ISO 13485

Medical Devices-Quality Management System

ISO 13485 is a standard that stipulates the requirements for the quality management system of organizations providing design and development, production, installation and additional services of medical device. In addition, this standard can be applied to external organizations that provide services such as sterilization, calibration, and sales. It can provide the basis for a quality management system to organizations that provide medical devices and related services.

• 

  ISO 13485:2016 Requirements

  ISO 13485 is an international standard for the quality management system of the medical device industry, which was established based on ISO 9001 by adding items related to medical devices.

  • 1. Scope
  • 2. Normative references
  • 3. Terms and definitions
  • 4. Quality Management System
  • 5. Management responsibility
  • 6. Resource management
  • 7. Product realization
  • 8. Measurement, analysis and improvement

• 

  The importance of ISO 13485

  Medical devices have a direct impact on human life and health, so they must ensure a higher level of stability than any other product. Therefore, the medical device industry must meet domestic regulatory systems, international standards and other requirements.
  
  In order to meet the requirements of the EU Medical Device Directive, a quality system must be established, and some countries, such as Canada, require ISO 13485 certification for product sales.
  
  With ISO 13485 system certification, A manufacturers who manufacture medical devices can demonstrate that their system meets the comprehensive requirements for quality management systems and the specific requirements for medical devices.
  
  This standard helps following :

  • 1. Management of all processes of the organization through ISO 13485 quality management system
  • 2. Improvement of Work environment
  • 3. Proactive quality management
  • 4. Improving the awareness of the quality management system for all employees
  • 5. Reduce cost and increase efficiency

• 

  Estimated Effectiveness of ISO 13485

  obtaining ISO 13485 certification, organizations can benefit from :

  1. Clients Satisfaction

  Achieved by delivering products that consistently meet customer requirements, including quality, safety and legal requirements.

  2. Reduction of Operational cost

  Operational efficiency improvement through continuous process improvement

  3. Improvement of a relationship between shareholders

  increase organizational awareness with employees, customers and suppliers

  4. Compliance

  Understanding legal and regulatory requirements that may affect the organization and its customers

  5. Improvement of risk management

  Improve risk management through improved traceability of products and services

  6. Verification of Business credibility

  business credential through certification to international standards

  7. Business Expansion

  Satisfying the requirements for entering overseas markets

• 

  IGC’s Competency

  IGC has been accredited for ISO 13485 by IAS, an Accreditation Body in the United States, and provides certification services for quality management systems.
  
  The auditors of IGC are contributing to the continuous development of customers by accurately assessing the suitability of the medical device quality management system through the technology and expertise accumulated over the years.
  
  As a trusted global leader in management system certification, IGC offers ISO 13485 certification as well as CE and FDA.
  
  IGC has up-to-date knowledge of a wide range of specific scopes and legal requirements in major markets around the world, and provides the knowledge and services to support your entire global operation.