ISO 13485:2016 Lead Auditor Online & Blended Training CQI & IRA Certified
This CQI & IRCA Certified blended course (online & classroom/virtual training) is ideal for anyone that has a good understanding of Quality Management Systems (QMS) and the requirements of ISO 13485:2016 and wants to gain the knowledge and skills required to perform first, second and third-party audits of QMS against ISO 13485:2016, in accordance with ISO 19011:2018 and ISO/IEC 17021-1:2015
Three learning objectives/outcomes:
At the end of this course, participants will be able to:
1. Explain the purpose of a quality management system, of quality management systems standards, of management system audit, of third-party certification and the business benefits of improved performance of the quality management system
2. Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up a quality management system audit in accordance with ISO 19011, and ISO/IEC 17021, as applicable
3. Plan, conduct, report and follow-up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011, and ISO/IEC 17021, as applicable
This is a blended learning program, consisting of:
16 hrs of online & self-paced modules (= 2 days training)
4 hr virtual course introduction one week before virtual workshops (9am - 1pm)
3 virtual classroom days (Practical Workshops)
Exam at the end of day 3 (via eAssessment)
Successful completion of this course will entitle each Participant to a CQI & IRCA Recognised ISO 13485:2016 Lead Auditor Certificate of Achievement.
Delegate cancellation policy
Any cancellations received in writing up to two weeks prior to the event are refundable. All bookings are provisional until full payment is received.
Photography at events
There may be a photographer and videographer at the event and we may publish images from this event on our website(s) and on our social media accounts.