ISO 13485 Details

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  • ISO 13485 is the model standard for medical device companies around the world and helps facilitate a quality management system for safe and effective medical devices.
  •  This standard is intended for any organization involved in the design, production, installation, and servicing of medical devices.
  •  ISO 13485 was based upon years of experience with the existing quality management standard ISO 9001 and was applied to the medical device industry.  It is recognized by the Global Harmonization Task Force (GHTF) which is an international platform for regulatory authorities in Europe, the United States, Canada, Japan, and Australia. 
  • ISO 13485 is divided in to five key sections- Quality Management System, management responsibility, resource management, product realization, and measurement, analysis, and improvement.  This standard is applied to any organization that produces Class I, II, or III medical devices but does not cover drug manufacturers.

What was the need for developing  ISO 13485?
Stakeholders for medical device companies realized that product or manufacturing regulations alone were not providing sufficient assurance of safe and effective medical devices.  They understood that the foundation for a high level of safety and effectiveness depended upon the implementation of a quality management system under which the applicable regulations could be executed.  Through the implementation of ISO 13485, companies increase the probability of making safe and effective medical devices, meeting regulatory requirements, and ultimately meeting customer expectations.   

ISO 13485 is based on ISO 9001:2008 but has more focus on regulatory requirements and requires quality management systems to be implemented and maintained where ISO 9001:2008 requires continuous improvement.  Most countries around the world have some form of quality management regulations currently in place.  For these countries ISO 13485 would help provide suggestions for improvements in order to comply with regulations.  For countries that currently do not have a quality management system in place or who are just starting to regulate medical device companies, ISO 13485 would serve as a model for development of regulation.

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