Medical Device Quality Management System Certification Specification, ISO 13485

ISO 13485 : Specifies the requirements of the quality management system to demonstrate an ability of an organization to provide legitimate medical devices and regarding services applicable to customer needs and medical devices and regarding services in 2003.

The major purpose of ISO 13485 is to facilitate the medical device regulations integrated with the quality management system. Accordingly, certain requirements for medical devices shall be included and some other requirements of ISO 9001 not in compliance with the regulations shall be excluded. Even if an organization’s quality management system complies with ISO 9001 specification for this exception, the organization in compliance with ISO 13485 can’t claim that it is also in compliance with ISO 9001 specification.

All requirements of ISO 13485 specification are specific to an organization supplying medical devices regardless of size and type of the organization and if regulatory requirements allow the exclusion of design development control, the exclusion may be justified from the quality management system. However, the exclusion of the design development control is reflected and compliance with ISO 13485 specification is responsibility of the organization.

The benefits of ISO 13485 certification are as follows. 

Enter overseas markets with the corresponding certification 

Reduce operating cost by identifying process defects and improving efficiency 

Provide good quality in an organized way and increase customer satisfaction by addressing customer complaints 

Demonstrate commitment to providing quality through the international standards

Transparency in handling customer complaints, follow-up, and recall

Facilitate entering into Asian countries in addition to CE countries