Title: The International Organization for Standardization
Course: BTEC-1300-301-302-303-F21 > Section: Regulations and Medical Devices

The International Organization for Standardization (ISO) is an international, standard-setting body composed of representatives from the standards organizations of the 162 member countries Founded on in 1947, the independent, non-governmental organization promotes worldwide proprietary, industrial, and commercial standards.

ISO standards are voluntary standards that governmental bodies may adopt as regulations that concern the health and safety of their citizens and environments. ISO is the world's largest developer of voluntary international standards and facilitates world trade by providing common standards between nations. Over twenty thousand standards have been set covering everything from manufactured products and technology to food safety, agriculture, and healthcare.

Popular ISO standards:

- ISO 9000 Quality management
- ISO 13485 Medical device quality management
- ISO 14000 Environmental management
- ISO 10993 Biocompatibility
- ISO 50001 Energy management
- ISO 31000 Risk management
- ISO 22000 Food safety management
- ISO 27001 Information security management
- ISO 20121 Sustainable events

ISO 13485 covers medical device quality management systems. It is incredibly similar to 21 CFR 820. The two are so similar in fact that ISO 13485 is said to be harmonized with FDA 21 CFR 820. This means that it is fairly easy to be compliant with both.

ISO standards are recognized globally by many agencies in many countries. A medical manufacturer who complies with ISO 13485 standards and FDA 21 CFR 820 standards has access to a larger global market. In the STUDENTfacturED lab we simulate a regulated environment that complies with both 21 CFR 820 and ISO 13485.

The FDA and ISO are not the only regulatory bodies worldwide. In order to manufacture or distribute medical devices in any country the regulatory standards for that country need to be met. Sometimes the standards may be lower than what the FDA requires; other times the FDA standard is not high enough. Some of the major medical device markets in the world are the European Union, China, Japan, India, Brazil, and South Africa. Each has its own regulatory agency with requirements for manufacturers of medical devices. While you don’t need to be concerned with these international standards in this class, it is important to know that most countries have their own regulations.

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.