ISO 9004:2018
Context of an organization – ISO 9004:2018

ISO 9004:2018 5.3: External and internal issues

What does 5.3 require?

The organization should consider external factors such as legal and regulatory requirements, sector specific requirements and agreements, competition, globalization, social, economic, political and cultural conditions, technology advances and the natural environment, and internal factors such as size and complexity, activities and processes, strategy, types of products and services, performance, resources, competence and organizational knowledge, maturity and innovation. Drawing on its past, its present situation and its strategic direction, it should determine which issues create risks or opportunities, have top management decide which to address and start the processes needed, and keep up a routine for tracking, reviewing and evaluating these issues and acting on the consequences.

Maintained by Gerard Blokdyk

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