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ISO-9001-Lead-Auditor Questions and Answers

Question # 1

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 decides to review the training course design process in more depth.

Select three options that provide a meaningful audit trail for this process.

A.

How are students advised about prior learning requirements?

B.

How is customer feedback integrated into the course?

C.

How is the cost of the course calculated?

D.

What risks and opportunities have been notified to interested parties?

E.

How is design documentation controlled and managed?

F.

How is technical content of courses verified as correct?

G.

How is the tutor trained to deliver the completed course?

Question # 2

Select one option that must be considered when determining the scope of a QMS to ISO 9001.

A.

Business improvement

B.

Performance of business processes

C.

External issues of the organisation's context

D.

Competence of top management

Question # 3

The following list gives examples of records that may be evidence of how an organisation has fulfilled the requirements of clause 8.4 of ISO 9001. Match the records to the appropriate requirement of clause 8.4.

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