ISO 13485 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM
The ISO 13485 standard is an international standard that is based on the ISO 9001 standard and includes special requirements for medical devices. When an organization in the medical device and medical instrument manufacturing sector requests certification from this standard, the institution is not required to be a manufacturer.
In addition to meeting legal requirements, medical device manufacturers who want to gain a competitive advantage must also prove that they comply with quality management system requirements.
The ISO 13485 standard is a standard compatible with the ISO 9001 standard, the main difference from the ISO 9001 standard is that the Customer Satisfaction element is not sought.
Other notable differences are;
- Observing sectoral requirements and legal or regulatory requirements such as the Medical Device Directive or FDA,
- Arranging working environments for product safety
- Product development and design stages
- Traceability for implanted devices
- Documentation and process validation for sterile devices
- Corrective and preventive activities
However, it is the first step for a medical device or medical product to enter the European Union market. One of the prerequisites of the EEC Medical Device Directive and the In Vitro Medical Devices Directive and the CE Marking Regulation is the ISO 13485 Certificate, which is sought together with these directives.
ISO 13485:2016 is the latest version of standard 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 mandatory to use the CE marking on Medical Devices.
- With ISO 13485, the organization expands its customer portfolio by documenting that it operates in accordance with an internationally recognized standard.
- It provides advantage and prestige against its competitors with the ISO 13485 Certificate.
- ISO 13485 reduces customer complaints.
- ISO 13485 Provides reduction in product defects.
- ISO 13485 System increases the profitability of the organization.
- With ISO 13485 Management System, the organization gains export advantage.
- With ISO 13485, organization activities can be systematically monitored by top management,
- ISO 13485 Quality Management System for Medical Devices enables the organization to detect and correct its deficiencies,