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During the consulting process, it is common to identify a wide variety of challenges, especially when working with the implementation or maintenance of ISO 9001 requirements. In addition, within Qualiexpert, having a continuously improving Quality Management System (QMS) gives us a special insight into how to apply these requirements for our own benefit.

Within the activities of risk and opportunity management, The use of the SWOT tool is unanimous and common. However, completing the tool can be challenging due to the need for initial brainstorming to fill in each component. Therefore, starting by analyzing the internal and external context and stakeholder requirements makes risk and opportunity management easier and more effective. This is an initial step that simplifies the process.

If you have a challenge related to this topic, this newsletter is for you!

Analyzing the Internal and External Context

Firstly, context is ”the set of circumstances that surround a fact and are essential for understanding it.”

Example: Imagine that in a business meeting, you hear someone say “sales are down 20%”. Without context, this might sound alarming. However, with the added context that “it was a low seasonal period and we are investing in a new product that will be launched next month”, you can better understand the situation and the company's strategy. 

Secondly, we know that analyzing risks means identifying potential problems that could materialize and identifying opportunities means recognizing favorable situations that can be used to achieve objectives and improve results. Therefore, understanding the context in which the company operates is fundamental.

The Quality professional together with Managers and Leaders can answer questions such as:

• What are the main market trends and technological advances that could impact our industry in the coming years?
• What recent or future environmental, legal and economic regulations and policies may affect our operations and compliance?
• How does our organizational culture and governance structure influence our ability to respond to changes and challenges?
• Which internal processes are most susceptible to failure?

Analyzing Stakeholders

Identifying the relevant stakeholders is the first step. Next, it is crucial to determine what each of them wants, including, for example, employees, leaders and the community. The answers to these questions form the basis for risk and opportunity management that is more likely to succeed.

Traceability of information

Traceability between the points identified in the analysis of the context and stakeholder requirements and preventive actions is also fundamental. Having a systems thinking will be a differential in day-to-day Quality Management.

Remember that as we are in a management system, where everything interfaces or interacts, these identified points will be addressed in the management review meeting, in the requirement for “changes in external and internal issues that are relevant to the QMS” and “feedback from interested parties relevant“.

Finally, remember “relevant”, The goal is not to embrace the whole world, but to identify points that are aligned with the company's objectives, values, mission and vision.

Practical example

XYZ Electronics, a company that manufactures consumer electronics, wants to expand its product range to include smart home devices such as thermostats and security cameras. To do this, the company carries out an analysis of the external and internal context and stakeholder requirements and determines preventive actions:

External Context: Growth in demand for smart home devices driven by virtual assistants.

• Preventive action: Invest in R&D to keep up with technological trends.

Internal context: Qualified software development team, but little experience in cyber security.

• Preventive action: Train staff in cyber security with workshops and specific training.

Stakeholder requirements: Customers - expect products that are easy to use, reliable and safe.

• Preventive action: Focus on user-centered design and data security.

Conclusion

Managing risks and opportunities effectively is a necessity and a viable way to drive innovation and ensure your company's sustainable success in line with its vision and mission. Finally, by understanding the internal and external context and stakeholder requirements, your company can turn risk management into a competitive advantage.

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Understanding and managing risks and opportunities is fundamental to your company's sustainability and success. At Qualiexpert, we offer expert guidance to analyze the external and internal context and identify stakeholder requirements. With our help, you can implement preventive actions that mitigate risks and ensure compliance, while seizing market opportunities.

Contact us for a detailed analysis and see how we can help turn risk management into a competitive advantage for your business. Together, we can ensure that your company is prepared to face challenges and thrive in a dynamic and ever-changing environment.

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