I F C
Medical Devices Quality Control System
Why
ISO 13485
ISO 13485: 2016 Standard is a parallel standard with ISO 9001: 2000-8 Standard and has been prepared on the basis of ISO 9001: 2000-8 Standard. ISO 9001: It is the form of the 2000-8 Standard adapted to medical devices and developed in this field. It is an international standard with special requirements for medical devices. ISO 13485 is also one of the most important arguments that medical device manufacturers can use when going for CE Marking. It is a system that companies must establish if the production quality assurance module is selected within the scope of CE Marking. Although it includes ISO 9001: 2000-8 Quality Management System as a basis, it has been made a standard of medical device manufacturers especially with its additional requests at the design stage and special conditions for sterile medical devices.
What is
ISO 13485
Based on the ISO 9001:2000-8 process approach model, this standard covers more comprehensive and specific quality system requirements than ISO 9001 that organizations must comply with if they want to provide medical devices and related services and to prove their ability to meet customer and regulatory requirements that are consistently applicable to medical devices.
ISO 13485, which is a standard that defines the specific requirements that quality systems must meet 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 related services.
Benefits
ISO 13485
It will be possible for the products to show health, safety and security features and to meet the minimum requirements with EN ISO 13485 certification and CE Marking studies.
It is a common language with the European Union and other countries in the production, sale and service of medical devices.
It is closely related to the CE Marking of medical devices.
It is a very important guide in sterilization and hygiene.
It carries special requirements for sterile medical devices.
It is a guideline in determining the risk groups of medical devices.
Purpose
ISO 13485
It allows for education, continuous improvement and development.
It is one of the most important tools for increasing quality awareness in companies.It enables the design, production and service levels of medical devices to be increased.
Simplifies compliance with laws and regulations.