Question 1

What is the LICQual ISO 13485:2016 Lead Auditor course?

Accepted Answer

This course is ideal for quality assurance managers, internal auditors, regulatory professionals, compliance officers, consultants, and anyone involved in the medical devices industry who wants to develop expertise in auditing quality management systems.

Question 2

How long does it take to complete the course?

Accepted Answer

The course typically runs over five consecutive days. It includes interactive lectures, group exercises, case studies, and a final assessment to evaluate participants' auditing capabilities and understanding of ISO 13485:2016.

Question 3

How is this course delivered?

Accepted Answer

The course can be delivered in-person or online through live virtual sessions. Both formats are led by qualified instructors and provide full access to course materials, practical exercises, and support.

Question 4

Does this certification help with career progression?

Accepted Answer

Yes, gaining lead auditor certification enhances your qualifications for roles in quality assurance, regulatory compliance, and audit consultancy within the medical device industry. It also prepares you for third-party auditing roles.

Question 5

Can this course help with ISO 13485 implementation in my organisation?

Accepted Answer

Absolutely. The course provides in-depth insights into the standard’s requirements and auditing processes, enabling participants to contribute effectively to implementing or maintaining a compliant ISO 13485 quality management system.

LICQual

LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor

LICQual ISO/IEC 17025:2017 Testing and Calibration Laboratories Lead Auditor

LICQual ISO 50001:2018 Energy Management System Lead Auditor

LICQual ISO 20121:2024 Event Sustainability Management Systems

LICQual ISO 37001:2016 Anti-Bribery Management Systems Lead Auditor

LICQual ISO 45001:2018 OHSMS Lead Auditor

LICQual ISO 14001:2015 EMS Lead Auditor

LICQual ISO 13216 ISOFIX Child Seats for Cars Lead Auditor

LICQual ISO 9001:2015 QMS Lead Auditor