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   What is ISO 13485?

   • Recently updated to ISO 13485:2016, the new version of the internationally recognized standard offers a framework to realize requirements of a medical devices quality management system and seeks to address the entire lifecycle of a medical device. Today’s environment is filled with intense scrutiny but being competitive means never standing still.

   ISO 13485 Medical Devices Management Systems | Audit

   saiassurance.com/iso-13485

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   What is ISO 13485 / 15579 / 2005?

   • The committee has decided to adopt this standard under dual numbering system and published it as IS/ISO 13485 : 2003. This standard supersedes IS 15579:2005 'Medical devices — Quality management systems — Requirements for regulatory purposes'.

   IS/ISO 13485 (2003): Medical Devices-Quality Management Systems

   archive.org/download/gov.in.is.iso.13485.2003/is.iso.13485.2003.pdf

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   How do I become ISO 13485 certified?

   • The process of becoming certified to ISO 13485 involves developing a management system based on the standards’ guidelines customized to your company and then hiring a recognized third party to conduct regular audits.

   ISO 13485 – Why It’s Important and How to Become Certified

   isoupdate.com/general/iso-13485-how-to/

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   What are the changes to ISO 13485 and ISO 9001?

   • Added requirement for the requirement to corrective verify that action the corrective to be taken action without does undue not have an adverse effect. delay. — Adds the requirement to verify that the preventive action does not have an adverse effect. — Correspondence between ISO 13485:2016 between ISO 9001:2015.

   INTERNATIONAL ISO STANDARD 13485

   dms.csoftintl.com/wp-content/uploads/2018/01/ISO-13485-2016-EN.pdf

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