Identifying External Issues for ISO9001

An organisation must determine the external issues and internal issues that are relevant to its purpose and strategic direction, as well as, those that affect its ability to achieve the intended results of its quality management system. This forms part of the ‘context’ analysis that helps to keep the management relevant.

The organisation must also monitor and review information about these external and internal issues.

Changes to these issues are now inputs to management review. These issues are also considered when determining the scope of the quality management system, and for determining the risks and opportunities faced by the quality management system.

Examples of possible external issues are:

  • Supply chain disruption
  • Loss of a key supplier
  • Technology shifts
  • Competitive pressures
  • Money exchange rates
  • Economic conditions
  • Inflation forecasts
  • Credit availability
  • Local infrastructure
  • Increased regulations
  • Patent expirations
  • Trade union regulations
  • Ventures into new markets
  • Changes in financial markets
  • Funding for non-profits
  • Scarcity of raw materials
  • Climate; natural disasters
  • International trade agreements
  • Political stability

I use a structure for identifying the diverse types of external issues; the PESTEL Model. It is a framework for reviewing the operating environment of the organization, including legal compliance obligations.


Political factors are basically how the government intervenes in the economy.


Economic factors include economic growth, interest rates, exchange rates, and the inflation rate. These factors greatly affect how businesses operate and make decisions.


Social factors include cultural aspects, health consciousness, population growth rate, age distribution, career attitudes, and emphasis on safety. High trends in social factors affect the demand for a company’s products and how that company operates.


Technological factors include technological aspects like research and development, automation, technology incentives, and the rate of technological change. These can determine barriers to entry and minimum efficient production level, as well as, influence outsourcing decisions. Technological shifts affect costs, quality, and innovation.


Environmental factors include ecological and environmental aspects such as weather, climate, and climate change, which may especially affect industries such as tourism, farming, and insurance. Furthermore, growing awareness of environmental impacts affects how companies operate and the products they offer, both creating new markets and diminishing or destroying existing ones.


Legal factors include discrimination law, consumer law, antitrust law, employment law, and health and safety law. These factors can affect how a company operates, its costs, and the demand for its products.


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