Lead Auditor ISO 13485:2016 IRCA Certified
Dates: 6th, 7th, 10th, 11th & 12th June 2019
This learning event is based on assisting and verifying the competencies / capabilities of the Learner to be able to effectively audit a complete QMS [Medical Device] based on ISO 13485:2016 requirements with specific emphasis of 2nd Party auditing [Customer / Supplier audits] and 3rd Party auditing [Certification Bodies]
During the delivery, the Learner will complete a Consultant facilitated complete systematic audit of a QMS [Medical Devices]
The facilitated audit of the QMS [MD] will cover the full audit life cycle as defined by ISO 19011 and the learner will have to demonstrate and be assessed on the effective application of audit tools and techniques, auditor skills and behaviours.
The learner is assessed based on participation and performance evaluation throughout the duration of the course. Full attendance is required during the training. There is a closed book (2hr) written exam set by IRCA as part of the final assessment
This course is fully recognised by IRCA. It is a IRCA Certified Course (A17584)