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>> Valid ISO-9001-Lead-Auditor Exam Dumps <<
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NEW QUESTION # 100
(Select the six statements that are required as part of a second-party audit to ISO 9001 carried out by an organisation to a key supplier (ABC), taking into account recommendations from ISO 19011.)
Answer: B,C,D,F,G,J
Explanation:
A second-party audit of a key supplier should focus on whether the supplier's QMS is suitable, effective, and capable of meeting requirements. ISO 19011 recommends considering context, changes, prior audit results, interested-party concerns, and effectiveness of key QMS processes.
B is relevant because outsourced processes affecting conformity may need to be audited or otherwise controlled. C and F are relevant because audit planning should consider changes since previous audits and previous audit results. D is relevant because ISO 9001 requires relevant interested parties and their requirements to be considered. I is relevant because the QMS must remain suitable and aligned with context and strategic direction. J is relevant because internal audit and management review are key mechanisms for evaluating QMS effectiveness.
A is mainly relevant to certification-body controls, not a supplier second-party audit. E is too prescriptive; ISO 9001 does not require annual audits of all external providers. G may be useful depending on scope, but the stronger required audit trails here are B, C, D, F, I, and J. H is outside ISO 9001 QMS audit scope unless directly relevant to contractual or QMS risks.
NEW QUESTION # 101
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 # 102
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 # 103
Which statement regarding the drafting of the audit conclusions is correct?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 6.4.9 (Audit Conclusions):
* Audit conclusions must be based on verified evidence.
* The evidence must be evaluated both quantitatively and qualitatively to ensure accuracy.
* Observations alone (A) are insufficient; conclusions must be supported by objective evidence.
Thus, B is the correct answer.
NEW QUESTION # 104
Which two of the following roles do not contribute to the audit outcomes?
Answer: A,F
Explanation:
The individual(s) managing the audit programme and the auditee are both roles that contribute to the audit outcomes. The individual(s) managing the audit programme are responsible for planning, conducting, and reporting on the audit activities, as well as ensuring that they are aligned with the organization's quality objectives and risk management processes1. The auditee is the person or entity that is subject to an audit, and their participation, cooperation, and feedback are essential for achieving a successful audit outcome2. References:
ISO 9001 Lead Auditor Reference Materials
ISO 9001 Lead Auditor Candidate Handbook
ISO 9001 Lead Auditor Course Material
ISO 9001 Lead Auditor Training Course IRCA Certified
NEW QUESTION # 105
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