Our Certificates

Quality and Certificates

Every product we supply and every process we run is based on documentation.

Our product acceptance policy

For a product to enter the catalogue, all of the conditions below are required.

ÜTS registration

For medical devices and consumables, the Product Tracking System registration and manufacturer/importer details are verified.

CE conformity

For products within the scope of the medical device regulation, the CE certificate and declaration of conformity are attached to the quote file.

Biocidal licence

For disinfectants and antiseptics, a Ministry of Health biocidal product licence or notification is required.

Standard and class

For personal protective equipment, the EN standard and protection class are labelled; products without a class are not accepted.

Lot and expiry

Lot number and expiry date are stated at delivery; short-dated products are not shipped.

Traceability

Every delivery is recorded in the digital archive with a waybill and delivery receipt; in case of a recall, products are traced by lot.

Our corporate certificates

Certificates can be verified through the relevant institutions' verification systems.

Ministry of Health Authorization Certificate

Republic of Türkiye Ministry of Health

Certificate of inclusion in the Ministry's authorized company list for health information systems.

ISO/IEC 27001

Information Security Management System

Protection of customer and order data at an international standard.

ISO/IEC 33002

Process Assessment Certificate

Maturity assessment of software and service processes.

Technological Product Certificate (TÜR)

Republic of Türkiye Ministry of Industry and Technology

Ministry approval certifying R&D-based product status.

Technological Product Experience Certificate

Republic of Türkiye Ministry of Industry and Technology

Experience certificate issued for WebAHBS, valid until 2031 (TÜRD2026/78).

Public IT Authorization Certificate

Republic of Türkiye Ministry of Industry and Technology

Authorization to provide IT products and services to public institutions.

Technoentrepreneurship Badge

Republic of Türkiye Ministry of Industry and Technology

Technology-based enterprise status.

Trademark Registration Certificate

Turkish Patent and Trademark Office

Registration of the Afinitem trademark.

Data security and KVKK

Afinitem holds an ISO/IEC 27001 Information Security Management System certificate and is a data controller registered with VERBİS. Order, quote and contact data are processed solely for the supply process; details are in the KVKK Privacy Notice.

KVKK Privacy Notice