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ISO 13485:2016 standard includes the requirements for the implementation of a quality management system for medical products.

Its structure and its requirements are similar to those of the international quality standard ISO 9001:2015 with the main differences to be 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.

Target Audience

  • Organizations of any size and type
  • Companies involved in one or more stages of the life cycle of medical devices, including the design and development, production, storage and distribution, installation, or repair of medical devices and the design and development or provision of related activities (e.g. technical support)
  • Suppliers or external entities providing medical devices

The benefits it offers

Safe products and meeting legal requirements

Improved quality of services/products

Satisfied customers

Better management control

The company that is interested in being certified according to ISO 13485:2016 contacts BQC and fills in the certification application and send it to info@bqc.gr or fax it to +302112213726.

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

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