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

PECB ISO-9001-Lead-Auditor Question Answer

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.

Establish how many interested parties need to be consulted

Establish how the organisation reviews information about external and internal issues

Establish how the organisation shares information with external interested parties

Establish what actions were taken to improve the QMS

Establish whether the SWOT analysis has been reviewed by the procurement manager

Establish whether the SWOT analysis is focussed solely on the QMS

Explanation:

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/

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