ISO 13485 Medical Devices Quality Managament Systems

UDEM, holds the accreditation of Turkish Accreditation Agency on ISO 13485:2016 Medical Devices – Quality Management System. 

• ISO 13485:2016 standard is an international standard involving special conditions for medical devices established based on the ISO 9001:2015 standard. It has been made into a standard that belongs to medical device producers thanks to the additional requests especially at the design stage. 
• This standard, which takes the process approach model as a basis, includes the quality control system requirements to be complied with by institutions willing to medical devices and related services, and prove their capacity to meet the customer and legislation requirements viably applicable to medical devices. 
• ISO 13485, which is a standard that defines the specific requirements to be met by quality systems for institutions carrying on a business in the trading and manufacture of medical devices, can be applied by all institutions covering the project, production, installation and supply stages of medical devices or services related thereto. 

Benefits of Holding a SO 13485:2016 Certificate 

• Provides competitive advantage
• Raises quality awareness among employees 
• Adopts a process-oriented approach
• Establishes the documentation (infrastructure) that will ensure standardization of operating activities
• Increases the prestige of the institution in the market
• Ensures global compliance with the quality rules for medical devices 
• Provides advantages in the exportation of medical devices especially to the European Union countries 
• Increases the reliance placed on the devices 
• Protects human health based on the increase in the quality of devices 
• Facilitates compliance with various laws and regulations on this issue