You are carrying out an annual surveillance audit at an organisation that has been certificated...

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PECB ISO-9001-Lead-Auditor Question Answer

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.

Has the PESTLE analysis been reviewed by the operations manager?

How many external interested parties were consulted?

What actions have been taken to address the risks and opportunities from the PESTLE analysis?

What, if any, training has been given in SWOT analysis?

How has the PESTLE analysis contributed to the improvement of the QMS?

How does the organisation share information with external interested parties?

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.

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You are carrying out an annual surveillance audit at an organisation that has been certificated...

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