Examples of External Issues

According to ISO 9001:2015, 4.1, Note 2, external issues arise from legal, technological, competitive, market, cultural, social, and economic environments (local, regional, national, or international). Examples of external issues are:

  • Supply chain disruption
  • Loss of a key supplier
  • Technology shifts
  • Competitive pressures
  • Money exchange rates
  • Oil price changes
  • Increased regulations
  • Patent expirations
  • Trade union regulations
  • Ventures into new markets
  • Changes in financial markets
  • Tightening of lending from banks
  • Funding for non-profits
  • Scarcity of raw materials
  • Natural disasters
  • Major road construction in service area
  • International trade agreements
  • Political stability


The PESTEL model is used as a framework for reviewing the business operating environment of an organization, including legal compliance obligations. It can also be used to identify categories for determining external issues.

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.

These above examples of external issues are covered in a team activity within our 1.5 day onsite ISO 9001:2015 Requirements course.