Medical Devices – Quality Management System

ISO 13485 certification 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:

  • Scope
  • Normative references
  • Terms and definitions
  • Quality Management System
  • Management responsibility
  • Resource management
  • Product realization
  • 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:

  • Management of all processes of the organization through ISO 13485 quality management system
  • Improvement of Work environment
  • Proactive quality management
  • Improving the awareness of the quality management system for all employees
  • 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.
  • Reduction of Operational cost: Operational efficiency improvement through continuous process improvement
  • Improvement of a relationship between shareholders: Increase organizational awareness with employees, customers and suppliers
  • Compliance: Understanding legal and regulatory requirements that may affect the organization and its customers
  • Improvement of risk management: Improve risk management through improved traceability of products and services
  • Verification of Business credibility: Business credential through certification to international standards
  • Business Expansion: Satisfying the requirements for entering overseas markets 

Prime’s Competency:

Prime Consultants and Trainers has superior team of consultants and trainers to complete the requirements and compliance of ISO 13485:2016 QMS-MD.The consultants of Prime are contributing to the continuous development of customers by accurately assessing the suitability of the management system through the technology and expertise accumulated over. As a trusted national leader in management system consultancy and training, Prime Consultants and Trainers offers ISO 13485 consultancy, training & certification as well as QualityEnvironmentalHealth & SafetyInformation TechnologyFood Safety and other Management System.Prime Consultants and Trainers 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.