ISO 13485 MEDICAL DEVİCE MANAGEMENT SYSTEM CERTIFICATION

ISO 13485 How Do I Get Medical Devices Quality Management System Certificate?
• Application and contracting (FR-SP-02 Certification Agreement),
• Planning the audit (PRS-11 audit planning procedure),
• Implementation of the audit (PRS-05 system certification procedure),
• Certification committee decision,
• Publication of the certificate.

ISO 13485 Medical Devices Quality Management System
Compliance with customer requirements, the ability to provide the product that meets the current legislation requirements regularly, continuous improvement and customer satisfaction

ISO 13485 Medical Devices Quality Management System Development
-First issue: ISO 13485: 1996
-1. revision: ISO 13485: 2003 – minor modification
-2. revision: ISO 13485: 2016 – major modification

Benefits of ISO 13485 Medical Devices Quality Management System
• Compliance with legal requirements
• Corporate building
• Traceability
• Transparency
• Efficiency
• Continuous improvement
• Conscious employee
• Customer focus
• Decisions based on data
• Wide viewing

Certificate Validity Period: 3 Years
Audit Period: No later than 12 months