ISO 13485:2016 MEDICAL DEVICES
ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers, suppliers, contract service and distributors of medical devices and equipment. The main objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical devices sector. ISO 13485 Certification Standard has been based on the requirements of ISO 9001 standard and has the same structure in terms of clauses. Even some clauses of ISO 13485 have been referred to ISO 9001.The ISO 13485 standard is for medical devices, quality management systems, requirements for regulatory purposes, is the basis for regulatory compliance in local and most global markets. Exporting medical Devices to various countries is mandatory. ISO 13485 Certification is an objective evidence of compliance of the requirements, regardless of the type
or size of the organization. This 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 services. ISO 13485 purchasing requirements cover purchasing from qualified suppliers, according to pre-established specifications, and assuring that purchased product meets those specifications.