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

Question 1

You are conducting a third-party audit to ISO 9001 and interviewing the Training Manager. She explains that training is more

important than ever because the organisation has had to reduce the number of staff employed. Many of the remaining staff

are now required to be 'multi-skilled'. You ask to see plans for the multi-skilling training and are shown plans that look

comprehensive, and include both 'on the job" training and internal and external training courses.

The records indicate that several staff required parts of their training to be repeated one month after the first training was

provided. You ask why this was needed and are told that an investigation of customer complaints identified that several staff

members did not complete certain tasks in the correct manner. The extra training was therefore recommended as a

corrective action.

Based on this interview, which two of the tollowing audit trails would be the most appropriate to follow?

Select the two most appropriate audit trails from the following.

AAsk if customer complaints had ceased since the multi-skilled training finished.

BAsk the members of staff whether they found the training received useful.

CAssess whether Quality objectives are being met.

DDetermine whether customers were consulted about the risks associated with the multi-skilling training.

EDetermine whether management has assessed the impact of staff reduction on the organisation's ability to meet its objectives.

FReview records to assess if all planned training has been completed.

Answer : A, F

When conducting a third-party audit to ISO 9001, especially in the context of training and corrective actions taken due to customer complaints, the most appropriate audit trails to follow would be:

A . Ask if customer complaints had ceased since the multi-skilled training finished. This audit trail is relevant because it directly relates to the effectiveness of the corrective action taken. If customer complaints have decreased or ceased, it could indicate that the additional training was effective1.

F . Review records to assess if all planned training has been completed. This trail is important to ensure that the training plan has been fully implemented and to verify that all staff members have received the necessary training. It also helps in assessing the adequacy of the training in terms of content, frequency, and outcomes1.

These two trails, A and F, are closely linked to the issue of customer complaints and the organization's response to them. They provide insight into whether the actions taken were suitable and whether they have led to improvements in staff performance and customer satisfaction1. The other options, while potentially useful, do not directly address the immediate concern of the effectiveness of the corrective actions taken in response to the customer complaints1.

Question 2

Which two of the following work documents are not required for audit planning by an auditor conducting a certification audit?

AA career history of the quality manager

BA checklist

CA list of interested parties

DAn audit plan

EAn evidence sampling strategy

FAn organisation's financial statement

Answer : A, F

Question 3

Which two of the following should be included in an audit plan?

AList of findings from the last audit

BName of the auditee general manager

CSignature of Certification Body Technical Reviewer

DSequence and timings of audit activities

EDate of next audit

FName of auditees and auditors

Answer : D, F

According to ISO 19011:2018, clause 6.3.2, an audit plan should include the following information:

The audit objectives, scope, and criteria

The audit team members and their roles and responsibilities

The audit schedule, including the sequence and timings of audit activities, such as opening meeting, document review, interviews, observations, closing meeting, etc.

The expected time and duration of each audit activity and location

The name and contact details of the auditee's representative and other relevant parties

The allocation of appropriate resources to support the audit activities

The audit methods and techniques to be used, such as interviews, observations, sampling, etc.

The audit documents and records to be prepared and retained

The audit language and communication methods

The audit risks and opportunities and how to address them

The audit follow-up arrangements, if applicable

Therefore, the correct answer is D and F, as they are essential elements of an audit plan. The other options are either irrelevant or optional for an audit plan.Reference:

ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.2

ISO 19011: Guidelines for Auditing Management Systems | ASQ, section ''Making audit arrangements''

ISO 19011 Management Systems Audit Checklist | Process Street, task 6.3.2

Question 4

A Health Trust has contracted with Servitup, a catering services organisation which has been certified to ISO 9001 for 1 year. It provides services to ten, small rural

hospitals in remote locations involving purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital

staff. An auditor is conducting the first sole surveillance audit at one site with the Deputy Catering Manager (DCM).

