Certification ISO 13485

ISO 13485 Quality Management System for Medical Devices

Target Group
  • The Standard can be applied by Organizations involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, repair and provision of corresponding activities (eg. technical support).
  • The requirements of ISO 13485 Standard are applicable to Organizations, regardless of their size and type.
  • ISO 13485 can also be used by suppliers or external parties that provide medical devices.

What is ISO 13485

ISO 13485 Standard includes the requirements for the implementation of a Quality Management System for medical devices.

The structure of the Standard and the requirements are similar to those of international Quality Standard ISO 9001. Their main differences are the requirements for monitoring records for each product, the risk management in all process stages, the monitoring of infrastructure maintenance, the documented procedures for the work environment, the service provision, the customer feedback as well as keeping interested parties informed.

The company that is interested in being certified according to the requirements of Ministerial Decision 1348, should contact BQC and fill in certification application and send it to This email address is being protected from spambots. You need JavaScript enabled to view it.or fax it to 2112213726

An initial audit is conducted and if successful, a certificate of compliance is issued that is valid for 3 years, provided that the organization undergoes an annual audit.

BQC is accredited by the Hellenic Accreditation System (ESYD), issues internationally recognized Certificates, and cooperates with experienced inspectors and experts from all over the world, ensuring the most updated and professional knowledge in any business sector.


The benefits are

Safe Products.
Meeting legislative requirements.

Improved quality of services / products.

Satisfied customers.

Better management control.

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