ISO 13485:2016-Medical devices




ISO 13485:2016 is a quality system standard designed specifically for medical device companies. The ISO 13485 is a standard measure that is more or less like ISO 9001 but simply acts as a criterion to measure best management practices in the health sector.

It is the most commonly chosen path for companies to meet the Quality Management System (QMS) medical device requirements in Europe, Canada, and Australia, and serves as the basis for QMS compliance in other countries such as Japan, Korea, and Brazil.

The certification provides a different kind of approach in the manufacture and distribution of medical equipments and there is no doubt that many medical practitioners have preferred equipment from providers who have been certified by the ISO 13485. The standardization criteria is simply a global initiative that aims at creating a more professional medical equipment production through world class management practices that are all within the ISO 13485 charter.

Among the basic and fundamental requirements the following are the most significant ones:

  • ISO 13485 requires that organizations develop and establish a quality medical equipment management practice and system in all sectors of production and distribution.
  • Calls for organizations to conduct comprehensive assessments of their production system to determine the strengths and weaknesses of their existing management system and further move on to develop possible solutions in regard to their findings.
  • Requires detailed presentation of the organization management system in order to make sure that all needs have been taken into close consideration.
  • The standardized measure also requires companies to implement and evaluate an internationally recognized quality management system in the production of their medical equipment.
  • Maintain and evaluate your medical equipment management system, documentation of procedures as well as development of an effective manual.
  • Promotes proper documentation of medical service and equipment management practices.

Benefits of being certified to ISO 13485?

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

  • Increase access to more markets worldwide with certification
  • Outline how to review and improve processes across your organization
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations