TEST ISO-9001-LEAD-AUDITOR CRAM PDF & ISO-9001-LEAD-AUDITOR DOWNLOAD PDF

Test ISO-9001-Lead-Auditor Cram Pdf & ISO-9001-Lead-Auditor Download Pdf

Test ISO-9001-Lead-Auditor Cram Pdf & ISO-9001-Lead-Auditor Download Pdf

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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
  • Managing an ISO 9001 audit program: This topic evaluates your abilities to establishing and managing a QMS audit program.
Topic 3
  • Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS 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.

PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q158-Q163):

NEW QUESTION # 158
What is the responsibility of the audit committee during an internal audit?

  • A. To define the audit schedule
  • B. To supervise all audit functions and activities
  • C. To establish an internal audit program

Answer: C

Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 5.2 (Audit Program Management):
* The audit committee is responsible for establishing the internal audit program.
* The audit schedule (A) is determined within the program, but it is not the main role of the committee.
Thus, C is the correct answer.


NEW QUESTION # 159
You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The organisation processes waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.
You: "Why are these plastic items being rejected at this stage?"
Auditee: "They do not meet our processing standards."
You: "What is the reason for that?"
Auditee: "These items are likely to damage the machinery down the line. They can also compromise our quality standards. We need to protect our reputation for good quality output materials." You: "What happens to the rejected items?" Auditee: "Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled." You: "What happens to the waste products?" Auditee: "I'm not sure. I suppose they go to landfill." Which two. of the following actions would you take to investigate further?

  • A. Determine whether there are quality objectives for reducing rejected material.
  • B. Find out if operators have regular hearing tests.
  • C. Ask to review the percentage of waste materials.
  • D. Check the process for handling nonconforming items.
  • E. Determine what happens to the waste products.
  • F. Ask about operator PPE (Personal Protective Equipment).

Answer: D,E

Explanation:
According to the ISO 9001:2015 standard, clause 8.7 requires that an organization identify and control any nonconforming outputs that do not conform to the requirements of the customer or other relevant requirements. Nonconforming outputs are any outputs from the process, product or service that do not meet the specified quality criteria. Nonconforming outputs must be dealt with in one or more of the following ways:
Correction of the nonconformity
Segregation, containment, return or suspension of provision of products and services Informing the customer Authorisation for acceptance under concession The organization must also retain documented information on the description of the nonconformity, the actions taken, any concessions obtained, and the identification of the authority deciding the action to resolve the nonconformity.
In this scenario, you have interviewed a line supervisor who is responsible for managing a manual picking line where operators are removing contaminant materials from incoming products. The supervisor has explained that these plastic items are rejected at this stage because they do not meet their processing standards and they can damage their machinery and compromise their quality standards. The supervisor has also mentioned that some of these rejected items are melted down in another process later on and some are disposed of as waste products that cannot be recycled.
B: Check the process for handling nonconforming items: You can verify whether there is a documented procedure for identifying, segregating, containing, returning or suspending provision of nonconforming items at this stage. You can also check whether there is a system for informing customers about any nonconforming items that may affect their satisfaction or expectations.
D: Determine what happens to the waste products: You can verify whether there is a documented procedure for disposing of waste products that cannot be recycled as per environmental regulations and customer requirements.
These two actions would help you to determine whether there are any nonconforming outputs at this stage and how they are controlled by the organization.


NEW QUESTION # 160
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 # 161
You work as an external quality consultant for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, 'B', to ISO
9001 which provides packaging materials to your organisation. It is 4 pm and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled at 5 pm.
You, as Audit Team Leader, audited top management. You explain to the audit team that you identified two nonconformities:
a. There is no documented information on Top Management Reviews, as required in clause 9.3 of ISO
9001:2015.
b. There is no evidence of Top Management Commitment as required in clause 5.1 of ISO 9001:2015. (e.g., not ensuring the availability of resources to operate the QMS, not ensuring the establishment of objectives, no promotion of improvement, no promotion of the process approach).
All agreed to present these two nonconformities. They went to meet the Top Management of 'B' and noticed that the General Manager and three other managers (Production, Human Resources, and Sales) were present in the meeting room.
Considering the seriousness of the two nonconformities to Top Management, as audit team leader, from the following select the best option:

