The ISO 13485:2016 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 and applicable regulatory requirements. ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organisations. ISO 17664 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilisation to ensure that the device is safe and effective for its intended use. ISO 10993 Biological evaluation of medical devices, Evaluation and Testing within a Risk Management Process, is the most widely used standard for assessing the biocompatibility of medical devices and materials, and provides a framework for determining the appropriate biocompatibility steps for planning a biological evaluation. GMP Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. Also cGMP from FDA USA , GMP Pharmaceuticals, Goods Distribution Practices for Medical Devices ( GDPMD) , Good Storage Practices ( GSP) ,
Requirements of ISO 13485:2016 are applicable to organisations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.