ISO 13485:2016
MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM
The ISO 13485 standard is an international standard that is based on the ISO 9001 standard and contains special conditions for medical devices. When an organization in the medical device and medical instrument production sector requests certification from this standard, this 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. Its main difference from the ISO 9001 standard is that the Customer Satisfaction element is not required.
Other obvious differences;
Compliance with sectoral requirements and legal or regulatory requirements such as the Medical Device Directive or FDA,
Organizing work environments for product safety
Product development and design stages
Traceability for implanted devices
Documentation and process validation 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 the EEC Medical Device Directive and the In Vitro Medical Devices Directive and the Ce Mark Regulation is required along with these directives, the ISO 13485 Certificate.
ISO 13485:2016 is the latest version of standard 13485. It is based on the ISO 9001:2015 risk and process approach model.
ISO certification
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 certifying that it operates in accordance with an internationally recognized standard.
- It provides advantage and prestige against its competitors with its ISO 13485 Certificate.
- ISO 13485 provides a reduction in customer complaints.
- ISO 13485 Reduces product defects.
- ISO 13485 System increases the profitability of the organization.
- With the ISO 13485 Management System, the organization gains export advantage.
- With ISO 13485, organizational activities can be systematically monitored by senior management,
- ISO 13485 Quality Management System for Medical Devices provides the opportunity to detect and correct the failing aspects of the organization,