INTRODUCTION TO ISO

ISO is the International Organization for Standardization. It was set up in 1947 and is located in Geneva, Switzerland. Its purpose is to facilitate and support international trade by developing standards that people everywhere would recognize and respect. ISO achieves this purpose through the participation and support of its member bodies. These member bodies currently come from 150 countries.

ISO standards are developed by technical committees. The people who serve on these technical committees come from many national standards organizations. Consequently, ISO standards tend to have worldwide support. ISO 13485 was developed by ISO Technical Committee 210. ISO/TC 210 is responsible for “quality management and corresponding
general aspects for medical devices”.

INTRODUCTION TO ISO 13485

Use ISO 13485 2003:

·         To establish a quality management system that is oriented towards the design, development, production, and installation of medical devices and related services.

·         To demonstrate your ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements.

·         To evaluate how well your organization is able to meet customer expectations and comply with regulatory requirements.

·         To become certified or registered.

ISO 13485 is not a product standard. It’s a process standard. Therefore, it’s not enough to establish a quality Management  system that complies with the ISO 13485 standard, you also need to comply with all relevant product and service oriented technical standards and regulations.

For more information visit: http://www.praxiom.com/iso-13485-standard.htm