(From the following, select six tasks you would expect to be completed during the audit team meeting of a second-party audit in preparation for the closing meeting of a four-day audit being performed by organisation ABC to an external provider.)
Answer : C, E, F, G, H, J
Comprehensive and Detailed Explanation From ISO 9001 / ISO 19011 Guidance:
ISO 9001:2015 requires audits to be planned and conducted objectively, but it refers auditors to ISO 19011 for detailed guidance on audit activities, including audit team meetings and preparation for closing meetings.
ISO 19011:2018 describes the purpose of the audit team meeting before the closing meeting as ensuring alignment, consistency, and clarity of audit conclusions and messages to the auditee.
Explanation of the selected tasks:
C . The audit team review any points raised by the auditee-nominated representative during the audit.
ISO 19011 requires the audit team to consider and evaluate information and concerns raised by the auditee to ensure audit findings are accurate, fair, and evidence-based before the closing meeting.
E . The audit team agrees on the audit opportunities for improvement to be presented to the supplier.
Before the closing meeting, the audit team must align on opportunities for improvement so that these are presented consistently and clearly, without contradiction between auditors.
F . The audit team agrees on the roles of each audit team member for the closing meeting.
ISO 19011 requires clear allocation of responsibilities within the audit team. Agreeing who will present findings, nonconformities, or conclusions is a normal and expected preparation activity.
G . The audit team leader writes all audit finding reports, taking into account the inputs provided by each auditor.
The audit team leader is responsible for consolidating audit inputs and ensuring consistency of reporting, even though individual auditors contribute evidence and findings.
H . Each audit team member completes the report of their individual findings.
ISO 19011 expects each auditor to document their findings and provide them to the audit team leader for consolidation into the final audit report.
J . The audit team agrees on the conformities and non-conformities to be included in the final audit report.
Before the closing meeting, the audit team must reach consensus on audit conclusions to ensure findings are clear, justified, and consistently communicated.
Explanation of why the other options are not selected:
A: Daily meetings with the auditee's Quality Manager are not part of an internal audit team meeting and may compromise independence.
B: The final audit report is not completed and signed during the audit team meeting prior to the closing meeting.
D: Refusing to review corrective actions is inappropriate; however, corrective actions are normally reviewed after the audit, not during preparation for the closing meeting.
I: Informing the Procurement Manager is an administrative action, not a task of the audit team meeting.
ISO-aligned conclusion:
Who maintains ownership of the audit report?
Answer : C
Comprehensive and Detailed In-Depth
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.
ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting)
Which of the following is a principle of maintaining audit work documents?
Answer : C
Comprehensive and Detailed In-Depth
Completeness ensures that all necessary audit evidence, observations, and findings are properly documented, which is critical for traceability and accountability in an audit.
While transparency and fair presentation are principles of auditing, completeness is specifically related to maintaining audit work documents, as required in ISO 19011:2018, Clause 6.5.4 (Preparing Audit Work Documents).
ISO 19011:2018, Clause 6.5.4 (Preparing Audit Work Documents)
During a second-party audit of a dairy farm (by a potential customer) complying with ISO 9001:2015, the auditor verifies that there is large variability in the daily production of the milking yard. The current agreement with their only customer is to provide 2,000 litres per day. However, in the last two years, they have noticed an increasing variability in daily production.
If they produce less than 2,000 litres, they are penalised with a fine of 1.5 pesos for every litre that they do not provide. If they produce more than 2,000 litres, they use the extra milk to feed the pigs.
This process has been in operation for decades. The dairy farm was founded by the grandfather of the current owners, who did not want to alter the established practices.
The auditor raises a nonconformity on the basis that the process is not under control (Clause 8.1).
If you had been the auditor, which one of the following actions would you have accepted?
Answer : B
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.
*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
What should the auditor document during the Stage 1 audit?
Answer : C
Comprehensive and Detailed In-Depth
Stage 1 Audit (ISO 9001:2015, Clause 9.2.2) is a documentation review to assess the readiness for a Stage 2 Audit. The auditor must document:
Observations that could lead to nonconformities, ensuring they are addressed before Stage 2.
Areas needing improvement, such as missing documented information or unclear process definitions.
While understanding the auditee's main processes is important, documenting interviews is not a requirement at Stage 1.
ISO 9001:2015, Clause 9.2.2 (Internal Audit Reporting)
Even though past audits have highlighted a consistently large number of nonconformities within an organisation's design team, the organisation has not varied the frequency or duration of audits on its audit plan.
The decision for whether this situation is acceptable or not should be governed by which of the following?
Answer : A
Which two of the following roles do not contribute to the audit outcomes?
Answer : A, B
The individual(s) managing the audit programme and the auditee are both roles that contribute to the audit outcomes.The individual(s) managing the audit programme are responsible for planning, conducting, and reporting on the audit activities, as well as ensuring that they are aligned with the organization's quality objectives and risk management processes1.The auditee is the person or entity that is subject to an audit, and their participation, cooperation, and feedback are essential for achieving a successful audit outcome2.Reference:
ISO 9001 Lead Auditor Reference Materials
ISO 9001 Lead Auditor Candidate Handbook
ISO 9001 Lead Auditor Course Material
ISO 9001 Lead Auditor Training Course IRCA Certified