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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

What is the responsibility of the audit committee during an internal audit?

Options:

A.

To define the audit schedule

B.

To supervise all audit functions and activities

C.

To establish an internal audit program

Question 18

A small cleaning services organisation is about to start work on a hospital cleaning contract for the local Health Trust. You,

as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract

requires that a cleaning plan is produced.

You: "How was the cleaning plan for the contract developed?"

Service Manager: "We have a basic template that covers the materials, labour requirements and cleaning methods to be

employed. Some of that is specified by the customer."

You: "How does the plan deal with locations like the intensive care wards and the operating theatres, which are included

in the contract?"

Service Manager: "The basic plan covers general wards, but we will do more frequent cleaning in those areas if the

hospital requests it."

You: "Are you aware of the regulatory requirements for cleaning standards in hospitals?"

Service Manager: "No. We depend on the hospital to look after that side of things in the contract."

You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001.

You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the

cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was

substituted to that specified in the contract. At the follow-up audit, the corrective action proposed was to

"obtain a concession from the Health Trust for use of the new chemical."

Which one of the following options is the reason why you did not accept this action taken?

Options:

A.

Staff have not been trained in the use of the new chemical.

B.

The action assumes that the Health Trust will agree to the change.

C.

The process for making changes to the contract has not been addressed.

D.

The substitute chemical has not been used before in the Health Trust.

E.

The substitute chemical may not be as effective as the original.

Question 19

You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers regulatory consultancy services to manufacturers of cosmetics. The business operates from ten regional offices.

You are nearing the end of the audit and need to decide if sufficient evidence of top management leadership and commitment with respect to the quality management system has been gathered.

Which four of the following would demonstrate top management leadership and commitment with respect to the quality management system?

Options:

A.

Approving company car budgets for the fiscal year

B.

Briefing staff on the development of an improvement culture

C.

Chairing management review meetings

D.

Conducting staff disciplinary meetings

E.

Investing time and money in corrective actions arising from nonconformities

F.

Not attending audit closing meeting

G.

Promoting the importance of following procedures

Question 20

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.