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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.
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 [email protected] 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.