MANAGEMENT SYSTEM FOR THE DESIGN AND MANUFACTURE OF MEDICAL DEVICES
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requi-rements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
ISO 13485 in part designed to produce amanagement system that facilitates compliance to the req-uirements of customers and various global regulators. While being certified to ISO13485 does not fulfill the requirements of either the FDA or foreign regulators, the certification aligns an organ-ization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout theworld.Therefore, ISO13485 certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer requirements.