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B. Applicable procedure: SP-701

D. Identification number of the washing machine

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

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

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

C. Competence record of the machine operator

The action that the auditor would have accepted is:

•Option B: Apply the existing process of addressing the risks and opportunities of milk production. This option is correct because ISO 9001:2015 clause 8.1 requires the organization to plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement actions determined in clause 6.1, which refers to the actions to address risks and opportunities. The organization should apply the existing process of addressing the risks and opportunities of milk production, which may include identifying the sources of variability, assessing the potential impacts and consequences, determining and implementing appropriate actions to reduce or eliminate the variability, monitoring and measuring the effectiveness of the actions, and reviewing and updating the actions as necessary.

The following options are not correct:

•Option A: Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and make an agreement with a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization’s commitment to meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.

•Option C: Retain the current contract and try to sell the occasional surplus milk to a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization’s commitment to meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.

•Option D: Analyse the daily dispatch of milk for 7 days to determine its variability. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization’s commitment to implement actions to address risks and opportunities, as required by ISO 9001:2015 clause 8.1.

The purpose of conducting a document review is to determine the conformity of the system, as far as documented, with audit criteria and to gather information to support the audit activities. A document review is a systematic and objective examination of the documented information that is relevant to the audit objectives and scope. It can help the auditor to verify if the documented information is complete, accurate, consistent, and up-to-date. It can also help the auditor to identify any gaps, errors, or nonconformities in the documented information that may affect the audit findings or conclusions.

The other options are not correct because they do not reflect the true purpose of a document review. Option A describes the purpose of an audit report, which is to communicate the audit results and recommendations to the management and other interested parties. Option B describes the purpose of an audit plan, which is to define the scope, objectives, criteria, methods, resources, and schedule of an audit. Option C describes the purpose of an audit evidence report, which is to provide evidence of nonconformities or opportunities for improvement identified during an audit. Option D describes the purpose of an audit decision report, which is to justify or explain why certain decisions were made during an audit.

I hope this answer helps you understand why option F is correct and why options A-C-D are incorrect. If you want to learn more about ISO 9001 Lead Auditor exam questions and answers, you can check out some of these resources:

ISO 9001 Lead Auditor Sample Exam Questions and Answers: This article provides some sample questions and answers for each section of the ISO 9001 Lead Auditor exam.

ISO 9001 (QMS) Lead Auditor Quiz Questions and Answers: This article provides some quiz questions and answers on various topics related to ISO 9001 QMS.

ISO 9001 Lead Auditor - Exam Practice Tests: This course offers practice tests with explanations for each question.

Irca Lead Auditor Exam Questions And Answers Pdf: This document contains some exam questions and answers in PDF format.

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 6.4.9 (Audit Conclusions):

Audit conclusions must be based on verified evidence.

The evidence must be evaluated both quantitatively and qualitatively to ensure accuracy.

Observations alone (A) are insufficient; conclusions must be supported by objective evidence.

Thus, B is the correct answer.

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:

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 6.2 (Quality Objectives and Planning to Achieve Them) states that an organization must establish measurable and relevant quality objectives to improve QMS effectiveness.

Bell's strategy for handling customer complaints aligns with this requirement because it includes specific, measurable goals (biweekly customer surveys) to enhance customer satisfaction and service quality.

Other options are not directly related to defining quality objectives:

Option B (Implementing a QMS) refers to the overall system, not specific objectives.

Option C (Creating a QMS team) is an implementation step, not an objective.

Option D (Assigning responsibilities) is necessary for QMS but does not define objectives.

Comprehensive and Detailed In-Depth Explanation:

Auditors must have competence in risk-based auditing to effectively assess an organization’s QMS performance and compliance.

Clause References:

ISO 19011:2018, Clause 7.2.3 – Determining Auditor Competence:

Auditors must have knowledge of risk-based thinking to assess risk impact on processes.

ISO 9001:2015, Clause 0.3.3 – Risk-Based Thinking:

The standard emphasizes proactive risk management, which auditors must understand.

Why is the Correct Answer B?

Risk-based auditing ensures audits focus on high-risk areas, improving audit effectiveness.

Auditors must assess how organizations apply risk-based thinking in decision-making, process control, and improvement.

Why are the Other Options Incorrect?

A (Industry knowledge) → While helpful, it is not mandatory for all auditors.

C (Expertise in all domains) → Auditors are not required to be experts in all areas, just in audit methodology.

D (Formal degree in quality management) → ISO does not require a formal degree, just competence in audit principles and methods.