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NEW QUESTION # 113
Knowledge and skills are requirements of the auditor's competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.
Answer: A,C
Explanation:
According to ISO 9001:2015, clause 7.2, an auditor shall have the competence to:
Understand the requirements of ISO 9001 and how they relate to the audit Understand the organization's quality management system and its processes Understand the applicable legal, regulatory, contractual and other requirements that affect the audit Understand the needs and expectations of interested parties other than customers Plan and conduct audits in accordance with ISO 19011 Evaluate audit evidence and draw appropriate conclusions Communicate audit findings effectively1 Therefore, knowledge of ISO 9001 requirements and ISO 19011 audit principles are essential for every member of an audit team auditing an ISO 9001 quality management system.
References:
ISO 9001:2015 - Quality management systems - Requirements
ISO 19011:2018 - Guidelines for auditing management systems
NEW QUESTION # 114
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures
cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: "I would like to begin by looking at the cleaning controls."
MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside." Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.
Answer:
Explanation:
NEW QUESTION # 115
You are an auditor from a construction organisation 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. " You continue to interview the operator and find that around 25% of the billets are sent back to the furnace.
This includes 80% of the borderline cases.
Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.
Answer: C,E,G
Explanation:
According to ISO 9001:2015, clause 9.1.1, the organization is required to determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results, and when the monitoring and measuring shall be performed. The organization is also required to retain appropriate documented information as evidence of the results.
Therefore, in the scenario given, the organization should have planned for monitoring and measuring the billet temperature, as it is a critical factor for the quality of the product and the process. The organization should also have established a procedure that provides instruction in taking billet temperature, using the pyrometer or other suitable methods, to ensure consistency and accuracy. The organization should also have performed periodic analysis of the results of temperature checks, to identify trends, problems, and opportunities for improvement.
Hence, the options that would provide evidence of conformance with clause 9.1.1 of ISO 9001 are A, E, and F, as they are aligned with the requirements of the clause. The other options are either irrelevant or not directly related to clause 9.1.1, as they do not pertain to the monitoring and measurement of the billet temperature.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 9.1.1 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6
NEW QUESTION # 116
What is reliability in the context of service quality?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:Reliability in service quality refers to the consistent and dependable delivery of promised services.
ISO 9001:2015 emphasizes reliability through:
* Clause 8.2.1 (Customer Communication) - Ensuring clarity in service commitments.
* Clause 8.5.1 (Control of Service Provision) - Ensuring processes meet requirements consistently.
Other options do not fully define reliability:
* Option A (Safe services) relates to safety, not reliability.
* Option B (Readiness and goodwill) relates to responsiveness, not reliability.
* Option D (Low cost) focuses on pricing, not quality.
NEW QUESTION # 117
Select the two statements that are true.
Answer: C,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 # 118
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