ISO 13485 Standards

Title of the standard: Medical Device Quality Management System

Current edition: ISO 13485

This standard can be used for internal and external parties, including certification bodies to assess the organizations ability to meet customer and regulatory requirements.

There is a wide variety of medical devices and some of the particular requirements of this standard only apply to named groups of medical devices. These groups are defined in the standard in clause 3.

This standard is based on a Process approach to quality management. Any activity that receives input and converts that input into outputs can be considered as a process.

While this standard is a stand alone standard it is based on ISO 9001.

ISO/TR 14969- is a Technical Report intended to provide guidance for the application of ISO 13485.

Important Note:  This International Standard specifies requirements for a Quality Management System that can be used by an organization for the design and development, production, installation and servicing of medical devices and of related services.

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