Free PECB ISO-9001 Lead Auditor Practice Exams - Page 3 of 6

Question #21

XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management. The Quality Manager complains that this has created a lot of resistance

to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.

How would you respond with the following options? Select three.

A . Suggest asking the certification body for guidance on this matter.
B . Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organisation’s requirements.
C . Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly.
D . Inform the Quality Manager that you will comment on the subject in your audit report.
E . Indicate that ISO 9001 requires a minimum of two quality objectives.
F . Suggest that all employees undertake a training course on ISO 9001.
G . Advise the Quality Manager that, as an auditor, you cannot provide advice to the organisation on how it should operate its QMS.
H . Suggest that the Quality Manager obtains external consultancy on the use of quality objectives.

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Correct Answer: BCD
BCD

Explanation:

According to the ISO 9001:2015 standard, clause 6.2.1 requires organizations to establish quality objectives at relevant functions, levels, and processes needed for the quality management system. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The quality objectives must also be measurable, monitored, communicated, and updated as appropriate.

In this scenario, the Quality Manager of XYZ Corporation has set quality objectives for every employee in the organization except top management. This has created a lot of resistance to the QMS, and the Chief Executive is asking questions about the cost and the method of setting objectives. The Quality Manager asks for your opinion as an auditor on whether this is the correct method of setting objectives.

As an auditor, you cannot provide advice to the organization on how it should operate its QMS. Your role is to assess the conformity and effectiveness of the QMS against the requirements of the standard and the organization’s own policies and objectives. Therefore, you should respond with the following options:

B. Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organization’s requirements: You can suggest that the Quality Manager should familiarize himself with the requirements of clause 6.2.1 and understand how they apply to his organization. He should also consider the context and the needs and expectations of interested parties when setting quality objectives. He should ensure that the quality objectives are aligned with the quality policy and the strategic direction of the organization.

C. Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly: You can inform the Quality Manager that you will evaluate the quality objectives during the audit and check whether they meet the requirements of clause 6.2.1. If you find any gaps or weaknesses in the quality objectives, you will raise an opportunity for improvement to help the organization improve its QMS. You will also verify whether the quality objectives are monitored, communicated, and updated as appropriate.

D. Inform the Quality Manager that you will comment on the subject in your audit report: You can inform the Quality Manager that you will document your findings and observations on the quality objectives in your audit report. You will also provide a summary of the audit results and any recommendations for improvement. You will also indicate the level of conformity and effectiveness of the QMS.

These three options would help you to maintain your impartiality and professionalism as an auditor and to provide constructive feedback to the organization

Question #22

You are a member of the audit team of a second-party audit of an organisation with 625 employees. The audit procedure recommends using sampling criteria which requires the review of the documented competence for 25 personnel. The audit team leader developed an audit plan allocating one hour to audit the Human Resources department (from 11:30 am to 12:30 pm). She told you that she could not allocate any additional time.

What would you do?

A . Extend the audit until 1.00pm and ask for a quick lunch later.
B . Plan to review less than 25 cases.
C . Plan to review as many as possible and see if you can extend the audit duration by one day.
D . Plan to miss lunch and review as many as possible.

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Question #23

During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at a major international airport, you interview the CD 9000’s General Manager (GM), who was accompanied by Jack, the legal compliance expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.

You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?"

GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon, shortage of chemicals for the analysis. It was quite a good experience."

You: "Did you document these issues?"

GM: "No. Jack said that ISO 9001 does not require us to document these issues."

You: "How did you determine the risks associated with the issues and did you plan actions to address them?"

GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence."

Select two options for how you would respond to the General Manager’s suggestion:

A . I would ask to audit the Technical Manager by phone.
B . I would ask for a different guide instead of the legal compliance expert.
C . I would look for evidence that the actions resulting from the risk assessment had been taken.
D . I would ask the consultant to leave the meeting since he is not an employee of the organisation.
E . I would delay the audit until the return of the technical manager
F . I would not accept the legal compliance expert answering the question.

