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NEW QUESTION # 79
Which of the following subjects should an auditor discuss when communicating with the auditee's top management?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:During communication with top management, the auditor should discuss:
* The quality policy (ISO 9001:2015, Clause 5.2.1), ensuring that it is established, communicated, and understood.
* Internal audits (ISO 9001:2015, Clause 9.2), verifying that they are planned and effectively implemented.
These discussions help assess leadership commitment and the effectiveness of the QMS.
NEW QUESTION # 80
You are the supervisor in Production of a medium size manufacturing organisation. You are qualified as an internal auditor. The Quality Manager asks you to lead the next internal audit of Production and Logistics Dispatch. The audit team includes two other internal auditors.
Answer:
Explanation:
Explanation:
Here is the correct matching of actions to the statements in the context of leading the internal audit:
* If practicablecarry out a formal opening meeting
* You should notaudit production (as you are a supervisor in that area, and this would compromise audit objectivity)
* You need notchange the audit team (unless there is a specific reason, such as conflict of interest)
* You mustraise audit findings if necessary (this is a key responsibility of an auditor when nonconformities are found)
* You must notsend the audit report to the Quality Manager (the audit report must be reviewed first; it is typically part of the internal audit process to go through necessary channels before final submission)
* You shouldsend the audit report to the Quality Manager (after appropriate reviews and approvals) This reflects key principles of conducting an internal audit according to ISO 9001:2015, ensuring objectivity, proper documentation, and clear reporting procedures.
NEW QUESTION # 81
How much time is usually spent on the Stage 1 audit?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015 (Conformity Assessment - Requirements for Certification Bodies), Clause
9.3.1.2, the Stage 1 Audit typically consumes around 30% of the total audit time.
This time is allocated to:
Reviewing documented information.
Assessing the readiness for Stage 2.
Identifying potential nonconformities.
A 20% allocation (Answer A) is too low, and 40% (Answer C) is excessive, as the majority of the audit should be spent on Stage 2 (on-site verification).
Reference:
ISO 17021-1:2015, Clause 9.3.1.2 (Determination of Audit Time)
NEW QUESTION # 82
Which of the following is a principle of maintaining audit work documents?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
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).
Reference:
ISO 19011:2018, Clause 6.5.4 (Preparing Audit Work Documents)
NEW QUESTION # 83
You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: " I ' d like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months? " Auditee: " We have made some strategic changes, the main one being that we no longer manufacture our own products in house. " You: " That sounds like quite a significant change. What has been the impact of that? " Auditee: " We now mainly sell other manufacturers ' products, under their brand names, and have outsourced manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging time. " You: " I ' m sure. What were the reasons for making the change? " Auditee: " Our manufacturing section was a small operation, and we struggled to cope with fluctuations in demand. During busy periods, we found it hard to meet lead times, and in quiet periods we had staff with little to do. This was having an impact on customer satisfaction and meant we had to charge premium prices that made our product uncompetitive. " You: " How did you go about the change? " In relation to the auditor ' s question about how the change was managed, the auditee mentions the steps listed below. Match the ISO 9001 clauses to the steps.
To complete the table, click on the blank section you want to complete so it is highlighted in red and then click on the ISO 9001 clauses listed below. Alternatively, drag and drop each clause to show which step the requirement applies to.
Answer:
Explanation:
Explanation:
Here is the correct matching of ISO 9001:2015 clauses to the steps mentioned in the change management process:
We identified risks and opportunities and fed these into our risk management processes.
Clause 6.1 (Actions to address risks and opportunities)
We found a suitable supplier.
Clause 8.4 (Control of externally provided processes, products, and services) We monitored customer feedback and noticed an increase in negative feedback about lead times.
Clause 9.1.2 (Customer satisfaction)
We put together a plan for implementation.
Clause 6.2.2 (Planning to achieve quality objectives)
We monitored the performance of the new supplier.
Clause 8.4.2 (Type and extent of control of external providers)
We noticed that productivity targets were being missed.
Clause 9.1.1 (Monitoring, measurement, analysis, and evaluation)
We communicated the plan internally.
Clause 7.4 (Communication)
We looked at the data at the management review and decided we needed to do something different.
Clause 9.3.2 (Management review inputs)
We reorganised the staffing and implemented redundancies.
Clause 7.1.2 (People)
We set an objective to effectively implement the transition and outsource manufacturing.
Clause 6.2.1 (Quality objectives and planning to achieve them)
This aligns the steps of the change process with relevant ISO 9001:2015 clauses related to risk, planning, communication, and monitoring.
NEW QUESTION # 84
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