Quality Training

ISO 13485:2016 Lead Auditor Training

Objectives

This CQI & IRCA Certified Blended ISO 13485:2016 Lead Auditor Course is ideal for anyone that wants to gain the knowledge and skills required to perform first, second and third-party audits of quality management systems against ISO 13485:2016, in accordance with ISO 19011:2018 and ISO/IEC 17021-1:2015

Content includes

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
 
Delivery:

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)

Who should attend

Successful completion of this course will entitle each Participant to a CQI & IRCA Recognised ISO 13485:2016 Lead Auditor Certificate of Achievement

Qualification

Successful completion of this course will entitle each Participant to a CQI & IRCA Recognised ISO 13485:2016 Lead Auditor Certificate of Achievement.
Course accreditation held by Comply Guru (Course No. 2244)

Upcoming dates:

Location
Dates

Online, Online
30 Nov. 1 & 2 Dec. 202016 hours online & self paced (= 2 days) 4 hour introduction 20 Nov. 9am-1pm 3 virtual classroom days (30 Nov. 1 & 2 Dec. 2020)Exam at the end of day 3 on 2nd Dec.
Book now

Course

ISO 13485:2016 Lead Auditor Training

Training Days

5 days

Training Location

Available nationally, based on demand

Course Cost

IMDA Skillnet Member: €848
Non-member rate: €1,130
* Cost quoted per person