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ISO 13485: 2016

Latest News
"New versions of ISO 9001:2015 & ISO 14001:2015 has been released, please update your systems as per the new versions." "ISO 45001 is awaited by 2017 to supercede OHSAS 18001:2007." "ISO 50001 is under revision, new version expected in 2017"

ISO 13485 is not a product standard. It’s a process standard . Therefore, it’s not enough to establish a quality management system that complies with the ISO 13485 standard, you also need to comply with all relevant product and service oriented technical standards and regulations.

  • To establish a quality management system that is oriented towards the design, development, production, and installation of medical devices and related services.
  • To demonstrate your ability to supply medical devices and related services those meets customer expectations and comply with regulatory requirements.
  • T o evaluate how well your organization is able to meet customer expectations and comply with regulatory requirements.
  • To become certified or registered.
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