ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

What will I learn?

• Understand the importance of complying with ISO 13485
• How to meet the requirements of ISO 13485
• Define ISO 13485 roles and responsibilities
• Understand the relationship between ISO 13485 and ISO 14971

Implementation 2 days.

This course will help you:

ISO 13485 is a quality standard for the design and manufacture of medical devices

• Understand how to implement a QMS as required by medical device directives
• Plan the implementation of ISO 13485:2016 within your organization
• Take the first steps towards ISO 13485:2016 certification
• Identify how you can better meet regulatory requirements
• Find ways to increase efficiency and add value through quality management
• Monitor supply chains to achieve continuous improvement

ISO 13485 Internal Auditor 2 Days

• Understanding of ISO 13485:2016 Auditing Principles
• Understand Auditor responsibilities and competence requirements
• Understanding Internal audit planning process and execution
• Documentation and reporting of non-conformities Reporting Internal audit
• Internal audit corrective actions verification and closure.
• This course will also provide understanding to first, second and third party auditors learn the ISO 13485:2016 auditing process