LATEST ISO-9001-LEAD-AUDITOR TEST MATERIALS, NEW ISO-9001-LEAD-AUDITOR PRACTICE QUESTIONS

Latest ISO-9001-Lead-Auditor Test Materials, New ISO-9001-Lead-Auditor Practice Questions

Latest ISO-9001-Lead-Auditor Test Materials, New ISO-9001-Lead-Auditor Practice Questions

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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
  • Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
Topic 3
  • Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.
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.
Topic 5
  • Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.
Topic 6
  • 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.

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New ISO-9001-Lead-Auditor Practice Questions & ISO-9001-Lead-Auditor Examcollection Dumps

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q85-Q90):

NEW QUESTION # 85
You are conducting an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements.
The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.
You have gathered audit evidence as outlined below. Match the ISO 9001 Clause 8 extract to the audit evidence.

Answer:

Explanation:

Explanation:
Here is the correct matching of the ISO 9001 Clause 8 extracts to the audit evidence:
* Audit evidence: Three subcontract trainers who had delivered training were not approved as defined in procedure SA1 Supplier Approval revision 3.ISO 9001 Clause 8 extract: 8.4.1 ...shall apply criteria for
... external providers...(This clause requires the organization to control external providers, including ensuring their approval and competence.)
* Audit evidence: A training programme for a customer was not documented as required in procedure TD
2 Training revision 2.ISO 9001 Clause 8 extract: 8.3.5 ...shall retain documented information on design and development outputs.(This clause addresses the need to retain documented information related to design and development outputs, such as a training programme.)
* Audit evidence: One trainer had not recorded the damage to a customer's training room wall caused by using sticky tape to hang training aids, as required in procedure TD 2 Training revision 2.ISO 9001 Clause 8 extract: 8.5.3 ...shall retain documented information on what has occurred.(This clause relates to retaining documented information on activities and outcomes, including records of damage or issues encountered.)
* Audit evidence: Five sales orders had no record of having been reviewed to verify the ability to provide these courses.ISO 9001 Clause 8 extract: 8.2.3.1 ...shall conduct a review before committing...(This clause specifies the requirement to review and verify the organization's ability to meet customer requirements before accepting sales orders.) These mappings reflect the specific requirements of ISO 9001:2015 for managing external providers, retaining documented information, and reviewing contracts.


NEW QUESTION # 86
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 what happens to the waste products.
  • B. Determine whether there are quality objectives for reducing rejected material.
  • C. Ask to review the percentage of waste materials.
  • D. Check the process for handling nonconforming items.
  • E. Find out if operators have regular hearing tests.
  • F. Ask about operator PPE (Personal Protective Equipment).

Answer: A,D

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.
Based on this information, you can investigate further by taking two actions:
A: 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 # 87
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 delay the audit until the return of the technical manager
  • B. I would ask for a different guide instead of the legal compliance expert.
  • C. I would ask to audit the Technical Manager by phone.
  • D. I would look for evidence that the actions resulting from the risk assessment had been taken.
  • E. I would not accept the legal compliance expert answering the question.
  • F. I would ask the consultant to leave the meeting since he is not an employee of the organisation.

Answer: C,D

Explanation:
* D. I would look for evidence that the actions resulting from the risk assessment had been taken.
* According to ISO 9001:2015, Clause 6.1.2 requires the organization to plan actions to address risks and opportunities. The organization must integrate and implement these actions into its quality management system and evaluate their effectiveness. The auditor should seek evidence that the organization has assessed the risks and taken appropriate actions.
* B. I would ask to audit the Technical Manager by phone.
* As the Technical Manager is responsible for this process and is absent due to illness, it is reasonable to attempt to contact him to obtain accurate information. This ensures that the audit process is not unduly delayed and that the information is obtained from the appropriate person.
* A. I would not accept the legal compliance expert answering the question.
* While the legal compliance expert might not be the best source for technical details, outright rejecting their input is not appropriate. It is better to first verify if the expert can provide relevant information.
* C. I would delay the audit until the return of the Technical Manager.
* This would be an inefficient approach. Contacting the Technical Manager by phone is a more practical and reasonable option.
* E. I would ask for a different guide instead of the legal compliance expert.
* The guide's role is not necessarily to answer technical questions but to facilitate the audit. Since Jack is already familiar with the situation, replacing him may not add value.
* F. I would ask the consultant to leave the meeting since he is not an employee of the organization.
* This is inappropriate and could disrupt the audit process. There is no rule in ISO 9001 preventing a consultant from assisting in the audit if authorized by the organization.
Why Not the Other Options:


NEW QUESTION # 88
Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.

  • A. To support the operation of the processes of the quality management system.
  • B. To safeguard the integrity of the quality management system.
  • C. To provide confidence in the effectiveness of the quality management system.
  • D. To facilitate auditing for proof of conformity to the standard.

Answer: A

Explanation:
Documented information is a means by which an organization demonstrates compliance. It communicates what we do and how we do things, it communicates what happened and what results were achieved. It is, essentially, a tool for communication. ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. The standard states that the organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned. Therefore, the purpose of retaining documented information is to support the operation of the processes of the QMS, not to facilitate auditing, provide confidence or safeguard integrity, which are secondary benefits of documented information.
References: Guidance on the requirements for Documented Information of ISO 9001:2015, ISO 9001:2015 documented information | CQI | IRCA, Documented Information Required by ISO 9001:2015 - 9000 Store


NEW QUESTION # 89
You are preparing for interviews with two members of top management. Based on the information that you gathered about the organization, you conclude that it is the top management who takes all the important decisions and closely supervises and controls employees. Based on this, which management style is practiced in the organization?

  • A. Autocratic
  • B. Centralized
  • C. Laissez-faire

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:An autocratic management style is characterized by:
* Top management making all decisions without delegation.
* Strict control over employees.
* A lack of employee input in decision-making.
Centralized management (Answer C) refers to decision-making being concentrated at the top, but it does not necessarily imply strict control. Laissez-faire management (Answer B) allows employees high independence, which contradicts the scenario.


NEW QUESTION # 90
......

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