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

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:

 First-party Management System audit → All members of an audited organisation

 Second-party Management System audit → Interested parties of an organisation

According to ISO 19011:2018 (Guidelines for Auditing Management Systems) and as reinforced in ISO 9001 Lead Auditor training materials , audit types are defined as:

First-party audit – conducted by the organization itself, or on its behalf (internal audit). ✅ The audit client is all members of the audited organisation , because the audit is internal, involving all functional areas under the organization’s control.

Second-party audit – conducted by a customer or other person on behalf of a customer (external but not by a certification body). ✅ The audit client includes interested parties of an organisation , such as customers who want to verify if their suppliers meet contractual or regulatory requirements.

These definitions are directly aligned with ISO 19011:2018, Clause 3.13 – Types of audits .

Why Other Options Are Incorrect:

Certification body / Accreditation body → These relate to third-party audits , not first or second.

Top management / Functions of an audited organisation → Refer to auditees or audit participants , not the audit client itself.

According to the ISO 9001:2015 standard, clause 6.2.1 requires organizations to establish quality objectives at relevant functions, levels, and processes needed for the quality management system. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The quality objectives must also be measurable, monitored, communicated, and updated as appropriate.

In this scenario, the Quality Manager of XYZ Corporation has set quality objectives for every employee in the organization except top management. This has created a lot of resistance to the QMS, and the Chief Executive is asking questions about the cost and the method of setting objectives. The Quality Manager asks for your opinion as an auditor on whether this is the correct method of setting objectives.

As an auditor, you cannot provide advice to the organization on how it should operate its QMS. Your role is to assess the conformity and effectiveness of the QMS against the requirements of the standard and the organization’s own policies and objectives. Therefore, you should respond with the following options:

B. Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organization’s requirements: You can suggest that the Quality Manager should familiarize himself with the requirements of clause 6.2.1 and understand how they apply to his organization. He should also consider the context and the needs and expectations of interested parties when setting quality objectives. He should ensure that the quality objectives are aligned with the quality policy and the strategic direction of the organization.

C. Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly: You can inform the Quality Manager that you will evaluate the quality objectives during the audit and check whether they meet the requirements of clause 6.2.1. If you find any gaps or weaknesses in the quality objectives, you will raise an opportunity for improvement to help the organization improve its QMS. You will also verify whether the quality objectives are monitored, communicated, and updated as appropriate.

D. Inform the Quality Manager that you will comment on the subject in your audit report: You can inform the Quality Manager that you will document your findings and observations on the quality objectives in your audit report. You will also provide a summary of the audit results and any recommendations for improvement. You will also indicate the level of conformity and effectiveness of the QMS.

These three options would help you to maintain your impartiality and professionalism as an auditor and to provide constructive feedback to the organization

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.

ISO 9001:2015 refers auditors to ISO 19011:2018 for guidance on audit planning, preparation, conduct, and reporting.

As members of an audit team, auditors commonly prepare working documents that assist them in conducting audits effectively and obtaining objective evidence.

Correct Answers

A. Audit Sampling Plan

An auditor frequently develops or contributes to an audit sampling plan.

Sampling is necessary because:

It is usually impractical to examine every record, process, or transaction.

Auditors select representative samples to obtain sufficient objective evidence.

ISO 19011 recognizes sampling as a normal audit activity and auditors prepare sampling arrangements as part of audit preparation.

Therefore, this document can be prepared by an auditor.

B. Checklist

Audit checklists are one of the most common auditor working documents.

They are used to:

Organize audit activities.

Ensure audit criteria are covered.

Record objective evidence.

Support consistency during interviews and document review.

ISO 19011 identifies checklists as typical audit working papers prepared by auditors.

Therefore, this document can be prepared by an auditor.

Why the Other Options Are Incorrect

C. Management Review Record

This is documented information generated by the auditee organization , typically as evidence of compliance with ISO 9001 Clause 9.3.

It is reviewed by auditors but not prepared by them.

D. Internal Audit Record

This is normally a record created by the organization ' s own internal audit process under Clause 9.2.

A third-party audit team reviews these records but does not prepare them.

E. List of Staff Required at the Closing Meeting

This is generally arranged by the auditee and coordinated through the audit team leader. It is not typically an auditor-prepared audit document.

F. Scope

The audit scope is established by the audit client, certification body, audit programme manager, or audit team leader during audit planning.

Individual auditors do not normally prepare the audit scope.

ISO-Aligned Summary

Documented Information

Prepared by Auditor?

Audit sampling plan

Yes

Checklist

Yes

Management review record

No

Internal audit record

No

List of staff required at the closing meeting

No

Scope

No

Answer: A and B

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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.

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.