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Lecture summary:

  • Understanding the context of your organization is key to a correct business strategy
  • You need to consider only issues that can affect customer satisfaction
  • You are responsible for monitoring and reviewing information about any interested parties and their relevant requirements.

Even just understanding your company falls within the essential requirements of the ISO 9001 standard. Why is this so important? Every organization is founded from different business entities (functions or systems—internal or external) that typically correlate with each other. This means you have to properly analyze every possible influence of various elements on the organization and how they would reflect on the Quality Management System. Also, it considers detecting risks and opportunities regarding your business. That’s why it’s important.

Understanding the context of your organization is key to a correct business strategy, let alone a correct quality strategy. It’s the foundation of your well established QMS.

The ISO 9001 standard does not prescribe any specific system for determining the context of any organization; it just describes a few legitimate steps and milestones.


Main goal

The main goal of understanding the context of your organization is to identify the external and internal issues. Those issues have to be relevant to the goals and ambitions of your company. Every area of expertise, sector, market, or product family has its relevant issues that are affecting your organizational context.

Those issues can be the availability of resources needed for the realization, Statutory and regulatory requirements, Competence of the human resource, technology changes, etc…


Internal and external issues

You should set up processes to seize, monitor, and review these issues.  It’s important to identify the internal issues that can affect your organization’s products, services, investments, and interested parties. The same goes for external issues.

Internal issues can include regulatory requirements, plan for objectives, relations with the employees, stakeholders, partners, and suppliers, then things like risk appetites, assets, products or service, etc.

External issues are more considered as issues that occur in the social, technological, environmental, ethical,  legal, and economic background.


Interested parties and regular reviews and monitoring

So, all your customers, partners, employees can affect your company. You have to keep in mind, they can influence your ability to consistently provide a product or a service that meets your customers’ needs, legal requirements, and regulations. It also affects the ability to enhance customer satisfaction by successfully applying your system.

You have to regularly review and monitor all internal and external issues that you have identified.

It is often recommended to do PEST, then SWOT analysis, because they are useful, took for understanding how your business environment behaves and affects your QMS.






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