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| Section | Objectives |
|---|---|
| Topic 1: Quality Management System (QMS) Fundamentals | - ISO 9001:2015 Structure and Clauses
|
| Topic 2: Conducting Audit Activities | - Audit Evidence Collection
|
| Topic 3: Audit Reporting and Follow-up | - Audit Reporting
|
| Topic 4: Audit Principles and Fundamentals | - Audit Concepts
|
| Topic 5: Audit Planning and Preparation | - Audit Preparation
|
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NEW QUESTION # 41
Which two of the following auditors would not participate in a first-party audit?
Answer: B,E
Explanation:
A first-party audit is an internal audit conducted by auditors who are employed by the organization being audited but who have no vested interest in the audit results of the area being audited1. The purpose of a first-party audit is to assess the conformity of the organization's quality management system to the requirements of ISO 9001 and to identify opportunities for improvement2. Therefore, the two auditors who would not participate in a first-party audit are:
*A. An auditor employed by an external consultancy organization: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit (if the external consultancy organization is a customer or supplier of the organization being audited) or a third-party audit (if the external consultancy organization is a certification body or registrar).
*F. An auditor from a customer: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit, as a customer is an interested party that has specific requirements for the organization being audited.
The other options are not correct, as they could participate in a first-party audit, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited:
*B. An auditor from an interested party: This auditor could be a first-party auditor, as long as the interested party is within the organization being audited. For example, an auditor from the finance department could audit the production department, as long as they are not involved in the production process or affected by its outcomes.
*C. An auditor trained in-house: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The source of the auditor's training is not relevant for determining the type of audit, as long as the auditor is competent and qualified to perform the audit.
*D. An auditor trained in the IRCA scheme: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The IRCA scheme is a professional certification scheme for auditors of management systems, which provides recognition of the auditor's competence and credibility3. However, being trained in the IRCA scheme does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.
*E. An auditor certified by IRCA: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. Being certified by IRCA means that the auditor has met the requirements of the IRCA scheme and has demonstrated their competence and credibility as an auditor of management systems3. However, being certified by IRCA does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.
References: First Party Audits: The 5 Steps to Success - Sync Resource Inc, ISO 9001 Auditing Practices Group, IRCA - International Register of Certificated Auditors
NEW QUESTION # 42
You are an auditor from a construction company who is conducting a second-party audit to ISO 9001 at a steel rolling mill producing structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.
You: "How do you tell when the billet is ready for the rolling stage?"
Operator: "I've done this job for 20 years. I can tell by the bright red colour." You: "What happens if the colour is wrong?" Operator: "The billet goes back into the furnace." You: "Is the pyrometer ever used?" Operator: "Only in borderline cases." Select the two checkpoints you should investigate further in the situation.
Answer: D,E
Explanation:
ISO 9001:2015 requires organisations to control production processes and ensure that personnel performing work affecting product conformity are competent and follow defined operational controls, particularly where objective measurement is available and specified.
Relevant ISO 9001 requirements include:
* Clause 8.5.1 - Control of production and service provisionProduction shall be carried out under controlled conditions, including the availability and use of suitable monitoring and measuring resources and the implementation of monitoring and measurement activities at appropriate stages.
* Clause 7.2 - CompetenceThe organisation shall determine the necessary competence of persons doing work that affects product conformity and ensure that these persons are competent on the basis of appropriate education, training, or experience.
Explanation of the correct checkpoints:
A). How is the unloading process controlled and managed?
The operator is relying on personal judgement rather than consistently using the specified measuring equipment (infrared pyrometer). This raises a clear audit concern about whether the unloading process is defined, standardised, and controlled in accordance with Clause 8.5.1, and whether required measurement methods are being followed.
C). What training does an operator need for the unloading task?
The operator's reliance on experience rather than defined criteria indicates the need to verify whether the organisation has formally defined competence requirements and training for this task, including the correct use of temperature-measuring equipment, as required by Clause 7.2.
Explanation of why the other options are not selected:
* B: Measurement of finished products occurs later and does not address the immediate process control issue identified at unloading.
* D: While risk-based thinking is important, the primary concern here is operational control and competence at the process level, not higher-level risk analysis.
* E: Customers do not define how internal furnace unloading operations are performed.
* F: The issue relates to operator behaviour and process control, not process design staff qualifications.
ISO-aligned conclusion:
In this scenario, the most relevant audit follow-up checkpoints are those that confirm:
* The process is controlled and defined, and
* The operator is competent and trained to perform the task in line with defined requirements.
Therefore, the correct answers are A and C.
NEW QUESTION # 43
(Select from the options which two of the following documented information examples are prepared by the auditor as a member of an audit team.)
Answer: D,F
Explanation:
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
NEW QUESTION # 44
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers.
You are interviewing the Quality Systems Manager (QSM).
You: "What risks and opportunities have the business identified?"
QSM: "I'1l show you. This was discussed with the Managing Director at the latest management review." Narrative: The QSM shows you the latest management review record and points to the following table:
You: "How is the business planning to address these risks and opportunities?" QSM: "The MD said that they already knew about them so it was not necessary."
Answer:
Explanation:
Explanation:
Non-Conformity Report:
ISO 9001 Clause Number
Nature of Problem
ISO 9001 Requirement That Has Not Been Fulfilled
6.1.1
Several risks and opportunities have not been determined.
"The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed."
6.1.2 (a)
Actions to address risks and opportunities not planned.
"The organization shall plan actions to address risks and opportunities." Step-by-Step Reasoning:
Clause 6.1.1 - Determining Risks and Opportunities:
Requirement: The organization must determine risks and opportunities that are relevant to its Quality Management System (QMS). This ensures that the QMS achieves intended results and prevents undesired effects.
Problem Identified: While some risks and opportunities were discussed, the organization did not perform a systematic evaluation of all risks (e.g., health and safety legislation changes, retiring trainers).
Clause 6.1.2 (a) - Planning Actions for Risks and Opportunities:
Requirement: The organization must plan actions to address identified risks and opportunities. These actions should be integrated into the QMS processes to ensure continuous improvement.
Problem Identified: The Quality Systems Manager confirmed that no plans were made to address the risks and opportunities because the Managing Director deemed it unnecessary. This violates the requirement to plan actions.
Correct Options Selected:
Clause 6.1.1 with the nature of the problem as: "Several risks and opportunities have not been determined." Clause 6.1.2 (a) with the nature of the problem as: "Actions to address risks and opportunities not planned." ISO 9001 Requirements Not Fulfilled:
For 6.1.1:"The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed." For 6.1.2 (a):"The organization shall plan actions to address risks and opportunities."
NEW QUESTION # 45
Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top- notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.
In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.
Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS.
They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.
During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS.
AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.
Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.
Based on the scenario above, answer the following question:
Which of the following misconceptions about ISO 9001 was present in scenario 1?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:One of the common misconceptions about ISO 9001 is that it only applies to manufacturing companies producing tangible goods. However, ISO 9001:2015 is designed for all types of organizations, including service providers such as financial, healthcare, and IT companies.
Clause 1 (Scope) clearly states that ISO 9001 is applicable to any organization, regardless of type, size, or the products and services it provides. AL-TAX, being a financial services company, is equally eligible for implementing a QMS under ISO 9001.
NEW QUESTION # 46
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