Discussions Populaires Dans la Communauté ISO 13485

What is the difference between ISO 9001:2015 & ISO 13485:2003?‎

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What is integrated management system(HSEQ)? what ISO guideline it concern beside ISO9K, 14K & 18K?how we can implement in our system?‎

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What are the new requirements added in the ISO 13485:2016?‎

What new procedures are incorporated in ETO validation procedure of ISO5: ‎

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La répondre a été ajoutée par  Ravindra Bharambe, Sr. Offficer QA, Pregna International Ltd
Depuis 8 années

9001 is a Quality Management system for all industries & 13485 is a Quality management system for only Medical Device industries.

 

La répondre a été ajoutée par  Hany EL Debeky , Project Manager , IETQAN
Depuis 8 années

Both describe the requirements for a quality management system . ISO 13485 is dedicated for companies who design , produce , manufacture medical devices ( incl. software) ... Voir Plus

 

La répondre a été ajoutée par  Mohammed Abu Sunineh, Senior Document Controller , Arkad Engineering & Construction
Depuis 4 années

ISO 13485/2016 maintains the same structure of its prior version (based on ISO 9001:2008), the new structure of ISO 9001:2015 has an entirely fresh look and feel. ISO 900 ... Voir Plus