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Pearson ISO-9001-Lead-Auditor New Attempt

QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

Question 9

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:

A.

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

B.

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

C.

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

D.

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

E.

8.6 - Dirty products were released to the customer.

F.

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

G.

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

Question 10

Will the auditee be subject to an audit follow-up if a minor nonconformity has been reported by the audit team leader in the audit conclusions?

Options:

A.

No, the auditee will be subject to an audit follow-up only if a major nonconformity is detected

B.

Yes, there should be an audit follow-up regardless of the type of nonconformities that are detected during the audit

C.

No, the audit team should suggest a recommendation only, in which it suggests an adequate corrective action for the nonconformity

Question 11

Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.

Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled. The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.

The top management, in cooperation with Sean, assigned 10 more employees to the audit team. Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.

Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting

The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.

Based on the scenario above, answer the following question:

Ten employees of POLKA were part of the audit team that conducted the internal audit. Is this acceptable?

Options:

A.

Yes, members of the company can join the internal audit team

B.

No, ISO 9001 requires hiring a professional team of auditors who are not part of the company to conduct the internal audit

C.

Yes, it is a requirement of ISO 9001 to include employees of the company in the internal audit

Question 12

Which one of the following options is the definition of the context of an organisation?

Options:

A.

Combination of internal and external issues that can have an effect on an organisation's approach to developing and achieving its objectives.

B.

Comparison of internal and external issues that can have an effect on an organisation's desire to achieve its objectives.

C.

Complexity of internal and external issues that can have an effect on an organisation's approach to developing and achieving its purpose.

D.

Coordination of internal and external issues that can have a positive or negative effect on an organisation's success.