The primary difference between iso 13485 and iso 9001 for medical devices is the scope of these quality standards iso 9001 is the international standard which provides specifications for a quality management system which can be applied at any organization regardless of industry product or service or company size. Divergence of iso13485 from iso 9001 the previous version iso134852012 included all requirements of iso90012008 and added specific requirements relevant to the medical device industry as such in many cases a single management system based on iso134852012 could also receive iso90012008 certification with little or no additional effort. To better demonstrate the benefits of adopting international standards were highlighting two relevant iso standards for medical devices iso 13485 and iso 9001 learn why these standards were established and how they differ from and can enhance fda 21 cfr 820 what is iso 13485. Aims and outcomes iso 9001 requirements are skewed heavily towards ensuring customer satisfaction while iso 13485 puts more emphasis on the safety and efficacy of medical devices continuous improvement focus iso 9001 now requires manufacturers to show continuous improvement iso 13485 on the other hand only requires demonstrating effective implementation and maintenance of the quality system
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