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

Topic	Details
Topic 1	Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.
Topic 2	Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.
Topic 3	Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
Topic 4	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.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q87-Q92):

NEW QUESTION # 87
How can an organization ensure the objectivity and impartiality of the internal audit function?

A. By assigning internal auditors that do not have operational roles related to the QMS
B. By having a representative of top management involved during the internal audit process
C. By always outsourcing the internal audit function to a third party

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 5.1 (Impartiality):
* Internal auditors must not audit areas where they have direct responsibilities to avoid conflicts of interest.
* Outsourcing (C) is not required, as long as impartiality is maintained internally.
Thus, B is the correct answer.

NEW QUESTION # 88
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

Answer:

Explanation:
A screenshot of a computer AI-generated content may be incorrect.

Comprehensive and Detailed In-Depth Explanation:
Clause 8.3.2 e) - Internal Resource Needs:Delays due to staff shortages highlight a lack of internal resources, directly relating to this clause that requires internal resource planning for design and development.
Clause 8.3.6 - Design and Development Changes:Ongoing formulation changes due to feedback need to be documented and reviewed. This clause requires retention of documented information on changes.
Clause 8.3.5 - Design and Development Outputs:Customer approvals for formulations are outputs of the design process and must be retained as documented information, as per this clause.
Clause 8.3.4 d) - Design and Development Controls:Consumer trials are a validation activity. This clause ensures such trials are conducted to confirm that resulting products meet defined requirements.
Clause 8.3.2 e) - External Resource Needs:Shelf-life tests done by an external lab are part of the external resources needed for development and are referenced here.

NEW QUESTION # 89
During the opening meeting of a third-party audit of a pharmaceutical organisation (CD9000) with seven COVID-19 testing laboratories in various terminals at a major international airport, you are asked if you could visit all laboratories. As audit team leader you say that, based on sampling criteria, you had planned to audit only three of them as CD9000 is a multisite organisation.
They tell you that they have worked so hard to get ready for the audit that the supervisors of those laboratories that would not be visited would be quite disappointed.
The following are possible responses to the request, select the two best responses:

A. We could stay every day for one hour longer to see those supervisors and their laboratories.
B. I could decide to extend the audit for an extra day.
C. Sorry, this is the plan, we cannot change it. However, they could attend the audit as observers.
D. I could try to revise the audit programme to see if I can audit all laboratories.
E. I could audit the other laboratories virtually at the end of this audit.
F. The programme manager has selected the sample and we must follow it.

Answer: D,E

Explanation:
In this scenario, the audit team leader must balance maintaining the integrity of the audit plan while considering the auditee's request. The two best responses allow for flexibility without compromising the audit's rigor:
A: I could audit the other laboratories virtually at the end of this audit: Virtual audits can be a valid option, especially in multi-site audits. ISO 9001:2015 does not prohibit virtual audits, and in certain situations, they are practical for reviewing documentation or observing operations remotely.
C: I could try to revise the audit programme to see if I can audit all laboratories: Revising the audit programme to accommodate additional site visits is a reasonable compromise. ISO 9001:2015 audits are based on risk and sampling, but the audit team leader has the flexibility to adjust the audit scope if it fits within the audit duration and resources.
The other options, such as extending the audit duration (B, F) or strictly adhering to the original plan (D, E), may not be practical or necessary. Revising the plan to audit all laboratories or using virtual auditing ensures that the audit remains efficient while addressing the organization's concerns.

NEW QUESTION # 90
How much time is usually spent on the Stage 1 audit?

A. 40% of the total audit time
B. 30% of the total audit time
C. 20% of the total audit time

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 # 91
What competence, among others, should each audit team member have?

A. Expertise in each domain to be audited.
B. Knowledge of the industry in which the auditee operates.
C. A formal degree in quality management.
D. Knowledge of the risk-based approach to auditing.

Answer: D

Explanation:
Comprehensive and Detailed In-Depth Explanation:
Auditors must have competence in risk-based auditing to effectively assess an organization's QMS performance and compliance.
Clause References:
* ISO 19011:2018, Clause 7.2.3 - Determining Auditor Competence:
* Auditors must have knowledge of risk-based thinking to assess risk impact on processes.
* ISO 9001:2015, Clause 0.3.3 - Risk-Based Thinking:
* The standard emphasizes proactive risk management, which auditors must understand.
Why is the Correct Answer B?
* Risk-based auditing ensures audits focus on high-risk areas, improving audit effectiveness.
* Auditors must assess how organizations apply risk-based thinking in decision-making, process control, and improvement.
Why are the Other Options Incorrect?
* A (Industry knowledge) # While helpful, it is not mandatory for all auditors.
* C (Expertise in all domains) # Auditors are not required to be experts in all areas, just in audit methodology.
* D (Formal degree in quality management) # ISO does not require a formal degree, just competence in audit principles and methods.
Reference:
ISO 19011:2018, Clause 7.2.3 - Determining Auditor Competence
ISO 9001:2015, Clause 0.3.3 - Risk-Based Thinking

NEW QUESTION # 92
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