PECB ISO-9001-Lead-Auditor Study & Exam Dumps 2025

QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

Get Free ISO-9001-Lead-Auditor Questions and Answers

Question 1

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 He asks that the nonconformity be withdrawn.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?

Options:

Accept the Quality Manager's request without reviewing the documentation.

Advise management that the information provided will be reviewed at the audit follow-up stage.

Ask the auditor (you) who raised the issue, to state what you think should happen

Indicate that the nonconformity is evidence of a system failure that needs to be rectified.

Refuse to accept the documentation produced and maintain the nonconformity.

Thank the Quality Manager for his contribution but dismiss the information as irrelevant after a quick review.

Buy Now

Question 2

An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:

"The reject rate of the finished product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%."

As the third-party auditor reviewing the internal audit process, you come across the nonconformity. For corrective action, the Quality Manager conducted an investigation into the reject rates. He reported that the collection baskets for products ejecting from the moulding machines were not large enough. About 6% of products fell onto the wet and dirty factory floor. Management stated that replacing the baskets was too costly and ordered the Maintenance Manager to ensure that the floor was kept clean and dry to prevent rejects. The auditor later checked the factory floor, which was wet and dirty in places.

From the following nonconformities, select three that the auditor could raise to ISO 9001.

Options:

10.3 - The organisation did not continuously improve. Reject rates were unchanged.

7.1.4 - The factory environment is not suitably maintained to prevent dirty products.

7.1.1 - The organisation failed to provide the required resources to prevent nonconforming products.

9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3).

8.6 - Dirty products were released to the customer.

7.3 - Staff were not aware that products were falling onto the factory floor.

10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity.

Answer:

A, B, C

Explanation:

The auditor could raise the following nonconformities to ISO 9001 based on the scenario:

•Option A: 10.3 - The organisation did not continuously improve. Reject rates were unchanged. This option is correct because ISO 9001:2015 clause 10.3 requires the organization to improve the suitability, adequacy and effectiveness of the quality management system. The organization did not demonstrate any improvement in reducing the reject rate of the finished product, which was a stated objective of top management. The corrective action taken by the organization was not effective in addressing the root cause of the problem and preventing its recurrence.

•Option B: 7.1.4 - The factory environment is not suitably maintained to prevent dirty products. This option is correct because ISO 9001:2015 clause 7.1.4 requires the organization to determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. The organization did not ensure that the factory floor was clean and dry, which affected the quality of the products and increased the risk of nonconformity.

•Option C: 7.1.1 - The organization failed to provide the required resources to prevent nonconforming products. This option is correct because ISO 9001:2015 clause 7.1.1 requires the organization to determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. The organization did not provide adequate collection baskets for the products ejecting from the moulding machines, which resulted in products falling onto the factory floor and becoming nonconforming.

The following options are not correct:

•Option D: 9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3). This option is not correct because ISO 9001:2015 clause 9.2.2 does not specify the requirements for the wording of nonconformities in internal audit reports. The nonconformity (NC 3) stated by the internal auditor was clear and relevant to the audit criteria and audit evidence. The issue is not with the report, but with the corrective action taken by the organization.

•Option E: 8.6 - Dirty products were released to the customer. This option is not correct because ISO 9001:2015 clause 8.6 requires the organization to implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met. The scenario does not indicate that the dirty products were released to the customer, but that they were recalled and repaired then returned to the customers. The issue is not with the release, but with the production process and the environment.

•Option F: 7.3 - Staff were not aware that products were falling onto the factory floor. This option is not correct because ISO 9001:2015 clause 7.3 requires the organization to ensure that the persons doing work under its control are aware of the quality policy, relevant quality objectives, their contribution to the effectiveness of the quality management system, and the implications of not conforming with the quality management system requirements. The scenario does not indicate that the staff were not aware of these aspects, but that the management did not provide adequate resources and environment for the staff to perform their work. The issue is not with the awareness, but with the management responsibility and resource provision.

•Option G: 10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity. This option is not correct because ISO 9001:2015 clause 10.2.1 requires the organization to react to the nonconformity and, as applicable, take action to control and correct it and deal with the consequences. The scenario indicates that the Quality Manager conducted an investigation into the reject rates and identified the cause of the nonconformity. The issue is not with the investigation, but with the corrective action taken by the management.

•Option H: 8.5.1 - Production operations were not properly controlled to avoid reject products. This option is not correct because ISO 9001:2015 clause 8.5.1 requires the organization to implement production and service provision under controlled conditions. The scenario indicates that the production operations were controlled by the moulding machines, which ejected the products into the collection baskets. The issue is not with the production operations, but with the size of the collection baskets and the condition of the factory floor.

[References:, •ISO 9001:2015 Quality management systems - Requirements, •ISO 9001 Lead Auditor Course Material, Module 6: Reporting Audit Findings, Slide 14: Writing Nonconformity Statements, •ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 6.2: Reporting Audit Findings, •Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection 3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies, , , ]

Question 3

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."

You: "I'm sure. What were the reasons for making the change?"

Auditee: "Our manufacturing section was a small operation, and we struggled to cope with fluctuations in

demand. During busy periods, we found it hard to meet lead times, and in quiet periods we had staff with

little to do. This was having an impact on customer satisfaction and meant we had to charge premium prices

that made our product uncompetitive."

You: "How did you go about the change?"

The auditor asks to speak to the purchasing manager about the selection of the subcontractor to

manufacture the company's own brand products.

You: "How did you choose a supplier to manufacture your products?"

Auditee: "We have had a long-term relationship with a supplier ABC Ltd - we gave them our design

drawings, got them to complete a supplier questionnaire and run a couple of trial batches for us. We were

happy with the result and we have used them ever since."

ISO 9001:2015, clause 8.4.1 outlines situations when controls need to be applied to externally provided processes, products and services. Which one of the following situations is applicable to this scenario?

Options:

Products and services for which the customer(s) supplies materials

A process or part of a process is provided by an external provider as a result of a decision by the organisation.

Products and services are provided directly to the customer(s) by external providers on behalf of the organisation.

Raw materials from external providers are intended for incorporation into the organisation's own products.

Get Free ISO-9001-Lead-Auditor Questions and Answers

Pre-Summer Sale 70% Discount Offer - Ends in 0d 00h 00m 00s - Coupon code: save70

PECB ISO-9001-Lead-Auditor Exam With Confidence Using Practice Dumps

ISO-9001-Lead-Auditor: ISO 9001 Exam 2025 Study Guide Pdf and Test Engine

Related PECB Exams

QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

Options:

Answer:

Options:

Answer:

Explanation:

Options:

Answer:

Explanation:

CompTIA

Fortinet

Microsoft

Salesforce