Introduction to ISO 13485:2016 Quality Standard for the Medical Device Industry
Delivered in-house, this practical ISO 13485 training workshop introduces the quality standard for the medical device industry and provides delegates with a basic knowledge of the background, structure and requirements of the Medical Device Directive and CE marking and how the Standard relates to those requirements.
Providing an overview of the intent and requirements of ISO 13485 and the related guides and standards, this introduction will guide organisations in reviewing current processes and systems, planning how to implement the Standard and understanding the challenges and benefits associated with the process approach to managing the quality management system.
- Introduction and overview of the requirements of ISO 13485
- Comparison of the requirements of ISO13485 with FDA’S QSR and ISO9001 requirements.
- Introduction to the Guide ISO/TR14969
- Risk management requirements and ISO 14791
- The implications of ISO 13485 for the Medical Device Industry in maintaining registration and market approval.
- ISO13485 is required by Canada, Japan and Australasia
- ISO13485 is the direct equivalent to QSR
- Analysis of a process-based management system and the impact this may have on a company’s procedural based system.
- The approach of Regulators.
- Sources of information and further development
- Executives and Senior Management
- General Managers/Business Unit Managers
- Quality and Regulatory Professionals
- Management Representatives/Internal and External Auditors
- Those seeking an understanding of the revisions
- Interpret the basic requirements of ISO 13485 as it relates to quality management systems.
- Apply the process approach to managing a company’s quality system, its control and effectiveness.
- Compare ISO 13485 with ISO9001 and the FDA’s QSR requirements with the view of implementing the Standard.
- Identify the importance of Design Control, Corrective and Preventative Action (CAPA) and Production and Process Control (P&PC) and how these can add value to processes.
- Practical workshops are designed to reinforce the discussions and topics. This style of delivery makes the course both memorable and enjoyable for participants, ensuring long-term learning