO 9001:2015 is a management system standard , and third-party certification provides independent assurance that an organisation ' s quality management system has been assessed against ISO 9001 requirements.

Explanation of the Correct Answers

A. Demonstrates that the quality management system conforms to ISO 9001.

This is a primary purpose and benefit of third-party certification.

Certification by an accredited certification body demonstrates that the organisation ' s quality management system has been audited and found to conform to the requirements of ISO 9001.

Relevant ISO 9001 requirements include:

Clause 4 to Clause 10 , which define the requirements that must be met for certification.

Certification confirms conformity of the management system , not individual products.

Therefore, this statement is correct.

B. Demonstrates that the quality management system is capable of consistently achieving its stated quality policy and objectives.

ISO 9001 is designed to ensure that organisations establish, implement, maintain, and continually improve processes that support achievement of quality objectives and intended results.

Relevant requirements include:

Clause 5.2 – Quality Policy

Clause 6.2 – Quality Objectives

Clause 9.1 – Monitoring, measurement, analysis and evaluation

Clause 10.3 – Continual improvement

Certification provides confidence that the management system is capable of consistently achieving planned results when effectively implemented.

Therefore, this statement is correct.

Why the Other Options Are Incorrect

C. Demonstrates that the quality management system can ensure the quality of their supplier.

ISO 9001 requires organisations to control external providers under Clause 8.4 , but certification does not guarantee supplier quality.

The organisation remains responsible for supplier evaluation and control.

Therefore, this is not a benefit guaranteed by certification.

D. Demonstrates that the quality management system can ensure their product has also been certified.

ISO 9001 certification applies to the management system , not to products.

A product can only be certified under a separate product certification scheme where applicable.

Therefore, this statement is incorrect.

E. Demonstrates that the quality management system does not have any non-conformities.

Certification does not mean there are no nonconformities.

During certification and surveillance audits, organisations may still receive nonconformities and maintain certification provided they address them appropriately.

Therefore, this statement is incorrect.

F. Guarantees that the organisation will not be audited by their customers.

Many customers continue to perform supplier audits even when suppliers hold ISO 9001 certification.

Certification may reduce the frequency of customer audits, but it does not guarantee they will not occur.

Therefore, this statement is incorrect.

ISO-Aligned Conclusion

Third-party ISO 9001 certification provides independent confidence that:

The quality management system conforms to ISO 9001 requirements , and

The quality management system is capable of consistently achieving its quality policy and objectives.

Therefore, the correct answers are:

A. Demonstrates that the quality management system conforms to ISO 9001.

B. Demonstrates that the quality management system is capable of consistently achieving its stated quality policy and objectives.

The responsibilities of an Audit Team Leader in a third-party certification audit are defined primarily in ISO 19011:2018 and reinforced by ISO/IEC 17021-1 for certification audits.

The Audit Team Leader is responsible for managing the audit process, coordinating the audit team, and maintaining communication with the auditee.

Correct Responsibilities

A. Holding the audit team meeting

The Audit Team Leader is responsible for:

Organising and leading audit team meetings.

Ensuring auditors understand their assignments.

Reviewing findings and audit conclusions.

Preparing the team for opening and closing meetings.

Therefore, this is a responsibility of the Audit Team Leader.

B. Adopting a risk-based approach to planning the audit

ISO 19011 promotes the use of a risk-based approach when:

Developing the audit programme.

Planning audit activities.

Allocating resources and audit time.

Determining audit priorities.

The Audit Team Leader applies this approach when preparing and managing the audit.

Therefore, this is a responsibility of the Audit Team Leader.

D. Chairing the audit opening and audit closing meeting

The Audit Team Leader normally:

Conducts the opening meeting.

Explains audit objectives, scope and methods.

Conducts the closing meeting.

Presents audit conclusions and findings.

Therefore, this is a responsibility of the Audit Team Leader.

F. Establishing contact with the auditee

Before and during the audit, the Audit Team Leader:

Establishes communication channels.

Confirms audit arrangements.

Coordinates schedules and logistics.

Clarifies audit activities.

Therefore, this is a responsibility of the Audit Team Leader.

Why the Other Options Are Incorrect

C. Issuing the management system certificate

Certification decisions and certificate issuance are the responsibility of the Certification Body , not the Audit Team Leader.

ISO/IEC 17021 requires certification decisions to be made independently of the audit team.

E. Auditing top management

The Audit Team Leader may audit top management, but this is not a management responsibility of leading the audit team . It is simply an audit assignment that could be performed by any competent auditor.

G. Selecting the audit team

Selection of auditors is normally the responsibility of the:

Audit Programme Manager,

Certification Body,

Individual(s) managing the audit programme.

Not the Audit Team Leader.

H. Preparing the audit nonconformity reports

Each auditor normally prepares and documents their own findings and nonconformities. The Audit Team Leader reviews, coordinates, and approves them, but does not necessarily prepare all nonconformity reports.

Therefore, this is not considered one of the key management responsibilities listed.

ISO-Aligned Summary

Option

Audit Team Leader Responsibility?

Holding the audit team meeting

Yes

Adopting a risk-based approach to planning the audit

Yes

Issuing the management system certificate

No

Chairing the audit opening and audit closing meeting

Yes

Auditing top management

No

Establishing contact with the auditee

Yes

Selecting the audit team

No

Preparing the audit nonconformity reports

No

Answer: A, B, D, F

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Approve Certification Body: Accreditation Body

Award certification: Certification Body

Recommend certification: Audit Team Leader

Maintain certification:

Comprehensive Detailed Explanation

In the context of a third-party ISO 9001 audit, different entities play specific roles in the certification process. Here ' s a detailed explanation of the responsibilities:

Approve Certification Body: Accreditation BodyThe Accreditation Body is responsible for approving Certification Bodies. Accreditation Bodies are independent entities that evaluate the competence of Certification Bodies, ensuring they meet international standards like ISO/IEC 17021, which sets out the criteria for bodies providing audit and certification of management systems. In this role, they confirm that the Certification Body is capable of conducting ISO 9001 audits and granting certifications in accordance with international guidelines.

Award Certification: Certification BodyThe Certification Body is the entity that ultimately awards the certification to an organization after verifying that it meets the ISO 9001 standards. Certification Bodies conduct audits, either directly or through a team of auditors, and based on the audit outcomes, they issue the certification, indicating that the organization complies with ISO 9001.

Recommend Certification: Audit Team LeaderThe Audit Team Leader is responsible for leading the audit and making a recommendation to the Certification Body. This recommendation is based on the audit findings—whether the organization meets the ISO 9001 requirements or if there are areas of non-compliance that need corrective action. The final decision on certification is not made by the Audit Team Leader but by the Certification Body.

Maintain Certification: Certification BodyMaintaining certification refers to the ongoing process of ensuring that an organization continues to comply with ISO 9001 requirements. The Certification Body conducts regular surveillance audits (e.g., annually) and may also perform recertification audits (typically every three years). This ongoing monitoring ensures that the certified organization continues to adhere to the quality management standards over time.

This breakdown clearly assigns responsibility based on the defined roles of Accreditation Bodies, Certification Bodies, and Audit Teams in the ISO 9001 certification process.

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.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 19011:2018, Clause 6.2.2 (Audit Planning):

The audit team leader is responsible for planning the audit and assigning roles.

Top management (A) does not plan the audit, but they provide resources.

While team members may provide input, the leader has the final authority.

Thus, B is the correct answer.

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