Quality Policy

ISO 13485, ISO 9001 and good distribution practice

Hemera Medikal works in the knowledge that a medical device directly affects patient safety. Our quality management system is built on ISO 13485:2016 and ISO 9001:2015 and is audited every year by independent bodies.

Our commitments

  • To sell only products that bear the CE (MDR) mark, are registered in UTS and have Turkish instructions for use
  • To record storage conditions (temperature, humidity, light) continuously and open the records to customer audits
  • To deliver every product traceable by serial and lot number
  • To assess nonconformities and complaints within two working days and reply in writing
  • To complete the annual training of technical staff with manufacturer-approved programmes

Good distribution practice

Our warehouses are operated in line with medical device storage regulations, in zones separated by product group, with incoming inspection and the FEFO principle (first expiry, first out). Reagents requiring a cold chain are transported at 2-8 °C in vehicles with temperature loggers and a record printout is supplied on delivery.

Continuous improvement

A customer satisfaction survey is run every quarter, and service response times and first-visit resolution rates are reviewed in management review. In 2025 our first-visit resolution rate was 87% and our average service response time was 11 hours.

Certificates and audits

Our quality system is reviewed each year by an independent certification body and customer auditors. A summary of audit reports is shared with customers who request it. Our quality objectives are measured as on-time delivery rate, first-visit resolution rate and complaint closure time, and are reviewed in management review.

Contact us for a device demo or a quotation

Our biomedical engineer will call you within the same working day.

WhatsApp +90 216 555 36 00 info@hemeramedikal.com.tr