Audit Scenarios - Section 5
Audit Scenarios - Section 5
Scenario 1:
**Situation:**
During an audit at a manufacturing company, the auditor observes that top management has not
actively demonstrated leadership and commitment to the quality management system.
**Description:**
2. **Neglect of Quality Objectives:** The quality objectives were established, but they are not actively
tracked or reviewed by top management. There's no evidence of discussions or decisions related to the
performance of the quality objectives.
3. **Limited Promotion of the Process Approach:** The process approach and risk-based thinking are
not actively promoted by top management. Employees are not encouraged to use these principles in
their daily work.
**Non-Conformity Assessment:**
This situation can be assessed as a non-conformity because top management is not effectively meeting
the requirements of ISO 9001:2015 Clause 5.1 regarding leadership and commitment to the quality
management system.
**Corrective Actions:**
To address this non-conformity, top management should consider the following corrective actions:
1. **Active Involvement:** Top management should actively participate in QMS meetings, demonstrate
an interest in QMS performance, and engage in discussions related to quality improvement.
2. **Regular Review of Objectives:** Regularly review the performance of quality objectives and make
informed decisions based on the results. Adjust objectives as needed to align with strategic goals.
3. **Promote Process Approach:** Encourage employees to use the process approach and risk-based
thinking in their daily work. Provide training and resources to support this approach.
Scenario 2:
Customer Focus**
**Situation:**
An auditor is conducting an audit at a service organization. During the audit, it becomes evident that the
organization has not effectively demonstrated customer focus.
**Description:**
1. **Undefined Customer Requirements:** The organization has not clearly defined customer
requirements, leading to misunderstandings and inconsistent service delivery.
2. **Inadequate Risk Assessment:** The organization has not assessed the risks and opportunities that
could affect customer satisfaction, such as service disruptions or delays.
3. **Lack of Customer Feedback:** The organization does not actively seek or collect customer feedback
to evaluate customer satisfaction and identify areas for improvement.
**Non-Conformity Assessment:**
This situation can be assessed as a non-conformity because the organization is not effectively meeting
the requirements of ISO 9001:2015 Clause 5.1.2 regarding customer focus.
**Corrective Actions:**
To address this non-conformity, the organization should consider the following corrective actions:
1. **Define Customer Requirements:** Clearly define customer requirements and expectations to
ensure consistent service delivery.
2. **Risk Assessment:** Conduct a thorough risk assessment to identify potential risks and
opportunities related to customer satisfaction. Develop strategies to address these risks.
3. **Customer Feedback Process:** Establish a process for actively seeking and collecting customer
feedback. Use this feedback to measure customer satisfaction and drive continuous improvement.
These scenarios represent common challenges that organizations may face in demonstrating leadership
and commitment and maintaining customer focus, as required by ISO 9001:2015 Section 5. Auditors play
a critical role in identifying non-conformities and helping organizations improve their quality
management systems.
Scenario 3:
An auditor is conducting an audit on a hospital that provides health care
services for various patients. The auditor reviews the quality policy and finds
that it is vague, generic, and does not reflect the purpose and context of the
hospital or its strategic direction. The quality policy does not provide a
framework for setting quality objectives, nor does it include a commitment to
satisfy applicable requirements or to continually improve the quality
management system. The auditor interviews the top management and learns
that they have not established, implemented, or maintained the quality policy,
nor have they communicated, understood, or applied it within the hospital or to
relevant interested parties. The auditor concludes that this is a nonconformity
because the hospital has failed to comply with the requirements of ISO
9001:2015 clause 5.2 Policy.
Scenario 4:
An auditor is conducting an audit on a school that provides education services
for various students. The auditor reviews the organizational roles,
responsibilities, and authorities and finds that they are not clearly defined,
assigned, communicated, or understood within the school. The auditor
interviews the top management and learns that they have not ensured that the
quality management system conforms to the requirements of ISO 9001:2015,
nor have they ensured that the processes are delivering their intended outputs.
