Free PECB ISO-9001-Lead-Auditor Practice Exam with Questions & Answers | Set: 3

The purpose of conducting a document review is to determine the conformity of the system, as far as documented, with audit criteria and to gather information to support the audit activities. A document review is a systematic and objective examination of the documented information that is relevant to the audit objectives and scope. It can help the auditor to verify if the documented information is complete, accurate, consistent, and up-to-date. It can also help the auditor to identify any gaps, errors, or nonconformities in the documented information that may affect the audit findings or conclusions.

The other options are not correct because they do not reflect the true purpose of a document review. Option A describes the purpose of an audit report, which is to communicate the audit results and recommendations to the management and other interested parties. Option B describes the purpose of an audit plan, which is to define the scope, objectives, criteria, methods, resources, and schedule of an audit. Option C describes the purpose of an audit evidence report, which is to provide evidence of nonconformities or opportunities for improvement identified during an audit. Option D describes the purpose of an audit decision report, which is to justify or explain why certain decisions were made during an audit.

I hope this answer helps you understand why option F is correct and why options A-C-D are incorrect. If you want to learn more about ISO 9001 Lead Auditor exam questions and answers, you can check out some of these resources:

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ISO 9001:2015 requires audit findings, including non-conformities, to be based on objective evidence and to be clearly described , stating exactly what requirement was not met and where .

A non-conformity statement must:

Reference the specific requirement (procedure or ISO clause), and

Describe the objective evidence observed , without assumptions, generalisations, or conclusions about causes.

In this scenario:

The requirement is clearly stated in Procedure P-02 Rev.3 , which requires samples sent to the laboratory to include reference to the raw meat batch number to ensure traceability.

The objective evidence observed by Auditor 1 is that samples from PL2 did not include the raw meat batch reference , while samples from PL1 did.

Why option C is correct:

C. “Samples of hamburgers sent to the HMB’s laboratory for analysis by PL2 did not refer to the raw meat batch number as required by P-02 Rev.3.”

This statement:

Accurately reflects what was observed,

Clearly identifies the affected process (PL2),

Directly references the unmet requirement (P-02 Rev.3), and

Is factual, specific, and evidence-based.

Why the other options are not the best description of evidence:

A is a generalised conclusion and does not describe the specific evidence observed.

B assumes a lack of awareness, which was not evidenced during the audit.

D refers to product identification for delivery to the client, which is not what was observed (the issue was laboratory sample identification).

ISO-aligned conclusion:

The correct way to describe audit evidence is to state precisely what was observed against the requirement , without interpretation or assumption. Therefore, the statement that best describes the identified evidence is Option C .

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.

ISO 9001:2015 requires top management to review the quality management system at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organisation . The auditor’s focus, especially during a surveillance audit covering improvement actions , must therefore be on evidence that management review is being carried out correctly and that it results in QMS-related decisions and changes .

Relevant ISO 9001 clauses include:

Clause 9.3.1 – Management review (General) Top management shall review the organisation’s quality management system at planned intervals.

Clause 9.3.3 – Management review outputs The outputs of management review shall include decisions and actions related to opportunities for improvement and any need for changes to the QMS.

Explanation of the correct options:

A. The date of the most recent management review meeting

This is directly relevant because ISO 9001 requires management reviews to occur at planned intervals . The auditor must confirm that the review has taken place and that it is current, especially during a surveillance audit.

E. Changes made to the quality system by the new Quality Manager

This is directly linked to management review outputs and improvement actions . Since a new Quality Manager has been appointed, the auditor must verify whether changes to the QMS were reviewed, approved, and monitored through management review in line with Clauses 9.3.3 and 10.3.

Explanation of why the other options are not relevant:

B : Workforce redundancies are a human resources or business decision unless they directly affect QMS effectiveness, which is not indicated here.

C : Increased profitability is a business outcome, not a required management review input or output under ISO 9001.

D : Pension scheme improvements are unrelated to QMS performance or improvement.

F : A bonus scheme may relate to productivity, but unless it directly affects QMS objectives or process performance reviewed in management review, it is not a required checklist item.

ISO-aligned conclusion:

For an audit focusing on improvement actions and management review , the auditor’s checklist should confirm:

That management review has been conducted as required, and

That QMS-related changes and improvements (especially under a new Quality Manager) are being reviewed and controlled.

The correct answer is:

Event

Selecting audit team = Individual(s) managing the audit programme

Conducting the audit = Audit team

Preparing the audit plan = Audit team leader

Requesting the audit = Audit client

To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below. Alternatively, drag and drop each option to the appropriate blank section. Responsibility:- Individual(s) managing the audit programme

Audit team

Audit team leader

Audit client

According to ISO 19011:2018, clause 5.3, the individual(s) managing the audit programme are responsible for selecting the audit team, taking into account the competence and availability of the auditors and any experts needed. 1

According to clause 6.2, the audit team is responsible for conducting the audit, which includes collecting and verifying audit evidence, evaluating audit findings, and preparing the audit report. 1

According to clause 6.1, the audit team leader is responsible for preparing the audit plan, which includes defining the audit objectives, scope, criteria, and duration, as well as assigning roles and responsibilities to the audit team members. 1

According to clause 5.2, the audit client is the person or organization that requests the audit, which can be the auditee (the person or organization being audited) or any other person or organization that has an interest in the audit results. 1

According to ISO 9001:2015, clause 4.1, the organisation must determine the external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended results of its quality management system. The organisation must also monitor and review the information about these issues. SWOT analysis is a tool that can help the organisation to identify its strengths, weaknesses, opportunities, and threats. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to review the information periodically and update it as necessary. Therefore, one audit trail would be to establish how the organisation reviews information about external and internal issues, such as how often, by whom, using what criteria, and with what results. 123