At the closing meeting attended solely by the DCM, the auditor informs him that he has found numerous gaps in the QMS processes which lead him to consider

recommending suspension of the organisation's certification. He is particularly concerned with the evidence that patient health is being adversely affected by produce

stored beyond its safe consumption date, poor kitchen hygiene and undercooked meals. The DCM says that he cannot make any decisions about these issues in the

absence of the Catering Manager due to illness but will write everything down and report to the Catering Manager.

Which two actions should you take in the context of the audit?

AClose the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit.

BCall the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body.

CContinue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course.

DConclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work.

ERecommend that all personnel should be given urgent in-depth training in the QMS.

FThank the DCM for his time and express an expectation that improvements will be made in the QMS.

Answer : B, C

The actions that should be taken in the context of the audit are:

*Option B: Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body. This option is correct because the auditor has found serious and significant gaps in the QMS processes that affect the health and safety of the patients, which is a major nonconformity that may warrant suspension of certification. The auditor should inform the individual(s) managing the audit programme of the situation and the audit findings, and recommend immediate suspension of certification to protect the integrity of the Certification Body and the credibility of the certification scheme. The auditor should also follow the Certification Body's procedures and rules for suspension of certification and communicate the decision and the consequences to the auditee.

*Option C: Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course. This option is correct because the auditor should not terminate or postpone the closing meeting due to the absence of the Catering Manager, as the DCM is the auditee's nominated representative for the audit. The auditor should continue with the meeting, present the audit conclusions and the audit findings, and inform the DCM that the organisation will receive the audit report in due course. The auditor should also explain the audit outcome recommendation and the suspension of certification, and request the DCM to acknowledge the receipt and understanding of the audit results.

The following options are not correct:

*Option A: Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit. This option is not correct because the auditor should not close the meeting without presenting the audit conclusions and the audit findings, as this would violate the audit principles of fairness and transparency. The auditor should also not advise that the issues will be addressed at the next surveillance visit, as this would imply that the auditor is accepting the auditee's delay and inaction, and that the auditor is not taking the major nonconformity seriously.

*Option D: Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work. This option is not correct because the auditor should not conclude the meeting early or reschedule it due to the absence of the Catering Manager, as this would disrupt the audit process and the audit schedule. The auditor should also not wait for the Catering Manager to return to work, as this would delay the communication and resolution of the major nonconformity, and potentially compromise the health and safety of the patients.

*Option E: Recommend that all personnel should be given urgent in-depth training in the QMS. This option is not correct because the auditor should not recommend or prescribe specific corrective actions to the auditee, as this would violate the audit principles of independence and objectivity. The auditor should only report the audit findings and the audit outcome recommendation, and leave the responsibility and authority for determining and implementing the corrective actions to the auditee.

*Option F: Thank the DCM for his time and express an expectation that improvements will be made in the QMS. This option is not correct because the auditor should not thank the DCM for his time and express an expectation that improvements will be made in the QMS, as this would imply that the auditor is satisfied and optimistic with the auditee's performance and response, and that the auditor is not taking the major nonconformity seriously. The auditor should instead express the concern and dissatisfaction with the auditee's QMS processes and the impact on the health and safety of the patients, and communicate the suspension of certification and the need for urgent and effective corrective actions.

*ISO 19011:2018 Guidelines for auditing management systems, Clause 6.4.2: Conducting audit activities, Subclause k) and l)

*ISO 9001 Lead Auditor Course Material, Module 5: Conducting an Audit, Slide 20: Closing Meeting

*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 5.5: Closing Meeting

*Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection 3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies

Question 5

Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.

AConcession

BCorrection

CCorrective action

DPreventive action

Answer : B

According to the ISO 9000:2015 - Quality management systems --- Fundamentals and vocabulary, correction is defined as ''action to eliminate a detected nonconformity''. A nonconformity is defined as ''non-fulfilment of a requirement''. Therefore, the process of modifying a non-conforming product to bring it within acceptance criteria is a correction, as it eliminates the non-fulfilment of the product specification. The other options are not correct, as they have different definitions and purposes:

*Concession: permission to release or use a nonconforming product, service or process

*Corrective action: action to eliminate the cause of a nonconformity and to prevent recurrence

*Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable potential situation

Question 6

You work 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', which provides packaging materials to your organisation. It is 4 p.m. 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

for 5 p.m.

