Search Harmonised Standards in ASEAN: ICS

Conformity assessment -- General requirements for accreditation bodies accrediting conformity assessment bodies / ISO/IEC 17011

ISO/IEC 17011:2004 specifies general requirements for accreditation bodies assessing and accrediting conformity assessment bodies (CABs). It is also appropriate as a requirements document for the…  [More Details+]

Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003 / ISO/TR 14969:2004

ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise…  [More Details+]

Medical devices -- Quality management systems -- Requirements for regulatory purposes / ISO 13485:2003

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that…  [More Details+]