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>> Certification ISO-9001-Lead-Auditor Sample Questions <<
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NEW QUESTION # 235
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: D
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 # 236
In the context of a third-party audit, match the event with the responsibility for conducting it.
Answer:
Explanation:
Explanation:
The correct answer is:
Event
Selecting audit team = Individual(s) managing the audit programme
Conducting the audit = Audit team
Preparing the audit plan = Audit team leader
Requesting the audit = Audit client
To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below. Alternatively, drag and drop each option to the appropriate blank section. Responsibility:- Individual(s) managing the audit programme Audit team Audit team leader Audit client According to ISO 19011:2018, clause 5.3, the individual(s) managing the audit programme are responsible for selecting the audit team, taking into account the competence and availability of the auditors and any experts needed. 1 According to clause 6.2, the audit team is responsible for conducting the audit, which includes collecting and verifying audit evidence, evaluating audit findings, and preparing the audit report. 1 According to clause 6.1, the audit team leader is responsible for preparing the audit plan, which includes defining the audit objectives, scope, criteria, and duration, as well as assigning roles and responsibilities to the audit team members. 1 According to clause 5.2, the audit client is the person or organization that requests the audit, which can be the auditee (the person or organization being audited) or any other person or organization that has an interest in the audit results. 1 References:
1: ISO 19011:2018 - Guidelines for auditing management systems
NEW QUESTION # 237
At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only two people are present and waiting for them: the Health and Safety supervisor and the Administrative Officer.
Neither has participated in the audit. However, the team had previously agreed with the auditee Quality Manager on two nonconformities identified during the audit (NC1 and NC2).
They said:
Health and Safety Supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and the other two managers have had to leave urgently to attend to the emergency." The Administration Officer: "Concerning 'nonconformity 2', the General Manager left a message asking us to tell you that he does not accept it and requests you not to include it in the audit report. Here is a note in which he explains why." Which one of the following would be your preferred answer (as team leader) to the General Manager's request?
Answer: C
NEW QUESTION # 238
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: E,F
Explanation:
According to the ISO 9001:2015 standard, clause 4.1 requires organizations to determine the external and internal issues that are relevant to their purpose and that affect their ability to achieve the intended outcomes of their quality management system. Clause 6.1 requires organizations to plan actions to address the risks and opportunities associated with these issues. These actions must be integrated into the quality management system processes and evaluated for effectiveness.
In this scenario, the General Manager of the pharmaceutical organization has shown a lack of understanding and involvement in the process of identifying and addressing the external and internal issues that affect their quality management system. The General Manager has relied on the legal compliance expert, who is not an employee of the organization, to guide them on this process. The General Manager has also admitted that they did not document these issues, which is contrary to the requirement of retaining documented information on the context of the organization. The General Manager has also delegated the responsibility of determining and planning the actions to address the risks and opportunities to the Technical Manager, who is absent due to COVID-19.
Based on this information, you can respond to the General Manager's suggestion by taking two options:
B: I would ask for a different guide instead of the legal compliance expert: You can request to have a different guide who is an employee of the organization and who is familiar with the quality management system processes and the external and internal issues that affect them. The legal compliance expert may not have the necessary knowledge and authority to answer your questions or provide you with the relevant evidence.
C: I would look for evidence that the actions resulting from the risk assessment had been taken: You can verify whether the organization has implemented and evaluated the actions to address the risks and opportunities associated with the external and internal issues. You can look for evidence such as records of risk analysis, action plans, monitoring and review results, and improvement measures.
These two options would help you to assess the conformity and effectiveness of the organization's quality management system with respect to the requirements of clauses 4.1 and 6.1.
NEW QUESTION # 239
(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: A,C,D,E,I,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 # 240
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