ISO 13485 QMS Certification in sazep refers to the quality management system in medical devices or equipments. This standard of ISO is introduced to identify risks and to control and manage to eliminate the hazardous parameters or situation in the medical device or equipment. The requirements and clauses of the ISO 13485 standard in sazep can be applicable to all types of organizations irrespective of size and nature. ISO 13485 standard also demonstrates the device specific and customer specific requirement. An organization has an advantage to enter into the international market by adopting the ISO 13485 standard. ISO 13485 Certification in sazep helps the medical device manufactures to meet with the Quality Management System requirement of European directives. Credibility to an organization is provided by the ISO 13485 Certification in sazep.