Iso 13485 standard is a quality management system for the medical device industry where an organization needs to demonstrate its ability to manufacture, procure, store and well medical devices and related services that consistently meet customer and applicable regulatory requirements.
Organizations can have multiple stages of lifecycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and other associated activities (e.g. Technical support).
In simple words, iso 13485 standard is a combination of iso 9001 requirements with an additional set of medical device requirements.
Benefits of iso 13485 certification to your organization
credibility – increase access to bigger market worldwide with the certification
process approach – increase efficiency, cut costs and monitor supply chain effectiveness
quality compliance – demonstrate that you produce safer and more effective medical devices
customer satisfaction – meet regulatory requirements and customer expectations
employee engagement – better people involvement to identify best solutions for improving processes
business excellence – shorter lead times and better services through quality and process improvement initiatives
benefits of iso 13485 certification to your customers?
provides management with a defined & efficient management process
responsibility across the organization to achieve the objective
one of the criteria of a tender to qualify for some public sector work
positive atmosphere & builds confidence in internal staff & customers
identifies areas to improve & reduce iterations
metrics to reduce resources (men, money, machine, material & method)
provides continuous assessment and improvement
marketing opportunities
improved customer retention and acquisition
globally recognized standard inviting for international opportunities

Iso 13485 standard is a quality management system for the medical device industry where an organization needs to demonstrate its ability to manufacture, procure, store and well medical devices and related services that consistently meet customer and applicable regulatory requirements.
Organizations can have multiple stages of lifecycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and other associated activities (e.g. Technical support).
In simple words, iso 13485 standard is a combination of iso 9001 requirements with an additional set of medical device requirements.
Benefits of iso 13485 certification to your organization
credibility – increase access to bigger market worldwide with the certification
process approach – increase efficiency, cut costs and monitor supply chain effectiveness
quality compliance – demonstrate that you produce safer and more effective medical devices
customer satisfaction – meet regulatory requirements and customer expectations
employee engagement – better people involvement to identify best solutions for improving processes
business excellence – shorter lead times and better services through quality and process improvement initiatives
benefits of iso 13485 certification to your customers?
provides management with a defined & efficient management process
responsibility across the organization to achieve the objective
one of the criteria of a tender to qualify for some public sector work
positive atmosphere & builds confidence in internal staff & customers
identifies areas to improve & reduce iterations
metrics to reduce resources (men, money, machine, material & method)
provides continuous assessment and improvement
marketing opportunities
improved customer retention and acquisition
globally recognized standard inviting for international opportunities