PERFECT ISO-9001-LEAD-AUDITOR ORIGINAL QUESTIONS HELP YOU TO GET ACQUAINTED WITH REAL ISO-9001-LEAD-AUDITOR EXAM SIMULATION

Perfect ISO-9001-Lead-Auditor Original Questions Help You to Get Acquainted with Real ISO-9001-Lead-Auditor Exam Simulation

Perfect ISO-9001-Lead-Auditor Original Questions Help You to Get Acquainted with Real ISO-9001-Lead-Auditor Exam Simulation

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

TopicDetails
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
  • 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
  • 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 4
  • Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
Topic 5
  • Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.
Topic 6
  • Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.

PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q46-Q51):

NEW QUESTION # 46
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization manufactures cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: "I would like to begin by looking at the cleaning controls."
MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside." Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.

Answer:

Explanation:

Explanation:
Nonconformity report
ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met." Evidence: 40 cleaning records are available for 63 batches.


NEW QUESTION # 47
Match each of the following statements into the table below to show whether they apply to first-party audits, second-party audits or third-party audits:

Answer:

Explanation:

Explanation:

Table
Statement
First-party audits
Second-party audits
Third-party audits
The audit scope is typically determined by the organisation being audited.
Yes
No
No
The outcome of the audit is typically certification to a recognised standard.
No
No
Yes
The audit scope is typically confined to service/product provision capability.
No
Yes
No
Here is a brief explanation of each statement:
The audit scope is typically determined by the organisation being audited: This statement applies to first-party audits, also known as internal audits, where the organisation audits its own processes and activities to ensure conformity and improvement1. The organisation can decide the scope of the audit based on its own needs and objectives2. This statement does not apply to second-party audits, where the customer audits the supplier, or third-party audits, where an independent body audits the organisation. In these cases, the audit scope is determined by the customer or the certification body, respectively34.
The outcome of the audit is typically certification to a recognised standard: This statement applies to third- party audits, where an independent body audits the organisation to verify that it meets the requirements of a specific standard, such as ISO 9001, and issues a certificate of conformity if the audit is successful34. This statement does not apply to first-party audits or second-party audits, where the outcome of the audit is not certification, but rather self-improvement or supplier qualification13.
The audit scope is typically confined to service/product provision capability: This statement applies to second- party audits, where the customer audits the supplier to ensure that they are meeting the requirements specified in the contract, such as service or product quality, delivery, or performance34. The audit scope is usually focused on the specific aspects of the service or product that are of interest to the customer3. This statement does not apply to first-party audits or third-party audits, where the audit scope is broader and covers the entire quality management system or the relevant clauses of the standard14.


NEW QUESTION # 48
A person who provides specific knowledge or expertise to the audit team during the audit is known as a
/an:

  • A. Technical expert.
  • B. Guide.
  • C. Observer.

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:
A technical expert is someone with specialized knowledge that helps the audit team understand specific technical aspects of the auditee's processes.
Clause References:
* ISO 19011:2018, Clause 7.3.4 - Use of Technical Experts:
* Technical experts support the audit team with specialized knowledge but do not perform the audit themselves.
Why is the Correct Answer B?
* A technical expert is needed when auditors lack deep expertise in specific areas, such as engineering, software, or medical devices.
* They assist in interpreting complex technical requirements but do not act as auditors.
Why are the Other Options Incorrect?
* A (Observer) # Observers do not contribute expertise; they only watch the audit (e.g., trainees).
* C (Guide) # Guides help with logistics but do not provide technical expertise.
Reference:
ISO 19011:2018, Clause 7.3.4 - Use of Technical Experts


NEW QUESTION # 49
What is a list of actions that should be performed during the audit with their respective timeline?

  • A. The audit objectives.
  • B. The audit criteria.
  • C. The audit offer.
  • D. The audit schedule.

Answer: D

Explanation:
Comprehensive and Detailed In-Depth Explanation:
The audit schedule provides a structured timeline of activities to be conducted during the audit.
Clause References:
* ISO 19011:2018, Clause 6.4.2 - Preparing the Audit Plan:
* Requires the development of an audit schedule, including the sequence and timing of activities
.
* ISO/IEC 17021-1:2015, Clause 9.1.3 - Audit Program:
* Certification bodies must establish a schedule for conducting audits.
Why is the Correct Answer C?
* The audit schedule ensures systematic execution of the audit by defining activities, responsible auditors, and timeframes.
* A well-planned schedule improves efficiency and helps auditors cover all necessary areas within the given time.
Why are the Other Options Incorrect?
* A (Audit objectives) # Define why the audit is conducted, not the schedule.
* B (Audit criteria) # Define the standards and requirements to be evaluated, not the timeline.
* D (Audit offer) # Refers to the initial proposal sent to the auditee, not the activity timeline.


NEW QUESTION # 50
"A set of interrelated or interlacing elements of an organization to establish policies and objectives, and processes to achieve those objectives" is the definition of a/an:

  • A. Organization scope
  • B. Management system
  • C. Quality manual
  • D. Standard

Answer: B

Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 9000:2015, which provides definitions for terms used in ISO 9001:2015, a management system is defined as a set of interrelated or interacting elements of an organization to establish policies, objectives, and processes to achieve those objectives.
A Quality Management System (QMS) is a type of management system that ensures organizations meet customer and regulatory requirements while improving performance.
Clause 3.5.3 of ISO 9000:2015 clearly defines "management system" and aligns with this question. The other options do not fit the definition:
* Standard refers to an established norm or requirement.
* Organization scope defines the boundaries of a QMS but is not a system itself.
* Quality manual is a document (optional under ISO 9001:2015) that describes a QMS but is not the system itself.
Reference:
ISO 9000:2015, Clause 3.5.3 - Management System
ISO 9001:2015, Clause 4.4 - QMS and its Processes


NEW QUESTION # 51
......

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