- Understand the operations of a Medical Devices Quality Management System based on ISO 13485
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Understand an auditor’s role to plan, lead, and follow up on a management system audit in accordance with ISO 19011
- Learn how to lead an audit and audit team
- Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
- Acquire the competencies of an auditor to plan an audit, lead an audit, draft reports, and follow up on an audit in compliance with ISO 19011
Day 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
Day 2: Audit principles, preparation, and launching of an audit
Day 3: On-site audit activities
Day 4: Closing the audit
Day 5: Certification Exam
- Higher Salary: Earn 20% more salary than non-certified professionals in the field
- Greater Responsibilities: Enhance your performance with additional responsibilities in the organization
- Diverse Job Roles: Broaden your scope at the organization as compared to your peers
- Global Recognition: Global recognition across different domains and industries with this certificate
- Versatile Opportunities: Land your dream job in a large organization with great expertise
- Sophisticated Skillsets: Validates the advanced experience, skills, and knowledge gained by professionals
- Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits
- Managers or consultants seeking to master a Medical Devices Quality Management System audit process
- Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements
- Technical experts seeking to prepare for a Medical Devices Quality Management System audit
- Expert advisors in Medical Devices Quality Management
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
Being an ISO 13485-certified professional imposes your determination to offer qualitative products and services to your company and/or clients. Attaining the necessary knowledge and skills to operate an ISO 13485 framework demonstrates your commitment to helping your company ensure continuous improvement and better work processes.
It also indicates that you understand the importance of the safety and performance of medical devices and how a medical devices quality management system can assure just that, consequently leading to customer satisfaction.
Similarly, it can introduce you to new opportunities, such as working for large companies that offer quality products and services. These companies will value your knowledge and expertise on this standard while enabling you to maximize your earning potential.
Achieving the ISO 13485 Lead Auditor certification opens up diverse career opportunities in the medical device industry:
- Lead Auditor: Conducting audits for certification bodies or consulting firms.
- Quality Assurance Manager/Director: Overseeing compliance and continuous improvement.
- Regulatory Affairs Specialist: Ensuring compliance with global regulations.
- Consultant: Advising on ISO 13485 implementation and improvement.
- Training and Development: Educating others on auditing and standards.
- Project Manager: Managing projects with a focus on quality and compliance.
- Supplier Quality Manager: Ensuring suppliers meet ISO 13485 standards.
These roles require expertise in auditing, compliance, and quality management, making the ISO 13485 Lead Auditor certification a key asset for career advancement in medical devices.
- The passing score exam: 70%.
- Duration: 3 hours
- Exam type: essay type
- Number of questions: 12
PECB
