Free ISO-9001-Lead-Auditor Exam Braindumps (page: 12)

Page 12 of 29

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.

  1. How are students advised about prior learning requirements?
  2. How is customer feedback integrated into the course?
  3. How is the cost of the course calculated?
  4. What risks and opportunities have been notified to interested parties?
  5. How is design documentation controlled and managed?
  6. How is technical content of courses verified as correct?

  7. How is the tutor trained to deliver the completed course?
  8. What are the qualifications of the administrative staff?

Answer(s): B,E,F

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.


Reference:

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



An audit team leader arrives at a printing company to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. The Quality Manager wants the ISO 9001 certificate to cover the new contract.

During the audit, a team member found that some print jobs had been rejected by several clients over some months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract.

The auditor finds that the responsibility for checking spelling errors is placed on the printer that sets up the print run.

In line with the policy of the certification body, the audit team raise improvement opportunities in the audit report.
Which three of the following options would represent acceptable opportunities for improvement in the report?

  1. Operational planning activities may benefit from a clearer risk-based approach.
  2. The organisation needs to delay its certification to gain more experience of the QMS.
  3. The responsibility for checking printing needs to be independent of the operators.
  4. A business consultant can be recommended for advice on improving operations.
  5. A plan to determine why the errors occur and to prevent them.
  6. An intensive training plan that involves all production personnel.
  7. The recruitment process to include spelling tests to filter out unsuitable candidates.
  8. More process time needs to be allocated to the new employees.

Answer(s): A,C,E

Explanation:

According to the ISO 9001 Auditing Practices Group Guidance on Improvement Opportunities1, an improvement opportunity is a suggestion made by the auditor for the auditee to consider that, if implemented, may enhance the performance of the QMS. Improvement opportunities are not mandatory, but they should be based on objective evidence and aligned with the audit criteria and objectives. Improvement opportunities should also be realistic, feasible, and beneficial for the auditee. In this case, the evidence statements that represent acceptable improvement opportunities in the report are A, C, and E, because they address the potential causes and effects of the spelling errors in the print run, and propose possible actions that may improve the quality of the products and services, and the effectiveness of the QMS. These options are consistent with the requirements and principles of ISO 9001, such as clause 6.1 on actions to address risks and opportunities, clause 8.1 on operational planning and control, clause 8.5.1 on control of production and service provision, and clause 10.2 on nonconformity and corrective action. The other options are not appropriate improvement opportunities, because they are either irrelevant, unrealistic, or unhelpful for the auditee. For example, option B may contradict the audit objective and scope, option D may imply a lack of auditor competence or impartiality, option F may not address the root cause of the problem, option G may not be applicable or effective, and option H may not be feasible or justified.


Reference:

ISO 9001 Auditing Practices Group Guidance on Improvement Opportunities, ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Audit Evidence



Takitup is a small fabrication organisation that manufactures steel fencing, stairs and platforms for the construction sector. It has been certified to ISO 9001 for some time and has appointed a new Quality Manager. The audit plan during a surveillance audit covers the organisation's improvement actions and the auditor asks to see the most recent management review meeting minutes.

The auditor finds that the management review report records that none of the improvement actions set by the previous review has been realised for a second time. A new Quality Manager has been brought in at the middle management level to rectify the situation as the organisation is concerned that it might lose its certification.
Select three options that would provide evidence of conformance with clause 10.3 of ISO 9001.

  1. Outsource more processes to external providers
  2. Removing expensive external providers from the database.
  3. An increase in the number of quality staff.
  4. A quality objective to achieve lower reject rates by quality control.
  5. Considering results from the analysis of the effectiveness of corrective actions to determine improvement opportunities.
  6. The certification body auditor reporting fewer nonconformities.
  7. An enhanced customer satisfaction survey score than in the previous year.
  8. Automate the fabrication process to increase profitability.

Answer(s): D,E,G



You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing structural steelwork.
When auditing the rolling process, you find that the operator who is unloading the furnace does not use the adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.

You: "How do you tell when the billet is ready for the rolling stage?"

Operator: "I've done this job for 20 years. I can tell by the bright red colour."

You: "What happens if the colour is wrong?"

Operator: "The billet goes back into the furnace."

You: "Is the pyrometer ever used?"

Operator: "Only in borderline cases."

You continue to interview the operator and find that around 25% of the billets are sent back to the furnace. This includes 80% of the borderline cases.

Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.

  1. Periodic analysis of the results of temperature checks.
  2. Certification of conformance to national standards from the manufacture of the pyrometer.
  3. An increase in the use of the pyrometer by operators.
  4. Maintenance plan for the furnace.
  5. A procedure that provides instruction in taking billet temperature.
  6. Planning for monitoring and measuring the billet temperature.
  7. A quality objective to achieve lower recycle rates for billets.
  8. Annual review records for furnace operators.

Answer(s): A,E,F

Explanation:

According to ISO 9001:2015, clause 9.1.1, the organization is required to determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results, and when the monitoring and measuring shall be performed. The organization is also required to retain appropriate documented information as evidence of the results.
Therefore, in the scenario given, the organization should have planned for monitoring and measuring the billet temperature, as it is a critical factor for the quality of the product and the process. The organization should also have established a procedure that provides instruction in taking billet temperature, using the pyrometer or other suitable methods, to ensure consistency and accuracy.

The organization should also have performed periodic analysis of the results of temperature checks, to identify trends, problems, and opportunities for improvement. Hence, the options that would provide evidence of conformance with clause 9.1.1 of ISO 9001 are A, E, and F, as they are aligned with the requirements of the clause. The other options are either irrelevant or not directly related to clause 9.1.1, as they do not pertain to the monitoring and measurement of the billet temperature.


Reference:

ISO 9001:2015(en), Quality management systems -- Requirements, clause 9.1.1 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6



Page 12 of 29



Post your Comments and Discuss EXIN ISO-9001-Lead-Auditor exam with other Community members:

Inbarajan commented on January 02, 2025
Very useful
Anonymous
upvote

Faith Egwuenu commented on December 09, 2024
The case studies/questions were very helpful.
Anonymous
upvote

Md. Jakir Hossain commented on November 17, 2024
pls help me given total question
BANGLADESH
upvote

Joseph commented on November 08, 2024
The questions and answers/explanations are very helpful and professional, thank you
Anonymous
upvote

Tadele commented on November 02, 2024
Help full to next exam
Anonymous
upvote

Arvind Sharma commented on October 27, 2024
Helpful questions for preparation foe LA exam
Anonymous
upvote

Rajesh Kumar M - commented on October 26, 2024
For the question 6- the continual improvement , the organization shall continually improve the suitability, adequacy and effectiveness of the QMS. Not Efficiency, Refer Clause 10.3 continual improvement in ISO 9001 :2015
Anonymous
upvote

jakir commented on October 24, 2024
its really more help full.
BANGLADESH
upvote

Apvj commented on October 17, 2024
Need to update section 5 questions,it was all new question today in exam , unitl section 4 it was fine even though pattern of question changed
Anonymous
upvote

vaibgav commented on October 13, 2024
nice paper for practise
Anonymous
upvote

Md Nur Hosen commented on September 21, 2024
Preparing for exam
Anonymous
upvote

SRILANKA commented on September 04, 2024
PREPARING FOR EXAM
Anonymous
upvote