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What new procedures are incorporated in ETO validation procedure of ISO5:
9001 is a Quality Management system for all industries & 13485 is a Quality management system for only Medical Device industries.
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
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