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NEW QUESTION # 51
Select the two statements that are true.
Answer: A,F
Explanation:
* Analyzing Each Statement:
* A.Incorrect. The audit team leader must communicate concerns as they arise, not just during the closing meeting. Per ISO 19011:2018 Clause 6.4.9, significant concerns should be shared promptly with the auditee and audit client during the audit process to allow for immediate understanding and potential resolution.
* B.Incorrect. The auditor or team leader is not specifically required to inform the general manager about uncontrolled documents. Instead, the issue is communicated within the framework of the audit findings to the audit client or auditee, as appropriate.
Reference: ISO 19011:2018, Clause 6.6.2.
D:Incorrect. Changes to the audit scope require the approval of the audit client (e.g., the certification body), not just the auditee. The scope is agreed upon in advance, and significant changes must be communicated with all stakeholders.
E:Correct. The audit team leader is responsible for periodically assessing the audit progress to ensure it aligns with the audit objectives and planned scope.Reference: ISO 19011:2018, Clause 6.4.5.
F:Incorrect. While immediate and significant risks should be communicated to the auditee, notifying the certification body is not an immediate responsibility of the audit team leader. The communication process depends on the procedures defined by the audit programme manager.
Why Options C and E Are Correct:
C: Communicating unattainable audit objectives ensures the audit remains effective and prevents unnecessary effort or misalignment with goals.
E: Periodic assessments by the team leader help in maintaining alignment with the scope, objectives, and time constraints, ensuring the audit's success.
Relevant References from ISO Standards:
ISO 19011:2018, Clause 6.6.2: Describes procedures for when audit objectives are unattainable.
ISO 19011:2018, Clause 6.4.5: Emphasizes the audit team leader's responsibility for ongoing assessment of audit progress.
NEW QUESTION # 52
You are conducting an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements.
The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.
You have gathered audit evidence as outlined below. Match the ISO 9001 Clause 8 extract to the audit evidence.
Answer:
Explanation:
Explanation:
Here is the correct matching of the ISO 9001 Clause 8 extracts to the audit evidence:
* Audit evidence: Three subcontract trainers who had delivered training were not approved as defined in procedure SA1 Supplier Approval revision 3.ISO 9001 Clause 8 extract: 8.4.1 ...shall apply criteria for
... external providers...(This clause requires the organization to control external providers, including ensuring their approval and competence.)
* Audit evidence: A training programme for a customer was not documented as required in procedure TD
2 Training revision 2.ISO 9001 Clause 8 extract: 8.3.5 ...shall retain documented information on design and development outputs.(This clause addresses the need to retain documented information related to design and development outputs, such as a training programme.)
* Audit evidence: One trainer had not recorded the damage to a customer's training room wall caused by using sticky tape to hang training aids, as required in procedure TD 2 Training revision 2.ISO 9001 Clause 8 extract: 8.5.3 ...shall retain documented information on what has occurred.(This clause relates to retaining documented information on activities and outcomes, including records of damage or issues encountered.)
* Audit evidence: Five sales orders had no record of having been reviewed to verify the ability to provide these courses.ISO 9001 Clause 8 extract: 8.2.3.1 ...shall conduct a review before committing...(This clause specifies the requirement to review and verify the organization's ability to meet customer requirements before accepting sales orders.) These mappings reflect the specific requirements of ISO 9001:2015 for managing external providers, retaining documented information, and reviewing contracts.
NEW QUESTION # 53
Scenario 2:
Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.
To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.
Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.
The team defined the QMS scope as:
"The scope of the QMS includes all activities related to food processing." Leslie established a quality policy and presented it to the team for review before top management approval
. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.
Which of the following indicates that Bell has defined its quality objectives?
Answer: A
Explanation:
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.
Reference:
ISO 9001:2015, Clause 6.2 - Quality Objectives and Planning to Achieve Them
NEW QUESTION # 54
Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?
Answer: C,E
Explanation:
According to ISO 19011:2018, clause 6.3, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the information listed in my previous response, such as the audit objectives, scope, criteria, schedule, team, methods, report, etc. The audit plan should be prepared and completed prior to the on-site audit, and should be communicated to the audit team and the auditee1.
According to ISO 19011:2018, clause 6.4.3, the checklist / prompts are documents that list the questions or topics that need to be covered during an audit. The checklist / prompts can help the auditor to collect and verify information relevant to the audit criteria, and to ensure the consistency and completeness of the audit.
The checklist / prompts should be prepared and completed prior to the on-site audit, and should be based on the audit plan and the audit scope and objectives1.
Therefore, the two documents that an auditor needs to prepare and complete prior to the on-site audit are B and D, as they are essential for planning and conducting the audit. The other options are not correct, as they are either prepared or completed after the on-site audit, or not required by the standard:
*A. Audit Report: The audit report is a document that provides a complete, accurate, concise, and clear record of the audit. The audit report should include the information listed in my previous response, such as the audit objectives, scope, criteria, findings, conclusions, etc. The audit report should be prepared and completed after the on-site audit, and should be distributed to the audit client and the auditee1.
*C. Procedures: Procedures are documents that specify the way activities are to be performed. Procedures may be part of the audit criteria, if they are part of the organization's management system, or part of the audit programme, if they are part of the certification body's or registrar's requirements. Procedures are not prepared or completed by the auditor prior to the on-site audit, but rather reviewed or followed by the auditor during the audit1.
*E. Risk Matrices: Risk matrices are tools that help to assess and prioritize the risks and opportunities associated with the audit programme or the audit. Risk matrices may be part of the audit programme management, if they are used to determine and evaluate the audit programme risks and opportunities, or part of the audit preparation, if they are used to determine and evaluate the audit risks and opportunities. Risk matrices are not prepared or completed by the auditor prior to the on-site audit, but rather used or updated by the auditor during the audit programme management or the audit preparation1.
*F. Findings: Findings are the results of the evaluation of the collected audit evidence against the audit criteria. Findings can indicate either conformity or nonconformity, as well as positive aspects or opportunities for improvement. Findings are not prepared or completed by the auditor prior to the on-site audit, but rather generated and recorded by the auditor during the audit activities1.
References: ISO 19011:2018(en), Guidelines for auditing management systems
NEW QUESTION # 55
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
According to Scenario 6, the audit team required DC's top management to submit corrective action plans within two weeks. Is this action acceptable?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions) states:
The auditor can set a reasonable deadline for corrective actions.
10 to 60 days is a best practice timeframe for the auditee to respond.
The auditee must propose corrective actions, but the audit team has the authority to set the deadline.
A 7-day deadline (A) is too short, and the audit team-not the auditee-determines the timeframe (B).
Reference:
ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions)
NEW QUESTION # 56
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