What is ISO 13485?

The international ISO 13485 standard "Medical devices - Quality management systems - Requirements for regulatory purposes" refers to quality management systems in the manufacture of medical devices. It defines the requirements for a quality management system that should be met by the organization throughout the production cycle. The requirements of the ISO 13485 standard apply to the organization regardless of its size and type.

The scope of application of the standard:

The ISO 13485 standard contains QMS requirements when the organization needs to demonstrate its ability to deliver medical devices and related services, constantly meeting customer requirements and applicable regulations. Such organizations may be involved in at least one stage of the product life cycle, including design and development, production, storage and distribution, installation or service of a medical device, and design and development or provision of related services (e.g. technical support).

This standard may also be used by suppliers or external parties that provide the product to such an organization, including QMS related services.

General requirements:

Each organization should:

  • Document the quality management system and maintain its effectiveness;
  • Establish, implement and maintain all requirements, procedures, activities included in the standard;
  • Determine the processes needed in the QMS and their application in the organisation;
  • Apply a risk-based approach to supervising relevant processes;
  • Determine the sequence of these processes and their interaction;
  • Manage these processes accordingly
  • Document the validation procedures for the use of computer software used in QMS;

Benefits of ISO 13485:

  • Increase the company's credibility;
  • The ability to access domestic and foreign markets;
  • Increasing the competitiveness of the organisation;
  • Organisational processes become more transparent;
  • Minimizing the risk of a defective product;
  • Reducing the amount of complaints.

Who should be ISO 13485 certified?

The quality management system according to ISO 13485 is introduced by manufacturers of medical devices and by other companies dealing in activities in the medical devices industry (eg: companies servicing medical equipment).