PECB ISO-9001-Lead-Auditor Exam Practice Test Instant Access

Question 1

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?

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

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

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

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

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

Answer : C

Question 2

Answer : B, C, D, H, I, J

B . Applicable procedure: SP-701

D . Identification number of the washing machine

H . The concentration of the cleaning liquid used vs the concentration fixed in SP-701

I . The planned duration of the process vs the minimum time required in SP-701

J . Weight of linen being washed vs the maximum weight required in SP-701

C . Competence record of the machine operator

Question 3

Even though past audits have highlighted a consistently large number of nonconformities within an organisation's design team, the organisation has not varied the frequency or duration of audits on its audit plan.

The decision for whether this situation is acceptable or not should be governed by which of the following?

AA risk-based approach to the audit programme

BThe authority of the audit team leader

CThe availability of competent internal auditors

DThe organisation's reasoning behind the lack of change to the audit plan

Answer : A

Question 4

Which one of the following documents addresses audit time calculation for third-party certification audits?

AISO 17021-1

BISO 19011

CISO 9000

DISO 9001

Answer : A

ISO/IEC 17021-1 is the standard that specifies requirements for bodies providing audit and certification of management systems. It includes provisions for determining audit time for third-party certification audits, ensuring that the audits are conducted in a consistent, comparable, and reliable manner, which can be applied to a variety of management systems, including ISO 9001.

Question 5

According to the ISO 9001 standard, which one of the following is a defined responsibility of top management?

ACommunicating the quality objectives needed for the Quality Management System.

BEnsuring customer requirements are consistently met.

CEstablishing the Quality Management System quality policy.

DPlanning actions to address risks and opportunities.

Answer : C

Top management is responsible for establishing, implementing, and maintaining the quality policy. The quality policy provides a framework for setting quality objectives and must be compatible with the context of the organization and support its strategic direction. It should also provide a commitment to satisfy applicable requirements and to continuous improvement.

Question 6

Read the following role descriptions. Select two roles that are not directly involved in the audit process.

AAn auditor-in-training - a person who accompanies the audit team leader or team members during the audit.

BA technical expert - a person who provides specific knowledge or expertise to the audit team but is not normally an auditor.

CAn audit team leader - a person responsible for managing an audit until the audit is completed.

DAn interpreter - a person who witnesses the audit to assist the auditors with language issues.

EAn observer - a person who sees the performance of the audit team leader, audit team members and/or auditee.

FA guide - a person who is appointed by the auditee to assist the audit team during the audit.

Answer : D, E

Question 7

'XYZ' has already sent to you a list with all documented procedures and work instructions related to the services provided to 'ABC' (a quality manual is not included in the list).

To complete the audit planning which additional information would you ask to XYZ to submit? Select four.

AXYZ's organisational structure

BThe quality manual

CA description of responsibilities and authorities of the key roles of XYZ

DThe number of personnel involved in activities related to the quality management system

EInformation to understand XYZ's operations

FThe results of XYZ's last internal audit

GThe results of the last two management reviews

HThe list of risks and opportunities determined by XYZ

Answer : A, C, D, E

The ISO 9001 Lead Auditor exam requires the auditor to have a thorough understanding of the ISO 9001:2015 standard and its requirements, as well as the organization's context, processes, risks, opportunities, and performance. Therefore, the auditor needs to ask for additional information that can help them verify these aspects during the audit planning stage. Some of the information that can be useful are:

A description of responsibilities and authorities of the key roles of XYZ: This can help the auditor to identify who is accountable for what in the organization and how they communicate with each other.

The number of personnel involved in activities related to the quality management system: This can help the auditor to assess if there are enough resources and competencies to support the QMS implementation and operation.

Information to understand XYZ's operations: This can help the auditor to understand how XYZ produces or delivers its products or services and what are its main processes and inputs.

The results of XYZ's last internal audit: This can help the auditor to evaluate if XYZ has implemented corrective actions based on previous audit findings and if it has maintained its QMS effectiveness.

The results of the last two management reviews: This can help the auditor to determine if XYZ has monitored its QMS performance against its objectives and if it has identified any significant changes or opportunities for improvement.

The quality manual (B) is not a required document for ISO 9001 certification, but it may be useful for internal reference or training purposes. It is not necessary for audit planning.

PECB ISO-9001-Lead-Auditor QMS ISO 9001:2015 Lead Auditor Exam Practice Test