ISO 13485:2003 "Quality Management System for Medical Devices: Requirements for Regulatory Purposes" is an independent standard for medical devices based on the ISO 9001 standard. This course will thoroughly explain the certification requirements of the medical device industry, enable you to fully grasp the requirements of the ISO 13485:2003 standard, and master the relevant requirements of the medical device industry as well as the skills and methods of internal auditing of the quality system.
Course Help
If you want to have a more in-depth understanding of this course, please refer to >>> DXC ISO13485 Internal Auditor Related Materials Manual
Course Objects
Medical device industry where the production of Class II and Class III products of medical device manufacturers must have 2-4 internal auditors, not equipped with internal auditors. Enterprises should send personnel to participate in the training.
Outline
Part I
◆ Introduction to the foundation of quality management system in the medical device industry
◆ ISO13485 Quality System for Medical Devices for Regulatory Purposes:
4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement, Analysis and Improvement
◆ ISO13485 System Documentation Requirements and the Requirements for the Medical Devices for Regulatory Purposes. ISO13485 System Documentation Requirements and Process Control: Risk Analysis/Assessment
Part II
◆ Regulatory Requirements for Medical Devices
European Medical Devices Directive MDD, Active Implantable Medical Devices Directive AIMD, In Vitro Diagnostic Medical Devices Directive IVDD, China's GMP, and so on.
◆ ISO13485 Internal Audit Work Planning
◆ Internal Audit Skills
◆ Third Party Quality System Certification Process and Common Problems in Certification
◆ Examination