ISO 13485 Medical Device Quality Management System

Share This Post


ISO 13485 is an international standard that sets out the requirements for a quality management system specific to the medical devices industry. It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services.


ISO 13485 QMS will help you:

  • Protect your company reputation as a responsible organization committed to quality and safety in the medical product sector.
  • Save costs by process optimization which allows organizations to establish a culture of continuous improvement and to eliminate deficiencies, which in turn reduces associated expenses; as well as to establish processes to manage risks and eliminate costs effectively.
  • Create new business opportunities since some organizations in the healthcare and medical device manufacturing sector demand that their suppliers are certified under this standard.
  • Gain competitive advantage especially since some national regulatory authorities require or strongly prefer medical device producers that have a certified management system in place. Investing in such a QMS speeds up access to those countries require it.
  • Demonstrate compliance with customer and regulatory requirements.

The formula to a more productive organisation with better and happier employees lies in your decision making.

Certification of management system serves as excellent marketing tools, enhancing brand recognition, and instilling greater confidence among your business partners and end customers.

Globally, GICG’s logo is widely recognised and respected as a trusted symbol of quality, safety and sustainability.

Let GICG help you to position your brand differently! Speak to us today!


Scroll to Top