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What is ISO 13485? ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers. The standard details requirements for a quality management system that ...
24 Αυγ 2017 · See what needs to be considered, beside specification or customer requirements, during design and development of medical devices according to ISO 13485:2016.
ISO 13485 is the internationally recognized standard for quality management systems in the design and manufacture of medical devices. It outlines specific requirements that help organizations ensure their medical devices meet both customer and regulatory demands for safety and efficacy.
ISO 13485:2016 — Medical devices — A practical guide 7 you are implementing a new QMS or updating your existing QMS, the advice given in this handbook is relevant.
After more than 10 years, the updated Quality Management standard with the revision of ISO 13485 for the medical device industry is here. The origins of ISO 13485 standard were closely related to the ISO 9001 standard that provides organizations guidance, context, and requirements for implementing a quality management system.
History and timeline for ISO 13485:2016 • Work kicked off in 2011, ISOTC210/WG1, SIS/TK355 • Purpose • 13485:2003 is 10+ years old • Scope to clarify other organization’s involvement • Include newer regulatory expectations • Better compatibility with other national regulations • Based on ISO 9001:2008 structure
This FAQ document is designed to answer some key questions around ISO 13485:2016 and EN ISO 13485:2016. Questions are grouped by key theme. The document accompanies two BSI Webinars covering the scope of the new standard, and a discussion of both ISO 13485:2016 and ISO 9001:2015. For more information, please see the ISO 13485:2016 revision webpage.