The top management has also not reported on the performance of the quality
management system or on opportunities for improvement, nor have they
ensured the promotion of customer focus throughout the school. The auditor
concludes that this is a nonconformity because the school has failed to comply
with the requirements of ISO 9001:2015 clause 5.3 Organizational roles,
responsibilities and authorities.
Scenario 5:
An auditor is conducting an audit on a restaurant that provides food and
beverage services for various customers. The auditor reviews the evidence of
leadership and commitment and finds that the top management has not
demonstrated leadership and commitment with respect to the quality
management system or customer focus. The top management has not taken
accountability for the effectiveness of the quality management system, nor have
they ensured that the quality policy and quality objectives are established and
compatible with the context and strategic direction of the restaurant. The top
management has also not ensured the integration of the quality management
system requirements into the restaurant’s business processes, nor have they
promoted the use of the process approach and risk-based thinking. The top
management has not communicated the importance of effective quality
management or of conforming to the quality management system requirements,
nor have they ensured that the quality management system achieves its
intended results. The top management has also not engaged, directed, or
supported persons to contribute to the effectiveness of the quality management
system, nor have they promoted improvement. The top management has also
not ensured that customer and applicable statutory and regulatory requirements
are determined, understood, and consistently met, nor have they determined
and addressed the risks and opportunities that can affect conformity of products
and services and the ability to enhance customer satisfaction. The top
management has also not maintained the focus on enhancing customer
satisfaction. The auditor concludes that this is a nonconformity because the
restaurant has failed to comply with the requirements of ISO 9001:2015 clause
5.1 Leadership and commitment.
Scenario 6:
An auditor is conducting an audit on a travel agency that provides tour packages and
booking services for various destinations. The auditor reviews the quality objectives
and finds that they are not consistent with the quality policy or the strategic direction
of the travel agency. The quality objectives are not measurable, achievable, relevant,
or time-bound, nor are they communicated or monitored within the travel agency. The
auditor interviews the top management and learns that they have not ensured that the
quality policy and quality objectives are established for the quality management
system and are compatible with the context and strategic direction of the travel
agency. The top management has also not ensured that the resources needed for the
quality management system are available, nor have they supported other relevant
management roles to demonstrate their leadership as it applies to their areas of
responsibility. The auditor concludes that this is a nonconformity because the travel
agency has failed to comply with the requirements of ISO 9001:2015 clause 5.1
Leadership and commitment.
Scenario 6:
**Situation:**
**Description:**
2. **No Commitment to Continual Improvement:** While the quality policy mentions the commitment
to satisfy applicable requirements, it does not explicitly include a commitment to continual improvement
of the quality management system.
3. **Lack of Employee Understanding:** Employees within the organization do not have a clear
understanding of the quality policy. There is minimal awareness of the policy's content and its relevance
to their roles.
**Non-Conformity Assessment:**
This situation can be assessed as a non-conformity because the organization is not effectively meeting
the requirements of ISO 9001:2015 Clause 5.2 regarding the establishment of an appropriate quality
policy.
**Corrective Actions:**
To address this non-conformity, the organization should consider the following corrective actions:
1. **Revise the Quality Policy:** Rewrite the quality policy to make it more appropriate to the
organization's purpose and context. Ensure that it aligns with the organization's strategic direction and
includes a commitment to continual improvement.
2. **Communication and Awareness:** Communicate the revised quality policy to all employees within
the organization. Conduct training sessions or awareness campaigns to ensure that employees
understand the policy and its relevance to their roles.
3. **Documentation and Availability:** Maintain the quality policy as documented information and
make it readily available to all employees. Ensure that it is accessible in relevant areas of the
organization.
By implementing these corrective actions, the organization can rectify the non-conformity and
demonstrate compliance with ISO 9001:2015 Clause 5.2, ensuring that the quality policy is appropriate,
well-communicated, and supports the organization's quality objectives and strategic direction.