The ISO 13485: 2016 standard is an international standard that has been created on the basis of the ISO 9001: 2008 standard and includes special requirements for Medical Devices. ISO 13485 is a system that Medical Device manufacturers can use when going for CE marking, and companies that prefer H module within the scope of CE marking must establish. Although it basically includes the ISO 9001: 2008 Quality Management System, it has been made a standard for medical device manufacturers, especially with additional requests at the design stage.

Based on the ISO 9001: 2008 process approach model, this standard covers more comprehensive and specific quality system requirements than ISO 9001, which should be followed by organizations that want to provide medical devices and related services, and to prove their ability to meet customer and regulatory requirements that are consistently applied to medical devices.

ISO 13485, a standard that defines the specific requirements of quality systems for organizations operating in the field of trade and manufacture of medical devices, can be applied by all organizations that include the project, production, installation, and supply phases of medical devices or their services.

What is the difference between EN ISO 13485: 2016 and ISO 13485: 2003?

Changes in the new EN ISO 13485: 2016 compared to the 2003 version are only for the foreword and Appendix Z. There has been absolutely no change in the Normative Text.

In the 2016 version of the standard, the new Annex Z provides further clarity on the applicability of the quality systems provisions of the three European Medical Device Directives (MDD, AIMD, and IVD) and ISO 13485.

Each Annex Z contains a different Annex for each Medical Directive. For example, Annex ZB of EN ISO 13485: 2016 shows the relationship between MDD 93/42 / EEC Annex II and the Full Quality Assurance clauses of ISO 13485.

Benefits of ISO 13485

• Providing a competitive advantage
• Increasing the awareness of quality among employees
• Adopting a process-oriented approach
• Creation of documentation (infrastructure) that will ensure standardization of business activities
• Increasing the organization's reputation in the market
• Ensuring global compliance of medical devices with quality rules
• Increasing the design, production, and service quality of medical devices
• Providing advantage especially in exports to European Union countries
• Increasing confidence in devices
• Due to the increase in the quality of the devices, protection of human health
Facilitating compliance with various laws and regulations on this subject

en ıso 13485:2016