Overview
The ISO 13485:2016 Lead Auditor Certification is designed for professionals who want to develop expertise in auditing quality management systems (QMS) within the medical device industry. This certification enables individuals to understand the ISO 13485 standard in-depth, prepare for audits, and lead teams to ensure compliance with regulatory requirements, safety standards, and continuous improvement practices.
Learning
Outcomes
- Understand the ISO 13485:2016 standard and its applicability to the medical device industry.
- Gain knowledge of the principles and processes of quality management in the design, development, manufacturing, and servicing of medical devices.
- Learn how to plan, execute, and follow-up on audits in compliance with ISO 13485, focusing on the assessment of QMS, regulatory requirements, and risk management.
- Master the roles and responsibilities of a lead auditor, including conducting internal audits, supplier audits, and third-party audits.
- Evaluate audit findings, generate non-conformity reports, and recommend corrective actions for improvements.
- Develop the skills to assess the effectiveness of the QMS and ensure that it meets the intended objectives in the medical device lifecycle.
Qualification
Specifications
United Kingdom (UK) & Internationally