OrthoSupplier. Medical Device Guidance and Standards. ISO.

International Organization for Standardization - "ISO is a worldwide federation of national standards bodies from some 140 countries, one from each country. ISO is a non-governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity."

Standards Search
Quality Management Principles
Transition to the ISO 9000:2000 series
Selection and Use of the ISO 9000:2000 family of standards
ISO 14969:1999
Quality systems--Medical devices--Guidance on the application of ISO 13485 and ISO 13488.
ISO 13488:1996
Quality systems--Medical Devices--Particular requirements for the application of ISO 9002.
ISO 13485:2003
Medical devices -- Quality management systems -- Requirements for regulatory purposes
ISO 13485:1996
Quality systems--Medical devices--Particular requirements for the application of ISO 9001.
ISO 9002:1994
Quality systems--Model for quality assurance in production, installation and servicing.
ISO 9001:2000
Quality management systems--Requirements.
ISO 9001:1994
Quality systems--Model for quality assurance in design, development, production, installation and servicing.
ISO 9000:2000 - The Basics

ISO 9000. What is ISO?

American Society for Quality (ASQ) Overview
- ASQ Resource Materials for ISO 9000:2000