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>> ISO-9001-Lead-Auditor Reliable Test Notes <<
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NEW QUESTION # 104
What are the objectives of the Stage 2 audit?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:The Stage 2 audit (ISO 17021-1:2015, Clause
9.3.1.3) is conducted to:
* Verify whether the QMS is effectively implemented and operational.
* Ensure compliance with ISO 9001 requirements in actual practice.
* Identify nonconformities that may impact certification.
Reviewing documented information (Answer B) is part of Stage 1, and gathering scope information (Answer C) is done before the certification audit.
NEW QUESTION # 105
You are an auditor and are in dialogue with the quality manager and the managing director of a small business that supplies specific IT hardware and software for manufacturers of medical equipment.
You: "I would like to look at how you manage the design and development of your products.
Auditee: "We have made some strategic changes, the main one being that since last month we no longer produce the software of our products in-house." You: "What has been the impact of that?" Auditee: "We now subcontract the provision of the software needed for our hardware. This allowed us to concentrate our efforts on the hardware and let specialised organisations develop the software. For the time being, we have subcontracted our software requirements to three different organisations.
You: "What were the reasons for making the change?"
Auditee: "Our IT software section was a small operation, and we struggled to cope with new technologies.
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." 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 actions listed below. Match the ISO 9001 clauses to show which action the requirement applies to.
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 clause the action applies to.
Answer:
Explanation:
Explanation:
Actions and Applicable ISO 9001:2015 Clauses
* We identified risks and opportunities.# Clause 6.1 (Actions to address risks and opportunities)
* We found suitable suppliers.# Clause 8.4 (Control of externally provided processes, products and services)
* We determined the need to keep updated with new IT technologies.# Clause 4.1 (Understanding the organization and its context)
* We put together a plan for the change to IT provision outsourcing.# Clause 6.3 (Planning of changes)
* We monitored the performance of the new suppliers.# Clause 8.4.2 (Type and extent of control of external providers)
* We monitored our productivity targets to understand why they were being missed.# Clause 9.1.1 (Monitoring, measurement, analysis and evaluation - General)
* 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) ISO 9001:2015 requires organizations to manage change in a planned, risk-based, and controlled manner, particularly when changes affect product realization and customer satisfaction.
* Clause 6.1 requires organizations to identify risks and opportunities arising from changes, such as outsourcing software development.
* Clause 4.1 supports understanding internal and external issues, including rapid changes in IT technology that affect strategic direction.
* Clause 6.3 requires changes to the QMS (such as outsourcing a core activity) to be planned, considering purpose, consequences, resources, and responsibilities.
* Clause 8.4 and 8.4.2 ensure that when processes are outsourced, the organization selects suitable providers and monitors their performance to ensure conformity.
* Clause 7.4 requires effective internal communication so that personnel understand changes and their roles.
* Clause 9.1.1 requires monitoring and measurement of performance indicators (such as productivity targets) to understand performance issues.
* Clause 9.3.2 requires top management to review performance data and determine actions when the QMS is no longer achieving intended results.
ISO-aligned conclusion:
The auditee's actions demonstrate a systematic and compliant approach to managing change, covering context analysis, risk-based thinking, planning, control of outsourced processes, performance monitoring, communication, and management review, all in line with ISO 9001:2015 requirements.
NEW QUESTION # 106
What must the auditor consider in order to mitigate audit risks and obtain reasonable assurance?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Auditors must focus on key processes that impact QMS effectiveness to ensure audit risks are minimized.
Clause References:
* ISO 19011:2018, Clause 6.3 - Managing Audit Risk: Auditors should prioritize critical processes to obtain reasonable assurance.
Why is the Correct Answer A?
* Some processes are critical (e.g., production quality, customer complaints handling).
* If these material processes fail, the QMS could collapse.
Why are the Other Options Incorrect?
* B (Needs of internal parties) # Important, but not the primary focus for reducing audit risk.
* C (Previous audit results) # Useful for improvement but does not directly reduce current audit risks
.
* D (Financial risks) # ISO 9001 focuses on quality risks, not financial risks.
NEW QUESTION # 107
During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.
You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?" GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon, shortage of chemicals for the analysis. It was quite a good experience." You: "Did you document these issues?" GM: "No. Jack said that ISO 9001 does not require us to document these issues." You: "How did you determine the risks associated with the issues and did you plan actions to address them?" GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence." Select two options for how you would respond to the General Manager's suggestion:
Answer: C,F
Explanation:
According to clause 4.1 of ISO 9001:2015, the organization should determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended results of its quality management system. The organization should monitor and review these issues and update them as necessary. Although the standard does not explicitly require documented information of these issues, it does require documented information as evidence of the implementation of the actions taken to address risks and opportunities, as per clause 6.1. The organization should also retain documented information as evidence of the results of the monitoring, measurement, analysis and evaluation of its QMS, as per clause 9.1. Therefore, the auditor should not accept the legal compliance expert answering the question, as he is not the person responsible for the process and may not have the necessary competence or knowledge of the QMS. The auditor should also look for evidence that the actions resulting from the risk assessment had been taken, as this is a requirement of the standard and a way to verify the effectiveness of the QMS. The other options are not appropriate courses of action for the auditor, because they do not address the audit objective or criteria, or they may compromise the audit integrity or impartiality. For example, option B may not be feasible or reliable, as the Technical Manager may not be available or able to provide the necessary evidence by phone. Option C may cause unnecessary delay and inconvenience for the audit process and the auditee. Option E may not solve the problem, as the guide is not the main source of evidence or information for the audit. Option F may be disrespectful or unprofessional, as the consultant may have a legitimate role or interest in the audit.
References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Context of the Organization, ISO 9001 Auditing Practices Group Guidance on Audit Evidence
NEW QUESTION # 108
ISO 9001 addresses changes through several requirements, two examples of which are Clause 6.3 (Planning of Changes) and Clause 8.5.6 (Control of Changes). How do the requirements of Clause 8.5.6 differ from those of Clause 6.3?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 recognizes change management as essential for maintaining process integrity and preventing nonconformities.
Clause References:
* Clause 6.3 (Planning of Changes) # Focuses on long-term changes that may impact QMS integrity.
* Clause 8.5.6 (Control of Changes) # Focuses on changes occurring during production and service provision to ensure conformity.
Why is the Correct Answer A?
* Clause 8.5.6 applies specifically to operational changes, ensuring that modifications in production or service processes do not compromise quality.
* Organizations must document who approves changes, how they are controlled, and how they affect product/service conformity.
Why are the Other Options Incorrect?
* B (Changes during design and development) # Covered under Clause 8.3 (Design and Development), not 8.5.6.
* C (Changes to legal and regulatory requirements) # Addressed under Clause 4.2 (Interested Parties
' Requirements).
* D (Leadership responsibilities) # Covered under Clause 5.1 (Leadership and Commitment), not
8.5.6.
NEW QUESTION # 109
......
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