International Organization for Standardization (ISO) is the world's largest developer and publisher of International Standards.

ISO is a network of the national standards institutes of 157 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.

Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society"[1]

Healthcare Standards[]

Commonly used healthcare ISO standards used today:

  • ISO 9001:2008 - Quality management systems: Requirements
  • ISO 13485:2003 - Medical devices: Quality management systems and Requirements for regulatory purposes
  • IEC 60601-2-52:2009 - Medical electrical equipment -- Part 2-52: Particular requirements for the basic safety and essential performance of medical beds.[2]



  1. International Organization for Standardization. "About." Accessdate: 7/30/2015.
  2. ISO. "Standards catalogue." Accessdare:7/30/15.