![]() – Management of white room under controlled conditions (procedure for cleaning and maintenance of filters) (if applicable). In particular, companies should evaluate following activities: The Certification UNI CEI EN ISO 13485:2016 is therefore reserved to those companies who design, produce and market medical devices. In order to be certified according to the Standard, organizations no longer need to be certified ISO 9000 and CEI 46000. 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. 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.
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