What is ISO 13485?

ISO 13485 specifies the requirements for Quality Management System (QMS) where an organization able to exhibit the competency to deliver medical devices and medical relevant services that can fulfill not only the requirements of customers’ but of applicable regulatory requirements. The most updated version of ISO 13485 is ISO 13485:2016. It is an internationally recognized quality management system for medical devices.

Why is ISO 13485 important?

The medical device industry can make use of ISO 13485 standard at any stage be it one of the stages of product life cycle development that include design and maturing the developed design, product manufacturing, storage and distribution of final product, installation and relevant services of medical devices along with provision of all the associated activities which might be in the form of technical (on-site or remote) support.

What are the benefits ISO 13485 – Medical Devices — Quality Management System?

A Quality Management System for medical devices complying with the international standard, such as ISO 13485 would increase your company’s worth manifolds. It will reduce your costs. Some notable benefits of being ISO 13485 certified are as follows:

  • An improvement in processes would see a reduction in operational costs
  • The stakeholder relationship with an organization will strengthen with a reliability of the management.
  • Fulfilling ISO 13485 requirements will project a trust-able and meticulous image of your organization which is all important in the Medical world.
  • The upgraded risk management will be cost-effective to your organization with its better consistency by adhering to ISO 13485 quality management principles.
  • You can accept a wider market range than the time when your organization wasn’t adhering to ISO 13485 standards. The internal and national authorities prefer a third-party audited and certified organization.
  • ISO 13485 requirements fully covers all the regulatory requirements of legal and contractual requirements and it has been recognized by Global Harmonization Task Force (GHTF) by becoming model MDQMS standard for the medical industry.
  • Since ISO 13485’s standard is very close to the requirements of Food and Drug Administration (FDA) so it partially covers criteria of FDA too.

Adherence to appropriate medical devices quality management principles will aid your organization in achieving business objectives and goals, whereas poorly designed quality management system would result in huge overall deterioration of your company’s structure.