In 1996, the International Organization for Standardization (ISO) released ISO 13485, Quality management systems – Medical Devices – Particular Requirements for the Application of ISO 9001 and ISO 13488, Quality management systems – Medical Devices – Particular Requirements for the Application of ISO 9002. These two international quality management systems standards, medical devices derivatives of ISO 9000, were developed by ISO Technical Committee (TC) 210, Quality Management and Corresponding General Aspects for Medical Devices. U.S. participation in ISO/TC 210 is organized and administered by the Association for the Advancement of Medical Instrumentation (AAMI).
ISO 13485:1996 and ISO 13488:1996 required accountability, compliance with regulations, such as the U.S. Food and Drug Administration (FDA)’s Current Good Manufacturing Practices (CGMP), maintenance of documentation and traceability of products, producing a world-class approach to the design, development, manufacture, distribution and servicing of medical devices. Such devices, coming in close contact with patients and ranging from minor support for conditions to life saving capability, demand high criteria.
ISO/TC 210, with the participation of the AAMI, has now revised ISO 13485 and ISO 13488 to align with the process-based ISO 9001:2008 and later revision ISO 9001:2008. The new version, ISO 13485:2003, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, was released in 2003.
Registration to ISO 13485, which can aid in complying with regulations, offers a major competitive edge for medical device companies and is becoming a virtual requirement to do business in many marketplaces. Far-sighted firms are planning for registration by conducting a thorough investigation of the standard=s revised requirements.