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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:

TopicDetails
Topic 1
  • Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.
Topic 2
  • Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.
Topic 3
  • Closing an ISO 9001 audit: The topic focuses on concluding a QMS audit and conducting audit follow-up activities.
Topic 4
  • Quality management system (QMS) requirements: It assesses your abilities to point out and explain different requirements for a quality management system based on ISO 9001.
Topic 5
  • Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.
Topic 6
  • Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q244-Q249):

NEW QUESTION # 244
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation 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.

Answer:

Explanation:

Explanation:

The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products.
"8.3.2 e) ... internal ... resource needs for the design and development of products ..." The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.
"8.3.5 ... retain documented information ..."
The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.
"8.3.6 ... retain documented information ..."
The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.
"8.3.4 d) ... conducted to ensure that the resulting products and services meet the requirements ..." The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.
"8.3.2 e) ... external ... resource needs for the design and development of products ..."


NEW QUESTION # 245
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: B,E

Explanation:
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.
References:
ISO 9001:2015 - Quality management systems - Requirements
ISO 19011:2018 - Guidelines for auditing management systems


NEW QUESTION # 246
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).

Answer:

Explanation:

Explanation:
Quality management principles:
Customer focus = Increased revenue and market share
Engagement of people = Enhanced trust and collaboration throughout the organisation Improvement = Enhanced drive for innovation Evidence-based decision-making = Increased ability to demonstrate effectiveness of past actions According to the Quality management principles document published by ISO, each quality management principle has a statement, a rationale, key benefits, and actions you can take to apply it. Based on these descriptions, the potential benefits can be matched to the corresponding principles as follows:
Customer focus: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. The key benefits of this principle include increased customer value, customer satisfaction, customer loyalty, repeat business, reputation, customer base, revenue and market share.
Engagement of people: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value. The key benefits of this principle include improved understanding of the organization's objectives and values, increased involvement in improvement activities, enhanced personal development, increased motivation and empowerment, enhanced trust and collaboration, and increased recognition and rewards.
Improvement: Successful organizations have an ongoing focus on improvement. The key benefits of this principle include improved organizational capabilities, alignment of improvement activities at all levels, increased ability to anticipate and react to opportunities and threats, enhanced drive for innovation, and increased levels of satisfaction.
Evidence-based decision-making: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. The key benefits of this principle include improved decision-making processes, increased ability to demonstrate the effectiveness of past decisions, increased ability to review, challenge and change opinions and decisions, and increased ability to improve performance.


NEW QUESTION # 247
You are carrying out an annual surveillance audit at an organisation that has been certificated to ISO 9001 for two years. The organisation offers home cleaning services. The scope of the quality management system covers planning the weekly activities, providing cleaning materials, cleaning the whole property (including outdoor space) alarm installation, alarm servicing, alarm monitoring and response. The business operates from a single office and employs subcontract cleaners across the whole city.
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 cleaning 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 PESTLE analysis (Political, economic, social, technological, legal, environmental).
You: Why did you not use the SWOT model (Strengths, Weaknesses, Opportunities, Threats)?
MD: I had used PESTLE in my previous job.
You: How have the outputs from your PESTLE been used?
Select two audit trails which would lead to a determination of how the PESTLE analysis would affect the planning of a QMS to ISO 9001.

Answer: E,F

Explanation:
ISO 9001:2015 requires organisations to understand their context and to use this understanding as an input to planning the quality management system. Tools such as PESTLE are acceptable methods, but auditors must verify how the outputs are used, not simply that the analysis exists.
Relevant ISO 9001 requirements:
* Clause 4.1 - Understanding the organisation and its contextThe organisation shall determine external and internal issues that are relevant to its purpose and strategic direction and that affect its ability to achieve the intended results of the QMS.
* Clause 6.1 - Actions to address risks and opportunitiesThe organisation shall plan actions to address risks and opportunities identified from context analysis and integrate these actions into the QMS processes.
Explanation of the correct audit trails:
C). What actions have been taken to address the risks and opportunities from the PESTLE analysis?
This audit trail directly links PESTLE outputs to Clause 6.1. It allows the auditor to determine whether the organisation has translated identified political, economic, social, technological, legal, and environmental issues into concrete actions within planning, operational control, or resource allocation. Without actions, the PESTLE analysis has no impact on QMS planning.
E). How has the PESTLE analysis contributed to the improvement of the QMS?
ISO 9001 requires context analysis to support improvement and strategic alignment of the QMS. This audit trail confirms whether PESTLE outputs are used as inputs to improvement activities, management review, or changes to processes, supporting Clauses 4.1, 6.1, and 10.3.
Explanation of why the other options are not selected:
* A: Review by a specific manager is not a requirement of ISO 9001 and does not demonstrate impact on QMS planning.
* B: PESTLE does not require consultation with external interested parties; that relates to Clause 4.2, not planning impact.
* D: Training in SWOT is irrelevant, as ISO 9001 does not mandate any specific analysis tool.
* F: Sharing information with external interested parties relates to communication, not to how PESTLE affects QMS planning.
ISO-aligned conclusion:
To determine how PESTLE analysis affects planning of a QMS, the auditor must follow audit trails that demonstrate:
* Conversion of identified issues into risk-based actions, and
* Use of those outputs to improve and adapt the QMS.
Therefore, the correct answers are C and E.


NEW QUESTION # 248
Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it at the moment. You learn that the shop managers were told to dismiss most of the claims on the basis of the poor quality of the laundered materials.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.

Answer:

Explanation:

Explanation:
The quality system failed to control the laundry services provided for customers in five shops.
The equipment used was not capable of consistently producing the required service.


NEW QUESTION # 249
......

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