According to ISO 9001:2015, clause 10.3, the organisation must continually improve the suitability, adequacy, and effectiveness of the quality management system. The organisation must also consider the results of analysis and evaluation, and the outputs from management review, to determine if there are any needs or opportunities for improvement. SWOT analysis can help the organisation to identify the areas where improvement is needed or possible, such as addressing the weaknesses and threats, or exploiting the strengths and opportunities. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to take actions to implement the improvement, such as setting objectives, allocating resources, assigning responsibilities, and evaluating the effectiveness. Therefore, another audit trail would be to establish what actions were taken to improve the QMS, such as what, when, by whom, how, and with what results. 124 References:

1: ISO 9001:2015 - Quality management systems — Requirements

2: Advisera, “Context of the organization in ISO 9001:2015 explained”, https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/

3: ISO Templates, “ISO 9001 - Clause 4: Context of the organisation explained”, https://resources.iso-templates.com/blog/iso-9001-clause-4-context-of-the-organisation-explained

4: Advisera, “How to implement continual improvement in ISO 9001”, https://advisera.com/9001academy/knowledgebase/how-to-implement-continual-improvement-in-iso-9001/

 Understanding " Context of the Organization " :

The term " context of the organization " is defined in ISO 9001:2015 Clause 4.1, which states:

" The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. "

The definition emphasizes identifying both internal and external issues that influence the organization ' s approach to developing and achieving its objectives.

 Option Analysis:

Option A:Correct. This option aligns with the standard definition as it explicitly mentions the combination of internal and external issues that affect the organization’s approach to achieving its objectives, which is the essence of Clause 4.1.

Option B:Incorrect. The term " comparison of internal and external issues " does not reflect the ISO 9001 requirements. The standard does not require a comparison but rather an understanding of these issues.

Option C:Incorrect. Although it mentions " complexity, " the focus of ISO 9001:2015 is on identifying relevant issues rather than the complexity of those issues.

Option D:Incorrect. This option mentions " coordination " and focuses only on the positive or negative effects. ISO 9001 requires identifying issues but does not emphasize coordination.

 Clause Reference and Relevance:

ISO 9001:2015 requires organizations to understand their context because internal and external factors can influence the Quality Management System ' s effectiveness. Understanding this context helps in:

Addressing risks and opportunities (Clause 6.1).

Aligning the QMS with the organization’s strategic direction.

 Why A is Correct:

" Combination of internal and external issues " captures the essence of Clause 4.1, making it the accurate definition of the context of the organization.

Establishing the audit programme objectives

Determining and evaluating the audit programme risks and opportunities

Establishing the audit programme

Initiating the audit

Preparing all audit activity

Conducting the audit activities

According to ISO 19011:2018, clause 5, the audit programme is a set of one or more audits planned for a specific time frame and directed towards a specific purpose. The audit programme includes all activities necessary to plan, organize, and conduct the audits. The audit programme management involves the following steps1:

Establishing the audit programme objectives: The audit programme objectives define the intended outcomes of the audit programme, such as verifying conformity, evaluating performance, identifying improvement opportunities, etc. The audit programme objectives should be aligned with the strategic direction and policies of the organization and the needs and expectations of the interested parties.

Determining and evaluating the audit programme risks and opportunities: The audit programme risks and opportunities are the factors that can affect the achievement of the audit programme objectives, such as changes in the internal or external context, availability of resources, competence of auditors, etc. The audit programme risks and opportunities should be identified, analyzed, and evaluated to determine the appropriate actions to address them.

Establishing the audit programme: The audit programme is established by defining the audit programme scope, criteria, methods, and resources. The audit programme scope defines the extent and boundaries of the audit programme, such as the processes, functions, sites, activities, etc. that will be audited. The audit programme criteria are the set of policies, procedures, or requirements used as a reference for the audits. The audit programme methods are the techniques used to conduct the audits, such as interviews, observations, document review, sampling, etc. The audit programme resources are the human, technical, and financial resources needed to implement the audit programme.

Initiating the audit: The audit initiation is the process of formally establishing the arrangements for an individual audit within the audit programme. The audit initiation involves contacting the auditee and the audit client, confirming the audit objectives, scope, and criteria, and obtaining the necessary information and access for the audit.

Preparing all audit activity: The audit preparation is the process of developing the audit plan and the audit work documents for an individual audit. The audit plan is a document that provides the basis for agreement regarding the conduct of the audit, such as the audit schedule, the audit team, the audit methods, the audit language, the audit report, etc. The audit work documents are the records that provide evidence of the audit activities, such as the audit checklist, the audit notes, the audit findings, etc.

Conducting the audit activities: The audit activities are the processes of collecting and verifying audit evidence and evaluating it against the audit criteria to make the audit conclusions. The audit activities include the opening meeting, the communication during the audit, the roles and responsibilities of the audit team and the auditee, the audit evidence collection and verification, the audit findings generation and recording, the closing meeting, and the audit report preparation and distribution.

Comprehensive and Detailed In-Depth Explanation:

A combined audit is when multiple management systems (e.g., ISO 9001 for Quality, ISO 14001 for Environmental Management, and ISO 45001 for Occupational Health & Safety) are audited together in a single organization.

Clause References:

ISO 19011:2018, Clause 5.4 – Combined Audits:

A combined audit is performed when two or more management systems are assessed simultaneously at the same auditee.

Why is the Correct Answer A?

A combined audit reduces duplication of effort by auditing multiple standards together at a single organization.

Example: A company certified to both ISO 9001 and ISO 14001 can have one audit covering both standards.

Why are the Other Options Incorrect?

B (Two or more auditing organizations cooperating on a single auditee) → This is a joint audit, not a combined audit.

C (Two or more management systems audited at multiple auditees) → This is a multiple-site audit, not a combined audit.