ISO 13485 is an ISO standard representing the requirements for a comprehensive management system for the design and manufacture of medical devices. Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices according to 93/42/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485 by a Notified Body. The result of a positive assessment is the certificate of conformity allowing the CE marking and the permission to sell the medical device in the European Union.
Fundamental differences between ISO 13485 and ISO 9001 are:
ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained
the promotion and awareness of regulatory requirements as a management responsibility. An example of market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
controls in the work environment to ensure product safety
focus on risk management activities and design transfer activities during product development
specific requirements for inspection and traceability for implantable devices
specific requirements for documentation and validation of processes for sterile medical devices
specific requirements for verification of the effectiveness of corrective and preventive actions