Skip to main content
Asked a question 4 days ago

What are the minimum requirements to achieve ISO 13485 Certification?

Where am I?

In ShopAtoZ you can ask and answer questions and share your experience with others!

noah aiden
certification iso 13485

Medical devices must be manufactured in accordance with a compliant quality management system. The system’s documentation should meet the defined requirements of this standard.

The manufacturer should have an efficient quality management system that is capable of meeting all their responsibilities under the Quality System Regulations (QSR) and other applicable regulations.

Manufacturers should have a management representative who is responsible for the quality system and be fully aware of the regulatory requirements and has the authority to ensure these are fulfilled. He/she should also determine how compliance with ISO 13485:2016 will be achieved, monitored, audited, maintained, and improved through documented procedures.

13485 Certification1

Related Questions