ISO 13485:2003 Medical Devices-Quality Management System

ISO 13485 is Quality Management System Standard for medical sector for manufacturers, distributors, exporters and importers and organizations that provide these services  
ISO 13485:2003 is written for Medical Devices as a specific standard base on ISO 9001:2008 . However, some special issues differs from ISO 9001:2008 standard. Just to ISO 9001:2008 as well as the new management system, the classic concept of the quality control process / process-based approach to making the transition, the organization expects to establish a direct connection between the main objectives of efficiency.
"Plan, Do, Check, Act" cycle is used for the compliance with legal requirements, maintaining the effectiveness of the current situation and the process approach  issues

Benefits of ISO 13485

- Aspects of the system to detect deficiencies, for clarifying to fix.

- Provide a competitive advantage Nationally and internationally.

- Provide Economic structure, increases efficiency and profitability.

- Provide a product/service reliability.

- Export and domestic market provides   easily acceptability by the customer of the organization.

- Provides the convenience for traceability .