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NEW QUESTION # 20
You are the supervisor in Production of a medium size manufacturing organisation. You are qualified as an internal auditor. The Quality Manager asks you to lead the next internal audit of Production and Logistics Dispatch. The audit team includes two other internal auditors.
Answer:
Explanation:
Explanation:
Here is the correct matching of actions to the statements in the context of leading the internal audit:
If practicablecarry out a formal opening meeting
You should notaudit production (as you are a supervisor in that area, and this would compromise audit objectivity) You need notchange the audit team (unless there is a specific reason, such as conflict of interest) You mustraise audit findings if necessary (this is a key responsibility of an auditor when nonconformities are found) You must notsend the audit report to the Quality Manager (the audit report must be reviewed first; it is typically part of the internal audit process to go through necessary channels before final submission) You shouldsend the audit report to the Quality Manager (after appropriate reviews and approvals) This reflects key principles of conducting an internal audit according to ISO 9001:2015, ensuring objectivity, proper documentation, and clear reporting procedures.
NEW QUESTION # 21
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. 80% of complaints originate from five shops in the same region. Most of these complaints relate to customer laundry not being cleaned as customers require. 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 now. You learn that the shop managers were told to dismiss most of the complaints because 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.
You raised a nonconformity against clause 8.5.1 of ISO 9001.
Based on the scenario, select the three options which best describe the evidence for raising such a nonconformity.
Answer: B,D,H
Explanation:
The nonconformity was raised against ISO 9001:2015 Clause 8.5.1 - Control of production and service provision. This clause requires organisations to carry out production and service provision under controlled conditions, including:
* the use of suitable infrastructure and equipment,
* the availability and use of appropriate monitoring and control, and
* the prevention of nonconforming outputs being delivered to customers.
In this scenario, the evidence shows a systemic failure in operational control, not isolated human error.
Explanation of the selected evidence:
E). The organisation failed to control the laundry operations in 5 shops adequately.
Clause 8.5.1 requires consistent control of service provision. The fact that 80% of complaints come from five specific shops demonstrates a lack of effective operational control in those locations.
G). The organisation failed to maintain all of its equipment to an adequate standard.
Clause 8.5.1 requires suitable infrastructure for service provision. Management acknowledged that equipment in these shops is old and cannot currently be replaced, meaning it is not being maintained at a level necessary to ensure conformity of service.
H). Some equipment used was not suitable for the laundry process.
The poor cleaning outcomes and high complaint levels directly indicate that the equipment is not fit for purpose, which is a clear breach of the requirement to provide suitable resources for controlled service provision under Clause 8.5.1.
Explanation of why the other options are not appropriate evidence for Clause 8.5.1:
* A relates to strategic planning and investment decisions, not directly to operational control.
* B and C relate to inspection activities, which were not evidenced in the scenario.
* D and F relate to complaint handling behaviour, which would align more closely with Clause 9.1.2 (customer satisfaction) or Clause 10.2 (nonconformity and corrective action), not Clause 8.5.1.
ISO-aligned conclusion:
The nonconformity is justified because the organisation is continuing to provide services using unsuitable and inadequately maintained equipment, resulting in repeated service failures in multiple locations. This demonstrates a clear failure to control service provision as required by ISO 9001:2015 Clause 8.5.1, supported by evidence E, G and H.
NEW QUESTION # 22
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?
Answer: A
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 # 23
You visit XYZ Corporation to conduct a Stage 2 certification audit as Audit Team Leader with one other auditor. You find that the Quality Manager has set a single quality objective for himself. This states that "The Quality Manager will drive multiple improvements in the QMS in the next year". The Quality Manager indicates that this gives him the authority to issue instructions to department managers when quality improvement is needed. He says that this approach has the full backing of senior management. He shows you his latest Quality Improvement Request for the HR Manager.
Select two options for statements which align with ISO 9001 6.2.
Answer: C,F
Explanation:
ISO 9001:2015 clause 6.2 requires quality objectives to be measurable, monitored, communicated, and updated as appropriate. It also requires the organisation to determine how the results will be evaluated.
A aligns with clause 6.2.2 because the results of actions taken to achieve quality objectives must be evaluated.
F aligns with clause 6.2.1 because the stated objective, "drive multiple improvements in the QMS in the next year," is vague and not clearly measurable.
NEW QUESTION # 24
(In the context of a second-party quality management system audit, select the two correct statements from the following:)
Answer: A,F
Explanation:
ISO 9001:2015 does not define detailed audit role terminology itself, but it explicitly refers to ISO 19011 for audit guidance. This makes ISO 19011 authoritative for defining audit roles and responsibilities within ISO
9001 audits.
ISO 9001:2015, Clause 9.2.2 - NOTE:
"See ISO 19011 for guidance."
Therefore, the correctness of the statements is determined using ISO 19011 (Auditing management systems) principles, which are fully applicable to second-party audits.
# B. An auditor is a person who conducts an audit
# Correct
* ISO 19011 defines an auditor simply and clearly as "a person who conducts an audit."
* This definition applies equally to first-, second-, and third-party audits.
This statement is universally correct and fully aligned with ISO auditing terminology.
# F. When needed, a translator appointed by the auditee
# Correct
* ISO 19011 allows the use of translators/interpreters to support communication during audits.
* Translators are typically appointed by the auditee, not the audit team.
* Translators are not members of the audit team and do not influence audit conclusions.
This is a valid and correct statement for second-party audits.
# Why the other options are incorrect
# A. Guide appointed by the audit team leader
* In ISO 19011, a guide is appointed by the auditee, not by the audit team leader.
* The guide assists with logistics and access, not audit execution.
# Incorrect appointment authority.
# C. The audit team cannot include auditors-in-training
* ISO 19011 explicitly allows auditors-in-training to be part of the audit team under supervision.
# Incorrect restriction.
# D. Observer provides information about the organisation
* An observer does not provide information or participate in the audit.
* Observers may attend (e.g. regulators, accreditation bodies) but remain passive.
# Incorrect role description.
# E. A technical expert is part of the audit team
* A technical expert supports the audit team, but is not considered an auditor.
* They provide subject-matter expertise under the direction of auditors.
# The statement is misleading and therefore incorrect.
NEW QUESTION # 25
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