You, as audit team leader, audited top management, the laboratory, and the storage of raw materials.

Auditor 1 audited the two manufacturing lines and dispatch areas.

You to Auditor 1: "What findings would you report?"

Auditor 1: "When reviewing the Dispatch records, I noticed that during the morning two different trucks (Number 011 and 025) delivered the same

batch number of the product (Batch 33555). Truck 011 left the plant at 9.15 am and Truck 025 left the plant at 11.30 am. Procedure P-02 Rev.3 says

that trucks should carry a complete batch. The batch number, once on the truck, is captured using a QR device."

You: "OK, what do you think?"

Auditor 2: "I think that this is a nonconformity."

You: "OK. How would you describe the evidence on which the nonconformity will be based"?

Identify which one of the following statements best describes the identified nonconformity.

ADispatch personnel are not fully aware of the need to conform to written procedures.

BDispatch personnel do not always carry out its activities in conformance with Procedure P-02 rev 3.

CThe batch 33555 was delivered split in two different trucks (011 and 025).

DA product delivered to the client was not identified as required in P-02 Rev 3.

Answer : C

According to the definition in ISO 9000, a nonconformity is ''non-fulfillment of a requirement''. There are three parts to a well-documented nonconformity: the audit evidence to support auditor findings; a record of the requirement against which the nonconformity is detected; and the statement of nonconformity1. In this case, the audit evidence is the dispatch records that show the same batch number of the product being delivered by two different trucks at different times. The requirement is the procedure P-02 Rev.3 that says that trucks should carry a complete batch. The statement of nonconformity is that the batch 33555 was delivered split in two different trucks (011 and 025), which does not conform to the procedure. Therefore, option C best describes the identified nonconformity, as it includes all three parts of a well-documented nonconformity. Option A is not correct, as it does not state the audit evidence or the requirement. Option B is not correct, as it does not specify the audit evidence or the statement of nonconformity. Option D is not correct, as it does not match the audit evidence or the requirement. Reference: 1: ISO 9001 Auditing Practices Group Guidance on Nonconformity - Documenting.

Question 7

Which one of the following options best describes the purpose of a Stage 1 third-party audit?

ATo determine the auditees understanding of ISO 9001.

BTo get to know the organisation's customers.

CTo learn about the organisation's procurement processes.

DTo introduce the audit team to the client.

Answer : A

The purpose of a Stage 1 third-party audit is to determine an organization's readiness for their Stage 2 Certification Audit. During the Stage 1, the auditor will review the organization's management system documented information, evaluate the site-specific conditions, and have discussions with personnel. The objective is to assess the alignment of the organization's design with ISO 9001 requirements and to identify any areas of concern that could be classified as a nonconformance during the Stage 2 Audit. The auditor will also use the Stage 1 Audit to complete Stage 2 Audit planning, including a review of the allocation of resources and details for the next phase of the audit. Therefore, the option that best describes the purpose of a Stage 1 third-party audit is A, to determine the auditees understanding of ISO 9001. The other options are not correct, as they are not the main focus of a Stage 1 audit:

*B. To get to know the organization's customers: This is not the purpose of a Stage 1 audit, as the auditor is not interested in the specific details of the organization's customers, but rather in the organization's ability to meet customer and applicable statutory and regulatory requirements.

*C. To learn about the organization's procurement processes: This is not the purpose of a Stage 1 audit, as the auditor is not interested in the specific details of the organization's procurement processes, but rather in the organization's ability to control externally provided processes, products and services.

*D. To introduce the audit team to the client: This is not the purpose of a Stage 1 audit, as the auditor is not there to make introductions, but rather to conduct a preliminary examination of the organization's compliance with ISO 9001 standards.

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