This programme is funded by Irish Medtech Skillnet
Irish Medtech Skillnet is co-funded by Skillnet Ireland and network companies. Skillnet Ireland is funded from the National Training Fund through the Department of Further and Higher Education, Research, Innovation and Science
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
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)
Entry Criteria (Prior Learning Requirements)
In registering for this course, each Learner must have the following prior knowledge before completing this course:
• The Plan, Do, Check, Act (PDCA) Cycle
• The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review and continual improvement.
• Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
• Knowledge of the requirements is a key pre-requisite in attending this course as without a good understanding, the course may be very challenging.
If any Learner does not meet the above entry criteria, successful completion of Comply Guru’s Online ISO 13485:2016 Foundation Course will ensure that they meet the above prior learning requirements.
FREE Foundation Course Included
Every participant will receive a complimentary license to Comply Guru’s CQI & IRCA Certified Online ISO 13485:2016 Foundation Course (8hrs). This course is recommended for everyone, both new & experienced Quality Professionals. For any Learners who declare that they fully meet the entry criteria, this course is not mandatory to complete but it is still recommended. A separate CQI & IRCA recognised certificate will be issued upon successful completion.
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)
12, 16, 17, 18 Feb 2021 [16 hours online & self paced (= 2 days)] [4 hr introduction is 12 Feb. 9am-1pm] [3 virtual classroom days 16, 17, 18 Feb] (The self paced 16 hrs need to be completed before the intro on 12 Feb)