ISO 13485 certification is valid in major countries including Europe, Australia, Canada, South Korea, Brazil and Japan.

It is the world’s most popular medical devices standard designed specifically for medical device-manufacturers. This standard is derived from quality management standard series (ISO 9000) and its main purpose is to facilitate harmonized regulatory requirements.  It is a standard developed for the Medical Device Industry.

The ISO 13485 is a standalone Standard that company that itself applies without any other quality system and prepared by Technical Committee ISO/TC 210 for medical devices. The Essential Requirements like EU MDD and the “CE marking “of the product are supported by this ISO13485 standard.


This ISO 13485 standard is compatible with other management systems, follows the way of ISO 9001 for the benefit of users in the medical device community.

Importance of ISO 13485

In the European Union, the requirements of ISO 13485 coordinate with the essential quality system requirements of the European Union’s MDD (93/42/EEC) the In Vitro MDD (98/79/EC) and the AIMD (90/835/EEC). In the U.S., the (FDA) allows device manufacturers to submit ISO 13485 certificate as a substitute of the evidence of compliance with its (QSR). Canada also requires ISO 13485 certification for marketing their medical devices products in Canada. The new quality assurance certification system have been introduced for Medical Devices – India’s New Quality Assurance Certification System for Medical Devices.

Who can apply for ISO 13485 certification?

All manufacturers and suppliers of medical devices, components, contract services and distributors of medical devices can apply for this certification. This certificate is not sufficient on its own; it also requires local regulatory certification for legal manufacturing and selling of medical devices.

Key Area of Difference (QSR / ISO 13485)

  • Customer focus
  • Complaint Handling
  • CAPA
  • Records
  • Documentation
  • Labeling

Requirements of the ISO 13485 standard

The specific requirements of the ISO 13485 standard for manufacture, installation and servicing requires

  • Risk management of product development and realization
  • Management review
  • Document and Data Control
  • Control of records
  • Internal Audit
  • Training
  • Corrective action
  • Preventive Action
  • Monitoring control and Measuring Equipments
  • Control of Monitoring of work environment
  • validation of sterilization process
  • Monitoring And Measurement of Processes
  • Analysis of Data
  • Issue procedure and Implementation of Advisory Notices
  • customer satisfaction survey
  • Purchasing
  • Control of Non–Conforming Products
  • Identification of products
  • Traceability
  • Preservation
  • Product safety

Key Benefits of the Certificate

  • Meet regulatory requirements
  • Safely produced medical device
  • Increasing device sales
  • Access to markets that recognize or require the certification including Canada and Europe.
  • Reduce operational costs by highlighting process deficiencies and improving efficiency
  • Add transparency to the way complaints, surveillance or product recalls are handled
  • Improved Performance