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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:

Topic	Details
Topic 1	Fundamental principles and concepts of a quality management system: The main objective of this domain is to evaluate your skills of explaining and applying ISO 9001 principles and concepts.
Topic 2	Quality management system (QMS) requirements: It assesses your abilities to point out and explain different requirements for a quality management system based on ISO 9001.
Topic 3	Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.
Topic 4	Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.

PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q101-Q106):

NEW QUESTION # 101
Match the following potential audit client options to the type of audit.

Answer:

Explanation:

Explanation:
First-party Management System audit # All members of an audited organisation Second-party Management System audit # Interested parties of an organisation According to ISO 19011:2018 (Guidelines for Auditing Management Systems) and as reinforced in ISO
9001 Lead Auditor training materials, audit types are defined as:
* First-party audit - conducted by the organization itself, or on its behalf (internal audit).# The audit client is all members of the audited organisation, because the audit is internal, involving all functional areas under the organization's control.
* Second-party audit - conducted by a customer or other person on behalf of a customer (external but not by a certification body).# The audit client includes interested parties of an organisation, such as customers who want to verify if their suppliers meet contractual or regulatory requirements.
These definitions are directly aligned with ISO 19011:2018, Clause 3.13 - Types of audits.
Why Other Options Are Incorrect:
* Certification body / Accreditation body # These relate to third-party audits, not first or second.
* Top management / Functions of an audited organisation # Refer to auditees or audit participants, not the audit client itself.
References:
ISO 19011:2018 Clause 3.13 - Types of audits
ISO 9001:2015 Clause 9.2 - Internal audit
ISO Definitions for First-party, Second-party, and Third-party audits

NEW QUESTION # 102
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:

A. I would ask to audit the Technical Manager by phone.
B. I would delay the audit until the return of the technical manager
C. I would ask for a different guide instead of the legal compliance expert.
D. I would ask the consultant to leave the meeting since he is not an employee of the organisation.
E. I would look for evidence that the actions resulting from the risk assessment had been taken.
F. I would not accept the legal compliance expert answering the question.

Answer: E,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 # 103
In the context of a third-party certification audit, how can the auditor demonstrate confidentiality? Select two.

A. Confirm the confidentiality arrangements with the auditee regarding the use of mobile devices/cameras.
B. Remove audit evidence without the permission of the auditee.
C. Adhere to the CQI Professional Code of Conduct.
D. Discuss sensitive personal information with the guides appointed by the auditee.
E. Share audit conclusions with competitor organisations.

Answer: A,C

Explanation:
In a third-party certification audit, auditors are responsible for maintaining confidentiality as part of their professional duties. Here's how they can demonstrate it:
A). Adhere to the CQI Professional Code of Conduct: The CQI (Chartered Quality Institute) Code of Conduct outlines ethical principles, including confidentiality. Auditors must adhere to professional standards, ensuring sensitive information is protected and not disclosed improperly.
B). Confirm the confidentiality arrangements with the auditee regarding the use of mobile devices/cameras:
Before using mobile devices or cameras, auditors must seek explicit permission from the auditee and agree on confidentiality terms, preventing unauthorized recording or sharing of sensitive information.
Options C, D, and E involve breaching confidentiality and are not acceptable practices in an ISO 9001:2015 certification audit. Sharing sensitive information, removing evidence without consent, or discussing it with unauthorized parties violates audit principles and the standard's confidentiality requirements.

NEW QUESTION # 104
An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:
"The reject rate of 'finished' product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%." Just before the Closing meeting of a third-party audit, the audit team leader is invited to a meeting with the Quality Manager. He tells the audit team leader that a member of the audit team was seen taking photographs of the factory on his phone during the day and wants him suspended from the Closing meeting with any nonconformities raised by him rescinded. The issue of photographs was not discussed during the opening meeting.
Select the three options for how the audit team leader might deal with this situation.

A. Delay the Closing meeting until the audit team leader has consulted his audit programme manager at Head Office
B. Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to the Quality Manager once this is done
C. Advise the Quality Manager that the auditor will be reported to Head Office
D. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered
E. Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting
F. State that the auditor will take no further part in the audit and all his photographs will be deleted

Answer: A,B,D

NEW QUESTION # 105
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
Why is it important to discuss the audit findings with DC's top management prior to the closing meeting and the submission of the final audit report?

A. To identify the persons responsible for the nonconformities
B. To verify whether the audit objectives have been met
C. To encourage the implementation of corrective actions as soon as possible

Answer: B

Explanation:
Comprehensive and Detailed In-Depth Explanation:
Discussing audit findings before the closing meeting ensures that:
* The audit objectives have been met (ISO 19011:2018, Clause 6.4.10).
* The auditee has an opportunity to clarify misunderstandings or provide additional evidence.
* The audit team and the auditee agree on the accuracy of findings before finalizing the report.
While encouraging corrective actions (B) is beneficial, the primary purpose of discussing findings is to ensure that the audit was conducted effectively and aligned with objectives. Identifying responsible persons (C) is not the auditor's role.
Reference:
ISO 19011:2018, Clause 6.4.10 (Communicating Audit Findings Before the Closing Meeting)

NEW QUESTION # 106
......

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PECB ISO-9001-Lead-Auditor Exam Dumps - Secret Hacks To Crack ISO-9001-Lead-Auditor Exam

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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:

PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q101-Q106):

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