The International Standard specifies requirements for Quality Management System that can be used by organizations for design and development, production, installation and servicing of medical devices, as well as design, development and allocation of related services. The main difference between UNI CEI EN ISO 13485:2016 and previous standards (UNI CEI EN 46000 and ISO 13485:2016) is to be self-supporting. In order to be certified according to the Standard, organizations no longer need to be certified ISO 9000 and CEI 46000.
The Certification UNI CEI EN ISO 13485:2016 is therefore reserved to those companies who design, produce and market medical devices. In particular, companies should evaluate following activities:
– Management of white room under controlled conditions (procedure for cleaning and maintenance of filters) (if applicable).
– Validation of white room (bio-contamination of air, surface and particle counting) (if applicable).
– Validation of sterilization process (if applicable).
– Procedures for handling of products and of personnel.
– Management and release procedures and / or products’ control.
– Traceability of products towards customers and suppliers.
– Risk management evaluation throughout product realization.