This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization. It is also designed to be used in conjunction with the ISO 9001 Quality Management System.
ISO 13485 is supported with other standard ISO/TR 14969- Guidance on implementation of 13485.Guidance contained in this technical report can be useful as background information for those representing Quality Management System assessors, Conformity Assessment bodies and regulatory bodies.
Guidance provided in this Technical Report has taken into consideration requirements and guidance contained in documents from the following organizations:
Global Harmonization Task Force (GHTF); International Organization for Standardization (ISO); European Committees for Standardization (CEN and CENELEC); National regulatory bodies.
Food and Drug Administration’s, U.S. (FDA), Quality System Regulation (QSR) Part 820, is harmonized with ISO 13485:2003. FDA, like any other countries requires a quality system called Current Good Manufacturing Practice (cGMP). The requirements of CGMP are defined in Part 820 of the Code of Federal Regulation Title 21, and these are the Quality System Regulation (QSR) of the FDA. ISO 13485 provides a means for organizations in the supply-chain of medical devices to manage regulatory and legal requirements including interaction with Health Insurance Portability and Accountability Act (HIPAA) and European Union MDD for CE Marking (CE)