ISO 13485:2016 – Medical Device- Quality Management System

ISO 13485:2016 – Medical Device- Quality Management System

Course Description

ISO 13485:2016 is a quality system management standard. It’s similar to ISO 9001 but has a few more stipulations to help companies meet the more specialized demands that come with making medical components and healthcare related products.

Course Content

• Explain the purpose of a medical device quality management system (MD-QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality management system.
• Explain the role and responsibilities of an auditor to plan, conduct, report, and follow- up a quality management system audit in accordance with ISO 19011 and ISO/IEC 17021.
• Plan, conduct, report, and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021.

Target Audience

This course is specially designed for who is or Aspires to be:

• A Third-Party Assessor or Lead Assessor of ISO 13485:2016
• Responsible for undertaking audits of suppliers/subcontractors as per ISO 13485:2016
• Responsible for implementing internal audits and audit programs as per ISO 13485:2016
• Responsible for implementing the ISO 13485 series of standards