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Free Access PECB ISO-9001-Lead-Auditor New Release

QMS ISO 9001:2015 Lead Auditor Exam Questions and Answers

Question 17

Which two of the following roles do not contribute to the audit outcomes?

Options:

A.

Individual(s) managing the audit programme

B.

Auditee

C.

Guide

D.

Consultant

E.

Observer

F.

Technical expert

Question 18

You work as an external quality consultant for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, 'B', to ISO 9001 which provides packaging materials to your organisation. It is 4 pm and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled at 5 pm.

You, as Audit Team Leader, audited top management. You explain to the audit team that you identified two nonconformities:

a. There is no documented information on Top Management Reviews, as required in clause 9.3 of ISO 9001:2015.

b. There is no evidence of Top Management Commitment as required in clause 5.1 of ISO 9001:2015. (e.g., not ensuring the availability of resources

to operate the QMS, not ensuring the establishment of objectives, no promotion of improvement, no promotion of the process approach).

All agreed to present these two nonconformities. They went to meet the Top Management of 'B' and noticed that the General Manager and three other managers (Production, Human Resources, and Sales) were present in the meeting room.

Considering the seriousness of the two nonconformities to Top Management, as audit team leader, from the following select the best option:

Options:

A.

Present the nonconformities to the whole group and inform that you will recommend your company to remove them from the approved suppliers list.

B.

Present the nonconformities to the managers, inform them that the report will be sent within 10 days, close the meeting and leave the site.

C.

Ask the General Manager to have a private conversation in which you present the nonconformities only to him because of their sensitive nature.

D.

Present the nonconformities to the whole group and analyse with them how to overcome this situation.

Question 19

You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing

structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the

adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.

You: "How do you tell when the billet is ready for the rolling stage?"

Operator: "I've done this job for 20 years. I can tell by the bright red colour."

You: "What happens if the colour is wrong?"

Operator: "The billet goes back into the furnace."

You: "Is the pyrometer ever used?"

Operator: "Only in borderline cases."

You continue to interview the operator and find that around 25% of the billets are sent back to the furnace. This includes 80% of the borderline cases.

Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.

Options:

A.

Periodic analysis of the results of temperature checks.

B.

Certification of conformance to national standards from the manufacture of the pyrometer.

C.

An increase in the use of the pyrometer by operators.

D.

Maintenance plan for the furnace.

E.

A procedure that provides instruction in taking billet temperature.

F.

Planning for monitoring and measuring the billet temperature.

G.

A quality objective to achieve lower recycle rates for billets.

Question 20

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.