ISO-9001-LEAD-AUDITOR RELIABLE EXAM BRAINDUMPS - DOWNLOADABLE ISO-9001-LEAD-AUDITOR PDF

ISO-9001-Lead-Auditor Reliable Exam Braindumps - Downloadable ISO-9001-Lead-Auditor PDF

ISO-9001-Lead-Auditor Reliable Exam Braindumps - Downloadable ISO-9001-Lead-Auditor PDF

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q105-Q110):

NEW QUESTION # 105
You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM) You: "Would you tell me about your management review process?" QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained." You: "May I see the records from the last two management reviews?" Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.
The Quality Manager then gives you the previous management review record, which took place one year before the latest review.
You: "Are there any other review reports in the last two years?
QM: "No, these are the only ones."

Answer:

Explanation:

Explanation:

Nonconformity report
ISO 9001 Clause Number: 9.3.1 Nature of problem: Management review has not been conducted at the defined frequency. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "Top management shall review the organization's quality management system at planned intervals." Evidence: The last management review took place nine months ago, and the previous one took place one year before the latest review. The planned interval is six months.


NEW QUESTION # 106
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:
2015 are true?

  • A. Verifies the degrees of customer satisfaction
  • B. Reviews the client's management system documented information
  • C. Verifies the compliance with legal requirements
  • D. Evaluates the conditions of all sites
  • E. During the Stage 1 audit, the audit team:
  • F. Evaluates the results of the last management review
  • G. Reviews the processes with high level of risk

Answer: B,G

Explanation:
* Reviews the client's management system documented information: This activity involves checking the documentation of the quality management system, such as the quality policy, the quality objectives, the scope, the processes, and the procedures, to ensure that they meet the requirements of ISO 9001:2015123. The audit team also evaluates the client's understanding and implementation of the standard, and identifies any gaps or nonconformities that need to be addressed before the Stage 2 audit123.
*Reviews the processes with high level of risk: This activity involves assessing the processes that have a significant impact on the quality of the products or services, or that pose a high risk of nonconformity or customer dissatisfaction123. The audit team also verifies the client's risk management approach, and evaluates the effectiveness of the controls and actions taken to mitigate the risks123.
The other options are not statements that are true for the Stage 1 audit, according to the web search results from my internal tool. They may be related to other stages or types of audits, but they are not the focus of the Stage 1 audit.
Therefore, the correct answer is D and G.
References: 1: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified 2: Stage 1 of your Audit
| NQA Blog 3: Getting Certified to ISO 9001 - the Stage 1 Audit


NEW QUESTION # 107
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 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:


NEW QUESTION # 108
You are conducting a third-party audit to ISO 9001 and interviewing the Training Manager. She explains that training is more important than ever because the organisation has had to reduce the number of staff employed. Many of the remaining staff are now required to be 'multi-skilled'. You ask to see plans for the multi-skilling training and are shown plans that look comprehensive, and include both 'on the job" training and internal and external training courses.
The records indicate that several staff required parts of their training to be repeated one month after the first training was provided. You ask why this was needed and are told that an investigation of customer complaints identified that several staff members did not complete certain tasks in the correct manner. The extra training was therefore recommended as a corrective action.
Based on this interview, which two of the tollowing audit trails would be the most appropriate to follow?
Select the two most appropriate audit trails from the following.

  • A. Assess whether Quality objectives are being met.
  • B. Ask if customer complaints had ceased since the multi-skilled training finished.
  • C. Determine whether customers were consulted about the risks associated with the multi-skilling training.
  • D. Determine whether management has assessed the impact of staff reduction on the organisation's ability to meet its objectives.
  • E. Ask the members of staff whether they found the training received useful.
  • F. Review records to assess if all planned training has been completed.

Answer: B,F

Explanation:
When conducting a third-party audit to ISO 9001, especially in the context of training and corrective actions taken due to customer complaints, the most appropriate audit trails to follow would be:
A: Ask if customer complaints had ceased since the multi-skilled training finished. This audit trail is relevant because it directly relates to the effectiveness of the corrective action taken. If customer complaints have decreased or ceased, it could indicate that the additional training was effective1.
F: Review records to assess if all planned training has been completed. This trail is important to ensure that the training plan has been fully implemented and to verify that all staff members have received the necessary training. It also helps in assessing the adequacy of the training in terms of content, frequency, and outcomes1.
These two trails, A and F, are closely linked to the issue of customer complaints and the organization's response to them. They provide insight into whether the actions taken were suitable and whether they have led to improvements in staff performance and customer satisfaction1. The other options, while potentially useful, do not directly address the immediate concern of the effectiveness of the corrective actions taken in response to the customer complaints1.


NEW QUESTION # 109
Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.
The auditor samples the design records for a recently completed course for the 247 Insurance organisation.
Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.
The auditor decides to review the training course design process in more depth.
Select three options that provide a meaningful audit trail for this process.

  • A. How is the cost of the course calculated?
  • B. How is design documentation controlled and managed?
  • C. How is customer feedback integrated into the course?
  • D. How is the tutor trained to deliver the completed course?
  • E. How are students advised about prior learning requirements?
  • F. What are the qualifications of the administrative staff?
  • G. What risks and opportunities have been notified to interested parties?
  • H. How is technical content of courses verified as correct?

Answer: B,C,H

Explanation:
According to clause 8.3 of ISO 9001:2015, the organization should establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. The design and development process should include the following activities:
*Determining the requirements for the products and services to be designed and developed, considering the intended use, the statutory and regulatory requirements, the customer and other relevant interested parties' needs and expectations, and the potential risks and opportunities.
*Defining the design and development objectives, stages, responsibilities, and authorities, and ensuring the availability of adequate resources and competence.
*Implementing design and development controls, such as reviews, verification, and validation, to ensure that the design and development outputs meet the design and development inputs, and to identify and resolve any problems or errors.
*Maintaining documented information on the design and development inputs, outputs, reviews, verification, validation, and changes, and ensuring the traceability and conformity of the products and services to the requirements.
*Managing the design and development changes, by identifying, reviewing, and controlling them, and evaluating their effects on the products and services and the QMS.
In this case, the evidence statements that provide a meaningful audit trail for the design and development process are B, E, and F, because they relate to the design and development controls, the documented information, and the verification activities that are required by the standard. These options can help the auditor to assess the effectiveness and conformity of the design and development process, and to identify any nonconformities or opportunities for improvement. The other options are not directly related to clause 8.3, although they may be relevant for other aspects of the QMS, such as clause 7.2 on competence, clause 7.3 on awareness, clause 7.4 on communication, clause 8.2 on requirements for products and services, clause 8.4 on externally provided processes, products, and services, and clause 8.7 on control of nonconforming outputs.
References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Design and Development, ISO
9001 Clause 8.3 Design and development of products and services


NEW QUESTION # 110
......

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