What is ISO 13485?

  • is the medical device industry’s most widely used international standard for quality management?
  • is an effective solution to meet the comprehensive requirements for a Quality Management System in the medical device industry.

What is the purpose of ISO 13485?


Starting with management support and identifying the customer requirements for the QMS, you will need to start developing documentation including the Quality Policy, Quality Objectives, and Quality Manual. Together, these define the overall scope and implementation of the Quality Management System. Along with these, you will need to create the mandatory and additional processes and procedures necessary for your organization to properly create and deliver your product or service.

What is the difference between ISO 9001 and ISO 13485?

Even though ISO 13485:2016 is a stand-alone standard, it is based on ISO 9001:2008, including additional requirements that are specific for companies that manufacture ISO medical devices.

Is ISO 13485 mandatory?

  • The short answer is no, ISO 13485 is not mandatory. You can create a QMS that suits your needs for your organization, so long as the processes of the QMS meet the legal and regulatory requirements for medical devices where you intend to manufacture and sell them. Even though ISO 13485 is not required for EU MDR compliance, the EU MDR regulation requires that you have a QMS in place, and the ISO 13485:2016 standard is the only QMS standard listed in the EU list of harmonized standards, so most companies will use the ISO 13485 requirements to implement their QMS.
  • By using the ISO 13485 requirements to create your QMS, you can ensure that you have a world-class system for meeting the needs of customers and legislators for your medical devices.
  • ISO 13485 provides you with more than the bare minimum to meet a legal requirement; it provides a whole system that is devoted to helping you make your quality processes better.