ISO 13485

Establish a Quality  System for Medical Devices

• Develop a quality management system for medical devices
• Implement a quality management system for medical devices
• Maintain your medical device quality management system

Document Your Medical Device Quality System

• Develop quality management system documents
• Prepare quality management system manual
• Control quality management system documents
• Maintain quality management system records

Support Quality

• Promote the importance of quality
• Develop a quality management system
• Implement your quality management system
• Maintain your quality management system

Focus on Customers

• Identify customer requirements
• Meet customers requirements

Establish a Quality Policy

• Define your quality policy
• Manage your quality policy

Perform Quality Planning

• Formulate quality objectives
• Plan quality management system

Control the Quality Management System

• Define responsibilities and authorities
• Appoint management representative
• Support internal communications

Carry Out Management Reviews

• Review quality management system
• Examine management review inputs
• Generate management review outputs

Provide Quality Resources

·         Identify quality management system resource requirements

·         Provide quality management system resources

Provide Quality Personnel

·         Use competent personnel

·         Support competence

Provide Quality Infrastructure

·         Identify infrastructure needs.

·         Provide needed infrastructure

·         Maintain your infrastructure

Provide Quality Environment

·         Identify needed work environment

·         Implement needed work environment

·         Manage needed work environment