Royan Stem Cell Technology Company, leveraging technology and aiming to ensure the sustainable quality of its services, established a **Quality Assurance Unit** approximately 8 years ago. This unit began its activities based on the requirements of the international standards **FACT-Netcord** and **AABB**, as well as Iran's national umbilical cord blood standards (developed by the Ministry of Health, Treatment, and Medical Education), to ensure the compliance of organizational processes with international standards. It has successfully obtained the following standard certificates from **IGC (Iranian Gawah Kowsar)**:

Royan Cord Blood Bank Certificates:

ISO 9001:2015 Certificate:

ISO 9001 is an international standard for establishing a Quality Management System (QMS) published by ISO (International Organization for Standardization). In fact, this standard is for implementing quality management system requirements within an organization.

ISO 13485:2016 Certificate:

ISO 13485 is an international standard that specifies requirements for a quality management system for manufacturers of medical devices. This standard helps companies produce safe and high-quality products and comply with medical industry laws and regulations.

ISO 45001:2018 Certificate:

ISO 45001 is a specialized standard for occupational health and safety management developed by the International Organization for Standardization (ISO). The ISO 45001 standard includes requirements and guidelines that help organizations worldwide address this burden by providing a framework to improve employee safety, reduce workplace risks, and create better and safer working conditions.

ISO 10002:2018 Certificate:

ISO 10002 is an international standard that guides organizations in effectively managing customer complaints. This standard helps organizations establish a structured and transparent process for receiving, recording, tracking, and resolving customer complaints. The goal of ISO 10002 is to increase customer satisfaction through proper complaint management and to bring about necessary improvements in the organization's internal processes.

ISO 10004:2018 Certificate:

ISO 10004 is an international standard that provides guidance for monitoring and measuring customer satisfaction. In fact, this international standard is developed and designed to achieve customer satisfaction from the services and products of organizations and companies. Applying this standard, by classifying customer needs, moves the company towards customer-centricity and customer satisfaction.
  

Amikar Product Certificates:
ISO 13485:2016 Certificate:

ISO 13485 is an independent quality management system standard for medical device manufacturers. In fact, this standard supports manufacturers in developing a quality management system that enables safe and effective processes. These processes are designed to ensure the design, development, production, installation, delivery, monitoring, and traceability of manufactured medical devices, covering their entire product lifecycle.