ISO 13485

Medical devices

ISO 13485 is a medical devices standard, not a product standard. The standard is based on ISO 9001 and organised in the same way using the same numbering and most of the requirements directly from ISO 9001. The standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements, applicable to medical devices and related services. The primary objective is to facilitate harmonised medical device regulatory requirements for quality management systems.

What are the benefits to me and my organization?

  • Demonstrates your ability to supply medical devices and related services, that meets customer expectations and complies with regulatory requirements
  • Evaluates how well your organization is able to meet customer expectations and comply with regulatory requirements

How can it help me to gain business?

  • Effective management systems are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world

What are the internal benefits for my business?

  • Establishes a management system that is oriented towards the design, development, production, and installation of medical devices and related services

Contact ABCI to get more information on the ISO 13485

Latest News

How to carry out a risk assessment at your workplace

Regardless of size, every company is affected by Health and Safety regulations that impose duties, obligations and penalties both on the companies concerned and on the management and directors personally.�

continue reading...

Do enterprises in developing countries benefit from ISO Standard conformities or are they a barrier to trade?

In coming years, developing countries will face intense competition which they have not experienced before. For developing countries that do not currently have meaningful export quantities, it will become even more difficult to enter or to remain in world markets.

continue reading...

Cyber Warfare Threat Warning: Information & Data Security

Cyber warfare has been cited as the �fifth domain of warfare� becoming just as critical to military operations as land, sea, air and space. It has been defined as being �actions by a nation-state to penetrate another nation�s computers or networks for the purposes of causing damage or disruption.�

continue reading...

ABCI Leaflet Gallery

ISO 9001 Leaflet ISO 14001 Leaflet BS OHSAS 18001 Leaflet ISO 27001 Leaflet ISO 13485 Leaflet ISO 22000 Leaflet ISO 20000 Leaflet BS 25999 Leaflet QAS Leaflet Adding Value Leaflet

Case Studies

These case studies show how organizations have successfully implemented ISO standards into their company's. They demonstrate that businesses
with the ISO Standards become more efficent, which in turn increases productivity and reduces costs.