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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q94-Q99):
NEW QUESTION # 94
'XYZ' has already sent to you a list with all documented procedures and work instructions related to the services provided to 'ABC' (a quality manual is not included in the list).
To complete the audit planning which additional information would you ask to XYZ to submit? Select four.
- A. The list of risks and opportunities determined by XYZ
- B. Information to understand XYZ's operations
- C. The quality manual
- D. The results of the last two management reviews
- E. XYZ's organisational structure
- F. The number of personnel involved in activities related to the quality management system
- G. The results of XYZ's last internal audit
- H. A description of responsibilities and authorities of the key roles of XYZ
Answer: B,E,F,H
Explanation:
The ISO 9001 Lead Auditor exam requires the auditor to have a thorough understanding of the ISO 9001:
2015 standard and its requirements, as well as the organization's context, processes, risks, opportunities, and performance. Therefore, the auditor needs to ask for additional information that can help them verify these aspects during the audit planning stage. Some of the information that can be useful are:
A description of responsibilities and authorities of the key roles of XYZ: This can help the auditor to identify who is accountable for what in the organization and how they communicate with each other.
The number of personnel involved in activities related to the quality management system: This can help the auditor to assess if there are enough resources and competencies to support the QMS implementation and operation.
Information to understand XYZ's operations: This can help the auditor to understand how XYZ produces or delivers its products or services and what are its main processes and inputs.
The results of XYZ's last internal audit: This can help the auditor to evaluate if XYZ has implemented corrective actions based on previous audit findings and if it has maintained its QMS effectiveness.
The results of the last two management reviews: This can help the auditor to determine if XYZ has monitored its QMS performance against its objectives and if it has identified any significant changes or opportunities for improvement.
The quality manual (B) is not a required document for ISO 9001 certification, but it may be useful for internal reference or training purposes. It is not necessary for audit planning.
NEW QUESTION # 95
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 raises a nonconformity against ISO 9001. Which one of the following options is the basis for the nonconformity?
- A. 8.3.4.d - Design validation is not always conducted. It is omitted about half of the time.
- B. 8.6 - Course materials are released without proper approval. A course for 247 Insurance was released on an urgent basis.
- C. 8.3.2.c - Design planning does not include design validation. Design verification is part of the planning process.
- D. 8.3.5 - The improvements made to course designs are not documented. Feedback from customers is not always actioned.
Answer: A
Explanation:
Clause 8.3.4.d of ISO 9001:2015 requires that design and development validation be performed to ensure that the resulting products or services meet the requirements for their specified application or intended use.
Validation is critical to confirm that the product works as intended in real-world conditions.
In this case, Noitol omitted the design validation step approximately 50% of the time, which is a direct violation of Clause 8.3.4.d. Although they collect feedback after the fact, this is not a substitute for formal validation before the product is released. The nonconformity arises because the process of validation was neglected, not the recording of improvements or feedback.
Other options, such as documenting improvements (A) or issues with planning verification (B), are important but do not directly address the primary concern: the lack of consistent design validation before product release. Option D (8.6) concerns product release, but this nonconformity focuses on the validation stage, not just approval for release.
NEW QUESTION # 96
A Health Trust has contracted with Servitup, a catering services company that has been certified to ISO
9001 for one year. It provides services to 10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager (DCM).
DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are really short of staff." You: "I see. It really shouldn't affect the QMS so the audit can progress as normal." DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is." You: "OK, let's start with the Quality Policy. What are the main issues for the QMS here?" DCM: Give me a minute. I need to look at the Quality Policy on the noticeboard in his office.
You find that two internal audits have been carried out in the first year by the Catering Manager. One of them indicates that complaints from patients are increasing in number, mainly due to food being served too cold. The DCM comments that the trolley thermometer is often unreliable.
Which two of the following actions would be "correction" in dealing with the complaints?
- A. Plug trolleys into ward electricity sockets to heat food to the correct temperature after a patient complains.
- B. Monitor and record the temperature of food on the trolleys against defined standards before release to the wards.
- C. Request ward staff to test the temperature of the food on the plates before serving to patients.
- D. Keep a spare thermometer in case of a thermometer malfunction.
- E. Calibrate thermometers more frequently to ensure accuracy of readings for food temperature on the trolleys.
- F. Purchase a new thermometer to replace the unreliable one used for the ward trolleys.
Answer: E,F
NEW QUESTION # 97
What is an advantage of group interviews?
- A. Equal duration of time for each interviewee to answer questions
- B. Auditors pay more attention to each interviewee
- C. Less time-consuming
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:Group interviews allow auditors to gather more information in less time by:
* Obtaining input from multiple participants simultaneously.
* Encouraging discussions that might highlight inconsistencies.
* Reducing the number of individual interviews needed.
While auditors strive for fairness, equal time for each interviewee is not guaranteed, and paying attention to each individual is more difficult in a group setting.
NEW QUESTION # 98
Which statement regarding the drafting of the audit conclusions is correct?
- A. The audit conclusions must be drafted based on observation
- B. The audit conclusions must be based on evidence that is examined and evaluated in terms of quantity and quality
- C. The audit conclusions must not include the revisions that resulted from the closing meeting
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 6.4.9 (Audit Conclusions):
* Audit conclusions must be based on verified evidence.
* The evidence must be evaluated both quantitatively and qualitatively to ensure accuracy.
* Observations alone (A) are insufficient; conclusions must be supported by objective evidence.
Thus, B is the correct answer.
NEW QUESTION # 99
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