ISO 13485 :2003

IISO 13485 is a Quality Management Standard for Medical Devices. ISO published the new ISO 13485: 2003 standard on July 15, 2003.


It replaces the old ISO 13485:1996 and ISO 13488:1996 standards. 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 requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.

ISO 13485 2003 can be used:
  • 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 those 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.
Benefits of ISO 13485 :2003
  • Improved legal and regulatory or contractual requirements compliance
  • Risk identification and management
  • Enhanced product safety
  • Proactive error detection and prevention
  • Formal certification, specifically for medical devices to ISO 13485: 2003 helps market products and services.
  • Operating costs drop as rework is reduced and efficiencies increase.
  • A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance to place your product in those countries.