  • A. Present the nonconformities to the whole group and inform that you will recommend your company to remove them from the approved suppliers list.
  • B. Present the nonconformities to the managers, inform them that the report will be sent within 10 days, close the meeting and leave the site.
  • C. Present the nonconformities to the whole group and analyse with them how to overcome this situation.
  • D. Ask the General Manager to have a private conversation in which you present the nonconformities only to him because of their sensitive nature.

Answer: C

Explanation:
According to the guidance on conducting the audit closing meeting1, the audit team leader should provide a summary of the audit findings and conclusions, invite discussions, and agree on timelines for any corrective actions. The audit team leader should also be respectful, constructive, and objective when presenting the nonconformities, and avoid any personal or emotional comments. The audit team leader should also consider the impact of the disruptive event (such as the Covid-19 pandemic) on the auditee's context, interested parties, and risks2, and acknowledge any good practices or improvements observed during the audit. Therefore, option D is the best option, as it follows the best practices for the closing meeting and allows the auditee to understand the nonconformities and their implications, and to participate in the analysis and resolution of the issues. Option A is not correct, as it is not respectful, constructive, or objective, and it does not invite any discussion or feedback from the auditee. It also assumes that the audit team leader has the authority to recommend the removal of the supplier from the approved list, which may not be the case. Option B is not correct, as it does not provide enough information or explanation to the auditee, and it does not allow any discussion or feedback from the auditee. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, acknowledging any good practices, and agreeing on timelines for corrective actions. Option C is not correct, as it does not involve the other managers who are responsible for the functions or processes that were audited, and who may have valuable input or information to share. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, inviting discussions, and agreeing on timelines for corrective actions. References: 1: Conducting the Audit Closing Meeting: Sharing the Results2: Auditing ISO 9001:2015 in the Context of a Disruptive Event.


NEW QUESTION # 162
You are conducting a Stage 1 audit at an organisation that services refrigeration equipment for a large customer base.
The scope of certification is "Provision of refrigeration equipment maintenance and repair services". You are interviewing the Managing Director to learn more about the organisation and to explore how the requirements for policy, objectives, and risks and opportunities in ISO 9001 are addressed.
The Managing Director explains that they only use sub-contract refrigeration engineers and do not have any full-time refrigeration engineers, which helps to optimise overhead costs. The full-time staff employed are essentially a small team of office staff who process customer enquiries, schedule jobs and process invoices.
The Managing Director adds that the ISO 9001 requirements for competence of personnel extends to both sub- contract and full-time staff. He also states that the full-time staff are aware of the Quality Policy, objectives and plans to address risk and opportunities.
You ask if the sub-contract engineers have been informed of the Quality Policy, objectives and plans to address risks and opportunities, to which the Managing Director replies that this is not applicable as they only use sub- contractors who operate ISO 9001 certificated quality management systems. The documented information provided to the auditor confirms this.
Which clause in ISO 9001 is most likely not to have been fulfilled in this instance?

  • A. 7.2 Competence
  • B. 7.3 Awareness
  • C. 7.5 Documented information
  • D. 7.4 Communication

Answer: D

Explanation:
Questions no: 16 Verified answer: = C. 7.4 Communication Comprehensive But Short Explanation: = Clause
7.4 of ISO 9001:2015 requires the organization to determine the internal and external communications relevant to the quality management system, including what will be communicated, when, with whom, and how. The scenario indicates a potential gap in communication with subcontractors regarding the Quality Policy, objectives, and plans to address risks and opportunities, which is a requirement even if the subcontractors have their own ISO 9001 certified systems123. References: = This response is based on the general requirements of ISO 9001:2015 related to communication with external parties, such as subcontractors, as outlined in various resources discussing Clause 7.4123.


NEW QUESTION # 163
......

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