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ISO 9001 ISO-9001-Lead-Auditor Book

QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

Question 41

When monitoring customer perceptions, which analysis is helpful to use?

Options:

A.

PEST analysis

B.

Market-share analysis

C.

Gap analysis

D.

Competitive benchmarking

Question 42

Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit

of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.

The auditor samples the design records for a recently completed course for the 247 Insurance organisation. Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage

was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.

The auditor raises a nonconformity against ISO 9001. Which one of the following options is the basis for the nonconformity?

Options:

A.

8.3.5 - The improvements made to course designs are not documented. Feedback from customers is not always actioned.

B.

8.3.2.c - Design planning does not include design validation. Design verification is part of the planning process.

C.

8.3.4.d - Design validation is not always conducted. It is omitted about half of the time.

D.

8.6 - Course materials are released without proper approval. A course for 247 Insurance was released on an urgent basis.

Question 43

Knowledge and skills are requirements of the auditor's competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.

Options:

A.

Requirements of ISO 9001

B.

ISO 19011 Audit principles

C.

Organisation's market sector

D.

Organisation's invoicing and profits of the last 5 years

E.

Organisation's processes

F.

Requirements of auditee's interested parties other than customers

Question 44

You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years

You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.

You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

Options: