Free PECB ISO-9001 Lead Auditor Übungsprüfungen - Seite 4 von 6

Question #31

Which two of the following are included in the objectives of the ‚Stage 1 initial certification audit‘?

A . To evaluate the performance of monitoring and reviewing activities.
B . To evaluate the preparedness of the organisation for a Stage 2 audit.
C . To evaluate the internal audit and management review processes.
D . To review the quality manual.
E . To make a decision on certification to ISO 9001:2015.
F . To evaluate the operational processes of the organisation.

Lösung einblenden Lösung ausblenden

Question #32

Select which one of the following statements is true.

A . The team leader shall be an auditor that is qualified in the scheme.
B . An audit team can include non-qualified auditors.
C . A technical expert can replace a qualified auditor on an audit team.
D . Audits leading to auditor qualification are undertaken annually.

Lösung einblenden Lösung ausblenden

Question #33

You will lead a third-party audit next Monday on ABC, an organisation that provides services for cleaning windows from the outside of tall buildings. They work on demand, and usually have 4-5 orders per week. All documented information on these activities is kept at the central office.

On Friday evening, before the audit, you are informed by mail that customers cancelled all orders for the next week; therefore, the auditors will not have the chance to see them working at the customer’s premises, but the field supervisors will be available at the ABC offices.

You have prepared the audit plan and the checklist. Choose the best action you would take:

A . Start the audit on Monday at ABC’s as planned, interviewing the functions that regularly work at the central office, and plan visits to ABC customers wherever they may be working during the following week.
B . Ask the Certification Body you work for how to proceed with the audit.
C . Start the audit on Monday as planned, interviewing the functions that regularly work at the central office, and visit another customer’s premises they cleaned the week before.
D . Complete the audit but ask the quality manager to clean some windows at the ABC’s office, simulating the process they carry out at customers‘ premises.

Lösung einblenden Lösung ausblenden

Richtige Antwort: B
B

Explanation:

According to ISO 19011:2018, clause 6.3.3, the audit plan should be reviewed and revised as necessary to address changes that occur during the audit planning. The audit plan should be agreed upon, preferably in writing, by the audit team leader, the audit client and the auditee1. Therefore, if there is a significant change in the auditee’s situation, such as the cancellation of all orders for the next week, the audit plan should be reviewed and revised accordingly, with the agreement of all parties involved.

According to ISO/IEC 17021-1:2015, clause 9.1.4, the certification body should have a process to ensure that the audit team has the competence to achieve the audit objectives, and that the audit methods are appropriate for the scope and complexity of the audit. The certification body should also have a process to ensure that the audit is conducted under reasonable conditions and within a reasonable time frame2. Therefore, if there is a risk that the audit objectives cannot be achieved, or that the audit methods are not suitable, due to the change in the auditee’s situation, the certification body should be consulted and informed on how to proceed with the audit.

Therefore, the best action to take is B, ask the certification body you work for how to proceed with the audit. This action will ensure that the audit plan is revised and agreed upon by all parties, and that the audit team has the competence and the methods to conduct the audit effectively and efficiently. The other options are not correct, as they may compromise the quality and validity of the audit:

• A. Start the audit on Monday at ABC’s as planned, interviewing the functions that regularly work at the central office, and plan visits to ABC customers wherever they may be working during the following week: This action may not be feasible or acceptable, as it may extend the audit duration and cost beyond the agreed terms, and it may not provide sufficient and appropriate audit evidence to verify the conformity and effectiveness of the auditee’s processes. Moreover, this action may not be agreed upon by the audit client and the auditee, and it may not be approved by the certification body.

• C. Start the audit on Monday as planned, interviewing the functions that regularly work at the central office, and visit another customer’s premises they cleaned the week before: This action may not be relevant or reliable, as it may not reflect the current performance and condition of the auditee’s processes. The audit evidence collected from the previous customer may not be valid or representative of the audit criteria, and it may not address the risks and opportunities associated with the auditee’s context and objectives. Moreover, this action may not be agreed upon by the audit client and the auditee, and it may not be approved by the certification body.

• D. Complete the audit but ask the quality manager to clean some windows at the ABC’s office, simulating the process they carry out at customers’ premises: This action may not be objective or impartial, as it may introduce bias and influence in the audit process. The audit evidence collected from the simulated process may not be accurate or authentic, and it may not demonstrate the actual capability and effectiveness of the auditee’s processes. Moreover, this action may not be ethical or professional, as it may compromise the integrity and credibility of the audit and the certification.

Reference: ISO 19011:2018(en), Guidelines for auditing management systems, ISO/IEC 17021-1:2015(en), Conformity assessment ― Requirements for bodies providing audit and certification of management systems ― Part 1: Requirements

Question #34

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?

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.

Lösung einblenden Lösung ausblenden

Question #35

Who would be defined as a witness during a witness audit? Choose two of the following options:

A . Someone with a qualification from the certification body
B . An auditor
C . An existing member of the audit team
D . An assessor for the accreditation body

Lösung einblenden Lösung ausblenden

Richtige Antwort: B,D
B,D

Explanation:

Comprehensive and Detailed = According to the web search results from my internal tool, a witness audit is a technique used during an accreditation audit, where the accreditation body observes the performance and competence of the certification body auditors in conducting an audit12. A witness audit can also be used by a certification body to monitor and evaluate its own auditors3.

During a witness audit, the following roles can be defined:

• An auditor: This is the person who is being witnessed by the accreditation body or the certification body. The auditor is responsible for conducting the audit according to the audit plan, criteria, and standards, and for providing audit evidence and findings123.

• An assessor for the accreditation body: This is the person who witnesses the auditor on behalf of the accreditation body. The assessor is responsible for evaluating the auditor’s performance and competence, and for providing feedback and recommendations to the accreditation body123. The other options are not defined as witnesses during a witness audit, according to the web search results from my internal tool.

They are:

• Someone with a qualification from the certification body: This is not a specific role in a witness audit, as anyone who is involved in the audit process should have a qualification from the certification body. Moreover, having a qualification does not necessarily mean that the person is a witness or an auditor4.

• An existing member of the audit team: This is not a specific role in a witness audit, as the audit team consists of the auditors who are conducting the audit, not the ones who are witnessing it. The witness audit is a separate activity from the audit itself, and the witness should not interfere with the audit process or influence the audit outcome123.

Therefore, the correct answer is B and D.

Reference:

1: DQS Inc. | Witness Audits | Auditor Training

2: Have you ever been involved with a witness audit? – IFSQN

3: Certac – Witness Audit of Certification Bodies

4: ISO 19011:2018 – Guidelines for auditing management systems

Question #36

In the context of a third-party certification audit, it is very important to have effective communication.

Which is not the responsibility of the audit team leader?

A . If audit objectives are unattainable, reporting the reasons to the accreditation body.
B . Planning formal communication arrangements, so an auditee can communicate with the auditor
any time during the audit.
C . Confirming formal communication channels between the audit team and the auditee during the opening meeting.
D . Communicating the progress, any significant findings and any concerns to the auditee and audit client, as appropriate.

Lösung einblenden Lösung ausblenden

Question #37

Audit criteria are a set of requirements used as a reference against which objective evidence is compared.

Which two of the following are not potential audit criteria?

A . ISO management system standards
B . Verbal statements by the general manager
C . Verbal agreements with interested parties
D . Health and safety notices
E . Written agreements with interested parties
F . Commercial advertisements
G . Organisation’s documented information
H . Claims made on the organisation’s website
I . Commitment to follow principles issued by an NGO
J . Environmental aspects register

Lösung einblenden Lösung ausblenden

Richtige Antwort: F,H
F,H

Explanation:

According to ISO 19011:2018, clause 3.2, audit criteria are a set of policies, procedures or requirements used as a reference against which objective evidence is compared. Audit criteria are usually selected by the audit client or by agreement between the audit client and the auditee, and they should be appropriate for the audit scope and objectives1.

Audit criteria may include, but are not limited to, the following sources2:

• ISO management system standards, such as ISO 9001, ISO 14001, ISO 45001, etc.

• Verbal statements by the general manager or other top management, as long as they are consistent with the documented policies and objectives of the organisation

• Verbal agreements with interested parties, such as customers, suppliers, regulators, etc., as long as they are documented and approved by the relevant authorities

• Health and safety notices, such as posters, signs, labels, etc., that communicate the organisation’s legal obligations, policies, or procedures

• Written agreements with interested parties, such as contracts, orders, specifications, etc., that define the requirements and expectations of the parties involved

• Organisation’s documented information, such as policies, procedures, manuals, records, etc., that describe the organisation’s management system and its processes

• Commitment to follow principles issued by an NGO, such as the United Nations Global Compact, the International Labour Organization, etc., as long as they are relevant to the organisation’s context and objectives

• Environmental aspects register, such as a list of the environmental impacts and risks associated with the organisation’s activities, products, and services

Therefore, the two options that are not potential audit criteria are F and H, as they are not reliable or verifiable sources of information, and they may not reflect the actual performance or conformity of the organisation’s management system. Commercial advertisements and claims made on the organisation’s website are forms of marketing communication that may be exaggerated, misleading, or inaccurate, and they are not subject to the same level of scrutiny or approval as the other sources of audit criteria.

Reference: ISO 19011:2018(en), Guidelines for auditing management systems, What are audit criteria? – ISO Update

Question #38

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

A . An auditor-in-training – a person who accompanies the audit team leader or team members during the audit.
B . A technical expert – a person who provides specific knowledge or expertise to the audit team but is not normally an auditor.
C . An audit team leader – a person responsible for managing an audit until the audit is completed.
D . An interpreter – a person who witnesses the audit to assist the auditors with language issues.
E . An observer – a person who sees the performance of the audit team leader, audit team members and/or auditee.
F . A guide – a person who is appointed by the auditee to assist the audit team during the audit.

Lösung einblenden Lösung ausblenden

Question #39

TIX provides services to the informatic equipment of large organisations. They operate an ISO 9001:2015 QMS that is being audited by an important customer (second-party audit). During the audit, the audit team has identified two nonconformities. When preparing the Closing meeting, the audit

team discussed and agreed both nonconformities with TIX’s quality manager. The Closing meeting was planned for 6pm with the general manager, quality manager and service manager at the meeting room.

At 6pm, when the audit team enters the meeting room, only two people are present and waiting for them: the Health and Safety supervisor and the warehouse supervisor. Neither have participated in the audit.

The dialogue among them is as follows:

Audit team leader: "Good evening, could you please inform the three managers that we are ready to start with the Closing meeting?"

Health and Safety supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and

the other two managers have had to leave urgently to attend the emergency."

Warehouse supervisor: "They have asked us to listen to what you need to say and to sign whatever we need to sign. We also have a message

from them about the two nonconformities. They wanted us to ask you if you could contact them in a couple of days to determine how to proceed."

Which one of the following options would be your preferred response to the final comment made by the warehouse manager?

A . Sorry, but we cannot proceed with the Closing meeting. So, we are leaving now, and please tell the quality manager that I will phone him tomorrow early in the morning.
B . We will hear what you were asked to tell us and will ask you to sign the nonconformity reports as evidence that you have accepted them. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to complete the Closing meeting.
C . We will hear what you were asked to tell us and will leave copies of the nonconformity reports that have been agreed with the quality manager. Please tell the managers that we will consider this as the Closing meeting and that the individual(s) managing the audit programme will send the full report in five days.
D . We will hear what you were asked to tell us and will then leave. Please ask the managers to contact us as soon as the emergency is over to agree on a new date to carry out the Closing meeting.

Lösung einblenden Lösung ausblenden

Question #40

During a second-party audit, the auditor examines the records that are available for the external provider, ABC Forgings, to whom manufacturing has recently been outsourced.

There are standard external provider checklists for three competitors for the contract and there are inspection records from the trial manufacturing batches produced by ABC Forgings. There is no documented evidence of the criteria used to confirm the appointment of ABC Forgings, and no contract or terms and conditions. Ongoing monitoring indicates that external provider performance is satisfactory, but no documented information has been retained.

Select two options for the evidence which demonstrates a nonconformity with clause 8.4 of ISO 9001.

A . There was no documentation which provided evidence of any monitoring of the external provider.
B . The auditee required the outsourced products on an urgent basis before the completion of the paperwork.
C . The auditee did not retain documentation on the selection and evaluation of the external provider.
D . The external provider asked for the contract details to be verbal only.
E . There were no receipt inspection records of the incoming materials.
F . The auditee trusted the external provider because of a long-standing relationship with them.

Lösung einblenden Lösung ausblenden

Richtige Antwort: A,C
A,C

Explanation:

According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements.

To do so, the organization should:

• Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently.

• Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed.

• Select the external providers that have demonstrated their competence and conformity to the requirements. The selection should be based on the evaluation results and the organization’s needs. The selection should be documented and approved.

• Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the

documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely.

• Monitor the performance and conformity of the external provider, using the established criteria and methods. The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed.

In this case, the evidence statements that demonstrate a nonconformity with clause 8.4 are A and C, because they show that the organization did not retain documented information of the selection and evaluation of the external provider, and the monitoring of the external provider’s performance.

These are requirements of the standard and essential for ensuring the quality of the externally provided processes, products, and services. The other options are not directly related to clause 8.4, although they may indicate other nonconformities or weaknesses in the organization’s QMS. For example, option B may relate to clause 7.1.3 on contingency planning, option D may relate to clause 8.2.3 on review of requirements, option E may relate to clause 8.6 on release of products and services, and option F may relate to clause 5.1.1 on leadership and commitment.

Reference: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems