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.
References:
*ISO 9001:2015 Quality management systems - Requirements, Clause 8: Operation, Subclause 8.1:
Operational planning and control, Subclause 8.2: Requirements for products and services
*ISO 9001 Lead Auditor Course Material, Module 4: ISO 9001:2015 Requirements, Slide 23: Clause 8 - Operation
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 4.2: ISO 9001:2015 Requirements, Subsection 4.2.8: Clause 8 - Operation
*Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection
3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies

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

According to the ISO 9001:2015 standard, clause 10.2.1 defines nonconformity as the non-fulfilment of a requirement. A requirement can be related to the quality management system, the products and services, the customer expectations, or the applicable statutory and regulatory requirements. Nonconformities can be detected through various sources, such as audits, inspections, tests, customer complaints, or internal reviews.
Nonconformities must be addressed by taking appropriate actions to correct them and prevent their recurrence.
In this scenario, the auditee has shown several issues that indicate nonconformities in their quality management system. Two statements that apply to the term nonconformity are:
A). No quality objectives planned for the top management team: According to ISO 9001, clause 6.2.1, the organization must establish quality objectives at relevant functions, levels, and processes. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The top management team is responsible for providing leadership and direction for the quality management system and ensuring its alignment with the organization's purpose and context. Therefore, the absence of quality objectives for the top management team is a nonconformity as it violates the requirement of clause 6.2.1.
E). Quality improvements not aligning with the quality policy: According to ISO 9001, clause 5.2.1, the quality policy is a statement of the organization's intentions and direction regarding quality, as formally expressed by top management. The quality policy must provide a framework for setting quality objectives and be compatible with the context and strategic direction of the organization. The quality policy must also be communicated, understood, and applied within the organization. Therefore, if the quality improvements are not aligned with the quality policy, it is a nonconformity as it violates the requirement of clause 5.2.1.

Based on the scenario provided, there is evidence of nonconformity with the requirements defined in:
C). Clause 7.5.1 Documented information - General: The scenario indicates that there is no formal process for informing users about updates to the SWIFT database, which suggests a lack of control over documented information. This could lead to users being unaware of important changes and not using the latest version of the software, which is required by the quality management system1.
E). Clause 7.5.3 Control of documented information: The Operations Director's approach to updating the SWIFT database and the lack of communication to users about these updates indicate that the documented information is not adequately controlled. Allowing users to revert to earlier versions of the software at their discretion further suggests that the organization does not have a proper mechanism in place to ensure the integrity and suitability of documented information2.
These clauses are part of the ISO 9001:2015 standard, which requires organizations to have a systematic approach to controlling and managing documented information as part of their quality management system.
The scenario described shows a casual approach to managing critical software updates, which could affect the organization's ability to consistently meet customer and regulatory requirements.

A properly written nonconformity statement should contain:
* A clear description of the objective evidence.
* Reference to the audit criteria not fulfilled.
* Identification of where and when the evidence was found.
* Sufficient traceability to allow investigation and corrective action.
* Classification/grade where required by the certification body ' s process.
Why B is Correct
If any of the ORANGE+ procedures for bottling and labelling products were not being met.
The nonconformity should reference the specific internal procedure or audit criterion that was not followed.
Why C is Correct
The grade of nonconformity (major or minor).
In certification audits, nonconformities are typically classified according to certification body rules.
Why D is Correct
The date on which the evidence was identified.
The audit record should identify when the evidence was observed.
Why F is Correct
Batch number audited.
The batch number provides traceability and allows the organisation to investigate the affected product.
Why H is Correct
The description of the ISO 9001:2015 requirement not being complied with and the clause number.
A nonconformity must reference the audit criterion that was not fulfilled.
Why I is Correct
The place where the bottles with the wrong label were found.
The location where the evidence was observed should be recorded as part of the objective evidence.
Why the Other Options Are Incorrect
A). The regulatory requirements that apply to the juice being bottled.
May be relevant background information, but it is not essential information required to complete the nonconformity statement.
E). Composition of both sugar and sugarless juices.
Not required to establish the nonconformity.
G). Name of the supervisor and of the workers who were responsible for the bottling process.
Auditors report system failures, not assign blame to individuals.
J). The signature of the M1's supervisor accepting the non-conformity.
ISO 9001 and ISO 19011 do not require the auditee ' s signature to validate a nonconformity.
ISO-Aligned Conclusion
The six items that should be added to complete the nonconformity report are:
B). If any of the ORANGE+ procedures for bottling and labelling products were not being met.
C). The grade of nonconformity (major or minor).
D). The date on which the evidence was identified.
F). Batch number audited.
H). The description of the ISO 9001:2015 requirement not being complied with and the clause number.
I). The place where the bottles with the wrong label were found.