أنشئ حسابًا أو سجّل الدخول للانضمام إلى مجتمعك المهني.
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) and also for companies who provide services to ensure the medical device integrity ( medical device testing laboratory) . ISO 9001 is generic requirements for any company regardless of industry ,size and products.
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 9001:2015 is based on Annex SL, which is intended to provide a uniform frame for writers to use when developing or revising standards. One goal of Annex SL is to support consistency in the writing of standards to make it easier to integrate multiple systems (e.g., quality, environmental, or safety).
The 2016 edition of 13485 does not follow the Annex SL structure, but it is possible that future editions of ISO 13485 may do so.
هل تحتاج لمساعدة في كتابة سيرة ذاتية تحتوي على الكلمات الدلالية التي يبحث عنها أصحاب العمل؟