What is ISO 13485?
ISO 13485* (and variations such as DIN EN ISO 13485) is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices. While it remains a stand-alone document, ISO 13485 is based on ISO 9001 with some additional clauses as well as the removal of some requirements.
ISO 13485 / DIN EN ISO 13485 2012 requires more attention to regulatory requirements and the exception of 9001’s requirement of continuous improvement. ISO 13485 only asks for the QMS to be implemented and maintained.For more information on ISO 13485 please see our tutorial: Basics of ISO 13485 which covers:
- What is ISO 13485?
- Why become ISO 13485 Registered?
- What are the requirements of the Standard?
- What are the steps to certification?
- And more…
Comparing ISO 9001 to 13485 compares ISO 13485 2012 to ISO 9001 2008, and outlines their:
To learn more about the Medical Device terminology, please view: ISO 13485 Definitions which covers the various classifications of medical devices across the globe.
When will 13485:2003 be updated?
ISO published a technical corrigendum for ISO 13485 in 2009, aligning ISO 13485 with ISO 9001:2000. (Yes, 2000 – NOT 2008). The next revision of the standards is scheduled to begin in 2011 to align ISO 13485 with next version of ISO 9001 (2014 or 2015).
ISO TC 210 Workgroup 1 (which is the working group responsible for ISO 13485) is cooperating with the work of the TC 176 work group which will develop the new version of ISO 9001.
TC 176 is currently requesting user feedback for the next version of ISO 9001 (for example, one of the areas being studied for inclusion is risk management). This will reflect on the new version of ISO 13485.
*The formal reference to the standard is ” ISO 13485:2003 Medial Devices – Quality management systems – Requirements for regulatory purposes”. However there is an alternate reference known as EN ISO 13485:2003. This was the nomenclature of the standard the European commercial entities involved agreed upon. The EN stands for “European Norm”, however there was no substantative difference in the 13485:2003 standard.
CEN (European Committee for Standardization) has created a minor change to the standard (in 2007) which is noted as EN ISO 13485:2003 / AC 2007. Changes only refer to the introductory elements of the document, specifically targeting the regulatory aspects of the standard. There also exists a document known as DIN EN ISO 13485:2007. Again, there are no substantive changes to the ISO 13485 standard but rather this merely prepends the DIN designation which essentially means that Germany has accepted the EN ISO 13485 as its own standard to be used in its national regulatory processes. So for all intents and purposes the following standard references are essentially the same adoption:
- ISO 13485
- ISO 13485:2003
- ISO 13485:2003 for Medical Devices
- EN ISO 13485
- EN ISO 13485:2007
- EN ISO 13485:2003 / AC 2007
- DIN EN ISO 13485
- DIN EN ISO 13485:2007