Informational ISO/CD 7101 Health Care Quality Management System Standard

poh.s.lim

Poh S. Lim (Minuteman MMXXIII)
It's about time that a healthcare quality management system came about. ISO 13485 is still at heart a manufacturing/production-centric standard as it is about medical devices. Care standards comes under its purview.
 

Sidney Vianna

Post Responsibly
Leader
Admin
It's about time that a healthcare quality management system came about. ISO 13485 is still at heart a manufacturing/production-centric standard as it is about medical devices. Care standards comes under its purview.
Over the years there have been some attempts. An ISO 9001 based system developed for the accreditation of healthcare organizations in the USA addressing Medicare requirements has been in used for several years now.

 

poh.s.lim

Poh S. Lim (Minuteman MMXXIII)
I was aware of a Joint Commission International (JCI) accreditation and certification system offered to healthcare organizations prior to hearing about the ISO 7101:2023 standard. I am wondering if the ISO technical committee (TC304) had members who were part of the JCI and brought part of their experience and expertise into the ISO 7101?
 

Randy

Super Moderator
I was aware of a Joint Commission International (JCI) accreditation and certification system offered to healthcare organizations prior to hearing about the ISO 7101:2023 standard. I am wondering if the ISO technical committee (TC304) had members who were part of the JCI and brought part of their experience and expertise into the ISO 7101?
Ask them, you'd probably get a more accurate answer.
 
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