PECB QMS ISO 9001:2015 Lead Auditor Exam Practice Test

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Total 110 questions
Question 1

You are carrying out an annual audit at an organisation that has been certificated to ISO 9001 for two years. The organisation offers home security

services. The scope of the quality management system covers alarm installation, alarm servicing, alarm monitoring and response. The business

operates from a single office and employs subcontract installers and service technicians across the country.

You have just completed the opening meeting. You are interviewing the Managing Director (MD).

You: "I would like to gain an understanding of how the quality management system has been supporting your business and its strategic direction."

MD: "We are continuing to face difficult times. The market is extremely competitive, and customers typically look for the least expensive option when

choosing home security services. We have not yet seen any business benefit from our quality management system."

You: "Tell me how you determine external and internal issues."

MD: "We use SWOT analysis (Strengths Weaknesses, Opportunities, Threats)."

You: "How have the outputs from your SWOT been used?"

Select two of the following audit trails would you take to explore the extent to which the SWOT analysis and the outputs from this

have been used to enable the business to achieve the intended results(s) of its quality management system according to ISO 9001.



Answer : B, D

Question no: 22 Verified Answer: = B. Establish how the organisation reviews

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 Reference:

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/


Question 2

'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.



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.


Question 3
Question 4

Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?

During the Stage 1 audit, the audit team:



Answer : B, E

The Stage 1 audit is a readiness review that verifies the organization's ability to conduct the Stage 2 audit. It involves reviewing the documented information, evaluating the site-specific conditions, and having discussions with personnel. The auditor does not verify the degrees of customer satisfaction, the compliance with legal requirements, or the results of the last management review during the Stage 1 audit. These are done during the Stage 2 audit or later in the certification process.Reference:

ISO 9001 Lead Auditor Reference Materials

ISO 9001 Lead Auditor Candidate Handbook

ISO 9001 Lead Auditor Course Material

ISO 9001 Lead Auditor Training Course IRCA Certified


Question 5

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?



Answer : A


Question 6

Knowledge and skills are requirements of the auditor's competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.



Answer : A, B

According to ISO 9001:2015, clause 7.2, an auditor shall have the competence to:

Understand the requirements of ISO 9001 and how they relate to the audit

Understand the organization's quality management system and its processes

Understand the applicable legal, regulatory, contractual and other requirements that affect the audit

Understand the needs and expectations of interested parties other than customers

Plan and conduct audits in accordance with ISO 19011

Evaluate audit evidence and draw appropriate conclusions

Communicate audit findings effectively1

Therefore, knowledge of ISO 9001 requirements and ISO 19011 audit principles are essential for every member of an audit team auditing an ISO 9001 quality management system.


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

ISO 19011:2018 - Guidelines for auditing management systems

Question 7

Which one of the following is not an ISO 9000:2015 quality management principle?



Answer : D

According to the ISO 9000:2015 quality management principles document1, risk-based approach isnotone of the seven quality management principles that ISO 9000, ISO 9001 and other related quality management standards are based on. The seven quality management principles are:

Customer focus

Leadership

Engagement of people

Process approach

Improvement

Evidence-based decision making

Relationship management

Therefore, risk-based approach isnota quality management principle under ISO 9001:2015.


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Total 110 questions