The purpose of the course:
Increasing students’ awareness of the concepts and requirements of the ISO 13485 standard and how to conduct the internal audit process in organizations based on the considerations contained in the ISO 19011 standard.
Headlines:
- Terms and definitions
- Explaining the requirements of the ISO 13485 standard, emphasizing:
- Medical equipment technical file
- Medical equipment classification rules in Iran and the world
- Validation of production and sterilization processes
- Control of environmental conditions in production, inspection and testing processes and transportation and delivery
- Special requirements for planting equipment
- Describe the process approach
- Explain the principles of auditing according to ISO 19011
- Conducting numerous training workshops to learn how to audit, including:
- preparation of audit checklists;
- review of documents;
- gathering evidence;
- detection of non-compliance and its reporting;
- preparing an audit report to present to the management;
- Audit psychology.
