ISO 13485 Medical Devices Certification Revision
Regulators in the medical-device sector are adding requirements that increase the need to monitor safety and quality at every stage of a product's lifecycle, including service and delivery.
ISO 13485 Medical devices, Quality management systems, Requirements for regulatory purposes is an internationally recognized standard that sets out the requirements for a quality management system specific to the medical-device sector.
What is a medical device?
A medical device is a product designed for use in the diagnosis, prevention, or treatment of disease or other medical conditions, such as an instrument, machine, implant, or in vitro reagent.
Who is ISO 13485 for?
ISO 13485 is designed for organizations involved in the design, production, assembly, and servicing of medical devices and related services. It can also be used by certification bodies and by internal and external parties to support the control of their own audit processes.
ISO 13485 Certification
Like other ISO management-system standards, ISO 13485 certification is not itself a regulatory requirement, and organizations can apply the standard without going through certification. However, third-party certification lets an organization prove that it applies the system and meets the standard's requirements.
Why is ISO 13485 being revised?
All ISO standards are reviewed every five years. ISO 13485:2016 is designed to respond to the latest quality management system practice, including changes in technology and in regulatory requirements and expectations.
What will the key updates be?
The new version puts more emphasis on risk management and risk-based decision-making, along with changes covering the increased regulatory requirements for organizations across the supply chain.
When will ISO 13485:2016 be published?
ISO 13485:2016 is expected to be published in early March 2016.
