Trending ISO 13485 Discussions

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

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

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

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

 

Answer added by  Ravindra Bharambe, Sr. Offficer QA, Pregna International Ltd
8 years ago

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

 

Answer added by  Hany EL Debeky , Project Manager , IETQAN
8 years ago

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

 

Answer added by  Mohammed Abu Sunineh, Senior Document Controller , Arkad Engineering & Construction
4 years ago

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 ... See More