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【General】 Authoritative PECB - Valid ISO-9001-Lead-Auditor Exam Experience

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q173-Q178):NEW QUESTION # 173
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of
45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
After reviewing the documented information, Li Na claimed that it was not necessary to report the minor nonconformities that were identified; instead, they would be discussed in the next audit phase. Is this acceptable?
  • A. Yes, all identified nonconformities throughout the audit need to be documented and communicated at the end of the audit.
  • B. No, identification of minor nonconformities or areas of concern that could become nonconformities need to be documented and communicated to the auditee before proceeding to the next audit phase.
  • C. Yes, during the review of documented information, only major nonconformities need to be documented if detected.
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:As per ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action), all identified nonconformities, including minor ones, must be documented and communicated to the auditee.
Minor nonconformities can lead to major issues if left unaddressed. The auditor must inform the organization before moving to the next audit phase so that corrective actions can be taken. Clause 9.2.2 (Internal Audit) states that audit findings should be reported without undue delay.
Since Li Na did not report the minor nonconformities immediately, her decision was incorrect. Minor nonconformities should always be documented and communicated before proceeding to the next phase.

NEW QUESTION # 174
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. 7.5 Documented information
  • B. 7.4 Communication
  • C. 7.3 Awareness
  • D. 7.2 Competence
Answer: B
Explanation:
Questions no: 16 Verified  = 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 # 175
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the release of the anodes to avoid late delivery as penalties would be Imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
At the Closing meeting, the audit team leader presents the findings of the audit and comes to the above nonconformity. The Quality Manager produces the test report for Project DK, which shows an acceptable galvanic efficiency, and presents an email from the customer confirming acceptance of the anodes. He asks that the nonconformity be withdrawn.
Which two of the following responses by the audit team leader would be acceptable?
  • A. Refuse to accept the documentation produced and maintain the nonconformity.
  • B. Ask the auditor (you) who raised the issue, to state what you think should happen
  • C. Accept the Quality Manager's request without reviewing the documentation.
  • D. Thank the Quality Manager for his contribution but dismiss the information as irrelevant after a quick review.
  • E. Advise management that the information provided will be reviewed at the audit follow-up stage.
  • F. Indicate that the nonconformity is evidence of a system failure that needs to be rectified.
Answer: E,F

NEW QUESTION # 176
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO
9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME's operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
After reviewing the documented information, Li Na claimed that it was not necessary to report the minor nonconformities that were identified; instead, they would be discussed in the next audit phase. Is this acceptable?
  • A. Yes, all identified nonconformities throughout the audit need to be documented and communicated at the end of the audit.
  • B. No, identification of minor nonconformities or areas of concern that could become nonconformities need to be documented and communicated to the auditee before proceeding to the next audit phase.
  • C. Yes, during the review of documented information, only major nonconformities need to be documented if detected.
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
As per ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action), all identified nonconformities, including minor ones, must be documented and communicated to the auditee.
Minor nonconformities can lead to major issues if left unaddressed. The auditor must inform the organization before moving to the next audit phase so that corrective actions can be taken. Clause 9.2.2 (Internal Audit) states that audit findings should be reported without undue delay.
Since Li Na did not report the minor nonconformities immediately, her decision was incorrect. Minor nonconformities should always be documented and communicated before proceeding to the next phase.
Reference:
ISO 9001:2015, Clause 9.2.2 (Internal Audit Reporting)
ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action)

NEW QUESTION # 177
Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.

Answer:
Explanation:

Explanation:
The quality system failed to control the laundry services provided for customers in five shops.
The equipment used was not capable of consistently producing the required service.

NEW QUESTION # 178
......
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