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Pass the PECB ISO 9001 ISO-9001-Lead-Auditor Questions and answers with ExamsMirror

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Viewing questions 51-60 out of questions

Questions # 51:

You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist

laboratory equipment and furniture.

You: "I'd like to look at how you manage change in the organisation. What changes have you made as a business, say,

over the last 12 months?"

Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our own products

in house."

You: "That sounds like quite a significant change. What has been the impact of that?"

Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced

manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members of our staff

redundant. This represents about 20% of our workforce, so this has been quite a challenging time."

This scenario presents a number of audit trails to different ISO 9001 requirements.

Which three of the following requirements would be relevant audit trails for this scenario?

Options:

Organisational knowledge

Control of externally provided processes, products, and services

Design and development of products and services

Documented information

Measurement traceability

Organisation roles and responsibilities

Preservation of product

Questions # 52:

You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements. The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.

You are interviewing the Training Manager (TM).

You: "What quality objectives apply to the training process?"

TM: "One of the quality objectives we aim for is a 90% minimum exam pass rate for all open training courses."

You: "How do you measure this objective?"

The Training Manager shows you a record on her computer and you see the following:

Question # 52

Which two of the following statements are true?

Options:

You would check the training of personnel.

You would determine how the exam pass rate figures were analysed.

You would determine the relative difficulty of each training course by reviewing them.

You would determine what corrective action was being taken to address the low pass rates.

You would raise a nonconformity as a requirement in clause 10.2 has not been fulfilled.

You would raise a nonconformity as a requirement in clause 8.7 has not been fulfilled.

Questions # 53:

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.

Li Na chose a sampling method that sufficiently represents customer complaints from both areas of ME’s operations. Which sampling method fits that description?

Options:

Systematic sampling

Stratified sampling

Block selection sampling

Questions # 54:

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation manufactures cosmetics for major retailers.

You are interviewing the Manufacturing Manager (MM).

You: "I would like to begin by looking at the cleaning controls."

MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside."

Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.

Question # 54

You decide to raise a non-conformity.

Question # 54

Options:

Questions # 55:

What type of audit evidence are policies and guidelines?

Options:

Confirmative evidence.

Technical evidence.

Documentary evidence.

Questions # 56:

Scenario 3:

Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team began by gathering information about Fin-Pro’s understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.

The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company’s working environment (social, psychological, and physical conditions).

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

What type of evidence has been collected by the ACB’s audit team, as presented in scenario 3?

Options:

Documentary, confirmative, verbal.

Verbal, documentary, physical.

Physical, verbal, analytical.

Observational, secondary, qualitative.

Questions # 57:

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 oll 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 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.

Which of the following options for the best description of the nonconformity?

Options:

A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager.

Release of the product without acceptable test results has been accepted by the customer for Project DK.

Products for Project DK have been released before product approval through the quality control process.

The untested product was not recalled until the galvanic efficiency of the anodes was verified.

Answer

Explanation

 Clause Reference – ISO 9001:2015 Clause 8.6 (Release of Products and Services):

ISO 9001 requires that products and services are not released to the customer until:

All planned verification activities have been completed.

Acceptance criteria have been met.

Any necessary approvals have been obtained.

In this scenario:

The sacrificial anodes for Project DK were shipped before the galvanic efficiency test results were analyzed.

This constitutes a nonconformity against Clause 8.6 because the products were released without completing the required tests.

 Option Analysis:

A. A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager:Incorrect. While obtaining a concession might mitigate the situation, the nonconformity pertains to the process failure of releasing the products without completing required tests, not the absence of a concession.

B. Release of the product without acceptable test results has been accepted by the customer for Project DK:Incorrect. The customer was not informed before the release, and there is no indication that this was accepted beforehand. Furthermore, ISO 9001 requires planned processes to be followed, regardless of later acceptance.

C. Products for Project DK have been released before product approval through the quality control process:Correct. This description accurately reflects the nonconformity. The quality control process required test results to be analyzed and verified before release, which did not happen.

D. The untested product was not recalled until the galvanic efficiency of the anodes was verified:Incorrect. The issue is not about recalling the product but about releasing it without completing the required tests. Recalling the product is not mentioned in the scenario.

 Why C is Correct:

The nonconformity is a clear breach of Clause 8.6, where the products were released without meeting the planned verification requirements.

This demonstrates a failure in adhering to quality control processes, which is a critical aspect of ISO 9001 compliance.

 Key ISO 9001 Reference:

Clause 8.6: Products and services shall not be released to the customer until all planned activities (e.g., testing) have been satisfactorily completed, or the customer has approved the release with knowledge of deviations.

Questions # 58:

Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).

Question # 58

Options:

Answer

Answer:

Explanation

Quality management principles:

Customer focus = Increased revenue and market share

Engagement of people = Enhanced trust and collaboration throughout the organisation

Improvement = Enhanced drive for innovation

Evidence-based decision-making = Increased ability to demonstrate effectiveness of past actions

According to the Quality management principles document published by ISO, each quality management principle has a statement, a rationale, key benefits, and actions you can take to apply it. Based on these descriptions, the potential benefits can be matched to the corresponding principles as follows:

Customer focus: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. The key benefits of this principle include increased customer value, customer satisfaction, customer loyalty, repeat business, reputation, customer base, revenue and market share.

Engagement of people: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value. The key benefits of this principle include improved understanding of the organization’s objectives and values, increased involvement in improvement activities, enhanced personal development, increased motivation and empowerment, enhanced trust and collaboration, and increased recognition and rewards.

Improvement: Successful organizations have an ongoing focus on improvement. The key benefits of this principle include improved organizational capabilities, alignment of improvement activities at all levels, increased ability to anticipate and react to opportunities and threats, enhanced drive for innovation, and increased levels of satisfaction.

Evidence-based decision-making: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. The key benefits of this principle include improved decision-making processes, increased ability to demonstrate the effectiveness of past decisions, increased ability to review, challenge and change opinions and decisions, and increased ability to improve performance.

Questions # 59:

Scenario 3:

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

Based on the last paragraph of scenario 3, which audit principle did the audit team follow?

Options:

Fair presentation.

Integrity.

Confidentiality.

Objectivity.

Questions # 60:

Scenario 3:

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.