Training background
The ISO 13485 standard specifies the requirements for quality management systems, which organizations can use to design and develop, produce, install, and provide
medical devices, as well as related services. This standard can also be used internally and externally (including certification bodies) to assess an organization's ability to
meet customer and regulatory requirements. Since its release in 1996, ISO 13485 has been widely implemented and applied worldwide. With the development of history,
the ISO organization has revised this standard twice on this basis, namely ISO 13485:2003 and ISO 13485:2012. Implementing ISO13485 can improve and enhance the
management level of enterprises, avoid legal risks, enhance and ensure the quality level of products, eliminate trade barriers, and enhance the competitiveness of products.
Training benefits
1. Understand the methods of quality management
2. Enhance enterprise competitiveness
3. Improving enterprise performance
4. Streamline operations and reduce waste
5. Encourage internal communication within the company
6. Improve customer satisfaction
7. Understand the ISO13485 certification process and methods
8. Obtain Internal Auditor Certificate
Training content
1. The Historical Background and Development Overview of ISO13485 Standard
2. Quality management system training
3. Management Responsibility Training
4. Resource management training
5. Product implementation training
6. Monitoring and measurement training
7. ISO13485 certification procedure
8. ISO13485 audit common issues
9. ISO13485 Internal Auditor Training
Training targets
1. Senior management personnel of enterprises
2. Representative of enterprise managers
3. Personnel responsible for product quality and safety in the enterprise
4. All personnel interested in ISO13485
5. Quality Management Internal Auditor
Training duration: 2 days
Training methods
Factory training or public training.
Training certificates and qualifications
Students who participate in this course training will receive a training certificate issued by MB.