This program offers instruction on the technical operation of sterilization centers and sterilizing agents. You will also learn about the standards, methods and controls used most frequently during sterilization.
The key standards under review are ISO 9001 – governing quality issues in general – and EN ISO 13485. This deals specifically with the installation and maintenance of quality management systems (QMS) governing medical devices. By deepening your knowledge of these regulations, you will acquire the skills to evaluate a quality system for these devices and to remedy any deficiencies or areas of non-compliance.
EN ISO 13485:2003 specifies the requirements for a QMS where an organization can demonstrate its ability to provide medical devices and related services that consistently meet the requirements of customers and regulators.
Course outline:
- Basics
- Sterilization process and control systems
- Validation of the sterilization process
- Quality indicators for a centralized sterilization system
- Re-use of medical devices
Find out more about the Sterilization of Medical Devices training from SGS, by contacting us today.