What is ISO 13485:2003?
ISO 13485:2003 an international standard designed to orient quality management systems
toward the design, development, production, and installation of medical devices
and related services. Medical Devices are products designed to cope with disease,
treat injuries, investigate and augment human functions and they also are made up
of a host of other apparatuses and appliances.
The European medical device quality system standard as of this writing is EN ISO
13485:2003. ISO 13485:2003 will replace current harmonized standards EN ISO 13485:2000
and EN ISO 13488:2000 after a three year transition ending in July 2006.
Purpose of ISO 13485:2003
A successful implementation will demonstrate a company's ability to supply medical
devices and related services to customers that comply with regulatory requirements.
ISO 13485 is not just product focused, but it focuses instead on the processes used
to develop medical devices. Keep in mind that you also need to comply with all relevant
product and service oriented technical standards and regulations in this area of
Although ISO 13485:2003 is based on ISO 9001:2008 quality management standard and
uses the same numbering system, ISO 13485 doesn't include the ISO 9001 requirements
related to continual improvement and customer satisfaction. ISO 13485 also focuses
more on how procedures regulate and control activity and process performance.
Highlights of ISO 13485:2003
The standard highlights the following important factors in the processes surrounding
medical device manufacture:
- FDA or other regulatory approval
- Cleanliness/sterility in the production area
- Traceability of non-conforming product
- Adequate testing of these important and sometimes life-saving devices.
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