ISO 13485 Medical Devices Quality Management System Standard

ISO 13485 Medical Devices Quality Management System Standard


ISO 13485 standard is an international standard created on the basis of ISO 9001 standard, containing special conditions for medical devices. When an organization in the medical device and medical device production sector requests certification this standard, it is not a requirement for this institution to be a manufacturer.

In addition to fulfilling legal requirements, medical device manufacturers who want to gain an advantage in competition must also prove that they comply with the quality management system requirements.

The ISO 13485 standard is a standard compatible with the ISO 9001 standard, the main difference the ISO 9001 standard is that Customer Satisfaction is not sought.

Other obvious differences;

- Observing the legal or regulations of the sectoral requirements such as the Medical Device Directive or FDA,
- Arrangement of working environments for product safety
- Product development and design stages
- Traceability for implant devices
- Documentation and process verification for sterile devices
Corrective and preventive actions

However, it is the first step for a medical device or medical product to enter the European Union market. One of the prerequisites of EEC Medical Device Regulations and In Vitro Medical Devices Directive and Ce Mark Regulations is required in ISO 13485 Certificate together with these directives.

ISO 13485: 2016 standard is the latest version of 13485. It is based on the ISO 9001: 2015 risk and process approach model.

What are the advantages of ISO 13485 Medical Devices?

- Demonstrates compliance with current legal requirements.
- It is compulsory to use CE marking in Medical Devices.
- With ISO 13485, the organization expands its customer portfolio by certifying that it works in accordance with an internationally recognized standard.
- It provides advantage and prestige to its competitors with ISO 13485 Certificate.
- ISO 13485 reduces customer complaints.
- ISO 13485 Provides a reduction in product errors.
- ISO 13485 System increases the profitability of the organization.
- The organization gains export advantage with ISO 13485 Management System.
- With ISO 13485, establishment activities can be monitored systematically by senior management,
- ISO 13485 Quality Management System for Medical Devices detects the disruptive aspects of the organization and has the opportunity to correct it.


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