McKesson
McKesson
Cranberry Township, PA

ISO Quality Systems: an Executive Summary

ISO 9000 is a family of standards and guidelines that represent an international consensus on good quality management practices and systems. ISO 9000 is maintained by the International Organization for Standardization. Only a company or organization that has been independently audited and certified to be in conformance may state that it is certified.

The standard is a tested framework for establishing processes that consistently turn out products that satisfy customer expectations. It applies regardless of the user organization’s industry, size, or position in the private or public sector, and without dictating how the organization should meet them.

For ISO certification, a business must:

  • Audit the effectiveness of its processes
  • Keep adequate records
  • Check output for defects, taking corrective action where necessary
  • Regularly review individual processes and quality system itself for effectiveness
  • Facilitate continual improvement

Other ISO standards incorporate requirements specific to certain industries, such as automotive (ISO/TS 16949), aerospace (AS9100) and medical (ISO 13485).

ISO 14000 is a family of standards and guidelines that address various aspects of environmental management. Similar to ISO 9000, an ISO Environmental Management System is a tool that enables and organization of any size or type to:

  • Identify and control the environmental impact of its activities, products, or services
  • Improve its environmental performance continuously
  • Implement a systematic approach to setting environmental objectives and targets, achieving them, and demonstrating that they have been achieved

ISO 14000 does not specify levels of environmental performance because, whatever an organization does, the goals of effective environmental management are the same. This policy helps create a common ground for communication among organizations and their customers, their regulators, the public, and other stakeholders.

ISO 14000 can help an organization to:

  • Reassure customers, the community, and regulatory agencies about environmental issues
  • Comply with environmental regulations
  • Support its claims about its own environmental policies, plans, and actions
  • Demonstrate conformity to environmental standards