ISO 9001 certification represents a formal acknowledgment by an accreditation organization that a company meets the intent of quality management standards issued by the International Organization for Standardization. A company receives this award after successfully passing an audit examining how well the standards were implemented and verifying the compliance of the company`s employees to the guidelines.


ISO 13485 certification 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.