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Correct Answer: BC
BC

Explanation:

According to the ISO 9001:2015 standard, clause 4.1 requires organizations to determine the external and internal issues that are relevant to their purpose and that affect their ability to achieve the intended outcomes of their quality management system. Clause 6.1 requires organizations to plan actions to address the risks and opportunities associated with these issues. These actions must be integrated into the quality management system processes and evaluated for effectiveness.

In this scenario, the General Manager of the pharmaceutical organization has shown a lack of understanding and involvement in the process of identifying and addressing the external and internal issues that affect their quality management system. The General Manager has relied on the legal compliance expert, who is not an employee of the organization, to guide them on this process. The General Manager has also admitted that they did not document these issues, which is contrary to the requirement of retaining documented information on the context of the organization. The General Manager has also delegated the responsibility of determining and planning the actions to address the risks and opportunities to the Technical Manager, who is absent due to COVID-19.

Based on this information, you can respond to the General Manager’s suggestion by taking two options:

B. I would ask for a different guide instead of the legal compliance expert: You can request to have a different guide who is an employee of the organization and who is familiar with the quality management system processes and the external and internal issues that affect them. The legal compliance expert may not have the necessary knowledge and authority to answer your questions or provide you with the relevant evidence.

C. I would look for evidence that the actions resulting from the risk assessment had been taken: You can verify whether the organization has implemented and evaluated the actions to address the risks and opportunities associated with the external and internal issues. You can look for evidence such as records of risk analysis, action plans, monitoring and review results, and improvement measures.

These two options would help you to assess the conformity and effectiveness of the organization’s quality management system with respect to the requirements of clauses 4.1 and 6.1.

Question #24

In the context of a third-party certification audit, how can the auditor demonstrate confidentiality? Select two.

A . Adhere to the CQI Professional Code of Conduct.
B . Confirm the confidentiality arrangements with the auditee regarding the use of mobile devices/cameras.
C . Discuss sensitive personal information with the guides appointed by the auditee.
D . Remove audit evidence without the permission of the auditee.
E . Share audit conclusions with competitor organisations.

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Question #25

DRAG DROP

You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.

You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.

You: "How do you ensure your regulatory team’s competence concerning regulatory requirements is maintained?"

TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry."

You: "How is their regulatory competence maintained?"

TD: "They are dedicated individuals with lots of contacts in the sector."

You: "How does the business enable them to maintain their understanding of current regulatory requirements?"

TD: "We leave that up to them."

You decide to raise a nonconformity.

To complete the nonconformity report click on the blank section you want to complete so itis highlighted in red and then did on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.

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Question #26

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

A . To determine the auditees understanding of ISO 9001.
B . To get to know the organisation’s customers.
C . To learn about the organisation’s procurement processes.
D . To introduce the audit team to the client.

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Correct Answer: A
A

Explanation:

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.

Reference: What is the difference between Stage 1 and Stage 2 Audits? – ISO Update, The ISO 9001 Audit Process Explained | ISO Explained, What is an ISO Stage 2 Audit? ― RiskOptics – Reciprocity

Question #27

DRAG DROP

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organization manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years.

You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.

You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

To complete the table click on the blank section you want to complete so it is highlighted in red and then click on the Iso 9001 cause 8.3 extracts listed below. Alternatively, drag and drop each clause to the audit evidence that applies.

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Question #28

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

A . Individual(s) managing the audit programme
B . Auditee
C . Guide
D . Consultant
E . Observer
F . Technical expert

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Question #29

The following actions need to be carried out during a third-party audit planning stage.

Which two actions correspond to the individual(s) managing the audit program before the involvement of the audit team leader?

A . Prepare the audit plan
B . Assign responsibilities within the audit team
C . Prepare the checklists
D . Provide the resources needed
E . Review the reports of previous audits
F . Select the audit team members

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Question #30

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

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Correct Answer: 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